INSIGHTS On Massachusetts Personal Injury Law

Welcome to the SUGARMAN blog. We'll be sharing our perspectives on the state of the law and current legal issues in Massachusetts personal injury law. Issues relating to medical malpractice, construction site injuries, premises liability, product liability, motor vehicle accidents, insurance, and more will all be reviewed here by our team of lawyers who have prosecuted some of the most complex cases in Massachusetts personal injury law.

Articles Posted in Transvaginal Mesh Litigation

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A federal jury in West Virginia recently returned a verdict of $3.27 million for a woman who filed suit against Ethicon, a unit of Johnson & Johnson, for injuries due to a defective transvaginal TVT-O mid-urethral sling. After a nearly two-week trial, the jury found in favor for the plaintiff, Jo Huskey, on her counts of strict liability, design defect, failure to warn and negligence. Ms. Huskey, now 52 years old, underwent the implantation procedure in 2011 for stress urinary incontinence and has suffered erosion of the mesh, which has caused severe pain and required her to undergo (unsuccessful) surgeries to remove the mesh. Ms. Huskey’s case was the first federal trial involving a claim pertaining to Ethicon’s TVT-O mesh sling, and the second case tried among the thousands that have been consolidated in multi-district litigation in West Virginia (the first ended in a win for Ethicon).

About one week following the verdict in Ms. Huskey’s trial, a Texas jury awarded $73.5 million to a woman in her case against Boston Scientific, in which she alleged that the bladder sling it manufactured caused her permanent injuries. The plaintiff, Martha Salazar, who is 42 years old, testified that she can no longer walk or sit normally as a result of the severe pain she has suffered since the Obtryx Transobturator Mid-Urethral Sling (MUS) System was implanted in 2011 to treat mild incontinence. Following the implantation, Ms. Salazar required four major surgeries and 42 additional procedures due to internal injuries caused by the sling. She is likely to require further surgery. After a two-week trial in Dallas, the jury awarded Ms. Salazar $23 million in compensatory damages and $50 million in punitive damages, the latter of which was premised on a finding of gross negligence against Boston Scientific, a company based in Natick, Massachusetts.

Over 60,000 cases against a number of mesh manufacturers currently await resolution across the country.

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On May 1, 2014, the U.S. Food and Drug Administration announced a proposed rule to reclassify surgical mesh for transvaginal pelvic organ prolapse (POP) repair from class II to class III. This proposed rule change acknowledges that there is insufficient evidence on the safety of mesh products for POP repair and would require any transvaginal mesh to undergo premarket approval to ensure the mesh’s safety and effectiveness before it can be marketed and implanted in women. This classification change would remove mesh products for POP from the much maligned 510K process, which does not require premarket approval. In making this significant announcement, the FDA identified numerous risks with the use of transvaginal mesh for POP repair, including mesh exposure and extrusion, vaginal scarring, pelvic pain, shrinking and tightening of the mesh, incontinence and infections such as pelvic abscesses. Comments on the proposed rule changes are due by July 30, 2014. Needless to say, the mesh manufacturers and their lobbyists are certainly expected to fight this proposed change.

SUGARMAN principals Marianne LeBlanc and David McCormack continue to represent clients who have been implanted with defective or recalled transvaginal mesh products. If you believe you may be suffering from adverse medical complications as a result of a defective or recalled transvaginal mesh product, fill out a Contact Form, call Marianne LeBlanc or David McCormack at 617-542-1000 or e-mail Marianne LeBlanc or David McCormack.

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In another in the series of ongoing bellwether cases, a Texas jury returned a verdict against Johnson & Johnson and its subsidiary Ethicon in a case involving defectively designed transvaginal mesh. The jurors decided that the design of an Ethicon TVT-O mesh sling was defective and was the cause of the plaintiff’s ongoing pain and pelvic symptoms. The jury, however, rejected the plaintiff’s claim that Ethicon failed to properly warn about the risks of the mesh and did not award punitive damages. While Johnson & Johnson has ceased selling various transvaginal mesh products and bladder slings, the Ethicon TVT-O mesh sling still remains on the market.

SUGARMAN principals Marianne LeBlanc and David McCormack continue to represent clients who have been implanted with defective or recalled transvaginal mesh products. If you believe you may be suffering from adverse medical complications as a result of a defective or recalled transvaginal mesh product, fill out a Contact Form, call Marianne LeBlanc or David McCormack at 617-542-1000 or e-mail Marianne LeBlanc or David McCormack.

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As discussed in a recent blog posting, counsel for the plaintiffs in the Ethicon transvaginal mesh Multi-District Litigation had recently petitioned the U.S. District Court for the Southern District of West Virginia to impose severe sanctions against Johnson & Johnson subsidiary, Ethicon, Inc., for its destruction of thousands of pages of documents that the plaintiffs claimed were relevant to their claims. Ethicon, Inc. manufactured various transvaginal mesh products that have caused severe personal injuries to thousands of women who had the mesh implanted for pelvic organ prolapse and/or stress urinary incontinence. Although she did not grant the more serious sanctions sought by the plaintiffs, Magistrate Judge Cheryl Eifert did grant the plaintiffs’ requests for the imposition of monetary sanctions for the destruction of the documents and for reasonable costs in pursuing their motion. While it may be disappointing that the Magistrate Judge did not impose more severe sanctions in order to deter corporations in product liability suits from committing discovery abuses, the court nonetheless acknowledged that abuses had occurred. Trials for several cases are currently scheduled to begin this month.
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In the Multi-District litigation in the U.S. District Court for the Southern District of West Virginia, attorneys for women who were implanted with defective Ethicon transvaginal mesh products have filed a motion to obtain a default judgment and other discovery sanctions. The motion accuses Ethicon, Inc. of destroying hundreds of thousands of relevant documents in violation of a court order. Ethicon, Inc. is a subsidiary of Johnson & Johnson and manufactured the TVT-O and Prolift transvaginal mesh products. The plaintiffs’ attorneys submitted evidence that Ethicon destroyed documents from the files of high-ranking executives at the company who had communicated with the FDA about warnings issued by the FDA, deleted computer files from employees leaving the company and even destroyed instructional videos concerning its transvaginal mesh products that contradicted the opinions of one of Ethicon’s expert witnesses. The plaintiffs’ attorneys also claimed that Ethicon failed to establish an appropriate document retention policy despite the ongoing litigation involving claims brought by thousands of women who were implanted with its mesh products. The motion argues that the plaintiffs have been severely prejudiced as a result of the destruction of these documents. These are serious allegations that could result in the Court entering a default judgment against Ethicon, Inc. in the cases that have been assigned a February, 2014 trial date. The court has yet to issue a decision on the motion.
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On August 15, 2013, a federal jury in West Virginia returned a verdict in favor of a woman who suffered permanent injuries after she was implanted with defective transvaginal mesh. The 45-year-old woman underwent implantation of Avaulta transvaginal mesh manufactured by C.R. Bard, Inc. due to pelvic organ prolapse, a common ailment affecting many women. Following the mesh implantation, the plaintiff had numerous complications and was forced to undergo several surgical procedures to repair the damage caused by the defective mesh. At trial, it was revealed that C.R. Bard, Inc. executives knew that the Avaulta transvaginal mesh should not be implanted in humans, but nevertheless continued to market and sell the product. The jury found C.R. Bard, Inc. liable and awarded the plaintiff $250,000 in compensatory damages and $1,750,000 in punitive damages, a sign of the extent to which the jury found C.R. Bard, Inc. to be negligent and/or reckless in selling a product it knew was not fit for use in humans.

SUGARMAN principals Marianne LeBlanc and David McCormack continue to represent clients who have been implanted with defective or recalled transvaginal mesh products. If you believe you may be suffering from adverse medical complications as a result of a defective or recalled transvaginal mesh product, fill out a Contact Form, call Marianne LeBlanc or David McCormack at 617-542-1000 or e-mail Marianne LeBlanc or David McCormack.

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E-mails uncovered during the discovery process in the transvaginal mesh Multi-District Litigation in West Virginia reveal that executives at a subsidiary of CR Bard, Inc. knew that a plastic used in its transvaginal mesh product was unfit to use in humans due to the risk of erosion. CR Bard, Inc. and its subsidiaries manufactured a number of defective transvaginal mesh products that were implanted in women suffering from stress urinary incontinence and pelvic organ prolapse. The FDA estimates that in the year 2010 alone over 250,000 women were implanted with some form of transvaginal mesh.
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As reported in a recent blog, a New Jersey jury awarded a South Dakota woman $3.35 million for her claims against Johnson & Johnson/Ethicon. The plaintiff claimed significant damages, including 18 revision surgeries, as a result of having Johnson & Johnson/Ethicon’s defective and recalled Prolift transvaginal mesh implanted in her. Just a few days later, the same jury ordered Johnson & Johnson/Ethicon to pay the woman an additional $7.76 million in punitive damages. In all, the jury verdict totaled $11.11 million. Although punitive damages are not available under Massachusetts law in the absence of a wrongful death claim, this verdict stands as a strong warning to manufacturers of transvaginal mesh who intend to try their cases to conclusion. The horrific damages suffered by many victims of transvaginal mesh may lead to additional large verdicts in the first wave of cases that are going to trial across the country in which the defective nature of the transvaginal mesh products is the central focus.
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In the first case to go to trial from the approximate 1,800 cases pending in New Jersey against Johnson & Johnson and its medical device subsidiary Ethicon, a jury on February 25th entered a $3.35 million verdict in favor of a woman who had defective transvaginal mesh implanted to treat pelvic organ prolapse. The plaintiff, Linda Gross, alleged in her lawsuit that Johnson & Johnson/Ethicon’s Gyncare Prolift vaginal mesh was defective and that Johnson & Johnson/Ethicon failed to properly warn of the dangers of the transvaginal mesh product. The Ethicon product in question was eventually recalled and taken off the market in the U.S. in 2012.

After undergoing surgery to implant the transvaginal mesh in 2006, Ms. Gross suffered from a variety of medical complications commonly associated with the defective mesh, including erosion of the mesh into her pelvic anatomy, formation of scar tissue, inflammation and neurologic complications. To date, she had undergone 18 operations to repair the damage done by the recalled Johnson & Johnson/Ethicon product.
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In what will likely be the first of many trials against manufacturers of  transvaginal mesh products across the country, a California woman, Christine Scott,  was recently awarded $5.5 million in damages by a jury in her case against C.R. Bard, the manufacturer of the Avaulta Plus Biosynthetic Support System, a vaginal mesh implant, which caused her debilitating injuries, requiring nine separate revision surgeries when the implanted mesh eroded.  

Ms. Scott underwent the implant procedure to treat urinary incontinence and pelvic organ prolapse.  Ms. Scott’s doctor, who implanted the device in 2008, was found responsible for paying 40% of the judgment.  The evidence at trial was that Ms. Scott suffered from incontinence, severe pain and an inability to engage in sexual relations with her husband due to the extrusion of the mesh into her vagina.

The plaintiff presented evidence at trial that the manufacturer did not test the medical device, and was not required to prove the safety of the device to the FDA pursuant to the controversial fast-track 510(k) approval process, before marketing it.  As part of their verdict, the jury found that Bard knew or should have known that surgeons “performing pelvic-floor repair would not realize the potential risks” posed by the implanted mesh.
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