Michigan Court Excludes Expert Testimony From Treater Aand Grants Summary Judgment

This post is from the non-Reed Smith side of the blog.

Usually when we are talking about Michigan, it's to praise the Michigan Products Liability Act which cuts off civil liability for drug manufacturers "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." M.C.L. § 600.2946(5). However, under Michigan law, the distinction between a drug and a device is significant. That is because device manufacturers are not afforded the same immunity. See M.C.L. § 600.2945(b). Of course, device manufacturers do have the broad preemption provided by the Medical Device Amendments. See Riegel v. Medtronic, Inc., 552 U.S. 312, 317 (2008). So it's somewhat rare to get to post on a Michigan law case that isn't focused on the statute or preemption, but we found one - Avendt v. Covidien, Inc., 2017 WL 2868487 (E.D. Mich. Jul. 5, 2017).

Avendt involves a biologic (as opposed to synthetic) mesh product that was used by plaintiff's surgeon in plaintiff's hernia repair surgery. Plaintiff suffered complications following surgery, including an infection and chronic non-healing wound that required multiple revision surgeries and eventual removal of the product. Id. at *1. The biologic mesh product at issue was approved by the FDA via the 510(k) substantial equivalence process. It was cleared to market for use only in "Class I/Clean wounds." Id. at *17. Plaintiff did not dispute that his wound was Class I and clean, in other words this is an on-label use case. Id. at *19. In addition, the product's labeling contained a warning that the mesh could weaken or breakdown if used in a contaminated or infected wound or if exposed to "high concentrations of digestive enzymes." Id. at *17.

Against this background, plaintiff filed suit alleging that defendant's product was defective due to failure to test and subsequent failure to warn. Id. at *1. More specifically, plaintiff argued that defendant's insufficient testing led it to market the product as a "biologic mesh," when in fact it performs like a synthetic mesh which was the characteristic of the product that led to plaintiff's injuries. Id. at *22.

In support of his claim, plaintiff disclosed only one expert, Dr. Michael J. Rosen. Dr. Rosen was plaintiff's treating surgeon who performed the surgery...