Riegel v. Medtronic

Issues 

Do the Medical Device Amendments, which were intended to replace state regulation of medical devices with centralized federal regulation, forbid injured patients from asserting state-law claims against manufacturers that received premarket approval from the Food and Drug Administration?

Oral argument: 
December 4, 2007

In 1996, a catheter burst during Charles Riegel's angioplasty. Riegel and his wife filed a product liability complaint against the catheter's manufacturer, Medtronic, Inc. A federal district court dismissed the complaint, holding that the Medical Device Amendments ("MDA") preempted most of the claims. The U.S. Court of Appeals for the Second Circuit affirmed the dismissal and the Riegels appealed to the U.S. Supreme Court. The MDA generally forbids states from imposing requirements on devices that received premarket approval from the Food and Drug Administration ("FDA"). Because the complaint depends on state law, Medtronic argues that letting it proceed would impose state requirements, usurp the power of the FDA, and stifle innovation in the medical field. Mrs. Riegel, who was substituted as plaintiff after her husband died, argues that while Congress gave the FDA power to regulate medical devices, it never meant to stop private citizens from suing negligent manufacturers. The outcome in this case will likely depend on the Supreme Court's style of statutory interpretation as well as its beliefs about the best way to manage the complex world of medical devices.

Questions as Framed for the Court by the Parties 

Whether the express preemption provision of the Medical Device Amendments to the Food, Drug, and Cosmetic Act, 21 U.S.C. § 360k(a), preempts state-law claims seeking damages for injuries caused by medical devices that received premarket approval from the Food and Drug Administration.

Facts 

In 1996, Dr. Eric Roccario attempted to unclog a "diffusely diseased" and "heavily calcified" artery supplying Charles Riegel's heart. See Riegel v. Medtronic, Inc., 451 F.3d 104, 107 (2d Cir. 2006). When several attempts using other devices failed, Dr. Roccario attempted an angioplasty by using an Evergreen Balloon Catheter, manufactured by Medtronic, Inc. ("Medtronic"). Id. Medtronic's balloon catheter burst while still inside Riegel's artery. See Brief for Petitioner at 10. The burst caused a complete heart block and Riegel lost consciousness. See Id. Riegel survived after receiving advanced life support and emergency coronary bypass surgery. See Id. at 11.

Riegel and his wife, Donna, sued Medtronic in the U.S. District Court for the Northern District of New York. See Riegel, 451 F.3d at 107. They asserted several New York common-law product liability claims, blaming Medtronic for the device failure. Id. In 2002, the District Court dismissed most of the Riegels' claims as preempted by the Medical Device Amendments to the Food, Drug, and Cosmetic Act. See Id. In 2003, the court dismissed the rest of the claims after finding insufficient evidence and concluding that Medtronic provided adequate warnings about the device's limitations. See Id. at 108.

The U.S. Court of Appeals for the Second Circuit upheld the dismissal. See Riegel, 451 F.3d at 127. Under federal law, the Evergreen Balloon Catheter was a Class III medical device.If the Food and Drug Administration ("FDA") imposes device-specific requirements on a Class III device, the states cannot impose additional or different requirements without prior permission. See 21 U.S.C. § 360k(a); Medtronic v. Lohr, 518 U.S. 470, 500 (1996). The court concluded that the FDA imposed device-specific requirements on the Evergreen Balloon Catheter. See Riegel, 451 F.3d at 119. It reasoned that if the Riegels reached trial and won, the awarded damages would amount to a state "requirement" which differed from or added to FDA requirements. See Id. at 121. Thus, the court held that federal law preempted the lawsuit. Id. at 123. The Riegels appealed to the U.S. Supreme Court, which granted certiorari on June 25, 2007. Supreme Court Order List: 551 U.S. (June 25, 2007).

Charles Riegel has now passed away, and Donna Riegel appeals on his behalf. See Riegel v. Medtronic, Inc., No. 06-179 (U.S. Oct. 1, 2007) (order granting motion to substitute). Riegel argues that preempting her lawsuit at this stage is unlawful and unjust. Brief for Petitioner at 14. Significant points of debate would be addressed at trial if the Supreme Court lets the case continue. Medtronic can defend itself by alleging negligence by Dr. Roccario. During the angioplasty, Roccario inflated the catheter to a pressure of ten atmospheres despite a warning on its label that named eight atmospheres as the rated burst pressure. Riegel, 451 F.3d at 125. Roccario responded that ten atmospheres fell within the catheter's test range in laboratory settings. Id. at 125-26. An engineer also claimed that Riegel's balloon catheter burst outward from the center rather than sideways, indicating a manufacturing defect. See Id. at 126. Medtronic disagrees, noting that the catheter's label warned against use on calcified blockages such as Riegel's because they may puncture the balloon catheter. Id. at 125. These merit-based arguments will not reach a jury if the Supreme Court upholds the dismissal.

Analysis 

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.

Discussion 

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.

Conclusion 

This case shows a conflict between manufacturers who obtained FDA approval and injured patients who still want the ability to expose potentially negligent designs. Patients who believe defective devices caused their injuries take little comfort in knowing that the devices had FDA approval. At the same time, device manufacturers who received FDA approval after extensive review want to avoid the same extensive review in our nation's courts. If the Supreme Court rules for Medtronic, it would immunize medical devices with premarket approval from many product liability suits based on state law, leaving some injured consumers without a judicial remedy against medical device manufacturers. If the Supreme Court rules for Riegel, however, it would allow injured patients to sue device manufacturers despite FDA findings of adequate safety. Ultimately, one may view this decision as a choice between a centralized regulatory framework and state law protection of medical device consumers beyond that of the FDA.

Written by: Suzanne Cook & Michael Litvin

Edited by: Cecelia Sander Cannon