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Judge Goodwin Defers Counterfeit Mesh Allegations Against Boston Scientific to the FDA

Judge Joseph Goodwin

Judge Joseph Goodwin

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.

 

BACKGROUND STORYbs logo

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.

 

Gavel 500DOCTRINE OF PRIMARY JURISDICTION

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.

Bruce Rosenberg

Bruce Rosenberg

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, Lana Keeton “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.  #

LEARN MORE

Memorandum and Opinion, So District of WV, Stevens v. Boston Scientific, Case no.  2:15-cv-00265, (requires Pacer account) 

https://ecf.wvsd.uscourts.gov/doc1/20116062508

 

 

 

 

 

 

6 Comments

  1. Mary Pat says:

    Ok, FDA, the world is watching you. Let’s see if you try to sweep this under the rug! That will be very revealing of the character and agenda of the FDA.

  2. Bruce says:

    Jane,

    To clarify the issue of tracking failed device issues: The manufacturer (and FDA) can actually track an individual device as each device sold has a LOT number provided on the package. Ethicon, for example provides several decals to peel off so that one can be placed on the patient’s file, one can go to billing, etc, creating a traceable record of a problem/reported injury should occur.

    The doctor is supposed to report any known device related injury to the manufacturer or FDA as an adverse event (MAUDE Report) report. Any patient who is injured may call the manufacturer and FDA them self and file one…and they should to increase documentation of this awful world-wide problem. They both will send a response asking several questions and a promise to follow up but don’t expect any. The manufacturer is supposed to provide “Post-market” reviews to the FDA, but as we have learned in the past these are very often completely false in terms of true outcomes.

    The e-mails are of course concerning because it makes no sense that David Krause would alarm a potential defendant of serious factual and hard evidence of a device failure and injury potential, without first deferring to their own Office of Criminal Investigation (“OCI”) to look into the serious nature of potential fraudulent marketing alleged by myself and Lana Keeton at that time. Note that the e-mails were in 2010…the FDA could have done something…anything to better inform the medical community and public they are entrusted to protect…but they didn’t and subsequently approximately 100,000 women and who knows how many others were confirmed to be severely and permanently injured by contracting, stiffening, eroding polypropylene mesh…a tragedy that could have been avoided…they were fools and they are suspect.

    • Jane Akre says:

      Thank you Bruce. I was taken aback when I saw the close buddy relationship, sort of like the FDA is the Washington DC office of Ethicon. BTW- I’ve heard on more than one occasion those “tabs” go missing from medical records. One should look for them. Sort of a loosely goosey way of tracking devices, no? How about a Vin number like a car.

  3. kitty says:

    It would be interesting to see what year/years many of the tabs were missing. In the beginning–There were tabs……….

  4. janet says:

    I really do not know about the FDA working on this

    They did nit protect us from the defective mesh and they knew

  5. […] Judge Goodwin refused to restrain Boston Scientific from marketing, selling or importing its mesh devices containing the allegedly counterfeit resin, made since 2012. […]

  6. Terri says:

    I can’t believe that they can you something that was never tested in the body I still have pieces of it in me that have grown into my artery do you think they’ll think about that I can’t even walk half the time I’m sure we’ll get messed over we need a woman judge she most likely would know what was going on with a woman’s body a man has no idea no disrespect to the judge but he really needs to think about women sex life’s gone husband’s gone how do you compensate for that

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