Unlike the U.S., where industry calls the shots and regulators mostly abide with business, the Scottish government has moved to regulate transvaginal or pelvic mesh treatment options offered to women with pelvic organ prolapse and stress urinary incontinence.
The UK Daily Record reported this week that three of four mesh procedures used routinely in Scottish hospitals will no longer be recommended by doctors. Scotland seems truly interested in protecting women at the expense of mesh makers, rather than the other way around, U.S. style.
DALLAS – Mesh News Desk reported that plaintiff’s expert Dr. M (name withheld to avoid red herring arguments from defense counsel) continued to testify for a second day, September 29, 2015. It would be the final day of the Plaintiff’s case in Cavness v. Ethicon (Cavness v. Kowalczyk et al., case # DC-14-04220).
A California urogynecologist and mesh removal expert, Dr. M continued his testimony about the pelvic mesh implanted in the plaintiff. He opined that the pain she continues to experience three years after her April 2012 implant is the same chronic pain felt by thousands of other women with pelvic mesh implants.
Day 6 – Sept. 28, 2015 – of the latest trial against Ethicon in Dallas brought testimony from Dr. M (name withheld to prevent defense lawyers’ red herring arguments), a urogynecologist from the San Francisco bay area, double board certified in Ob-Gyn and Urogynecology. Dr. M testified that he has done more than 25,000 surgical procedures, including 5,000 to 6,000 for stress urinary incontinence and the rest – some 14,000 – related to POP (pelvic organ prolapse). He also performs about six surgeries a week to remove plastic mesh from women.
Note: Much of this story comes from Mesh News Desk.
Day two in the latest pelvic mesh trial in Dallas brought evidence from the plaintiff’s attorneys that Johnson & Johnson and Ethicon executives identified red flags during the development of the Prosima pelvic mesh, yet chose to put the product on the market anyway. It was later withdrawn after problems continued and the FDA called for safety testing.
Readers are cautioned and advised that the plaintiff’s lawyers get to present the plaintiff’s side first; then the defense gets to present its case. Defense attorneys made many objections to the release of the internal Ethicon emails below, which were entered into evidence in this case.
The Cook Group Inc.faces at least 100 lawsuits over its blood clot filters. Patients from around the country have filed lawsuits against the Bloomington, Indiana-based Cook. Lawsuits allege the company’s blood-clot filters have broken apart, migrated and/or perforated the inferior vena cava, the blood vessel in which where they are implanted. The inferior vena cava brings blood from the lower body back to the heart; the filter is designed to keep blood clots from reaching the lungs.
Begun in 2012, the Cook litigation has recently been consolidated in federal court in Indianapolis.
The Journal of the American Medical Association pointed out in March 2013 that IVC blood clot filters are widely used despite a dearth of efficacy evidence. Some 250,000 Americans get a Bard IVC filter or some other blood clot filter implanted in their chests each year, despite the fact that such implantations have shown evidence of harm without evidence of benefit.
JAMA asks, “How could a medical device be so well accepted without any evidence of efficacy?” Answers to that question show the deplorable state of medical device safety testing and monitoring in the U.S.
The maker of a medical device implanted in thousands of Americans at risk for blood clots may have misled the FDA, the public, and doctors about the device’s potentially fatal flaws. The Bard Recovery blood clot filter may be fatally flawed.
Good news for the thousands of women injured by pelvic mesh. The first mesh verdict against Johnson & Johnson and Ethicon stands. Federal judge Joseph Goodwin has denied J&J and Ethicon attorneys’ motions to overturn the unanimous $3.27 million verdict awarded to an Illinois woman Sept. 5, 2014 in the multidistrict litigation (MDL) court in West Virginia.
Update: The verdict is on appeal; so no recovery has been made despite the verdict.
The legal machinations of Johnson & Johnson have been rejected by a federal judge.
After almost three years of pretrial discovery and hearings, the case of a San Antonio woman vs. Johnson & Johnson and Ethicon was all set to be tried where it was filed, in Bexar (pronounced: Bear) County court in San Antonio, in July 2015. The plaintiff resides in San Antonio, was implanted with mesh there, alleges injury there, and was medically treated repeatedly there for her mesh-related injuries; so the venue was convenient, and it seemed entirely appropriate to the plaintiff and her attorneys.
Johnson & Johnson, however, did not want to try the case in San Antonio. Twenty-eight days before the trial was to begin, J&J removed the case to the federal multi district litigation court in Charleston, West Virginia. J&J improperly claimed that despite having been on file for almost three years, Plaintiff’s claims against her doctor, who had implanted the faulty mesh, were not sincere.
C.R. Bard withdrew its Recovery IVC filter in 2005. The Bard Recovery blood clot filter has been linked to a 40% risk of filter fracture after five years. NBC News revealed the Recovery may have a fatal flaw, and that it may have gained FDA clearance – though not approval – through outright forgery.
IVC Filters Flawed – NBC Nightly News
Related: IVC Filters not FDA approved
Even those who don’t suffer life-threatening complications must have frequent monitoring to check for emerging IVC filter problems. Doctors are often unable to safely remove it. In addition, there is no evidence IVC blood clot filters help.
Bard Recovery Filter Lawsuits
Some two dozen Bard Recovery filter lawsuits and Bard G2 filter lawsuits sit pending in U.S. District Courts across the nation. Additional cases over problems with the inferior vena cava (IVC) filters will likely be filed in the near future.
All complaints against Bard IVC filters share similar allegations. Plaintiffs say they experienced complications after being implanted with the small blood clot filters in the inferior vena cava. The filters are designed to “catch” blood clots to stop them traveling to the lungs and causing pulmonary embolism. The problem is the filters have been linked to hundreds of adverse event reports. They can puncture the vena cava, tilt out of position, or fracture so that small fragments migrate to the heart or lungs.
The U.S. JPML determined in an August 17 transfer order that similar questions of fact and law raised in the cases justify coordinated pretrial proceedings. Consequently, cases pending throughout the federal court system will now be transferred to U.S. District Judge David G. Gampbell.