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attorneys 311 articles

Attorneys investigating cases of melanoma among Viagra users

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The number of lawsuits against Pfizer, the maker of the erectile dysfunction drug Viagra, are mounting after a recent scientific study linked use of the drug with an increased risk of melanoma, the deadliest form of skin cancer. The study, published in June by JAMA Internal Medicine, reported that Viagra users were 84 percent more likely to develop melanoma over a 10-year period. Even men who had stopped using Viagra were at increased risk compared to men who had never used the drug. The study, which involved 26,000 men who had used Viagra, was conducted by researchers with Harvard Medical ... Read More

Woman blames power morcellator surgical tool for cancer spread

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A California woman is suing Gyrus ACMI alleging the company’s power morcellator surgical tool used during a hysterectomy caused cancer to spread throughout her abdomen. Lisa Nielsen filed a lawsuit last month in federal court claiming she did not know when she had a hysterectomy that she had uterine cancer. During her surgery, her doctor used a power morcellator, which is used to grind up and remove uterine fibroids or entire uteruses. Nielsen’s lawsuit claims that the process of grinding her uterus caused cancer cells to spread throughout her uterus. More than a year after her hysterectomy, she was diagnosed ... Read More

Ovarian cancer drug fails to meet secondary target in late-stage trial

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Oncologists say Amgen Inc.’s experimental ovarian cancer drug trebananib offers little to no benefit in terms of overall survival, leading analysts to predict it has little change of winning approval from drug regulators. Amgen Inc. reported no statically significant improvements in overall survival rates in a late-stage trial pitting trebananib plus chemotherapy against chemotherapy alone in ovarian cancer patients. Statistically significant improvement in overall survival was the secondary goal of the TRINOVA-1 trial, the first of three late-stage studies to evaluate safety and efficacy of the medication. The drug reached its main target, which was to improve survival in ovarian ... Read More

Stryker settlement estimated at $1.43 billion for victims of metal-on-metal hip implants

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Medical device maker Stryker had agreed to pay $1.43 billion to settle thousands of lawsuits claiming the company’s metal-on-metal hip implant was defective and caused injuries and poisoned the blood of patients who had them. The agreement was brokered by a New Jersey Superior Court and settles both state and federal lawsuits waged against the company. Stryker said the settlement amount was the “low end of the range of probable loss to resolve these matters.” The settlement covers lawsuits against two Stryker artificial hips, which the company recalled in 2012 after discovering the all-metal devices were corroding inside patients’ bodies, ... Read More

Lawsuit claims company’s surgical gowns do not protect against Ebola, as promised

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Hrayr Shahinian along with a half million other plaintiffs are suing Kimberly-Clark Corp. for $500 million for allegedly falsely claiming its surgical gowns protect against the deadly Ebola virus. Kimberly-Clark claimed its Breathable High Performance Surgical Gown provided the highest protection against infectious diseases despite failing industry tests. The company has been marketing the gowns since 2011. Plaintiffs are pushing for an immediate recall saying health care workers and patients are at “considerable risk” as long as the gowns are on the market. “Kimberly-Clark needs to immediately recall these gowns and come clean with the FDA, CDC, health care professionals ... Read More

New warnings added to label of potent painkiller Zohydro ER

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Just months after the new potent painkiller Zohydro ER hit the market amid a slurry of controversy, a long list of new warnings including black box warnings, have been added to the opioid’s safety label. Zohydro, made by Zogenix, is the first pure hydrocodone to be approved in the United States. Hydrocodone is a potent opioid painkiller that is already marketed in combination with other painkillers such as with acetaminophen in the drug Vicodin. The FDA approved Zohydro under the premise that people with chronic pain need more treatment options. Also, the combination hydrocodone with acetaminophen puts patients at risk ... Read More

Statins linked to weight gain, increased blood sugar, type 2 diabetes

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Statins were once considered the holy grail of medications, lowering cholesterol levels and promising protection against heart attacks, strokes and premature death. But decades later, with millions of user side effect reports filed away, the ugly truth comes out – statins can make you resist exercise, gain weight, increase your blood sugar levels, and raise your chances of developing type 2 diabetes. Statins, including the widely prescribed Lipitor, are one of the most prescribed drugs in the world. New guidelines offered by the American Heart Association and other organizations are recommending wider use of the drugs, which means even millions ... Read More

Whistleblower case against guardrail manufacturer to be re-tried this week

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A whistleblower who claims a leading guardrail manufacturer secretly changed the design of its guardrail systems, making them extremely dangerous and in some cases deadly, will have his case heard again this week after the first trial ended in a mistrial. Joshua Harmon, a safety advocate from Virginia, is suing Trinity Industries Inc. under the qui tam provisions of the federal False Claims Act, which allow private individuals to sue on behalf of the U.S. government. Mr. Harmon alleges that Trinity secretly changed the design of its widely used ET guardrail system to save money, shortening the end terminals. But ... Read More

TSA whistleblower enjoys widespread support as case moves to Supreme Court

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Federal agencies should not be allowed to dodge whistleblower protections by adapting rules prohibiting the disclosure of certain information, the Office of Special Counsel (OSC) advised the U.S. Supreme Court in a brief Monday. The brief was filed in support of Robert MacLean, a former Transportation Security Administration (TSA) air marshal who was fired in 2006 after blowing the whistle on the agency’s plans to stop placing air marshals on long-distance flights amid heightened terrorist threats to air travel. The Supreme Court is expected to hear oral arguments in the case starting November 4. In April 2013, a Federal Circuit ... Read More

Medical device and drug manufacturers among those critical of FDA Guidance Policy

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The U.S. Food and Drug Administration (FDA) has been petitioned to reform its guidance process used by drug and medical device makers in order to make the system faster and create a more responsive process. According to the FDA, guidance documents represent the Agency’s current thinking on a particular subject. Critics are accusing the FDA of becoming “sluggish and secretive” when dealing with the guidance process, but FDA attorneys are claiming that the agency is open to reform. Two years ago, Bradley Merrill Thompson, an attorney at Epstein Becker Green, filed a 400-page citizen petition concerning these issues, hoping for a response ... Read More