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Pharmaceutical 3728 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.

Heart safety trial on diet drug Contrave halted prematurely

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Takeda Pharmaceuticals Co. is threatening to sever its partnership with Orexigen Therapeutics Inc. after a safety study on the diet drug Contrave was halted because trial data was released prematurely. Orexigen had announced last March – when only about 25 percent of the data was in – that early data from a clinical trial to evaluate cardiovascular outcomes with Contrave showed patients taking the obesity medication had a reduction in heart-related deaths. The information was released as part of a patent application. The Food and Drug Administration (FDA) criticized Orexigen for releasing the information too soon, saying the trial’s integrity had ... Read More

New adverse reaction added to Januvia, Janumet safety label

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The safety label of the type 2 diabetes drugs Januvia, Janumet and Janumet XR have been updated to include a warning for pruritus, also known as itching. Pruritus can be associated with a number of disorders, including dry skin, skin disease, pregnancy, and in some cases, cancer. It has also been associated with some medications. In some cases, pruritus is accompanied with a rash. Januvia, Janumet and Janumet XR contain the active ingredient sitagliptin. Janumet and Janumet also contain the diabetes medciation metformin. These drugs belong to a class of type 2 diabetes medications known as incretin mimetics. In 2013, ... Read More

Homeland Security investigates security vulnerabilities with Hospira pumps

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The Food and Drug Administration (FDA) and Hospira Inc. have issued a Safety Communication warning of security vulnerabilities including sofetware codes with Hospira’s LifeCare PCA3 and PCA5 Infusion Pump Systems. If exploited, an unauthorized user with malicious intent could access the pump remotely and modify the dosage it delivers, which could lead to over- or under-infusion of critical therapies. At this time, the FDA is not aware of any adverse events to patients or unauthorized device access related to these vulnerabilities. The agency is actively investigating the situation and working closely with Hospira and the Department of Homeland Security. The ... Read More

FDA warns of serious ketoacidosis from type 2 diabetes drugs

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The Food and Drug Administration (FDA) is warning that a class of type 2 diabetes drugs called sodium-glucose contransporter-2 (SGLT2) inhibitors has been linked to ketoacidosis, a serious condition characterized by the buildup of acids, called ketones, in the blood that can be life threatening if untreated for an extended period. The condition is caused by an insulin deficiency that forces cells to burn fat for energy instead of glucose, which produces ketones. The FDA received 20 reports of ketoacidosis in patients taking the drugs from March 2013 to June 6, 2014, and all those patients required emergency room visits ... Read More

Johnson & Johnson introduces controversial anesthesiology machine

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A new, one-of-a-kind machine designed to sedate patients for medical procedures the way an anesthesiologist would typically do was introduced at four hospitals in the United States, and all eyes are watching to see if the machine will be successful in replacing doctors in much the same way machines have replaced factory workers in some automobile plants. But the question on most peoples’ minds is how safe the anesthesia-delivering machines will be for patients. Johnson & Johnson won Food and Drug Administration (FDA) approval for the Sedasys anesthesiology machine in 2013, but delayed the rollout anticipating concerns not only about the ... Read More

Experimental IUD offers less pain with insertion

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Clinical trials on an experimental intrauterine device, or IUD, show women experience less pain with insertion from the new devices than with another marketed IUD. IUDs are small devices that are placed in the cervix and prevent pregnancy. Brand names include the Mirena IUD. While IUDs are effective at preventing pregnancy, they can carry side effects such as expulsion and migration to other parts of the body where they can cause tissue and organ damage. They can also be quite painful when inserted. The VeraCept made by ContraMed is deigned to be more flexible and thus offer less pain during insertion. It ... Read More

FDA questions J&J request to update label of antipsychotic

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Federal regulators slapped Johnson & Johnson subsidiary Janssen Pharmaceuticals with a “complete response letter” requesting more information about the supplemental New Drug Application (sNDA) to expand the label of its long-acting antipsychotic drug Invega Sustenna. The drug company wanted to include on the drug’s safety label data from the Paliperidone Palmitate Research in Demonstrating Effectiveness (PRIDE) clinical trials which evaluated the drug’s efficacy against other widely prescribed oral drugs for the treatment of schizophrenia. Invega Sustenna, known generically as paliperidone palmitate, is an injectable drug administered once a month. In July 2009, the medication became the first atypical long-acting injectable ... Read More

Odd medical symptoms caused by corroding metal-on-metal hip implants

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It was nagging back pain, a presumed “pinched nerve,” that couldn’t be relieved with pain pills that sent Di Harvey to an orthopedic surgeon, but his diagnosis left her speechless. The back pain was not caused by a problem with her back, but was transferred pain from her artificial right hip, which had been implanted seven years earlier in 20013. The news was unbelievable to Di because the hip implant she received was considered the “Rolls-Royce of hips,” a new metal-on-metal hip implant made of cobalt and chromium designed to be more durable than traditional ceramic or plastic hip implants. This ... Read More

Sun exposure, Viagra increase risk of skin cancer

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More than three quarters of people in the United Kingdom do knot know what causes skin cancer, according to research conducted by the British Association of Dermatologists (BAD) as part of the 2015 Sun Awareness Week. The research involved of survey of more than 1,000 Brits, and revealed that 84 percent of participants said they were concerned about the growing prevalence of skin cancer. However, 96 percent admitted they did not check their skin for signs of the disease at least once a month, as recommended. Seventy-seven percent said they didn’t think they could identify melanoma, the most deadly form ... Read More

Endo announces transvaginal mesh settlement agreement

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Endo International PLC, has reached a settlement with about 108 plaintiffs in a multidistrict litigation claiming that the company’s subsidiary American Medical Systems’ transvaginal mesh was defectively designed and caused injuries. All parties have until April 2016 to submit an agreed order of dismissal with prejudice or the cases would be dismissed without prejudice. The settlement agreement comes about a month after Endo “compromised and settled all claims” from another 360 cases, 30 of which Endo had requested claims against other manufacturers of transvaginal mesh, including Boston Scientific and C.R. Bard, be transferred to multidistrict litigations for those companies. Last ... Read More