Pharmaceutical 4156 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.

Johnson and Johnson’s knowledge of power morcellator risks questioned


Rep. Tim Murphy, chairman of the Subcommittee on Oversight and Investigations questioned whether Johnson & Johnson and Brigham & Young Hospital violated federal law by not reporting reports of cancer spread in patients who had undergone hysterectomies and uterine fibroid removals using power morecellator tools. During a hearing by the Subcommittee on Health, Murry asked Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health, “Are you aware of this problem?” meaning whether manufacturers of power morcellators, including Johnson & Johnson, or the hospitals that used them had failed to notify the agency of any adverse events, according to ... Read More

European group issues statement regarding use of testosterone replacement therapy

Low T

Recent controversy in the United States regarding the overprescribing of testosterone replacement therapy to aging men, and cardiovascular side effects associated with the hormones, have prompted the European Menopause and Andropause Society (EMAS) to issue a statement saying testosterone treatments should not be offered to all aging men, and that candidates be evaluated for co-morbidities that could affect natural testosterone levels and increase side effects from treatment. Testosterone treatments, which includes the brand names AndroGel and Axiron, are intended for men who suffer from hypogonadism, a condition in which men do not produce enough testosterone due to disease or injury. ... Read More

Fresenius slapped with wrongful death lawsuit


A man is suing Fresenius Medical Care and others, claiming negligence on behalf of the dialysis company and members of Huntington Internal Medicine Group in Huntington, W. Va., which he claims caused injuries and the premature death of his father. John. E. Bourdelais was undergoing dialysis treatment under the care of the defendants on July 13, 2013, when he suffered life-threatening injuries including hemorrhagic shock, cardiopulmonary arrest, bilateral pleural effusions, cardiac arrhythmias, hypovolemic arrest, traumatic hemothorax and multiple fractured ribs secondary to resuscitation. This, the lawsuit claims, shortened his life by two years. The lawsuit was filed by John M. ... Read More

Newer users of non-insulin diabetes drugs at greater risk for pancreatic cancer


People who recently started using a type 2 diabetes medication from a newer class known as incretin mimetics had double the risk of pancreatic cancer compared to diabetics who did not take the medication. However, the risk dropped to baseline with prolonged use, according to a new study published in the journal Diabetes, Obesity and Metabolism. Researchers from Maastricht University Medical Center in the Netherlands conducted a retrospective population-based cohort study involving 182,428 patients with at least one non-insulin anti-diabetic drug (NIAD) prescription and matched them with a control group of patients who did not have diabetes. They also used a ... Read More

AF patients should weigh stroke risk against bleeding risk with blood thinners


Atrial fibrillation, or AF, is the most common type of heart rhythm abnormality in which the heart beats too fast, too slow, or with an irregular rhythm. This causes blood to pool in the chambers of the heart, which can lead to blood clots that can break loose and travel to the brain, causing a stroke. Thus, patients with AF are at an increased risk of stroke. To reduce this risk, AF patients are often treated with blood thinners. But the decision to prescribe anticoagulants to AF patients is a gamble, says Dr. John Mandrola, in an editorial for Medscape. “The drugs ... Read More

Physicians group calls for ban of drug ads aimed at consumers

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The American Medical Association (AMA) is calling for an end to pharmaceutical companies’ direct-to-consumer advertising, saying the billions of dollars spent each year on the ads lead consumers to demand prescriptions that are often unnecessary and potentially dangerous. The AMA, which represents about a quarter of a million physicians nationwide, voted this week to take action against drug companies that heavily promote their treatments to consumers, arguing that such advertisement “inflates demand for new and more expensive drugs, even when these drugs may not be appropriate,” said AMA board chair-elect Patrice Harris in a statement. Case in point, manufacturers of ... Read More

Mirena IUD linked to increased risk of breast cancer

mirena IUD

The Mirena intrauterine device (IUD) has been linked to complications that can cause lasting injuries, but a new study suggests it may also increase the risk of breast cancer. The Mirena IUD is inserted into the cervix where it releases a small amount of the progestin hormone levonorgestrel. It is intended to prevent pregnancy for up to five years. It has been linked to serious adverse side effects and potentially life threatening complications following implantation including migration of the device from its intended place in the cervix, perforation into other organs, embedment in the uterus, and expulsion of the IUD. ... Read More

Updated blood clot warnings added to Ortho Evra birth control patch


The Warnings and Precautions section on the label of the hormonal birth control patch Ortho Evra has been updated to include more detailed information about the risk of blood clots in the vein, known as venous thromboembolism, or VTE. The edited warning now states that “the risk of VTE is highest during the first year of use of CHCs (combined hormonal contraceptives) and when restarting hormonal contraception after a break of four weeks or longer. The risk of thromboembolic disease due to CHCs gradually disappears after CHC use is discontinued. The safety of the Ortho Evra patch has come under ... Read More

Women asking congressional lawmakers to ban Essure contraceptive device


Three woman who claim to have been injured by the Essure nonsurgical permanent contraceptive are knocking on the doors of congressional lawmakers asking for support in getting the Food and Drug Administration (FDA) to pull the device off the market. Essure, manufactured by Bayer Healthcare, is the only FDA-approved nonsurgical permanent birth control method. The device consists of two small nickel alloy coils that are inserted into the fallopian tubes where they work with the body to create scar tissue barriers that prevent the sperm from reaching the egg. Since its approval in 2002, Essure has been linked to complications ... Read More

FDA inspection finds potency, sterility issues at compounding pharmacy


An inspection by federal drug regulators of Pharmacy Creations found numerous quality control issues that put into question the potency and sterility of its products. A Food and Drug Administration (FDA) inspection report on the company’s Parsippany facility in New Jersey found that batches of drug products were not tested to gauge when they would expire. The facility also did not have enough procedures in place to prevent microbiological contamination of its sterile products. Contaminated drug products could cause serious or life threatening infections. Pharmacy Creations is a compounding pharmacy that custom mixes drug products based on medical prescription. The ... Read More