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Pharmaceutical 6218 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.

Basil seeds contaminated with Salmonella

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L.A. Lucky Import & Export Inc., is recalling its L.A. Lucky Brand Basil Seeds in 2.1-ounce packages because laboratory testing found Salmonella in packets of the product. Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people and those with weakened immune systems. Healthy individuals who become infected with salmonella often experience symptoms such as fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., ... Read More

Do acid-reducing PPIs cause kidney damage?

PPI, kidney, chart - Shutterstock

Kaiser Health News reports on the growing body of research that has linked acid-reducing proton pump inhibitors (PPIs) to kidney damage. Some popular brand names include Prevacid, Nexium and Prilosec. Particularly concerning were two very large studies published last year including data from hundreds of thousands of patients taking prescription PPIs. Kaiser Health News noted that these types of observational studies, as opposed to clinical trials, suggest associations, but were not designed to prove cause and effect. Both of these studies compared PPI users to those taking another type of heartburn medication, H2 blockers, which include Pepcid, Tagamet and Zantac. ... Read More

Heart device controller recalled after injury, death reports

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Abbott-Thoratec is recalling the Pocket System Controller, a power supply that connects to its implanted HeartMate II LVAS pump through a lead under the skin, after receiving a total of 70 reports of incidents in which its heart device controller had malfunctioned including 19 injuries and 26 deaths. The controller helps power the LVAS system, a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. The controller is powered by batteries or connected to a main power supply. The HeartMate II LVAS Pocket System Controller is intended for ... Read More

AAP: take fruit juice off the table for babies

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Fruit juice offers no nutritional benefit compared to whole fruit for infants and children, and should not be consumed by children younger than 1, the American Academy of Pediatrics (AAP) said in a policy statement. Additionally, the AAP warned fruit juice could pave the way for tooth decay and weight gain in babies. However, 100 percent fresh or reconstituted fruit juice can be healthy if it is part of a child’s well-balanced diet for children older than 1, the AAP said. The statement, published in the journal Pediatric, is the first change in recommendations on fruit juice consumption for children and ... Read More

Woman says Physiomesh stretched, hernia recurred

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A Canada woman says the Physiomesh hernia repair mesh used to repair her hernia”stretched out,” resulting in her hernia recurring, more painful than before. Colleen Copeland is a 34-year-old Canadian who had hernia surgery in February 2016. Doctors repaired the hole in her abdomen left after the surgery with plastic hernia mesh, called Physiomesh, made by Ethicon, a subsidiary of Johnson & Johnson. She says the mesh has since stretched, leaving her in excruciating pain. “The pain is always there. It feels like my insides are going to explode,” Copland told CTV News. “If I cough or sneeze I have to hold my stomach. It is a ... Read More

MRI contrast agent not a risk FDA says

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Gadolinium-based contrast Agents (GBCAs) used during magnetic resonance imaging (MRI) may leave deposits of gadolinium, a type of heavy metal, in the brain and other body tissues, but there is no evidence that gadolinium retention in the brain from any of the GBCAs is harmful, the Food and Drug Administration (FDA) announced in a Safety Communication. As a result, the agency said there is no evidence to suggest the use of GBCA should be restricted at this time. “We will continue to assess the safety of GBCAs and plan to have a public meeting to discuss this issue in the ... Read More

Pfizer seeks to expand Viagra sales to over-the-counter

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According to the Pharmaceutical Journal, Pfizer, the manufacturer of erectile dysfunction (ED) drug Viagra (sildenafil) has set its sights on having the drug, which has been prescribed for more than 64 million men worldwide, available over-the-counter as well. Ten years ago Pfizer applied to the European Medicines Agency (EMA) for non-prescription status of Viagra, but the agency had concerns that in bypassing the need for a prescription from a general practitioner (GP), men whose symptoms would have led to diagnosis of cardiovascular disease might self-diagnose and treat ED symptoms over-the-counter, missing the underlying more serious disease. The agency also expressed ... Read More

Connecticut Woman claims IVC Filter injury

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A Connecticut woman has filed a lawsuit against Rex Medical for injuries she claims are linked to her failed inferior vena cava (IVC) filter. IVC filters are devices resembling a spider inserted into the vena cava for the purpose of catching blood clots before they cause pulmonary embolism by travelling to the heart or lungs. The Daily Hornet reports that Peggy F. from Connecticut was inserted with an IVC filter on Feb. 2, 2014, at Yale New Haven Hospital in Connecticut. The filter was called an Option retrievable filter made by Rex Medical. Retrievable models are fashioned with a hook at the tip ... Read More

Bodybuilding supplement recalled

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Dynamic Technical Formulations LLC is recalling all lots of Tri-Ton, a dietary supplement promoted for bodybuilding, because the product contains andarine and ostarine, which are selective androgen receptor modulators, or SARMSs. These anabolic steroid-like substances are considered unapproved drugs by the Food and Drug Administration (FDA) and carry health risks to those who consume them. SARMs and anabolic steroid-like drugs are linked to serious side effects including acute liver injury. Abuse of these substances can also lead to serious long-term adverse health consequences in men, women and children, such as shrinkage of the testes, male infertility, masculinization of women, breast ... Read More

Group seeks regulation changes after clinical trial deaths

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Last May, Max Vokhgelt, 24, died from cerebral edema two days after starting an experimental cancer treatment with a Juno Therapeutic drug during a phase II clinical trial. After a review, Juno and the Food and Drug Administration (FDA) determined that a change in trial protocol was not necessary at the time. Max’s death was not reported until nearly two months later, after two other patients participating in the clinical trial died from cerebral edema. At that point, the FDA issued a clinical hold of the trial, but lifted the hold five days later after Juno convinced the agency that the deaths ... Read More