J&J must face Kentucky woman's claim that mesh caused 'debilitating' pain

FILE PHOTO: The Johnson & Johnson logo is displayed on a screen on the floor of the NYSE in New York
The Johnson & Johnson logo is displayed on a screen on the floor of the New York Stock Exchange in New York, U.S., May 29, 2019. REUTERS/Brendan McDermid
  • Court says doctor's testimony not enough to defeat failure to warn claim
  • Case is among more than 100,000 filed over pelvic mesh

(Reuters) - A federal appeals court on Friday revived a Kentucky woman's lawsuit claiming she suffered "debilitating" pain as a result of defective pelvic mesh made by Johnson & Johnson's Ethicon unit.

A unanimous three-judge panel of the 6th U.S. Circuit Court of Appeals ruled that a jury should be allowed to hear plaintiff Connie Thacker's claims and that a lower court judge placed too much weight on the testimony of Thacker's doctor when he ruled in the company's favor without trial.

"The opinion clarifies any uncertainty in what evidence must be presented in a failure to warn and design defect case brought under Kentucky law," Thacker's lawyer, Sean Jez of Fleming Nolen and Jez, said in a statement.

J&J did not immediately respond to requests for comment.

Thacker sued Ethicon in Lexington, Kentucky, federal court in 2012. She said that in 2009, at the advice of her doctor, J. Michael Guiler, she had two mesh devices implanted to treat a rectocele, a weakening of the wall between the vagina and the rectum.

Thacker said the mesh caused her severe pain and other symptoms, which persisted despite two further surgeries. She accused the company of failing to warn of the products' risks. She also said they were defectively designed because the mesh material, polypropylene, was unsafe.

Her lawsuit was one of more than 100,000 against J&J and other pelvic mesh manufacturers consolidated in several related multidistrict litigations (MDLs) in Charleston, West Virginia.

The cases have resulted in over $8 billion in settlements. J&J has denied wrongdoing but stopped selling pelvic mesh in 2012. The MDLs have been wound down, with remaining cases, including Thacker's, sent back to their original courts.

U.S. District Judge Joseph Hood in November 2021 granted Ethicon summary judgment, citing Guiler's testimony that he still believed the mesh was the best option despite having learned more about the risks. Because Kentucky follows a so-called "learned intermediary" doctrine, in which manufacturers' duty to warn is to doctors, not patients, Hood found that a stronger warning would not have changed the outcome.

Circuit Judge Eric Clay wrote Friday that Kentucky law "does not support such a narrow approach." A jury should have been allowed to consider whether Guiler might have discussed stronger warnings with Thacker, in which case she might not have agreed to the surgery, he said.

Clay, joined by Circuit Judges John Rogers and Raymond Kethledge, also rejected Hood's finding that Thacker failed to support her defective design claim because her expert's proposed alternative design was not supported by evidence, writing that a jury should consider that as well. A plaintiff must show that an alternative design would have been safer in order to win a design defect claim.

The case is Thacker v. Ethicon Inc et al, 6th U.S. Circuit Court of Appeals, No. 21-6193.

For Thacker: Sean Jez of Fleming Nolen and Jez

For J&J: Amy Pepke of Butler Snow

Read more:

California appeals court cuts $42 million off J&J mesh-marketing judgment

Woman's mesh lawsuit not 'shotgun pleading' despite lack of detail

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Brendan Pierson reports on product liability litigation and on all areas of health care law. He can be reached at brendan.pierson@thomsonreuters.com.