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Pharmaceutical 7037 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.

Federal court swells with additional talc ovarian cancer cases

A Supreme Court ruling in a Bristol-Myers Squibb (BMS) case that limited where companies could be sued by requiring a stronger connection between the plaintiff’s claim and the company’s misconduct, has resulted in the near doubling of talc ovarian cancer cases consolidated in New Jersey federal court. Following the BMS ruling, Judge Freda L. Wolfson of the U.S. District Court for the District of New Jersey issued an order that allowed plaintiffs to re-file their cases in the consolidated litigation in order to avoid the potential challenge of jurisdiction. Since Wolfson’s order, more than 1,900 plaintiffs – most of whom ... Read More

Baxter expands recall of intravenous heart drug

Baxter International is expanding a November 2017 recall of the heart drug Nexterone due to the presence of particle matter found floating in bags of the solution. If a patient receives an intravenous dose of a solution containing sterile particulate matter, he could experience adverse health reactions, the extent and severity of which depends on the size, number and composition of the foreign material and the patient’s underlying medical condition. “In the absence of in-line filtration,” the company said in a news release, “these particles may cause local vein irritation, inflammatory reaction, aggravation of preexisting infections, allergic reactions, phlebitis, pulmonary ... Read More

Anti-nausea drug linked to anaphylaxis, hypersensitivity reactions

The anti-nausea injectable drug Varubi (rolapitant) has been associated with cases of anaphylaxis, anaphylactic shock, and other serious hypersensitivity reactions, some of which have required hospitalization, the Food and Drug Administration (FDA) announced in a Safety Communication. The reactions have occurred during or soon after infusion with the injectable emulsion, with most reactions occurring within the first few minutes of administration. Symptoms of anaphylaxis can include wheezing or difficulty breathing; swelling of the face or throat; hives or flushing; itching; abdominal cramping, abdominal pain or vomiting; back pain or chest pain; hypotension or shock. Varubi injectable emulsion is used to prevent ... Read More

BD discontinues use of defective rubber stoppers for syringes

A day after the Food and Drug Administration (FDA) warned Becton Dickinson (BD) & Company that it had uncovered significant violations of federal law by the company during an ongoing investigation into a lead testing issues, the company announced that it will no longer use the rubber stopper material connected to a drug potency issue in its general use syringes, and has instead returned to a rubber stopper it used previously in the syringes. In 2015, the FDA told health care professionals not to administer compounded and repackaged drugs stored in certain sizes of general use BD syringes after receiving ... Read More

Makers of blood collection tubes for lead testing system hit with FDA warning letter

Becton Dickinson (BD) & Company was hit with a Food and Drug Administration (FDA) warning letter for numerous violations of federal law including marketing significantly modified versions of certain blood collection tubes, called BD Vacutainers, without FDA approval and failing to submit medical device reports within the required timeframe. The violations were discovered during an inspection of BD’s New Jersey facility, during which the agency discovered that the company failed to evaluate and investigate a complaint involving variability test results observed when certain BD Vacutainer blood collection tubes were used with Magellan Diagnostics’ LeadCare test systems. The inspection was part ... Read More

PharMEDium expands recall of compounded drug products

PharMEDium Services LLC is expanding a Dec. 27, 2017, recall to include additional lots of sterile drug products due to the sterility concerns that could cause serious and potentially life-threatening infections to patients. A list of affected products can be found on the company’s website. The recall was expanded because PharMEDium conducted an extensive review of all commercially distributed product lots compounded in the Memphis, Tennessee, location currently within their labeled expiration date in response to a request by the Food and Drug Administration (FDA) regarding microbial program controls for the ISO5 environment, personnel glove sampling results, media fill results, ... Read More

Heart valve device recalled due to dangerous defect

Edwards LifeSciences is recalling a heart valve device due to a defect that could cause the device to break off inside the patient, which could obstruct blood flow to critical organs leading to severe neurologic, cardiac, limb, renal, or gastrointestinal injuries. The recall involves Edward LifeSciences’ Certitude Delivery System, used for delivery of the Edwards SAPIEN 3 transcatheter heart valve (THV), which is typically used during a transcatheter aortic valve replacement. The recall is being initiated due to a molding overflow defect in the button vale within the loader. The overflow material could detach during placement of the delivery system ... Read More

FDA limits pediatric use of opioid-containing cough medicines

Prescription cough and cold medicines containing opioids will no longer be indicated for use to treat cough in children younger than 18 because of serious risks that “outweigh their potential benefits with this population,” the Food and Drug Administration (FDA) announced in a News Release. The agency said it was also adding new safety information for adult use to the drugs’ labels and expanding the Boxed Warning on the products to include additional safety information regarding the risk of misuse, abuse, addiction, overdose and death, as well as slowed or difficult breathing that can result from exposure to these products. ... Read More

Ohio workers comp bureau restricts opioids for back injuries

A new rule by the Ohio Bureau of Workers’ Compensation – the nation’s largest state-run injured-worker fund – has put in place an aggressive restriction regarding back surgery and the prescribing of opioids often used to treat pain following surgery. The organization is requiring injured workers to undergo at leas 60 days of alternative care while avoiding opioid use, if possible, before undergoing spinal fusion surgery. Some exceptions apply for the most severe back injuries, but by restricting opioid use, the state has put forth a more aggressive plan than other states. It represents another example of how local governments ... Read More

Blood thinner recalled over drug ingredient mixup

International Laboratories LLC is recalling one lot of the blood thinner Clopidogrel because the pills may contain the cholesterol-lowering statin Simvastatin instead. The recall affects Lot # 117099A of Clopidogrel Tabloets, USP 75mg, packaged in bottles of 30 tablets. The affected lot was delivered to distribution centers in Arkansas, Georgia, Indiana, California and Maryland, and then distributed to retail stores throughout the U.S. Patients prescribed Clopidogrel, the active drug ingredient in Plavix, who miss doses of this medication are at an increased risk of heart attack and stroke, both of which can be life threatening. Additionally, unintentional consumption of Simvastatin, ... Read More