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Pharmaceutical 3583 articles

Beasley Allen has one of the largest and most technologically advanced Mass Torts practices in the country. The Mass Torts division represents numerous people in claims against companies that manufacture and/or market defective pharmaceuticals and/or medical devices. The resources devoted to this division allow the firm to competently and conscientiously handle any group of cases, no matter how large, along with particular catastrophic injury cases.

Our firm was recently involved in one of the greatest victories in Mass Torts history, against drug manufacturer Merck regarding the drug Vioxx. After more than five years of hard-fought and difficult litigation, Merck agreed to pay $4.85 billion, the largest pharmaceutical settlement in U.S. history, to resolve certain Vioxx-related claims involving plaintiffs who suffered a heart attack, including sudden cardiac death, or a stroke.

Bard battles with supplier over liability in transvaginal mesh case

transvaginal mesh

Medical device maker C.R. Bard and supplier Sofradim Production of Trevoux, France are battling in a New Jersey federal court over who should take responsibility for injuries caused by Bard’s Uretex Sling transvaginal mesh product. Bard claims Sofradim is under contractual obligation to indemnify it, while the French supplier says it is owed indemnity by Bard. Bard claims that a 2002 contract with Sofradim that gave Bard the right to sell the Uretex Sling in the United States and Canada obligated Sofradim to defend Bard against any past, present or future claims related to injuries caused by the transvaginal mesh. Bard ... Read More

Researcher warns against giving children sleep aid melatonin

child hospital patient - FDA image

Children with problems sleeping are sometimes given the hormone supplement melatonin to help them fall asleep, but an Australian professor warns that doing so may not be safe for children. Melatonin is a naturally occurring hormone that helps regulate circadian rhythms in humans. It is sold over-the-counter as a supplement as well as by prescription in larger doses. It is not intended for use in children, though David Kennaway of the University of Adelaide says an increasing number of children are being prescribed melatonin off-label. Doctors are at liberty to prescribe drugs for uses that are not approved by the ... Read More

Cases of superbug outbreaks likely grossly underreported

duodenoscope

Specialized endoscopes at the center of a deadly superbug outbreak at UCLA Medical Center were discovered to be the same type of surgical equipment implicated in a previously unreported outbreak in Florida six years ago, raising concerns that cases of infection may be grossly underreported. Revelation of the Florida outbreak, which sickened 70 patients and contributed to the deaths of 15 patients, is one of a handful of outbreaks that have come to light since the UCLA incident was made public last month. Outbreaks were discovered at two separate hospitals in Florida. The scopes at the center of the controversy ... Read More

NaturaLyte, GranuFlo linked to hundreds of dialysis deaths

dialysis

GranuFlo, a concentration used to help balance electrolytes in patients undergoing dialysis treatment, is the most widely prescribed dry acid product in the dialysis industry, but it has been blamed for hundreds of deaths across the country. GranuFlo, manufactured by dialysis products and services giant Fresenius Medical Care, is intended for on-site concentrate mixing. It is used in both Fresenius-owned and non-Fresenius-owned clinics. It is given to patients during dialysis treatment, during which the product metabolizes into a substance known as bicarbonate, an important buffer in the blood that prevents the blood from becoming too acidic. However, if there is too ... Read More

Endoscope at center of superbug outbreak was never FDA approved

duodenoscope

The manufacturer of the specialized endoscope at the center of the deadly drug-resistant bacteria outbreak at UCLA never obtained approval from drug and medical device regulators to sell the surgical tool in the United States, CNN has learned. Olympus began selling its TJF-Q180V duodenoscope in 2010. The Food and Drug Administration (FDA), didn’t realize until late 2013 or early 2014 that Olympus had never filed for FDA approval on the device. Duodenoscopes are a type of flexible endoscope fitted with a camera that is put down throats of patients to treat a variety of gastrointestinal conditions. A half million duodenoscope ... Read More

Heart pumps recalled due to dangerous defect

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Heartware International is recalling its older Ventricular Assist System Controller, a type of miniaturized implantable heart pump, because of a defect that may have contributed to the death of one patient and a serious injury to another. The devices were distributed in the U.S. during clinical trials prior to Food and Drug Administration (FDA) approval in 2012. The ventricular assist devices are used to treat patients suffering from advanced heart failure. The affected controllers have a higher susceptibility to electrostatic discharge (ESD) than newer, commercial controllers. An ESD event could result in the pump stopping, which could cause serious injury or ... Read More

FDA requires cardiovascular warning for testosterone therapy products

Low T

Manufacturers of testosterone therapy products have been ordered by the Food and Drug Administration (FDA) to change the labels on their products to warn of a possible increased risk of heart attacks, strokes and death in patients using the drugs, and to better clarify for which patients the treatments are intended. The FDA cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. The benefit and safety of testosterone therapy has not been established in the treatment of age-related low testosterone, even if a man’s symptoms appear related to low levels ... Read More

Trials underway on experimental diabetes drug

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Novo Nordisk’s new oral diabetes drug is proving to be just as effective as its injectable counterpart in clinical studies. The drug, known as OG217SC, is an oral version of the company’s experimental weekly injectable medication semaglutide, from a class of type 2 diabetes drugs known as glucagon-like peptide-1 receptor agonist, or GLP-1 drugs. The drugs work by promoting the body’s natural production of insulin, which not only helps manage insulin levels but also can with weight loss. Weight gain is a contributing factor in type 2 diabetes and many diabetic patients are encouraged to lose weight by following a ... Read More

Janssen ordered to pay $136 million for Risperdal illegal marketing

risperdal

The South Carolina Supreme Court has ordered Johnson & Johnson subsidiary Janssen Pharmacetuicals to pay $136 million to the state for deceptively marketing its antipsychotic drug Risperdal. The decision upholds penalties against the company but reduces the damages, which were originally set at $327 million by a trial court in 2011. Justices said the penalty had to be reduced because of South Carolina’s three-year statute of limitations. Risperdal, known generically as risperidone, is used to treat adults and children with schizophrenia, bipolar disorder and irritability with autism. The drug has also been prescribed off label to treat attention deficit hyperactivity ... Read More

Analysis: Statins benefits overrated, side effects underreported

lipitor

Statin medications, such as the widely prescribed Lipitor, can drive down elevated cholesterol levels, but they have failed to substantially improve users’ chances of having a heart attack or stroke. The drugs also have numerous serious side effects that are pushed under the radar by supporters of statin therapy, according to a study published in the March edition of the medical journal Expert Review of Clinical Pharmacology. Dr. David M. Diamond, a professor of psychology, molecular pharmacology and physiology at the University of South Florida, and Dr. Uffe Ravnskov, an independent health researcher and an expert in cholesterol and cardiovascular ... Read More