Pharmaceutical 5359 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 cites 15 hospitals for failing to report medical device-related adverse events


Fifteen hospitals – including Los Angeles-based Cedars-Sinai Medical Center and Boston-based Brigham and Women’s Hospital – have been called out by the Food and Drug Administration (FDA) for failing to report adverse events involving medical devices. From December 2015 to April 2016, the agency conducted inspections of 17 hospitals that were selected because high-profile medical device-related adverse events had been reported at the facilities. Those included uterine cancer spread from a gynecological device called a power morcellator, and bacterial infections caused by contaminated specialized endoscopes, called duodenoscopes. Both highly publicized medical device errors resulted in a call for more government ... Read More

NCI researcher waited too long to report deaths during lymphoma clinical trial

clinical trial, research test tubes

A National Cancer Institute (NCI) researcher did not follow protocol and waited too long to report two deaths from fungal infections that may have been caused by a lymphoma treatment used during a clinical trial, health officials concluded. The protocol breach was reviewed by National Institutes of Health Director Francis Collins, acting NCI Director Doug Lowy, and other officials during a board meeting on patient safety at the Clinical Center, the NCI’s flagship hospital. The early stage clinical trial in question began enrolling patients in 2014. The patients had been diagnosed with lymphoma of the central nervous system, an often ... Read More

Eliquis sales poised to top Xarelto on heels of new safety study


Sales of Eliquis, the third drug in a novel new oral anticoagulant (NOAC) class to hit the market, are booming and may soon eclipse that of the market leader, Xarelto, according to recent data from IMS Health. Xarelto, known chemically as rivaroxaban, now has 46.5 percent of the NOAC market followed by Eliquis, known chemically as apixaban, with 42.5 percent. Xarelto’s growth has tapered since it peaked at about 60 percent of the market. Eliquis, on the other hand, has enjoyed continuous growth in the market. Pradaxa, the first drug in the class to hit the market, has 10.5 percent ... Read More

Drug company accused of falsely marketing cancer drug Taxotere now faces lawsuits

bald woman, Taxotere - Pixabay image

Chemotherapy drug Taxotere is under fire not only for allegedly causing permanent hair loss, but also because drugmaker Sonafi SA allegedly falsely marketed the drug’s “superior efficacy” compared to similar competing drugs. According to Law360, one suit against the pharmaceutical company alleges that the company based its marketing on self-sponsored clinical trials while other studies were finding that competing drugs were more effective in certain patients. “Contrary to defendants’ claims of superior efficacy, post-market surveillance has shown that the more potent and more toxic Taxotere does not, in fact, offer increased efficacy or benefits over other taxanes, as defendants have ... Read More

HeartWare recalls defective heart pump


HeartWare Inc. is recalling HVAD pumps used to pump blood through the bodies of deathly ill patients with end-stage left ventricular heart failure awaiting a heart transplant, due to a design defect that may cause the pump to malfunction or stop working, which could result in dire consequences for patients. The issue involves the driveline, a tube that connects the HVAD’s pump to the external controller and power source. Contamination of the driveline may result in fluid or other material entering the pump and causing electrical issues or pump stops that may lead to serious health consequences, including death. The HVAD ... Read More

FDA warns of abuse risk and heart, mental health side effects with testosterone replacement therapy

Low T

The labels on all prescription testosterone replacement therapies have been changed to include a new Warning related to heart and mental health, and to update the Abuse and Dependence section to include new safety information from published literature and case reports regarding risks associated with abuse of and dependence on testosterone and other androgenic steroids (AAS), the Food and Drug Administration (FDA) announced in a drug safety communication. The Anabolic Steroids Control Act of 1990 placed AAS, including testosterone, in Schedule II of the Controlled Substances Act. Testosterone and other AAS are abused by adults and adolescents, including athletes and ... Read More

Study links common blood pressure meds to mood disorders

blood pressure check up - wikimedia commons

Patients taking beta-blockers or calcium channel blockers to manager their hypertension are twice as likely to be hospitalized for mood disorder issues than patients taking the blood pressure-lowering ACE inhibitors or antiotension II receptor blockers (ARBs), according to research published in the journal Hypertension. The study, conducted by researchers at the Institute of Cardiovascular and Medical Sciences at the University of Glasgow, used data from 525,046 patients, 144,066 of whom met the inclusion criteria of being between 40 and 80 years of age, and taking either an ACE Inhibitor, ARB, beta-blocker, calcium channel blocker, or thiazide diuretics for at least ... Read More

Bleeding side effects plaguing newer blood thinners


Boehringer Ingelheim’s novel oral anticoagulant (NOAC) Pradaxa was shown to be more effective than the long-used warfarin in a new, real-world study published in the American Journal of Pharmacy Benefits, giving hope that Pradaxa can push ahead of its NOAC competitors – Eliquis and Xarelto – in the billion-dollar blood thinner market. The study showed that among the nearly 4,000 patients with non-valvular atrial fibrillation, patients treated with Pradaxa had lower all-cause hospitalizations than those treated with warfarin. They also had fewer stroke-related hospitalization and doctor visits, as well as fewer bleeding-related emergency department visits. Pradaxa was approved by the ... Read More

Studies identify drugs that can reverse hair loss

bald woman, Taxotere - Pixabay image

Scientists are working to find treatments for people who are suffering physically and emotionally from hair loss. CNN reports about a recent study that has had success for alopecia patients. Sixty-five participants of a recent study conducted at Stanford, Yale and Columbia took rheumatoid arthritis medication, Xeljanz. More than half of the study subjects saw hair regrowth and a third recovered more than 50 percent of their lost hair. One man CNN features grew his hair back within seven months and expressed great satisfaction with the results. “It affects every part of your life. I got very depressed, and it was ... Read More

Bariatric Surgery Patient Registry Shows Higher Mortality Rate with IVC Filter vs. Without

IVC filter

Bariatric surgery patients that received an inferior vena cava (IVC) filter to prevent pulmonary embolism (PE) had a significantly higher risk of venous thromboembolism (VTE) with a higher mortality rate than patients that did not receive a filter, according to a large bariatric surgery registry. Jonathan D. Finks, MD, of the University of Michigan in Ann Arbor, reported in an American Society for Metabolic and Bariatric Surgery meeting that out of 1,045 patients who received an IVC filter, VTE occurred in 1.8 percent. In a propensity-matched cohort, only .4 percent of patients without a filter experienced VTE. The 30-day mortality was .07 percent of patients with a filter, ... Read More