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Pharmaceutical 3735 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.

Statin therapy may be unnecessary, cause side effects in elderly

Senior African American couple

People older than 75 who have high cholesterol but no evidence of heart disease may not benefit from statin therapy, according to Sanford cardiologist Dr. Joshua Wynne, who writes the Health Matters column in the Grand Forks Herald. “The problem is that we have very little clinical evidence that statins are beneficial for primary prevention in people … who are over the age of 75. Not only that, but there is some evidence to suggest a higher cholesterol level in the elderly may be associated with less risk of complications,” he writes. Statins, such as the widely prescribed Lipitor, are used ... Read More

$200 million settlement to compensate fungal meningitis victims

Syringe

A federal bankruptcy judge in Boston, Mass., announced he plans to approve a $200 million settlement agreement to compensate victims of a deadly fungal meningitis outbreak caused by contaminated steroid shots manufactured and distributed nationwide by the now-defunct New England Compounding Center (NECC). The fund will be used to cover the compounding pharmacy’s creditors as well as patients who received the shots and developed fungal infections including fungal meningitis. More than 98 percent of creditors voted on the plan and approved it unanimously. Victims are expected to begin receiving compensation by the end of 2015. More than 3,000 parties have ... Read More

Researchers developing personalized vaccines for advanced melanoma patients

melanoma

Research on various cancer vaccines have shown mixed results, but a new study on a personalized vaccine to treat melanoma is showing more promising results. Researchers with Washington University School of Medicine in St. Louis have developed tailor-made vaccines to treat melanoma that have produced a powerful immune response against unique mutations in patients’ tumors. Individual vaccines were given to three patients with advanced melanoma. After treatment, all three experienced a noticeable increase in the number and diversity of T cells that fight cancer by attacking cancerous tumors. The vaccines involved sequencing the genomes of a patient’s tumor and samples ... Read More

Weight loss from newer diabetes drugs may come at steep price

bathroom scale

Newer classes of type 2 diabetes drugs can help patients lose weight, but that benefit may come at a high price. Being overweight is a risk factor for type 2 diabetes. Patients diagnosed with the chronic disease are generally advised to adopt a healthy diet and get regular exercise to help keep their blood sugar levels in check. Uncontrolled diabetes can increase the risk of serious health problems including heart disease, kidney disease, some cancers, blindness, neuropathy, and dementia. Losing weight through diet and exercise can help diabetics better manage and, in some cases, fend off the disease. However, reaching ... Read More

ONJ risk factors defined on safety labels of osteoporosis drugs

jawbone - By Gregory F. Maxwell

The safety labels of all medications in a class of osteoporosis drugs called bisphosphonates have been updated to include a list of factors that may increase a patient’s risk of developing a serious side effect of the medication called Osteonecrosis of the Jaw, or ONJ. ONJ occurs when the jawbone is exposed and begins to starve from a lack of blood, a condition often referred to as bone death. Effective treatments for ONJ have not yet been established, and more severe cases require surgical removal of the affected bone. Bisphosphonates include the following brand name drugs Actonel (risedronate sodium) Tablets ... Read More

Janssen agrees to pay $7.8 million to settle Risperdal lawsuit

risperdal

Johnson & Johnson has agreed to pay $7.8 million to settle a lawsuit claiming the drug company’s subsidiary Janssen Pharmaceuticals committed Medicaid fraud and violated state law in its promotion and labeling of the antipsychotic Risperdal to Arkansas doctors. The lawsuit was originally filed in 2008. Three years ago, a Pulaski County jury found the drug company guilty of the charges and imposed a $1.2 million fine on Johnson & Johnson. The Arkansas Supreme Court overturned the decision. Janssen Pharmaceuticals said the settlement agreement is not an admission of guilt. Risperdal, known generically as risperidone, was originally approved by the ... Read More

ADHD drug labels now warn of serious muscle injury

adhd-drugs-pharmaceutical

The safety labels of stimulants used to treat attention deficit hyperactivity disorder, or ADHD, have been updated to include a new side effect for a severe muscle injury known as rhabdomyolysis. The new information will be added to the Adverse Reactions section of the following ADHD drugs: Adderall (mixed salts of a single-entity amphetamine product) Tablets Adderall XR (dextroamphetamine mixed salts of a single entity amphetamine product) Capsules Concerta (methylphenidate HCl) Extended-release Tablets Daytrana (methylphenidate transdermal system) Desoxyn (methamphetamine hydrochloride) Tablets Dexedrine (dextroamphetamine sulfate) Spansule Sustained Release Capsules Focalin (dexmethylphenidate HCl) tablets Focalin XR (dexmethylphenidate HCl) Extended-release Tablets Metadate CD ... Read More

Heart safety trial on diet drug Contrave halted prematurely

bathroom scale

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

januvia - sitagliptin

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

Recalls - Hospira-logo

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