judge mallet 200Readers of Mesh News Desk have seen this before.

A law firm spends millions of dollars preparing a case for trial. Expert witnesses are deposed and paid, usually $500 an hour to review documents in preparation for trial. Lawyers travel around the world to take depositions of witnesses, scientists, experts, life planners, consultants. A normal life is put aside as the legal team laser focuses on trial preparation. The lawyers who take the case do so on a contingency fee –meaning that they won’t get paid and won’t recover their expenses unless they win the case. It’s a high risk, high stakes litigation.

And then the day comes- anything can happen. And usually does. 

A collective sigh was heard July 29, as the case of Albright v. Boston Scientific ended in a Woburn, Mass. courtroom with the first jury decision for the defendant in transvaginal mesh litigation. A half dozen cases against C.R. Bard and Ethicon in different courts have, so far, generally ended with a favorable jury award for the mesh-injured woman or a quiet settlement on the eve of trial.

Not this time.

Pinnacle Pelvic Floor Repair kit

Pinnacle Pelvic Floor Repair kit

The complaint said that plaintiff Albright and her doctor were not warned about the dangers of pelvic mesh or that there were safer alternatives to address her pelvic organ prolapse and a recurrent cystocele.

Boston Scientific should have known about the complications associated with its product, according to the Albright Stamped Complaint (link).

But instead, eleven of the 13 jurors agreed that the Pinnacle Mesh Kit implanted in Albright was not defective and neither were the instructions to the end user who is the doctor.

Motley Rice and attorney, Fidelma Fitzpatrick, prepared the case for Diane Albright. After two weeks the product liability trial went to the jury Monday, July 28, 2014.

Fitzpatrick says what was critical in this case was what was not allowed to be presented as what was.  

First Fitzpatrick tells Mesh News Desk, “We are extremely disappointed with the jury’s verdict in this case. Despite that, it was a privilege to represent Ms. Albright, to give her a voice, and to allow her story to be told.”

So what was missing from the case?

522 Studies

For starters the Albright team was prohibited from presenting the critical evidence of the FDA 522 letters. In January 2012 the Food and Drug Administration send 33 mesh manufacturers, including Boston Scientific, letters ordering three years of post-approval monitoring of mesh-implanted women to chronicle their complications. Post approval monitoring falls under FDA regulation 522, hence the name.  (Here is a background story).

The 522 inquiry would have shown that the FDA had concerns about the high number of adverse event reports coming into the FDA at that time, which had jumped five-fold in just two years. It would also have told the jury the true story of why the Pinnacle was taken off the market by Boston Scientific.

 

Material Safety Data Sheet (MSDS)

Remember the MSDS in the Cisson v. Bard case?  The instructions that accompanied the raw resin supplier Phillips Sumika sold to mesh maker C.R. Bard was accompanied by a MSDS or instructions for use. It specified that under no circumstances were implantable medical devices to be made from that raw material.  While skeptics saw the warning as a cover one’s behind move, Bard went to extraordinary lengths to create a dummy company to purchase the raw resin, so Phillips Sumika would not know that creating an implantable mesh was exactly what C.R. planned to do with the Marlex plastic resin.

In the Albright v. Boston Science case, the MSDS, containing the same warning, was not allowed to be shown to the 13 jurors, according to Superior Court Judge Diane M. Kottmyer.

The Plaintiff believed that this evidence was critical for the jury to understand the dangers of the product and Boston Scientific’s disregard for the safety of the women who would receive its Pinnacle device.

510(k)

The approval of the polypropylene mesh that went into the Pinnacle through the FDA’s fast-track 510(k) process was allowed in part only, says Fitzpatrick.

While the jury knew that the produce was cleared, the Plaintiffs were not allowed to present evidence about what was wrong with that 510(k) application process, a process that clears mesh for sale and not based on safety.That left the jury with the impression that the product was “legal” even though the Plaintiff vigorously argued that the product was not safe and was not effective. In doing so, it essentially eliminated the argument that safety and efficacy of the mesh was not assured by the FDA, since this approval process tests neither safety nor efficacy.

Also the time period the jurors were allowed to consider was 2009 and before. In that year Boston Scientific sold the Pinnacle device to the implanting hospital, Mary Rutan Hospital in Bellefontaine, Ohio.

Much has happened since 2009 including the July 2011 FDA safety alert that mesh complications are “not rare” and that mesh implant may have more risk than benefit.  Judge Kottmyer also excluded the evidence of this safety alert, and jurors were not allowed to consider the fact that the FDA found that the complications are not rare, are potentially severe, and that mesh repairs are not more effective than native tissue repairs.   These rulings kept critical facts from the hands of the jury itself and prevented a full discussion on some of the most central and critical facts in the TVM story.

 

Defective Product?

The Pinnacle Mesh Kit was voluntarily removed from the market on May 10, 2011. Boston Scientific sent an “URGENT MEDICAL DEVICE RECALL-IMMEDIATE ACTION REQUIRED” letter to all affected customers concerning its Class 2 recall for the Pinnacle Pelvic Floor Repair Kit because “the device may exhibit low tensile strength between the needle and suture and led to needle detachment during mesh leg placement.”

Would that not show a concern the product was defective?

Boston Scientific argued the recall was a business decision and not evidence of a lack of safety.  Meanwhile the judge allowed the defendant to present evidence concerning the safety of all polypropylene in the pelvis, including repairs with mesh kits, mesh slings, and sheet mesh used for abdominal sacrocolpopexies.

Plaintiffs argued that the case should be limited to arguments and evidence concerning the Pinnacle itself, arguing that the Pinnacle was not the standard of care to use near delicate pelvic organ tissues.

The jurors were left with a muddy record on the controversial plastic used in almost all pelvic organ mesh implants.

Expert Witnesses

Mesh News Desk reports on the  experts who appeared at this case but that information is made available to individuals and businesses who enroll in the newsletter on Page One of Mesh News Desk. Mesh injured individuals will not be charged but businesses may incur a charge for the remainder of the story. Contact Janeakre@meshnewsdesk.com  for more information or use the Paypal option on Page One of Mesh News Desk. Thank you.