Preemption of state law claims, particularly in the area of medical devices and drugs, has been a hot topic lately. MassTortDefense has posted on it here and here, and there are numerous good posts on the topic at Drug and Device Law.
In the latest development, Congressman Henry A. Waxman (D-Calif.), Chair of the House Committee on Oversight and Government Reform recently sent a letter to Food and Drug Administration Commissioner Andrew C. von Eschenbach, requesting information about the agency’s stance on federal preemption issues under the Bush administration.
The FDA believes, correctly, that state product liability lawsuits which challenge or undermine or invite conduct inconsistent with the federal agency’s authority can have a detrimental effect on public health. Waxman calls this a “reversal of FDA’s long-standing position on preemption.” Waxman’s view about the FDA’s position isn’t so firmly grounded, as seen in the back and forth between the majority and the dissent in Colacicco v. Apotex Inc., 2008 WL 927848 (3d Cir. Apr. 8, 2008), concerning whether the FDA has been “inconsistent” in its positions towards preemption. Going back to the Clinton era (Bill), for example, the FDA has repeatedly stated that FDA regulations may displace both state legislative requirements and state common law duties. In 2000, the FDA fretted that consumers in court would have to prove that harm was linked to the substance based on a standard that might vary by jurisdiction or at the “whim of a jury.” 65 Fed. Reg. 43269, 43278-79 (FDA July 13, 2000). And in an FDA final rule regarding FDA-mandated adverse event reports in state-law civil litigation, the agency stated that implied preemption was appropriate because state or local laws, rules, regulations, or other requirements would impede FDA’s ability to monitor product safety after approval to ensure that human drug products, biologics, and medical devices are safe and effective for their intended uses. “Thus, under principles of preemption law, congressional intent to preempt State law can be inferred.” 60 Fed. Reg. 16962, 16963 (FDA Apr. 3, 1995). See also 59 Fed. Reg. 3944, 3948 (FDA Jan. 27, 1994).
Nevertheless, Waxman is asking for numerous documents from the agency, including:
-all documents since Jan. 20, 2001, concerning communications between FDA and private individuals about preemption;
-all documents since that date, relating to internal FDA communications about preemption;
-all documents since Jan. 20, 2001, relating to communications between FDA officials and officials in the Department of HHS, the White House, and other federal agencies about preemption;
-all amicus briefs since Jan. 20, 2001, filed by FDA in product liability suits; and
-all drafts since that date of the final drug labeling rules issued Jan. 24, 2006.
Liberal Democrats in Congress have been buzzing about the Supreme Court’s decision in Riegel v. Medtronic Inc., in which the Court held that federal law preempted state-law claims against the manufacturer of a medical device that went through the Food and Drug Administration’s premarket approval process. And they introduced H.R. 6381 that would reverse the effects of Riegel in medical device lawsuits. Waxman’s letter also comes in anticipation of the Court’s consideration of the extent to which the Food, Drug and Cosmetic Act impliedly preempts state law claims against drug makers. See Wyeth v. Levine, U.S., No. 06-1249, review granted 1/18/08. Of course, DOJ/FDA filed an amicus brief arguing in favor of preemption in that case.