The Deregulatory Effects of Preempting Tort Litigation: Title and subTitle BreakFDA Regulation of Medical Devices

Charles Riegel underwent coronary angioplasty in 1996, shortly after sustaining a myocardial infarction. Mr Riegel's physician inserted the Evergreen balloon catheter, a medical device approved by the US Food and Drug Administration (FDA), into his patient's coronary artery in an attempt to dilate the artery, but the catheter ruptured. Mr Riegel developed complete heart block, was placed on life support, and underwent emergency coronary artery bypass graft surgery. He sued Medtronic, the manufacturer of the device, alleging that the company was liable under New York tort law in designing, testing, inspecting, labeling, and marketing the catheter. On February 20, 2008, the Supreme Court held that the Medical Device Amendments of 1976 (MDA) bars common law claims challenging the safety or effectiveness of a medical device marketed in a form that received premarket approval from the FDA. Riegel v Medtronic Inc has broad implications for patient safety because it removes all means of judicial recourse for most consumers injured by defective medical devices.¹

The Federal Food, Drug, and Cosmetic Act (FDCA) has long required FDA approval for the introduction of new drugs to the market, but historically states have regulated medical devices. That changed with the enactment of the MDA in 1976 in light of the proliferation of complex devices and high-profile failures, most notably the Dalkon Shield intrauterine device, which was associated with multiple infections, unwanted pregnancies, miscarriages, and deaths. The MDA imposes various levels of FDA oversight. Class I devices (eg, bandages and gloves) are subject to “general controls” such as labeling; class II devices (eg, powered wheelchairs and surgical drapes) are subject to “special controls” such as performance standards; and class III devices (those used to support human life or prevent impairment of human health, such as heart valves, defibrillators, and pacemakers) are generally subject to premarket approval based on finding “a reasonable assurance” of the device's “safety and effectiveness.” This standard is lower than that for pharmaceuticals, which may be approved only if they are shown to be safe and effective for their intended use.

The MDA expressly preempts, or supersedes, any state “requirement which is different from, or in addition to” MDA requirements and that “relate to the safety or effectiveness of the device.”¹ The Supreme Court interprets the MDA's preemption in a manner “substantially informed” by FDA regulations, which state that preemption occurs only when the agency has established “specific counterpart regulations” or other specific requirements applicable to that particular device.² Justice Scalia, writing for the Court in Riegel, found that the MDA preempts Mr Riegel's tort action because the FDA's premarket approval process establishes specific safety “requirements” and that New York's common law claims impose “different or additional requirements.”¹ The Court cited its 1992 decision in Cipollone v Liggett Group Inc, in which it found that because Congress required cigarette companies to have warning labels, most smokers could not bring tort suits in state courts,³ demonstrating the potentially wide deregulatory effects of preemption.

Riegel v Medtronic Inc leaves most injured patients without a remedy because Congress has not authorized any federal products liability claims or any other type of compensation mechanism, and the Supreme Court has eliminated almost all state claims. States may still impose general requirements that are not targeted to specific medical devices, but the Court made clear that tort law claims are quite specific and therefore preempted. States also may create a cause of action for claims premised on a violation of FDA regulations, but that still creates virtual immunity from products liability suits if a company receives FDA premarket approval, regardless of the harms caused by the device. In effect, the Supreme Court is authorizing businesses to use federal patient safety legislation as a shield against state tort law designed to safeguard the public's health.

Sponsors of the MDA protested that Congress never intended to bar state tort actions. The overriding purpose of the legislation was to provide additional protection to consumers, not to withhold existing safeguards against defectively designed or labeled devices. Rather, Congress sought merely to ban states from implementing their own premarket approval processes, which many states had enacted in response to public revulsion over the Dalkon Shield and other high-profile medical device failures.⁴ If states imposed safety requirements that conflicted with FDA rules, the resulting regulatory confusion would thwart national policy. But the idea that FDA approval would effectively bar patients who were seriously injured by defective medical devices from suing was never envisaged.

For 25 years, the FDA had held the view that Congress wanted federal approval and tort liability to operate simultaneously, “each providing a significant, yet distinct, layer of consumer protection.”⁵ The FDA reversed its position in 2004, an action that some charged was a political decision influenced by the White House, intended to give the industry protection from tort litigation.⁶ The Court's decision has the “perverse effect” of granting broad immunity “to an entire industry that, in the judgment of Congress, needed more stringent regulation.”² As Justice Ginsburg noted in dissent in Riegel, “state premarket regulation of medical devices, not any design to suppress tort suits, accounts for Congress' inclusion of a preemption clause in the MDA.”¹

The Supreme Court characterized the FDA premarket approval process as “rigorous,” entailing an average of 1200 hours of review of a device's properties as well as of manufacturing methods and research studies. But the court's confidence that the agency has the expertise, resources, and information necessary to ensure the safety of food, drugs, and medical devices is misplaced. The FDA is responsible for the safety of approximately 80% of food sold and all human drugs, vaccines, and medical devices—goods worth about $1 trillion per year, or about 25% of all consumer spending.⁷ Yet Congress has starved the agency of funds, even as the FDA's functions have expanded vastly and public concern for the safety of foods, drugs, and medical devices has increased. The agency has only 9000 employees nationwide and needs twice its current level of funding to properly fulfill its mission.⁷ The FDA is similarly hampered by organizational problems, lack of leadership, and improper political influence in decisions that are supposed to be science-based, as apparently occurred when it denied approval for over-the-counter sale of the emergency contraception drug “plan B” to women younger than 18 years.

The FDA's own blue ribbon panel concluded that “the scientific demands on the Agency far exceed its capacity to respond. This imbalance is imposing a significant risk to the integrity of the . . . regulatory system, and hence the safety of the public.”⁷ The Institute of Medicine similarly concluded that the FDA “lacks the resources needed to accomplish its large and complex mission today, let alone to position itself for an increasingly challenging future.”⁸

These resource deficits have resulted in high-profile regulatory failures involving serious safety risks of recently approved cyclooxygenase 2 selective nonsteroidal anti-inflammatory drugs (refecoxib, valdecoxib) and type 2 diabetes medications (rosiglitazone). Litigation revealed that manufacturers might have known about these risks but did not promptly inform the FDA. The safety risks of medical devices may be higher than those for pharmaceuticals due to the more limited premarket testing of medical devices. In recent years, manufacturers have recalled defibrillators, pacemakers, heart valves, hip and knee prostheses, and heart pumps, “all of which have exacted a serious toll on patients who face the daunting prospect of removal and replacement surgery.”⁹

Furthermore, the premarket approval process can offer, at best, only a modest assurance of long-term safety. At the time of review, the FDA may not have all the information or sufficient human resources needed to assess those data it does have. More importantly, drugs and medical devices have not been widely tested in the population, which can reveal deficiencies in safety and effectiveness that were unknown at the time of approval. Because the agency is unable to require rigorous postmarket surveillance and thereby provide critical ongoing oversight, patients are left unprotected once a device enters the market. Ideally, the FDA would have the power and resources to systematically review and monitor the safety and effectiveness of products over time. But the tort system is currently needed to fill the glaring gaps in agency oversight.

Given the FDA's apparently close relationship with industry as well as its scarcity of resources, vast increase in congressionally mandated responsibilities, and politicization, it is not surprising that the agency has rapidly lost prestige. As recently as the 1970s, 80% of the public expressed confidence in the FDA, but by 2006, that proportion had dropped to 36%.⁷

Justice Scalia disparaged juries, stating that they weigh only the dangers and not the benefits of a product.¹ He preferred a cost-benefit calculation that permits the FDA to approve a device if that device offers great benefits in light of available alternatives, even if it poses significant safety hazards. Yet, in thinking about tort law as a tool of public health, it is important to emphasize the role of litigation in preventing risk behavior and providing incentives for safer products. State tort law provides a system of civil justice designed to compensate patients, deter unreasonably hazardous conduct, and encourage innovation in product design, packaging, labeling, and advertising. Tort law, therefore, can be seen as closing regulatory gaps in the FDA premarket approval process and providing some much-needed postmarketing surveillance.¹⁰

Certainly, tort litigation is imperfect, as it can increase industry costs, discourage commercialization, or delay introduction of products onto the market. Nevertheless, the tort system offers several clear benefits for patients and the health system. Tort law assists patients who have been harmed by defective products, providing compensation for medical costs, pain, and disability. Currently there is no government compensation program for patients injured by defective drugs or medical devices similar to the childhood vaccine compensation system. Furthermore, tort law deters industry negligence and deception and encourages disclosure and innovation to improve product safety. Common law failure-to-warn claims, for example, create incentives for companies to revise their labels in light of risks that were unknown at the time of approval or risks that are greater than originally thought, thereby alerting physicians and patients to potential hazards.⁹ If corporations know they are immune from lawsuits, they may be less likely to conscientiously monitor a product's safety, disclose health hazards, and promptly recall hazardous devices from the market.

The tort system has another benefit that is not often fully recognized—through the discovery process, it can compel corporations to disclose everything they know, or reasonably should know, about the product's safety and effectiveness. Tort law, therefore, offers a backup system to uncover vital information about industry practices, as it did so successfully with tobacco litigation. The discovery process provides a “feedback loop” to the FDA, which in the past has changed its regulatory decisions in light of information revealed in court. Litigation can thus be socially and politically mobilizing by uncovering poor industry practices, drawing the attention of the public and policy makers, and driving regulatory reform.

From a common sense perspective, there are deep concerns about the positions staked out by the FDA and the Supreme Court. Is it reasonable for a consumer protection agency, with the concurrence of the nation's highest court, to conclude that injured patients should be effectively barred from recourse against companies that aggressively market hazardous drugs or medical devices knowing the risks? The public might express even greater skepticism if tort immunity were granted to corporations that defraud the agency. But that may be precisely the position of the Supreme Court, which permits a corporation to use FDA approval as a shield against litigation even if it deceived the agency into granting that approval.

In Buckman Co v Plaintiffs' Legal Committee, the Court held that state law fraud-on-the-FDA claims were preempted by the MDA.¹¹ Chief Justice Rehnquist dismissed plaintiffs' claims that the FDA would not have approved the use of orthopedic bone screws had the manufacturer not made fraudulent representations to the agency. Arguably, fraud should vitiate any protection the industry could gain from FDA approval. Certainly, the FDA has the power to punish fraud against the agency, but that still leaves injured patients without a remedy or compensation for their injuries. In the post-Riegel world, moreover, lawsuits likely will be dismissed before plaintiffs' lawyers can use discovery to prove manufacturers deceived the FDA by providing false information or withholding relevant information. The prospect of less discovery is also concerning because the agency is increasingly reliant on the industry's own data and analysis throughout the regulatory process. Notably, for pharmaceuticals, the FDA already relies on industry user fees to fund the agency's review.

In Warner-Lambert Co v Kent, announced weeks after Riegel, the Supreme Court was asked to determine whether a state products liability statute that creates a “safe harbor” from liability for FDA-approved drugs, but that carves out an exception for fraud, was also preempted. The Court was deadlocked in a 4-to-4 vote, which does not create a precedent. The tied vote had the effect of upholding the Second Circuit decision, allowing the suit to proceed because the tort claims “depend primarily on traditional and preexisting tort sources, not at all on fraud-on-the-FDA cause of action.”¹² Chief Justice Roberts did not participate in the Court's decision, leaving open the possibility that if the issue comes back before the Court, it could be decided in favor of preemption.

Following Riegel, the courts immediately began considering whether to dismiss thousands of claims against medical device manufacturers, involving products ranging from heart valves, artificial hips, spinal disks, and defibrillators to drug-coated heart stents and stimulators to control pain. To avoid dismissal, plaintiffs' lawyers will have to claim that a device was made improperly, in violation of FDA specifications—a so-called manufacturing as opposed to a “design” defect. Going forward, the FDA reviews dozens, if not hundreds, of new devices annually, which could receive protection against liability. The FDA is even more extensively involved in pharmaceutical approvals. If the courts were to grant drugs the same liability protections offered to medical devices, it would have more systemic effects on the health care system.

The MDA preempts state law that conflicts with federal safety requirements, but the FDCA, which regulates pharmaceuticals, has no express preemption clause. During its 2008-2009 term, the Supreme Court will hear Wyeth v Levine, asking whether the FDCA impliedly preempts state products liability claims against pharmaceutical manufacturers. Diana Levine developed gangrene and had her arm amputated after promethazine was administered for treatment of migraine and associated nausea through an intravenous push rather than intramuscular injection. She argues that Wyeth did not provide adequate warnings, but the company seeks tort immunity from any state common law duty to provide a warning stronger than that required by the FDA.¹³

The FDA is urging the Supreme Court to preempt stronger state regulation of pharmaceuticals. If the FDA's view were to prevail, patients would have no safety net in the likely event that the agency fails to detect and correct safety hazards. After all, there are 11 000 FDA-regulated drugs, with nearly 100 more approved each year, making it virtually impossible to monitor comprehensively the performance of all drugs on the market.¹⁴ As Kessler and Vladeck argue, “Given the FDA's inability to police drug safety effectively on its own, we question the wisdom of the FDA's efforts to restrict or eliminate the complementary discipline placed on the market by litigation.”¹⁴

In the end, the public is caught in a catch-22. At the same time the FDA is widely perceived as ineffectual and the hazards of widely used drugs and devices are revealed, the Supreme Court is making it more difficult for patients to discover wrongdoing, even fraud, and to be fairly compensated for their avoidable injuries.¹⁵