IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA

SECOND AMENDED COMPLAINT

PARTIES

1. Plaintiff Nancy Rugo is a citizen of the State of Washington with an address at 2004 East Buckeye Avenue, Spokane, Washington. Nancy Rugo is the sister of Spc. Sandra Larson (ASandra Larson'), deceased, and Administratrix and Personal Representative of the Estate of Sandra Larson.

2. Plaintiff Ronda Wilson is a citizen of the State of Georgia with an address at 179 Lions Gate Road in Savannah, Georgia.

3. Plaintiffs Patrick J. Cradit and Kristi Cradit are citizens of the state of South Carolina with an address at 702 Maple Street, Spartanburg, South Carolina, and they are husband and wife.

4. Plaintiff Kenalee Dougherty is a citizen of the state of Idaho with an address at 1084 E. Bergeson Street in Boise, Idaho.

5. Plaintiffs Don Sedrick and Wendy Sedrick are husband and wife and citizens of the state of South Carolina with an address at 107 McCally Court, Buford, South Carolina.

6. Plaintiff Robert Soska is a citizen of the state of Georgia with an address of 7421-B Chowan Court, Ft. Stewart, Georgia.

7. Plaintiff Peter J. Martuscello is a citizen of the state of Kansas with an address of 1247 Emerson, Wichita, Kansas.

8. Plaintiffs Dennis K. Brewster and Mary L. Brewster are husband and wife and citizens of the state of Kansas with an address of 15085 SW Ohio St., Augusta Kansas.

9. Plaintiff Steven Robert Fisher is a citizen of the state of Virginia with an address of 18333 Shannon Rd., Triangle, Virginia.

10. Plaintiff Dennis Krammes is a citizen of the state of Pennsylvania with an address of R.D. #6, Box 357, 275 Frantz Rd., Pine Grove, Pennsylvania.

11. Plaintiff Jason M. Nietupski is a citizen of the state of California with an address of 1220 N. Fair Oaks, #2214, Sunnyvale, California.

12. Plaintiff David Irvin, Sr., is a citizen of the state of Washington with an address of 4220D Grayback Circle, Silverdale, Washington.

13. Plaintiffs Scott M. Pratt and Maria Valentina Folizon Pratt are husband and wife and citizens of the state of New York with an address of 677 Rte. 9, Gansevoort, New York.

14. Plaintiffs Tanya R. Bowermeister and Dana Smith are husband and wife and citizens of the state of Ohio with an address of P.O. Box 193, West Alexandria, Ohio.

15. Plaintiffs Kenneth Trotman and JoAnn Trotman are husband and wife and citizens of the state of Virginia with an address of 7424 Gleneagles Rd., Norfolk, Virginia.

16. Plaintiffs Dennis Granger and Glenda Granger are husband and wife and citizens of the state of Maryland with an address of 45252 Andy Way, California, Maryland.

17. Plaintiffs Jon Irelan and Patricia Irelan are husband and wife and citizens of the state of Oregon, with an address of 2138 17th Avenue, Forest Grove, Oregon.

18. Plaintiffs Vance Wasden and Michelle Wasden are husband and wife and citizens of the state of Idaho with an address of 495 Washington Ave., Pocatello Idaho.

19. Defendant BioPort, Inc. ('BioPort'), a Michigan corporation with its principal place of business located at 3500 Martin Luther King, Jr. Blvd.,
Lansing, Michigan 48906, is currently the sole manufacturer, designer, distributor, producer and seller of anthrax vaccine adsorbed ('AVA'), and does substantial and continuing business with the United States Department of Defense ("DOD.")

20. Defendant Michigan Department of Public Health ('MDPH'),through its Biologic Products Division, is a citizen of the state of Michigan with its principal place of business located at Lewis Cass Building, Sixth Floor, 320 S. Walnut Street, Lansing, MI 48910, is a predecessor of BioPort and was engaged in private enterprise by manufacturing, designing, distributing, producing and selling AVA from 1970 to 1995 and, by information and belief, was indemnified at various times by policies of insurance and/or by the federal government.

21. Defendant Michigan Biologic Products Institute ("MBPI") a citizen of Michigan with its principal place of business located at Lewis Cass Building, Sixth Floor, 320 S. Walnut Street, Lansing, MI 48910, was the immediate predecessor to BioPort and was an autonomous temporary two-year agency created by Executive Order 1995-25, removing the Biologic Products Division from the MDPH. MBPI continued the private enterprise of MDPH as it continued to manufacture, design, distribute, produce and sell AVA until it was sold to BioPort in 1998. Upon information and belief, MBPI was also indemnified at various times by policies of insurance and by the federal government.

22. Defendant Robert C. Myers ("Myers") is a citizen of Michigan with its principal place of business located at 3500 Martin Luther King, Jr. Blvd., Lansing, Michigan 48906, is the current Chief Operating Officer of BioPort and former Chief of the Biologic Products Division of the MDPH and former Director of the MBPI. Myers is a citizen of the State of Michigan.

JURISDICTION AND VENUE

23. This Court's jurisdiction is based, in part, upon diversity of citizenship as set forth in 28 U.S.C. §1332, in that plaintiffs are citizens of the States of Washington, Georgia, South Carolina, Idaho, Georgia, Kansas, Virginia, Pennsylvania, California, New York, Ohio, Maryland and Oregon and defendants are citizens of the State of Michigan. The amount in controversy is in excess of Seventy Five Thousand Dollars ($75,000.00).

24. This Court has jurisdiction based upon 28 U.S.C. 1331 for cases involving a federal question in that certain counts raise federal questions under 42 U.S.C. §1983. This Court has jurisdiction over the balance of the counts by way of pendant jurisdiction..

25. Venue is proper because plaintiffs' claims arose in the District of Columbia. The DoD, located in the District of Columbia, has had substantial and continuing business with each of the defendants, including negotiations with defendants to prepare the AVA and enter into an exclusive contract to distribute the AVA to only United States military personnel and indemnify each of the defendants due to the unusually hazardous risks associated with the potential for adverse reactions from the AVA. All of the decisions to implement the vaccine program and interim supervision of the manufacturing process of the AVA were all made in or about the District of Columbia.

26. Venue is also proper in this District because the plaintiffs claim that the AVA is an investigational new drug ('IND'), requiring the DoD to secure the informed consent of those persons taking it, before the DoD may administer the AVA to them. MBPI manufactured AVA and submitted an IND application for the AVA to amend the license, rendering the AVA an IND in circumstances germane to this suit.

BACKGROUND FACTUAL ALLEGATIONS

27. The first anthrax vaccine was created in the 1950s as a way to protect animals from the deadly disease of cutaneous anthrax, the form of anthrax infection that occurs though the skin; humans can become infected with cutaneous anthrax by handling products from infected animals.

28. Another form of anthrax infection is inhalation anthrax which occurs by inhaling anthrax spores. Anthrax has been seen as a likely biological weapon when inflicted as an airborne poison.

29. The AVA manufactured, designed, produced and sold by the defendants is a cell free filtrate, which means it uses dead bacteria as opposed to live bacteria and is a sterile product made from a strain of the anthrax organism that does not cause disease.

30. The AVA was not licensed and has never been licensed to protect people from inhalation anthrax.

31. The AVA was only licensed for protection against cutaneous exposure to anthrax and must be taken in six doses on an 18 month schedule followed by annual boosters.

32. In 1960, Dr. Phillip S. Brachman, Dr. Herman Gold, Dr. Stanley Plotkin, Dr. F. Robert Fekevy, Milton Werrin, and Dr. Norman Ingraham conducted an efficacy study for a cutaneous anthrax vaccine. Though this study was done on an earlier vaccine, it has been used to justify the vaccine's effectiveness today.

33. In 1962, in a report titled AField Evaluation of Human Anthrax Vaccine,' researchers reported that the vaccine was still highly effective for cutaneous anthrax, though the case study focused only on local and systematic reactions and not long term adverse effects.

34. Before the AVA was licensed, the Centers for Disease Control performed an observational study of the current vaccine in order to demonstrate its safety. The investigators performed active surveillance for local vaccine reactions only, at 24 and 48 hours after administering the vaccine, but paid only cursory attention to systematic reactions.

35. On November 2, 1970, the United States Public Health Service issued the AVA license to the state-owned facility operated by the MDPH for protection against cutaneous anthrax only. (A copy of the AVA product insert extract, December 1979, is attached as Exhibit 'A.') This was two years before efficacy data were required for licensing by the FDA.

36. Prior to the issuance of the AVA license, experiments with the AVA were performed under a program called Operation Whitecoat at Fort Detrick, Maryland, which was initiated by the DoD. No records were taken to fully investigate long term effects of the AVA.

37. There had been no appropriate clinical trials of the AVA prior to the issuance of the license.

38. On 1985, the Division of Biologic Standards, currently named the Food and Drug Administration ('FDA'), began licensing vaccines, and it reassessed the AVA previously approved.

39. By the Mid 1980s, after the efficacy of the AVA was demonstrated for cutaneous anthrax, the FDA approved the AVA for two limited markets: (1) individuals who may come in contact with animal products or high-risk persons such as veterinarians and others handling potentially infected animals; and (2) individuals engaged in diagnostic or investigational activities using anthrax. (A copy of the AVA Product Insert, 1987, is attached as Exhibit 'B.')

40. From 1970 to 1990, only a limited number of individuals received the AVA as reported by Dr. Kwai Chan's General Accounting Office report to Congress.

41. In 1985, the DoD issued a Request for Proposal ('RFP') soliciting the development of a new anthrax vaccine. The RFP stated that there was no vaccine in current use that would safely and effectively protect military personnel against exposure to anthrax. (See a copy of the RFP DAMD17-85-R-0078 attached as Exhibit 'C.')

42. On December 13, 1985, the FDA published a Proposed Rule for a specific product review of the AVA, stating that the vaccine's Aefficacy against inhalation anthrax is not well documented.' (See copy of Federal Register dated December 13, 1985 attached as Exhibit 'D.')

43. On August 24, 1989, Assistant Secretary of Defense Robert B. Barker wrote in a letter to Senator John Glenn that Acurrent vaccines, particularly the anthrax vaccine do not readily lend themselves to use in mass troop immunizations for a variety of reasons... a higher than desirable rate of reactogenicity and, in some cases, lack of strong efficacy against infection by the aerosol route of exposure.' (See copy of letter to Senator Glenn attached as Exhibit 'E.')

44. In March 1990, Army doctors Col Takafuji and Col. Phillip K. Russell described the AVA as a Alimited use vaccine' and an Aunlicenced experimental vaccine' in an article, AMilitary Immunizations,' in Infectious Disease Clinics of North America.

45. MBPI continued to produce and sell AVA but could not and did not test AVA's safety or efficacy for inhalation anthrax.

46. Beginning in 1990, despite the absence of any proof of safety or efficacy of the AVA, about 150,000 U.S. troops and personnel received at least one dose of the AVA during Operations Desert Shield and Desert Storm, purportedly for the purpose of protection against inhalation anthrax if it were used as a biological weapon by Iraq.

47. In 1991, MBPI and the U.S. Army entered into an agreement for the manufacture of the AVA.

48. Army Secretary Michael P. W. Stone approved a request to indemnify MBPI against all liability arising from Athe unusually hazardous risks associated with potentially severe adverse reactions and the potential lack of efficacy of the AVA.' The indemnification concerns were a result of the limited use of the vaccine on too small a scale to permit accurate assessments of types and severities of adverse reactions and insufficient experience in mass immunization programs to evaluate the efficacy of the vaccine. (See copy of Indemnification Agreement attached as Exhibit 'F.')

49. The U.S. Army, an agency of the DoD, awarded MDPH the Commander's Award for Public Service in 1991 for their supply of the AVA during the Gulf War.

50. After the war, thousands of the Gulf War veterans suffered from what is known as Gulf War Syndrome that, upon information and belief, is caused by AVA.

51. On May 7, 1993, MDPH failed an FDA inspection of its facilities.

52. On November 26, 1993, the Pentagon's deliberative process of mass vaccination of military personnel with the AVA began with the development and implementation of DoD's Directive 6205.3, DoD Immunization Program for Biological Warfare Defense.

53. In 1995, MBPI was created by Executive Order of the Governor of the State of Michigan in order to make the move from state owned and operated to private ownership. On August 31, 1995, the FDA issued a warning letter to MBPI requiring it to remedy the violations at its facility.

54. In 1995, the Department of the Army contracted with the Science Applications International Corporation ('SAIC') to develop a plan to obtain FDA approval for a license amendment for the AVA in order to add inhalation anthrax exposure to the product license and to enable the defendant to list on the product license that the AVA was effective against inhalation anthrax. The SAIC license amendment plan states that the AVA is not licensed as protection for aerosol anthrax exposure as expected in a biological warfare environment. (See copy of October 5, 1995 License Amendment Plan attached as Exhibit 'G.')

55. On October 20, 1995, the Army Joint Program Office for Biological Defense noted that there was insufficient data to demonstrate protection against inhalation anthrax. (See copy of minutes of October 20, 1995 meeting attached as Exhibit 'H.')

56. In 1996, the DoD sought and received permission from the FDA to begin vaccinations of all military personnel without obtaining a new licensed indication for the AVA.

57. Although the FDA was required to inspect the anthrax portion of the manufacturing plant every two years, it did not fulfill this obligation, but allowed the U.S. Army to perform its own inspections, which allowed MBPI to remain in business.

58. Once the FDA finally went into the facility, it found that the facility was not up to FDA standards; eleven lots of the vaccine were quarantined; and the use of prophylaxis against biological warfare was not an FDA approved indication for the vaccine. MBPI had to shut down for major repairs and renovations.

59. On September 20, 1996, as part of the Army/SAIC plan, MBPI submitted an IND application in order to modify the product's license to add an indication for inhalation anthrax. (See copy of September 20, 1996 letter to Dr. Kathryn C. Zoon attached as Exhibit 'I.') This IND application for license modification for inhalation anthrax has been supplemented and remains current and pending. (See copy of IND application supplements attached as Exhibit 'J.')

60. In 1997, MBPI executed another U.S. Army contract in order to maintain the AVA stockpile.

61. On March 11, 1997, even with the new contract, the FDA sent MBPI a Notice of Intention to Revoke because no real changes had been made to the facility.

62. On November 27, 1997, MBPI failed another FDA inspection.

63. Less then a month later, Secretary of Defense William Cohen announced the Anthrax Vaccination Immunization Program (AVIP) for all U.S. military personnel on December 15, 1997.

64. The AVIP that began in December 1997, intended to immunize over 2.4 million members of the military against the hypothetical threat of inhalation anthrax as a biological weapon.

65. The program required that between 1997 and 2003, all military personnel, including all new recruits, would begin receiving the six-shot series of the anthrax vaccination in the following inoculation program: (1) Phase 1: Forces assigned now or rotating to high threat areas in Southwest Asia and Korea; (2) Phase 2: Early deploying forces into high threat areas; (3) Phase 3: Remainder of the force and new recruits; and (4) Phase 4: To Continue the Program, annual booster shots.

66. On February 20, 1998, the FDA issued a report finding that the manufacturing process for Anthrax was not validated and listed 11 pages of quality-control failures for anthrax vaccine production, including reuse of expired vaccine, grossly inadequate testing, and use of lots that failed testing.

67. Despite this report, the immunizations began in March 1998.

68. In April 1998, Army Secretary Togo West, Jr. took steps to approve a request to indemnify MBPI against all liability arising from Athe unusually hazardous risks associated with potentially severe adverse reactions and the potential lack of efficacy of the AVA.' The indemnification concerns, according to Secretary West, were a result of the limited use of the vaccine on too small a scale to permit accurate assessments of types and severities of adverse reactions and, insufficient experience in mass immunization programs to evaluate the efficacy of the vaccine. (See copy of Indemnification Agreement attached as Exhibit 'K.')
69. The inoculations were non-voluntary, and any soldier who refused the inoculations was disciplined.

70. No soldier was informed that the AVA for inhalation anthrax was unlicenced for use to prevent inhalation anthrax and no animal studies or human clinical trials demonstrated either safety or efficacy of the vaccine.

71. The use of the AVA for a purpose which is the subject of a currently pending IND application means that the DoD is using the AVA as an IND.

72. On September 4, 1998, BioPort purchased MBPI for approximately $24 million. BioPort's shares are owned by Intervac, LLC and Michigan Biologic Products, Inc., which is composed of MBPI's former lab directors, including Myers.

73. BioPort became the sole licensed producer of the AVA in the United States by way of a privatization process initiated by the State of Michigan.

74. Within weeks after BioPort's purchase of MBPI, BioPort received a $29.4 million dollar contract with the DoD to supply 8.7 million doses of the AVA at a price of $4.36 per dose.

75. In 1999, BioPort was still unable to ship the AVA, and at BioPort's request, the DoD restructured BioPort's contract, providing BioPort with $24.1 million in relief, reducing the number of doses demanded to 4.6 million, and agreeing to raise the price per dose to $10.64.

76. On September 29, 1999, Dr. Kathryn Zoon wrote to Dr. Sue Bailey, Assistant Secretary of Defense Health Affairs, reiterating her position that the AVIP follow the FDA approved schedule. (See copy of letter to Bailey attached as Exhibit 'L.')

77. In November 1999, BioPort's manufacturing plant was found to have about thirty (30) deficiencies in safety, sterility and consistency.

78. On March 22, 2000, Office of Inspector General, DoD, issued an audit report D-2000-105, reporting that over $2 million in taxpayer funds advanced to BioPort was not spent on improvements to vaccine production but spent on office remodeling, furniture for the CEO, parking lot re-paving, unwarranted travel expenses, unsubstantiated consulting costs, and an unrelated medical program. Additionally, senior managers planned on rewarding themselves $1.2 million in bonuses and a retired employee is collecting $10,000/month in severance and consulting fees.

79. On April 3, 2000, the Full Committee on Government Reform adopted the Subcommittee report recommending suspension of the AVIP.

80. As of April 12, 2000, 425,976 service members had received 1,620,793 doses of AVA.

81. In June 2000, the DoD had to curtail the anthrax program because of vaccine shortages at BioPort, forcing some soldiers to actually suspend vaccination mid-process. Still, BioPort was awarded a new contract which provided for $2 -$2.5 million per month to cover costs related to getting the company to pass FDA approval of renovated anthrax production facilities.

82. In August 2000, BioPort voluntarily recalled the AVA because wrong expiration dates were put on the labels; at the same time, BioPort's scientists sought royalties for their part in changing the anthrax vaccination process.

83. The AVA stockpile was old and many lots had expired but had been re-dated, as if they were new, with only a retest of potency and some lots used on service members were produced with bovine materials of unknown origin and squalene.

84. The defendant were far out of compliance with good manufacturing practices and have never had their anthrax line properly inspected.

85. During the manufacturing process of the AVA, defendants mishandled and contaminated the AVA, and lots of the AVA were left out in the open for more than 24 hours.

86. Since 1998, the AVA shipments from BioPort have been suspended by the FDA because of questions about the facility's quality control.

87. According to the U.S. General Accounting Office, Medical Readiness: Safety and Efficacy of the Anthrax Vaccine, Report GAO/SSIAD-99-148, 1999, there have been no completed studies of the long-term side effects of AVA using active surveillance and the rate of acute adverse reactions to the AVA has ranged from 30-70 percent. The DoD has admitted that 5-35 percent of vaccines report muscle aches, joint aches, headaches, rash, chills, fever, nausea, loss of appetite, malaise, or related symptoms shortly after vaccination.
88. In fact, FDA inspections have repeatedly shown that BioPort still cannot produce the same vaccine of the same potency and consistency twice in a row.

89. The AVA is unlicensed for its use to prevent inhalation anthrax, the FDA has never officially approved the AVA for use against inhalation anthrax, and no
animal studies or human clinical trials demonstrate either safety or efficacy for such use.
SPC. SANDRA LARSON

90. In 1995, Sandra Larson joined the U.S. Army.

91. In 1998, Sandra Larson left for a year tour duty at Camp Stanley, South Korea.

92. On September 16, 1998, Sandra Larson received her first of six AVA injections in the 18-month anthrax vaccine series. The Lot Number of this first AVA injection was FAV017.

93. Prior to September 16, 1998, Sandra Larson was in excellent health.

94. On September 30, 1998, October 13, 1998 and April 6, 1999 she received her next three AVA injections from Lot FAV017.

95. On September 10, 1999, she received her fifth AVA injection from Lot FAV044.

96. Almost immediately after her first injection, Sandra Larson began having adverse reactions to the vaccine, including exhaustion and fatigue, skin rashes and numbness and pain in her hands.

97. After these symptoms did not dissipate, she was granted a two week leave.

98. By October 1999, Sandra Larson was relieved of her duties in South Korea and her new orders required her to relocate to Fort Riley, Kansas.

99. On March 12, 2000, she received her sixth and final injection of the AVA from Lot FAV031.

100. On April 7, 2000, Sandra Larson's blood capillaries were bursting and she was experiencing heavy vaginal bleeding.

101. On April 8, 2000, she was admitted to the hospital, and on April 10, 2000, Sandra Larson was put into the intensive care unit at Kansas Medical Center and was diagnosed with aplastic anemia, where her bone marrow had stopped producing blood cells.

102. The direct and proximate cause of Sandra Larson's condition was her involuntary inoculation with the AVA.

103. Upon information and belief, clinical evidence indicates that AVA Lot FAV017 was an unlicenced experimental vaccine that was selectively
administered without informed consent.

104. An FDA Inspection Report dated February 20, 1998, reported that Lot FAV044, filled on January 7, 1998 had an Ainvalid' potency test on
December 8, 1997. Also, Lot FAV031 was whole or partially formulated from subplots contaminated with microorganisms.

105. On May 2, 2000, Sandra Larson was supposed to be transferred to Ft. Lewis in order to be treated at Madigan Army Medical Center; however, the
plane that was transferring had to make an emergency landing at Travis Air Force Base in California.

106. On June 12, 2000, breathing through a ventilator, Sandra Larson went into a coma.

107. On June 14, 2000, as a direct and proximate result of the inoculation of the AVA, Sandra Larson died.

RONDA WILSON

108. In 1993, Ronda Wilson joined the U.S. Army.

109. Ronda Wilson was Chief Warrant Officer and a helicopter pilot; the only female pilot in her squadron. She was in perfect health.

110. In December 1998, Ronda Wilson received her first AVA injection from Lot FAV036.

111. Almost immediately, Ronda Wilson began having adverse reactions to the vaccine, including a form of gastroparesis which caused her to lose 1/3 of her body weight within 5 months as she was unable to eat solid foods, and she could no longer menstruate.

112. In January 1999, she received her second AVA injection and immediately thereafter she experienced numerous other symptoms including: unrelenting nausea, stomach pain and seizure-like spasms.

113. By May 1999, after she received her third AVA injection with Lot FAV041, had significant memory loss and her bowel, small intestine, colon and heart were all damaged.

114. On September 12, 2001, Ronda Wilson was discharged.

115. The direct and proximate cause of Ronda Wilson's condition was her involuntary inoculation with the AVA.

116. Upon information and belief, Lot FAV036 was at room temperature for a certain number of hours and then the filling operation was aborted and it was placed back in the refrigerator. In addition, there is no stability information regarding product exposure to room temperature.

117. Upon information and belief, the second AVA injection was from a lot that was left out at room temperature for at least 24 hours.

118. Upon information and belief, the third AVA injection was from a lot that was filled on November 11, 1997 and had an Ainvalid' potency test on September 30, 1997. This lot also contained squalene.

PATRICK J. CRADIT

119. In 1984, Patrick J. Cradit joined the U.S. Army.

120. In March 1998, Patrick J. Cradit received his first AVA injection from Lot FAV020.

121. Prior to March 1998, Patrick J. Cradit was active and experienced no health problems.

122. In April 1998, he received his second and third AVA injections from Lot FAV020.

123. By May 1998, Patrick J. Cradit began having adverse reactions to the vaccine, including body aches, nausea, fever, chills and chest pains.

124. In June 1998, Patrick J. Cradit was hospitalized

125. On April 13, 1999, Patrick J. Cradit was discharged.

126. Patrick J. Cradit continues to exhibit many of the original symptoms including high fever, chills, exhaustion and body aches.

127. The direct and proximate cause of Patrick J. Cradit's condition was his involuntary inoculation with the AVA.

128. MBPI re-labeled the expiration dates of Lot FAV020 from 1993 to post-1996. This lot also contained squalene.

KENALEE DOUGHERTY

129. In or about 1987, Kenalee Dougherty joined the Idaho Air National Guard in Boise, Idaho.

130. She was an active guard reserve serving as a technical sergeant E-6.

131. On February 27, 2000, Kenalee Dougherty received her first AVA injection.

132. Prior to receiving her first AVA injection, Kenalee Dougherty was an active and healthy mother of two children.

133. Prior to receiving her first AVA injection, Kenalee Dougherty was warned that anyone who refused to take the AVA would be court martialed and sent to prison.

134. On the night after receiving the first AVA injection, Kenalee Dougherty began having adverse reactions to the vaccine, including nausea and headaches.

135. Two weeks later, on March 13, 2000, despite continuing to experience nausea and headaches, Kenalee Dougherty received her second AVA injection.

136. After her second AVA injection, Kenalee Dougherty's arm began to swell, red spots appeared all over her body and she was later diagnosed with, among others, the following: gastroparesis, small fibre poly-neuropathy, fibro-myalgia and chronic fatigue syndrome.

137. Kenalee Dougherty symptoms included short-term memory loss, fatigue, insomnia, constipation, and she was confined to a wheelchair for five (5) months, a walker for nine (9) months and currently requires a cane to walk.

138. Kenalee Dougherty was recently discharged and given 50% disability due to depression.

139. The direct and proximate cause of Kenalee Dougherty's condition was her involuntary inoculation with the AVA.

140. Upon information and belief, the lot numbers of the vaccine given to Kenalee Dougherty were re-dated and had expired.

DON SEDRICK

141. In 1989, Don Sedrick joined the U.S. Airforce as a First Class Airman.

142. On September 11, 1998, while stationed in South Korea, Don Sedrick received his first of five AVA injections. The Lot Number of this first AVA injection was FAV017.

143. Prior to September 11, 1998, Don Sedrick was in excellent health and his physical fitness was in the top five percent for his age group.

144. On September 25, 1998 and October 16, 1998 he received his next two AVA injections from Lot FAV017.

145. On June 29, 1999 and January 7, 2000, he received his fourth and fifth AVA injections from Lot FAV041 and Lot FAV031 respectively.

146. Within days after his third injection, Don Sedrick began having adverse reactions to the vaccine, including a temporary loss of vision in his right eye, losing approximately 40 pounds from his 200 pound frame and extreme exhaustion and fatigue.

147. On January 7, 2000, immediately after his fifth AVA injection, Don Sedrick lost feeling in his fingertips and had massive swelling of his arm near the injection site.

148. By the night of January 7, 2000, Don Sedrick could not sleep as he was coughing and having difficulty breathing; within days he had suffered a heart attack.

149. By the end of January 2000, Don Sedrick had no strength or stamina and could barely walk from room to room in his home.

150. Since January 2000, Don Sedrick experiences lung spasms every night and has been treated with eight separate rounds of steroids because he could not breathe. His symptoms also include constant diarrhea, intestinal bleeding, fatigue and short-term memory loss. He has been diagnosed with reactive airway disease and asthma induced GERD.

151. The direct and proximate cause of Don Sedrick's condition was his involuntary inoculation with the AVA.

152. Upon information and belief, clinical evidence indicates that AVA Lot FAV017 was an unlicenced experimental vaccine that was selectively administered without informed consent.

153. An FDA Inspection Report dated February 20, 1998, reported that Lot FAV031 was whole or partially formulated from subplots contaminated with microorganisms.

154. On August 23, 2000, Don Sedrick was discharged.

155. Don Sedrick's technical sergeant, who had reported that Don Sedrick had an adverse event associated with the AVA, was reprimanded for making such a report.
RANDI ALLAIRE

156. In 1991, Randi Allaire joined the Army National Guard in Michigan as a part time specialist in flight operations.

157. In 1996, Randi Allaire was transferred to the Michigan Air National Guard in Battle Creek and became a full time information manager for the 110th Fighter Wing.

158. On September 18, 1998, while stationed in Battle Creek, Michigan, Randi Allaire received her first of four AVA injections. The Lot Number of this first AVA injection was FAV030.

159. Prior to September 18, 1998, Randi Allaire was a healthy 25 year old woman in excellent health.

160. On October 2, 1998 and October 16, 1998, she received her next two AVA injections from Lot FAV030.

161. On March 14, 1999 she received her fourth AVA injections from Lot FAV036.

162. Immediately after her third AVA injection, Randi Allaire began experiencing joint pain and fatigue, along with a temporary numbness on the left side of
her body.

163. Within days after her fourth injection, Randi Allaire became extremely fatigued and was bedridden for 1 week.

164. Within 1 week of her fourth injection, she began having other adverse reactions to the vaccine, including abdominal cramping, joint pain, shooting pains up from her forearms, muscle weakness, migraines, shortness of breath, short-term memory loss, vision difficulties, dizziness, diarrhea, nausea and numbness in her face.

165. Randi Allaire continues to exhibit most of the original symptoms.

166. The direct and proximate cause of Randi Allaire's condition was her involuntary inoculation with the AVA.

167. Upon information and belief, Lot FAV036 was at room temperature for a certain number of hours and then the filling operation was aborted and it was placed back in the refrigerator. In addition, there is no stability information regarding product exposure to room temperature.

168. In December 1999, Randi Allaire was denied medical discharge and officially discharged from service.

ROBERT SOSKA

169. In 1982, Robert Soska joined the military and is currently on active duty.

170. Prior to March 1998, he was a healthy 35 year old, in excellent health.

171. On March 23, 1998, April 6, 1998 and April 21, 1998, Robert Soska received his three AVA injections from Lot FAV020.

172. Almost immediately, Robert Soska began having adverse reactions to the vaccine, including chronic fatigue, migraines, chemical hyper-sensitivities, joint and muscle pain, vision problems, short-term memory problems, irritable bowel syndrome, hemorrhoidal bleeding, paresthesias, myofascial pain, burning
semen and tinnitus. He has been diagnosed with multi-symptom disorders.

173. Robert Soska continues to exhibit all of the original symptoms.

174. The direct and proximate cause of Robert Soska's condition was his involuntary inoculation with the AVA.

175. MBPI re-labeled the expiration dates of Lot FAV020 from 1993 to post-1996. Upon information and belief, this lot also contained squalene.

DENNIS K. BREWSTER

176. In 1979, Tanya Bowermeister ointed the U.S. Air Force.

177. Tanya Bowermeister entered the Kansas Air National Guard in 1987. He was in good health.

178. In June 1999, Tanya Bowermeister received his first AVA injection from Lot FAV044.

179. Within one week of the injection, Tanya Bowermeister began having adverse reactions to the vaccine, including flu-like symptoms, chronic fatigue, headaches and joint aches.

180. In July 1999, he received his second and third AVA injections with Lot FAV044 and continued to experience the same adverse reactions.

181. By January 2000, after he received his fourth AVA injection with Lot FAV024, he had numerous urinary tract infections, pain in the left side of his abdomen, severe headaches, fatigue, colon problems, pain in extremities and neck and was diagnosed with fistulizing diverticulitis, depression/anxiety and inflammatory bowel disease.

182. On November 4, 2001, Tanya Bowermeister was discharged.

183. The direct and proximate cause of Tanya Bowermeister's condition was his involuntary inoculation with the AVA.

184. An FDA Inspection Report dated February 20, 1998, reported that Lot FAV044, filled on January 7, 1998 had an Ainvalid' potency test on December 8, 1997.

STEVE FISHER

185. In 1972, Steve Fisher entered the U.S. Navy.

186. Steve Fisher entered the Kansas Air National Guard in 1981. He was in good health.

187. In June 1999, Steve Fisher received his first AVA injection from Lot FAV044.

188. Shortly after the first AVA injection, Steve Fisher began having adverse reactions to the vaccine, including diarrhea, fatigue, dizziness, and weakness that impacted on his ability to perform his reserve duties as well as his civilian job as an electrician.

189. These symptoms faded in a few days until he received his second AVA injection in July 1999 wherein the symptoms returned and lasted several months. He received his second and third AVA injections with Lot FAV044 and continued to experience the same symptoms.

190. By January 2000, after he received his fourth AVA injection with Lot FAV024, his chief complaints included tinnitus, malaise, fatigue, dizziness, chest pain, headaches, sore throat, back pain, muscle and joint aches and gastronomical problems.

191. On August 6, 2001, Steve Fisher was discharged.

192. The direct and proximate cause of Steve Fisher's condition was his involuntary inoculation with the AVA.

193. An FDA Inspection Report dated February 20, 1998, reported that Lot FAV044, filled on January 7, 1998 had an Ainvalid' potency test on December 8, 1997.

PETER J. MARTUSCELLO

194. In 1968, Peter Martuscello entered the U.S. Air Force.

195. Peter Martuscello entered the Kansas Air National Guard in 1984. He was in good health.

196. In June 1999, Peter Martuscello received his first AVA injection from Lot FAV044.

197. The day after his first AVA injection, Peter Martuscello began having adverse reactions to the vaccine.

198. In July 1999, Peter Martuscello received his second and third AVA injections from Lot FAV044.

199. As a result of these vaccinations, Peter Martuscello suffers from imbalance, visual judgment impairment, nausea, tingling nerves in arms, temporary paralysis in lower back and legs and chronic fatigue.

200. On September 29, 2000, Peter Martuscello was discharged.

201. The direct and proximate cause of Peter Martuscello's condition was his involuntary inoculation with the AVA.

202. An FDA Inspection Report dated February 20, 1998, reported that Lot FAV044, filled on January 7, 1998 had an Ainvalid' potency test on December 8, 1997.

DENNIS A. KRAMMES, JR.

203. In February 1991, Dennis Krammes entered the U.S. Air Force. He was in excellent health and became a crew chief and aircraft production controller.

204. In July and August 1999 and January 2000, Dennis Krammes received four AVA injection from Lot FAV044.

205. On August 8, 2000, the day he received his third AVA injection, Dennis Krammes began having adverse reactions to the vaccine, including migraines and fatigue.

206. On January 22, 2000, the day he received his fourth AVA injection, Dennis Krammes began experiencing debilitating migraines and tremors.

207. As a result of these vaccinations, Dennis Krammes is completel y disabled. He suffers from cluster migraine headaches, joint pain, muscle pain, chronic fatigue, seizures, hand tremors, light sensitivity, dizziness, ear pain, numbness in his arms, hands and fingers, heat flashes and loss of concentration.

208. On August 31, 2001, Dennis Krammes was discharged.

209. The direct and proximate cause of Dennis Krammes' condition was his involuntary inoculation with the AVA.

210. An FDA Inspection Report dated February 20, 1998, reported that Lot FAV044, filled on January 7, 1998 had an Ainvalid' potency test on December 8, 1997

JASON M. NIETUPSKI

211. In 1995, Jason Nietupski entered the U.S. Army and became the youngest military officer in his department's history.

212. Since May 2000, he has served the 104th Fighter Wing at Barnes Air National Guard Base for the Massachusetts Air National Guard.

213. In February 2000, Jason Nietupski was ordered to take three AVA injections from the U.S. Army Medical Department prior to his deployment to South Korea for his annual training. He was 23 years old and in excellent health.

214. In February and March 2000, Jason Nietupski received his AVA injections from Lots FAV024 and FAV041.

215. Immediately after receiving the first AVA injection, Jason Nietupski began experiencing adverse reactions to the vaccine and these chronic multi-system disorders have since progressed in severity.

216. As a result of these vaccinations, Jason Nietupski has been diagnosed with Stevens Johnson's autoimmune disorder, lyme-like diseases, chronic fatigue syndrome, throat, liver and lympthatic disorders and joint pain, .

217. In February 2001, he was diagnosed with Deep Venus Thrombosis.

218. The direct and proximate cause of Jason Nietupski's condition was his involuntary inoculation with the AVA.

219. An FDA Inspection Report dated February 20, 1998, reported that Lot FAV041, filled on November 18, 1997 had an Ainvalid' potency test on September 30, 1997.

DAVID IRVIN, SR.

220. In 1982, David Irvin entered the U.S. Navy.

221. His last sea tour duty was on the U.S.S. Carl Vinson homeported in Bremerton, Washington, where he checked on board in September 1997.

222. Prior to reporting to the Carl Vinson, he was in excellent health.

223. In November and December 1998, David Irvin received his first of four AVA injections from Lot FAV034.

224. After each of the AVA injections, David Irvin's arm burned, swelled and was red.

225. After the fourth AVA injection, David Irvin's arm not only swelled at the injection site but he became short of breath, fatigued and began experiencing hand tremors.

226. In August 1999, David Irvin received his fifth AVA injection from Lot FAV044.

227. By November 2000, as a result of these vaccinations, he was constantly fatigued and the tremors he had originally experienced in just his fingers and hands progressed to his arms and legs.

228. On March 23, 2001, David Irvin was discharged.

229. The direct and proximate cause of David Irvin's condition was his involuntary inoculation with the AVA.

230. An FDA Inspection Report dated February 20, 1998, reported that Lot FAV044, filled on January 7, 1998 had an Ainvalid' potency test on December 8, 1997.

SCOTT M. PRATT

231. In 1990, Scott Pratt entered the U.S. Army.

232. In or about May 1999, Scott Pratt received his first AVA injection.

233. Prior to his first AVA injection he was in excellent health with no prior medical problems.

234. Approximately two weeks after his first AVA injection, he began having adverse reactions to the vaccine, including muscle pain and extreme fatigue.

235. In the months after his first AVA injection, Scott Pratt received three additional AVA injections.

236. As a result of these vaccinations, Scott Pratt suffers from severe headaches, chronic fatigue, blacks outs, short term memory loss, intestinal problems and had to have his appendix removed.

237. On May 6, 2000, Scott Pratt was discharged.

238. The direct and proximate cause of Scott Pratt's condition was his involuntary inoculation with the AVA.

TANYA R. BOWERMEISTER

239. In 1988, Tanya Bowermeister jointed the Air Force Reserves as an examiner flight nurse.

240. In May 1999, Tanya Bowermeister received three AVA injections from Lot FAV 043.

241. In November 1999, Tanya Bowermeister received her fourth AVA injection from Lot FAV 043.

242. In May 2000, Tanya Bowermeister received her fifth AVA injection from Lot FAV 044.

243. Prior to receiving the AVA injections, Tanya Bowermeister was an active woman with minimal medical problems.

244. Prior to her fourth AVA injection, as a result of these vaccinations, she began experiencing severe joint pain, leg pain and numbness, extreme fatigue and headaches.

245. By April 2000, as a result of these vaccinations, she began experiencing extreme pain and a lump in her groin, right shoulder, legs and hips. She was unable to sleep without medication and complained of reflux.

246. By June 2000, as a result of these vaccinations, her body had a severe rash and was covered with papules, which were filled with a clear fluid which burned her skin when the papules broke leaving permanent scars.

247. By September 2000, she was suffering from a bleeding gastric ulcer and was unable to concentrate or read and retain information or finish sentences.

248. By November 2000, Tanya Bowermeister was suffering skin pain, continued extreme fatigue, angina, palpitations, gout-like pain in her right foot, constipation and migraines.

249. The direct and proximate cause of Tanya Bowermeister's condition was her involuntary inoculation with the AVA.

250. An FDA Inspection Report dated February 20, 1998, reported that Lot FAV044, filled on January 7, 1998 had an Ainvalid' potency test on December 8, 1997 and Lot FAV043, filled on December 25, 1997 had an "invalid" potency test on November 18, 1997.

KENNETH TROTMAN

251. Kenneth Trotman is a 43 year-old gentleman who, until three years ago, directed construction for the U.S. Navy in Europe, North Africa and West Asia. He was a marathon runner in excellent health.

252. In April 1999, he received his first AVA injection from an unspecified lot.

253. In May and June 1999, he received his second and third AVA injections.

254. After the first AVA injection, Kenneth Trotman developed flu-like symptoms which progressed following the next two vaccine doses until he became so exhausted he was unable to continue work.

255. Kenneth Trotman has had gradual worsening which has been steady since the onset of his illness, in terms of pain, congnition, weakness and gastrointestinal symptoms.

256. As a result of the AVA injections, he has developed testicular atrophy and has multiple symptoms that restrict him from almost all normal activities.

257. His symptoms include chronic fatigue, shortness of breath, chest pain, low back pain which extends from his back to his toes, joint pain, swelling of his hands, headaches, migraines, abdominal pains, constant nausea, insomnia, memory loss, hearing sensitivity, light sensitivity, chemical sensitivity, vision problems, decreased hearing, tinnitus, vertigo, impaired balance, decreased cognitive function, unresponsiveness,

258. Kenneth Trotman has been diagnosed with chronic fatigue syndrome, fibromyalgia, multiple chemical sensitivity, testicular failure, hypothyroidism, and B12 deficiency, chronic diarrhea, gastroesophageal reflux disease, significant cognitive impairment, difficulties with balance and likely 8th nerve dysfunction and possible autoimmune vasculitis.

259. The direct and proximate cause of Kenneth Trotman's condition was his involuntary inoculation with the AVA.

DENNIS GRANGER

260. In 1995, Dennis Granger joined the Navy. He had no medical problems.

261. In April 1998, Dennis Granger received the first of three AVA injections from Lot FAV020.

262. After his second AVA injection, he began to experience fatigue and vertigo.

263. After his third AVA injection, he began to experience sleep problems, diarrhea, headaches and sensitivity to light.

264. Within months his headaches and diarrhea became more severe and he developed earaches and had at least one seizure.

265. In August 1999, Dennis Granger received his fourth AVA injection from Lot FAV044.

266. In October 2001, Dennis Granger was discharged.

267. Dennis Granger continues to exhibit his original symptoms in addition to sleep disorders, fatigue, weakness, memory loss, congnitive impairment and rectal bleeding.

268. The direct and proximate cause of Dennis Granger's condition was his involuntary inoculation with the AVA.

269. MBPI re-labeled the expiration dates of Lot FAV020 from 1993 to post-1996.

270. An FDA Inspection Report dated February 20, 1998, reported that Lot FAV044, filled on January 7, 1998 had an 'invalid' potency test on December 8, 1997
JON IRELAN

271. In 1981, Jon Irelan joined the U.S. Army and served for 20 years as a Lieutenant, Captain and Major. His positions included Company Commander, Tactics Instructor, Ranger Instructor, Plans Officer, Battalion Executive Officer, Detachment Commander, Intelligence Operations Adviser and Senior Advisor.

272. In February, March and April 1999, Jon Irelan received three AVA injections from Lots FAV033 and FAV043.

273. In October 1999, after his fourth AVA injection from Lot FAV041, he immediately began experiencing adverse reactions to the vaccine including high fever, abdominal pain, loss of strength and testicle pain and shrinkage.

274. At present, as a result of the AVA injections, Jon Irelan continues to suffer from chronic fatigue and the aforementioned symptoms. In addition, he has to administer testosterone injections every 10 days or as needed, and he suffers from tinnitis, cutaneous Leischmaniasis that disfigures his face, chronic joint pain and complete loss of strength and/or balance.

275. The direct and proximate cause of Jon Irelan's condition was his involuntary inoculation with the AVA.

276. In June 2001, Jon Irelan retired from the military.

VANCE WASDEN

277. In 1995, Vance Wasden joined the Air Force. He was in excellent health.

278. In 1998, Vance Wasden received three AVA injections from Lot FAV020.

279. Within days after receiving the third AVA injection, he began experiencing adverse reactions to the vaccine including high fever, fatigue, migraines and light sensitivity.

280. At present, as a result of the AVA injections, Vance Wasden walks with a cane, has major skin problems, migraines, fatigue, and arthritic pain throughout his entire body.

281. He suffers from and has been diagnosed with rectal bleeding, chronic fatigue, bilateral knee condition, viral syndrome, chronic headaches, disease disorder of hepatabeliary system and pancreas, lower back condition, left shoulder/arm/wrist condition, fibromyalgia, reactive arthritis, bi-ankle foot condition, inflamatory bowel disease, ulcerative colitis, chronic, dermititis, heart murmur and anal fissure..

282. The direct and proximate cause of Vance Wasden's condition was his involuntary inoculation with the AVA.

283. Vance Wasden was discharged in October, 2001.

COUNT ONE - SANDRA LARSON
NEGLIGENCE

284. Plaintiffs incorporate by reference the above paragraphs as if same were set forth at length herein.

285. Defendants were careless, negligent, breached their duties and obligations owed to Sandra Larson by various sections of the Restatement of Torts, 2d, breached duties pursuant to Section 402(a) of the Restatement of Torts, 2d, and are liable for causing injuries to Sandra Larson for the following reasons:

a. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product in a defective condition;

b. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was unreasonably dangerous to the user;

c. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was not safe for normal handling and consumption;

d. failing to have adequate warnings on the product;

e. failing to provide adequate warnings;

f. failing to provide instructions to be followed with regard to the use of this product;

g. failing to warn users of the dangers inherent in using this product;

h. failing to instruct users of this product on its safe use;

i. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which could have been designed more safely;

j. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which lacked all necessary safety features to protect users of said product;

k. failing to have proper warnings and instructions concerning the use of this product accompanying the same;

l. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product wherein it was foreseeable that someone would injure themselves based on the product's design and assembly;

m. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which could not be safe during normal use;

n. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was not safe for its intended use;

o. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was lacking of one or more elements necessary to make it safe for its intended use;

p. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was defective and which could cause injury to the user;

q. failing to exercise reasonable care in the design of this product;

r. failing to adequately and properly test said product;

s. failing to use reasonable care under the circumstances;

t. violation of Section 402(a) of the Restatement of Torts, 2d;

u. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which defendant knew or should have known would cause injury to the user;

v. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was defective and could cause injury to the user;

w. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product that defendant knew or should have known increased the risk of harm to the user;

x. failing to fix the conditions which increased the risk of harm to the users during the times when this product was serviced;

y. violation of application sections of the Restatement of Torts, 2d;

z. engaging in other acts regarding the manufacturing, designing, maintaining, preparing, producing, distributing, installing, advising and selling of this product as will be learned in discovery.

286. As a result of the carelessness and negligence of defendants, and their failure to conform to their obligations and duties as designers, manufacturers, producers, assemblers, distributors, suppliers, installers, services, and sellers under Section 402(a) of the Restatement of Torts, 2d, other sections of the Restatement of Torts, 2d, and at Common Law, Sandra Larson was caused to suffer extreme pain and suffering ultimately resulting in her death.

287. As a result of the carelessness and negligence of defendants, in violation of Section 402(a) of the Restatement of Torts, 2d, other sections of the Restatement of Torts, 2d, and Common Law, Sandra Larson incurred medical care and treatment and/or other financial expenses or losses for herself to her great detriment and expense.

WHEREFORE, plaintiff Nancy Rugo, as Administratrix and Personal Representative of the Estate of Spc. Sandra Larson, demands judgment against defendants for a sum in excess of One Million ($1,000,000.00) Dollars in damages, punitive damages, attorneys fees, interest and cost of suit.

COUNT TWO - SANDRA LARSON
BREACH OF WARRANTIES

288. Plaintiffs incorporate by reference the above paragraphs as if same were set forth at length herein.

289. Defendants breached their expressed and implied warranties, that the AVA designed, assembled, installed, produced, distributed, supplied, delivered, serviced and sold by them was safe and proper for its intended use, was designed and manufactured in accordance with prevailing and existing standards in the industry, and was properly and adequately manufactured, designed, maintained, prepared, produced, distributed, sold, installed and had proper warnings.

290. Defendants breached their expressed and implied warranties by designing, manufacturing, producing, servicing, assembling, distributing, delivering, installing, supplying, and selling the AVA which was unsafe, defective, of non-merchantable quality and was not reasonably safe for its intended purpose or use.

291. Defendants breached their expressed and implied warranties, duties and obligations and thereby caused injury to Sandra Larson, and did so by:

a. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product in a defective condition;

b. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was unreasonably dangerous to the user;

c. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was not safe for normal handling and consumption;

d. failing to have adequate warnings on the product;

e. failing to provide adequate warnings;

f. failing to provide instructions to be followed with regard to the use of this product;

g. failing to warn users of the dangers inherent in using this product;

h. failing to instruct users of this product on its safe use;

i. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which could have been designed more safely;

j. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which lacked all necessary safety features to protect users of said product;

k. failing to have proper warnings and instructions concerning the use of this product accompanying the same;

l. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product wherein it was foreseeable that someone would injure themselves based on the product's design and assembly;

m. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which could not be safe during normal use;

n. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was not safe for its intended use;

o. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was lacking of one or more elements necessary to make it safe for its intended use;

p. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was defective and which could cause injury to the user;

q. failing to exercise reasonable care in the design of this product;

r. failing to adequately and properly test said product;

s. failing to use reasonable care under the circumstances;

t. violation of Section 402(a) of the Restatement of Torts, 2d;

u. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which defendant knew or should have known would cause injury to the user;

v. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was defective and could cause injury to the user;

w. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product that defendant knew or should have known increased the risk of harm to the user;

x. failing to fix the conditions which increased the risk of harm to the users during the times when this product was serviced;

y. violation of application sections of the Restatement of Torts, 2d;

z. engaging in other acts regarding the manufacturing, designing, maintaining, preparing, producing, distributing, installing, advising and selling of this product as will be learned in discovery.

292. As the manufacturer of the AVA, defendants have committed themselves to the responsibility of producing a safe and effective product that does what they claim.

293. Defendants broke this Agreement to make a quality vaccine.

294. Defendants did not produce the AVA to follow their claim to protect people from inhalation anthrax.

295. As a result of defendants' breach of their implied and expressed warranties, Sandra Larson was caused to experience great pain and suffering and, ultimately, to die.

296. As a result of defendants' breach of expressed and implied warranties, Sandra Larson incurred medical care and treatment and/or other financial expenses or losses, all to her great detriment and expense.

WHEREFORE, plaintiff Nancy Rugo, as Administratrix and Personal Representative of the Estate of Spc. Sandra Larson, demands judgment against defendants for a sum in excess of One Million ($1,000,000.00) Dollars in damages, punitive damages, attorneys fees, interest and cost of suit.

COUNT THREE - SANDRA LARSON
BREACH OF THE RIGHT TO BE TREATED
WITH ESSENTIAL HUMAN DIGNITY

297. Plaintiffs hereby incorporate all of the above Paragraphs as if set forth in full herein.

298. Defendants knew they were distributing the AVA for unlicenced purposes and for which it was untested as to its safety and efficacy.

299. Defendants knew soldiers like Sandra Larson were involuntarily compelled to submit to the vaccine without knowledge of these facts and circumstances.

300. Soldiers such as Sandra Larson thus became human guinea pigs made to test a product over which defendants had a monopoly.

301. Such conduct was a willful and/or negligent breach of Sandra Larson's right to be treated with essential human dignity, a fundamental right of all citizens of the United States.

302. As a result of defendants' conduct, Sandra Larson has suffered great pain and suffering ultimately resulting in her death.

WHEREFORE, plaintiff Nancy Rugo, as Administratrix and Personal Representative of the Estate of Spc. Sandra Larson, demands judgment against defendants for a sum in excess of One Million ($1,000,000.00) Dollars in damages, punitive damages, attorneys fees, interest and cost of suit.

COUNT FOUR - SANDRA LARSON
STRICT PRODUCTS LIABILITY

303. Plaintiffs hereby incorporate all of the above Paragraphs as if each were set forth in full herein.

304. Defendants manufactured and supplied the vaccine that caused great physical pain and suffering to Sandra Larson.

305. Defendants breached their duties and obligations to Sandra Larson by various sections of the Restatement of Torts, 2d, including Section 402 A and are liable for causing injuries to her by:

a. designing, manufacturing, selling and/or distributing a product in a defective condition;

b. designing, manufacturing, selling and/or distributing a product which was unreasonably dangerous;
c. failing to have adequate warnings on the product;

d. failing to warn users of the dangers inherent in using this product;

e. designing, manufacturing, selling and/or distributing a product which could have been produced and manufactured more safely;

f. designing, manufacturing, selling and/or distributing a product wherein it was foreseeable that someone would be harmed by the product's use;
g. failing to ensure that ultimate users were advised of the dangers of said product;

h. failing to exercise reasonable care in the design of this product;

i. failing to adequately and properly test this product;

j. producing a product which was defective and could cause injury to the user;

k. supplying a product which was defective and could cause injury to the user;

l. failing to adequately and properly test the product after its design and manufacture;

m. failing to investigate and analyze prior adverse reactions and information in order to warn and/or notify ultimate users of the product defects and dangers.

306. By conducting themselves as aforesaid, defendants increased risk of harm, thereby causing the injuries to Sandra Larson.

WHEREFORE, Nancy Rugo, as Administratrix and Personal Representative of the Estate of Spc. Sandra Larson, demands judgment against defendants for a sum in excess of One Million ($1,000,000.00) Dollars in damages, punitive damages, attorneys fees, interest and cost of suit.

COUNT FIVE - SANDRA LARSON
FRAUD

307. Plaintiffs hereby incorporate all of the above Paragraphs as if each were set forth in full herein.

308. Defendants committed common law fraud in their intentional pervasion of truth regarding the safety and efficiency of the AVA.

309. Defendants never warned Sandra Larson of the potential dangers and risks of taking the AVA as a result of defendant's silence.

310. The misrepresentations of risks set forth above were done with the knowledge that they were false when made.

311. Defendants' AVA was a false representation of a matter of fact that deceives and is intended to deceive another by the suppression of truth.

312. Defendants' direct falsehood resulted in Sandra Larson's suffering and death.

WHEREFORE, Nancy Rugo, as Administratrix and Personal Representative of the Estate of Spc. Sandra Larson, demands judgment against defendants for a sum in excess of One Million ($1,000,000.00) Dollars in damages, punitive damages, attorneys fees, interest and cost of suit.

COUNT SIX - SANDRA LARSON
WRONGFUL DEATH

313. Plaintiffs hereby incorporate by reference the above paragraphs as if fully set forth at length herein.

314. As a result of the careless, negligent and reckless conduct of the defendants, Sandra Larson was caused to suffer excruciating and agonizing pain and discomfort and ultimately died as a result of defendants' conduct.

315. The defendants, by and through their separate and respective agents, servants, workmen, representatives, physicians, nurses, staff, contractors, medical personnel, medical assistants and employees were careless, negligent and reckless in:

a. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product in a defective condition;

b. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was unreasonably dangerous to the user;

c. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was not safe for normal handling and consumption;

d. failing to have adequate warnings on the product;

e. failing to provide adequate warnings;

f. failing to provide instructions to be followed with regard to the use of this product;

g. failing to warn users of the dangers inherent in using this product;

h. failing to instruct users of this product on its safe use;

i. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which could have been designed more safely;

j. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which lacked all necessary safety features to protect users of said product;

k. failing to have proper warnings and instructions concerning the use of this product accompanying the same;

l. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product wherein it was foreseeable that someone would injure themselves based on the product's design and assembly;

m. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which could not be safe during normal use;

n. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was not safe for its intended use;

o. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was lacking of one or more elements necessary to make it safe for its intended use;

p. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was defective and which could cause injury to the user;

q. failing to exercise reasonable care in the design of this product;

r. failing to adequately and properly test said product;

s. failing to use reasonable care under the circumstances;

t. violation of Section 402(a) of the Restatement of Torts, 2d;

u. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which defendant knew or should have known would cause injury to the user;

v. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was defective and could cause injury to the user;

w. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product that defendant knew or should have known increased the risk of harm to the user;

x. failing to fix the conditions which increased the risk of harm to the users during the times when this product was serviced;

y. violation of application sections of the Restatement of Torts, 2d;

z. engaging in other acts regarding the manufacturing, designing, maintaining, preparing, producing, distributing, installing, advising and selling of this product as will be learned in discovery;

aa. failing to inform Sandra Larson of all the risks of the AVA so as to afford her with the opportunity to make an informed decision whether to take the AVA;

bb. acting negligently per se.

316. As a direct and proximate result of the carelessness, negligence, gross negligence, recklessness and willful and wanton conduct of the defendants, by and through their separate and respective agents, servants, workmen, representatives, physicians, nurses, staff, contractors, medical personnel and employees, Sandra Larson was caused to sustain serious and excruciating personal injuries which ultimately led to her death.

317. Sandra Larson was caused to suffer agonizing aches, pains and mental anguish; she sustained loss of enjoyment of life and loss of life's pleasures.

318. As a result of her wrongful death she has been prevented from performing all of her usual duties, occupations, recreational activities and avocation all to her and her beneficiaries' loss and detriment.

319. By conducting themselves as aforesaid, defendants increased the risk of harm, thereby causing the wrongful death of Sandra Larson.

320. As a direct and proximate result of the foregoing, Sandra Larson's wrongful death beneficiaries suffered, are suffering from an indefinite period of time in the future damages, injuries and losses, including, but not limited to, a loss of financial support, and the beneficiaries have been wrongfully deprived of the contributions they would have received from Sandra Larson, including monies which decedent would have provided for such items such as clothing, shelter, food, medical care and education.

321. As a direct and proximate result of the foregoing, Sandra Larson's wrongful death beneficiaries would have been, continue to be and will be in the future wrongfully deprived of large and various sums of money which decedent would have contributed to their support.

322. As a direct and proximate result of the foregoing, Sandra Larson's wrongful death beneficiaries incurred or have been caused to incur and paid large and various expenses including funeral, burial and estate administration.

323. Nancy Rugo makes claim, on behalf of Sandra Larson's heirs?at?law and next?of?kin, for the loss of love, affection, services, earnings, support and all other damages recoverable for her sister's wrongful death.

WHEREFORE, Nancy Rugo, as Administratrix and Personal Representative of the Estate of Sandra Larson, claim of the defendants, damages in excess of One Million Dollars ($1,000,000.00), interest and allowable costs of suit.

COUNT SEVEN - SANDRA LARSON
SURVIVAL ACTION

324. Plaintiffs incorporate by reference the above Paragraphs as if fully set forth at length herein.

325. As a direct and proximate result of the foregoing, Sandra Larson, has been, is being and will be in the future wrongfully deprived of earnings and the right to earn a living.

326. To address the foregoing, the Estate of Sandra Larson is entitled to recover in this action an amount equal to the gross amount Sandra Larson would have earned between the date of her death and the end of her life expectancy, subject to her cost of maintenance.

WHEREFORE, Nancy Rugo, as Administratrix and Personal Representative of the Estate of Spc. Sandra Larson, claims of the defendants, damages in excess of One Million Dollars ($1,000,000.00), interest and allowable costs of suit.

COUNT EIGHT - SANDRA LARSON VS. MYERS, MDPH AND MBPI
42 U.S.C. 1983 - CIVIL RIGHTS

327. Plaintiffs hereby incorporate all of the above paragraphs as if each were set forth in full herein.

328. The defendants Robert C. Myers, MDPH and MBPI at all times material to the allegations in the Amended Complaint, were acting under the color and the laws of the State of Michigan.

329. As set forth above, the defendants, under color of State Law, deprived Sandra Larson of her constitutional rights including the right to essential human dignity, all without due process of law, to her great detriment and damage.

WHEREFORE, Nancy Rugo, as Administratrix and Personal Representative of the Estate of Sandra Larson, claims of the defendants, damages in excess of One Million Dollars ($1,000,000.00), interest and allowable costs of suit.

COUNT NINE - SANDRA LARSON
PUNITIVE DAMAGES

330. Plaintiffs hereby incorporate all of the above Paragraphs as if each were set forth in full herein.

331. Defendants' actions were intentional, wanton, willful and outrageous.

332. Defendants were grossly negligent and acted with reckless disregard of and with deliberate, callous and reckless indifference to the rights, interest, welfare and safety of Sandra Larson.

WHEREFORE, Nancy Rugo, as Administratrix and Personal Representative of the Estate of Spc. Sandra Larson, demands judgment against defendants for a sum in excess of One Million ($1,000,000.00) Dollars in damages, punitive damages, attorneys fees, interest and cost of suit.

COUNT TEN - RONDA WILSON
NEGLIGENCE

333. Plaintiffs hereby incorporate all of the above Paragraphs as if each were set forth in full herein.

334. Defendants were careless, negligent, breached its duties and obligations owed to Ronda Wilson by various sections of the Restatement of Torts, 2d, breached duties pursuant to Section 402(a) of the Restatement of Torts, 2d, and are liable for causing injuries to Ronda Wilson for the following reasons:

a. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product in a defective condition;

b. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was unreasonably dangerous to the user;

c. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was not safe for normal handling and consumption;

d. failing to have adequate warnings on the product;

e. failing to provide adequate warnings;

f. failing to provide instructions to be followed with regard to the use of this product;

g. failing to warn users of the dangers inherent in using this product;

h. failing to instruct users of this product on its safe use;

i. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which could have been designed more safely;

j. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which lacked all necessary safety features to protect users of said product;

k. failing to have proper warnings and instructions concerning the use of this product accompanying the same;

l. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product wherein it was foreseeable that someone would injure themselves based on the product's design and assembly;

m. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which could not be safe during normal use;

n. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was not safe for its intended use;

o. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was lacking of one or more elements necessary to make it safe for its intended use;

p. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was defective and which could cause injury to the user;

q. failing to exercise reasonable care in the design of this product;

r. failing to adequately and properly test said product;

s. failing to use reasonable care under the circumstances;

t. violation of Section 402(a) of the Restatement of Torts, 2d;

u. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which defendant knew or should have known would cause injury to the user;

v. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was defective and could cause injury to the user;

w. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product that defendant knew or should have known increased the risk of harm to the user;

x. failing to fix the conditions which increased the risk of harm to the users during the times when this product was serviced;

y. violation of application sections of the Restatement of Torts, 2d;

z. engaging in other acts regarding the manufacturing, designing, maintaining, preparing, producing, distributing, installing, advising and selling of this product as will be learned in discovery.

335. As a result of the carelessness and negligence of defendants, and their failure to conform to is obligations and duties as designers, manufacturers, producers, assemblers, distributors, suppliers, installers, services, and sellers under Section 402(a) of the Restatement of Torts, 2d, other sections of the Restatement of Torts, 2d, and at Common Law, Ronda Wilson was caused to suffer extreme pain and suffering.

336. As a result of the carelessness and negligence of defendants, in violation of Section 402(a) of the Restatement of Torts, 2d, other sections of the Restatement of Torts, 2d, and Common Law, Ronda Wilson incurred medical care and treatment and/or other financial expenses or losses for herself to her great detriment and expense.

WHEREFORE, Ronda Wilson demands judgment against defendants for a sum in excess of One Million ($1,000,000.00) Dollars in damages, punitive damages, attorneys fees, interest and cost of suit

COUNT ELEVEN - RONDA WILSON
BREACH OF WARRANTIES

337. Plaintiffs hereby incorporate all of the above Paragraphs as if each were set forth in full herein.

338. Defendants breached their expressed and implied warranties, that the AVA, designed, assembled, installed, produced, distributed, supplied, delivered, serviced and sold by them was safe and proper for its intended use, was designed and manufactured in accordance with prevailing and existing standards in the industry, and was properly and adequately manufactured, designed, maintained, prepared, produced, distributed, sold, installed and had proper warnings.

339. Defendants breached their expressed and implied warranties by designing, manufacturing, producing, servicing, assembling, distributing, delivering, installing, supplying, and selling the AVA which was unsafe, defective, of non-merchantable quality and was not reasonably safe for its intended purpose or use.

340. Defendants breached their expressed and implied warranties, duties and obligations and thereby caused injury to Ronda Wilson, and did so by:

a. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product in a defective condition;

b. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was unreasonably dangerous to the user;

c. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was not safe for normal handling and consumption;

d. failing to have adequate warnings on the product;

e. failing to provide adequate warnings;

f. failing to provide instructions to be followed with regard to the use of this product;

g. failing to warn users of the dangers inherent in using this product;

h. failing to instruct users of this product on its safe use;

i. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which could have been designed more safely;

j. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which lacked all necessary safety features to protect users of said product;

k. failing to have proper warnings and instructions concerning the use of this product accompanying the same;

l. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product wherein it was foreseeable that someone would injure themselves based on the product's design and assembly;

m. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which could not be safe during normal use;

n. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was not safe for its intended use;

o. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was lacking of one or more elements necessary to make it safe for its intended use;

p. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was defective and which could cause injury to the user;

q. failing to exercise reasonable care in the design of this product;

r. failing to adequately and properly test said product;

s. failing to use reasonable care under the circumstances;

t. violation of Section 402(a) of the Restatement of Torts, 2d;

u. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which defendant knew or should have known would cause injury to the user;

v. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was defective and could cause injury to the user;

w. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product that defendant knew or should have known increased the risk of harm to the user;

x. failing to fix the conditions which increased the risk of harm to the users during the times when this product was serviced;

y. violation of application sections of the Restatement of Torts, 2d;

z. engaging in other acts regarding the manufacturing, designing, maintaining, preparing, producing, distributing, installing, advising and selling of this product as will be learned in discovery.

341. As the manufacturer of the AVA, defendants have committed themselves to the responsibility of producing a safe and effective product that does what they claim.

342. Defendants broke this Agreement to make a quality vaccine.

343. Defendants did not produce the AVA to follow their claim to protect people from inhalation anthrax.

344. As a result of defendants' breach of their implied and expressed warranties, Ronda Wilson was caused to experience great pain and suffering and continues to experience great pain and suffering.

345. As a result of defendants' breach of expressed and implied warranties, Ronda Wilson incurred medical care and treatment and/or other financial expenses or losses, all to her great detriment and expense.

WHEREFORE, Ronda Wilson demands judgment against defendants for a sum in excess of One Million ($1,000,000.00) Dollars in damages, punitive damages, attorneys fees, interest and cost of suit.

COUNT TWELVE - RONDA WILSON
BREACH OF THE RIGHT TO BE TREATED
WITH ESSENTIAL HUMAN DIGNITY

346. Plaintiffs hereby incorporate all of the above Paragraphs as if set forth in full herein.

347. Defendants knew they were distributing the AVA for unlicenced purposes and for which it was untested as to its safety and efficacy.

348. Defendants knew soldiers like Ronda Wilson were involuntarily compelled to submit to the vaccine without knowledge of these facts and circumstances.

349. Soldiers such as Ronda Wilson thus became human guinea pigs made to test a product over which defendants had the monopoly.

350. Such conduct was a willful and/or negligent breach of Ronda Wilson's right to be treated with essential human dignity, a fundamental right of all citizens of the United States.

351. As a result of defendants' conduct, Ronda Wilson has suffered and continues to suffer great pain and suffering.

WHEREFORE, plaintiff Ronda Wilson demands judgment against defendants for a sum in excess of One Million ($1,000,000.00) Dollars in damages, punitive damages, attorneys fees, interest and cost of suit.

COUNT THIRTEEN - RONDA WILSON
STRICT PRODUCTS LIABILITY

352. Plaintiffs hereby incorporate all of the above Paragraphs as if each were set forth in full herein.

353. Defendants manufactured and supplied the vaccine that caused great physical pain and suffering to Ronda Wilson.

354. Defendants breached their duties and obligations to Ronda Wilson by various sections of the Restatement of Torts, 2d, including Section 402 A and are liable for causing injuries to her by:

a. designing, manufacturing, selling and/or distributing a product in a defective condition;

b. designing, manufacturing, selling and/or distributing a product which was unreasonably dangerous;

c. failing to have adequate warnings on the product;

d. failing to warn users of the dangers inherent in using this product;

e. designing, manufacturing, selling and/or distributing a product which could have been produced and manufactured more safely;

f. designing, manufacturing, selling and/or distributing a product wherein it was foreseeable that someone would be harmed by the product's use;

g. failing to ensure that ultimate users were advised of the dangers of said product;

h. failing to exercise reasonable care in the design of this product;

i. failing to adequately and properly test this product:

j. producing a product which was defective and could cause injury to the user;

k. supplying a product which was defective and could cause injury to the user;

l. failing to adequately and properly test the product after its design and manufacture;

m. failing to investigate and analyze prior adverse reactions and information in order to warn and/or notify ultimate users of the product defects and dangers.

355. By conducting themselves as aforesaid, defendants increased the risk of harm, thereby causing injuries to Ronda Wilson.

WHEREFORE, plaintiff Ronda Wilson demands judgment against defendants for a sum in excess of One Million ($1,000,000.00) Dollars in damages, punitive damages, attorneys fees, interest and cost of suit.

COUNT FOURTEEN - RONDA WILSON
FRAUD

356. Plaintiffs hereby incorporate all of the above Paragraphs as if each were set forth in full herein.

357. Defendants committed common law fraud in their intentional pervasion of truth regarding the safety and efficiency of the AVA.

358. Defendants never warned Ronda Wilson of the potential dangers and risks of taking the AVA as a result of defendants' silence.

359. The misrepresentations of risks set forth above were done with the knowledge that they were false when made.

360. Defendants' AVA was a false representation of a matter of fact that deceives and is intended to deceive another by the suppression of truth.

361. Defendants' direct falsehood resulted in Ronda Wilson's pain and suffering.

WHEREFORE, plaintiff Ronda Wilson demands judgment against defendants in sum in excess of One Million ($1,000,000.00) Dollars in damages, punitive damages, attorneys fees, interest and cost of suit.

COUNT FIFTEEN - RONDA WILSON VS. MYERS, MDPH AND MBPI
42 U.S.C. 1983 - CIVIL RIGHTS

362. Plaintiffs hereby incorporate all of the above paragraphs as if each were set forth in full herein.

363. The defendants Robert C. Myers, MDPH and MBPI at all times material to the allegations in the Amended Complaint, were acting under the color and the laws of the State of Michigan.

364. As set forth above, the defendants, under color of State Law, deprived Ronda Wilson of her constitutional rights including the right to essential human dignity, all without due process of law, to her great detriment and damage.

WHEREFORE, Ronda Wilson claims of the defendants, damages in excess of One Million Dollars ($1,000,000.00), interest and allowable costs of suit.

COUNT SIXTEEN - RONDA WILSON
PUNITIVE DAMAGES

365. Plaintiffs hereby incorporate all of the above Paragraphs as if each were set forth in full herein.

366. Defendants' actions were intentional, wanton, willful and outrageous.

367. Defendants were grossly negligent and acted with reckless disregard of and with deliberate, callous and reckless indifference to the rights, interest, welfare and safety of Ronda Wilson.

WHEREFORE, plaintiff Ronda Wilson demands judgment against defendants for a sum in excess of One Million ($1,000,000.00) Dollars in damages, punitive damages, attorneys fees, interest and cost of suit.

COUNT SEVENTEEN - PATRICK J. CRADIT
NEGLIGENCE

368. Plaintiffs hereby incorporate all of the above Paragraphs as if each were set forth in full herein.

369. Defendants were careless, negligent, breached their duties and obligations owed to Patrick J. Cradit by various sections of the Restatement of Torts, 2d, breached duties pursuant to Section 402(a) of the Restatement of Torts, 2d, and are liable for causing injuries to Patrick J. Cradit for the following reasons:

a. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product in a defective condition;

b. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was unreasonably dangerous to the user;

c. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was not safe for normal handling and consumption;

d. failing to have adequate warnings on the product;

e. failing to provide adequate warnings;

f. failing to provide instructions to be followed with regard to the use of this product;

g. failing to warn users of the dangers inherent in using this product;

h. failing to instruct users of this product on its safe use;

i. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which could have been designed more safely;

j. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which lacked all necessary safety features to protect users of said product;

k. failing to have proper warnings and instructions concerning the use of this product accompanying the same;

l. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product wherein it was foreseeable that someone would injure themselves based on the product's design and assembly;

m. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which could not be safe during normal use;

n. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was not safe for its intended use;

o. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was lacking of one or more elements necessary to make it safe for its intended use;

p. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was defective and which could cause injury to the user;

q. failing to exercise reasonable care in the design of this product;

r. failing to adequately and properly test said product;

s. failing to use reasonable care under the circumstances;

t. violation of Section 402(a) of the Restatement of Torts, 2d;

u. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which defendant knew or should have known would cause injury to the user;

v. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was defective and could cause injury to the user;

w. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product that defendant knew or should have known increased the risk of harm to the user;

x. failing to fix the conditions which increased the risk of harm to the users during the times when this product was serviced;

y. violation of application sections of the Restatement of Torts, 2d;

z. engaging in other acts regarding the manufacturing, designing, maintaining, preparing, producing, distributing, installing, advising and selling of this product as will be learned in discovery.

370. As a result of the carelessness and negligence of defendants, and their failure to conform to is obligations and duties as designers, manufacturers, producers, assemblers, distributors, suppliers, installers, services, and sellers under Section 402(a) of the Restatement of Torts, 2d, other sections of the Restatement of Torts, 2d, and at Common Law, Patrick J. Cradit was caused to suffer extreme pain and suffering.

371. As a result of the carelessness and negligence of defendants, in violation of Section 402(a) of the Restatement of Torts, 2d, other sections of the Restatement of Torts, 2d, and Common Law, Patrick J. Cradit incurred medical care and treatment and/or other financial expenses or losses for herself to her great detriment and expense.

WHEREFORE, Patrick J. Cradit demands judgment against defendants for a sum in excess of One Million ($1,000,000.00) Dollars in damages, punitive damages, attorneys fees, interest and cost of suit.

COUNT EIGHTEEN - PATRICK J. CRADIT
BREACH OF WARRANTIES

372. Plaintiffs hereby incorporate all of the above Paragraphs as if each were set forth in full herein.

373. Defendants breached their expressed and implied warranties, that the AVA, designed, assembled, installed, produced, distributed, supplied, delivered, serviced and sold by them was safe and proper for its intended use, was designed and manufactured in accordance with prevailing and existing standards in the industry, and was properly and adequately manufactured, designed, maintained, prepared, produced, distributed, sold, installed and had proper warnings.

374. Defendants breached their expressed and implied warranties by designing, manufacturing, producing, servicing, assembling, distributing, delivering, installing, supplying, and selling the AVA which was unsafe, defective, of non-merchantable quality and was not reasonably safe for its intended purpose or use.

375. Defendants breached their expressed and implied warranties, duties and obligations and thereby caused injury to Patrick J. Cradit, and did so by:

a. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product in a defective condition;

b. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was unreasonably dangerous to the user;

c. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was not safe for normal handling and consumption;

d. failing to have adequate warnings on the product;

e. failing to provide adequate warnings;

f. failing to provide instructions to be followed with regard to the use of this product;

g. failing to warn users of the dangers inherent in using this product;

h. failing to instruct users of this product on its safe use;

i. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which could have been designed more safely;

j. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which lacked all necessary safety features to protect users of said product;

k. failing to have proper warnings and instructions concerning the use of this product accompanying the same;

l. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product wherein it was foreseeable that someone would injure themselves based on the product's design and assembly;

m. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which could not be safe during normal use;

n. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was not safe for its intended use;

o. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which was lacking of one or more elements necessary to make it safe for its intended use;

p. designing, manufacturing, producing, assembling, servicing, maintaining, distributing, delivering, selling and/or supplying a product which wa