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Pharmaceutical 5830 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.

Metallosis Linked to Metal-on-Metal Hip Implant may lead to Dementia-Like Symptoms

DePuy-ASR-hip-recall

Recently, a Texas jury awarded six plaintiffs with a $1 billion verdict against DePuy Orthopaedics, a subsidiary of Johnson & Johnson, over its metal-on-metal hip implant design that many patients claim has caused them pain, inflammation, bone erosion, tumors and tissue death. The company is facing a total of 8,900 lawsuits from people who say they have experienced adverse effects from the artificial hip. The metal-on-metal hip implant is a design meant for younger patients, or patients who have a more active lifestyle. They were intended to be more sturdy and durable with a longer lifespan than traditional ceramic implants, but have been ... Read More

FDA mum about whether amputation warning will be added to Invokana, Invokamet

Invokana

The Food and Drug Administration (FDA) has not tipped its hand on whether it will require updating of the safety labels of the type 2 diabetes drugs Invokana and Invokamet to include new warnings of lower limb amputations following an announcement earlier this week that European drug authorities were ordering the updates on labels of Invokana and Invokamet as well as others in the same class. Invokana and Invokamet (marketed as Vokanamet in Europe) are in a class of type 2 diabetes medications known as sodium-glucose go-transporter 2 (SGLT2) inhibitors. Other drugs in this class include Forxiga and Jardiance. Both ... Read More

Unapproved HCG weight loss treatment recalled due to sterility concerns

bathroom scale

Concerns about sterility of an unapproved weight loss treatment have prompted Synergy Rx Pharmacy to recall all lots of Human Chorionic Gonadotropin (HCG). Administration of a drug intended to be sterile that is not could result in serious infections that could be life threatening. To date, Synergy Rx Pharmacy has not received any reports of adverse events related to this recall. HCG is a hormone produced by the human placenta and found in the urine of pregnant women. It is FDA-approved for the treatment of select cases of female infertility and hormone treatment in men. The products are only available ... Read More

FDA slaps dietary supplement maker with warning letter over significant violations

dietary supplements - pills, probiotics

California-based dietary supplement manufacturer Herbal Sciences International received a warning letter from the Food and Drug Administration (FDA) following an inspection of the plant during which agency inspectors “identified a number of significant violations of FDA’s Current Good Manufacturing Practices (CGMP) in the Manufacturing, Packaging, Labeling or Holding Operations for Dietary Supplements Regulations.” The company manufactures dietary supplements under the names Xiao Ke Wan (Diabetic Formula), Ping Ya San (Pressure Reduce Formula), Ruan Jian Xiao Zhen Tang (Tumor, Cancer Fighter #1, 10:1), She Hu Xiao Zhong Wan (Prostate Ease), An He Jian Fei Wan (An Ho Diet Pills); Geng Nian ... Read More

Cobalt and Chromium Toxicity from Metal-on-Metal Hip Resulted in Neuropsychiatric Symptoms

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According to a study published in January in BMC Psychiatry, an online journal of psychiatric disorders, cobalt and chromium toxicity from metal-on-metal hip implant failure resulted in neuropsychiatric complications after revision surgery. Metal-on-metal hip implants are designed using a metal ball and metal socket made of a cobalt-chromium alloy. When the parts rub together during normal use, the parts may shed metal ions, which can pollute the bloodstream and damage the surrounding tissue. The normal range occurring in a person’s system due to normal environmental exposure is 0–20 nmol/l for cobalt and 0–100 nmol/l for chromium. Nine of the 10 patients in this ... Read More

Shoulder replacement device recalled due to high fracture rate

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Zimmer Biomet has issued a recall of a shoulder replacement device because the device has been fracturing at a higher than expected rate, which can lead to the need for revision surgery and increase the patient’s risk for serious health consequences such as permanent loss of shoulder function, infection, or, in rare cases, death. The recall affects 3,662 Zimmer Biomet’s Comprehensive Reverse Shoulder devices. The device is surgically implanted to help restore arm movement. The device is used n patients with conditions should as rotator cuff tears who have developed a severe type of shoulder arthritis known as arthropathy and previously failed ... Read More

Talc industry influenced regulatory agencies’ public opinion of talc safety, lawyers claim

talc justice

The first talc trial of the new year is underway in Missouri and Law360 is closely following the proceedings. Johnson and Johnson and talc provider Imerys Talc America are being sued by Nora Daniels, who blames Johnson’s Baby Powder for the ovarian cancer she developed after years of using it for feminine hygiene. Last year St. Louis courts held Johnson and Johnson responsible in three similar cases, ordering the company to pay damages of nearly $200 million. Imerys was also found liable in the most recent of the three trials. According to Law360, in the opening arguments the plaintiffs’ attorney ... Read More

Guidelines needed to rein in opioid use following vaginal delivery with aim of preventing abuse

World of Pain

Opioid-prescribing recommendations for common obstetrics procedures including vaginal delivery are needed to prevent the potential for abuse, according to a study published in the journal Obstetrics & Gynecology. The retrospective cohort study, conducted by researchers with the University of Pittsburgh, involved nearly 165,000 Medicaid-enrolled women who give birth to a live baby vaginally from 2008 to 2013. Researchers examined the prevalence of opioid prescription filling and refilling after delivery. They found that 12 percent of women who had left the hospital after giving birth filled a prescription for an opioid five days or less after delivery. Among these women, 14 ... Read More

Diet pills blamed in cases of serious liver injuries

bathroom scale

Diet pills and energy boosters marketed online and at retail stores as natural herbal supplements may sound safe and effective, but buyer beware. These so-called “natural” dietary supplements may cause dangerous side effects. Robert J. Fontana, M.D., a hepatologist and medical director of the Liver Transplant Program at the University of Michigan Health System, published a paper in which he detailed seven cases of patients hospitalized with liver injury after taking the weight loss product OxyELITE Pro. The patients were treated at various medical centers across the country participating in the Drug-Induced Liver Injury Network (DILIN). The six patients noted by ... Read More

Antibiotic Zithromax linked to stomach problem in newborns

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The Warnings and Precautions section on the safety labels of the antibiotic azithromycin, which includes the brand-name drugs Zmax and Zithromax, used to treat viral infections, has been updated to include a new subsection regarding the risk of infantile hypertrophic pyloric stenosis (IHPS). IHPS is a condition in which the opening between the stomach and small intestine thickens, causing the pylorus muscles to block food from entering the small intestine. This can lead to forceful vomiting, dehydration and weight loss. It occurs most often in babies younger than 6 months of age and most often in males. “Following the use of ... Read More