In the bruising battle over vaginal mesh devices – pitting the manufacturers of the defective devices against the thousands of women harmed–women are proving to be the winners.
In the most recent case in June, C.R. Bard and Medtronic’s subsidiary, Covidien, settled 134 product lawsuits, according to an article in Massdevice.com.
The terms of the settlement weren’t disclosed.
Judge Joseph Goodwin of the U.S. District Court for Southern West Virginia, presiding over the Multi-District litigation (MDL) vaginal mesh cases, dismissed all of the 134 cases with “prejudice”, meaning they can’t be appealed “because all claims have been compromised and settled, including all claims, counterclaims, cross-claims and third party claims,” according to court documents.
The dismissals include 104 suits filed against Bard and another 30 suits against Bard and Covidien, owned by Medtronic.
In April, Judge Goodwin dismissed nearly 150 product liability lawsuits brought against C.R. Bard over its pelvic mesh products, after an appeals court earlier this year upheld a $2 million verdict against the company in a suit in January.
The devices are designed to treat female urinary incontinence and pelvic organ prolapse.
Medtronic-owned Covidien, which supplied the mesh to Bard, was also included in the court’s dismissals.
$2 Million Verdict
In January, a Federal appeals court upheld a $2 million verdict against Bard in a suit brought over its Evault pelvic mesh.
A jury awarded plaintiff Donna Cission $250,000 in compensatory damages and $1.75 million in punitive damages in August 2013.
Bard, which recalled the Avaulta product in 2012, appealed the decision to the U.S. Court of Appeals for the 4th Circuit.
The company argued that Goodwin was wrong to exclude evidence of the 510K medical device clearance Bard won from the FDA, wich allegedly proved that the device was safe and effective; and wrong to allow the admission of a Material Safety Data Sheet for the polypropylene resin used to make Avaulta mesh.
Bard also argued that Goodwin’s jury instructions were improper and that the punitive damages award was too high.
Cission argued further that Georgia’s split-recovery statute, awarding 75 percent of punitive damages award to the state, violates the Takings Clause of the 5th Amendment to the U.S. Constitution.
The 4th Circuit Court of Appeals upheld Goodwin on all counts, ruling that the lower court was right not to allow Bard to introduce its 510K FDA medical device clearance as evidence that its vaginal mesh was safe and effective.
Defective Medical Devices
Tens of thousands of women who underwent surgical repair of pelvic organ prolapse (POP) or stress urinary incontinence (SUI) received transvaginal mesh devices to help support internal organs.
If you received transvaginal mesh, also known as bladder slings, in one of these procedures, you should be concerned about the mounting evidence of transvaginal mesh failure and related health complications.
However, because complications have been associated with transvaginal mesh devices made by different manufacturers and no specific brands or models have been recalled, you likely won’t know if your transvaginal mesh product is a defective medical device unless you develop side-effects, which include:
- Internal Bleeding
- Organ damage
- Pain during urination
- Pain during intercourse
- Recurrence of POP or SUI
- Vaginal pain
- Vaginal scarring
The resulting complications of defective transvaginal mesh can necessitate revision surgery or other emergency care, and may result in extensive medical expenses and time away from work.