Lower Courts Navigate Medical Device Preemption After Riegel v. Medtronic

Since the Supreme Court's 2008 decision in Riegel v. Medtronic—which held that the Medical Device Amendments to the Food, Drug, and Cosmetic Act (MDA) preempt many tort claims against manufacturers of PMA-approved devices—lower courts have struggled to determine which claims are still viable.

Riegel says that states may provide a damages remedy for claims that "parallel" federal requirements under the MDA; in other words, a state-law claim may proceed, in theory, as long as it does not interfere with the federal regulatory scheme. But the Supreme Court provided no guidance regarding which state-law claims are "parallel." Consequently, plaintiffs have continued to bring product liability claims against manufacturers of PMA-approved devices, arguing that such claims do not add to or conflict with FDA requirements, but rather constitute a form of "parallel enforcement."

Lower courts are now left with the challenging task of sorting out which state-law claims "parallel" FDA regulations and which ones interfere. Not surprisingly, courts have disagreed on where to draw the line.

Lower Courts Are Divided, But Most Favor Preemption

Two views on the scope of federal preemption have emerged since Riegel: one that favors a broad reading of permissible "parallel" tort claims (which allows more tort claims to proceed), and another that is more deferential to the FDA's decision to approve the device (which leads to more cases being dismissed as preempted).

An Indiana federal court adopted the first view in Hofts v. Howmedica. In that case, the court held that the MDA does not prevent a state from providing a damages remedy for claims premised on a violation of the FDCA, and on that basis allowed a product liability claim involving a PMA-approved device to proceed. According to this view, a medical device manufacturer could be liable under state tort law for any departure from its approved PMA. Thus, under Hofts, common-law tort claims that many thought were preempted by Riegel—such as strict liability and implied warranties—may proceed.

The second view was first articulated in In re Medtronic Sprint Fidelis Leads Product Liability Litigation and further developed in Riley v. Cordis Corp. This approach agrees with Hofts that if the medical device manufacturer's alleged conduct is prohibited by the FDCA, then a state-law claim premised on that conduct is not expressly preempted by the MDA. In fact, to be a "parallel claim" and avoid express preemption the claim must be based on a violation of the FDCA.

Where Sprint Fidelis and Riley diverge from Hofts is in their recognition that state-law claims may also be impliedly preempted. This stance gains support from the Supreme Court's 2001 decision in Buckman Co. v. Plaintiffs' Legal Committee. In Buckman, the Court found that because enforcing the FDCA is considered the province of the federal government, there is no private right of action under the FDCA. Consequently, a private litigant cannot sue a defendant for violating the FDCA. Similarly, a private litigant cannot bring a state-law claim against a defendant when the state-law claim is, in essence, a claim for violating the FDCA. In other words, the conduct on which the claim is premised must give rise to liability under state law even if the FDCA had never been enacted.

In summary, Sprint Fidelis and Riley find that Riegel and Buckman leave a narrow gap through which a plaintiff's state-law claim must fit for it to escape preemption. To survive, the plaintiff must claim that the device manufacturer's conduct violates the FDCA (to avoid express preemption by the MDA), while not interfering with the FDA's enforcement of the FDCA (to avoid implied preemption under Buckman).

The obvious question, then, is what types of claims are not preempted under the Sprint Fidelis and Riley? The answer largely depends on future decisions in similar cases. Sprint Fidelis, however, provides some guidance today. A state statute providing a remedy for a violation of the FDCA, for example, may escape federal preemption. But generalized common law theories, such as strict liability, negligence and breach of implied warranties do not, as long as the product at issue has an approved PMA.

To date, no other court has followed Hofts. Instead, a majority of courts agree with Sprint Fidelis and Riley and hold that most state-law claims are preempted. It is still unclear, however, whether the Buckman implied preemption doctrine cited in Sprint Fidelis and Riley will play a major role in future cases.

Preemption of Express Warranties

The broad reading most courts give Riegel leaves product liability plaintiffs with few options for redress against medical device manufacturers. Riegel, however, did not address express warranties. After finding that the MDA did not preempt the plaintiff's express warranty claim, the district court in Riegel granted the defendant's motion for summary judgment on that issue. As a result, plaintiffs continue to plead express warranties claiming that they "parallel" the federal requirements under the MDA.

Most courts agree that express warranties made by the manufacturer that exceed the scope of the PMA process are not preempted by the MDA. Yet the courts remain divided on the preemption of express warranty claims stemming from a label approved during the PMA process.

A minority of courts follow the district of New Jersey's decision in Huber v. Howmedica in finding that the MDA does not preempt claims based onexpress warranties. These courts cite the Supreme Court's decision in Cipollone v. Liggett Group, Inc. In the context of the Federal Cigarette Labeling and Advertising Act, Cipollone states that "the ‘requirements' imposed by an express warranty are not ‘imposed under state law' but rather are imposed by the warrantor." Consequently, "a common-law remedy for a contractual commitment voluntarily undertaken should not be regarded as a ‘requirement imposed under state law…." Based on this theory, Huber argues that the enforcement of an express warranty, even if based on a label approved during the PMA process, is not a requirement "in addition to" a federally imposed requirement. Instead, an express warranty claim "parallels" the federal requirements under the MDA by enforcing the very language approved during the PMA process.

However, most courts foreclose plaintiffs from recovering under an express warranty claim. These courts reason that permitting a plaintiff's express warranty claim to go forward would contradict the FDA's determination that the representations made on the label were appropriate, and thereby impose requirements "in addition to" those imposed by federal law. The conflict may require the Supreme Court to clarify the law surrounding the preemption of express warranties for medical devices.

Medical Device Safety Act of 2009

The thorny issues that have arisen since Riegel may eventually be mooted by Congress. In early March, the Medical Device and Safety Act of 2009 was introduced in the House of Representatives. The act, if adopted, would amend the MDA to state that "[n]othing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any State." Put simply, the act would effectively overrule Riegel. So far, only one subcommittee has held hearings and no congressional action is pending. But a number of prominent politicians have promised to roll back Riegel, so a battle in Congress over the scope of device preemption seems likely to occur in the near future.