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attorneys 306 articles

New warnings added to label of potent painkiller Zohydro ER

Blue pills

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


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

osha whistle

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


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


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

Plaintiff claims Actos bladder cancer warnings were not strong enough to convey risks

Actos (pioglitazone) Type 2 diabetes medication

Takeda Pharmaceutical Co., attempted to convince a Philadelphia jury that it adequately warned of bladder cancer risks on the label of its type 2 diabetes drug Actos by presenting testimony from a former senior official with the Food and Drug Administration (FDA) David Feigal Jr., an expert witness for the drug company, said that Takeda had funded several studies to gauge the cancer risks with its once-blockbuster drug and had included that information on the drug’s insert. However, plaintiff Frances Wisniewski claims differently. She took Actos for seven years and developed tumors in her bladder. Her lawsuit alleges that Takeda ... Read More

Anti-addiction groups call for FDA chief’s resignation amid prescription drug abuse epidemic


Frustrated by the Food and Drug Administration’s approval of potent opioid medications during a nationwide epidemic of prescription drug abuse, anti-addiction activists are calling for the resignation of the agency’s top official. More than a dozen groups have banded together and are appealing to the Obama administration to replace FDA Commissioner Dr. Margaret Hamburg, who has headed up the agency since 2009. Activists have been vocal about their disappointment with the agency for its approval of Zohydro, the only single-ingredient hydrocodone on the market. Hydrocodone is in a class of narcotics known as opioids, which are known for their euphoric effects. ... Read More

Pinnacle hip implant executive pressed to show safety tests on device

metal on metal hip parts

Attorneys for a woman who was poisoned by an allegedly defective hip implant grilled an executive at Johnson & Johnson’s DePuy Orthopaedics unit over what studies the company performed on its Pinnacle metal-on-metal hip replacement system in an attempt to show jurors that the company was negligent in proofing the device’s safety before they were approved by the Food and Drug Administration (FDA) in 2000. Plaintiff Kathy Herlihy-Paoli’s lawsuit is the first of more than 6,000 lawsuits claiming DePuy’s Pinnacle hip implants caused injuries from premature failures and corrosion of the metal parts causing a type of blood poisoning known ... Read More

Former Peanut Corporation of America Officials Convicted on Criminal Charges


“Just ship it.” These three words have come to haunt former Peanut Corporation of America (PCA)owner Stewart Parnell since he sent them in an email to a plant manager in March 2007 concerning tainted peanut products. U.S. prosecuting attorneys brought this statement to light in the opening statements of brothers Stewart and Michael Parnell’s trial concerning the 2009 outbreak of salmonella poisoning linked to their company’s tainted products. In an unprecedented conviction, a federal jury returned guilty verdicts against two former officials and one broker for the Peanut Corporation of America for the unlawful sale of salmonella-tainted peanuts and peanut ... Read More

Judge orders mediation to resolve Fosamax lawsuits claiming femur fractures


A New Jersey federal judge told Merck & Co. that it is time to settle with plaintiffs in multidistrict litigation over femur fractures allegedly caused by its osteoporosis drug Fosamax. About 900 cases are still pending in the litigation, which stated in 2006. U.S. District Judge Joel A. Pisano ordered Merck and a steering committee representing the plaintiffs to propose a mediator within 30 days, and within five days the parties must provide a written status update regarding the mediation. Merck updated its safety labels in January 2011 to include a warning for potential femur fracture. Barbara Gaynor, whose lawsuit ... Read More