The Back Door is Open …

Ok, so you spend millions of dollars on Congressional elections trying to avoid responsibility for making a product that a jury may determine is defective or unreasonably dangerous and you can’t get enough votes to make it happen.

What’s a Pharma to do?

Go through the back door, via regulation, with some help from your friends at the FDA. As of June 30 new regulations were placed in force to provide more concise and better organized patient information package insert sheets. In return for the huge inconvenience this places on drug manufacturers, the FDA included language that would exempt drug manufacturers from state product liability.

Sidley Austin distributed this newsletter piece about the changes.

The rule itself does not preempt state claims; the FDA’s attempt to preempt state lawsuits is found in the preamble to the new regulations. An excerpt:

“. . . FDA believes that at least the following claims would be preempted by its regulation of prescription drug labeling: (1) Claims that a drug sponsor breached an obligation to warn by failing to put in Highlights or otherwise emphasize any information the substance of which appears anywhere in the labeling; (2) claims that a drug sponsor breached an obligation to warn by failing to include in an advertisement any information the substance of which appears anywhere in the labeling, in those cases where a drug’s sponsor has used Highlights consistently with FDA draft guidance regarding the ”brief summary” in direct-to-consumer advertising . . . ; (3) claims that a sponsor breached an obligation to warn by failing to include contraindications or warnings that are not supported by evidence that meets the standards set forth in this rule, including ㋔ 201.57(c)(5) (requiring that contraindications reflect ”[k]nown hazards and not theoretical possibilities”) and (c)(7); (4) claims that a drug sponsor breached an obligation to warn by failing to include a statement in labeling or in advertising, the substance of which had been proposed to FDA for inclusion in labeling, if that statement was not required by FDA at the time plaintiff claims the sponsor had an obligation to warn (unless FDA has made a finding that the sponsor withheld material information relating to the proposed warning before plaintiff claims the sponsor had the obligation to warn); (5) claims that a drug sponsor breached an obligation to warn by failing to include in labeling or in advertising a statement the substance of which FDA has prohibited in labeling or advertising; and (6) claims that a drug’s sponsor breached an obligation to plaintiff by making statements that FDA approved for inclusion in the drug’s label (unless FDA has made a finding that the sponsor withheld material information relating to the statement). Preemption would include not only claims against manufacturers as described above, but also against health care practitioners for claims related to dissemination of risk information to patients beyond what is included in the labeling. (See, e.g., Bowman v. Songer, 820 P.2d 1110 (Col. 1991).)”