As a dangerous medical device lawyer, I was extremely disappointed by the U.S. Supreme Court’s 2008 ruling in Riegel v. Medtronic. That decision said injured people may not bring medical device lawsuits because of a loophole in federal law. The federal law on medical devices expressly preempts state laws; thus, any state-law claim that the manufacturer was negligent must be dismissed, no matter how badly injured victims may be or how clear the manufacturer’s negligence was. That was the fate of Degelmann et al. v. Advanced Medical Optics. Alexis Degelmann brought a proposed class action on behalf of a group of contact lens wearers, alleging false advertising by AMO after one of its products was associated with a breakout of serious eye infections. The Ninth U.S. Circuit Court of Appeals upheld dismissal of their claim, but on a different basis from the one the trial court cited.
In 2007, the CDC reported that AMO’s Moisture Plus contact lens solution was associated with an amoebic eye infection called Acanthamoeba keratitis. AMO recalled Moisture Plus and refunded the money of purchasers; various people who had contracted the infections filed suit. Degelmann and the proposed class did not get the infection, but had used Moisture Plus. Their complaint alleged that AMO falsely advertised Moisture Plus as an effective disinfectant and cleaner even though users were seven times more likely to develop an infection than users of other brands. AMO misled consumers, they alleged. The trial court invited AMO to file for summary judgment and then granted that motion, finding the plaintiffs did not have standing to sue because they had suffered no eye infections or financial losses. AMO’s motion mentioned federal preemption, but the trial court did not reach it. The plaintiffs appealed.
The Ninth Circuit agreed that the suit should be dismissed, but found a different basis than the one the trial court used. In fact, the appeals court disagreed that the plaintiffs suffered no injury in fact under California’s Unfair Competition Law. While the law does require injury in fact, the court said, a claim that they were misled into purchasing Moisture Plus is sufficient to show an economic injury. However, the Ninth Circuit went on to dismiss the claim based on federal preemption, noting that appeals courts may uphold trial courts based on anything in the record. AMO’s contact lens products are regulated by the Medical Device Amendments of the Food, Drug and Cosmetic Act. AMO has shown that it met FDA regulatory requirements, the Ninth said. But those amendments say state and local governments may not further regulate already-regulated devices. And in order to win their lawsuit, the court said, the plaintiffs would have to be able to show that California law requires something different from what the Medical Device Amendments require. Thus, the lawsuit cannot stand, the court said, and the district court was correct in dismissing it.
I cannot argue with the Ninth Circuit’s legal logic. But as a defective medical device attorney, I believe the legal situation that created this ruling is dangerous for American patients. By removing patients’ ability to file any lawsuit at all against medical device makers, the Supreme Court has absolved those manufacturers of responsibility for their actions. Thus, while the lawsuits over the Acanthamoeba keratitis infections may have prevailed in 2005, the same lawsuits cannot prevail today. That’s true no matter how clear it is that the manufacturer’s negligence caused the injury. This is undoubtedly advantageous for manufacturers, but it leaves Americans at the mercy of FDA regulations, which are frequently disinterested (and often declawed when the presidency changes). As a pharmaceutical liability lawyer, I hope Congress passes a law to correct this situation before their hand is forced by a widespread health emergency.
Based in St. Louis, Carey, Danis & Lowe represents clients who suffered illness, injury or lost a loved one because of a defective drug or medical device. To learn more about your legal options and tell us your story, call us today at 1-877-678-3400 or send us a message online.
Similar blog posts:
Congress Considering Restoring Patients’ Ability to File Defective Medical Device Lawsuits
Congress Considers Legislation to Reverse Supreme Court Decision on Defective Medical Device Lawsuits
U.S. Supreme Court Rules FDA Approval Does Not Bar Pharmaceutical Injury Lawsuits