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Pharmaceutical 5846 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.

Dr. Reddy recalls generic version of Zyprexa for schizophrenia, bipolar disorder

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Pharmaceutical company Dr. Reddy’s Laboratories is recalling a generic version of the antipsychotic Zyprexa, known chemically as olanzapine, because the drug failed impurity and degradation specification testing. “Due to out-of-specification results for the Related Substance Compound C (Impurity 6 – N-Oxide at the 18 month stability station,” the recall noticed stated. The recall is classified as a Class III, which is a less serious type of recall reserved for products in which use of exposure is not likely to cause adverse health consequences. Olanzapine was approved by the Food and Drug Administration (FDA) in 2009 under the brand name Zyprexa. It ... Read More

Viagra being studied in pregnant women; is it safe?

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Researchers from the University of British Columbia (UBC) have conducted an initial trial of Viagra as a treatment for early intrauterine growth restriction, according to Counsel and Heal. In this rare condition, the placenta does not supply enough nutrients to the fetus which results in premature delivery or stillbirth. Treatment options for this condition are limited. Scientists wondered if sildenafil, the active ingredient in Viagra, which works by increasing blood flow, might be able to increase the flow of nutrients to the fetus. According to Dr. Kenneth Lim of B.C. Women’s Hospital, the results of the small initial study were promising ... Read More

FDA speeds up medical device recall notification in 2017

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The Food and Drug Administration (FDA) vowed that it will deliver warnings regarding recalled medical devices to the public in a more timely manner in 2017. The FDA defines a medical device recall as a correction or removal action to address a problem with a device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. When the FDA learns of a company’s recall or removal action regarding a medical device, the agency reviews the strategy the company poses ... Read More

First Xarelto trial delayed due to NBA All Star game

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The first bellwether trial in the massive multidistrict litigation (MDL) involving bleeding risks with the blood thinner Xarelto was scheduled to begin this month in the Eastern District of Louisiana, but the National Basketball Association (NBA) All Star game occurring in New Orleans at the same time pushed U.S. District Judge Eldon Fallon to delay trial until March. The Xarelto MDL under Judge Fallon has swelled to nearly 14,000 lawsuits since the it was first consolidated in December 2014. Last summer, Judge Fallon had scheduled the first cases to be tried, with the first to be tried in February. But the ... Read More

House seeks to give FDA authority to require recalls of dangerous OTC drugs

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A bill introduced in the U.S. House of Representatives will give the Food and Drug Administration (FDA) the authority to require manufacturers of over-the-counter (OTC) medicines to stop marketing unsafe products. The Recall Unsafe Drugs Act, introduced by Rep. Rosa DeLauro (D-CT), would give the FDA the authority to wield its power over medicines and homeopathic products, closing up a loophole that currently allows companies to refuse the FDA’s request that they remove products from the market if they are deemed unsafe. For example, last month the FDA asked Standard Homeopathic Company to recall its Hyland’s homeopathic teething gels and tablets ... Read More

Dietary supplement maker agrees to stop selling unapproved products

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Dietary supplement maker Cili Minerals has agreed to stop manufacturing and selling untested products that promised to treat serious conditions including heart disease, multiple sclerosis, and cancer. The agreement, penned by the Justice Department and the U.S. Attorney in Lafayette, Louisiana, also requires Cili Minerals to recall and destroy all products it made and distributed since June 1, 2014. Lafayette, Louisiana-based Cili Minerals is owned by Anton S. Botha, and operated under names including Pick and Pay Inc., and Pick and Pay Hyper Inc. Its products were sold under various names including ProLith, Germanium and CilZinCo. The company’s products were ... Read More

Real-world data shows Xarelto has greater bleeding risk than Pradaxa

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The blockbuster blood thinner Xarelto, prescribed to millions of patients worldwide, may have a higher bleeding risk than its competitor Pradaxa, according to a study based on real-world data published in JAMA Internal Medicine. The study involved records on 118,000 Medicare patients with atrial fibrillation who were treated with either Pradaxa or Xarelto for the prevention of strokes associated with the heart ailment. When compared to patients treated with Pradaxa, the Xarelto group had significant increases in intracerebral hemorrhage, major extracranial bleeding, and gastrointestinal bleeding. Pharmaceuticals are approved for marketing in the U.S. after undergoing a series of clinical trials ... Read More

Gist reasoning test can help better identify chronic TBI in patients

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A sensitive reasoning test developed by clinicians and cognitive neuroscientists at the Center for BrainHealth at UT Dallas may be better at identifying certain cognitive defects caused by traumatic brain injury (TBI) than traditional cognitive tests. In a study published in the Journal of Applied Biobehavioral Research, researchers found that a so-called gist reasoning test was better at helping doctors identify previously undiagnosed cognitive changes that could explain why people experience difficulty solving problems, understanding complex information or maintaining friendships. Researchers used a gist reasoning measure called the Test of Strategic Learning to accurately identify 84.7 percent of patients with chronic ... Read More

Ethicon loses appeal in $3 million pelvic mesh verdict

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Johnson and Johnson unit Ethicon is unhappy with and petitioning against the Fourth U.S. Circuit Court of Appeals’ recent decision to uphold a $3.27 million jury verdict in the second Ethicon pelvic mesh bellwether trial. This was the first of the 31,676 lawsuits to go to trial in the New Jersey multidistrict litigation against Ethicon related to the mesh devices. The trial, which concluded on Sept. 5, 2014. involved plaintiffs Jo and Allen Huskey, who alleged that because of a design defect in Mrs. Huskey’s TVT-O sling she experienced severe pain. The sling had eroded and surgery could not completely remove ... Read More

J&J remains mum about results of Invokana study data

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Results from the CANVAS and CANVAS-R study investigating cardiovascular risks with the blockbuster type 2 diabetes drug Invokana are expected later this year. Invokana manufacturer Johnson & Johnson (J&J) and its subsidiary Janssen Pharmaceuticals are hoping for label-changing results like that of rival Jardiance, which showed the drug reduced the risk of cardiovascular death in diabetics with heart disease. But some analysts are skeptical. “While pure speculation on our part, it’s possible that J&J has seen more of the CANVAS/CANVAS-R data since the Q3 call and feels less confident in the outlook,” Wells Fargo Securities noted following the drug company’s ... Read More