TVM/Bladder Sling Litigation Moves Forward

There have been more than 60,000 lawsuits filed over transvaginal mesh (TVM) and bladder slings, medical device products that are used to address stress urinary incontinence in women. Devices are made of strips of surgical mesh and are inserted through one incision in the vagina and two in the abdomen.

The plaintiffs in the lawsuits allege that faulty design caused them physical pain and other injuries, including actual damage to reproductive, urinary and digestive systems. They were required to undergo revision surgery to remove the devices, in some instances more than once. They charge that in addition to the physical damage caused by the devices, they also suffered emotional and financial distress.

Complications Arising From TVM /Bladder Slings

Specific physical complications caused by the devices include:

• Difficulty urinating
• Urinary urgency
• Infections at screw or staple points
• Internal bleeding
• Organ damage caused by erosion of synthetic sling material into the pelvic cavity, specifically the vagina and rectum
• Organ perforation
• Inflammation and rejection of the sling
• Mesh contraction

Largest Medical Mass Tort Ever

The lawsuits filed against the primary makers of TVM and bladder slings make this litigation one of the largest medical mass tort liability litigation ever. Defendants in the cases include American Medical Systems and Ethicon, the two companies with the largest number of claims against them. Other manufacturers include Boston Scientific, C.R. Bard, Coloplast, Cook Medical, and Neomedic. Because some of the products are still on the market, the number of lawsuits will only continue to grow.

Results of Lawsuits Against TVM Manufacturers

A few of the lawsuits have been resolved. According to MarketWatch, recent results have included $5.5 million jury award in 2012 (California); $11 million in February 2013 (Atlantic City, New Jersey); and $2 million in August 2013 (Charleston, West Virginia). The most recent award came from Dallas, Texas, where a woman received a $73 million jury award in a lawsuit against Boston Scientific after a two-week trial.

Why Boston Scientific Was Found Liable

In this case, the judge found that Boston Scientific failed to warn of the serious complications that could arise after implantation of the Obtryx sling. The judge further found that the company was aware of the design defects, but failed to warn despite its knowledge. Evidence that the company knew about the product’s defects included an internal email directing sales representatives to not discuss the results of an internal company study that investigated the safety of the device.

How Victims Can Receive Compensation

Results such as these come from individual lawsuits. There are other ways that plaintiffs (the people alleging injury) can become involved with the legal system when filing a claim against a manufacturer, such as the companies that make TVM/bladder slings.

One company, American Medical Systems, has offered $830 million to settle the claims against it out-of-court. A much smaller company, Coloplast, has already settled the claims against it for $16 million. However, Ethicon, a division of Johnson & Johnson, has refused to settle, despite already receiving a few multi- million dollar verdicts against it.

The vast remainder of the cases have been consolidated into multi-district litigation (MDL) which is being handled in federal court in the southern district of West Virginia. There are another 6,000 cases pending in New Jersey state court as well as other individual cases in state courts throughout the country. The purpose of consolidating the cases is to conserve judicial resources by handling discovery and other issues that apply in all the cases.

These mass tort cases are different from the more widely known class action case, in which a specific plaintiff (or plaintiffs) stands in for the entire class. In mass tort cases, an individual plaintiff’s specific circumstances are still considered. In the case of the current MDL, the judge has issued an order that will group plaintiffs with like situations for trials with the goal of speeding up the process. The judge has also ruled that expert witnesses will be allowed to discuss their opinions that Boston Scientific slings are defective. He also granted a motion by the plaintiffs’ attorneys to exclude testimony by a Boston Scientific expert witness.

What Does the Future Hold?

Many pundits have predicted that some of the TVM/bladder sling cases will be resolved by the end of 2014, especially as smaller companies seek to settle the claims against them to eliminate uncertainty among shareholders going forward. However, individual cases continue to be filed in state courts around the country. This, along with the huge number of cases pending in the MDL, make the problem one that is not going to go away, either for the victims or many of the manufacturers of these devices.