IN THE UNITED STATES DISTRICT COURT

FOR THE NORTHERN DISTRICT OF OKLAHOMA

 

 

DAWANNA ROBERTSON and STEPHEN )

ROBERTSON, Individually and as Parents and Next )

Friends of SYDNEE ROBERTSON, a minor child, )

JEFFREY TEEL and PAIGE TEEL, JULIE HORN, ) Case No.: 01CV00GOH(M)

Individually, and as Administratrix of the ESTATE )

OF DON E. HORN, DEBORAH BUTLER, and )

WESLEY BUTLER, DOROTHY WYNN, MARK )

GAFFNEY, BEVERLY ANN HARRIS and LESTER )

HARRIS, PATRICIA ANNE YOUNG, SHARON ) JURY TRIAL DEMANDED

LEA MORGAN, and RONALD EUWELL WATKINS, )

Individually, and as the Co-Trustees of the ELLA )

OLGIA WATKINS REVOCABLE TRUST, )

SHIRLEY ROGERS and BOB ROGERS, PATRICK )

ADMIRE, as Personal Representative of the Estate )

of KATHLEEN C. WEDDLE, Deceased, PHYLLIS )

FRIESNER, as Personal Representative of the Estate )

of JAMES F. FRIESNER, Deceased, and SANDRA )

GRUBBS, as Administratrix of the Estate of )

TERRELL GRUBBS, Deceased. )

)

PLAINTIFFS, )

)

vs. )

)

J. MICHAEL MCGEE, M.D., F.A.C.S., DANIEL )

C. PLUNKET, MD, LINDA ANDREWS, R.N., )

KEVIN DONOVAN, M.D., LARRY EVANS, J.D., )

GLENN LYTTE, M.D., KATHLEEN RAYMAN, )

PH.D., R.N., TERRY MOORHEAD, R.PH., JULIE )

WARRECK, M.D., ANTONIO DELEON, JR., M.D., )

PAM PRICE HOPKINS, PH.D., R.N., MICHAEL )

BOYLE, M.D., STEVE BUCK, EDWARD )

WORTHAM, JR., PH.D, DAVID L. BOREN, )

HAROLD L. BROOKS, M.D., THOMAS )

BROUGHAN, M.D., ST. JOHN MEDICAL CENTER, )

HOAG CANCER CENTER, PATRICK GOMEZ, )

M.D., CANCER & HEMATOLOGY CENTER and )

IMMUNEX CORPORATION )

)

DEFENDANTS. )

 

FIRST AMENDED COMPLAINT

COME NOW, the Plaintiffs above named, and for their complaint and causes of action against the Defendants, allege and state:

PARTIES

1.                   Plaintiff Dawanna Robertson is a citizen of the United States and the State of Oklahoma and is a resident of the County of Okmulgee.

2.                   Plaintiff Stephen Robertson is a citizen of the United States and the State of Oklahoma and is a resident of the County of Okmulgee. Stephen Robertson is the husband of Dawanna Robertson.

3.                   Plaintiff Sydnee Robertson is a minor and a citizen of the United States and the State of Oklahoma and is a resident of the County of Okmulgee. This action is brought on behalf of Sydnee Robertson by her mother, Dawanna Robertson.

4.                   Plaintiff Jeffrey Teel is a citizen of the United States and the State of Oklahoma and is a resident of the County of Tulsa.

5.                   Plaintiff Paige Teel is a citizen of the United States and the State of Oklahoma and is a resident of the County of Tulsa. Paige Teel is the wife of Jeffrey Teel.

6.                   Plaintiff, Julie Horn, Individually and as Administratrix of the Estate of Don Horn, Deceased, is a citizen of the United States and the State of Oklahoma, and is a resident of Muskogee County, and is formerly a resident of the State of Maryland, wherein the Estate of Don Horn, Deceased was probated. Julie Horn was the wife of Don Horn.

7.                   Plaintiff Deborah Butler is a citizen of the United States and the State of Oklahoma and is a resident of the County of Tulsa.

8.                   Plaintiff Wesley Butler is a citizen of the United States and the State of Oklahoma and is a resident of the County of Tulsa. Wesley Butler is the husband of Deborah Butler.

9.                   Plaintiff Dorothy Wynn is a citizen of the United States and the State of Oklahoma and is a resident of the County of Muskogee.

10.               Plaintiff Mark Gaffney is a citizen of the United States and the State of Oklahoma and is a resident of the County of Tulsa.

11.               Plaintiff Beverly Ann Harris is a citizen of the United States and the State of Missouri.

12.               Plaintiff Lester Harris is a citizen of the United States and the State of Missouri. Lester Harris is the husband of Beverly Ann Harris.

13.               Plaintiff, Patricia Anne Young, Sharon Lea Morgan, and Ronald Euwell Watkins, Individually and as the Co-Trustees of the Ella Olgia Watkins Revocable Trust, are citizens of the United States and the State of Oklahoma, and are residents of Tulsa County. That Ella Olgia Watkins, Deceased, is formerly a resident of the State of Oklahoma and Tulsa County.

14.               Plaintiff, Patrick Admire, as Personal Representative of the Estate of Kathleen C. Weddle, Deceased, is a citizen of Tulsa County, State of Oklahoma.

15.               Plaintiff, Phyllis Freisner, as Personal Representative of the Estate of James F. Freisner, Deceased, is a citizen of Tulsa County, State of Oklahoma.

16.               Plaintiff, Sandra Grubbs, as Administratrix of the Estate of Terrell Grubbs, Deceased, is a citizen of the State of Florida.

17.               Defendant J. Michael McGee, M.D., F.A.C.S., was an Assistant Professor of Medicine, Division of Surgery, University of Oklahoma Health Sciences Center-Tulsa ("OUHSC-T"), is a citizen of the United States and the State of Oklahoma and is a resident of the County of Tulsa.

18.               Defendants Daniel C. Plunket, MD, Linda Andrews, R.N., Kevin Donovan, M.D., Larry Evans, J.D., Glenn Lytte, M.D., Kathleen Rayman, Ph.D., R.N., Terry Moorhead, R.PH., Julie Warreck, M.D., Antonio deLeon, Jr., M.D., Pam Price Hopkins, Ph.D., R.N., Michael Boyle, M.D., and Steve Buck (collectively "IRB Defendants") are individual citizens of the United States and the State of Oklahoma and believed to be residents of the County of Tulsa. Each was a member of the Institutional Review Board ("IRB") of OUHSC-T ("Tulsa IRB"). Defendant Antonio deLeon is also Chairman of the St. John Medical Center IRB. Defendant Kevin Donovan is also the Chief Bioethicist who consulted with the Tulsa IRB and OUHSC-T.

19.               Defendant Edward Wortham, Jr., PhD, the former Director of the Office of Research at the OUHSC-T, is a citizen of the United States and the State of Oklahoma and is a resident of the County of Tulsa. Dr. Wortham was responsible for supervising all research conducted at OUHSC-T, in general, and supervising the work of the Tulsa IRB, in particular.

20.               Defendant David L. Boren, President of the University of Oklahoma, is a citizen of the United States and the State of Oklahoma. Senator Boren presides over the Board of Regents which conducts the affairs of the University of Oklahoma.

21.               Defendant Harold L. Brooks, M.D., the former Dean of the Oklahoma University College of Medicine in Tulsa, is a citizen of the United States and the State of Oklahoma and is a resident of the County of Tulsa. Dr. Brooks was in effect the chief operating officer of OUHSC-T and was responsible for the manner in which it conducted its affairs.

22.               Defendant Thomas Broughan, M.D., the Chairman of the Department of Surgery at OUHSC-T, is a citizen of the United States and the State of Oklahoma and is a resident of the County of Tulsa. Dr. Broughan is the supervisor of Dr. McGee.

23.               The IRB Defendants and defendants Dr. McGee, Dr. Brooks, Dr. Broughan, Dr. Wortham and Senator Boren (collectively "State Actor Defendants") at all times material to the allegations in the Complaint were acting under the authority of their offices with the University of Oklahoma and under the color and the laws of the State of Oklahoma.

24.               Defendant St. John Medical Center is believed to be a corporation and citizen of Oklahoma with an address at 1923 South Utica Avenue, Tulsa, Oklahoma 74104.

25.               Defendant Hoag Cancer Center is believed to be a corporation and citizen of the State of California with an address at One Hoag Drive, Building 41, Newport Beach, California 92658.

26.               Defendant Cancer & Hematology Center is believed to be a corporation and citizen of the State of Missouri with an address of Whiteside Medical Building, 2115 S. Freemont Street, Suite 300, Springfield, Missouri 65804.

27.               Defendant Patrick Gomez, M.D., the principal investigator at the Cancer & Hematology Center, is a citizen of the United States and the State of Missouri.

28.               Defendant Immunex Corporation ("Immunex") is a corporation believed to be a citizen of the State of Washington with an address of 51 University Street, Seattle, Washington 98101.

JURISDICTION

29.               This action is a civil action in which this Court has original jurisdiction pursuant to 28 U.S.C. '1331, in that certain counts raise federal questions under 42 U.S.C. '1983 and 45 C.F.R. Part 46.

30.               This Court has jurisdiction over the balance of the counts by way of pendant jurisdiction.

31.               Venue is appropriate because the claims arose in the Northern District of Oklahoma.

FACTUAL ALLEGATIONS COMMON TO ALL PLAINTIFFS

The Protocol

32.               On December 30, 1996, Dr. McGee submitted to the Food and Drug Administration ("FDA") an Investigational New Drug application ("IND") proposing to conduct a human clinical trial at OUHSC-T.

33.               Dr. McGee named the drug "Melanoma Vaccine," which was renamed "Allogenic Melanoma Cell Line (IIB-MEL-J), University of Oklahoma Vaccine" ("the Vaccine"). The FDA assigned the application the control designation "BB-IND 6992."

34.               The IND was deficient and misleading because, among other things, it referenced preclinical animal studies for a vaccine other than the one which was the subject of the IND and failed to state that no preclinical animal studies supported the injection of the subject Vaccine into humans.

35.               At or about this same time, Dr. McGee submitted to the Tulsa IRB protocol number 96-0080-7, proposing to conduct a human clinical trial of the Vaccine ("the Trial") at OUHSC-T involving no more than 15 subjects.

36.               The Tulsa IRB approved the protocol on January 8, 1997, and permitted Dr. McGee to begin enrolling patients shortly thereafter and well before the FDA approved the IND on March 11, 1997.

37.               As set forth in the protocol submitted to the FDA, the purpose of the Trial was to conduct a controlled clinical trial in a regulated environment to determine the toxicity of the Vaccine. Thereafter, Dr. McGee revised the protocol for a phase I/II study to determine safety/efficacy of the Vaccine and received approval to enroll 25 patients for this phase of the Trial.

38.               Over the course of the Trial, certain other entities joined with Dr. McGee to cosponsor the Trial. These were defendants St. John Medical Center, Immunex Corporation, and the Hoag Cancer Center ("the Sponsor Defendants").

39.               Throughout the course of the Trial, with the approval and knowledge of the Tulsa IRB, and the Sponsor Defendants, Dr. McGee instead considered it "his goal" to treat patients with a product he considered to be a cure for cancer. That "goal" was in complete disregard of the applicable federal rules and regulations, the protocol approved by the FDA and the Tulsa IRB, and international standards governing the conduct of human clinical trials.

40.               Upon obtaining approval to begin the Trial, Dr. McGee sought to obtain patients with varying degrees of melanoma. To that end, Dr. McGee and defendant St. John Medical Center began advertising the Trial, including buying time for a commercial designed to look like a newscast in which the Vaccine was represented to be a cure for cancer. Ultimately, more than 90 patients were admitted to the Trial, more than three times the number in the FDA approved protocol.

The Vaccine

41.               The Vaccine was a biological agent prepared by Dr. McGee and his staff using human cancer cells. At a later point, defendant Hoag Cancer Center participated in the process of manufacturing the Vaccine. The Vaccine failed to meet the following standards for the production of such drugs.

1.                   Cell lines used for preparing the Vaccine were stored with other research cell lines in liquid nitrogen which raised the possibility of exposure to adventitious agents.

2.                   Because of the absence of defined cell banks, adventitious agent testing described for the cell banks in the IND submission lacked validity, which raised the possibility that the Vaccine was prepared from potentially infected cell lines.

3.                   No efforts were made to monitor for or maintain the documented heterogeneity of the melanoma cell line. Because no defined cell bank was established for preparation of the Vaccine and because the cell culture conditions for preparation of the Vaccine varied from lot to lot, there was no assurance of consistency in the Vaccine from lot to lot.

4.                   No logs were maintained for the cell lines used to manufacture the Vaccine to document passage history or conditions of propagation.

5.                   No formally established standard operating procedures to direct the manufacturing or testing of the Vaccine existed.

6.                   With respect to the first and second clinical lots, cell culture medial components and the formulation buffer for the Vaccine were changed between the referenced lots; no assessment was done on the potential impact of these changes on product quality or safety.

7.                   Regarding the manufacture of lot 98MEL1, cell pellets were pooled from cells grown in serum containing and serum free media without an assessment on the impact of these changes on cell culture conditions on product quality.

8.                   There was no formal or documented characterization of the cell lines used to manufacture the Vaccine.

9.                   Sterility testing was only performed on one or two vials from a batch size that ranged from 300 to approximately 1000 vials.

10.               Testing for endotoxins, mycoplasma and adventitious agents suffered from the same lack of statistically significant sampling as the Sterility testing to detect potential contamination.

11.               98MEL1 batch b was released and injected into patients prior to the appropriate testing for safety and quality.

12.               Western Blot testing for identity performed on 98MEL1 batch b revealed the presence of a new band. The lot was released for patient use without determining the impact of the presence of the new band on product quality or safety. In addition, the same band of unknown origin was present in 99MEL1 batches b and c.

13.               99 MEL1 batch b and c were released without appropriate testing for adventitious virus, endotoxin, and general safety.

14.               There was no quality assurance/quality control review of the batch records or test results for any of the clinical lots prior to release for patient use.

15.               No formally established quality assurance unit was in place.

16.               Stability data did not support the five-year expiration period assigned to the Vaccine.

17.               No cleaning validation or test data was in place to support the effectiveness of the cleaning procedures used on equipment, glassware, or areas where the Vaccine was manufactured.

18.               The dry heat oven used to sterilize and depyrogenate manufacturing and test equipment was not validated.

19.               No study existed to demonstrate the container closure integrity for the cryovials in which the Vaccine was dispensed and stored.

20.               No formal study existed to determine the Endotoxin Inhibition/Enhancement properties of the Vaccine for 97MEL1, 98MEL1 (all batches), and 99MEL1 (all batches).

21.               The individuals involved in the manufacturing of the Vaccine lacked appropriate training, such as "current Good Manufacturing Practices" ("cGMP") training. In addition, there was not an adequate number of personnel to perform the required manufacturing and testing operations.

22.               The area(s) where the manufacturing and testing operations took place were not of adequate size and did not facilitate cleaning, maintenance and proper operations. In addition there were no designated areas to perform various manufacturing and testing operations. There were no separate areas designed to prevent mix-ups between quarantined and approved components and finished products.

23.               There was a lack of accountability for the finished Vaccine; the number of vials manufactured for a particular lot was unclear or unknown; the current inventory numbers for finished vials for the various lots was unknown; the calculations of yields did not exist.

24.               No established procedures were in place to direct the following operations:

(1)                 receipt and testing of components;

(2)                 cleaning operations;

(3)                 environmental monitoring;

(4)                 storage of vaccine;

(5)                 shipping of vaccine.

IMMUNEX CORPORATION

42.               On or about February 5, 1999, defendant Immunex agreed to cosponsor the Trial and to provide a biochemical drug to be used in the Trial in combination with the Vaccine known as sargramostim, a recombinant human granulocyte macrophage-colony stimulating factor ("GM-CSF"), which causes certain cells to multiply. In exchange, Immunex received a right of first negotiation to obtain a worldwide license to any patentable drug or protocol arising out of the Trial.

43.