Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Friday, August 21, 2015

Reasonable jury verdict: J&J pays $3M for surgical mesh patient harm

No retrial for Ethicon in $3m pelvic mesh loss


A federal judge today shot down a bid by Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon to overturn a $3.3 million judgment in a pelvic mesh product liability lawsuit and denied the company’s move for a new trial.
A jury in the U.S. District Court for Southern West Virginia awarded Jo Huskey and her husband damages of $3.2 million, finding in September 2014 that Ethicon’s TVT-O transvaginal sling caused her injuries and that the company failed to warn about the stress urinary incontinence treatment’s risks.
Ethicon asked Judge Joseph Goodwin, who’s overseeing 10s of thousands of product liability lawsuits brought over pelvic mesh products, to overturn the verdict or, alternatively, to grant a new trial.
But Goodwin today declined to disturb the jury’s verdict, finding that “[t]he evidence on the defective design claim is particularly strong and is capable of upholding the verdict on its own.”
A reasonable jury, Goodwin ruled, could conclude that the risks of the TVT-O product “are not justified by the benefits, and as a result, the TVT-O cannot, as a matter of law, qualify as an unavoidably unsafe product.”
“In short, while Ethicon produced evidence of the TVT-O’s usefulness and benefits, the plaintiffs countered with evidence of the TVT-O’s high risks of injury and how Ethicon could have mitigated those risks through alternative designs,” Goodwin wrote, according to court documents. “Taking the evidence as a whole and viewing it in the light most favorable to the plaintiffs, it is clear that reasonable persons could balance the risks and benefits against Ethicon. As a result, I cannot displace the jury’s verdict on these grounds.”
Goodwin also cited evidence produced at trial that Huskey’s physician would not have used the TVT-O device had she been warned that it was contra-indicated for active patients like Huskey. The doctor was also unaware of other risk factors from the product, the judge ruled, including that the mesh itself could cause infection and that the amount of mesh material in the product could cause more complications.

“The plaintiffs presented sufficient evidence on Ethicon’s knowledge of dangerous propensities of the TVT-O and failure to warn about those propensities such that a reasonable jury could conclude that Ethicon was negligent,” Goodwin wrote.

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