Maryland Injury Lawyer Blog

A new rule promulgated by the Food and Drug Administration yesterday to make drug labels more calculated to warn and inform patients and doctors also seeks to preempts state laws in failure to warn cases.

The new rule - the first revision of its kind in 25 years - includes language preempting state laws, stating that an FDA-approved label preempts conflicting or contrary state law, regulations, or decisions of a court of law for purposes of product liability litigation. This mirrors the position FDA attorneys have taken for the past 5 years in amicus briefs filed in products cases around the country arguing that agency labeling guidelines preempt state law.

The attorneys for the pharmaceutical companies for years have been pushing preemption as means of getting around their failure to properly inform health care providers of the risks associated with their drug or medical device. They have inundating plaintiffs' lawyers with mountains of briefs on preemption, arguing that it is impossible to comply with FDA approved labeling and still give a more stringent warning about a drug's risks. These lawyers further argue that more explicit warnings would frustrate congressional purpose by overdeterring the use of that drug by physicians and patients. These arguments have generally been rejected. For an example opinion, click here.

Pfizer's "impossibility of compliance" argument has been rejected because the FDA regulatory requirements only established minimum safety standards. The federal regulations themselves actually encouraged strengthened warnings in appropriate situations. 21 C.F.R. §314.70 is the federal regulation governing supplements to approved new drug applications. This regulation states that a change to labeling that "add[s] or strengthen[s] a contraindication, warning, precaution, or adverse reaction" is within the category of changes that "may be made before FDA approval." 21 C.F.R. §314.70(C)(2)(i). Plaintiffs' attorneys in drug injury cases have also historically relied 21 C.F.R. §201.57(e), which requires a warning whenever there is a "reasonable possibility" of an association between the drug and a serious, particularly life-threatening, side effect. At the time section 201.57(e) was promulgated, the FDA Commissioner made clear that "these labeling requirements do not prohibit a manufacturer, packer, relabeler, or distributor from warning health care professionals whenever possibly harmful adverse effects associated with the use of the drug are discovered...additions to labeling and advertising of additional warnings, as well as contraindications, adverse reactions, and precautions regarding the drugs, or the issuance of letters directed to health care professionals (e.g. "Dear Doctor" letters containing such information) is not prohibited by these regulations." 44 Fed.Reg. at 37,447 (June 26, 1979).

These new regulations may change the landscape. Expecting that the FDA would take this position on preemption the National Conference of State Legislatures, a bipartisan group representing state legislators, issue a statement that the FDA would be seizing authority that it did not have. But frankly, much of the law surrounding warnings and preemption revolves around interpretation of these FDA regulations. Congress may need to get involved to remedy this wrong but no one should expect that this Congress will. Accordingly, I think the hill for plaintiffs' attorneys representing drug injury victims just got steeper.