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Michigan’s Virtual Immunity Statute for Drug Manufacturers Being Attacked by Lawmakers


A tort reform effort closely related to preemption is the concept of virtual immunity.  This concept was first introduced in 1995 when the Michigan legislature introduced Senate Bill 344.  This bill ultimately was passed and became Michigan’s pharmaceutical products liability statute.  (See MCLS § 600.2946(5) (2006).)  The statute essentially finds manufacturers of drugs to be immune to liability if they are found to be in compliance with the FDA.

The statute also provides in Subpart (a), if a manufacturer “intentionally withholds from or misrepresents” to the FDA any information concerning the drug that is required to be submitted, and if that drug would not have been approved by the FDA if the information was submitted, then no immunity may be granted.  (MCLS § 600.2946(5)(a).)  In addition, there can be no virtual immunity if a manufacturer pays a bribe to have its drug approved.  (MCLS § 600.2946(5)(b).) 

MCLS section 600.2946(5) has since been affirmed with Michigan’s Supreme Court case of Taylor v. SmithKline Beecham Corp., 468 Mich. 1, 658 N.W.2d 127 (2003).  That case found the statute to be constitutional. 

Now, the statute is being attacked once again.  This time, lawmakers are attempting to amend the statute and remove the immunity language from the law.  On January 24, 2007, Michigan Senators introduced Senate Bill No. 43.  One proposed amendment is to state that evidence of compliance with generally recognized and prevailing nongovernmental standards “is” admissible as opposed to “shall be” admissible.  (See, 2007 MI S.B. 43 at ¶ 1.)  In addition, and more noteworthy, the proposed amendments seek to completely delete subsection (5) of MCLS section 600.2946.  If passed, this change would effectively remove any virtual immunity on the part of drug manufacturers even if compliance with the FDA is shown.