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Boston Scientific Plans Mass Pelvic Mesh Settlements

Mesh Medical Device News Desk, May 9, 2017 ~ According to its quarterly federal filing, Boston Scientific, one of seven medical device manufacturers  facing thousands of product liability cases over its pelvic mesh, plans to settle 37,000 cases with certain plaintiff attorneys without admitting any fault.

Quarterly reports that shareholders read are always enlightening as to how a company deals with allegedly defective products.  In its latest quarterly report (10-Q), filed with the Securities and Exchange Commission (SEC) May 3, Boston Scientific (BSC)  says whether patent infringement, intellectual property rights or product liability, lawsuits  are a “normal course of business.”

AUGS Exhibit floor

But extraordinary within its pages is the admission that 37,000 of a pending 43,000 product liability cases filed against BSC will be resolved. Of those approximately 12,000 have met the condition of settlement and are final.

BSC likes to point out that the settlements came about through compromise with “without any admission or concessions by us of any liability or wrongdoing.”

The cost of legal matters was $2 billion as of the last day of December. Another $1.75 billion, including the estimated costs of settlement, damage and defense, has been accrued by March 31, 2017.

The 10-Q filing does not specify how much has been set aside specifically for transvaginal mesh settlements.

“We recorded $3 million of litigation-related charges during the first three months of 2017 and $10 million of litigation-related charges during the first three months of 2016.”

BSC says it has put aside money for these and future cases and claims which it believes is adequate but, “changes to this accrual may be required in the future as additional information becomes available.”

The pending cases are filed in both state and federal courts and include eight class actions filed in Canada (one certified and three potential class actions) and fewer than 25 class claims in the UK.

These are claims for design and manufacturing defects, a failure to warn, breach of warranty, fraud, violations of state consumer protection laws and loss of consortium.

 

Polypropylene resin

RICO CLAIMS

The SEC filing specifically points to Teresa Stevens, who in January 2016 filed a RICO claims against BSC on behalf of women who allegedly received mesh made from counterfeit or adulterated resin products imported (smuggled) from China.

RICO stands for Racketeer Influenced and Corrupt Organizations Act, charges of which are usually reserved for organized criminal activity.

On January 26, 2016, the Court issued an order staying the case and directing the plaintiff to submit information to allow the FDA to weigh in.  The FDA deferred to Boston Scientific to determine if its resin from China implants were substantially different from resin sources in the U.S. There’s been no update from BSC.

The 10-Q continues, “In addition, we are in contact with the United States Attorney’s Office for the Southern District of West Virginia and are responding voluntarily to their requests in connection with that office’s review of the allegations concerning the use of mesh resin in the complaint.”

Another complaint alleging RICO violations was filed February 27, 2017 in the U.S. District Court for the Middle District of Florida, Orlando Division against Boston Scientific. Carolyn Turner also alleges violations of the Racketeer Influenced and Corrupt Organizations Act (RICO) and heads a class alleging she was harmed by vaginal mesh made from counterfeit resin brought in from China.  This was served against the company April 7, 2017.

Yimao Plastic Molding, did it sell resin to BSC?

“We deny the plaintiff’s allegations and intend to defend ourselves vigorously.”

Another RICO case was filed in the Eastern District of New York by Frances Peel Hennington, who heads the class. See Mesh News Desk story here. Read the Complaint here:

BSC says it has put aside money for these and future cases and claims which it believes is adequate, “changes to this accrual may be required in the future as additional information becomes available.”

In the federal court in Charleston West Virginia, May 5 the court entered PTO Order #160 appointing Cathy Yanni as special master for private settlement agreements between BSC and certain plaintiffs’ counsel, among them Skikos, Crawford, Skikos & Joseph LLP.

 

Pinnacle Pelvic Floor Kit

TRIALS SO FAR

Trial results have been both favorable and unfavorable but BSC says it does not believe that is an indicator of potential outcomes of all cases related to transvaginal mesh.

There are more than 3,100 cases filed in state court in Massachusetts and certain state attorneys general are also considering actions and have filed discovery requests on BSC.

The Southern District of West Virginia is the federal home of the bulk of transvaginal mesh claims against Boston Scientific. As of today there are 24,751 cases filed with 9,190 that claim to be closed. This includes cases filed as early as May 2011.

The Charleston, West Virginia court is where multidistrict litigation (MDL) assembled more than 102,000 claims against six manufacturers. Boston Scientific is MDL 2326.

March 1, 2017, on the eve of a product liability trial, Sullivan v. Boston Scientific settled.    See MND story. 

A Mass. appeals court decided last September that the Albright case against Boston Scientific should receive a new trial because of information omitted by the Massachusetts trial court judge. See MND coverage here.

A RICO case was filed last June in federal court in Charleston, WV alleging Boston Scientific purchased counterfeit Marlex to make its pelvic mesh from a Chinese counterfeiter.  See MND coverage here.

A North Carolina jury found for Boston Scientific and its Uphold mesh in the trial of Carlson v. Boston Scientific, October, 2015.  See MND coverage here. 

In September and again in November 2014, Boston Scientific lost two trials, one in Miami and another in Charleston, West Virginia that represented four plaintiffs each. The Eghnayem trial in Miami concerned BSC’s Pinnacle and resulted in a award total of $26.7 million. See MND coverage here.

In the Tyree case, which involved BSC’s Obtryx pelvic mesh, the litigants were awarded a total of $18.5 million.  See MND coverage here.  

The largest mesh award so far went to plaintiff Martha Salazar who was implanted with the Boston Scientific Obtryx. A Texas jury awarded her $73.46 million, which was later reduced by the trial court judge to $34.6 million under tort reform restrictions.  See MND coverage here.

Obtryx II

 

STILL ON THE MARKET

Boston Scientific still sells mid-urethral slings – the Advantage Fit, Advantage, Lynx, Obtryx II, Solyx, according to its website here.

The Pinnacle, pelvic organ prolapse mesh has been removed from the market. The only other pelvic floor mesh includes the Repliform, a human dermal graft, Uphold LITE Vaginal support System, and Upsylon Y-Mesh.

A year ago Boston Scientific bolstered its pelvic mesh warning label. See the MND story here.

The notice also makes changes to the label on the BSC Pinnacle LITE pelvic floor mesh, not current available in the Boston Scientific U.S brochure,  but the label changes for the international community indicate it is still being used overseas. Boston Scientific surgical mesh made after 2012 may be made from counterfeit resin smuggled to the U.S. from China.  See the background here.

Michael Mahoney, CEO Boston Sci

Michael Mahoney is CEO who reaped a total of $35.7 million in total compensation in 2016, according to bizjournals Boston.

Mahoney was hired away from Ethicon/ Johnson & Johnson in September  2011, (See MND story here)  where he worked in sales and marketing selling nuclear medicine cardiology systems to small hospitals in the Carolinas.

While at J&J he worked alongside the president of DePuy Orthopaedics. In 2007, he was promoted to J&J’s knee and hip joint business. By August 2010, the DePuy ASR XL acetabular hip replacement was recalled because it was failing in the patients it was supposed to help.  Marketed as an alternative hip replacement for the younger, athletic patient, the metal-on-metal prosthesis led to metal poisoning and repeated revisions.  J&J did not warn physicians or patients and J&J paid out nearly $1 billion in legal costs and settlements.

Instead of losing his job, Mahoney was promoted within J&J to the head of J&J’s medical device and diagnostics group.

In 2011, J&J insisted on enforcing a non-compete clause to keep Mahoney from joining Boston Scientific, but then relented allowing the transition if Mahoney agreed not to work in any competing business to J&J such as stents or implantable defibrillators. ###

 

 

LEARN MORE:

Mesh News Desk, Boston Scientific Must Pay Salazar $73.5 Million, September 8, 2014
http://meshmedicaldevicenewsdesk.com/patient-profiles/breaking-news-boston-scientific-must-pay-salazar-72-million/


See Mesh winners and losers so far
http://www.meshmedicaldevicenewsdesk.com/transvaginal-mesh-trials-far-winners-losers/

 

 

 

10 Comments

  1. Anon says:

    The attorneys they are settling with are looking out for themselves and not the clients. That’s why they said certain plaintiff attorneys

  2. Mart says:

    It’s about time they started settling these cases it’s been going on long enough Boston scientific needs to step up to the plate and handle there business they didn’t have a problem with selling there faulty devices they shouldn’t have a problem with taking care of the woman that have been injured

  3. Mart says:

    And yes you are right most of the money will go to the attorneys nothing but GREED GREED GREED it’s really sad but you know Philadelphia is getting cases done really fast West Virginia is very slow with this madness I bet you once the judge can’t milk the cow any further watch how quickly the cases start to move along

    • Advocate says:

      A wise person once said… It’s not what you know that will kill you. It’s what you think you know and don’t, that will.
      In this instance, what you don’t know is, judges have nothing to gain by delaying cases as you suggest. Greed is an easy allegation and the judges and attorneys helping you have become easy targets. Any wonder they’ve grown weary of the litigation?
      Perhaps you believe you could do a better job? If so, fire your attorney and take your case on yourself. Be sure to leave behind all the information and testimony that has been gathered on the backs of these greedy judges and attorneys though, because you don’t want to jump into the fire with their blood money.
      Good luck and be sure to come back and let everyone know how well you did.

      • Jane Akre says:

        Advocate- People forget that… thanks for the reminder. The system isn’t perfect but it has worked for some women, especially the bellwethers….

  4. Jan says:

    Oh well it cost them 2 Billion. Before trials ever started they stated they had 185 Billion to fight against us.. my hole theory is be honest
    Run an honest company walk with pride because you are honest.Boston scientific should have been honest they should have settled these cases with that 185 Billion dollars instead they let dishonesty and greed take the best of them
    So, they need to get there stories correct I am still willing to play honestly because I want very little on judgement day to answer for.. but I guess they are willing to take that chance and play with God..

  5. Jody says:

    The system isn’t perfect by any means However when you decide to take on the Pharmaceutical companies you better have a team of great lawyers because it’s going to take a lot of money not to mention resources.

  6. V says:

    Jane. In the report did they say which lawyers or law firms that they were working with?

    • Jane Akre says:

      No they didn’t but if you go to the MDL, you may see the firms dealing with Boston Scientific under orders.

  7. V says:

    Thanks for answering. Is there a link? I don’t know how to get there and search that. Thank for your help.

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