Coloplast (CPH:COLO B) can’t dodge a personal injury lawsuit filed in a Colorado federal court over its Virtue urethral sling, but the majority of the counts and moves for legal fees and punitive damages were stricken from the case.
John Lautzenhiser sued Coloplast in July 2011, 2 years after he was implanted with a Virtue sling to treat his stress urinary incontinence. Lautzenhiser’s SUI worsened and the device had to be explanted, leaving him with "permanent and substantial physical pain, loss of ability to perform sexually, lost wages and impairment of ability to earn wages, lengthy delay in prognosis and corrective action, and shortening of life expectancy," according to court documents.
Lautzenhiser alleges negligence, defective design, failure to warn, breach of express warranty, breach of implied warranty, negligent misrepresentation, fraud, negligently providing misinformation, violation of the Indiana Deceptive Consumer Sales Practices Act and unjust enrichment. Lautzenhiser was implanted with the Virtue sling in
Judge Richard Young of the U.S. District Court for Southern Indiana granted the medical device company’s motion to dismiss 6 of the 10 counts against it, but allowed 4 other counts to proceed under Indiana state law: Negligence, defective design, failure to warn and breach of implied warranty.
"Defendants’ alleged marketing of the Virtue device for non-FDA-approved purposes, combined with failing to warn customers or train and educate physicians about the device, once they knew about potentially adverse side effects, qualifies under failure to provide adequate warnings or instructions. Plaintiff has also alleged sufficient damages caused by the defective product. Finally, there need not be plausible allegations of negligence, since the IPLA is a strict liability regime as against manufacturers," Glasscock wrote, according to the documents.
Glasscock also denied Lautzenhiser’s claim for attorney fees and punitive damages, according to the documents.