A California jury smacked down vaginal mesh implants in the first of hundreds of lawsuits challenging their safety to go to trial. As Bloomberg reports, jurors in California state court in Bakersfield decided that a woman and her husband are owed $5.5 million in damages due to injuries alleged to be caused by C. R. Bard's ($BCR) Avaulta Plus implant.
Because the jury assigned 40% fault to plaintiff Christine Scott's surgeon, the court entered a $3.6 million judgment against Bard, according to a company spokesperson, who noted that the surgeon involved was assigned the difference in liability and ordered to pay $1.9 million. Vaginal mesh devices are used to treat prolapsing organs and also incontinence.
Bard spokesman Scott Lowry told Bloomberg in an e-mailed statement that the company was disappointed with the decision and would appeal it.
"While we empathize with the complications suffered by the plaintiff, those complications are not the fault of any conduct by the company," Bloomberg quotes Lowry as saying. "We believe the evidence establishes that our Avaulta mesh products, cleared by the FDA, are safe and effective and provide significant benefits to patients."
A subsequent statement from Bard issued to FierceMedicalDevices noted that "due to the many irregularities of this trial, [the company did] not believe this verdict is representative of the other women's health product cases pending against Bard."
Bard isn't the only company whose vaginal mesh products will face legal challenges over their safety. Bloomberg notes, for example, the recent consolidation of federal suits involving Johnson & Johnson ($JNJ), Boston Scientific ($BSX), and the American Medical Systems unit of Endo Pharmaceuticals ($ENDP), as well as Bard. The first trial in those cluster of cases set to launch on Feb. 5, 2013.
In January, the FDA took notice, ordering 31 manufacturers, including Bard, J&J, Covidien ($COV), Boston Scientific and others to study the rates of organ damage and other complications with the devices over three years, after complaints began to mushroom that the devices were harming women. An FDA expert panel has also recommended reclassifying the mesh devices as Class III, a more serious designation than their typical clearance under the 510(k) process.
Johnson & Johnson/Ethicon, meanwhile, recently decided to stop selling four vaginal mesh implants in the face of hundreds of lawsuits challenging the products' safety.
- read the Bloomberg story
Editor's note: This story was updated in the first paragraph, with new second and fifth paragraphs added. The edits and changes are designed to correct and clarify the initial Bloomberg report cited in this story that suggested the $5.5 million verdict was solely against Bard.