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 Tagged with Implants

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Medtronic, one of the world’s most prominent manufacturers of medical devices, has been named in a whistleblower lawsuit alleging that it regularly promoted its spinal implants for use in the neck despite the fact that the devices were not approved for such use by the FDA and specifically were labeled as being inappropriate for the cervical spine. The specific implant was the Medtronic VERTE-STACK, which is “intended for vertebral body replacement to aid in the surgical correction and stabilization of the spine” and is part of Medtronic’s INFUSE Bone Graft system.  The whistleblower suit alleges that Medtronic defrauded government healthcare entities by charging for the implantation of the spinal implant devices when the company knew that the use was illegal or unsafe.  The company is already facing thousands of potential personal injury lawsuits related to the INFUSE products.

This lawsuit is just one example of what seems to be a common practice for medical device and pharmaceutical drug manufacturers – promoting “off-label” use of its products to physicians despite federal prohibitions against such practices and despite the risk for patient safety.  Such practices, while making millions for medical device manufacturers, pose significant and sometimes deadly risks to patients who are implanted with the devices.

The personal injury attorneys at SUGARMAN have litigated complex medical device and defective product cases for decades.  If you believe you may have a claim involving a defective medical device, please fill out a Contact Form, call us at (617) 542-1000 or e-mail info@sugarman.com.

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Johnson and Johnson has tentatively agreed to pay up to $4 billion to settle claims brought by patients who were implanted with defective DePuy ASR artificial hips. The plan is subject to court approval and has not been formally announced. According to reports, the $4 billion settlement would be distributed amongst all patients who required replacement of their ASR hip with the per patient payout being dependent on several factors, including the patient’s age and medical condition. As more patients undergo revision surgeries to replace their failing ASR hip implants, the cost of the settlement could rise even higher. In total, approximately 60,000 patients in the U.S. received a defective ASR hip. The formal deal is likely to be announced later this week.

In addition to representing patients implanted with the recalled DePuy ASR hips, SUGARMAN has formed a team led by partners Stephen Sugarman and Benjamin Zimmermann to represent clients who have been injured as a result of defective Stryker Rejuvenate and ABG II hip implants. If you have any questions regarding a Stryker hip implant, please fill out a Contact Form, call Stephen or Ben at 617-542-1000 or email ssugarman@sugarman.com or bzimmermann@sugarman.com.

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Since Stryker recalled its Rejuvenate and ABG II hips in July of 2012, medical science has been quickly evolving to identify and diagnose metal-on-metal complications harming patients. Surgeons have been using metal artifact reduction sequence MRIs, also referred to as “MARS” MRIs, to identify suspected prosthetic hip complications
including metallosis, pseudotumors, inflammatory responses, and tissue and bone necrosis. (See prior blogs on these Stryker hip-related injuries.) Traditionally, metal from prosthetic implants produces a large area of signal and extensive distortion around the defective implant on an MRI. The MARS MRI, however, minimizes this metal “artifact” effect and allows undistorted visualization of bone marrow, soft tissues, fluids, tumors and even cement adjacent to implant hip screws.

Recent studies have also shown that ultrasound is a very useful tool for detecting pseudotumors in hip implant patients. Some current medical studies find that ultrasound may be superior to MRI for diagnosing pseudotumors in asymptomatic patients. In some instances where a MARS MRI generates equivocal results, surgeons may order additional follow-up ultrasonic evaluation to rule in or out metal-on-metal disease.
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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.