We’ve seen an increase in allegations of “unjust enrichment,” particularly in strike suits seeking recovery of purely economic loss. A number of states don’t even recognize this theory as a separate cause of action (according to Bexis’ book, these include California, New Jersey, Pennsylvania, and Tennessee), and others preclude it when there is an “adequate
Some states have statutes that we find very helpful. Louisiana has the Louisiana Product Liability Act, with its strong exclusivity clause; New Jersey’s PLA provides some very helpful presumptions, including a presumption of adequacy for FDA-compliant drug labeling. We have often cited the Texas statute that creates a presumption that pharmaceutical manufacturers and sellers are…
Here’s another guest post this time by Clem C. Trischler and Jason M. Reefer, of Pietragallo Gordon, about a recent litigation involving the Michigan immunity statute and when a “drug” (according to plaintiffs) isn’t a “drug.” You’ll like it – the plaintiff lost.
As always our intrepid contributors deserve all the credit, and any blame, although there’s not likely to be any this time around.
We cheer them again
We cheer and cheer again
For Michigan, we cheer for Michigan
We cheer with might and main
We cheer, cheer, cheer
With might and main we cheer!
Those words were written in 1898 by Louis Ebel after the University of Michigan’s football team defeated the heavily-favored Maroons by one point. But if you didn’t know the history of “The Victors,” you might have thought the lyrics were written by Bexis. That is because “[i]n 1995, the [Michigan] Legislature amended M.C.L. 600.2946 to provide immunity for products-liability claims against a manufacturer or seller of a drug that was approved for safety and efficacy by the FDA and labeled in compliance with FDA standards.” Attorney Gen. v. Merck Sharp & Dohme Corp., 807 N.W.2d 343, 347 (Mich. Ct. App.), appeal denied, 803 N.W.2d 696 (2011).
Quite simply, “the Michigan Legislature made a policy judgment intending to shield drug manufacturers from liability.” Devore v. Pfizer Inc., 58 A.D.3d 138, 141 (N.Y. App. Div. 2008). Accord Taylor v. Smithkline Beecham Corp., 658 N.W.2d 127, 131 (Mich. 2003) (“[T]he Legislature has determined that a drug manufacturer or seller that has properly obtained FDA approval of a drug product has acted sufficiently prudently so that no tort liability may lie.”). As such, unless a plaintiff alleges and proves an exception, “MCL 600.2946(5) now establishes an absolute defense for drug manufacturers and sellers in a product liability action . . . .” Duronio v. Merck & Co.,, No. 267003, 2006 WL 1628516, at *3 (Mich. Ct. App. June 13, 2006).
Those exceptions are (1) selling the drug after the FDA withdraws it from the market; (2) bribing an FDA official; and (3) committing fraud on the FDA. See M.C.L. §600.2946(5)(a)-(b). The first two should rarely arise, and the third is preempted by federal law. See Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961, 966 (6th Cir. 2004) (holding that a drug manufacturer is immune from suit unless “the FDA itself determines that a fraud has been committed on the agency during the regulatory-approval process”) citing Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 350 (2001) (emphasis in original).
We haven’t heard the folks on the other side say it much, since ATRA’s pretty much taken over squatter’s rights to the phrase “Hellhole Jurisdiction,” but if they listed theirs, we suspect that Michigan would be right up there at the top of their list – at least where prescription drug product liability…