The day after we ran our post alerting readers to the threat suddenly being posed by House language concerning preemption, “The Hill” blog ran a much more detailed piece on the same subject.

The Hills’ report provides the exact text of the anti-preemption language that’s been circulating in the draft House of Representatives bills:

“Nothing in this act or the amendments made by this act may be construed as having any legal effect on any cause of action for damages under the law of any state (including statutes, regulations, and common law).”

According to The Hill, ATLA – the plaintiffs’ trial lawyers’ group that now goes by the more politically correct (or at least more ambiguous) name of “American Association for Justice” – says they are responsible for this little addition. Both the language of the amendment and its source leave no doubt that the intent is to roll back well-established preemption precedent with respect to pre-market approved medical devices and to prevent the development of a more favorable preemption environment in the prescription drug area.

This is definitely anti-preemption language. Similar language in OSHA reads:

Nothing in this chapter shall be construed. . .to enlarge or diminish or affect in any other manner the common law or statutory rights, duties, or liabilities of employers
and employees under any law with respect to injuries, diseases, or death of employees arising out of, or in the course of, employment.

29 U.S.C. § 653(b)(4). That OSHA language has been interpreted as restricting the preemptive effects of OSHA regulations in tort suits. E.g., Lindsey v. Caterpillar, Inc., 480 F.3d 202, 209 (3d Cir. 2007); Pedraza v. Shell Oil Co., 942 F.2d 48, 53 (1st Cir. 1991); In re Welding Fume Products Liability Litigation, 364 F.Supp.2d 669, 686 (N.D. Ohio 2005). The trial lawyers are smart guys. They’re hardly ignorant of the OSHA example. We’re equally aware that this seemingly innocuous language in the House version of FDARA would open the door to similar arguments being made against preemption under the FDCA.

The timing is significant as well. The trial lawyers stealth amendment came into being shortly after: (1) the solicitor general advised the Supreme Court not to hear the appeal in Riegel v. Medtronic, a case in which the Second Circuit had followed the majority rule recognizing extensive PMA preemption (see our post here on Riegel); and (2) the Supreme Court asked for the SG’s views on whether to accept an appeal in Levine v. Wyeth, a case presenting the prescription drug preemption issue that involves the FDA’s final rule (see our post here on Levine). Because the SG almost always advocates the position of the affected federal agency, it is not at all unlikely that the SG might recommend that the Court take and reverse Levine.

The Supreme Court’s a pretty pro-business court at the moment, as yesterday’s antitrust/securities decision suggests:

We believe it fair to conclude that, where conduct at the core of the marketing of new securities is at issue; where securities regulators proceed with great care to distinguish the encouraged and permissible from the forbidden; where the threat of antitrust lawsuits, through error and disincentive, could seriously alter underwriter conduct in undesirable ways, to allow an antitrust lawsuit would threaten serious harm to the efficient functioning of the securities markets.

Credit Suisse Securities (USA) LLC v. Billing, 2007 WL 1730141, at *13 (U.S. June 18, 2007). It’s entirely possigle that Court could issue a similar opinion substituting “FDA” for “securities regulators,” “drugs/devices” for “securities,” and “tort” for “antitrust.”

Thus the trial lawyers’ anti-preeemption poison pill. This is serious business because the FDA has recognized that tort suits undermine industry’s ability to comply with regulatory mandates – and would equally (if not worse) complicate industry’s ability to comply with the new regulatory authority that FDARA would confer.

What does this tell us? To us it demonstrates that ATLA’s pretense that they’re seeking to protect consumer “safety” is nothing more than that. If they want to sink the Senate’s carefully crafted FDA-strengthing bill – which would increase safety-related review of drugs (and secondarily devices) in real, concrete ways, this will do it.

As the Hill’s post makes clear, the anti-preemption language will cause both industry and the FDA itself to walk away from what otherwise seems to be a major increase in FDA oversight powers, particularly for newly-approved products. Obviously the trial lawyers and their fellow travelers don’t really care about increasing safety – they care about increasing lawsuits. Preemption restricts lawsuits, so preemption must go.