In May of 2012, a woman in Texarkana, TX filed an injury lawsuit against Boston Scientific over the vaginal sling that was implanted in her body two years ago to address the symptoms of stress incontinence (bladder control). After the surgery, she began experiencing unusual pain and bleeding as well as a condition known as dyspareunia, which adversely affects intimacy. She's suing for compensatory damages, punitive damages, exemplary damages, incidental damages, consequential damages, attorney's fees, and court costs. (Since she's experiencing dyspareunia, it sounds as if her husband has a case against Boston Scientific as well as on the grounds of loss of consortium – a legal term describing a situation in which intimate relations between partners are no longer possible.
Meanwhile, another woman is suing pharmaceutical manufacturer Boehringer Ingelheim over its highly profitable anti-coagulant medication, Pradaxa (dabigatran) – which the lawsuit alleges was the cause of her mother's untimely death. What would otherwise have been a minor bump on the head resulted in a fatal hemorrhage. This lawsuit is yet another case to address the Pradaxa bleeding problem.
What is at the heart of both the Pradaxa bleeding and transvaginal mesh complications complaints is a failure to warn. In each case, the plaintiffs allege that the manufacturers of both products that (A) the manufacturers knew there were risks and potential problems with their products, (B) had a duty to warn the plaintiffs, and (C) had failed in that duty.
This is your basic negligence lawsuit. It focuses on the manufacturers of these products, as opposed to a “strict liability” case that focuses on the product itself.
In the transvaginal mesh complications case, Boston Scientific is accused of breach of warranty as well as failure to warn. A warranty may be express – meaning it is clearly stated and in writing – or implied, in which it is presumed because of the circumstances and nature of the sale. In this case, the Texarkana woman (and anyone else in her circumstances) had a reasonable expectation of safety because it was a medical device that would be surgically implanted into their bodies – even though there was nothing in writing.
In both cases, it boils down to proving what these companies knew or didn't know. Representatives for Pradaxa manufacturer Boehringer Ingelheim insist that potential risks were not “hidden or minimized.” Furthermore, the company claims that the 260 recorded patients that have died as the result of uncontrolled bleeding due to the drug “ are not outside the parameters of a major clinical trial.”
Anyway, the FDA (which continues to state that “Pradaxa provides an important health benefit when used as directed”) gave its approval – right?
While it is arguable as to whether or not Boehringer Ingelheim knew about the risks associated with dabigatran, it 's pretty certain that Boston Scientific, Johnson & Johnson and other manufacturers of pelvic slings had a good idea. After all, their products – which are “devices” and not “drugs,” and that has made all the difference – were pushed through on to the market via the now-notorious and highly questionable 510(k) Clearance process. This means they didn't have to be tested; they just had to be “substantially similar” to a previously-approved device – even if there were serious concerns about the earlier device's safety.
Keahey, Michelle. “Texarkana Woman Files Personal Injury Lawsuit Over Vaginal Mesh Implant.” The Southeast Texas Record, 21 May 2012.
Malisow, Craig. “Pradaxa Can't Stop The Bleeding.” Houston Press News, 24 May 2012.