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Pharmaceutical 3816 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 warns consumers about unapproved prescription ear drops

Ear - Earrr by צביה Licensed under CC BY-SA 3.0 via Wikimedia Commons

The Food and Drug Administration (FDA) is vowing to come down hard on drug companies who are manufacturing and selling unapproved prescription ear drops labeled to relieve ear pain, infection, and inflammation. The ear drops contain active ingredients such as benzocaine and hydrocortisone, which have not been evaluated by the FDA for safety, effectiveness and quality. The agency has informed the companies that manufacture these illegal ear drops to stop or face enforcement actions including seizure, injunction, and/or criminal proceedings. The agency said that the drops’ labels do not indicate that they are not FDA approved, thus health care professionals may ... Read More

FDA investigates safety of codeine in children’s cough and cold medicine

children-smiling for WEB

Children younger than 18 who have suffered serious side effects after taking cough and cold medicine containing codeine has prompted the Food and Drug Administration (FDA) to launch an investigation into the safety of the medications in children. Side effects include slowed or difficult breathing. Children with breathing problems may be more susceptible to respiratory adverse events. In April, the European Medicines Agency (EMA) banned the use of codeine to treat coughs and colds in children younger than age 12, and recommended the drug not be used in children and adolescents between 12 and 18 who have breathing problems, such as asthma. The ... Read More

SSRIs linked to bone fractures in menopausal, postmenopausal women

Blue pills

Menopausal women who take a class of commonly prescribed antidepressants are more likely to break a bone compared to women who did not take the drugs, according to a new study published in the British Medical Journal. Menopause can cause a host of symptoms from hot flashes and mood changes including depression. They are also prone to osteoporosis, a condition that causes bones to become weak and brittle to the point that a fall or even mild stresses like bending over or coughing can cause a fracture. To treat mood symptoms associated with menopause, some doctors have turned to a ... Read More

New weight loss treatment carries cancer risks

bathroom scale

A new weight loss treatment is available to obese patients but researchers warn the drug has been linked to serious side effects, including cancer risks. The new iinjectable obesity drug, Saxenda, was approved late last year by the Food and Drug Administration (FDA) for patients with a BMI of 30 or more, or for patients with a BMI of 27 with at least one other weight-related condition, such as high blood pressure. The active ingredient, liraglutide, is the same drug in the type 2 diabetes treatment Victoza. Saxenda, however, contains a higher dose than Victoza. New patients will be required ... Read More

First oral testosterone treatment on track to seek FDA approval

Low T

Pharmaceutical company Lipocine Inc. is poised to gain Food and Drug Administration (FDA) approval for LPCI 1021, the first swallowable oral testosterone treatment that investors say could make the company’s shares rise more than 80 percent of all goes smoothly. Testosterone treatments generally come in topical gels or patches that deliver testosterone through the skin, or injections that are administered with a shot. The gels are the most popular version though they carry a black box warning because they can be unintentionally transferred to women, children and pets. Thus, an oral version of testosterone would be more convenient than other ... Read More

Another power morcellator lawsuit filed against Johnson and Johnson

morcellator

Jonel Davis-Johnson underwent a thorough cancer screening, which turned out negative, before she underwent a power morcellation procedure in June 2012 for a hysterectomy to remove uterine fibroids. Her husband Arthur claims the operation ultimately killed her. Power morcellatiors are a type of surgical tool that is fitted with a blade that minces entire uteruses or uterine fibroids within the body and removes them through a small incision in the abdomen. The procedures have been favored over open surgeries by many doctors in years past because they are less invasive, leave less scar tissue and offer less recovery time. About ... Read More

Smartphones can cause pacemakers to stop working

heartbeat

People with pacemakers are advised to keep a safe distance from smartphones and mobile phones to avoid unwanted painful shocks or pauses in function, medical device manufacturers and the Food and Drug Administration (FDA) warn. Pacemakers and other implantable cardioverter-defibrillators (ICDs) are small devices that are placed in the chest or abdomen to help control abnormal heart rhythms by using electrical pulses to prompt the heart to beat at a normal rate. Studies from a decade ago have found that pacemakers can sometimes mistakenly detect electromagnetic interference, or EMIs, from smartphones and mobile devices as a cardiac signal that can ... Read More

Statin users with subclinical hypothyroidism at greater risk of diabetes

lipitor

People with hypothyroidism are at an increased risk of type 2 diabetes; however, people with subclinical hypothyroidism, or the earlier stages of the condition, are only at increased risk of developing diabetes if they are using cholesterol-lowering statin drugs, according to new research. Researchers with the Israel Institute of Technology and other institutions conducted a two-phase investigation that included analyzing electronic medical data from more than 20,000 patients with diabetes who began statin treatment from 2004 to 2005 who were randomly matched to nearly twice as many non-statin users. Patients were followed until December 2010. Researchers evaluated to cohorts for thyroid ... Read More

FDA panel to address injuries, deaths with Essure birth control device

Essure

Reported health problems – including at least four deaths – not listed on the safety label of the implantable permanent birth control Essure have prompted the Food and Drug Administration (FDA) to conduct an investigation into the safety of the devices. Essure is a nonsurgical permanent birth control implant shaped in a spiral that is inserted through the cervix and through the uterus into the fallopian tubes to block fertilization. Bayer Healthcare’s unit Conceptus Inc., received FDA approval to market the device in 2002. Since then, nearly 5,100 reports of complications have been associated with the device, including four deaths. ... Read More

Attorneys request consolidation of power morcellator lawsuits

morcellator

Attorneys for six women suing Johnson & Johnson over injuries they claim to have suffered after undergoing gynecological procedures with the company’s power morcellator device have filed a request with the U.S. Judicial Panel on Multidistrict Litigation to consolidate with at least 22 similar lawsuits pending in 16 different federal district courts. The motion seeks to transfer the cases to U.S. District Judge Kathryn Vratil in Kansas. The request comes just weeks after the Wall Street Journal reported that Johnson & Johnson was being investigated by the Federal Bureau of Investigation (FBI) about how much the company knew about cancer ... Read More