Boston Scientific on Hot Seat Amid Chinese Mesh Allegations

May 13, 2016

Boston Scientific on Hot Seat Amid Chinese Mesh Allegations

Original Story: http://www.meshmedicaldevicenewsdesk.com/boston-scientific-hot-seat-amid-chinese-mesh-allegations/

Mostyn Firm Shaking Up Transvaginal Mesh Litigation

May 9, 2016

By Mesh Medical News Desk

By his own admission Steve Mostyn was late to the game of pelvic mesh litigation but the speed of catchup has been lightning.

Two years ago, the Houston-based Mostyn Law firm, he heads with his wife, Amber, was wrapping up litigation involving Hurricane Sandy, which wound up in a segment on 60 Minutes. http://www.cbsnews.com/news/hurricane-sandy-60-minutes-fraud-investigation/

Known for fighting insurance companies on behalf of homeowners in the aftermath of natural disasters like Sandy and Texas storm Hurricane Ike, Mostyn Law has caused some of the most dramatic developments so far in what appears to be the largest mass tort ever assembled in one court – transvaginal mesh.

TVM as it’s called, is made from polypropylene plastic and implanted in women to shore up sagging pelvic organs. Lawsuits have proven the defective mesh causes life-altering complications. To make matters worse, it’s a permanent implant and practically impossible to remove.

A trickle of bellwether cases has led to some large plaintiff jury awards while Big Pharma mesh makers have flexed their muscle vowing to hold out and fight mesh-injured women in court rather than settle.

That promises to be a long wait for the 100,000+ cases filed in the U.S. Meanwhile, some law firms have tired of the protracted litigation and paltry settlements and are clearing out their “inventory” of cases.

It took a fresh set of eyes from Mostyn to launch a proactive campaign and a series of firsts – the first amended Class Action petition alleging fraud, the first Citizen’s Petition to get Boston Scientific mesh off the market; the first court order barring Boston Scientific from destroying evidence; and the first to get the FDA to acknowledge the potential contamination of mesh by counterfeit raw material.

The effort amassed enough evidence and now a grand jury has begun a criminal investigation into one of the largest pelvic mesh makers, Boston Scientific.

CHINESE WHAT?

Steve Mostyn was reviewing some of the ten million pages of mesh discovery documents late one night several days before Christmas 2015.  Why was Boston Scientific (BSC) going to China to get polypropylene (PP) resin beads to make its pelvic mesh?

PP plastic is a polymer, a cheap plastic output of the petroleum industry which is the main ingredient of hernia, surgical and transvaginal mesh. But China has no petroleum industry and shipping is expensive.  It simply made no sense.

“I came across an email titled ‘Re: Counterfeit material from a supplier you use – ACTION REQUIRED.”  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.

Boston Scientific had smuggled some grade of plastic resin out of China with no paperwork, no oversight and certainly with no approval. What was in this product? God only knows was right.

“I held a meeting with the team in the morning and the mood was somber. We all knew the potential consequences to our clients of having this resin implanted in them,” he says.

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.

From its review of the documents,  show Boston Scientific was involved in an international conspiracy to defraud regulators in both China and the U.S.

When its polypropylene resin supplier, Chevron Phillips, decided to stop selling to the company, BSC turned to China, smuggling in 15 tons of raw resin without verifying its contents, while at the same time telling authorities in the U.S. it was authentic Phillips Marlex, the proprietary name of its product.

Documents showed BSC turned to China as a supplier between June 2011 and the fall of 2012 after BCS’s 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 counterfeiter of plastic 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 raw mesh 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?

Among other things, “Hygiene, what was that?” says Mostyn. “It’s dumped and transported in a dirty old railcar,” said Steve Mostyn, adding that resin for the permanent implants is not sterile or anything close to medical grade that might be used to make a syringe.

While the US media has largely ignored the issue of mesh, the story made headlines in the Sunday Mail in Scotland where an aggressive reporter and active community of mesh-injured women addressed Parliament. It acknowledged this was a major public health issue and Scotland suspended the use of pelvic mesh implants more than a year ago.

The Daily Mail reports Boston Scientific “confirmed that all mesh products they have made in the past three years contain the Chinese resin.”

RICO ACTION

Teresa Stevens, 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 filed a federal racketeering class action lawsuit against Boston Scientific – the first RICO lawsuit filed in transvaginal mesh litigation.

RICO, based on the Racketeering Influenced and Corruption Organization statute (RICO), has long been used to target organized crime.

Lead plaintiff, 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 punitive 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.

CITIZEN’S PETITION

Knowing the FDA could take action to stop further hurting women, 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.

In January Mostyn firm had requested Judge Joseph Goodwin, overseeing the multidistrict litigation 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 essentially let Boston Scientific investigate the safety and effectiveness of the product it produces, despite the acknowledgement the 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.”

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. https://www.bostonglobe.com/business/2016/04/13/grand-jury-convened-probe-boston-scientific/v00hHy7djMd3xJfAH5f37J/story.html 

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.

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.

“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.”

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.

“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.

An entire generation of sisters, mothers, wives, reduced to barely sustaining with life-altering complications chronic pain and misery all while the company claims “Nothing is more important than women’s health,” and “Excellence is inherent in everything we do.”

“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.”