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Boston Scientific Loses Bid to Throw Out Claims Tied to Vaginal Mesh Device
Apr 27, 2015 | Fierce Medical Device
By Emily Wasserman
...Boston Scientific ($BSX) is facing more bad news in its ongoing vaginal mesh saga, as a federal judge rejected the company's bid to toss out claims for damages in one of its more than 15,000 product liability suits... -
Punitive Damages Claims Stand in Boston Scientific Pelvic Mesh Case
Apr 27, 2015 | Mass Device
By Brad Perriello
Boston Scientific this month lost a bid to remove claims for punitive damages from 1 of the 15,000 product liability lawsuits brought over its pelvic mesh products. -
New Health Website Launched to Support Mesh Implant Survivors Who Have Suffered Across the World
Apr 27, 2015 | Daily Record and Sunday Mail
By Jeff Holmes
A new website which has been launched to help victims of the mesh implants scandal has been given the thumbs-up by a Paisley-based politician.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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Boston Scientific Loses Bid to Throw Out Claims Tied to Vaginal Mesh Device
Apr 27, 2015 | Fierce Medical Device
By Emily Wasserman
Boston Scientific ($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.
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Punitive Damages Claims Stand in Boston Scientific Pelvic Mesh Case
Apr 27, 2015 | Mass Device
By Brad Perriello
Boston Scientific this month lost a bid to remove claims for punitive damages from 1 of the 15,000 product liability lawsuits brought over its pelvic mesh products.
Sharon Kay Pelkey was implanted with Boston Scientific's Advantage Fit device for treating stress urinary incontinence in February 2010 in Virginia, according to court documents. Pelkey claimed that the implantation resulted in multiple complications, prompting her to sue Boston Scientific in April 2013 for negligence, strict liability for design defect, manufacturing defect, and failure to warn, breaches of express and implied warranties and punitive damages, according to the documents.
Boston asked Judge Joseph Goodwin of the U.S. District Court for Southern West Virginia to toss the punitive damages claim, arguing that Pelkey presented no evidence of malice or criminal indifference.
Pelkey contended that the company knew the polypropylene resin used to make the mesh was not meant for permanent implantation, citing a material safety data sheet from the resin's supplier, Chevron Phillips Chemical. The MSDS contained a "medical application caution" not to use the material "in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues," according to the documents.
Pelkey also alleged that Boston "knew it needed to conduct long-term safety studies of the polypropylene material in the Advantage Fit," citing a provision of the supply deal with Chevron Phillips cautioning Boston to "make its own determination of the safety and suitability of the polypropylene material," court filings show.
"It is the ultimate responsibility of Boston Scientific to ensure that the PSPC polypropylene product is suited to Boston Scientific's specific application," according to the filings.
Goodwin agreed with Pelkey, allowing the punitive damages claim to stand.
"Despite the MSDS warning and the admonition from BSC's polypropylene supplier to conduct its own tests, an internal BSC document indicates that BSC sponsored no clinical studies on the Advantage Fit before selling the device to the public. Furthermore, BSC never warned through its directions for use that the Advantage Fit was made of a component that was not safe for permanent implantation in the human body," Goodwin wrote
"In light of the MSDS warning and BSC's failure to conduct clinical testing, a reasonable jury could find that BSC acted in conscious disregard of Ms. Pelkey's rights, or acted with reckless indifference to the consequences. A reasonable jury could also find that BSC knew that the Advantage Fit 'probably would cause injury to another,' and that BSC was aware of the danger involved with placing the Advantage Fit into the stream of commerce," he wrote.
Late last year Boston Scientific lost a pair of pelvic mesh trials. A West Virginia jury in Novemberawarded 4 women $18.5 million for injuries they said were caused by the Massachusetts-based company's Obtryx device for stress urinary incontinence, including $4 million for "gross negligence."That verdict came one week after a Miami jury awarded $26.7 million to 4 women implanted with the company's Pinnacle device for pelvic organ prolapse.
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New Health Website Launched to Support Mesh Implant Survivors Who Have Suffered Across the World
Apr 27, 2015 | Daily Record and Sunday Mail
By Jeff Holmes
A new website which has been launched to help victims of the mesh implants scandal has been given the thumbs-up by a Paisley-based politician.
Renfrewshire South MSP Hugh Henry, who has been backing the Scottish Mesh Survivors group throughout their Hear Our Voice campaign, heaped praise on the two women behind the new website.
Olive McIlroy, from Renfrew, and East Renfrewshire woman Elaine Holmes – both mesh sufferers – are the brains behind the new initiative.
Mr Henry praised Elaine and Olive for their hard work on behalf of all those women whose lives have been devastated after mesh surgery.
And he congratulated the women on the launch of their website, which aims to bring help and advice to people across Renfrewshire and beyond who may feel alone as they try to cope with possible life-changing complications after undergoing mesh surgery for incontinence and pelvic organ prolapse.
Mr Henry told the Paisley Daily Express: “This website is informative and contains good, solid advice.
“It will make a huge difference to every single person living with pain and complications after mesh implant surgery.
“You can often feel isolated when you suffer severe complications after any surgery but, thanks to Elaine and Olive, no one will now have to feel they are unique.
“Elaine and Olive have refused to give up the fight and have brought mesh implant problems into the spotlight.
“This site will also help victims all over the country to organise their fightback and to make sure they get the support and justice they fully deserve.”
Mrs Holmes said she has been delighted with the response to the website following its launch.
She added: “We hope it will encourage women to ask questions and be aware that there are viable alternatives to mesh surgery.”
For more information on mesh implants and the help available through the Hear Our Voice campaign, log on to www.scottishmeshsurvivors.com.
Support Hugh Henry is pictured with mesh survivor Olive McIlroy, from Renfrew
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