This post comes from the Cozen O’Connor side of the blog.
Michigan’s product liability statute says that a drug is neither defective nor unreasonably dangerous, and the manufacturer and seller cannot be liable in a product liability suit, if the FDA approved it and the drug and its labeling were in compliance with that FDA approval:
In a product liability action against a manufacturer or seller, a product that is a drug is not defective or unreasonably dangerous, and the manufacturer or seller is not liable, if the drug was approved for safety and efficacy by the United States food and drug administration, and the drug and its labeling were in compliance with the United States food and drug administration’s approval at the time the drug left the control of the manufacturer or seller.
MCL 600.2946(5). There are two exceptions (which, as discussed below, present their own problems): withholding or misrepresenting information that would have resulted in FDA non-approval, and bribing the FDA:
This subsection does not apply if the defendant at any time before the event that allegedly caused the injury does any of the following:
(a) Intentionally withholds from or misrepresents to the United States food and drug administration information concerning the drug that is required to be submitted under the [FDCA] and the drug would not have been approved, or the United States food and drug administration would have withdrawn approval for the drug if the information were accurately submitted.
(b) Makes an illegal payment to an official or employee of the United States food and drug administration for the purpose of securing or maintaining approval of the drug.
MCL 600.2946(5) (a) & (b).
In the consolidated litigation concerning Lipitor, Michigan recently faced an effort by plaintiffs to expand these exceptions. There, plaintiffs alleged that the Pfizer failed to conduct post-marketing surveillance that would have changed Lipitor’s labeling regarding diabetes, arguing that this too triggered an exception to immunity under the statute. Trees v. Pfizer, Inc., 2018 Mich. App. LEXIS 3757, at *11 (Mich. Ct. App. 2018). After plaintiffs lost at summary judgment, the issued was teed up for the Court of Appeals of Michigan. The result was a per curiam affirmance.
In short, the Court of Appeals didn’t bite. It confirmed that statutory immunity attaches if the FDA approved the drug and the drug and its labeling complied with that approval:
MCL 600.2946(5) specifically provides that . . . the manufacturer or seller is not liable, if two conditions are met: (1) the drug was approved for safety and efficacy by the FDA and, (2) the drug and its labeling were in compliance with the FDA’s approval at the time the drug left the control of the manufacturer or seller.
Adopting the Sixth Circuit’s decision in Marsh v Genentech, Inc., 693 F3d 546 (6th Cir. 2012), the Court of Appeals held that immunity under Michigan’s product liability statute is based on “substantive compliance with FDA approval,” something that Pfizer did by marketing Lipitor under the FDA approved label. Plaintiffs’ allegations, on the other hand, suggested only “procedural non-compliance” with general FDA regulations on post-marketing safety information that apply to all manufacturers. That was insufficient to set aside the immunity granted by the statute, id. at *10-11, something that the Michigan Supreme Court has described as “an absolute defense to a products liability claim.” Taylor v. Smith-Kline Beecham Corp., 658 N.W.2d 127, 130-31 (Mich. 2003).
The statute meant what it said: “unless the fraud exception in subsection a or the bribery exception contained in subsection b applies (plaintiffs make no such claim here), a manufacturer or seller of a drug that has been approved by the FDA has an absolute defense to a product liability claim if the drug and its labeling were in compliance with the FDA’s approval at the time the drug left the control of the manufacturer or seller.” Id. at *12-13.
There is meaningful subtext to this decision. By arguing non-compliance with general FDA regulations on post-marketing surveillance, plaintiffs were trying to set aside the manufacturer’s statutory immunity while side-stepping implied Buckman preemption that would have almost certainly preempted a claim that the manufacturer withheld required information from the FDA. The Marsh court, relied on by the Court of appeals, took this issue head-on, as we discussed over six years ago here. So now, as it turns out, in Michigan, no matter how a plaintiff massages its allegations concerning post-marketing surveillance, the result will be the same. The manufacturer has immunity.