Mesh Medical Device News Desk, June 2, 2018 ~ The jury trial of Ana Martinez v Boston Scientific got underway May 31st in Middlesex County trial court in Woburn, Massachusetts, before Judge Thomas P. Billings. Case No. 1281CV03081.
Days before the trial got underway, the judge in this trial court decided what jurors will and will not hear, part of the Motions in Limine.
In December 2010, Ms. Martinez was implanted with two meshes made by the Marlborough – based company – the Pinnacle Pelvic Floor Repair system to treat prolapse, and the Obtryx mid-urethral sling to treat female stress urinary incontinence.
Image: Dr. Kord Strebel, YouTube
Dr. Kord Strebel, MD from Valley Hospital Medical Center in Las Vegas was the implanting physician. Ms Martinez resides in Nevada but since the company is based in Mass. that state is the proper venue.
Plaintiffs allege a design and manufacturing defect, a failure to warn, breach of express warranty (that its merchantability or fitness for intended purpose), loss of consortium, a violation of consumer protection laws, and they seek punitive damages.
SUMMARY JUDGMENT DENIED
Two days before trial, Judge Billings ruled on Boston Scientific’s (BSC) Motion for Summary Judgment.
The company alleged there is no evidence that the company breached its duty to the plaintiff because its actions did not fall below the reasonable standard of care. BSC said it followed the FDA guidelines for getting its meshes on the market, using the 510(k) clearance path, and that the plaintiff “cannot prove that a design defect of the devices caused her alleged injuries.”
Judge Billings denied the motion to dismiss the case.
MOTIONS IN LIMINE
The week of the trial, the docket shows a number of Motions in Limine were decided. Those are items of information both sides would like to eliminate from jury consideration.
Some of the controversial issues:
* The FDA’s 510(k) clearance process – and its lacking assurances for safety and efficacy. Judge Billings agreed to the plaintiffs’ Motion in Limine #3 to exclude the argument that the FDA approved the defendants’ use of Marlex PP in its mesh devices and any discussion of the 510(k) clearance process for the Pinnacle. Taking time to explore and dissect the FDA’s regulations takes valuable courtroom time with the potential to confuse the jury. The FDA is not on trial.
* MAUDE Database – The plaintiffs wanted to preclude any statistical compilation of the FDA database on complications stating these complications are “inherently unreliable.” The judge agreed.
* The Gold Standard – The judge agreed to exclude the sling and mesh products as being referred to as the Gold Standard by AUGS, the American Urogynecologic Society.
* Dr. M. Tom Margolis MD – The Defendant wanted to limit the testimony of M. Thomas Margolis MD; to limit evidence or arguments concerning the medical application caution contained in the Marlex MSDS. That motion was tabled by the judge.
* Mention of ProteGen – This was the first pelvic mesh on the market. Boston Scientific beat out its competition creating the ProteGen pubovaginal sling and it served as a “predicate” for generations of meshes to follow. ProteGen was made from polyester fabric woven and coated with bovine collagen, not polypropylene. Cleared by the FDA in April 1997, ProteGen was recalled in January 1999 after numerous reports of complications were reported.
“The probative value of this evidence is substantially outweighed by its potential for unfair prejudice, confusion and waste of time,” Judge Billings writes.
However, the judge added, the ProteGen evidence may have sufficient impeachment value to warrant its admission and the plaintiff may introduce the ProteGen evidence if the “door has been opened.
* Pinnacle Recall – Pinnacle Pelvic Floor Repair system was the subject of an FDA Immediate Recall in May 2011 for malfunctioning, while a new version of Obtryx, Obtryx II, remains on the market. Generally, the current status of a mesh is not allowed in these cases.
The meshes are made of Marlex, a type of polypropylene plastic. In the 1950s, Marlex was used to make Hula Hoops and lawn mowers. Some history of polypropylene will be allowed before jurors.
Typically in these mesh product liability trials, past trial outcomes, the number of women injured, and the number of doctors still using mesh are not mentioned.
STRICT LIABILITY – Failure to Warn:
The plaintiff must prove the inadequate warning caused her injuries.
A warning is adequate if it communicates the dangers that may result from its use or foreseeable misuse, otherwise the product is defective, says the judge quoting case law.
The doctor is the so-called “learned intermediary.”
If the doctor is provided adequate warnings and all relevant safety information for that product, then the medical device manufacturer is immune from liability under the learned intermediary doctrine. The issue in this case will be how adequate was the warning that BSC provided.
Additionally, BSC says the instruction pamphlet, the so-called Directions for Use (DFU) list all of the possible complications including vaginal erosion, incontinence, device migration, dyspareunia and pain. The doctor was aware of these risks and regularly provided information to his patients.
Martinez’ attorneys argue the warnings were inadequate because BSC never performed any tests on PP’s effect on the human body.
Without that, “It could not possibly have issued an adequate warning of risks,” writes the judge.
The plastic materials should never have been implanted in the human body according to the MSDS, (material safety data sheet which accompanies raw resin) which Boston Scientific knew as early as 2004 but never included that fact in its DFU.
And missing from the DFU are risks such as chronic pain, pain syndromes; incapacitating pelvic pain; complex mesh erosions: chronic foreign body reaction; mesh retraction, shrinkage and folding of mesh; curing of mesh; permanent dyspareunia; inability to remove the mesh; bio incompatibility with human tissue; and rates of mesh erosion.
At the request of Boston Scientific in 2008, Joseph Macaluso conducted a search of the literature and at the conclusion he warned Boston Scientific that “mesh should only be used if really necessary.”
Expert Dr. Suzanne Parisian, formerly a regulator with the FDA, opinioned that the DFU are inadequate because BSC knew that permanent placement increased long-term exposure to PP mesh risks and that the mesh might not be able to be totally removed. That was not communicated to the doctors.
Dr. Strebel testified he was unaware of certain risks including the rate of erosion, the permanence of dyspareunia, the lack of clinical trials, foreign body reaction and the impossibility of mesh removal; if he had been so informed, he would have told the plaintiff.”
The trial timing is not ideal for Boston Scientific. Two weeks ago, the news magazine, 60 Minutes led its Sunday segment with damning evidence showing the company knowingly smuggled substandard polypropylene resin from China after its U.S. supplies would no longer sell to the company.
One of the reasons – the Material Safety Data Sheet (MSDS)- which accompanies raw materials processed in U.S. plants, explicitly said “MEDICAL APPLICATION CAUTION: Do not use this Phillips Sumika Polyproylene Company material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues.”
60 Minutes showed the emails between company executives as they knowingly hid the shipment marking from U.S. Customs by over bagging them. Despite the fact that BSC knew the lot number on the bags didn’t match lot numbers from the Texas-based petroleum company, which the Chinese importer said was the resin supplier, BSC bought enough raw resin to make pelvic meshes for the next 30 years.
A polymer expert told 60 Minutes that regardless of where it’s sourced, polypropylene has no business being permanently implanted in the human body. ###
60 Minutes, May 13, 2018, 100,000 Women on pelvic mesh injuries
Pinnacle FDA Recall, May 10, 2011
MND, Appeals Court Upholds BSC $19 Mill Loss
MND, November 2014, $26.7 Million Awarded in Eghnayem Pinnacle case
MND, Sept. 2016, Plaintiff Wins New Trial in Overturned Boston Scientific Case
MND, Miller, the Father of Pinnacle, Nov. 2014