Mensing

Failure To Warn Claims: The Two-Front War Against the Manufacturers Of Prescription Drugs

Stephen J. Imbriglia

Newark

New York

Trenton

Philadelphia

Wilmington

Pliva, Inc. v. Mensing: Whether federal law preempts state law causes of action based on a claim that a generic drug approved by the Food and Drug Administration was inadequately labeled.

Wyeth v. Levine, 129 S. Ct. 118 (2009) Federal law does not preempt state tort claims against brand-name manufacturers for failure to warn. State-law failure-to-warn suits posed no obstacles to federal objectives under FDCA. Also, Congress did not enact an express preemption provision despite its awareness of the prevalence of state tort litigation.

Federal regulations provide a mechanism for the company to change its label and seek FDA approval later.

Mensing: Do generic manufacturers have the same opportunities and requirements to effect labeling changes through the FDA as brand-name manufacturers?

Do state-law failure-to-warn cases pose an obstacle to federal objectives under the Hatch-Waxman Amendments to the FDCA?

U.S. Constitution, Article VI, Clause 2 “This Constitution, and the Laws of the United States which shall be made in Pursuance thereof…or which shall be made, under the authority of the United States, shall be the supreme Law of the Land; and the Judges in every State shall be bound thereby, any…Law of any State to the Contrary notwithstanding.”

Federal Preemption A. Express B. Implied 1. Field Preemption 2. Conflict Preemption

a. Impossibility Preemption b. Obstacle Preemption

Mensing Gladys Mensing, Julie Demahy were prescribed generic form of Reglan, metaclopramide, for gastric disorders. Both took the drug for approximately four years before developing tardive dyskinesia, a serious neurological disorder. Mensing, Demahy bring state-law products liability claims for failure to warm.

Allegation: Despite mounting evidence that long-term use carried a risk of tardive dyskinesia far greater than indicated on the label, no metoclopramide manufacturer changed the labeling to enhance the warning.

FDA Action On February 26, 2009, FDA ordered manufacturers of Reglan and metaclopramide to add “black box” warning advising of increased risk of tardive dyskinesia from long-term metaclopramide use.

Circuit Court Decisions Fifth, Eighth Circuits: Claims against generics not preempted. Mensing v. Wyeth, Inc., 588 F.3d 603 (8th Cir. 2009) Demahy v. Actavis, Inc., 593 F.3d 428 (5th Cir. 2010)

Generic Manufacturers Argue: 1. Generic Manufacturers cannot unilaterally add safety information to labeling. For a generic drug to be approved, the manufacturer must show that the proposed labeling is “the same” as that for the listed drug. FDA regulations provide for revocation of prior approval, if once on the market, a generic drug’s labeling is no longer consistent with that for the listed drug.

2. Generic manufacturers, unlike brand-name manufacturers, cannot issue letters to prescribing doctors with supplemental information.

Respondents Argue: 1. Congress did not intend to preempt state-law tort claims. There is no express preemption in HatchWaxman Amendments.

2. Generic manufacturers have ways to comply with both federal and state law, for example, the PAS process, in which a generic manufacturer submits an application to FDA for a change to ANDA, and the CBE process, in which a generic company may petition for increased label warnings.

Justice Scalia

The Second Front Liability for another company’s product? Plaintiffs contend that brand-name companies can be held liable for products of generics.

Arguing that claims against brand companies are not product-liability claims, but classic claims for fraud and misrepresentation, plaintiffs contend that defendants knew that prescriptions would be filled with generic products; knew that consumers would be harmed; and took no steps to inform the medical community of earlier misrepresentations about metoclopramide.

Conte v. Wyeth, 168 Cal. App. 4th 89 (2008): Brand drug manufacturer owes a duty to use due care when providing product warnings, and this duty extends not only to consumers of its products but to consumers of generic products.

Conte “foreseeability analysis”: Because it is foreseeable that a prescription written in reliance on a brand manufacturer’s product information would be filled with a generic product, there is a duty running from the brand manufacturer to the consumer of the generic product. That the brand manufacturer did not manufacture or sell the metoclopramide Conte ingested does not relieve the company of “its general duty to use due care in disseminating product information to those it knows or should know are likely to be harmed as a result of their physician’s reliance on that information.”

The Prevailing View Conte is distinctly minority view. See Foster v. American Home Products Corp., 29 F.3d 165 (4th Cir. 1994): (1) plaintiffs’ claims an attempt to evade product liability law; (2) nothing in federal regulatory scheme imposes liability on brand manufacturer for competitor’s generic product; and (3) brand manufacturer has no duty to consumers of other companies’ products. Foster has been frequently followed. See, e.g., Finnicum v. Wyeth, Inc., 708 F. Supp. 2d 616 (E.D. Texas 2010).

Concluding Points Opportunities for implied preemption defense in failureto-warn cases appear to be narrowing. Without an explicit agency decision, establishing preemption will be difficult. Plaintiffs are attempting to expand failure-to-warn liability beyond manufacturers and sellers. By focusing on the concept of duty, and dispelling the notion that foreseeability equates with duty, product manufacturers and sellers will prevail.