Defense Digest

Pennsylvania - Medical Devices & Pharmaceutical Litigation
Medical Devices And Double Secret Probation

Thoratec Corporation went through a 17-year-long FDA pre-market approval (PMA) process for its ventricular support device (HeartMate), submitting more than 90 amendments and supplements to its PMA application, to comply with every FDA requirement, and finally achieved approval.

Little did Thoratec know that, like Delta fraternity in the movie ANIMAL HOUSE (1978), it had been on Double Secret Probation. And when a part of a HeartMate device implanted at Hershey Medical Center worked its way loose and permitted an air bubble to enter the heart and travel to the brain of Daniel Ray Horn, the Public Citizen Litigation Group, on behalf of his widow, filed suit in the Middle District of Pennsylvania, alleging strict liability in tort and product liability causes of action under Pennsylvania common law, for defective design and manufacture and failure to warn of the alleged defects.

The District Court granted Thoratec's motion for summary judgment and held that these state law claims were preempted by federal law. The judgment was appealed to the Third Circuit Court of Appeals, where briefs were also submitted on behalf of the FDA, the U.S. Chamber of Commerce and the Product Liability Advisory Council.

In a 48-page opinion, two of three Third Circuit judges affirmed, in the face of a 21-page dissent. The ruling was a major victory for manufacturers of medical devices in that general tort duties under common law (e.g., to make a safe product), not specific to the device in question, were found to impose an additional burden or "requirement" above and beyond those imposed by federal law and, hence, were preempted. At issue is the question of whether states may impose a higher burden than the FDA. In reality, however, the real question is whether juries, not a state agency or a Legislature, may decide that a device is defective in its design or manufacture, even when the FDA says it is not. Some background is in order.

Medical Devices – Preemption

Background

Pursuant to the Supremacy Clause of the United States Constitution, the laws of the United States are "the supreme Law of the Land;…any Thing in the constitution or Laws of any State to the contrary notwithstanding." When a state law conflicts with a federal regulation or statute, the federal law preempts the state law. State laws, however, are not to be preempted by a federal statute "unless that [is] the clear and manifest purpose of Congress" to do so. Congress may either expressly or implicitly preempt state law. Implied preemption occurs where Congress has evinced an intent to completely occupy the field of regulation, or where a state requirement is in actual conflict with a federal requirement. We will restrict our discussion to express preemption.

Express preemption occurs when a federal statute explicitly states that it displaces state law. A federal statute that expressly addresses preemption, which also provides a reliable indication of congressional intent as to state authority, governs the preemptive scope of the legislation.

Medical Device Classification

The Medical Device Amendments of 1976 (MDA), which amended the Food, Drug and Cosmetic Act (FDCA), classifies medical devices into three categories based on the potential risk they pose to the public. Class I and II devices pose less serious risks to the public and require little to moderate regulatory oversight prior to being marketed. Class III devices are those devices that pose the risk of severe injury or death. The FDA requires manufacturers to provide "reasonable assurance" that the device is safe for medical use, which is known as the "premarket approval" or "PMA" process. Through the MDA, Congress broadened the FDA’s authority to regulate medical devices, while also allowing medical device technology to advance and not be "stifled by unnecessary restrictions."

Express Preemption

The MDA’s express preemption clause provides, "No state or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement –

If a state statutory preemption provision exists, generally, an express preemption analysis should be undertaken. Since 1996 the scope of federal preemption of state law tort claims in products liability actions for alleged injuries caused by medical devices (and prescription drugs) has been guided by the Supreme Court’s decision in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).

In Lohr, the issue before the Court was whether the MDA preempted the plaintiffs’ state common law tort claims. The medical device involved was a Class III device that received approval from the FDA through the §510k process as "substantially equivalent" to a pre-existing device that was on the market before the MDA was enacted. (Under the §510k process, and unlike the PMA process, the FDA does not evaluate the safety of a device but merely determines whether the device is "substantially equivalent" in terms of safety and effectiveness to a pre-existing device. If the FDA concludes that the device is "substantially equivalent" to a pre-existing device, the device can be marketed without further regulatory review.) Most Class II devices are marketed pursuant to the §510k process. On average, devices undergoing the less rigorous 510(k) process constitute 99.5% of the 10,000 or so applications submitted each year.

In a plurality decision, the Court held that none of the plaintiffs’ claims were preempted. The Court produced three opinions, however, without a clear majority, regarding the scope of the express preemption clause.

Justice Stevens’ opinion concluded that Congress, through section 360k, intended to preempt only "specific, conflicting state statutes and regulations rather than the general duties enforced by common-law actions." Conversely, Justice O’Connor’s opinion concluded that, consistent with prior decisions, state law tort actions were "requirements" under the language of section 360k and, therefore, the statute preempted these claims "to the extent that their recognition would impose ‘any requirement’ different from, or in addition to, FDCA requirements applicable to the device." Justice O’Connor further concluded that the state common law claim must be "specific" to medical devices to be preempted. Justice Stevens did not take this position.

Justice Breyer’s concurrence, however, has been especially important in the years since Lohr was decided. While he concurred with the plurality opinion, he also agreed with Justice O’Connor’s opinion that state common law actions constituted state requirements that conflict with federal requirements. Justice Breyer also predicted that preemption would most likely occur when there was an actual conflict between the state "requirement" and the federal one.

But, in Lohr there was no preemption because of the lack of specificity of the federal regulations applicable to the device at issue (a cardiac pacemaker). The Medtronic pacemaker only received §510k clearance and did not go through the full PMA process. The majority was disinclined to preempt state tort claims regarding a device that had not gone through the intense "safety and effectiveness" scrutiny of the PMA process. Justice Stevens recognized that the §510k process is "focused on equivalence, not safety," and as a result, "substantial equivalence determinations provide little protection to the public."

Since Lohr, however, the general landscape of the preemption doctrine has been changing. The FDA’s interjection of its view on preemption into private litigation through amicus brief filings has added further complexity to the federal preemption analysis in the drug and medical device area. One such example is the case under discussion, which did involve the full PMA review process.

In Horn v. Thoratec Corp., 376 F.3d 163 (2004), the Third Circuit held that the requirements the FDA imposed on the HeartMate were "precisely ‘the sort of concerns regarding a specific device’ which the Supreme Court intimated would give rise to preemption under section 360k(a)."

Before the Third Circuit, the FDA filed an amicus curiae letter brief stating it had a strong interest in seeing its decisions regarding medical products implemented. The Agency contended that the PMA process is detailed, covers every aspect of an approved product to assure reasonable safety and effectiveness, and creates specific federal requirements.

The court concluded there was "no doubt" that the long PMA process undertaken by Thoratec "imposed mandatory conditions … pertaining to the HeartMate’s manufacturing, packaging, storage, labeling, distribution and advertising" that triggered federal preemption. The plaintiff’s state tort claims were preempted because they sought to impose requirements that differed from the federal requirements.

In dissenting, Judge Fuentes stated, "Section 360k(a) preemption works only against state requirements that are 'different from, or in addition to' federal requirements. In my view, because Horn's suit is not seeking to impose any specific requirement on the HeartMate, it is not preempted. Additionally, I believe that allowing common-law liability would simply have the effect of encouraging TCI and other device manufacturers to go above and beyond FDA standards, and this effect would clearly not contradict the MDA's purpose of enhancing medical device safety. … Horn argues that a state common-law claim is preempted only if the state claim is device-specific and the purportedly preempting federal regulation is device-specific. TCI responds that the District Court correctly analyzed only the federal side of the equation, because Medtronic made that the only relevant inquiry. The Circuits are split on this question, with the Seventh and Ninth Circuits holding that preemption requires only a device-specific federal regulation, … and the Tenth Circuit holding that preemption additionally requires a device-specific state law…"

Describing Medtronic v. Lohr as a "fractured opinion," Judge Fuentes further argued that "[t]he FDA regulations concerning preemption clarify that preemption only occurs when the FDA "has established specific counterpart regulations or there are other specific requirements applicable to a particular device under the act." The preemption clause does not "preempt State or local requirements of general applicability where the purpose of the requirement relates either to other products in addition to devices (e.g., [the UCC]) or to unfair trade practices in which the requirements are not limited to devices."

Yet, Judge Fuentes did concede, "It is true that Horn's cause of action may have the indirect consequence of holding the HeartMate to a higher standard than does the FDA." But he argued that this is not inconsistent with Congressional intent in enacting the Medical Device Amendments, which was "to protect consumers by ensuring the safety and effectiveness of medical devices," rather than to protect manufacturers from excessive regulation or from product liability actions that might hamper the development of medical devices.

The stage is, therefore, set for the United States Supreme Court to resolve the conflict between the Third, Sixth and Ninth Circuits on the one hand, and the Tenth Circuit on the other in the setting where a state law imposes higher standards than the FDA does on a medical device. (Ironically, some states, such as New Jersey, have gone the other way and enacted "tort reform" statutes which bar state products liability claims for inadequate product warnings where the FDA has approved the warning in question.) Given the changes in the composition of the high court since Medtronic, it is likely that the majority view among the circuits will be upheld. In Lohr, now-retired Justice O'Connor was of the view that state law requirements must be device-specific in order to be preempted. However, Justice Breyer agreed with a four-Justice bloc (Stevens, Kennedy, Souter and Ginsburg) that the term "requirement" in § 360k(a) is ambiguous and does not entail the preemption of all common-law tort suits holding manufacturers to higher standards than the FDA. Therefore, even with two new Bush appointees, the result is not a foregone conclusion.

Since about 50 PMA submissions are made each year, and fewer are approved, the chances of such a case presenting itself as a vehicle for the high court are questionable. In the meantime, whether medical device manufacturers are on Double Secret Probation remains a secret.

*Steve is a shareholder in our King of Prussia, PA office. He can be reached at (610) 354-8254 or saryan@mdwcg.com.