Boston Scientific on Hot Seat Amid Chinese Mesh Allegations
Mesh News Desk, May 14, 2016 ~ It’s been a circuitous route.
The latest news that mesh maker Boston Scientific (BSC) used substandard polypropylene resin smuggled in from China to make its pelvic mesh, comes all the way from Scotland.
Award winning reporter, Marion Scott writes, It was always scandalous. Was it criminal? in the April 24 pages of Scotland’s Sunday Mail.
Scott reports, “The firm, who supplied Scottish hospitals with Obtryx, Pinnacle and Advantage implants, have confirmed that all mesh products they have made in the past three years contain the Chinese resin.”
Reporter Scott says the quote in the story was directly from the company.
While BSC stands by its mesh, this is the first confirmation from BSC that it made pelvic mesh implants with Chinese-sourced resin.
Meanwhile publicly Boston Scientific clings to its many mottos – “Nothing is more important than women’s health,” and “Excellence is inherent in everything we do.”
MOSTYN FIRM- OLD EVIDENCE, FRESH EYES
By his own admission Steve Mostyn was late to the game of pelvic mesh litigation. Focusing primarily on natural disasters and insurance companies reluctant to pay, Mostyn Law of Houston is headed by Steve and his wife Amber. Media coverage shows they’ve been successful and effective.
Late one night several days before Christmas 2015, Steve was reviewing some of the ten million pages of documents produced so far in pelvic mesh litigation.
“I came across an email titled ‘Re: Counterfeit material from a supplier you use – ACTION REQUIRED.” [LINK] There was an email from another division engineer saying their supplier attempted to sell them counterfeit goods and said God only knows what’s in there.’ I was shocked by this email.”
He spent most of the night digging further and the story emerged.
Further inquiry showed Boston Scientific had smuggled some grade of polypropylene (PP) out of China with no paperwork, no oversight and certainly with no approval. What was in this product? God only knows was right.
CHINESE RESIN- The Latest Assault
What the Mostyn firm has uncovered has ignited a new controversy in this ongoing defective product litigation that threatens Boston Scientific and its $120 million a year pelvic mesh business.
Documents showed BSC turned to China as a supplier between June 2011 and the fall of 2012 after former supplier, Phillips Sumika refused to sell to BSC “at any price.” Phillips knew it product was being used for implantable medical devices and wanted no part of it. Fearful its PP resin supply would dry up, BSC bought enough Chinese resin, 34,000 pounds of unknown quality to make pelvic mesh implants into the year 2032.
The supplier, EMAI Plastics Raw Materials Inc., located in Guangzhou, Guangdong Province was a known supplier of counterfeit products. China, with little environmental and consumer products regulation, has sent toxic dog treats to the U.S. and fed melamine-tainted milk to its infants, both with fatal results.
Not surprisingly, some of the resin was discovered by the firm to contain high levels of selenium, a trace element toxic in high levels. What did this mean for women implanted with mesh made from raw resin allegedly transported loose amid the debris and droppings on the floor of a rail car?
Teresa Stevens, 46, a West Virginia native, was implanted with a Boston Scientific pelvic mesh, the Obtryx-Halo Urethral Sling System made of Marlex in October 2014, to treat incontinence. Soon afterward she began having complications – urinary tract infections, shooting pains in her abdomen and painful sex.
She grew despondent, not unlike many of the 55,000 other women who receive a BSC pelvic mesh every year.
But Teresa Stevens v. Boston Scientific Case no. 2:16-cv-00265, stands out from the 91,000 other defective product cases filed in multidistrict litigation in West Virginia.
In January, the Mostyn firm, along with the Bell Law firm of Charleston, WV, filed a federal racketeering class action lawsuit against Boston Scientific – the first RICO lawsuit filed in transvaginal mesh litigation. RICO alleges fraud and the Racketeering Influenced and Corruption Organization statute (RICO), has long been used to target organized crime such as the Hell’s Angels, the Gambino family and even pedophile priests.
Leading a class action of injured women, Stevens, alleges for the class that BSC engaged in a pattern of unlawful activities including fraud, intentional misrepresentation, and negligent misrepresentation, violations of WV trade or consumer practices, and unjust enrichment. It seeks unspecified damages on behalf of the women who would have received a BSC pelvic mesh made since September 2012, the date after which Boston Scientific allegedly defrauded the women by using the fraudulently obtained polypropylene resin to make its mesh.
RICO lawsuits can level both civil sanctions and criminal penalties and jail time, not to mention threefold the damages if successful.
Knowing the FDA has the ability to issue a recall, the Mostyn firm did what no other has – file the first Citizen’s Petition to seek an immediate Class I recall of the BSC products and to quarantine the Chinese resin so no future products would be made from it.
The U.S. Food and Drug Administration has the power to revoke or amend its Federal Food, Drug and Cosmetic Act which oversees the fast-tracking of pelvic mesh to market.
On March 30, 2016, the petition was filed on behalf of Ms. Stevens containing a 35-page narrative of Boston Scientific’s alleged misconduct in sourcing PP resin in China and asks the agency to seek out the source of the raw material. Judge Joseph Goodwin overseeing 21,000 cases against BSC, was asked to move to restrain BSC from marketing or selling the mesh.
But instead of taking action, Judge Goodwin deferred the case to the FDA under primary jurisdiction doctrine. Ultimately, he decided, the FDA was best equipped to determine the safety and efficacy of the Boston Scientific mesh implants.
Saying it wasn’t aware of any safety issues, the FDA made a lackluster announcement on April 1, agreeing to let Boston Scientific investigate the safety and effectiveness of the its own products,
while acknowledging BSC urogynecologic surgical mesh “may” contain counterfeit raw material.
“Sort of like asking drug dealer to determine if the cocaine he was caught selling was really cocaine,” says Mostyn. “I believe we will find there is no consistency in the product at all. With that province, a garbage dump for all sorts of industrial plastics, the FDA is not acting on behalf of the public and is abrogating its duty to public health and safety by giving Boston Scientific a pass.” ~ Steve Mostyn
In an April letter to FDA commissioner Dr Robert Califf and Health and Human Services Secretary Sylvia Mathews Burwell, Amber Mostyn urged the FDA to step up its investigation into criminal conduct and not allow Boston Scientific to simply compare new mesh implants to old ones.
“Does the FDA believe equivalence is a defense to trafficking of counterfeit raw material in violation of 18 U.S.C. § 2320 (Trademark Counterfeiting Act)?” she asked.
GRAND JURY INVESTIGATION
Largely due to the new revelations uncovered by the Mostyn firm, federal prosecutors have now impaneled a grand jury to launch a criminal investigation into charges of fraudulent activity by Boston Scientific Corp.
Criminal penalties for smuggling counterfeit material and endangering public health can range from 20 years in prison for serious bodily harm, to life in prison for death and a $15 million fine for a company.
The grand jury in Charleston, W.Va., has sent out multiple subpoenas in recent months, one of which was obtained by the Boston Globe (here).
The investigation will determine whether Boston Scientific engaged in deceptive trade practices by receiving the substandard materials which it fraudulently sold to health care providers and ultimately implanted in unsuspecting women like Teresa Stevens.
Boston Scientific, responding to an inquiry by the Globe, denied it uses counterfeit or adulterated materials in its medical devices.
“Boston Scientific has a robust quality system and dedication to patient safety. We stand behind out products, the materials used in those products and our commitment to women’s health,” said a spokesperson. BSC has not responded to an inquiry by Mesh News Desk.
GREEN LIGHT TO MORE DISCOVERY
In the latest turn, on May 5th, in the court overseeing transvaginal mesh medical products cases in California, Judge William F. Highberger denied Boston Science’s motion to bring a halt to future discovery into the Chinese resin issue.
Additional depositions and discovery will be conducted of Boston Scientific’s current and former employees, people in the know.
In making the ruling Judge Highberger ruled, “If the product is equivalent chemically but counterfeit in terms of its actual producer source, that raises legitimate questions as to why a manufacturer of products intended for human implantation would resort to such ruses to obtain needed raw material. Plaintiffs so far “have made a sufficient showing that it has a reasonable potential for relevance, at least as to the issue of punitive damages.”
Steve Mostyn says in many ways the story of the entire mesh mishap is just beginning to be told. They’ve identified 10 prior manufacturers from 2003 to 2010 who refused to sell PP for use in implants. Why did those manufacturers shy away from the transvaginal mesh business? Mostyn’s instincts are still kicking in.
“The reality is you must have this fundamental information before you can evaluate the cases we have found many things that do not relate to China but are highly relevant and we are now on a systematic review of all ten million pages and have requested additional documentation to fill in the holes.”
“I believe we will find chemists within the company said you can’t put this stuff in the body,” he says.
The implications for all manufacturers in the mesh mess are huge.
“It was a straight up experiment.” Mostyn says. “That’s the core of it. I think synthetic polypropylene meshes for vaginal use should be off the market. Period.”
On Monday, April 16 Figueroa v. Boston Scientific will begin in a Dallas court before Judge Ken Molberg. Ms Figueroa was implanted with a Boston Scientific Solyx SIS mesh for incontinence in June 4, 2011, the same month the company allegedly began sourcing its pelvic mesh resin from China.
**UPDATE** As of Friday, May 13, 2016, the Figueroa v. Boston Scientific trial has been rescheduled (again) to September 12, 2016. #