DRUG PRODUCT LIABILITY

I. Experience with suits against drug manufacturers

Consider the example of the drugs that transmitted the AIDS virus to many thousands of patients with hemophilia. That was one of the worst drug-related medical disasters in history.

I brought suits on behalf of affected hemophilia patients in Texas and other states in the 1990’s. I also worked on the litigation’s national Plaintiffs Steering Committee.

The suits charged the drug manufacturers with negligence for failing to develop a viral inactivation process before the AIDS epidemic struck and failing to warn patients when they recognized that their drugs were likely to transmit the AIDS virus.

Four large companies manufactured the deadly drugs. They were made from extracts of human plasma.

Incredibly, much of that plasma came from high risk plasma centers located in skid row inner city areas and state and federal prisons (like Angola Prison in Louisiana). “Donors” were attracted by paying them on the order of $10 for a unit of their plasma.

Long before the AIDS epidemic struck, it was well known that drugs made from high risk paid donor plasma were certain to be contaminated with hepatitis B virus if they were not treated with a viral inactivation process.

Despite that risk, the FDA did not require the manufacturers to develop a viral inactivation process and it allowed them to continue obtaining cheap plasma from the world’s highest risk “donors.”

Thomas Drees, a former president of one of the manufacturers later said that officials of the FDA tended to drag their feet and were too chummy with industry. (1)

For the litigation to succeed, it was necessary to present expert witnesses to testify on the key issues. Apart from my work on individual cases, I was chosen by the litigation’s national Plaintiffs Steering Committee to recruit a number of expert witnesses and work with them in preparation for their depositions (which could be used in cases around the country).

The most critical need was for an expert to testify on the technical feasibility of developing a viral inactivation process for hemophilia drugs before the AIDS epidemic began in the 1980’s.

After reviewing scientific literature on that subject, I determined that the most distinguished expert we could present on that subject was Frank Putnam, Ph.D., the editor of a five-volume treatise on plasma proteins and a renown member of the National Academy of Sciences.

Dr. Putnam allowed me to present him with scientific literature along with documents from the manufacturers. After many conferences, he agreed to serve as an expert witness.

Dr. Putnam went on to testify that the manufacturers could have used existing technology to develop a viral inactivation process before the AIDS epidemic struck. That testimony helped convince the manufacturers to settle a large number of cases.

In the latter 1990s and 2000s, I also worked on litigation involving the drug, Gammagard, an intravenous immunoglobulin also manufactured from an extract of human plasma. Suits were brought because Gammagard transmitted hepatitis C virus.

The manufacturer was charged with negligence for failing to warn of the hazard and failing to develop a viral inactivation process. I was chosen by the national Gammagard Plaintiffs Steering Committee to recruit and work with expert witnesses. After those expert witnesses were deposed, individual cases were settled on a confidential basis.

II. “A tidal wave of government investigations and civil and criminal lawsuits”

Today, more product liability lawsuits are filed against prescription drug manufacturers than against all other industries combined.

In addition to product liability suits, the drug industry has been hit with what one commentator called “a tidal wave of government investigations and civil and criminal lawsuits.” (2)

The litany of charges includes:

  • illegally overcharging Medicaid and Medicare,

  • paying kickbacks to doctors,

  • engaging in anticompetitive practices, colluding with generic companies to keep generic drugs off the market,

  • illegally promoting drugs for unapproved uses,

  • engaging in misleading direct-to-consumer advertising and

  • covering up evidence. (3)

It is hard to avoid the conclusion that the drug industry puts its aggressive pursuit of profit far above any concern for the health of patients taking its drugs.

The Food and Drug Administration (FDA) should be the protector of the public interest but it has shown itself to be “a servant of the industry it regulates.”

In particular, it has allowed the sale of drugs with uncertain benefits even when there are serious side effects, and worse, it has repeatedly failed to respond promptly to evidence that a drug is dangerous. (4)

References

1. Shaw D. On The Trail Of Tainted Blood—Hemophiliacs Say U.S.Could Have Prevented Their Contracting Aids. Philadelphia Inquirer. April 16, 1995.

2. Schmit J. More drugs get slapped with lawsuits. USA Today, 8/23/06.

3. Angell M. Your Dangerous Drugstore. NY Review of Books. June 8, 2006.

4. Angell M. FDA: This Agency Can Be Dangerous. NY Review of Books. September 30, 2010.