Oral argument: December 4, 2007
Appealed from: United States Court of Appeals, Second Circuit (May 16, 2006)
PRODUCTS LIABILITY, CLAIM PREEMPTION, PREMARKET APPROVAL, FOOD AND DRUG ADMINISTRATION (FDA), MEDICAL DEVICE AMENDMENTS OF 1976 (MDA), FOOD, DRUG, AND COSMETIC ACT (FDCA)
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.
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.
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?
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.
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.
At issue is whether federal premarket approval ("PMA") by the Food and Drug Administration ("FDA") immunizes medical device manufacturers from product liability suits based on state law. Before the Medical Device Amendments of 1976 ("MDA"), the FDA had little control over the sale of medical devices. See Brief for Respondent at 2. By passing the MDA, Congress gave the FDA authoritative control. See id. The MDA splits medical devices into three categories: Class I devices such as bandages, Class II devices such as hearing aids, and Class III devices such as pacemakers and catheters. See Brief for Petitioner at 2-3; see also 21 U.S.C. § 360c.
Because Class III devices pose the biggest health risks, they must pass the FDA's most thorough review process, PMA. See Brief for Petitioner at 3. Two exceptions exist to this requirement. See 21 U.S.C. § 360e. First, a device marketed before the MDA can stay on the market unless the FDA singles it out for review. See 21 U.S.C. § 360e(b)(1)(A). Second, a Class III device that is substantially equivalent to a device marketed before the MDA requires only a relatively fast "notification process" to confirm the similarity. See Brief for Respondent at 4; see also 21 U.S.C. §§ 360e(b)(1)(B), 360c(f). To grant PMA, the FDA must find "reasonable assurance" that the device will be safe and effective when designed, manufactured, and labeled as proposed in the application. See 21 U.S.C. §§ 360e(d)(1)(A), 360e(d)(2). Only after receiving PMA can the manufacturer sell the device to doctors and patients. See Brief for Respondent at 6-7.
To bolster the FDA's authority over medical devices, the MDA includes an express preemption provision. See 21 U.S.C. § 360k(a). Under this provision, states cannot impose requirements on medical devices which would be "different from, or in addition to, any requirement" imposed by the FDA. Id. The Supreme Court further clarified the meaning of this provision in Medtronic v. Lohr, 518 U.S. 470 (1996). In Lohr, a pacemaker recipient alleged that her Medtronic pacemaker was defective under state law. 518 U.S. 470. Medtronic argued that the MDA preempted the lawsuit, but the Supreme Court disagreed, allowing the patient to sue. See id., at 503.The Court explained that Medtronic's pacemaker was a Class III device that fell into the "notification process" exception to PMA review, and that the FDA had not imposed device-specific requirements. See id. at 478-79. Without device-specific requirements, held Lohr, states can impose their own safety requirements and patients can allege defects under state law. Id. at 500.
With Lohr as its guide, the Court will face two major issues in this case. First, did the FDA impose device-specific requirements on the Evergreen Balloon Cather? Second, would Riegel's lawsuit impose different or additional state-law requirements in violation of the MDA?
Did the FDA Impose Device-Specific Requirements on the Evergreen Balloon Catheter?
Riegel argues that the FDA never imposed device-specific requirements on the Evergreen Balloon Catheter. See Brief for Petitioner at 24. According to Riegel, "device-specific requirements" are predetermined manufacturing instructions included in FDA regulations. In this case, the FDA never issued specific instructions about how manufacturers should design catheters. See id. The PMA only determined that the Evergreen Balloon Catheter met minimal thresholds of safety and effectiveness, and therefore in Riegel's view state law should not be barred from further protecting consumers. See id. For example, the catheter's PMA contrasts with the FDA regulations setting performance standards for certain lasers: "Device must emit a laser beam with the following parameters: wavelength = 1064 nanometers; spot size = 50 to 100 microns . . ." Id. at 28. While manufacturers of medical laser devices must abide by predetermined requirements, Medtronic designed the catheter without input from the FDA. See id.
Medtronic argues that the FDA did impose device-specific requirements on the Evergreen Balloon Catheter. See Brief for Respondent at 16. Although Medtronic proposed the design and labeling, the FDA used its regulatory power to "lock" the final product into a set form. See id. at 17. Medtronic could market the catheter only as specified in the PMA application. See id. Medtronic emphasizes the rigors of the PMA process: "The FDA spends hundreds of hours during the PMA process reviewing . . . studies to [determine whether the] device would be safe and effective when designed, manufactured, and labeled in conformity with the . . . PMA application." Id. Medtronic argues that no requirements can be more specific than the FDA's approval of the actual specifications used to make the marketed device. See id.
Riegel's response is that the FDA's approval does not eliminate Medtronic's responsibility for matters not specifically covered by the PMA. Brief for Petitioner at 29. According to Riegel, Medtronic's responsibility to patients did not end when it obtained PMA for its catheter. See id. Riegel notes that if a safer design existed, Medtronic should have contacted the FDA to modify the design from the one detailed in its PMA application. See id. Likewise, if the catheter's warning label was too convoluted for doctors to understand, Medtronic could have sent doctors supplemental letters to explain. See id. at 31.
Medtronic's position is that this logic ignores the Supreme Court's distinction between cursory and detailed review by the FDA. Brief for Respondent, at 21. In Lohr, the Court found that Medtronic's pacemaker did not receive thorough review by the FDA. See 518 U.S. at 478-79. Because the pacemaker qualified for the "notification process" exception, Medtronic only had to show that it was substantially equivalent to a device that was on the market before the MDA took effect. See id. at 478. The pacemaker in Lohr received approval after a process that takes about twenty hours and does not involve tests of safety and effectiveness. See Brief for Respondent at 5. In contrast, the Evergreen Balloon Catheter received approval after a process that takes hundreds of hours and considers numerous such tests. See id. at 17. According to Medtronic, if the Court fails to find device-specific requirements in this case, it will ignore its own distinctions in Lohrbetween fast-paced review and detailed approval of design specifications. See id. at 21.
Is Riegel Trying to Impose Different or Additional State-Law Requirements in Violation of the MDA?
If the Court finds that device-specific requirements exist in this case, it will consider whether the state common-law claims would impose different or additional requirements. If they do not, the preemption provision of the MDA does not apply. Under the preemption provision, "no State or political subdivision of a State may [impose] . . . any requirement . . . which is different . . . or in addition" to FDA requirements. 21 U.S.C. § 360k(a).
Riegel argues that the lawsuit does not impose the kind of different or additional requirements barred by the statute. Brief for Petitioner at 34-35. She notes that the literal language of the statute only prohibits such requirements if a state or political subdivision of a state establishes them and targets them specifically at medical devices. Id. This situation is very different from a private lawsuit trying to enforce common-law duties of care that are generally applicable to all manufacturers. Id. As the Court wrote in Lohr, state-law doctrines of negligence were not developed with medical devices specifically in mind. 518 U.S. at 501. Such general causes of action came from the idea that manufacturers have a duty to prevent foreseeable harms. Id.. Therefore in Reigel's view the lawsuits are not additional or different state requirements. Brief for Petitioner, at 34-355. She urges the Court to consider that a ruling in favor of Medtronic would effectively block all consumers injured by PMA-approved devices from asserting defective design claims. See id.at 14.
Medtronic, however, argues that a successful lawsuit would impose different or additional state-law requirements on top of the FDA's requirements. Brief for Respondent at 26. Medtronic focuses on the ultimate goal of Riegel's suit. Id. If Riegel wins the right to sue, she will ask a jury to conclude that Medtronic defectively designed and manufactured the Evergreen Balloon Catheter, though the FDA found it to be reasonably safe and effective. See id. If the jurors agree and the court upholds their verdict, Riegel will be able to use a state institution to demand a damages award from Medtronic. See id. Medtronic argues that paying damages after complying with FDA regulations would mean that it was liable for violating requirements which differed and added to those of the FDA. See id. at 27.
To bolster its argument equating requirements and damages, Medtronic points to the Court's holdings outside the realm of medical devices: State "regulation can be as effectively exerted through an award of damages as through some form of preventive relief. The obligation to pay compensation can be . . . a potent method of governing conduct. . . ." See Brief for Respondent at 27, quoting San Diego Bldg. Trades Council v. Garmon, 359 U.S. 236, 247 (1959). Given this principle, Medtronic urges the Court to avoid making distinctions between private lawsuits and state regulations. See Brief for Respondent at 27. Medtronic further urges the Court to avoid feelings of sympathy for potential plaintiffs if their product liability suits are preempted, because it was within Congress' power to do so. See id. at 33.
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.
Edited by: Cecelia Sander Cannon
- Law about. Products Liability, Food and Drug Law, Negligence
- Journal of Medical Device Regulation
- National Institute of Health: Medical Device Safety