Mesh News Desk, January 27, 2016~Judge Joseph Goodwin who is overseeing thousands of pelvic mesh injury cases in his West Virginia court has decided to let the U.S. Food and Drug Administration (FDA) handle the latest hot potato – counterfeit mesh from China.
Citing the doctrine of primary jurisdiction, the federal judge, in a January 26 Memorandum Opinion and Order, said the FDA is the administrative agency with the most knowledge over whether the mesh manufactured by Boston Scientific comes from counterfeit, adulterated polypropylene resin smuggled in from China and not the Marlex polypropylene the manufacturer is approved to use.
“The FDA is in the best position to determine whether Boston Scientific’s mesh device is in compliance with the FDA’s own statutes, regulations, and directives – particularly because the FDA was the very agency that cleared Boston Scientific’s mesh device in the first place.” ~ Judge Joseph Goodwin
The plaintiff complaint, Teresa L. Stevens v. Boston Scientific 2:16-cv-00265, accuses the company of racketeering and asked the court to restrain Boston Scientific from marketing, selling or importing its mesh devices containing the alleged counterfeit polypropylene resin.
That request was stayed until Judge Goodwin hears an updated status report from the FDA and plaintiffs’ lawyers no later than May 1, 2016.
Boston Scientific says each year approximately 55,000 women are implanted with its pelvic mesh, Marlex HGX-030-1. This is mesh that the FDA cleared for use in the Boston Scientific pelvic meshes it manufactures. Technically, if the company uses any other polypropylene to make its Marlex mesh, that product would not be approved for sale by the FDA.
Marlex is made from polypropylene resin in pellet form by a joint venture between the Chevron Corporation and Phillips Sumika Polypropylene Company of LaPorte, Texas.
According to the Stevens complaint, by 2011, Boston Scientific (BSX) began running out of Marlex supplies because Phillips decided to discontinue selling it to the company. BSX then allegedly resorted to smuggling counterfeit Marlex pellets out of China into Belgium and ultimately the U.S. between June 2011 to the fall of 2012. The plaintiff alleges women were implanted with a counterfeit, adulterated product that was not approved by the FDA under Boston Scientific’s 510(k) application.
The Houston-based Mostyn law firm filed Stevens v. Boston Scientific January 12 making claims under the Racketeer Influenced and Corrupt Organizations Act or RICO, used to prosecute organized crime. The actions employed by BSX were also a violation of West Virginia’s Consumer Credit and Protection Act, it said and Boston Scientific “acted like a drug dealer” to hide overseas shipments from regulators in both China and the U.S. See the Stevens RICO-Complaint January 2016.
Judge Goodwin’s court will retain jurisdiction over the case until there is an FDA determination to the specific allegations.
In 1907, the U.S. Supreme Court decided the courts should promote proper relationships with administrative agencies charged with particular regulatory duties. In that case, a shipper claimed a carrier’s rate was unreasonable and sued the carrier in state court. The US Supreme Court decided the Interstate Commerce Commission alone was competent to determine whether the rate was reasonable.
In other words, agency expertise is needed to resolve the issue before a court can allocate jurisdiction. The court can stay the proceedings and look to the FDA for a determination, it may request an amicus curiae brief from the FDA (friends of the court) or it may certify questions to the agency.
FDA AND THE INDUSTRY IT REGULATES
The plaintiffs say the court will not benefit from agency expertise. Judge Goodwin disagreed, citing confidence in the federal agency.
The FDA tightened some control over medical devices with the enactment of the Medical Device Amendments of 1976 (MDA) but the bulk of medical devices are approved under 510(k) with an exchange of paperwork and the naming of a “predicate” device already on the market.
Judge Goodwin states the FDA can require medical device companies to conduct post-approval marketing, such as what its done with the mesh makers. The agency can adopt a method of tracking a device within the marketplace, he writes, however, while that has been discussed, the FDA still has no way to track a troubling medical device. If an automobile has a problem, its VIN number can be traced. Not so with medical devices.
The FDA can have a device recalled, but it rarely does. Generally that is left up to the manufacturer to enact a voluntary recall or a quiet withdrawal from the market, as has occurred with Johnson & Johnson and C.R. Bard.
Judge Goodwin says private individuals may initiate an administrative proceeding to petition the FDA commissioner to take administrative action.
Mesh News Desk has reported on what happened to Bruce Rosenberg when he tried to do just that. Calling a member of the FDA’s medical device division, he wanted to show them a videotape made by Johnson & Johnson that showed the company knew its Prolene hernia mesh was too stiff for use in humans. In the video, a consultant/doctor is shown hitting a hardened piece of plasticized mesh against a table. The video was made to promote a softer mesh.
See MND, Tale of the Tape here.
When Rosenberg, who heads the nonprofit Meshoma Foundation, called the agency, a device regulator, David Krause, whose job it was to authorize 510(k) clearances for medical devices including pelvic mesh, called the head of regulatory affairs for Ethicon, Peter Cecchini. Cecchini replied in an internal Ethicon October 20, 2010, email,
“According to David K., it seems that Bruce Rosenberg claims to have a DVD that speaks to a mesh that falls apart after 1 year implantation. David would like the details of this and has requested a copy of the DVD. He did state that if this is true the product should be removed from the market and the 510(k) removed.”
Krause calls consumer groups headed by Rosenberg and patient advocate and another woman “serious, irrational and nasty.”
Mesh News Desk has also obtained notes from a meeting between industry and the FDA prior to an expert panel meeting in September 2011 that clearly show industry schooling the agency about mesh.
Additionally, the FDA has no mechanism by which to review medical devices on the market that named a “predicate” device that’s been found to be defective as was the case with the ProteGen mesh, which was removed from the market.
The Mostyn firm is hoping to turn the Stevens case into a class action and to try and stop the sale of transvaginal mesh implants made by Boston Scientific. #
Memorandum and Opinion, So District of WV, Stevens v. Boston Scientific, Case no. 2:15-cv-00265, (requires Pacer account)