According to a jury in the first of 180 cases in a Prolift mass tort, Johnson & Johnson’s Ethicon unit must pay $5.5 million in compensatory damages and $7 million in punitive damages The Prolift lawsuit was heard in the Court of Common Pleas of the State of Pennsylvania, County of Philadelphia.
There are approximately 8,000 additional pelvic mesh lawsuits pending in New Jersey state court and 35,000 lawsuits pending in federal court. According to the jury, negligence on the part of scientists led to the woman’s injuries—including dyspareunia (painful or difficult intercourse)—following implantation of the Prolift, Law360 wrote. Ethicon’s Prolift is constructed of a polypropylene mesh that is inserted through a vaginal incision.
Thousands of women have been implanted with transvaginal mesh devices, which have been the subject of increasing debate with many women alleging serious complications related to the devices’ defects. In a prior U.S. Food and Drug Administration (FDA) Safety Communication, the most commonly reported adverse reactions associated with transvaginal mesh include, mesh erosion through the vagina (exposure, extrusion, protrusion); pain; infection; bleeding; pain during sexual intercourse; organ perforation; and urinary problems. When erosion occurs, the pelvic mesh travels through the body’s tissues, often becoming embedded in inappropriate areas. This may lead to multiple surgeries and, in many cases, erosion is so significant and widespread that the mesh is never be completely removed. Also, not all of the very serious reactions to which transvaginal mesh has been associated are physical.
Allegations include that pieces of the Prolift mesh were released into the woman’s body; that scientists and other officials did not disclose adverse reactions tied to the Prolift, including hiding these risks from the woman’s surgeon; and that Prolift’s design is utterly flawed and constructed with too much mesh and too few holes. This design flaw, according to the allegations, caused the mesh to lead to the growth of scar tissue, which led to tissue contraction, mesh pulling, and vaginal shrinkage, Law360 wrote. The woman in this case was implanted with the Prolift in 2009 to correct pelvic organ prolapse (POP) (sagging internal organs). The device was implanted between the woman’s bladder and vagina, ultimately becoming implanted in her bladder.
Ten of the 12 jurors found that Ethicon did not warn the woman’s surgeon of Prolift’s risks; that it was Prolift’s defective design that left the woman unable to have sex; and that Ethicon should be subject to punitive, as well as compensatory damages, Law360 reported.
Ethicon previously announced that it would no longer sell four types of transvaginal mesh devices: Prolift + M™, TVT Secur, Prolift, and Prosima. The FDA also previously warned that complications associated with transvaginal mesh implants are “not rare” and that there exists no clear evidence to indicate that transvaginal mesh is superior to non-mesh methods for treating POP and Stress Urinary Incontinence (SUI); the agency asked 33 pelvic mesh manufacturers to conduct post-market studies to evaluate any dangers associated with the devices.
Pelvic mesh devices were approved through a fast-track process known as the 510(k), under which a formal review for safety and efficacy is neither required nor performed. Because the 510(k) route has been used to gain clearance for other controversial products, including metal-on-metal hip implants, the process has drawn increasing criticism. Mounting complication reports, litigation, and concerns over the lack of clinical testing on these pelvic devices have increased the controversy surrounding their safety and efficacy, as well.
from Parker Waichman http://www.yourlawyer.com/blog/jjs-ethicon-unit-liable-for-over-12-million-in-compensatory-and-punitive-damages-prolift-pelvic-mesh-jury-finds/
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