SCOTUS May Consider FDA Status in Device Suits
The Supreme Court will decide this term whether to review a product liability lawsuit that raises the question of whether a medical device manufacturer may introduce evidence related to FDA premarket review and clearance of a medical device in a case in which a consumer alleges that the device is defective and unsafe. In Ethicon v. Huskey, a federal district court judge prohibited a medical device manufacturer from introducing evidence of its compliance with agency premarket notification requirements, according to an Alston & Bird client alert.
The case involved a woman who experienced complications from implantation of a transvaginal mesh medical device that was cleared for marketing by FDA in 2003 under the 510(k) premarket notification and review process. The manufacturer was precluded from telling the jury that its device had received FDA premarket review and clearance, and the trial resulted in a $3.27 million verdict against Ethicon.
According to the alert, the trial court ruled that evidence of the FDA premarket clearance would be of limited value and could potentially confuse jurors. On appeal, the appeals court agreed with the lower court and said that such evidence raises a “risk of confusing the jury … by causing a battle of the experts over the robustness of the [FDA] safety examinations” and could result in “wasted time.”
The Alston & Bird attorneys say that even if the Supreme Court overturns the lower court rulings, admission of FDA premarket review and clearance evidence would not provide device manufacturers with an automatic win. “FDA clearance decisions are based on varying degrees of safety data,” they write, “so a plaintiff’s attorney would still be permitted to challenge the weight that such evidence should be given. Ultimately, a jury would determine how persuasive the evidence of premarket clearance is based on the facts specific to the individual product’s clearance. And that is the point. The jury is the stalwart of the American legal system and should be allowed to consider this evidence so that medical device companies may fully defend themselves. This is especially true in product defect cases where the companies face significant allegations of wrongdoing and potentially huge adverse verdicts.”