Blog Post
Preemption + FDA = No liability for intentional contamination and death
Posted by: Spencer Pahlke
May 03, 2008
Topic: Threats to Plaintiffs' Rights
Now this stretches me past the realm of disappointment, through the range of anger, and somewhere into the vicinity of dizziness and confusion. The FDA is now admitting that the contaminants in the Heparin--that killed 81 people--could have been put there intentionally. The reason? As the New York Times reports, the contaminant-oversulfated chondroitin sulfate-runs at only a "cost $9 a pound compared to with the $900 a pound for heparin." Of course, it has the added advantage of being fatally poisonous.
Obviously, a drug that kills those who take it is a defective product. The company that produced it should be liable for that defect--especially when it intentionally created the defect. This sound reasoning, however, is under assault.
In a case the Supreme Court will consider this fall, it may rule that lawsuits based on defective and dangerous medication are "preempted." This means that they such lawsuits will be thrown out of court. The reason, the Court is likely to say, is that the FDA had the opportunity to examine these drugs and found them safe-who are civil juries then to question the FDA?
One of the many problems with this reasoning is that the FDA is not only nothing close to omniscient about future risks posed by drugs, it is dangerously understaffed. With the heparin, for instance, it "mistakenly failed to conduct an inspection of the" offending drug plant. The reason was serious understaffing, a problem that will only get much worse in the future because the FDA is underfunded. Its budget for next year, for instance, only increases by 3%--which is not enough to cover even its expected cost increases.
At Walkup, we fight every day to protect the rights of people injured or killed by defective drug or medical device to take their cases before a juries of their peers.
