Answering a federal appeals court's call for briefs in response to the government's amicus filing in a medical device preemption case, the plaintiff and the manufacturer differed in their interpretation of the FDA's new position that federal device law bars state claims (Horn v. Thoratec Corp., 3d Cir., No. 02-4597, briefs filed 6/1/04).

At issue is the preemptive scope of the Medical Device Amendments to the Food, Drug, and Cosmetic Act. The MDA's preemption clause, Section 360k(a), bars states from establishing or allowing any requirement that is "different from or in addition to" a federal regulation applicable to a covered device.

Summary Judgment on Preemption Grounds.

Barbara Horn sued Thoratec Corp., asserting claims of negligence, strict liability, and breach of warranty. Thoratec manufactured a device called the HeartMate Implantable Left Ventricular System, which was implanted in Horn's husband, Daniel R. Horn, who was awaiting a heart transplant. FDA approved the HeartMate in 1994. Horn experienced complications with the device and died shortly after undergoing exploratory surgery to determine what caused his medical problems.

Thoratec moved for summary judgment on preemption grounds. According to the manufacturer, Horn sought to impose requirements different from, or in addition to, requirements imposed by the FDA's premarket approval process. Horn appealed the trial court's judgment for the manufacturer and the Third Circuit asked the government to submit an amicus brief detailing the FDA's position on the preemption question.

Reversing its prior position, the FDA said the premarket approval process imposes a device-specific requirement that triggers preemption. It said Horn's state claims sought to impose a different requirement, and her claims were preempted (32 PSLR 511, 5/31/04).

But according to Horn, the FDA's new position is entitled to no weight because the agency has altered its long-standing position on the preemptive scope of Section 360k(a) and because the government's brief is inconsistent with an existing FDA regulation interpreting the device law.

According to Horn, the FDA's "newfound position" contradicts arguments made to the U.S. Supreme Court in Smith Industries Medical Systems v. Kernats, (S. Ct., No. 96-1407) and the agency's previous construction of its preemption regulation, 21 C.F.R. section 808.1(d). Section 808.1(d) states that preemption is limited to instances in which the FDA "has established specific counterpart regulations or there are other specific requirements applicable to a particular device" or class of devices. The regulation also states that section 360k(a) "does not preempt State or local requirements of general applicability."

Weight Given to FDA Interpretation.

The Supreme Court in Medtronic Inc. v. Lohr, 518 U.S. 470 (1996), gave substantial weight to the FDA's interpretation of this regulation, Horn said. The FDA has never questioned the continued viability of these regulations. But the letter brief neither discusses the regulation nor explains how its new view is consistent with it.

According to Horn, the FDA acknowledges that its regulation and Medtronic limit preemption to instances in which the agency has established a "specific counterpart regulation or other specific requirement" for the product.

"It then states that PMA constitutes a specific federal requirement because, once the FDA has approved a product for marketing, the approved 'attributes are fixed in place, as they can be materially changed only with FDA approval," Horn said.

FDA Did Not Distinguish Medtronic.

Yet the same was true of the device at issue in Medtronic, the Horn brief said. Although it is true that the review process in Medtronic is less comprehensive than premarket approval, the requirements imposed on a manufacturer once a device is cleared are similar. "Either way, the manufacturer cannot generally alter the device's design before obtaining the FDA's permission."

By focusing on the differences in the route to marketing, the FDA fails to address the requirements actually imposed on manufacturers once their products reach the market, and thus fails to distinguish Medtronic, Horn argued. "Because the post-marketing requirements are the ones under which a manufacturer is operating at the time of the events giving rise to a product liability suit, it is those requirements that are relevant to the preemption analysis introduced by the FDA in its regulation and adopted by the majority opinion (and in Justice Breyer's concurrence) in Medtronic," Horn argued.

The majority opinion in Medtronicalso relied on the FDA's regulation to hold that preemption requires a counterpart state requirement specific to devices. As in Medtronic, the claims in this case are based on state-law duties of general applicability, not requirements specific to devices, Horn said.

"Not only does the FDA's letter brief fail to identify any device-specific (that is, heart-pump-specific) requirement on the federal side of the analysis, it simply ignores the 'specificity' issue on the state-law side entirely."

The specific federal and state requirements are important because Horn's claims are grounded in large part "on aspects of the HeartMate's design and labeling that were not considered in the PMA process and were not the subject of any requirements imposed through it," the brief said. For example, nothing in the PMA process forbade Thoratec from warning that the heart pump should not be installed if the sutures would face upward, toward the patient's sternum.

New View Inconsistent With MDA Purpose.

And the FDA's new view is inconsistent with the purpose of the Medical Device Amendments, Horn said. Although the agency argues that its new position promotes public policy, its "suggestion that federal regulation provides consumers more protection than state tort systems not only ignores instances of indisputable regulatory failure (e.g., the Guidant stent device, the Bjork-Shiley heart valve, the Vitek jaw implant, the Bard heart catherer) but it compares apples to oranges.

"The agency overlooks a key distinction: Injured patients cannot seek compensation through the regulatory system. State-law product liability suits are the sole means for compensation when medical devices injure or, as in Mr. Horn's case, kill the patients who use them."

For this reason, the Supreme Court has observed that Congress can and does rationally preempt state regulatory efforts, while at the same time leaving in place state-law systems for compensating individuals injured by federally regulated products and industries.

Before the MDA was enacted, individuals could seek redress for injuries caused by medical devices through state-law damages claims. When Congress enacted the Food, Drug, and Cosmetic Act in 1938, it rejected a proposal to include a private right of action for damages caused by faulty products on the ground that such a right of action already existed under state common law. When the MDA was enacted in the wake of the Dalkon Shield tragedy, Congress "said nothing to indicate that it disapproved of these suits or that it was seeking to immunize manufacturers from such suits in the future," Horn argued.

The FDA's position here is particularly extraordinary given that Congress expected that 510(k) devices would be phased out because FDA would call for PMA for all Class III devices within a few years. Class III devices are the riskiest and most likely to cause injury. "The notion that, in 1976, a in a bill sponsored by Sen. Edward Kennedy [D-Mass.] Congress intended to effect tort reform on the large scale suggested by the FDA's brief, and without any specific discussion of such an intent, is not credible," Horn asserted.

Manufacturer: Agency Reached Correct Conclusion.

Thoratec said it agrees with the FDA's conclusion and analysis in the determination that the PMA preempts state law tort claims.

The weight accorded a revised agency interpretation will depend, in part, on such factors as the thoroughness evident in the agency's consideration and the validity and persuasiveness of its reasoning, Thoratec argued.

"In light of the thoroughness of its analysis and the persuasiveness of its reasoning, the FDA's May 14 letter brief should be accorded substantial deference by the Court," the manufacturer asserted.

Agency Considered New Developments.

The agency's analysis is plainly based on a number of new developments as well as revised policy determinations, Thoratec said. The FDA's brief said it considered the decisions applying Medtronic in the seven years since that case was decided. Additionally, the FDA has determined that acceptance of Horn's arguments "would largely nullify" the MDA's express preemption clause.

Moreover, the agency concluded that the position stated in its 1997 brief "does not adequately account for the highly detailed and prescriptive nature of the PMA process and the approval order that results from it" and "does not take sufficient account of the state-of-the-art risk management principles that FDA currently follows."

Thoratec cited the FDA's observation that more risk minimization does not necessarily yield greater public health benefits because too much warning can dissuade beneficial uses of a product.

Additionally, FDA's revised position is based on "very strong public policy considerations that support the Government's view that PMA approval by FDA preempts a state common law tort suit that would, if successful, impose liability when a manufacturer is doing only what FDA approved," Thoratec said, citing the FDA's brief.

FDA legitimately believes that state tort suits threaten the framework for medical device regulation because they require law judges and juries to second-guess the balancing of benefits and risks of a specific device. In light of these policy considerations, FDA has now concluded that preemption is "compelled" in cases such as this "in order to achieve Congress's important public health protection purposes, carried out through FDA's implementation of the FDCA."

That well-considered and well-supported judgment ought to receive deference from this Court," Thoratec argued.

Thoratec also observed that, although the FDA's brief is limited to express preemption, many of the points it makes also provide powerful support for Thoratec's implied preemption arguments.

Thoratec pointed out to the Third Circuit that the FDA agrees with it about the proper disposition of the appeal, and also rejected all of Horn's arguments.

Horn's brief was filed by Allison M. Zieve and Brian Wolfman of Public Citizen Litigation Group in Washington, D.C.; and John M. Humphrey of Rieders, Travis, Humphrer, Harris, Waters & Waffenschmidt in Williamsport, Pa.

Thoratec's brief was filed by Alan Untereiner of Robbins, Russell, Englert, Orseck & Untereiner in Washington, D.C.