Friday, February 18, 2011

A Mixed Bag In The Kugel Mesh Litigation

We have mentioned before on occasion rulings in the pretrial phase of the Kugel Mesh Hernia Repair Patch Litigation, MDL No. 1842 (D.R.I.). But we haven’t talked much about the litigation, maybe because we had a hard time figuring out how they made mesh out of kugel, until we learned that the mesh is actually named for Dr. Robert Kugel, its inventor. The defense prevailed in the first trial in that litigation, but the second trial resulted in a verdict for plaintiffs. Thorpe v. Davol, Inc., 2011 WL 470613 (D.R.I. Feb. 4, 2011). The court’s ruling on post-trial motions, like some kugel (but presumably not like Dr. Kugel), has good stuff and not as good stuff in it.

The plaintiff had a hernia, which was repaired with an XL CK Patch in 2005. The plaintiff had problems with the area around the repair over the next three years, and the XL CK Patch was eventually removed in 2008. During the same time period, Davol received and investigated problems with the XL CK Patch, which led to a recall in late 2005 and a conclusion that the instructions for use were deficient. The jury awarded plaintiff $1.3 million and his wife $200,000 for loss of consortium.

The good part is that the court granted defendants’ motion for judgment as a matter of law on the inadequate warning claim. The court found that even if Davol had known its product was defective and its instructions for use were inadequate before plaintiff received the CK Patch, the plaintiffs still had to prove these problems were the proximate cause of the injury – and there was no evidence that different instructions would have prevented the injury. Nothing in the surgeon’s account of the surgery showed that he “handled the patch in a manner that Davol failed to warn against.” Id. at *32. The court found “entirely speculative” the suggestion that the surgeon would not have chosen the XL CK Patch with different instructions. Id. The court’s ruling is a nice reiteration of the idea that proximate cause is not a given in failure to warn cases, even when the warnings are bad and the product was recalled.

The not so good part is that the court rejected the rest of the defense arguments, but the rulings are very fact-specific and should not give plaintiffs much comfort in other cases. The court rejected defendants’ motion to strike plaintiffs’ experts, who were an assistant professor of surgery at Harvard Medical School and a long-time professor of bioengineering and orthopedic surgery research at the University of Pennsylvania. We don’t see many plaintiffs’ experts with those kind of credentials, and their credentials and experience appear to have persuaded the court to overlook an otherwise shaky foundation for their testimony. The court also upheld the jury’s verdict for plaintiffs on the inadequate design claim based on specific testimony and facts of this case, a ruling that will help only other plaintiffs with the same facts, which will be few and far between.

In short, even though the defense ultimately did not prevail, defendants may be able to cite the good parts of this opinion in future litigation without much concern about swallowing the bad stuff.