Mesh Medical Device News Desk, June 7, 2017 ~ The pelvic mesh case of Huskey v. Ethicon has been in the courts since 2012.
After she won a defective product case before a jury in 2014 and was awarded $3.27 million, J&J appealed and lost.
Now Ethicon/ J&J wants the U.S. Supreme Court to hear the Huskey pelvic mesh case!
Is Huskey going to the Supremes?
The case of Jo Huskey v. Ethicon was the first bellwether pelvic mesh case naming Ethicon (Johnson & Johnson) to go to trial in multidistrict litigation in Charleston, WV., (Case no. 2:12-cv-05201).
It concluded September 5, 2014 with a $3.27 million jury verdict in compensatory damages and a decision the pelvic mesh was defective.
Ethicon then appealed the verdict, first to Judge Joseph Goodwin, who refused to throw out the verdict or allow for a new trial.
Then Ethicon took the case to the Fourth Circuit Court of Appeals which also handed Ethicon a defeat, rejecting Ethicon’s argument that Huskey failed to prove the TVT-Obturator sling was defective. Huskey et al. v. Ethicon Inc. et al., (Case number 15-2118).
The appeals court also affirmed a defective design because Huskey lawyers provided evidence that the heavyweight polypropylene (PP) mesh could have been made safer with a lighter weight mesh, less likely to cause scar plate formation, inflammation or incite a foreign body response.
TVT-O was cleared for marketing by the FDA in 2003 under the 510(k) clearance process and Tension-Free Vaginal Tape-Obturator uses a heavyweight polypropylene laser cut mesh to treat stress urinary incontinence. It remains on the market.
The appeals court also rejected the Ethicon argument about “comment k.” Comment K is a product liability doctrine that states some products are unavoidably unsafe such as vaccines, though not unreasonably dangerous, therefore manufacturers are shielded from liability. As an Illinois resident, a case by case determination is made as to the weight of that doctrine. The panel said Ethicon is not shielded by “comment k.”
Not to be deterred, Ethicon now wants to take it one step higher and has appealed to the U.S. Supreme Court.
In filing a writ of certiorari on May 23, Ethicon challenges the 4th Circuit U.S. Court of Appeals decision that the trial court rightly excluded testimony about Ethicon’s compliance with the FDA’s 510(k) clearance as a way of entering the market.
Ethicon said the trial court excluded all FDA-related evidence from trial.
If they had been allowed, Ethicon said it would have presented evidence that the TVT-O was cleared through the 5 10(k) process, and that the FDA concluded that SUI slings were safe and effective and clinical trials were not needed.
Ethicon also argued that Prolene suture makes up TVT-O and it has FDA approval/ clearance and a history of use.
Ethicon wants the Supreme Court to address the view that the 510(k) clearance is not a safety and effectiveness determination, “an error of law that only it can straighten out.”
The request is signed by Charles C. Lifland of O”Melveny & Myers LLP.
In the Linda Gross case, Ethicon also attempted to have the Supreme Court address what it thought were outstanding issued. The High Court denied the Ethicon plea.
Check out comment k doctrine. Huskey is from Illinois and state law determines if a specific product is covered by comment k doctrine. http://biotech.law.lsu.edu/Courses/drugsf02/comment_k.htm
MND, Huskey Case Affirmed by Appeals Court, February 2017
MND, Closing Arguments in Huskey case
MND, Day 8 Wrapup Huskey v. Ethicon
MND, Day 4 Huskey takes the Stand
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