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By: Marilyn McGoldrick, Esq.
A new lawsuit accuses transvaginal mesh manufacturer Boston Scientific of smuggling counterfeit pelvic mesh materials from China. Boston Scientific is charged with intentionally defrauding and endangering women by secretly importing defective polypropylene resin that wasn’t approved by the FDA.
According to the suit, the FDA gave 510(k) approval to Boston Scientific’s pelvic mesh devices made with polypropylene resin pellets (known as “Marlex”) manufactured by Chevron Phillips Chemical Co. But in 2005 Chevron Phillips stopped selling Marlex to them, warning that polypropylene resin should not be used in any product “involving permanent implantation in the human body or permanent contact with internal body fluids or tissues.”
In 2011, running out of their supply of Marlex (the only mesh ingredient the FDA had approved), Boston Scientific embarked on a worldwide search for a replacement product. Their search led them to Chinese supplier EMAI Plastic Raw Materials Inc., a “known counterfeiter of plastic products,” in Guangzhou, China, which claimed to have Marlex manufactured by Chevron Phillips in storage. According to the suit, “EMAI had no paperwork documenting that the product was authentic Marlex.”
To avoid detection, the material was packaged into 500 separate bags and shipped by three ocean shipments on three different dates. The complaint charges that “The deception went to high levels within BSC. There is evidence that a BSC executive made separate and contradictory reports about the origin of the resin in order to clear Chinese Customs, and then U.S. Customs.” After being smuggled, the resin was processed at Boston Scientific subsidiaries around the world and marketed to the as many as 55,000 women per year who receive transvaginal mesh implants manufactured by Boston Scientific.
Filed as a RICO (Racketeering and Corrupt Organizations Act) action, the lawsuit seeks class action status for all women who have received Boston Scientific mesh since September 2012. In addition to Boston Scientific, the defendants include Chinese supplier EMAI Plastics Raw Materials Inc., and two Boston Scientific subsidiaries, Proxy Biomedical Limited of Galway, Ireland and Luxilon Industries NV of Belgium. The lawsuit was filed in federal court in West Virginia, where all federal lawsuits for defective mesh claims are consolidated.
Boston Scientific issued a statement denying the lawsuit’s claims.
Earlier this month, the FDA reclassified surgical mesh for Pelvic Organ Prolapse (POP) a “high-risk” medical device. The agency has received tens of thousands of complaints of side effects from transvaginal mesh implants, including bleeding, pain, infection, mesh contraction, mesh erosion, mesh protruding into the vagina, urinary problems, severe pelvic pain, vaginal tightening or shortening, additional surgeries, painful sexual intercourse, inability to engage in sexual intercourse, or organ perforation. More than 70,000 lawsuits have been filed by women who have suffered complications after receiving pelvic mesh implants.
Women who have been injured by a defective transvaginal mesh implant can contact the transvaginal mesh lawyers at Thornton Law Firm for a free, no-obligation consultation. You can tell us your story online or call Attorney Marilyn McGoldrick at 888-341-1405 for a confidential evaluation of your legal case. Time limits for filing claims are short, so don’t delay seeking legal advice.
Boston Scientific won a defense verdict in the first transvaginal mesh (TVM) case to go to trial in Middlesex Superior Court. The jury ruled that plaintiff Diane Albright had not proved that her Pinnacle vaginal mesh device was defectively designed, or that it lacked adequate warnings. While Boston Scientific won this round, we believe that there are four reasons to believe that TVM cases going forward will be won by the plaintiffs.
1. This plaintiff never had her mesh implant removed.
She hadn’t undergone revision surgery – the device was not removed from her body despite the pain it had caused her since implantation in 2010. One of the plaintiff’s attorneys, Jonathon D. Orent, commented “Ms. Albright’s doctors ultimately concluded that it would be more dangerous for her to have surgery to try and remove the mesh. I think the jury had difficulty in identifying with her injuries because of her doctors’ decision not to pursue aggressive surgery.”
2. This case was tried using Ohio law.
Because Ms. Albright lived in Ohio and had the Pinnacle mesh device surgically implanted in the state of Ohio, Ohio law controlled the result. The Ohio Product Liability Act, passed in 2005, requires a different, more difficult burden of proof than would be required under common law, and limits the theories under which a plaintiff can pursue a claim against a product manufacturer.
3. This plaintiff didn’t argue polyproplyene isn’t fit for human implantation
The plaintiff’s attorneys argued that the Pinnacle transvaginal mesh device was defective because it contained too much polypropylene, not that the polypropylene shouldn’t have been used at all. The plaintiffs’ lawyer’s decision to argue the case this way was likely because the plaintiff could not have the device removed. Despite the fact that the decision not to remove the device was based on the advice of her doctors, jurors may have concluded that if it shouldn’t have been used at all, wouldn’t she have had it removed?
4. This was a case the defense picked.
Finally, this case was selected as a bellwether trial by Boston Scientific precisely because they believed it was a weak case that they could win. Other bellwether trials of cases selected by plaintiffs’ counsel will likely lead to very different outcomes.
Thornton Law Firm’s Drug and Medical Device lawyers represent women in transvaginal mesh claims against Boston Scientific Corp., as well as Caldera, C.R. Bard, Inc., Ethicon (subsidiary of Johnson & Johnson) and Sofradim/Covidien. If you have a transvaginal mesh implant and have suffered complications including pain, mesh erosion, mesh contraction, additional surgeries, urinary problems, severe pelvic pain, infection, bleeding, vaginal tightening or shortening, painful sexual intercourse, inability to engage in sexual intercourse, or organ perforation, and would like a free, confidential evaluation of your legal claim, please tell us your story here or call us at our toll free number 888-341-1405.
Marilyn T. McGoldrick, Esq.
Posted on June 19, 2013
Last week the West Virginia court overseeing the vaginal mesh litigation involving Johnson & Johnson’s Ethicon unit issued a pair of new pre-trial orders. The first rescheduled the presentation of possible bellwether cases to the court by one week, to July 25, 2013. The court will review the cases presented and decide which cases will be the first to go to trial, and in what order they will be tried. None of the other dates in the court’s pre-trial order were changed, so the first trial is still scheduled to be held on January 14, 2014 in front of Judge Joseph R. Goodwin.
The second new pre-trial order adopts a stipulation agreed to by both sides regarding documents produced in response to subpoenas to third parties. It gives Johnson & Johnson & Ethicon 30 days to review the documents and designate any portions as confidential or proprietary information. The plaintiffs will have copies of all the documents from the beginning including the 30 day period of confidentiality review. We believe this is a fair agreement and it will speed up the acquisition of the documents we believe will strengthen the plaintiffs’ cases.
Thornton Law Firm mesh lawyers continue to investigate transvaginal mesh claims against J&J and Ethicon, as well as against the other vaginal mesh manufacturers American Medical Systems, Inc., C.R. Bard, Inc., and Boston Scientific Corp. We offer free consultations. If you are one of the thousands of women who received painfully defective mesh implants, tell us your story here, or call us at 888-341-1405 to discuss your legal rights. Time limits for filing a claim are short so do not delay.