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Pharmaceutical 3675 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.

Consumers beware of counterfeit Botox injections

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The Food and Drug Administration (FDA) is alerting doctor’s offices and medical clinics across the country to look for shipments of possible counterfeit Botox injections made by an unlicensed supplier that is not authorized to ship or distribute the drug in the United States. Packages of the counterfeit Botox are strikingly similar to the FDA-approved packages of Botox, which is made by Allergan. But the fake Botox can be discerned from the approved drug in a few ways. For example, the active ingredient on the outer carton and vial of the authentic Botox is listed as “OnabotulinumtoxinA.” However, the outer ... Read More

GSK recalls thousands of 4-in-1 flu vaccinations

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GlaxoSmithKline (GSK) is recalling its four-in-one flu shot over concerns that it can lose its effectiveness over time and fail to adequately protect against some strains of the flu. The recall affects the Flualval Quadrivalent Thimerosal-free vaccine in prefilled syringes. GSK sent a letter to roughly 1,000 U.S. wholesale distributors, pharmacies, government agencies and physicians saying it “cannot rule out potential suboptimal protection” for people who received the vaccine in early January or later. About 1.7 million doses are affected by the recall, which represents about 7 percent of the 24 million flu shots GSK distributed this flu season. GSK’s ... Read More

FDA warns consumers to avoid potentially dangerous muscle-building supplements

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The Food and Drug Administration (FDA) is warning consumers to avoid muscle-building supplements made by Extreme Products Group after three people who used the company’s Tri-Methyl Xtreme supplements suffered injuries. Agency investigators say that some of the dietary supplements may contain anabolic steroids that can cause liver damage. Extreme Products Group, based in Las Vegas, distributes capsules as a muscle-building supplement, and claims that they contain anabolic steroids. The supplements are sold online and by some retailers. The FDA warns consumers who have taken Tri-Methyl Xtreme to be aware of unusual side effects including unexplained fatigue, abdominal or back pain, or ... Read More

FDA panel recommends heart failure warning for Type 2 diabetes drugs

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The Type 2 diabetes drugs Onglyza and Kombiglyze should carry warnings that use of the medication may cause heart failure and death, a Food and Drug Administration (FDA) advisory panel warned. The recommendation is based on the expert panel’s review of a 16,000-patient study that looked at heart health among patients taking either Onglyza or Kombiglyze. Panel members voted 14-1 to recommend that the drugs’ safety labels should include information to alert patients that using the drugs could lead to an increased risk of hospitalization for heart failure and death from any cause. Despite this risk, panel members voted 13-1, ... Read More

Infant, pediatric ICU catheters recalled after serious patient injury

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Infant and pediatric ICU catheters used to assist with mechanical cardiopulmonary bypass procedures to support the lungs and heart in newborns and children are being recalled after the product malfunctioned and seriously injured a patient. The recall involves one lot of OriGen Biomedical’s VV13F Reinforced Dual Lumen ECMO (extracorporeal membrane oxygenation) Catheter used as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less in Neonatal Intensive Care and Pediatric Intensive Care ECMO centers. Extracorporeal life support is a type of cardiopulmonary bypass that ... Read More

Duodenoscope makers didn’t report or delayed reporting infections to FDA

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Warning bells that could have stifled or at least tempered the spread of deadly superbugs among hospital patients due to contaminated surgical tools arrived months too late and sometimes not at all to federal officials, new documents reveal. Medical device manufacturers are required to file reports to the Food and Drug Administration (FDA) within 30 days of learning that their devices may cause health injuries to patients or others. But the FDA was told months too late or not at all of outbreaks of the superbug in patients who had undergone procedures with a specialized endoscope known as a duodenoscope. ... Read More

Novartis settles lawsuit claiming osteoporosis drug caused jawbone decay

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A lawsuit against the makers of the osteoporosis drug Zometa claiming the medication caused serious jawbone decay has been settled, just as a state appeals court was scheduled to rule whether to affirm or reverse the no-cause verdict won previously by Novartis Pharmaceuticals Corp., against the plaintiff. The terms of the agreement will not be disclosed. The lawsuit, filed by plaintiff Beverly Meng, was only the second to go to trial in New Jersey. Another 119 lawsuits in New Jersey name Novartis’ Zometa or the company’s other bone loss drug Aredia claiming jawbone injury are yet to be heard. The ... Read More

New black box warnings added to type 2 diabetes drugs

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The safety labels of four type 2 diabetes drugs have been updated to include new black box warnings for thyroid cancer, according to the Food and Drug Administration (FDA). The new warnings were added to Bydureon (exenatide extended-release) injection, Tanzeum (albiglutide) injection, Trulicity (dulaglutide) injection, and Victoza (liraglutide) injection. All the drugs are in a class of diabetes medications known as incretin mimetics. The warning informs physicians and patients that the drugs cause an increased incidence in thyroid C-cell tumors in laboratory rats compared to ones who were not treated with the drugs. The warnings explain that it is unknown ... Read More

IUD side effects may outweigh benefits

mirena IUD

Women who used an intrauterine device, or IUD, were less likely to develop preeclampsia in subsequent pregnancies, but the protective effect was only found in women who had never been pregnant before getting the IUD, according to a new study. Intrauterine devices, such as the Mirena IUD, are T-shaped devices that are inserted into the cervix to prevent pregnancy. IUDs are considered highly effective but they are not 100 percent effective. The risk of becoming pregnant while implanted with an IUD are greatest during the first year, and women who become pregnant with an IUD in place are at greater risk of ... Read More

Study: Viagra most effective for ED, but carries many side effects

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Viagra is the most effective treatment for men who cannot get an erection, but users suffer more side effects while taking the drug compared to other erectile dysfunction treatments, according to a large analysis published in the journal European Urology. Men who have trouble getting or keeping an erection have a variety of medication options. The first to hit the market was Viagra (sildenafil) followed by Cialis (tadalafil), Levitra (vardenafil) and Stendra (avanafil). The drugs are in a class of medications known as phosphodiesterase type 5 inhibitors, or PDE5 inhibitors. The drugs work by relaxing smooth muscle, allowing the penis to ... Read More