It reads like something out of an espionage thriller: major medical device company smuggles counterfeit materials into the U.S. and causes massive injuries to an unsuspecting public. Unfortunately, it’s far from fiction. A West Virginia plaintiff is suing claiming medical device maker Boston Scientific used counterfeit resin in vaginal mesh product.
It reads like something out of an espionage thriller: major medical device company smuggles counterfeit materials into the U.S. and causes massive injuries to an unsuspecting public. Unfortunately, it’s far from fiction. A West Virginia plaintiff is suing claiming medical device maker Boston Scientific used counterfeit resin in vaginal mesh product.
U.S. District Judge Joseph Goodwin, overseer of the huge vaginal mesh class action litigation, advised plaintiff Teresa Stevens to seek FDA review of Boston Scientific’s use of the counterfeit resin. The goal is to have the agency determine the safety of the product. Judge Goodwin used the doctrine of “primary jurisdiction” to make the referral to the FDA. Under the primary jurisdiction doctrine, a judge can pause proceedings to allow a regulatory agency to determine certain technical issues.
None of Stevens’ claims were dismissed and Judge Goodwin, knowing that the FDA can’t decide all of her claims, retained the court’s jurisdiction over the case. He’s ordered a status report on the FDA investigation for May 1.
Stevens’ attorneys, Amber and Steve Mostyn of Houston-based Mostyn Law, filed the suit against Boston Scientific and three other defendants under RICO, the Racketeer Influenced and Corrupt Organizations Act. Stevens and other plaintiffs claim their injuries, such as bleeding, infections, severe discomfort, urinary problems and painful intercourse, stem from the surgical mesh used to treat pelvic organ prolapse (POP) and urinary incontinence.
A press release issued by Amber Mostyn on January 27 stated, “Our efforts to get justice for women who have been harmed by Boston Scientific’s dangerous surgical mesh are far from over. The court has given the FDA an opportunity to act, but retained jurisdiction over the lawsuit while the FDA investigates. Boston Scientific is making a product that harms tens of thousands of women with counterfeit plastic that contains high levels of toxic selenium. The company should take this product off the market immediately. And if Boston Scientific won’t do the right thing, the FDA should make them do it without delay. In the meantime, Boston Scientific should release its documents to the FDA and the public. We won’t stop until we get to the bottom of this and will continue to seek justice for women who have already suffered from Boston Scientific’s reckless disregard for their health.”
Judge Goodwin’s decision is the latest chapter in this true crime thriller. The suit is based on internal Boston Scientific emails and other confidential communiqués that Mostyn Law obtained through other civil suits against Boston Scientific. Allegations against the medical device manufacturer include participation in an international conspiracy, the goal of which was the importation from China of counterfeit plastic resin for the company’s surgical mesh product.
As expected, Boston Scientific has filed a motion fighting to keep these confidential communications confidential. Mostyn Law asserts this is to “conceal serious misconduct.”
The firm petitioned Judge Goodwin to make the internal communications public in the interest of “public health and safety.” While he has yet to rule on that petition, he did agree to allow the release of one of Mostyn’s filings that refers to “facts taken from [Boston Scientific] internal documents and emails.”
Mostyn Law has asked Goodwin to publicly release all of the internal communications to protect “public health and safety.”
These messages, sent from 2011 – 2012, expose Boston Scientific’s serious concern over the reliability of its Chinese resin supplier. They also show the shocking plan Boston Scientific concocted to smuggle 34,000 pounds of the questionable resin into the U.S. with no verification and without fully testing it. In the filing that Judge Goodwin released, an employee of Boston Scientific expressed the following concern:
“God knows what grade, or even recycled material” the resin contains.
The company continues to assert that Stevens’ suit is without merit. Amber Mostyn’s response is plain and simple, “If Boston Scientific thinks we’re wrong, it could immediately release the documents and let the FDA and the public decide for themselves. Right now, we can’t share our evidence with the FDA.”
That yet-to-be unsealed evidence shows Boston Scientific’s detailed plan – including a timeline – to buy from a known material counterfeiter in China following warnings from a U.S. supplier that its plastic resin wasn’t meant for use in the human body. That supplier stopped selling it to surgical mesh manufacturers.
RICO is usually used by the Department of Justice as a means of tackling criminal organizations. However, the Act also applies to civil suits, such as Stevens’.
Case information: Charleston Division of the Southern District of West Virginia Case No. 2:16-CV-0265.
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