Riegel v. Medtronic: Vaccination Against Medical Device Liability?

Commentary by Sandeep Mangalmurti MD, JD PGY-2

It is difficult to overstate the importance of the Supreme Court’s recent decision in Riegel v. Medtronic [1] the first of a series of cases that may fundamentally alter medical liability lawsuits for decades to come.

The case involves Charles Riegel, who in 1996 suffered complications secondary to coronary angioplasty. During the procedure, the angioplasty balloon burst, and the patient required emergent coronary artery bypass graft to save his life. He later sued Medtronic, the manufacturer of the balloon, for negligence in producing a defective device, and for failure to completely warn patients of the risks. Sadly, Mr. Riegel died before his case reached the Court, but his wife continued the lawsuit on his behalf.

The defendant, Medtronic, presented a relatively straightforward defense: it claimed that Mr. Riegel’s lawsuit was barred by federal law. Specifically, it claimed that since the FDA had approved the device after a rigorous series of premarketing tests and declared it safe for use, Medtronic was then immune from state lawsuits alleging its device might be dangerous.

To fully appreciate the implications of both the plaintiff and defendant’s position, some background is needed. The FDA’s authority to regulate medical devices is derived from the Medical Devices Amendments of 1976, appended to the Food, Drug and Cosmetic Act. This Amendment was a response to the deaths and injuries caused by the Dalkon Shield [2], and was an attempt by the FDA to expand its traditional oversight of medications to medical devices as well.

One unanswered question was where to place this Amendment in the larger framework of liability law. Simply put, if a device was declared as safe and effective by the FDA, could a jury then hold the manufacturer of that device liable for making a defective product? Is there a second standard for safety to be found in the court system, or does the rigorous pre-market testing of the FDA immunize a manufacturer from later lawsuits? [3]

There are powerful arguments on either side of this debate. Issues of legal and constitutional interpretation aside, there are significant public policy issues at stake.

First, allowing the FDA testing to pre-empt all future lawsuits places a great deal of confidence in pre-market testing, confidence that may be misplaced. Recent examinations by the Institute of Medicine [4] and Government Accounting Office [5] assert that the FDA is currently incapable of effectively protecting the public against unsafe drugs and medical devices.

Even if operating under ideal circumstances, the FDA may find its job impossible to perform alone. Litigation may play an invaluable role in uncovering risks and dangers that only become apparent after the approval process is completed. In fact, there is evidence to suggest that lawsuits have helped uncover unseen dangers in medical products, and forced both manufacturers and agencies to act more decisively. For example, more complete labeling of the risks of paroxetine was due directly to patient lawsuits. [6]

However, allowing such lawsuits may have long term effects on public health by decreasing incentives to innovate. As Chief Justice Roberts wrote in an amicus brief prior to his elevation to the High Court:

“The divergent patchwork of state products liability laws in this country imposes a ‘liability tax’ that is passed on to all of us in the form of increased product costs and insurance premiums. In the case of medical products, however, products liability laws exact an additional, far greater societal toll: they stunt the development of new and improved medical products and drive existing products from the marketplace. Thus, many potentially life-saving medical products are not developed by manufacturers today because of liability concerns, and existing, FDA-cleared products are pulled from the market by manufacturers facing massive liability in suits brought by users…The quality of patient care in this country suffers as a result.” [7]

Furthermore, it is important to remember that the pre-emption against lawsuits is not a blanket immunization; it applies only to devices that have undergone pre-market testing by the FDA. In general, only the newest and most innovative devices undergo such testing; many others are approved without this high level of scrutiny. If pre-market testing provides protection against lawsuits, perhaps more manufacturers will request it…the upshot might be more universal screening of products before they even reach the public. Whether this decision has that effect remains to be seen.

Ultimately in Riegel, the Court (with Justice Scalia writing for an 8 to 1 majority) held that state lawsuits against medical devices manufacturers are pre-empted by federal law, provided the device underwent FDA pre-market approval. Noting that state statutory law would almost certainly be pre-empted by federal regulation of medical devices, the Court argues that state tort law is even less deserving of deference. In doing so, Justice Scalia argues that juries may not be the best guardians of public health:

State tort law that requires a manufacturer’s catheters to be safer, but hence less effective, than the model the FDA has approved disrupts that federal scheme no less than state regulatory law to the same effect…A state statute, or a regulation adopted by a state agency, could at least be expected to apply cost-benefit analysis to that applied by the experts at the FDA: How many more lives will be saved by a device which, along with its greater effectiveness, brings a greater risk of harm? A jury, on the other hand, sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in Court. [8]

Possibly foreshadowing future decisions, the Court left open the possibility that these liability protections may be extended to pharmaceutical companies as well. The Court specifically states that it has not ruled on this matter, and has already agreed to hear a case that is directly on point.

In what is likely the continuation of an attempt by the Court to fundamental reshape the medical liability landscape, the Court will hear Levine v. Wyeth Pharmaceuticals in October, 2008. The facts of this case are saddening; the plaintiff, Diana Levine, was an otherwise healthy 62 year old musician who visited a Vermont hospital for a migraine headache. The patient was given Phenergan for nausea, but received the dose intravenously instead of intramuscularly. Unfortunately, her catheter had been accidentally place in her artery, and even worse, the medication was given IV push. The patient’s vasculature was so damaged by the bolus of Phenergan that she eventually required limb amputation. She sued Wyeth Pharmaceuticals, the manufacturer of Phenergan, claiming that the dangers of IV push administration were never mentioned on the drug label. Wyeth Pharmaceuticals counters that the labeling for Phenergan was pre-approved by the FDA, and there is no additional labeling standards to which it should be required to conform. The medical and legal communities eagerly await oral arguments later this year.

References:

[1] 552 U.S. ___(2008)

[2] The Dalkon Shield was an intra-uterine contraceptive removed from the market in 1974 after it was associated with an increased risk of pelvic inflammatory disease and septic abortion.

[3] The Court partially addressed this issue in Medtronic v. Lohr, 518 U.S. 470 (1996) where it held that the Medical Devices Amendment did not preclude state liability claims. However, this case differs from Riegel v. Medtronic in that device in the former did not undergo extensive pre-market testing, and was instead approved as being “substantially equivalent” to previously approved devices.

[4] The Future of Drug Safety: Promoting and Protecting the Health of the Public, The Institute of Medicine, Released September 22, 2006

[5] Medical Devices: Challenges for FDA in Conducting Manufacturer Inspections, Statement of Marcia Crosse, Director, Health Care. General Accounting Office, Testimony Before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives. Released January, 29, 2008.

[6] Kesselheim A, et al. The Role of Litigation in Defining Drug Risks, JAMA 297; 3:308-311 (2007)

[7] Brief for The Center for Patient Advocacy and the California Health Care Institute as Amici Curiae Supporting Petitioner/Cross-Respondent, Medtronic v. Lohr, 518 U.S.470 (1996) (Nos. 95-754,95-886)

[8] Riegel v. Medtronic 552 U.S. ___(2008)

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