Riegel v. Medtronic

This case will determine the dividing line between state and federal regulation of medical devices that the Food and Drug Administration ("FDA") has approved through its premarket approval ("PMA") process. Medical devices are divided into three classes; the PMA is required for Class III medical devices, those that pose the greatest risk of serious injury to consumers. 21 U.S.C. § 360c(a)(1)(C). The medical device at issue is in that category. Riegel v. Medtronic, Inc., 451 F.3d 104, 109 (2d Cir. 2006). After the failure of a catheter led to serious injury, the Riegels brought several state-law claims against its manufacturer, Medtronic. Id. at 107. The district court dismissed most of the claims as preempted by the Medical Device Amendments("MDA") to the Food, Drug, and Cosmetic Act. Id. The MDA preempts states from imposing any requirements on medical devices with PMA that are different from or in addition to FDA requirements. See Id. The U.S. Court of Appeals for the Second Circuit affirmed the lower court's holding that the state common law in question imposes such a requirement. Id. at 123.

If the Supreme Court rules in favor of Riegel, it would allow courts to enforce state regulations on medical devices with PMA unless the state regulations conflict with corresponding FDA restrictions. See Brief for Petitioner at 25-26. For example, if the FDA required that a hearing aid have two-inch wires, it would preempt a state requirement that it have one-inch wires, but not necessarily a state requirement that the manufacturer package it in a certain manner. Id. at 26. A decision in favor of Medtronic, however, would prevent courts from enforcing state regulations on medical devices with PMA unless those restrictions are identical to corresponding FDA restrictions. This may prevent consumers injured by such devices with unsafe designs from receiving compensation for their suffering and may leave them without the ability to pay for the medical care they need because of that injury. See Brief Amici Curiae of AARP et al. at 26-27. This does not leave consumers without recourse against manufacturers, however, since they may pursue other remedies such as negligent manufacture or breach of express warranty. Brief Amicus Curiae of Washington Legal Foundation at 14. Consumers could also sue parties other than manufacturers, such as the treating physicians. Id.

The parties disagree on how much regulation is necessary to ensure the safety of medical devices. Medtronic argues that state regulation of medical devices with PMA is unnecessary because the process is rigorous and results in design, manufacturing, and labeling requirements that reasonably assure the safety and effectiveness of the device. See Brief for Respondent at 1, 3, 17. Riegel argues that no amount of rigor in the process can predict all possible problems with a device or its use. Brief for Petitioner at 5. In the words of Senator Edward Kennedy when he introduced the MDA, "The legislation is written so that the benefit of the doubt is always given to the consumer. After all, it is the consumer who pays with his health and his life for medical device malfunctions." Id. at 2. The amici curiae AdvaMed and the Medical Device Manufacturers Association, however, note that FDA oversight continues after the device reaches the market, which could correct oversights in the PMA process. Brief Amici Curiae of AdvaMed and MDMA at 11-13.

Riegel still contends, however, that FDA regulation alone may not adequately protect consumer safety. Without the threat of lawsuits, manufacturers may hide safety flaw information from the FDA during and after the PMA process. Brief Amici Curiae of AARP et al. at 22-26. Because the FDA does not conduct its own studies into device safety, the PMA process typically relies on those provided in the manufacturer's application, which may exclude those with unfavorable results. See Id. at 8. Additionally, because the FDA has limited funding, it has turned to industry financing through "user fees" which could influence FDA approval. Id. at 12-13. A survey conducted by non-profit organizations found that sixty percent of FDA scientists knew of cases where commercial interests had influenced FDA approval. Id. at 12; see also Union of Concerned Scientists, "Voices of Scientists at FDA", brochure of survey summary at 2. One-third of outside scientists enlisted by the FDA to aid in product approval had a more than $50,000 financial interest in the manufacturer of that product. Brief Amici Curiae of AARP et al. at 12-13. Further, if the MDA does not preempt them, consumers may benefit from state-law suits over dangerous devices because they could inform the public of the danger, give compensation to the victims, and give manufacturers an incentive to protect consumer safety. Id. at 5, 18-30.

Medtronic disagrees that lawsuits will improve product safety. It argues that unnecessary restrictions imposed by states would instead stifle innovation and reduce the availability of existing, beneficial medical devices. See Brief for Respondent at 11; Brief Amici Curiae of AdvaMed and MDMA at 19-26. For example, Bendectin, a morning sickness drug, was withdrawn from the market because the cost of defending against tort lawsuits over birth defects was high compared to the profit from the drug, despite the manufacturer winning those suits on the merits. Brief Amici Curiae of AdvaMed and MDMA at 23-24. That situation discouraged other companies from developing morning sickness treatments. Id. at 24. In addition to deterring some manufacturers from developing life-saving devices, the cost of litigation may encourage "defensive labeling," causing those devices to be underutilized.Brief for Respondent at 46-49. Moreover, manufacturers factor the cost of litigation into the prices of products, potentially placing them out of reach for some consumers and increasing the cost of health insurance. See Amicus Curiae of Product Liability Advisory Council at 21.

Lawsuits are of substantial concern to manufacturers. The cost of litigation can be high, particularly in the case of medical devices, because they often turn on factual issues that survive summary judgment, prolonging the case. Brief Amicus Curiae of Product Liability Advisory Council at 20. Such lawsuits may result in unfairly high verdicts, since lay juries tend to overreact to risks with low probabilities. Brief Amici Curiae of AdvaMed and MDMA at 16. If the manufacturer loses the suit, that loss could trigger a multitude of similar cases. Amicus Curiae of Product Liability Advisory Council at 21.