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Drug Injuries From Clinical Trials Raise Serious Legal Issues

Feb 1, 2008 | Parker Waichman LLP

Drug companies, under mounting financial pressure to bring new drugs to market, have increased the frequency and speed with which clinical trials occur.  Given this, drug injuries from clinical trials are becoming a more common  occurrence. Unfortunately, clinical trail participants have very little recourse if they are injured while testing a drug.  Federal law does not require researchers to compensate participants who are harmed in clinical trials.  The law only requires that consent forms spell out whether compensation will be available for research-related injuries in trials that involve more than a minimal. So what happens when something goes wrong with a clinical trial?  

The wording in clinical trial consent forms can be confusing and vague.  Often it is difficult to discern which research entity is responsible for compensating injured clinical trial participants, how much an injure clinical trial subject will be paid toward the cost of subsequent care, and under what circumstances a research entity is obligated to pay.  Another issue is that it is often difficult to determine what subsequent injuries are related to the clinical trial and what are from the overarching disease.  Drug companies "do not want to end up paying for all of somebody's care when that care may simply be the product of the fact that that person had a grave illness," says Haavi Morreim, a University of Tennessee bioethics professor who has studied clinical-trials lawsuits.

Drug industry trials increased globally from 40,000 to 59,000 in the six-year period from 2000 to 2006, according to an estimate from the clinical trial listing service, CenterWatch.  The growth of clinical trials is due, in part to the increasing use of small, early-stage trials which are meant to help drug companies eliminate ineffective treatments earlier in the trial process.  Also, makers say it is becoming customary to test one drug multiple times to determine if the one drug can treat different conditions.

There is not much confirmed data on the number of injuries from clinical trials, in part because there is no one government agency that regulates all of the trials. However, the problem of resultant injuries from the trials is receiving increased attention following some lawsuits which caught the media’s eye.  One such situation was the lawsuit over the 1999 death of Jesse Gelsinger, an 18-year-old who participated in a gene therapy trial conducted at the University of Pennsylvania.  Another case involves Suzanne Davenport, who entered a clinical trial testing treatment for Parkinson's disease.  Although Davenport entered the trial able to drive, cook, and care for herself, within months, she was wheelchair-bound and forced to live in a nursing home.  The family is suing the two drug makers that ran the trial and the university that enrolled Davenport in the trial.

The Gelsinger case helped raised public awareness of the safety issues surrounding clinical trials and proved that it is possible to find flaws in the informed consent process paperwork and that there is enough ambiguity in consent paperwork wording to enable for a successful end to a horrible situation for patients and patients’ families.  Consent forms and compensation plans vary by institution and while there have been requests to standardize these programs, none have been widely adopted.


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