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Pharmaceutical 3930 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.

Teleflex Medical recalls leaking breathing tubes

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Teleflex Medical is recalling a type of breathing tube after a complaint that the device has a defect that may cause it to leak, which could result in patients not getting enough oxygen and suffering respiratory distress, which could cause patient injury or death. The issue involves Teleflex Medical’s endobroncial tube’s double swivel connector, which can break or separate on the tube, causing the leak. An endobronchial tube is a plastic tube that is inserted through the mouth into the main passageway into the lungs, called the bronchi. The tube is used during a medical procedure called a bronchospirometry, which ... Read More

OmniPod insulin delivery system recalled due to multiple failure reports

Omnipod insulin delivery system

More than 40,000 boxes of OmniPod Insulin Management System Pods by Insulet Corporation are being recalled because the Pods have been failing at a high rate, putting diabetics who use these products at risk of hyperglycemia, which, if left untreated, can result in diabetic ketoacidosis (DKA). OmniPods are insulin pumps used to help patients manage their diabetes by offering continuous insulin delivery. Insulet Corporation says there are two ways in which the Pods can fail. The cannula can completely retract or fail to fully deploy, which may result in the patient not receiving the expected insulin dose. Or, the Pod ... Read More

Allergan recalls eye ointments

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Allergan recalled three types of ointments used to treat various eye conditions because small black particles were found floating in the products. The Allergan recall includes specific lots of Refresh Lacri-Lube 3.5g and 7g for dry eye, Refresh P.M. 3.5g for dry eye, FML (fluorometholone ophthalmic ointment) 0.1% (sterile ophthalmic ointment topical anti-inflammatory agent for ophthalmic use, 3.5g), and Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile topical ophthalmic ointment combining an antibacterial and a corticosteroid, 3.5g. Specific lot numbers can be found here. The recall was initiated after customer complaints about small black particles in the ointments. Allergan says ... Read More

FDA recalls defective Alaris infusion pump systems

CareFusion Alaris pump

The Food and Drug Administration (FDA) is recalling two Alaris infusion pump systems due to defects that can cause serious injury or death. An error in one model of the Alaris Syringe Pump by CareFusion triggers a visual and audible alarm and causes the pump to stop supplying the infusion to the patient. This problem persists even after the error code has been cleared. Failure of the syringe module may result in a delay of therapy and lead to serious patient injury or death. To date, 108 reports of this issue occurring have been reported to CareFusion. None have resulted ... Read More

FDA warns of severe joint pain with class of type 2 diabetes drugs

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People taking a certain class of type 2 diabetes medications known as DPP-4 inhibitors are at risk of joint pain that can become so severe that it can be debilitating, the Food and Drug Administration (FDA) warned. The agency advised patients to not stop taking their diabetes medications and to talk to their doctors right away if they experience any severe and persistent joint pain. The agency has ordered makers of these drugs to update the Warnings and Precautions section on the drugs’ labels, and also notified doctors to be aware of this new side effect. The warnings arose from ... Read More

FDA warns of severe allergic reactions, shingles rash from Picato gel

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Severe allergic reactions and the shingles rash (herpes zoster) have been reported with the use of Picato gel (ingenol mebutate), a treatment for certain skin conditions, the Food and Drug Administration (FDA) announced in a safety communication. Adverse event reports associated with the topical gel include several involving severe eye injuries and skin reactions. Some cases were related to the gel not being used according to the instructions for use on the label. As a result, the FDA is requiring changes to the safety label to warn about these new safety risks and to provide additional instructions on the safe ... Read More

Testosterone replacement therapy offers no proven benefits for aging men

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There is no proof that testosterone replacement therapy is safe and effective for aging men, Food and Drug Administration (FDA) authorities said in a paper published in the Aug. 20 edition of the New England Journal of Medicine. Testosterone supplements have been heavily marketed to men as a treatment for so-called Low-T, or low testosterone levels. The ads ask men if they suffer from symptoms of this condition, which include low libido, weight loss and muscle loss. The marketing has been so successful that prescriptions for the hormone have jumped into the millions. Between 2009 and 2013, the number of U.S. ... Read More

Study: Statin side effects caused by damaged stem cells

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Cholesterol-lowering statins prevent stem cells from growing into beneficial bone and cartilage cells, increase stem cell aging and death rates, and diminish the cells’ ability to repair DNA, which translates into side effects including memory loss, muscle problems and type 2 diabetes, according to new research. Dr. Eckhard Alt, director of cardiovascular research at Tulane University says he has identified the process that causes statin side effects, and it involves harming vital stem cells. The findings, he says, should “balance your decision to take statins a little more critical.” Statins, such as the widely prescribed Lipitor, are designed to lower ... Read More

Diabetes drug maker announces results from cardiovascular study

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Type 2 diabetes is a serious disease that increases the risk for life threatening health conditions including heart disease, kidney disease and cancer. Medications can help diabetics manage their blood sugar levels but their side effects can be just as concerning. Many of the newer diabetes treatments have been linked to cardiovascular events or cancer risks. But a new study suggests the diabetes drug Jardiance can help reduce the risk for heart attacks, strokes and other cardiovascular damage. Jardiance contains the active ingredient empagliflozin, and was approved by the FDA in August 2014. It is in a new class of diabetes ... Read More

Xarelto linked to major bleeding events

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Gloria Glatz, 88, didn’t let her advancing age keep her from being active. She played Scrabble religiously, enjoyed vising the casino, and was known for whipping up a mean batch of potato salad. When she was diagnosed with a common heart rhythm abnormality known as atrial fibrillation, a condition that causes the blood to clot in the heart, increasing the risk for stroke, instead of treating her with the long-used blood thinner warfarin, her doctors opted for a newer treatment, Xarelto. Introduced in 2011, Xarelto was one of the first drugs in a new class of anticoagulants designed to be ... Read More