Watching for Wyeth: High Court Decision Could Have Strong Implications for Medical Device Manufacturers

At the beginning of this month, the U.S. Supreme Court heard oral arguments in Wyeth v. Levine, potentially a landmark case regarding federal preemption of state tort lawsuits filed against manufacturers of drugs and biologics.¹ In Wyeth v. Levine, the plaintiff Diana Levine claimed that she was injured by the inappropriate administration of Wyeth's antinausea drug Phenergan, which caused her to develop gangrene and resulted in the amputation of a portion of her arm.

Wyeth v. Levine follows closely on the heels of Riegel v. Medtronic Inc., in which the Court barred a suit claiming a New York man suffered permanent injury when a heart catheter burst during an angioplasty procedure.² While both cases deal with the extent of federal preemption of state law, drugs and medical devices are governed by similar, but slightly different, provisions. In the case of medical devices, federal law expressly provides for the preemptionof state tort claims under certain conditions. But in the case of drugs or combination products (that is, medical devices with drug or biologic elements), there is no analogous explicit protection..

Preludes

In Riegel, the Supreme Court ruled that federal medical device law preempts state tort claims against manufacturers whose products are approved through FDA's premarket approval (PMA) process. Under the Medical Device Amendments to the Federal Food Drug and Cosmetic Act (FD&C Act), federal law bars the imposition of any state requirements that are different from or in addition to requirements established by FDA.³

The Supreme Court had previously held that this express preemption provision does not bar state law claims regarding medical devices cleared through FDA's premarket notification (510(k)) process, because that process does not create device-specific federal requirements that trigger preemption. But in that case, Medtronic Inc. v. Lohr, the Supreme Court left unanswered the question of whether the PMA process—which is more rigorous than the 510(k) process—creates the kind of device-specific federal requirements needed for preemption.⁴

In the Riegel case, Donna Riegel argued that claims arising out of injuries caused by the bursting of a balloon catheter during an angioplasty procedure should be allowed, even though the catheter had been approved via the PMA process. The Supreme Court rejected that argument and held that the express preemption language governing medical devices barred such litigation.

The Riegel decision aligns with the majority of cases in which courts have considered whether approval via the PMA process bars state claims. It is widely considered an important legal victory for device manufacturers.

The Pharma Twist

Federal law does not provide drug manufacturers with the same immunity from state tort liability that was available to the defendant in Riegel, because the FD&C Act contains no express federal preemption provision for human drug products. In the pending Wyeth v. Levine case, a Vermont jury found that the Phenergan label should have more strongly warned physicians against intravenous  administration via injection because of the known risk of gangrene associated with that procedure.. Wyeth maintains that Levine's state tort claims are preempted, because FDA approved the Phenergan label with warnings that the agency deemed appropriate.

Possibly complicating the Supreme Court's analysis, in a surprise move (just days before the scheduled oral arguments) Levine's counsel requested that the Court also consider a just-released report by the staff of the House Committee on Oversight and Government Reform.⁵ The staff report, which is not a report of the committee as a whole, asserts that under the Bush administration, FDA ill-advisedly retreated from its longstanding position that private litigation can provide “an additional layer of protection against unsafe drugs.” The report describes documents illustrating the concern of two FDA officials who questioned the premises of agency policy in support of federal preemption of state tort lawsuits.

The report also discusses the issue of preemption in light of FDA's August 2008 rule allowing drug manufacturers to change a product's label to reflect newly acquired information or to add or strengthen language regarding contraindications, precautions, warnings, or adverse reactions, provided there is a sufficient causal association with the product.⁶ The new rule permits manufacturers to submit label changes through ‘changes being effected' supplements, rather than through supplements requiring prior approval. This means that such label changes will occur prior to FDA review.

The agency's rationale for this change was to ensure that scientifically accurate information appears on FDA-approved labeling. Consumer advocacy groups have argued that the new rule shields manufacturers from product liability. FDA disagrees, stating in the preamble to the regulation that the new rule merely formalizes FDA's existing labeling standards and policies, and in no way changes the labeling standards under which manufacturers are required to provide warnings regarding risks.

The internal criticisms described in the staff report include the charge that the agency's arguments in favor of preemption were “based on a false assumption that the FDA-approved labeling is fully accurate and up-to-date in a real-time basis.” An FDA official also contested the proposition that, without preemption, drug manufacturers would err on the side of adding too much risk information and warnings. “We rarely find ourselves in situations where sponsors want to disclose more risk information than we think necessary,” the official noted.

Among some observers, the timing of the staff report's release, and its reliance on the statements of just two FDA officials, have raised concern. Those observers view the report's use as a preemptive strike in support of plaintiff Levine and other opponents of federal preemption of state tort lawsuits.

Device Implications

Although the immediate implications of a decision in Wyeth v. Levine are greatest for drug companies, there also are potential ramifications for medical device manufacturers. The most obvious is the impact the decision will have on future cases involving state tort claims where PMA approval is ambiguous.

For example, if the Court determines that Wyeth knew or should have known of a foreseeable, serious, and irreversible injury associated with intravenous administration of Phenergan, this might suggest that FDA's approval was based on incomplete information. Arguably, under such circumstances FDA's approval would not preempt a state tort claim regarding the drug. One assumes that this would also be the case for PMA devices, in spite of the explicit provisions in the FD&C Act and the holding in Riegel.

Also of great practical import to device manufacturers is the extent to which the Court's ruling may inform strategic decisions in the case of combination products. For most combination products, a single marketing application is sufficient for the product's approval. If the Court rejects Wyeth's claim of preemption, will manufacturers of combination products with device components that are subject to premarket approval insist on submission of a PMA rather than another type of marketing application? Will manufacturers be more likely to claim that the product's primary mode of action—that is, its most important therapeutic action—is that associated with a device rather than a drug or biologic?

Conclusion

While a decision in Wyeth v. Levine is expected this term, industry observers also expect that the coming political changes in the White House and Congress will increase the likelihood of new legislation to respond to Riegel v. Medtonic and Wyeth v. Levine. Any such legislation is expected to seek to minimize the impact that both decisions have on product liability lawsuits.

Legislative efforts in the last Congress are instructive. Last summer, in the wake of the Riegel v. Medtronic decision, Congressional Democrats proposed antipreemption bills that would have preserved state tort liability.⁷ A defense victory in Wyeth v. Levine could serve to spur on additional antipreemption legislation activities.

References

1. U.S. no. 06-1249.

2. U.S. no. 06-179.

3. Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act.

4. 518 U.S. 470 (1996).

5. FDA Career Staff Objected to Agency Preemption Policies, majority staff report (Washington, DC: U.S. House of Representatives, Committee on Oversight and Government Reform, 2008 [cited 19 November 2008]); available from Internet: http://oversight.house.gov/documents/20081029102934.pdf.

6. “Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices,” Federal Register 73, no. 164 (Rockville, MD: FDA, August 22, 2008 [cited 19 November 2008]): 49603–49610; available from Internet: http://www.setonresourcecenter.com/register/2008/aug/22/49603A.pdf.

7. Medical Device Safety Act of 2008 (HR 6381; S 3398).

Karen A. Gibbs is a partner in the healthcare and antitrust groups of Crowell & Moring LLP (Irvine, CA); she can be reached directly at [email protected] and 949/798-1329. Heather L. Hodges, counsel, is a member of the firm's torts and product risk management practice groups; Cathy L. Burgess is a counsel in the firm's healthcare group; both attorneys practice in the firm's Washington, DC, office.

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