In the first federal lawsuit against Boston Scientific Corp. over its defective vaginal mesh product, the company has been ordered by jurors in a Miami federal court to pay nearly $27 million to four Florida women who say they were injured by the medical devices.
Although the company faces some 23,000 lawsuits over the problem, only a handful have gone to trial. Of the three that have thus far gone to trial, the first two, in Massachusetts, resulted in victory for the company. The third, in Texas, resulted in a $73 million verdict for the plaintiff, though that award was later reduced to $34 million per state-mandated damage caps.
The Miami verdict represents the first federal case to go to trial. Another began in West Virginia shortly thereafter. The judge who oversaw the case, U.S. District Judge Joseph Goodwin, is overseeing more than 65,000 vaginal mesh lawsuits against seven companies that make the device.
Our Fort Lauderdale product liability lawyers understand the crux of the plaintiff argument in the Florida case against Boston Scientific is the firm prioritized speedy manufacturing of a profitable device over the care and safety of patients. The company reportedly rushed the devices to market in an effort to keep pace with competitors, even though the product had never been tested on humans or animals and used materials engineers knew weren’t intended for permanent implantation in human bodies. The products thus erode in the body once implanted, causing a host of health problems.
The mesh has historically been used to address a number of ailments. In women, it is routinely used to treat pelvic organ prolapse or urinary incontinence. These companies promoted the procedure and the device as a safe, low-risk procedure. But in fact, the degree of safety wasn’t actually known because the product had not undergone the rigorous safety testing required by the U.S. Food & Drug Administration. Instead, it was green-lighted through an abbreviated approval process, which allows manufacturers to shortcut normal regulatory procedures, so long as companies can attest their product is “substantially equivalent” to a product already on the market.
Many are now arguing for that regulatory shortcut, called 510(k), to be eliminated.
Meanwhile, litigation marches on. It’s estimated that in 2010 alone, doctors inserted more than 70,000 of these devices just in the U.S. In an overwhelming number of cases, the devices are not working as intended. Between 2008 and 2010, the FDA received approximately 1,500 reports of injury and even death associated with this device. The FDA finally issued a warning about the products last July.
Women experience immense pain and suffering and often must undergo multiple revision surgeries to correct problems relating to this device. The original condition for which the surgery was intended to correct often resurfaces, sometimes worse than before. There are reports of perforation of the bowel, blood vessels and bladder, internal tearing and bleeding, and serious infection.
This is not to mention the serious psychological problems that can occur when these devices fail. Patients often report becoming depressed, anxious and emotionally damaged due to the sensitive nature of these injuries, as well as the interruption of once-healthy sexual activity.
Call Freeman Injury Law — 1-800-561-7777 for a free appointment to discuss your rights.
Boston Scientific Loses First Federal Trial Over Mesh, Nov. 14, 2014, By Jef Feeley and Susannah Nesmith, Bloomberg
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