Status Conference Held for Vaginal Mesh Lawsuits in West Virginia MDL

Transvaginal mesh injuries are not new, nor are they uncommon in the United States. In 2008, the FDA announced it had received over 1,000 complaints about transvaginal mesh implants within a three-year period. In 2011, the FDA issued another transvaginal mesh alert, stating that it had received almost 2,900 more complication reports, with injuries allegedly caused by surgical mesh implants.

The West Virginia conference announced that the state court’s general policy is that if a device is not found to be reasonably safe to use for its intended purpose because of a design flaw, then the device is defective. More specifically, the elements that must be proven in a design defect lawsuit are:

• The product was not reasonably safe to use for its intended purpose
• The unsafe nature of the product was from a design defect
• The defect was the proven cause of the person’s injury

The court states that for the first element noted, the product should have been tested by a reasonably prudent manufacturer at the time of manufacturing, and a risk-utility analysis should have been performed to determine if the design was reasonable for its intended purpose. More often than not, many medical devices get pushed through the manufacturing phase too quickly, leaving safety holes in the products, which could potentially lead to use-related injuries.

While any defective products are serious, defective medical devices have potential to not only harm the safety of one person, but the potential to endanger the health and safety of millions who might use the device.

Ethicon Inc., a division of Johnson & Johnson, is one of the companies in hot water over vaginal mesh implant injuries.

The company has been hit with hundreds of vaginal mesh implant lawsuits, including one filed March 4, 2013 by an Iowa woman in the West Virginia federal court. The lawsuit illustrates the importance of product safety and the harm of product negligence.

According to the Ethicon lawsuit, the plaintiff allegedly suffered serious injuries from the defects of her Ethicon transvaginal mesh implant. This complaint also alleges that Ethicon knew or should have known about defects associated with these bladder sling implants but failed to properly warn the public or their patients about the serious injuries that could possibly occur from using them.

According to the FDA transvaginal mesh safety alert issued in July 2011, some of the serious complications and injuries associated with Ethicon’s transvaginal mesh implants are:

• Pelvic and urinary pain
• Pain during intercourse
• Vaginal scaring
• Mesh erosion through the vaginal lining
• An increased risk of infection
• Puncturing of the blood vessels, bowels, bladder, and recurrence of SUI