An MD&DI March 1997 Feature
To protect themselves against product liability, medical device manufacturers should understand the implications of the Supreme Court's decision.
The Supreme Court's recent and highly publicized decision in Medtronic, Inc. v. Lohr has attracted the attention of the medical device industry because the Court clarified the defenses that medical device companies may use when battling product liability suits.1 The Court's ruling restricted the federal preemption defense--the argument that federal regulatory requirements bar product liability claims. Although the full scope of these restrictions is debatable, the Supreme Court did indicate that the federal preemption defense typically will not protect manufacturers against product liability claims involving allegations that a manufacturer violated FDA regulations. As a result, manufacturers can expect that increasing numbers of product
liability plaintiffs will allege such violations as a basis for their lawsuits. This shift in focus for product liability exposure makes it more critical than ever for manufacturers to ensure and document regulatory compliance.
PRODUCT LIABILITY AND REGULATORY COMPLIANCE BEFORE LOHR
Before the early 1990s, most medical device product liability cases proceeded somewhat independently of FDA compliance issues. Although regulatory compliance may have been relevant in certain cases, it did not necessarily determine liability. Thus, compliance with FDA regulations was not a defense to a product liability suit, and violation of agency regulations frequently did not establish liability conclusively, although violations were taken into account as evidence of liability.
In the early 1990s, manufacturers increasingly asserted the federal preemption defense to product liability claims involving allegations of FDA regulatory violations. The basis for the federal preemption defense is the U.S. Constitution, which provides that "the Laws of the United States . . . shall be the supreme Law of the Land."2 Under this supremacy clause, the U.S. Congress has the power to pass legislation that invalidates, or preempts, state law in a particular area. Congress included a preemption provision in section 521 of the Food, Drug, and Cosmetic Act (FD&C Act). This provision invalidates state law requirements that are "different from, or in addition to" federal requirements applicable to a medical device.
The premise of the preemption defense is that section 521 invalidates product liability claims. The Supreme Court made clear more than 50 years ago that the types of claims asserted in product liability suits involve the application of state law.3 Because product liability claims impose state law requirements, they are as vulnerable to preemption under section 521 as state statutes and regulations.
Before the Supreme Court's Lohr decision last June, many lower courts decided that the federal preemption defense bars product liability claims, including those asserting violations of FDA regulations. One classic example is the decision of the U.S. Court of Appeals for the First Circuit in Talbott v. C.R. Bard, Inc., in which the court held that federal preemption bars product liability claims alleging regulatory violations, even when the manufacturer has admitted committing those violations.4 Courts like the First Circuit, which affirmed preemption of claims alleging regulatory violations, concluded that the federal government has the unique authority to enforce FDA's regulations, and that private plaintiffs simply are not authorized to police regulatory compliance.
According to these courts, one major reason for exclusive federal control of compliance is that it maintains uniform court interpretations of FDA regulatory requirements; in contrast, allowing private plaintiffs to bring lawsuits interpreting FDA regulations would inevitably lead to differing, and perhaps contradictory, interpretations by courts across the country. Because the purpose of the federal preemption provision is to maintain a uniform rule of law at the federal level, these courts concluded that claims asserting regulatory violations are preempted.
PREEMPTION IN THE WAKE OF LOHR
In Lohr, the Supreme Court sharply limited the broad protections that many lower courts had extended against claims asserting FDA regulatory violations. The Court concluded that nothing in the FD&C Act preemption provision denies "a traditional damages remedy for violations of common-law [product liability] duties when those duties parallel federal requirements."5 The Court emphasized that this conclusion was at "an early stage in the litigation," leaving open the possibility that such claims could be preempted under other facts in other cases.6 But the thrust of the opinion significantly restricted federal preemption of claims asserting regulatory violations.
Manufacturers can expect that the Supreme Court's decision may well lead to more claims asserting regulatory violations. With the preemption doctrine often unavailable as a defense to these claims, plaintiffs will be freer to assert them successfully. In addition, plaintiffs will likely find these claims attractive, because other types of claims are still barred by the preemption defense. Justice Breyer stated in Lohr that he did not expect that "future incidents of [FD&C Act] preemption of common-law [product liability] claims will be 'few' or 'rare,'" and four other justices agreed that the FD&C Act "clearly preempts any state common-law [product liability] action" to the same extent that it preempts an equivalent state statute or regulation.7 With federal preemption available as a defense against many other types of claims, plaintiffs may be encouraged by the Lohr decision to couch their claims as alleged violations of FDA requirements.
PROTECTING YOUR COMPANY
Manufacturers can help protect themselves against such claims by ensuring regulatory compliance through use of effective standard operating procedures and appropriately trained personnel and by gaining a thorough understanding of relevant FDA requirements. However, companies can implement additional procedures that will offer still more protection.
Document Objections to FDA Allegations of Noncompliance. Every time FDA issues an FDA-483, warning letter, or any other document alleging possible regulatory violations, there is an opportunity for plaintiffs' attorneys to assert
a claim for regulatory noncompliance. When manufacturers have legitimate disagreements with FDA over regulatory requirements, they should make that clear in correspondence with the agency. Even if the agency's position is supportable, manufacturers should address FDA's concerns without admitting violations; such admissions could have significant ramifications in later product liability litigation.
Use Attorney Oversight for Regulatory Compliance Audits. Although FDA has not typically requested access to manufacturers' regulatory compliance audit reports, the same is not true for plaintiffs' attorneys. Under court rules authorizing broad discovery, plaintiffs' attorneys will be allowed access to relevant audit reports unless they are legally privileged. Depending on their contents, these audit reports could dramatically increase product liability exposure. The manufacturer's best protection is to generate the audit report in a manner that is privileged and therefore protected from disclosure. The most significant protections are provided by the attorney-client privilege, which precludes discovery of communications between attorneys and clients for the purpose of obtaining legal advice. With attorney involvement in the audit plan, most audit reports can be generated as privileged documents.
Document FDA Opinions on Regulatory Compliance. Manufacturers should make contemporaneous records of favorable comments from the agency regarding regulatory compliance. Whether made in management conferences at the close of an inspection or in meetings at district offices or at one of the centers, favorable FDA comments can add credibility to a manufacturer's claims of regulatory compliance. It may also be worth documenting circumstances in which the agency does not object to company practices (even if FDA does not make favorable comments). Examples include extensive inspections that end without the issuance of an FDA-483, or important meetings with the agency in which no corrective actions are requested.
Obtain Agency Inspection Documents under the Freedom of Information Act (FOIA). Establishment inspection reports and other agency inspection documents are available under FOIA. Manufacturers should routinely file FOIA requests for these documents following an inspection. If the documents support the company's regulatory compliance, they will be helpful in protecting against product liability claims alleging noncompliance. If the documents contain errors that could entice plaintiffs to make allegations of regulatory noncompliance, manufacturers should correct the record promptly through correspondence with the agency.
Although manufacturers always have needed to emphasize regulatory compliance, potential product liability exposure following the Lohr decision makes compliance even more critical. The remedies imposed by FDA for regulatory violations are substantial, but they typically do not involve monetary payments. Although the FD&C Act's medical device provisions were amended in 1990 to provide for payment of civil penalties, for example, the agency has not emphasized this enforcement tool to date. In contrast, product liability claims asserting regulatory noncompliance can impose financial burdens that in some cases are large enough to threaten the manufacturer's very existence. The manufacturer's best protection against these claims is scrupulous adherence to regulatory requirements.
1. Medtronic, Inc. v. Lohr, 116 SCt 2240 (1996).
2. U.S. Constitution, art. VI, cl. 2.
3. Erie Railroad Co. v. Tompkins, 304 US 64 (1938).
4. 63 F3d 25 (1st Cir 1995), cert. dismissed, 116 SCt 1892 (1996).
5. 116 SCt 2255.
6. 116 SCt 2256.
7. 116 SCt 2262-63.