The U.S. Supreme Court has taken a great interest in suits that pit FDA's authority against state tort laws when a patient has allegedly been harmed by an FDA-approved product. The court ruled in favor of FDA authority preempting state torts in a device case in February, heard arguments last week in a case about whether a Michigan state jury should be allowed to decide if a company defrauded FDA, and has agreed to hear a third preemption case related to FDA-approved drug labels.
The focus of the justices' questions during oral arguments in Warner-Lambert v. Kent last week suggests they favor preemption, although they asked questions that suggest they have concerns about going too far in that direction.
While many stakeholders contacted by BioCentury believe the court's opinion in Kent will affect only the Michigan statute, they also say the justices' attitudes give some insights into what might happen in other preemption cases.
The most anticipated Supreme Court preemption case is Wyeth v. Levine, which will address the much broader issue of whether an FDA-approved label preempts state product liability claims.
Biotech and pharma companies are hoping the court rules for preemption across the board. More likely, according to attorneys familiar with the cases, is that the high court will strengthen FDA preemption, but not as much as industry would like.
Neither outcome would eliminate tort claims against drug companies, but verdicts strongly in favor of preemption in both Kent and Levine would knock out the most common avenue for tort suits and the easiest for plaintiffs to win.
Warner-Lambert v. Kent
The case before the Supreme Court last week is focused on Rezulin troglitazone. The drug was approved by FDA in January 1997 to treat diabetes, and Warner-Lambert Co., now part of Pfizer Inc., launched Rezulin in March of that same year. It was the first drug in the then new class of compounds called glitazones.
Liver toxicity was a concern during Rezulin's development and remained so once it reached the market. Over the next three years, FDA pushed the company to modify Rezulin's label five times to require increased