Pharmaceutical 3680 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.

New cancer drug improves survival odds in patients with advanced melanoma


Merck & Co.’s cancer drug Keytruda (pembrolizumab) was more successful at improving survival odds of patients with melanoma than the Bristol-Myers Squibb Co.’s Yervoy (lpilimumab) in a clinical trial that pitted the two drugs against each other. Keytruda and Yervoy are immunotherapies that work differently to toughen the body’s immune system to destroy cancerous tumors. Yervoy has emerged as the first-line treatment for advanced melanoma since its approval in 2011. Keytruda was approved in 2014 to treat melanoma in patients whose disease progressed after treatment with Yervoy. Yervoy was the first medication approved for advanced melanoma that studies showed could ... Read More

U.S. Marshals seize $1.5 million in illegal prescription drugs


Unapproved prescription drugs valued at more than $1.5 million made by Sonar Products and marketed by Stratus Pharmaceuticals, were seized by U.S. Marshals. The Food and Drug Administartion and the U.S. Attorney for the Southern District of Florida ordered the seizure of the products because they may not be safe or effective. The products seized include a solution used to treat excessive sweating; an antibiotic cleanser to treat skin conditions including acne, rosacea and seborrhea; a topical ointment used to treat wounds; a topical cream and gel to treat psoriasis, eczema and other skin conditions; and analgesic ear drops to ... Read More

Black box label updated for Estrasorb hot flash treatment


The black box warning on the menopausal cream Estrasorb has been updated to include warnings for endometrial cancer, cardiovascular disorders, breast cancer and probable dementia. Estrasorb is a topical cream that is used to treat moderate to severe hot flashes in postmenopausal women. It contains the hormone estradiol, which is the predominant female hormone. As women age, levels of estrogen drop, which can lead to symptoms including hot flashes and vaginal dryness. The updated boxed warning for Estrasorb informs users of an increased risk of endometrial – or uterine – cancer in women who still have their uteruses. The label ... Read More

Study: Greater risk of diabetes with statin therapy


The risk of developing type 2 diabetes among people who use cholesterol-lowering statin therapy is greater than previously thought, a new study published in the journal Diabetologia, has found. For years, researchers have known that statins, such as the widely prescribed Lipitor, can increase blood sugar levels, a precursor to type 2 diabetes. In 2013, the British Medical Journal reported that statin therapy increased a person’s risk of developing type 2 diabetes by 22 percent. The news sent shockwaves around the world, as statins are the most prescribed drug in the world, and type 2 diabetes is growing worldwide in epidemic proportions. ... Read More

Liquid Mucinex recalled due to labeling error

Recall - Liquid Mucinex

Several lots of the over-the-counter cold medicine Mucinex are being recalled by the manufacturer because the packages may be mislabeled with incorrect drug facts. This could prevent consumers from knowing the risks or side effects associated with certain ingredients which could lead to health complications requiring urgent medical intervention, particular for people with liver impairment. The recall includes several lots of liquid Mucinex Fast-MAX Night Time Cold & Flu; Mucinex Fast-MAX Cold & Sinus; Mucinex Fast-MAX Severe Congestion & Cough; and Mucinex Fast-MAX Cold, Flu & Sore Throat. A full list of lot numbers can be found here. The medicines ... Read More

Consumers beware of counterfeit Botox injections

Botox logo

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


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

bodybuilding suppliments

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


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

preemie baby

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