C.R. Bard ($BCR) is facing a new civil trial alleging the company sold vaginal mesh implants that it knew were unsafe, leaving a patient with major health problems and physical damage.
As Bloomberg reports, the trial began this week in federal court in West Virginia, with attorney Henry Garrard arguing that his client began suffering pelvic and rectal pain, bleeding and bladder spasms after getting an Avaulta Plus implant in 2009 to support organs that were collapsing into her pelvis. Garrard also alleged that Bard knew some of its vaginal mesh devices were made of a plastic unsafe for human implantation and declined to disclose this to doctors and patients.
Bard denies any wrongdoing here. The company's attorneys said that Garrard's client--55-year-old Donna Cisson--received a device that was properly designed to do its job (treat prolapsing organs and incontinence). They also pointed out that the plastic used in the device has met legal and safety requirements in countless other medical devices and sutures for 5 decades, according to the article.
But Garrard noted that his client has already had several surgeries to remove the mesh product after the complications arose and insists the product was the problem.
And so it goes in the start of a trial that will last for two weeks.
Whatever the outcome, this is far from the end of things. Bard faces at least 3,600 lawsuits alleging the company sold faulty vaginal mesh implants, and many of those have been consolidated, the Bloomberg story explains. Just last year, the company lost a civil suit in California in which the jury found both Bard and the surgeon who implanted the mesh to be liable for damages another woman faced during surgery.
Many other companies, from Johnson & Johnson ($JNJ) to Boston Scientific ($BSX), Endo Health Solutions ($ENDP) and others, are dealing with similar legal problems involving their own vaginal mesh implants, with thousands of lawsuits in the pipeline. The FDA is also soliciting safety data from 31 manufacturers of vaginal mesh implants.
- read the Bloomberg story