Category

Pharmaceutical 3235 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.

Whistleblower lawsuits accusing Merck of mumps vaccine deceptions will proceed to court, judge decides

whistleblower

Two lawsuits accusing Merck & Co. of lying about the efficacy of its mumps vaccines to keep competitors from introducing similar vaccines to the market will be proceed to trial after a federal judge in Pennsylvania refused to dismiss the suits. U.S. District Judge C. Darnell Jones II ruled that one of the lawsuits, filed by a pair of whistleblowers who worked as virologists for Merck, provided enough evidence that the pharmaceutical giant lied about the vaccine’s efficacy to the federal government. The judge also ruled that the other lawsuit, filed by a group of physicians and direct buyers, could ... Read More

Pfizer skirts patent lawsuit but Lipitor diabetes lawsuits continue to mount

lipitor

A U.S. District judge has dismissed an antitrust lawsuit accusing drug makers Pfizer and Ranbaxy Laboratories of conspiring to delay sales of generic versions of their best selling cholesterol-lowering statin drug Lipitor. Judge Peter Sheridan said that the plaintiffs, retailers and distribution companies that bought Lipitor from Pfizer did not provide enough details to convince him that Pfizer and Ranbaxy had violated patent agreements. The lawsuit stems from a 2008 settlement of a patent settlement reached between Pfizer and Ranbaxy regarding Ranbaxy’s plan to make generic versions of Lipitor. Under that agreement, Pfizer agreed to drop damage claims against Ranbaxy, ... Read More

FDA approves new pill for dialysis patients with warnings

dialysis

Keryx Biopharmaceuticals received Food and Drug Administration (FDA) clearance for its ferric citrate drug to treat complications with kidney disease, but the approval requires the drug company to add a warning to the safety label that using the drug can cause “iron overload,” which may require physician supervision while the patient is being treated. The drug is designed to treat dialysis patients with hyperphosphatemia, or elevated phosphates, which can lead to heart disease, bone density problems, and death. Keryx said that because ferric citrate can boost patients’ iron levels, dialysis patients who used anemia drugs and intravenous iron could reduce ... Read More

FDA approves new diet pill Contrave

bathroom scale

A new prescription diet pill has been given clearance by the Food and Drug Administration (FDA) for marketing in the United States. Contrave, made by Orexigen Therapeutics, is a combination of bupropion, an antidepressant that is also used for smoking cessation, and naltrexone, a drug used to treat drug and alcohol dependence. Contrave is approved for overweight or obese patients with a body mass index (BMI) of 30 or higher, as well as people with a BMI of 27 or higher with at least one other health issue such as diabetes. Patients treated with Contrave lost an average of 4.2 ... Read More

Children can be prescribed statins as young as age 8

lipitor

Children with a genetic cholesterol disorder can lower their risk of developing cardiovascular disease by taking cholesterol-lowering statins, according to a long-term European study. The research involved 194 children and teenagers with an inherited high cholesterol disorder known as familial hypercholesterolemia, a condition that affects about one in 500 people. People with this condition are at risk for premature hardening of the arteries (atherosclerosis). The children and teens were prescribed a statin drug and were followed for 10 years. Statins include the widely prescribed brand name drug Lipitor. According to researchers, taking statins prevented premature atherosclerosis. The younger a child ... Read More

FDA to reassess appropriateness, usefulness of testosterone replacement drugs

Low T

The U.S. Food and Drug Administration (FDA) will hold an advisory panel meeting Sept. 17 on the safety and usefulness of testosterone replacement drugs, which a number of pharmaceutical manufacturers are promoting and selling aggressively to men who may be stricken with low testosterone levels, or “Low T.” FDA officials added briefing documents to the agency website earlier this month, acknowledging that while testosterone levels commonly drop in men as they age, studies indicate that lower levels of the hormone do not necessarily lead to serious health problems, such as testicular and pituitary disease. Still, as the agency notes, testosterone ... Read More

FDA panel recommends approving diabetes treatment for obese patients

diabetes_illus250x03

A Food and Drug Administration (FDA) advisory panel has given a thumbs-up recommendation to Novo Nordisk’s type 2 diabetes drug liraglutide for the treatment of chronic obesity in patients with at least one weight-related health issue, such as hypertension or pre-diabetes. Liraglutide, known commercially as Victoza, would be sold under the label Saxenda for the obesity indication if it is approved by the FDA. The agency is not required to follow the recommendations of its advisory panels, but it usually does. The positive recommendation was based on a clinical trial in which patients were given 3 mg of liraglutide. About ... Read More

Former NECC pharmacist arrested on criminal charges stemming from fungal meningitis outbreak

syringe

A man was arrested last week as part of an ongoing investigation into the deadly fungal meningitis outbreak linked to a Massachusetts compounding pharmacy by the Justice Department’s Civil Division and U.S. Attorney’s Office for the District of Massachusetts. Glenn Adam Chin was attempting to board a plane to Hong Kong when federal authorities arrested him on one count of mail fraud. According to the Department of Justice, the maximum sentence under the statute is 20 years in prison followed by three years of supervised release and a $250,000 fine. The U.S. Attorney’s Office and the Civil Division’s Consumer Protection ... Read More

Hospira recalls heparin vials due to contamination with human hair

Recalls - Hospira-logo

Hospira, Inc., is recalling one lot of its blood thinner Heparin after confirming that a piece of human hair was found floating in a sealed vial. The nationwide user-level recall involves one lot of Heparin Sodium, 1,000 USP Heparin Units/500 mL (2 USP Heparin Units/mL) in 0.9 percent Sodium Chloride Injection, 500 mL, NDC 0409-7620-03 Lot 41-046-JT with expiration date of 01NOV 2015. The injection of particulate material, such as human hair, may cause local inflammation, phlebitis, and/or low-level allergic response. Capillaries, which may be as small as the size of a red blood cell, approximately seven microns in diameter, ... Read More

DEA introduces new drug take-back program to combat prescription drug abuse

pills

A new Drug Enforcement Administration (DEA) rule aims to combat a growing epidemic of prescription drug addiction and abuse by authorizing pharmacies, hospitals, clinics, and others to serve as drop-off sites for unused prescription medications. Attorney General Eric Holder said that the new regulation will help save lives and protect families from the dangers of prescription drug misuse. In 2011, unintentional prescription drug overdoses accounted for more than half of the 41,300 drug overdose deaths in the U.S. Prescription opioids, which are increasingly prescribed for pain relief, are particularly addictive and likely to be abused. Opioid pain killer overdose caused ... Read More