Zimmer Biomet (NYSE:ZBH) last week won the 2nd bellwether lawsuit brought over its NexGen Flex knee replacement, after a federal judge in Illinois found that the plaintiff failed to prove that a design defect caused his implant to fail.
The FDA in 2007 cleared the NexGen Flex implant, designed to provide more flexibility than other knee replacement devices. Plaintiffs in the thousands of product liability lawsuits filed since then allege that the device can’t withstand the extra flexion, despite the Warsaw, Ind.-based company’s marketing claims. The plaintiffs also allege that a design flaw makes the device more prone to premature loosening requiring revision procedures.
Zimmer Biomet denies that the devices are defective and said they have a successful track record. In the 1st bellwether trial in the multi-district litigation over NexGen Flex, an Illinois jury in November 2015 cleared the company, finding that plaintiff Kathy Batty failed to prove her defective design and failure to warn claims.
The 2nd bellwether never made it before a jury, after Judge Rebecca Pallmeyer of the U.S. District Court for Northern Illinois ruled Oct. 21 that plaintiff Theodore Joas failed to prove that the implant’s design caused it to loosen after excluding the testimony of a key expert witness for Joas. Dr. Joseph Fetto, a plaintiff’s witness in both lawsuits whose testimony was partially excluded in the Batty case, submitted a new analysis for the Joas suit.
The new analysis failed for 2 reasons, Pallmeyer found.
“First, Dr. Fetto does not explain how he reaches many of his conclusions. Most prominently, he fails to offer any new support for a number of opinions that the court found to be inadequately explained in Batty,” she wrote, according to court documents. “Second, Dr. Fetto uses inconsistent bases for ruling causes in and out of his differential etiology, such that his etiology is not systematic and the court cannot conclude that it is reliable.”
Pallmeyer, who is overseeing the NexGen Flex MDL, also found that Joas failed to offer evidence of a safer alternative design, as required Wisconsin product liability law.
“In addition to plaintiffs’ lack of specific causation evidence, plaintiffs’ design defect claim thus fails under Wisconsin law because they have not offered sufficient evidence of any safer alternative design,” the judge wrote.
At least 5,900 NexGen product liability lawsuits have been consolidated into the MDL under Pallmeyer, but the going has been anything but smooth. It was a challenge to find suitable bellwethers; in June 2015 the judge issued a so-called “Lone Pine” order requiring plaintiffs to prove their cases. Named for a 1986 decision dismissing a mass toxic tort case against a New Jersey landfill, a Lone Pine order requires plaintiffs to show a link between their injuries and the product accused of causing them.