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| Boston Scientific's Advantage Fit sling--Courtesy of Boston Scientific |
Boston Scientific ($BSX) is facing more bad news in its ongoing vaginal mesh saga, as a federal judge rejected the company's bid to toss out claims for damages in one of its more than 15,000 product liability suits.
The Marlborough, MA-based company asked Judge Joseph Goodwin of the U.S. District Court for Southern West Virginia to throw out one patient's request for punitive damages, arguing that the plaintiff did not present evidence of malice or criminal indifference. But Goodwin allowed the claims to stand, MassDevice reports. Sharon Pelkey received the company's Advantage Fit implant for stress urinary incontinence in 2010 and experienced multiple complications, spurring her to sue Boston Scientific in 2013 for negligence, design and manufacturing defects, failure to warn about the defects and punitive damages.
Pelkey claimed the devicemaker knew that resin used to make the mesh was not meant for permanent implantation after getting a material safety data sheet (MSDS) from the supplier, but allowed it to remain in the devices anyway. She also alleged that Boston Scientific never completed long-term safety studies for the polypropylene material in its Advantage Fit devices, even though its supplier advised the company to conduct its own tests.
Goodwin agreed with Pelkey, citing a Boston Scientific internal document that showed the company did not sponsor clinical studies on the product before putting it on the market and saying the company never warned the public that the device contained materials making it unsafe for permanent implantation.
"In light of the MSDS warning and Boston Scientific's failure to conduct clinical testing, a reasonable jury could find that Boston Scientific acted in conscious disregard of Ms. Pelskey's rights, or acted with reckless indifference to the consequences. A reasonable jury could also find that Boston Scientific knew that the Advantage Fit 'probably would cause injury to another,' and that Boston Scientific was aware of the danger involved with placing the Advantage Fit into the stream of commerce," Goodwin wrote in his ruling, as quoted by MassDevice.
The decision does not bode well for Boston Scientific, as it continues to deal with the legal fallout over its vaginal mesh implants. In November, a federal court jury ordered the company to pay $26.7 million to four women who claimed its Pinnacle devices caused them undue pain and suffering, awarding more than $6.7 million in damages to three woman and one woman more than $6.5 million. A week later, a federal jury ordered Boston Scientific to pay $18.5 million in damages to four women who alleged the company's Obtryx implants resulted in constant pain and injuries. Boston Scientific still faces more than 23,00 claims related to vaginal mesh implants in U.S. state and federal courts, including cases consolidated before U.S. District Judge Goodwin in West Virginia and 1,700 cases assigned to one judge in Massachusetts state court.
- read the MassDevice story