VA Researchers Sued for Alleged Patient Deaths

VA Researchers Sued for Alleged Patient Deaths; Class Action Against Feds Planned

M. Alexander Otto

BNA's Daily Report for Executives

March 19, 2003

Two former Department of Veterans Affairs researchers have been sued and a lawsuit is being prepared against the U.S. government for injuries and deaths in medical studies at the Stratton Veterans Affairs Medical Center in Albany, New York.

Human research plaintiffs attorney Alan C. Milstein March 18 filed a complaint for damages and class action against former Stratton research assistant Paul Kornak and oncologist Dr. James Holland (Steubing v Kornak, N.D.N.Y., doc. no. not available, complaint filed 3/18/03).

Milstein, with Sherman, Silverstein, Kohl, Rose & Podolsky, Pennsauken, N.J., told BNA he also plans to file a federal tort claims notice, which could clear the way for a class action suit against the federal government.

The suits are the first of what could be a string of legal problems arising from how studies are conducted at Veterans Affairs Medical Centers. In addition to Albany, VA investigators have found research problems at the Detroit, Mich. VA medical center. Additional mishaps are suspected at the Portland, Ore., Fargo, N.D., and North Port, N.Y. centers, a government source said.

The VA spends $1.3 billion annually on medical studies, making it one of the country's leading research institutions. Much of that money comes from the pharmaceutical industry.

Decorated Veteran

The March 18 complaint was brought on behalf of the widow of Carl Steubing, who died after participating in a Stratton stomach cancer trial run by Kornak and Holland.

The suit seeks to enroll in a class action lawsuit the 100 or so patients Holland and Kornak studied between 1999 and 2003. Jayne Steubing is the only named plaintiff so far. Damages in excess of $2 million are sought.

Carl Steubing was "a painter, musician, composer, award-winning photographer, gourmet cook, downhill skier, golfer, fisherman, and avid sports fan," the complaint states.

He won a Purple Heart and Bronze Star at the World War II Battle of the Bulge and had a day named in his honor by the Governor of New York "for his lifetime of extraordinary contributions to the community and to humanity," according to the suit.

Jayne Steubing was unavailable for comment late March 18.

Taking Short-Cuts

In the seven cancer studies they conducted together, Holland, Kornak or both altered medical records to conceal kidney disease, cancer surgeries, and severe heart problems, including a possible heart attack, according to a Food and Drug Administration inspection report obtained by BNA. Blood chemistries, cancer bone scans, echocardiograms, prostate cancer checks, and other necessary tests were not performed, though study records indicated they had been.

Tests that were done had dates and results altered. Drugs were given in wrong doses and, in one case, patients already hard of hearing got a medication that could make hearing worse, FDA found.

The altered records made patients appear sicker or healthier than they actually were, so that they could be enrolled in drug studies for which they would not otherwise have qualified. Consequently, subjects were given drugs they should not have gotten, in ways their makers had not intended them to be administered, the inspectors concluded.

VA investigators have concluded the actions probably caused one death and may have caused at least four more. An ongoing federal criminal investigation could bring murder charges.

Stratton officials hired Kornak to recruit for and monitor patients in sensitive cancer studies despite knowing his medical license had been revoked in two states, a move that implicates the federal government in negligence, Milstein said.

Fifth Amendment Claims

Steubing's history of colon cancer should have kept him out of the stomach cancer trial, but his medical history and lab tests were "willfully ignored," the suit states. Steubing died in March, 2002, about eight months after receiving experimental cancer drugs.

"After Mr. Steubing's death, the Chief of Staff of Stratton informed Mrs. Steubing that her husband's condition may have been compromised by defendants' wrongful conduct and that he may not have been qualified for the study," the complaint states.

Kornak and Holland's conduct caused Steubing and others "to suffer physical pain and suffering up to and including death as well as irreparable harm to their essential human dignity," according to the suit.

Claimed damages are based on violations of federal human research regulations and the rights to bodily integrity and human dignity as guaranteed under the Fifth Amendment and the Nuremberg Code, a list of research ethics drafted in response to Nazi war atrocities.

"Federal authorities were warned seven years ago that veterans with cancer at Stratton ... were being given drugs in violation of medical protocols," the suit notes. Staff members complained that Stratton patients were treated "as guinea pigs."

"Veterans are considered an ample available resource for the research industry because veterans as a group are considered patriotic, civically minded and trusting of authority," according to the complaint, which also notes that researchers are often given bonuses to sign patients up for trials.

Milstein is being helped in the case by Donald T. Kinsella, a former U.S. attorney now with Green & Seifter in Albany.

Reproduced with permission from Daily Report for Executives, No. 53, pp. A-25 - A-26

(March 19, 2003). Copyright 2003 by The Bureau of National Affairs, Inc. (800-372-1033)