FDA | Law Firm Newswire

Austin, TX (Law Firm Newswire) January 5, 2017 – Over 23,641 physicians reported the adverse effects of the transvaginal mesh (TVM) device, used for stress urinary incontinence (SUI) or pelvic organ prolapse (POP). In addition, 25,000 attorneys and over 1,000 hospitals sent negative reports of TVMs to the Food and Drug Administration (FDA). Furthermore, there was a high number of medical device distributor reports to the FDA, as well. According to the FDA, there were 126,349 adverse events reported relating to TVM kit failures and 49 recalls for the various medical device manufacturers involved which included Boston Scientific, Bard, Medventure […]


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Tampa, FL (Law Firm Newswire) June 22, 2016 – The Department of Veterans Affairs (VA) in May announced its purchase of 20 ReWalk exoskeleton systems for a national clinical trial. The multicenter trial is the country’s first-ever study to evaluate the impact of daily exoskeleton use in an everyday setting. The first phase of the trial will be held in VA medical centers in Florida, California, Massachusetts, Texas and Virginia. It will consist of 160 eligible participants who will be enrolled later this year. The six medical centers have already received ReWalk systems for training purposes. “The ReWalk device has […]


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Austin, TX (Law Firm Newswire) May 18, 2016 – In an ugly twist of fate, products touted as being the best on the market to deal with pelvic organ prolapse (POP) and stress urinary incontinence (SUI), caused irreparable harm to women it was allegedly designed to help. Millions of dollars paid out in settlements and legal costs result in Endo stopping production of transvaginal meshes to treat POP and vaginal slings to treat SUI. Endo shuttered its Astora Women’s Health device unit in March 2016 to reduce potential liability relating to over 46,000 severe adverse reaction lawsuits allegedly caused by […]


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Houston, TX (Law Firm Newswire) December 30, 2014 – Studies are again criticizing the Food and Drug Administration (FDA), saying its fast-track process for medical devices approves many that do not meet regulatory standards. The National Center for Health Research reports that a worrying majority of medical devices approved under the FDA’s fast-track process lack publicly available safety documentation. Without this documentation, doctors and hospitals cannot accurately assess the risk a device poses to patients. “The FDA gets a lot of pressure from medical device companies that want to beat the competition to market,” commented Richard LaGarde, a defective products […]


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Waxahachie, TX (Law Firm Newswire) December 24, 2014 – A new study has found that the blood thinner Pradaxa carries a significantly higher risk of major internal bleeding than warfarin, a traditional medication that has been used for decades to help prevent blood clots. According to reports in HealthDay News and Harvard Health, this is major news because until now, doctors prescribing Pradaxa have been told that it offers a lower internal bleeding risk than warfarin. Many doctors and patients are alarmed, as new data show that the risks are much higher than were claimed when the drug was initially […]


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Waxahachie, TX (Law Firm Newswire) November 14, 2014 – Recently, U.S. courts have issued a series of decisions regarding venues in several of the ongoing lawsuits addressing birth defects caused by Paxil, an antidepressant drug made by GlaxoSmithKline (GSK). GSK recently lost its bid to have a group of cases heard in federal court rather than in Pennsylvania state court. In a different lawsuit, GSK won its appeal to have a case heard in Ohio rather than in Pennsylvania. In that case, the plaintiff’s attorneys now claim that GSK will unfairly benefit, as ex-employees of GSK will be less likely […]


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Waxahachie, TX (Law Firm Newswire) November 7, 2014 – A Dallas jury has awarded $73 million to a patient who suffered severe complications from a transvaginal mesh implant. Martha Salazar received an Obtryx sling implant to treat minor incontinence. According to her lawsuit against the device’s maker, Boston Scientific, the implant eroded within her body, causing constant pain. Salazar required four major surgeries to remove the device. Although the judge in the case later reduced the award to $34 million because of punitive damage caps in Texas, defective medical device attorneys argue that the verdict still marks a turning point. […]


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Waxahachie, TX (Law Firm Newswire) September 18, 2014 – Johnson and Johnson has issued a global recall as evidence mounts that a commonly used surgical device can accelerate the spread of uterine cancer. The recalled device is a laparoscopic surgical instrument known as a power morcellator, frequently used for minimally-invasive hysterectomies and for the removal of uterine fibroids. The morcellator grinds tissue into smaller pieces for later vacuuming, according to Medical Daily.  New research published in major medical journals suggests that if the tissue being treated contains cancerous or precancerous cells, the device can spread those cells across a wide […]


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Little Rock, AR (Law Firm Newswire) July 22, 2014 – Although bed rails are designed to keep frail nursing home residents in their beds, they may instead end up killing them. “Nursing homes and other elder care facilities have many residents that benefit from a bed rail to help them get in and out of bed, or keep them safe if they are sleeping and restless. It most instances, bed rails provide an extra bit of mobility. However if they are not used correctly, not installed properly, or are defective and a patient is severely harmed or dies, the home […]


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Austin, TX (Law Firm Newswire) July 14, 2014 – The FDA has announced new regulations pertaining to surgical mesh used in transvaginal surgery to repair pelvic organ prolapse. “The new regulations are supposed to impose greater levels of scrutiny on such products and mandate that manufacturers submit a pre-market approval application to have their product evaluated. Prior to issuing these new regulations, the transvaginal mesh kit was rated as being a moderate risk device. However, in the face of thousands of lawsuits against various mesh makers, the FDA had to move to do something. Because the mesh was rated as […]


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Austin, TX (Law Firm Newswire) July 7, 2014 – According to numerous media reports and court docket records, many more vaginal mesh lawsuits are being settled out of court. “It’s good news that vaginal mesh lawsuits are being settled out of court more often. It demonstrates that even though the mesh maker does not admit to wrongdoing, they are stepping up to bat to rectify the damage they have caused to millions of women,” says Bobby Lee, an Austin personal injury lawyer handling vaginal mesh lawsuits. “The most recent out of court settlement was Endo International PLC, the parent of […]


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Austin, TX (Law Firm Newswire) August 15, 2013 – Thousands of transvaginal lawsuits are now underway in West Virginia and New Jersey. Thousands more are being filed in multiple other jurisdictions, including Texas. “There seems to be a never-ending revolving door when it comes to women filing transvaginal mesh lawsuits. In terms of a class action case, the numbers of cases are astounding. The justice being sought for those who have been victims of the mesh implant nightmare is what keeps many injury lawyers up at night, prepping their cases,” said Bobby Lee, an Austin injury lawyer of Lee, Gober […]


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Chicago, IL (Law Firm Newswire) July 4, 2013 – Demoted workers may genuinely not be meeting employer’s expectations. “In this recent case, Banthia v. Roche Diagnostics, No. 11-3290, 7th Cir., 2012, the 7th Circuit Court of Appeals found in favor of the defendant employer. Justices ruled that even if a demoted worker had consistently received good performance reviews, it does not mean that the employee is still meeting workplace expectations,” stated Timothy Coffey, a Chicago employment lawyer and principal attorney for The Coffey Law Office, P. C., an employment litigation firm dedicated to representing employees in the workplace. The worker […]


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Austin, TX (Law Firm Newswire) June 14, 2013 – Each passing day brings the news that more transvaginal lawsuits have been filed across the nation. “It was just five short years ago that the Food and Drug Administration (FDA) indicated there were risks involving mesh implants. Since that time, the number of lawsuits, as a result of mesh implant side effects, has increased astronomically,” remarked Austin personal injury attorney Bobby Lee, of Lee, Gober and Reyna in Austin, Texas. Why the apparent sudden increase in the number of transvaginal lawsuits filed? At first, it was a trickle of complaints about […]


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Waxahachie, TX (Law Firm Newswire) May 6, 2013 – The FDA has issued a recall for anemia drug Omontys. Omontys has been recalled by the U.S. Food and Drug Administration (FDA). Doctors and their patients have indicated that some individuals have experienced a life-threatening and serious allergic reaction to Omontys after receiving an injection. Anaphylaxis causes breathing passages to swell shut, among other things. It requires immediate medical intervention to prevent death. An artificial protein, Omontys is used to treat anemic adults undergoing dialysis. Omontys, made and distributed by two Big Pharma companies, Affymax, Inc. and Takeda Pharmaceuticals, was designed […]


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