Product Liability and Drug Defect Lawyer Weighs In On March 2013 Supreme Court Arguments Over Generic versus Brand Name Drug Maker Liability
On Tuesday, March 19, 2013, the United States Supreme Court will hear arguments in a case that has far-reaching implications. This case will be closely watched by pharmaceutical companies, regulators, lawyers, and consumer safety advocates. Mutual Pharmaceutical Company—a manufacturer of numerous generic drugs—has asked the high court to overturn a $21 million dollar jury award to Karen Bartlett, a New Hampshire woman who took Mutual’s generic non-steroidal anti-inflammatory drug Sulindac when it was prescribed by her doctor for shoulder pain, in 2004.
The plaintiff, Karen Bartlett, was diagnosed with a rare hypersensitivity reaction associated with the drug (Stevens-Johnson Syndrome toxic epidermal necrolysis), three weeks after she began taking it. Her skin began to peel off, and she was left with burn-like lesions over two-thirds of her body. She spent close to two months in a hospital burn unit, and some of that time was in a medically-induced coma. She has subsequently undergone 13 eye surgeries. She sued Mutual in 2008 for alleged design defects, under New Hampshire law, and was awarded $21 million dollars for injuries. Mutual is now attempting to argue that Federal law bars this claim because the drug had been approved by the U.S. Food and Drug Administration. The company also contends that it had no control over the drug’s design or labeling.
As a Pennsylvania product liability and product defect lawyer, I am greatly concerned about the safety implications of defective drugs and medical devices. I believe that the risks of the drug involved in this case outweighed its benefits, thereby making it unreasonably dangerous to others.
There are currently 17 non-steroidal anti-inflammatory drugs (NSAIDs) on the market that do not have the high risk of Stevens-Johnson Syndrome toxic epidermal necrolysis associated with Sulindac. Of these, 10 are equally effective, as the lower courts concurred, when Karen Bartlett was awarded $21 million dollars for injuries that will require a lifetime of care.
I do not feel that there should be a difference in legal standards applicable to generic drugs and brand name drugs. All manufacturers must be held responsible for the design and safety of their drugs, at all times. Pharmaceutical manufacturers will always argue that, since the drug or device had been approved by the FDA, the product is safe, and that Federal law preempts state law. However, nothing could be further from the truth.
For this reason, the FDA requires warning labels to be constantly updated, and has recommended that certain drugs and devices be withdrawn from the market for being unsafe, as in the cases of Darvocet, Bextra, DePuy hips, and Sprint Fedilis defibrillator leads. Bextra is another good example of a NSAID that was removed from the market for its high risk of triggering Stevens-Johnson Syndrome.
Suits like Karen’s may be one of the only effective ways that society can police the promulgation and dissemination of new safety information. Jury verdicts on behalf of injured individuals send a message to corporations that manufacturing dangerous products—including unreasonably dangerous drugs—is unacceptable, and that such products should be withdrawn from the market.
In 2009, the Supreme Court of the United States asserted in the famous Wyeth v. Levine case that “state tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly. They also serve a direct compensatory function that may motivate injured persons to come forward with information.” Failure-to-warn actions, in particular, lend force to the FDA’s premise that manufacturers, not the FDA, bear primary responsibility for their drug labeling, at all times. Thus, the FDA has long maintained that state law offers an additional, and extremely important, layer of consumer protection that complements FDA regulation.
I believe that the safety of consumers must never be trumped by the profitability concerns of corporate America and its powerful lobbyists.