Boston Scientific Accused of Using Counterfeit Pellets in Pelvic Mesh

January 25, 2016

Boston Scientific Accused of Using Counterfeit Pellets in Pelvic Mesh

By Linda Harris, Legal Reporter
Posted: Jan 21, 2016 11:30 AM CST
Updated: Jan 24, 2016 5:00 AM CST

Original story:

Attorneys for a West Virginia woman suing the makers of a product used to treat pelvic organ prolapse and urinary incontinence claim confidential documents the company turned over in related complaints suggest some of the mesh being implanted in women isn’t even the real deal.

The complaint, which names Teresa Stevens as lead plaintiff, was filed Friday, Jan. 15 in federal court in Charleston by attorneys with the Houston, Texas-based Mostyn Law Firm and Harry Bell of Harry F. Bell Law in Charleston.

It alleges Boston Scientific, maker of Advantage mesh, panicked a decade ago when its U.S. supplier cut off its supply of Marlex, the pellets used to make Boston Scientific’s mesh products, and substituted a counterfeit product its people found in China without notifying the women in whom it was implanted or the U.S. Food & Drug Administration of the change.

Marlex — more specifically, Marlex HGX-030-1 — is a polypropylene compound developed by Phillips Sumika, an American company. Intended uses were woven industrial fabric and bags, woven carpet backing, bags and rope, according to product data sheets posted online.

Material Data Safety Sheets revised in 2007 specified the material should not be implanted in the human body, either permanently or temporarily, the suit said.

Kelly Leadem, director of media relations and executive communications for Boston Scientific, said patient safety “is of the utmost importance, and we dedicate significant resources to deliver safe, high-quality products.”

“We don’t believe the case has merit and intend to vigorously defend these claims,” Leadem said.

Counterfeit smuggling claims

The suit, however, claims counterfeit pellets were smuggled out of China, processed at plants in Belgium and Ireland, and then shaped and knitted at an Indiana facility, all to protect Boston Scientific’s $120-million- a-year revenue stream from the sale of pelvic mesh products.

“… the counterfeit Marlex (was smuggled) out of China by telling the Chinese the product was made in China (obviating the need for a Certificate of Compliance) and then imported … into the U.S. by claiming the product was authentic Marlex (thereby avoiding problems with the FDA),” the suit alleges.

The suit alleges Boston Scientific purchased counterfeit pellets from EMAI, a company that operates out of China’s Guandong region.

“China has a well-known history of supplying counterfeit plastic raw materials,” the 48-page document alleges. “The medical device maker Bard was forced to recall thousands of its mesh products because it used a counterfeit Marlex. (Boston Scientific) looked at five potential Chinese (suppliers) and ultimately settled on EMAI.”

Stevens’ complaint claims Phillips Sumika terminated its contract with Boston Scientific in 2005, allowing the company to purchase only an additional 4,000 pounds and refusing to sell it more “at any price.”

“After that, as far as Phillips was concerned, Boston Scientific was cut off from getting any more authentic Phillips Marlexto permanently implant into women,” the suit stated. By 2011 the company’s supply “began to run precariously low. BSC projected it would run out of this critical component of mesh by (the fall) of 2012.”

When the company couldn’t locate a viable Marlex supply, the complaint suggests Boston Scientific’s Women’s Health Division turned to EMAI even though it had  been “notified by the head of another division that EMAI had attempted to sell a counterfeit plastic product to (them) at about the same time Boston Scientific was buying the EMAI resin.”

According to Stevens’ lawsuit, Boston Scientific’s mesh products — Advantage Mesh, Advantage Fit and Lynx Systems — had been cleared under FDA’s 510(k) process. Essentially, a manufacturer has to prove the product it wants to put on the market is substantially equivalent to predicate devices cleared by the FDA. In this case, Boston Scientific piggybacked the Marlex-based products on approvals it had won years before for ProtoGen, mesh the company voluntarily recalled in 1999 after only three years on the market. Because the predicate device, ProtoGen, had not been recalled by the FDA, the suit said under 510(k) Boston Scientific was able to bring its newer products to market.

The lawsuit contends that, had the company told FDA it had changed resins, it would have had to have gone through the FDA approval process again.

Tens of thousands of suits

Tens of thousands of federal lawsuits have already been filed against the makers of pelvic mesh products, including Boston Scientific: As of Jan. 20, only about 12,400 of the nearly 86,500 pelvic mesh cases filed in the southern district had closed. Boston Scientific was named in at least 19,829 of those complaints.

Other cases have been or are being tried in state courts throughout the United States.

Women in whom the devices were implanted complain of infections, organ damage, horrific pain and incontinence and scarring, and say they’ve had to undergo multiple painful surgeries to try having the mesh removed.

“You’ve got women who are having all sorts of horrible problems, a worsening of the problems they were trying to fix in the beginning — bleeding, pain, organ puncture, painful sex for them and their partners,” Mostyn Law’s Amber Mostyn said. “If you add in the possibility of toxic contamination, it’s really hard to fathom.”

In the suit, Stevens’ legal team admits the complaint is based on information contained in millions of documents produced during discovery in other pelvic mesh cases. Those documents were classified as “confidential” when they were provided to the court in those other cases, though Stevens has petitioned the judge to declassify them.

She also asked the court for a restraining order temporarily barring Boston Scientific from selling its pelvic mesh products, and a preliminary injunction.

U.S. District Judge Joseph Goodwin has already denied the temporary restraining order, saying that while Stevens’ lawyers had attempted to contact Boston Scientific by phone and email, at no time had they mentioned they were going to seek a TRO. Federal Rules of Civil Procedure stipulate that, “in view of the possibly drastic consequences of a temporary restraining order, the opposition should be heard, if feasible, before the order is granted.”

“Plaintiff’s counsel omitted his intention on multiple occasions to file a motion for a TRO,” Goodwin opined. “The court finds that the plaintiff’s counsel has not complied with the strict requirements” of the rule.

Reserved judgment

Goodwin, however, reserved judgment on the injunction request.

Boston Scientific has asked Goodwin to deny Stevens’ motion for an expedited hearing on the injunction request. In their motion, they accused Stevens’ legal team of “improper use of discovery in the ongoing multi-district litigation, in violation of the Stipulated Protective Order entered by this Court in that action.”

“Having failed in their effort to ambush Boston Scientific with a temporary restraining order purposefully filed without notice to Boston Scientific, while knowing full well the identity of BSC’s lawyers and the method for serving them, Plaintiff’s attorneys now seek to prejudice BSC and prevent this Court from deciding their motion on a more fully developed record by requesting an expedited schedule,” Boston Scientific said. “They do this for a motion that they have prepared at their leisure based on improper use of discovery in the ongoing multidistrict litigation…”

Rules governing use of protected documents require the parties to resolve the dispute by either removing the confidential designation, creating a “mutually acceptable redacted version” or “confer about methods to avoid or limit public disclosure of such information during testimony.”

“Instead, in an apparent publicity stunt intended to draw attention to the complaint, plaintiff’s lawyers simply incorporated the contents of confidential documents into their filings and attached a number of the confidential documents to the complaint and motion papers, and then moved in this action to declassify them,” the Boston Scientific brief noted.

Stevens’ suit, which seeks class action status, also alleges federal racketeering violations.

This story first appeared in the print edition of The State Journal.