Conning the IADC Newsletters.

• Position: International Association of Defense Counsel

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.F.R. [section] 201.57, which details one aspect of the requirements that must be satisfied to obtain approval of an NDA. With its NDA, a pharmaceutical manufacturer must include labeling that comports with [section] 201.57. The FDA reviews the NDA, including the proposed labeling, and advises the manufacturer what changes to make before approval will be granted. Approval of an NDA is within the sole purview of the FDA.

Once the product is approved, the manufacturer must submit supplements to the NDA in order to effectuate changes. Although some changes require pre-approval by the FDA, other changes may be made pending FDA approval of the supplement. In both instances, however, FDA approval is mandated. 21 C.F.R. [section] 324.70. If approval is not forthcoming, the manufacturer is not permitted to make the change unilaterally. Those rules apply to all facets of the approved NDA.

With regard to labeling, 21 C.F.R. [section] 314.70(c) provides that changes in labeling to "add or strengthen a contraindication, warning, precaution, or adverse reaction" may be made before the FDA approves the supplement, but if the change is not approved, the manufacturer must revise its labeling to reflect the original content.

In 1979, FDA promulgated regulations designating a required format for the physician labeling of prescription drugs. 44 Fed.Reg. 37434. They provided standards for the types of information that must appear in each section of the required format. The FDA's intention in issuing the regulations was "to improve prescription drug labeling by establishing standards that [would] bring all prescription drug labeling up to the level of the better labeling currently available." The new regulations required pharmaceutical companies to utilize standardized terminology and structure when setting forth information relating to their products, and they are very specific as to the content to be disclosed under the headings established. 21 C.F.R. [subsection] 201.56 and 201.57.

Pre-emption case law

The U.S. Supreme Court's decisions in Medtronic Inc. v. Lohr, 518 U.S. 470 (1996), and Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001), as well as the Eighth Circuit's decision in Brooks v. Howmedica, 273 F.3d 785 (8th Cir. 2001), cert. denied, 535 U.S. 1056 (2002), provide the framework for a preemption defense in cases involving pharmaceuticals.

Lohr

The plaintiffs in Lohr asserted claims of negligence and strict liability with respect to the design, manufacture and labeling of a pacemaker, including claims of common law failure to warn and violations of FDA regulations. Medtronic, the manufacturer of the pacemaker at issue, argued that the failure to warn claim was pre-empted by the express pre-emption provision of the MDA.

The Supreme Court split in its decision. Justice Breyer was the swing vote, joining first one group then the other. Justice Stevens wrote the opinion for a four-justice plurality, stating that Section 360k would rarely, if ever, pre-empt state common law claims. Justice O'Connor, joined by four dissenting justices, disagreed, stating that Section 360k pre-empts any state requirement, including a common law duty, that is "different from, or in addition to" a federal requirement. Although Justice Breyer agreed that state common law claims can be subject to pre-emption under section 360k, he joined Justice Stevens and the plurality in ruling on Lohr's claim for failure to warn.

Justice Stevens, in a portion of the opinion joined in by Justice Breyer, examined, and was "substantially informed" by, the regulations promulgated by the FDA, which state the agency's interpretation of Section 360k and attempt to clarify the intended meaning of the statutory language.

21 C.F.R. [section] 808.1(d) (2000) states in pertinent part:

(d) State or local requirements are preempted only when the [FDA] has established specific counterpart regulations or there are other specific requirements applicable to a particular device under the act, thereby making any existing divergent State or local requirements applicable to the device different from, or in addition to, the specific [FDA] requirements.... (1) [[section] 360k] does not pre-empt State or local requirements of general applicability where the purpose of the requirement relates either to other products in addition to devices ... or to unfair trade practices in which the requirements are not limited to devices.... (6)(ii) Generally, [[section] 360k] does not preempt a State or local requirement prohibiting the manufacture of ... misbranded devices [unless] such a prohibition has the effect of establishing a substantive requirement for a specific device, e.g., a specific labeling requirement, [that is] different from, or in addition to, a Federal requirement established under the act.... Following his examination, Justice Stevens described various requirements for finding pre-emption under the MDA. According to the Stevens majority, state requirements are pre-empted only if they relate to the "safety or effectiveness of the device." In other words, state requirements must be "with respect to" medical devices, and state requirements of "general applicability" are subject to pre-emption only if they have the effect of establishing a substantive requirement for a specific device. In addition, federal requirements must be "applicable to the device" at issue--that is, they must be "specific counterpart regulations" or specific to the particular device. State law will be pre-empted under the MDA when a "particular state requirement threatens to interfere with a specific federal interest."

As Lohr's failure to warn claim was too general, the Court found it was not preempted. The Court noted that all manufacturers have a duty to warn users of potential dangers associated with a product, but it found that general duty was "not specifically developed 'with respect to' medical devices." As a result, the Court concluded Medtronic's duty to warn with respect to the pacemaker was not the type of "requirement" that Congress and the...