Category

Pharmaceutical 7071 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.

FDA promises better oversight of talc-containing cosmetics

The Food and Drug Administration (FDA) is taking new steps to protect consumers from dangerous cosmetics. “We’ll soon be working with cosmetics manufacturers and requesting information about what procedures they use to ensure their cosmetics are safe and, in particular, about how they ensure that talc used in any cosmetic product is free from asbestos,” FDA Commissioner Dr. Scott Gottlieb said in a prepared statement. The agency will investigate how manufacturers source talc and whether they test the raw talc they use and/or their finished products. The agency also aims to know how many cosmetic products contain talc and whether ... Read More

Third cancer-causing impurity found in certain ARB blood pressure drugs

A third type of cancer-causing impurity has been found in a type of high blood pressure and heart failure medication from a class of drugs known as ARBs (angiotensin receptor blocker), the Food and Drug Administration (FDA) announced in a news release. The impurity N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), was detected in losartan potassium tablets made by Hetero Labs Ltd., and distributed by Camber Pharmaceuticals. As a result, Hetero Labs recalled 87 lots of the pills in 25mg, 50mg, and 100mg dosages. Since last summer, the FDA has issued numerous recalls of the ARBs losartan, valsartan and irbesartan mainly due to the ... Read More

Claire’s tween makeup products test positive for asbestos

The Food and Drug Administration (FDA) is warning consumers not to use three types of talc-containing makeup marketed to tweens and sold at Claire’s retailers because they tested positive for cancer-causing asbestos. The agency requested the company recall the products but Claire’s refused. Thus, the FDA is urging consumers to be aware of the risks posed by the products and to report any adverse reactions caused by exposure to the products. The Claire’s products that tested positive for asbestos include: Claire’s Eye Shadows – Batch No/Lot No: 08/17 Claire’s Compact Powder – Batch No/Lot No: 07/15 Claire’s Contour Palette – ... Read More

Rare breast implant-related cancer reported in patient with buttock implants

A woman who received buttock implants developed the same rare form of cancer linked to breast implants, according to a case study published in the journal Aesthetic Surgery Journal. The woman received bilateral textured silicone gluteal implants. A year later, she developed ulceration at the site of the implants and soon after was diagnosed with gluteal implant-associated anaplastic large cell lymphoma (ALCL), according to the case report. “As far as we are aware, this is the first reported case of ALCL that may be associated with textured gluteal implants,” Dr. Joseph Carey, assistant professor of clinical surgery at the Keck ... Read More

Camber recalls ARB losartan due to cancer causing impurity

Camber Pharmaceuticals Inc., is recalling 87 lots of its high blood pressure and heart failure medication losartan because the drug is contaminated with a potential human carcinogen. Camber is one of three companies to recall the drug lorsartan, and one of several to issue recalls involving high blood pressure drugs from a class known as ARBs, or angiotensin II receptor blockers. The recalled Camber products include losartan packaged in 30, 90, 500 and 1000-count bottles. A full list of Camber’s recalled losartan medications can be found on the company’s news release. The impurity detected in the drugs is called N-Nitroso ... Read More

FDA warns against robotically assisted surgical devices for mastectomy

Doctors should be cautious when using robotically assisted surgical devices for mastectomy and other cancer-related surgeries that are not approved by the Food and Drug Administration (FDA), the agency said in a Safety Communication. The robotic devices are not generally used for cancer surgeries, and the safety and effectiveness of these devices for mastectomy have not been established, said Terri Cornelison, M.D., Ph.D., assistant director for the health of women in the FDA’s Center for Devices and Radiological Health. The Safety Communication comes three weeks after Medscape Medical News published a story in which Hooman Noorchashm, M.D., Ph.D., a surgeon ... Read More

FDA wants to know if opioids actually work for chronic pain

Food and Drug Administration (FDA) chief Scott Gottlieb M.D., wants to know whether opioids already on the market to treat chronic pain actually work. Opioids are a class of painkillers that also give users a feeling of euphoria, and oftentimes as the drug is continued, greater doses are needed to quell the pain, leading to dependence and addiction. Prescription opioids have opened the door to abuses of heroin and synthetic opioids like fentanyl, and created an opioid epidemic that in 2017 alone took the lives of 46,000 Americans. Studies have suggested that opioids may not be as effective for some ... Read More

Opioids more often to blame in fatal two-car crashes

The opioid epidemic has “spilled over to our national highway system with deadly consequences,” according to a Columbia University researcher, with drivers of fatal two-car accidents twice as likely to test positive for prescription opioids than those in two-car wrecks deemed not at fault. The study, published in JAMA Network Open, was taken on by Dr. Gouhua Li, founding director of the Center for Injury Epidemiology and Prevention at the Mailman School of Public Health at Columbia University, and colleagues, in order to investigate the impact of opioids on fatal car crashes. Researchers analyzed data from 18,321 fatal two-car crashes ... Read More

Too much off-label prescribing of potent fentanyl, study finds

Nearly half of the patients prescribed high potent transmucosal immediate-release fentanyl (TIRF) reserved to treat breakthrough pain in cancer patients already on round-the-clock opioid therapy, were given the drugs off-label. Yet, when this evidence surfaced, the Food and Drug Administration (FDA) dragged its feet on addressing the problem. And when it did, the agency only made a “few substantive changes” to its Risk Evaluation Mitigation Strategy (REMS), according to a study published in JAMA. The REMS for TIRF drugs was approved by the FDA on Dec. 28, 2011, because the medications were very potent and there was a high risk ... Read More

French officials call for ban of Allergan texture breast implants

French health regulators are calling for a ban of Allergan’s textured breast implants, and cautioning doctors and patients about texture implants from other manufacturers. The implants are associated with an increased risk for a type of non-Hodgkin lymphoma called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Textured implants makeup about 85 percent of the implants used for cosmetic and reconstructive breast surgeries in France. The National Agency for Safety of Medicines and Health Products (ANSM) recommendation comes after two days of testimony during a public hearing about the safety concerns with the breast implants, and days after the U.S. Food ... Read More