Conning the IADC Newsletters

Defense Counsel Journal, July 2004 | Go to article overview

Conning the IADC Newsletters


Recognizing that a wide range of practical and helpful material appears in the newsletters prepared by committees of the International Association of Defense Counsel, this department highlights interesting topics covered in recent newsletters and presents excerpts from them.

Pre-emption as a Defense In Pharmaceutical Litigation

Writing in the March issue of the newsletter of the Drug, Device and Biotech Committee, Linda E. Maichl and Joseph P. Thomas of Ulmer & Berne, Cincinnati, tell about the latest in federal pre-emption:

Historically, the pre-emption defense has met with little or no success in pharmaceutical litigation. While it has been asserted successfully in cases involving Class III medical devices under the Medical Device Amendments (MDA) to the federal Food, Drug and Cosmetic Act (FDCA), in cases involving pharmaceuticals courts have found that the Food and Drug Administration's labeling impose only "minimum" standards that are open to supplementation by state law through jury verdicts enforcing the duty to warn.

But in Ehlis v. Shire Richwood Inc., 233 F.Supp.2d 1189 (N.D. 2002), a case now on appeal to the Eighth Circuit, a federal court held that state law failure-to-warn claims relating to a pioneer drug are preempted by the FDCA. In addition, the FDA has filed amicus briefs advocating preemption of certain claims in three separate cases, mentioned later, involving pharmaceutical products.

A close look at the provisions of the FDCA, the regulations promulgated by the federal Food and Drug Administration, and case law on pre-emption shows that, in fact, pre-emption is a viable defense to product liability claims against pharmaceutical companies based on a failure to warn.

Types of pre-emption

Pre-emption generally is referred to in terms of "express" or "implied." Express pre-emption occurs when Congress, in enacting a federal statute, expresses a clear intent to pre-empt state law. Pacific Gas & Electric Co. v. State Energy Resources Conservation & Development Commission, 461 U.S. 190 (1983).

Implied pre-emption can occur in one of two ways. First, if Congress reveals an intent to "occupy the field" of regulation, as in Silkwood v. Kerr-McGee Corp., 464 U.S. 238, 248 (1984). That type of implied pre-emption occurs when there is a "scheme of federal regulation ... so pervasive as to make reasonable the inference that Congress left no room for the states to supplement it" or "because the act of Congress may touch a field in which the federal interest is so dominant that the federal system will be assumed to preclude enforcement of state laws on the same subject." Fidelity Federal Savings & Loan Ass'n v. Cuesta, 458 U.S. 141, 153 (1982).

A second type of implied pre-emption occurs when state law actually conflicts with federal law. This occurs when "compliance with both federal and state regulations is a physical impossibility" (Florida Lime & Avocado Growers Inc. v. Paul, 373 U.S. 132, 142-43 (1963)), or where state law "stands as an obstacle to the accomplishments and execution of the full purposes and objectives of Congress" (Hines v. Davidowitz, 312 U.S. 52, 67 (1941).

Regulation of pharmaceutical products

Under the FDCA, 21 U.S.C. [section] 301 et seq., which was enacted in 1938, a drug could not be marketed without the submission of a new drug application, known as an NDA. In 1962, Congress amended the FDCA to require affirmative approval by the FDA of all new drug applications before they were marketed. The 1962 amendments required applicants to show that their products were both safe and effective. On or after October 10, 1962, no new drugs could be marketed without an approved NDA containing sufficient safety information and substantial evidence establishing the drug's effectiveness for its intended use. 57 Fed.Reg. 17950.

The information required in a pharmaceutical product's labeling is enumerated in 21 C. …

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