Readers 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.
And then the day comes- anything can happen. And usually does.
A collective sign was heard as the case of Albright v. Boston Scientific ended with the first jury decision for the defendant in transvaginal mesh litigation held in state court in Woburn, Mass. 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.
Not this time.
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, the doctor.
Fidelma Fitzpatrick is the lawyer who prepared the case for her client Diane Albright. After two weeks it 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, 'It was a privilege to represent Ms. Albright, to give her a voice."
So what was missing from the case? For starters the Albright team was not allowed to present the critical evidence of the FDA 522 letters. In 2011 the agency ordered 33 mesh manufacturers to conduct post-approval monitoring of women implanted with pelvic mesh. Post approval monitoring is allowed under FDA regulation 522. (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.
Second- Material Data Safety Sheet - Remember the MSDS in the Cisson Bard case? The instructions that accompanied the raw resin supplied to C.R. Bard by plastics supplier Philllips Sumika? It specified that under no circumstances were implantable medical devices to be made from that raw material. While skeptics saw the warning as a CYA move Bard went to extraordinary lengths to create a dummy company so Phillips Sumika would not know that creating implantable mesh was to be created from the Marlex plastic resin.
In this case the Material Data Safety Sheet, with the same instructions, was not allowed to be shown to the 13 jurors, according to Superior Court Judge Diane M. Kottmyer.
The approval of the polypropylene mesh that went into the Pinnacle through the FDA's fast-track process was allowed in "spirit" only says Fitzpatrick. In doing so, it essentially eliminated the argument that safety and efficacy of the mesh was not assured by the FDA. "It became difficult to explain the breadth and extensiveness for women" she said.
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.
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 that polypropylene is used in the pelvic floor and that it is considered the standard of care while the plaintiffs' argued the Pinnacle was not the standard of care to be used 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.
DONT UNDERSTAND THIS: thmanufacturers side, allowed def to make the case about all pp used in pelvic floor she allowed to make the case about still no pp should be used on pelvic floor or its okay… wouldn’t you agree pp is the standard of care for pelvic organ issues… the pinnacle is not the standard of case re so she really only allowed a muddled record to go in front… never argue that.
Expert witnesses for the plaintiffs included Dr. Neil Galloway from Emory University, John Stegy of the University of North Carolina, Dr. Scott Belcher from Vanderbilt and Thomas Barker of Georgia Tech. One of the original critics of polypropylene mesh implants - Dr. Donald Ostergard - took the stand on behalf of Diane Albright.
The Middlesex Superior Court has 1,700 cases filed including the next product liability case facing Boston Scientific to be heard August 11, one beginning September 2 and another in January 2015.
Federal court in Charleston, West Virginia will be the location of another defective product case against Boston Scientific November 3.
An appeal is likely in the Albright case, according to her attorney. #
The two week trial of Diane Albright v. Boston Scientific d/b/a Mansfield Scientific, Inc. and Microvasive, Inc. is expected to go to the jury Monday, July 28, 2014 after closing arguments.
The product liability lawsuit was filed in Middlesex Co in Massachusetts, Superior Court Action 12-0909.
Boston Scientific is headquartered in Middlesex County, MA.
On March 9, 2010, Albright received the implant made by Boston Scientific – the Pinnacle Pelvic Floor Repair Kit. The mesh was implanted at Mary Rutan Hospital in Bellefontaine, Ohio.
Albright did not, according to her complaint, receive any informed consent about what could go wrong or mesh injuries which was “negligently designed and manufactured,” according to her complaint.
Neither Albright or her doctor were warned about the dangers of pelvic mesh or that there were safer alternatives to address her pelvic organ prolapse. She was diagnosed with a recurrent cystocele.
Boston Scientific should have known about the complications associated with its product, according to the Albright Stamped Complaint.
Those complications include the design and manufacture of the mesh, the raw plastic edges made of polypropylene, a polymer plastic that incites immune and foreign body reaction. The transvaginal placement introduces bacteria into the body; the biomechanical issues that result from the bio incompatibility of plastic mesh and delicate tissue; the pelvic mesh anchors placed too near major nerve routes; and the degradation of mesh over time.
The product liability action says the mesh is defective in its design and manufacture and that the company was negligent in its failure to disclose to Albright and her physician the defective nature of the medical device that had the potential to cause mesh erosion, failure and permanent injury.
In fact, according to the complaint, the company over-promoted the safety and efficacy and benefits of the Pinnacle even though it had not conducted clinical trials to assure patient safety since they were not mandated by the Food and Drug Administration (FDA).
According to the FDA here:
“In 2011, Boston Scientific issued a 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.”
The three counts charged are breach of warranty, negligence and a failure to warn. The Albright case was filed in Massachusetts March 6, 2012.
She is represented by Fidelma l. Fitzpatrick and Jonathan D. Orent of Motley Rice.
Mesh News Desk does not have a reporter in the courtroom in Woburn, Mass. so has to rely on documents coming out of the court. Anyone interested in attending is invited to share her courtroom observations with Mesh News Desk. Thank you!