Christmas cactus, 2016
Mesh Medical Device News Desk, December 29, 2016 ~ It may not seem like much has happened in the world of polypropylene mesh implants this year, but a review of 2016 tells otherwise.
There have been changes and shifts in litigation and research, albeit moving much too slowly for the 100,000 or so mesh-injured patients waiting for some resolution.
Here are some highlights from 2016:
Prolift, MedTech Marketing
PROLIFT FOUND DEFECTIVELY DESIGNED – It was the last trial of 2015, the Hammons trial in Philadelphia Court (here) of Common Pleas found Prolift was defectively designed and awarded Ms. Hammons $5.5 million in compensatory damages.
The jury returned to award $7 million in punitive damages. MND coverage here.
This marks the first time document destruction by Johnson & Johnson (Ethicon) was brought before a jury.
J&J quietly removed Prolift from the market in mid-2012, but it remains one of the most injurious pelvic mesh devices ever made.
The Philadelphia court then yielded a $13.5 million verdict for plaintiff Sharon Carlino concerning her TVT tape, also made by Ethicon. That award contains $10 million in punitive damages intended to punish the company for wrongdoing.
Judge Robert M. Scheiber, 16th Judicial Circuit Court, Missouri
BOSTON SCIENTIFIC AND C.R. BARD TRIAL - In February, 2016, jurors, in the only pelvic mesh trial to name two defendants, handed Boston Scientific and C.R. Bard a victory in a Kansas City, Missouri courtroom in the Sherrer case.
See coverage here.
The trial had been extended and interrupted throughout the holiday season, and at 40-days, was the longest in pelvic mesh litigation history.
This is also the trial Mesh News Desk became part of the story when a disparaging comment by a reader, (Maria.Garcia) led to defense attorney Lori Cohen's complaint to the judge. He decided MND should lose its access to the trial.
Even when MND filed an appeal, MND was excluded from the Courtroom News camera access.
JOHNSON & JOHNSON OFFERED FIRST TRANSVAGINAL MESH SETTLEMENT - At $120 million, J&J and its Ethicon subsidiary, offered to pay $120 million to settle anywhere from 2,000 to 3,000 defective product lawsuits. The average award in the vicinity of $50,000 varied depending on the severity of injury.
J&J offered its second pelvic mesh settlement of $112 million to 1,000 women in September of 2016. See coverage here.
Yimao Plastic Molding, Guangdong Province, China
CHINESE RESIN IN BOSTON SCIENTIFIC MESH – Judge Joseph Goodwin, the federal judge overseeing thousands of pelvic mesh lawsuits consolidated in his court, decided to let the U.S. Food and Drug Administration (FDA) deal with the question of whether or not Boston Scientific (BSC) pelvic mesh was made from adulterated polypropylene smuggled into the U.S. from China.
In January 2016, the Mostyn law firm uncovered the finding in court documents and filed a RICO lawsuit (Stevens v. Boston Scientific 2:16-cv-00265) in Judge Goodwin’s court alleging racketeering in the sale of the allegedly substandard mesh and representing the 55,000 women who had received BSC mesh since 2012.
Mostyn said BSC acted like a drug dealer to hide 37,000 pounds of the substandard resin from customs agents in the U.S. and China.
See MND coverage here . Here is the RICO lawsuit.
Another case over Chinese mesh from BSC was filed in the Eastern District of New York in November, alleging 13 violations including violation of federal anti-racketeering law, negligence, strict liability, unjust enrichment, breach of warranty, all elements of organized crime. Under RICO, damages can be tripled.
More MND coverage here.
Judge Goodwin refused to restrain Boston Scientific from marketing, selling or importing its mesh devices containing the allegedly counterfeit resin, those made since 2012.
BSC was forced to source polypropylene resin from China when its supplier, Phillips Sumika, stopped selling to the company to make its pelvic mesh medical devices. Technically, any variation in the device approved by the FDA is supposed to undergo another approval, which never happened.
In February 2016, a Grand Jury was convened in West Virginia to look into criminal charges against Boston Scientific over counterfeit mesh.
Scotland called for criminal investigations into the counterfeit mesh allegations against Boston Scientific. MND coverage here and here.
Linda and Jeff Gross, from PBS Need to Know
LINDA GROSS CASE SURVIVES APPEALS – In March 2016, the pelvic mesh case of Linda Gross survived a three judge appellate panel.
Ms. Gross and her husband were awarded $11.1 million in February 2013 in her defective product liability trial against J&J over her injuries from a Prolift mesh. J&J immediately appealed.
In November, the company’s last chance at an appeal to the New Jersey Supreme Court was denied. According to her attorney, J&J can appeal that denial and try again to get to the high court in New Jersey, but at this writing, the company has exhausted all appeals in the Gross case. See MND coverage here.
Scottish Mesh Survivors
SCOTLAND HALTS PELVIC MESH PROCEDURES – Scottish Mesh Survivors spoke directly to a parliamentary committee in that country and in June, Health Secretary Alex Neil suspended surgeries using transvaginal mesh for pelvic organ prolapse and to treat stress urinary incontinence.
The country promised a national review. Mesh would still be available to those who requested it.
CALDERA DENIED SETTLEMENT OPTION - Caldera Medical had claimed it was insolvent and offered women injured by its pelvic mesh a few thousand dollars.
At the same time, the company announced it would expand its operations, joining with another company to offer mesh implants to one million third world women.
With about 4,000 women awaiting some Caldera settlement, in July, the judge overseeing the proposed Caldera Medical settlement denied the company claim that it was insolvent and denied its final settlement (here).
Meanwhile, more settlement funds were whittled away as Caldera fought Federal Insurance (Chubb). Most of the remaining Caldera Medical assets went to lawyers for the two companies fighting each other.
At this writing, the Caldera Mesh settlement has not been approved.
“Samantha” filed her own objection to the Caldera settlement, pro se, and the issue is still not resolved. See MND coverage here and here.
Federal Insurance v. Caldera lawsuit here.
KY AG Beshear
ATTORNEYS GENERAL FILE SUIT AGAINST J&J – By May 2016, both California and Washington State attorneys general had filed lawsuits against Johnson & Johnson for deceiving the public about the safety of its pelvic mesh implants, a violation of state consumer protection laws. Kentucky later joined in filing its own lawsuit against J&J.
All three states seek to be reimbursed for each woman who was implanted with J&J mesh and to seek costs, fees and restitution. The fines could reach tens of millions of dollars for J&J. At this writing, the AG actions remain open.
See the MND coverage here.
J&J denied it did anything wrong and called the lawsuits unjustified.
Here is the Washington State complaint.
UCLA RESEARCHES AUTOIMMUNE MESH LINK – A link between polypropylene mesh implants and autoimmune reactions has long been suspected among hernia mesh and pelvic mesh recipients. Some suffer unexplainable autoimmune reactions to their mesh implant.
No one was acknowledging much less looking at the connection until August, when UCLA announced it was beginning an autoimmune registry of mesh complications.
Opened to men and women, in the U.S. and globally, it will add to the UCLA research on biofilms and is the first official recognition that there may be a link. Those experiencing autoimmune issues since their implant are asked to add their experience. It can be done anonymously.
The link to the registry is in this MND story.
Bear at Denver Conv. Center
AUGS CALLS OUT MESH-INJURED MOVEMENT - When your editor attended the 2016 meeting of the American Urogynecologic Society (AUGS), she was surprised to see a number of things- the president of the society called the mesh-injured community an “anti-mesh movement," some doctors said mesh injured women were "looking for a payday,” while some were not really injured, others concluded.
One opinion expressed by some in attendance was that trial attorneys had targeted urogynecologists and many were unfairly being brought into the pelvic mesh litigation.
At the same time, AUGS stood by its mid-urethral slings as the gold standard and a “treatment worth protecting,” though some doctors who have been sued, have given up the use of polypropylene mesh.
Those members of AUGS who have been shown at trial to be those most influential as “preceptors” to other doctors, were again, representing device companies, teaching sessions at AUGS on new medical devices to fellow urogynecologists. Patient presence was absent from the gathering in Denver, while a plethora of manufacturers shared their wares in the trade show exhibit hall.
The only session specifically scheduled to discuss litigation issues was abruptly cancelled the day it was to be held.
See MND coverage here and here and here.
Judge Diane M. Kottmyer
BOSTON SCIENTIFIC PINNACLE PELVIC MESH VERDICT OVERTURNED – A decision by a Massachusetts Appeals Court in September 2016, meant a mesh injured woman from Ohio will receive a new trial against Boston Scientific.
Diane Albright claims she was injured by the Pinnacle Pelvic Floor Repair Kit. A jury in 2014 concluded her mesh was not defective and the warnings to her doctor were adequate.
Motley Rice, the lawyers for Albright, immediately filed an appeal on the basis that key evidence was omitted from trial by Judge D. Kottmyer, specifically the Material Safety Data Sheet, a document that details environmental hazards of raw polypropylene. It says the material is not to be used to make implantable medical devices.
Jurors also could not see an FDA letter that ordered post-approval surveillance of Pinnacle, a mesh kits that Boston Scientific took off the market in May 2011.
See MND story here. The case has not yet been rescheduled.
As 2016 wraps up, some of the oldest J&J pelvic mesh cases are being readied for trial in West Virginia.
All of the pretrial proceedings should be completed by May, 2017. Mullins et all and its 31 plaintiffs from West Virginia, is scheduled to begin March 6, 2017.
The Sullivan v. Boston Scientific case is set for February 27, 2016 in Philadelphia.
The Smith TVT-O case set for January 9, 2017 in Bergen Co. New Jersey has just been resolved. See the documents here.