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Pharmaceutical 5867 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.

Judge rules Invokana lawsuits will stay in federal court

Invokana

More than a hundred lawsuits waged against Johnson & Johnson’s Janssen Pharmaceuticals alleging the company’s type 2 diabetes drug Invokana caused kidney injuries will stay in federal court after they were removed from state court, a Pennsylvania federal judge ruled. Attorneys representing the 106 plaintiffs had sought to consolidate the cases in Philadelphia Court of Common Pleas, but Janssen removed the cases to federal court under the Class Action Fairness Act. Janssen had asked that the cases ultimately be transferred to New Jersey, where several other Invokana lawsuits are pending. Invokana, known chemically as canagliflozin, was approved by the Food ... Read More

Motion sickness patch linked to debilitating long-term side effects

motion sickness patch, recall, Transderm Scop

Another report of a person suffering from disabling long-term side effects after discontinuing the prescription skin patch scopolamine was reported in the journal Clinical Neuropharmacology. The case study involves a 62-year-old woman who was prescribed a standard 1.5-mg transdermal scopolamine (TDS) patch to prevent motion sickness during a sailing trip. She had used the patches previously without significant adverse effects. On this occasion, however, the woman wore the scopolamine patch for seven days, and about 24 to 36 hour after removing it developed dizziness, nausea, sweating, fatigue, and drowsiness. The symptoms lasted two days and she recovered without medical intervention. ... Read More

Antibiotic contaminated with potentially dangerous bacteria

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Four lots of VistaPharm Inc.’s Nystatin Oral Suspension, an antibiotic used to treat fungal infections of the mouth including oral thrush, were found to be contaminated with the Burkholderia cepacia, a bacteria that can cause life threatening bloodstream infections, particularly in patients with weakened immune systems. B. cepacia infections can range from mild with no symptoms to severe with serious respiratory symptoms. It is especially dangerous to patients with cystic fibrosis. VistaPharm identified the source of the bacterial contamination as likely being purified water that was used to manufacture the drug products. Affected products include prescription only Nystatin Oral Suspension, ... Read More

Changes in epilepsy treatment may affect patients’ wellbeing

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Adjusting anti-seizure treatment for patients with epilepsy can negatively impact the patient’s emotional wellbeing, according to a study published in the journal Epilepsy and Behavior. The study was designed to help physicians better understand how changes with anti-epileptic drugs (AEDs) affect patients’ emotions. For the study, researchers asked members of an online epilepsy community to participate in a survey consisting of 31 questions. The 345 participants, all of whom had a diagnosis of epilepsy or seizure disorder, were asked to rate their feelings on a recent AED change. Researchers also collected comments from epilepsy-related online forums and social media websites ... Read More

AndroGel makers try to shake testosterone side effects lawsuits

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AbbVie Inc., and Abbott Laboratories are trying to wiggle their way out of a massive multidistrict litigation (MDL) over side effects allegedly caused by testosterone replacement therapies by arguing to an Illinois federal judge that plaintiffs have not shown that use of testosterone supplements increases the risk of heart attacks or strokes. Days earlier, the drug companies filed a separate summary judgment arguing that plaintiffs’ claims that they marketed testosterone treatments for unapproved uses was incorrect because Food and Drug Administration (FDA) officials had OK’d their marketing materials. The motions for summary judgment were filed just months before the companies ... Read More

FDA warns Fresenius subsidiary over omitting risk information on blood bank product

Fresenius sign

Fresenius Kabi AG’s subsidiary Fenwal Inc., was slapped with a Food and Drug Administration (FDA) warning letter for repeatedly omitting all risk information from a blood bank product. “Promotional materials are misleading if they fail to reveal facts that are material in light of the representations made by the materials or with respect to consequences that may result from the use of the drug as recommended or suggested by the materials,” the letter states. The issue involves Fenwal’s distributed promotional material for InterSol, an isotonic solution. The information cautions against intravenous infuse, reuse of the product and use of cloudy ... Read More

FDA warning letter: Pfizer’s generic of top-selling MS drug Copaxone likely to be delayed

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Food and Drug Administration (FDA) clearance of Pfizer Inc.’s generic version of the top-selling multiple sclerosis (MS) drug Copaxone is expected the first quarter of 2017, but an agency warning letter disclosed last week regarding a May 2016 inspection could delay that approval. Copaxone is manufactured by Teva Pharmaceutical Industries Ltd., and is one of the world’s best-selling drugs, generating sales of $3.5 billion last year in the U.S. alone. Pfizer’s generic, called Glatopa, is manufactured partnership with Sandoz Inc. and Momenta Pharmaceuticals Inc. Glatopa has been available in a 20-milligram version since 2015, but the 40-milligram version makes up about 84 percent ... Read More

Study: Testosterone treatment has no effect on memory, mental function in older men

Low T

Testosterone replacement therapy is approved for the treatment of hypogonadism, a condition in which men do not produce enough of the male hormone due to disease, injury or defect. But manufacturers of testosterone treatments have heavily promoted the product to treat symptoms of so-called “Low T,” such as low libido, memory loss, weight gain, muscle loss and mood swings. The marketing strategy worked surprisingly well, resulting in skyrocketing sales of testosterone replacement therapies that eventually raised concerns that the drugs were being prescribed to men who actually didn’t need it, such as older men who naturally see a dip in ... Read More

Synergy Rx Pharmacy expands recall to include weight loss treatments, acne creams, chemical peels

acne

Synergy Rx Pharmacy has expanded a recall issued earlier this month on all lots of injectable Human Chorionic Gonadotropin (HCG), to include the following non-sterile products – Sublingual Tablets, HCG and HCG with resveratrol Human Chorionic Gonadoptropin), Non Sterile Dermatology creams all strengths (retinoic acid creams, hydroquinine creams, bleaching creams), Numbing Creams, acne creams, hair growth serums with minoxidil, betamethasone creams and Chemical Peels (salicylic acid peels, trichoracetic acid peels, glycolic acid peels, Jessners Peels, custom peels solutions). The recall was initiated due to lack of quality assurance. Administration of a drug product which does not meet the quality assurance ... Read More

Sexual enhancement dietary supplement recalled

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Organic Herbal Supply Inc., has issued a nationwide recall of all lots of XtraHRD Natural Male Enhancement capsules after a Food and Drug Administration (FDA) analysis found that the dietary supplements contained a hidden drug ingredient, Tadalafil, the active ingredient in the prescription erectile dysfunction drug Cialis. This drug poses serious health risks to men who take nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. The recall comes about two weeks after the FDA warned consumers not ... Read More