Monthly Archives: August 2013

Mesh Implant Recall Lawsuit

The second federal trial related to a C.R. Bard transvaginal mesh lawsuit came to an early conclusion last week after the parties were able to reach an undisclosed settlement. According to a report from the Charleston Daily Gazette, lawyers in the case were just about to begin their opening statements when the settlement was announced.
It would have been the second trial in a federal multidistrict litigation established for C.R. Bard vaginal mesh lawsuits in the U.S. District Court, Southern District of West Virginia. In the litigation’s first trial, a week prior, the Plaintiff was awarded $2 million in compensatory and punitive damages for vaginal mesh complications she sustained due to C.R. Bard’s Avaulta Plus pelvic mesh device.
These lawsuits are among thousands that have been filed across the country by women who allegedly suffered horrific complications following implantation of pelvic mesh during uro-gynecological surgeries to treat pelvic organ prolapse and stress urinary incontinence.
Numerous medical device makers, including American Medical Systems, C.R. Bard, Boston Scientific, and Johnson & Johnson’s Ethicon unit all have been named in mesh implant lawsuits.
To date, plaintiffs have prevailed in every transvaginal mesh lawsuit that has gone to trial. In addition to last week’s loss in court, a California trial last year involving the same Avaulta Plus mesh device led to a $3 million judgement against C.R. Bard. The first Ethicon mesh lawsuit to go to trial ended in March in New Jersey Superior Court, with the jury awarded awarding more than $11 million in compensatory and punitive damages to woman who was injured by the company’s Gynecare Prolift device.
Synthetic mesh has been popular with surgeons and been used to shore up the vaginal wall in cases of pelvic organ prolapse – a weakening of the muscles and ligaments that support organs like the bladder and uterus. The condition causes extreme discomfort and is potentially dangerous. Symptoms caused by mesh erosion include:

  • Bleeding
  • Urinary problems
  • Vaginal scarring
  • Infections
  • Pain during sex
  • Discomfort
  • Bowel, bladder, and blood vessel perforation

Use of transvaginal mesh to repair pelvic organ prolapse had grown in popularity, in spite of early reports of problems caused by the mesh. In 2008, the Food & Drug Administration issued a warning that the use of vaginal mesh was associated with complications but said at the time that such problems were rare. However, according to Dr. William Maisel, the chief scientist of the F.D.A. division that oversees medical devices, from 2008 to 2010 there was a fivefold increase in adverse event reports related to the use of vaginal mesh to treat pelvic organ prolapse.
A research study released in 2010 in the journal Obstetrics and Gynecology reported 15 percent of the women treated with vaginal mesh experienced potential complications. The study also concluded that mesh did not provide greater benefits than the traditional surgical treatment in which a patient’s own ligaments are used to strengthen the vaginal wall.
In July 2011, the F.D.A. warned that it had received an increasing number of adverse event reports associated with the use of such products and since then litigation for mesh implant lawsuits has built steadily.
In lawsuits involving transvaginal mesh devices it has been alleged that these products were defectively manufactured and inadequately tested. It has also further been alleged that transvaginal mesh implant manufacturers failed to provide adequate warnings about their dangers.
The makers of transvaginal mesh continue to deny responsibility for the horrible problems experienced by women who have received the device. However, justice has yet to be on their side as litigation continues to favor plaintiffs. The question remains, are the manufacturers more concerned about their profits, or the patients they serve?

Lawsuit Evidence and FDA Actions Doom Metal Hip Implants

Lawsuit Evidence and FDA Actions Doom Metal Hip Implants
A front page article in the January 23 New York Times, Maker Aware of 40% Failure in Hip Implant, revealed that Johnson & Johnson knew of widespread failure with the troubled all-metal hip joint it had recalled in 2010. Even as the company became aware of the extent of the products failure, it continued to publicly play down similar findings from the British implant registry.
The internal study, conducted by Johnson & Johnson, is just one of hundreds of documents expected to be made public as the first of over 10,000 lawsuits begins this week in California superior court in Los Angeles.
In the analysis, Johnson & Johnson found that nearly 40 percent of the patients who received the now-recalled Articular Surface Replacement, or ASR joint, would experience failure within five years. It also found that thousands more patients will likely experience premature failure in up-coming years and be forced to undergo painful and costly replacement surgery.
The trial is expected to uncover what officials of Johnson & Johnson’s DePuy Orthopedics division knew about the device’s problems, both pre- and post-recall, and what actions they took. This episode represents one of the biggest medical device failures in decades and these early documents bring into question how forthright DePuy was in dealing with the problem. Even after the company recalled the device in 2010 it continued to challenge the validity of the British registry findings, which had found a failure rate in at least one-third of patients with the device.
Metal hip implants made by all manufacturers have been failing at an unacceptable rate for years. The DuPuy ASR joint was only the first to be recalled. Since then the Smith & Nephew R3 and the Zimmer Durom Cup have also been recalled. The Stryker Rejuvenate was recalled in 2012 for metal contamination as well but in that case the metal was leaching from the modular neck joint.
As a result of these failures the FDA recently posted a proposed order addressing metal hip implants. The new order, if approved, will require all hip implant manufacturers to go through Premarket Approval Process to keep any existing metal-on-metal hip implant on the market or to put a new metal on metal product on the market.
Metal on Metal joints still on the market such as The Biomet Magnum, the Encore and the Wright Profemur Converse, Dynasty, and Lineage are also failing at unacceptably high rates. Ironically the new order and PMA process faced by these manufacturers might allow them to avoid recalls. By citing the prohibitive cost of preparing a PMA application they can simply cease production without ever acknowledging an admission of failure in the joints.
So, as the trial prepares to begin in California this week, the early release of documents showing that DePuy long knew of the high failure rate while simultaneously trying to downplay the situation would indicate the company was more concerned with limiting its financial liability than being forthright with patients. Even after the company instituted its own recall of the suspect joint in 2010 it methodically continued to challenge medical findings that indicated a high failure rate.
Continued public disclosure of documents from the civil lawsuits and the data collected by the FDA will help protect the public from companies that put their own profits ahead of safety.