Lawyers in our Mass Torts Section have been very busy this year. They are working on litigation involving a wide range of products. A number of projects in the Section are nearing completion, but many more are ongoing. Others are just getting started with investigation and research in the early stage. The Section’s lawyers will continue to get into new areas. I will give a brief overview of some of these projects that are ongoing in the Section. More detail will also be given on some of the products.
Xarelto – Lawsuits filed against Johnson & Johnson subsidiary Janssen Pharmaceuticals and Bayer Corp. over the blood thinner Xarelto have been consolidated in Louisiana federal court. Xarelto has been linked to serious side effects including internal bleeding, gastrointestinal bleeding, brain bleed and death. The Xarelto lawsuits come on the heels of the recent $650 million Pradaxa settlement. Researchers linked Pradaxa, also a blood thinning medication, to more than 500 deaths. Xarelto blood thinner litigation has been consolidated before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana, who presided over suits against Merck & Co. over its medication Vioxx. The Vioxx litigation resulted in a $4.85 billion settlement in 2007. We will expand on the Xarelto litigation in this issue. Contact David Byrne or Melissa Prickett at 800-898-2034 or by email at David.Byrne@beasleyallen.com or Melissa.Prickett@beasleyallen.com.
Talcum powder and ovarian cancer – As many as 2,200 cases of ovarian cancer diagnosed each year may have been caused by regular use of talcum powder. Talc is a mineral made of up various elements including magnesium, silicon and oxygen. Talc is ground to make talcum powder, which is used to absorb moisture and is widely available in various products including baby powder and adult products including body and facial powder. Talc products used regularly in the genital area increase the risk of ovarian cancer. A jury recently found consumer health care products manufacturer Johnson & Johnson knew of the cancer risks associated with its talc products but failed to warn consumers. I will write separately about the first trial date. Contact Ted Meadows or Melissa Prickett at 800-898-2034 or by email at Ted.Meadows@beasleyallen.com or Melissa.Prickett@beasleyallen.com.
Power morcellator - In April, the U.S. Food and Drug Administration (FDA) urged doctors to stop using a medical device called a power morcellator, because studies showed the device may spread cancer. An estimated 1 in 350 women develops uterine sarcoma – a type of uterine cancer – after undergoing a morcellator procedure. Morcellators are typically used to grind away uterine growths such as fibroid tumors, and in hysterectomies. They became popular as a less invasive surgical alternative. The FDA conducted a formal review of the devices in July and announced that its concerns with the morcellator were confirmed. During this time, Johnson & Johnson announced it would stop selling the surgical tools. Contact Melissa Prickett at 800-898-2034 or by email at Melissa.Prickett@beasleyallen.com.
Transvaginal mesh – The FDA has issued an updated safety communication warning doctors and patients that the placement of surgical mesh through the vagina to treat pelvic organ prolapse may present greater risk for the patient than other options. This is also called transvaginal mesh. According to the FDA, reported complications from using the mesh include the mesh becoming exposed or protruding out of the vaginal tissue, pain, infection, organ perforation and urinary problems. Contact Leigh O’Dell, Chad Cook or Melissa Prickett at 800-898-2034 or by email at Leigh.Odell@beasleyallen.com, Chad.Cook@beasleyallen.com or Melissa.Prickett@beasleyallen.com.
Lipitor – Lipitor is a statin drug designed to treat high cholesterol. It was approved by the FDA in 1996 and is one the best-selling prescription medications in the world. Recent studies have found a possible link between Lipitor and the risk of developing Type 2 diabetes. A University of Massachusetts study found a potential link in postmenopausal women, particularly those who had a Body Mass Index (BMI) less than 30. Of the 153,840 women evaluated, more than 10,000 had developed Type 2 diabetes by the end of the study. Contact Frank Woodson or Melissa Prickett at 800-898-2034 or by email at Frank.Woodson@beasleyallen.com or Melissa.Prickett@beasleyallen.com.
Testosterone Replacement Therapy (TRT) – These products for men have been linked to an increased risk of death, heart attack and stroke. Researchers found men who used testosterone therapy were 30 percent more likely to have a heart attack, stroke, or die after three years of use. A second study found that men had a significant increase in risk of heart attack and stroke in just the first 90 days of testosterone therapy use. Furthermore, men who started the study with clear, unobstructed coronary arteries were just as likely to have a heart attack, stroke or die as men who entered the study with established coronary artery disease. Testosterone therapy, such as the prescription topical treatments Androgel, Testim and Axiron, are used to help boost testosterone levels in men who have a deficiency of the male hormone. Symptoms of low testosterone include decreased libido and low energy. Contact Matt Teague or Melissa Prickett at 800-898-2034 or by email at Matt.Teague@beasleyallen.com or Melissa.Prickett@beasleyallen.com.
Viagra – A preliminary study indicates the erectile dysfunction drug Viagra (sildenafil) may increase the risk of developing melanoma, the deadliest form of skin cancer. The study, published in the JAMA Internal Medicine journal, analyzed data from nearly 26,000 men, 6 percent of whom had taken Viagra. The men who used Viagra at some point in their lives had about double the risk of developing melanoma compared to men who had never taken the drug. Men who were currently taking Viagra were at an 84 percent greater risk of developing melanoma. We are currently looking at cases involving men who are taking or have taken Viagra and were diagnosed with melanoma. Contact Melissa Prickett at 800-898-2034 or by email at Melissa.Prickett@beasleyallen.com.
Risperdal – The atypical antipsychotic drug Risperdal is used to treat schizophrenia and certain problems caused by bipolar disorder. It has been linked to the development of gynecomastia in boys and young men. Gynecomastia is a condition that causes boys to grow breasts. The drug is manufactured by Johnson & Johnson. Contact James Lampkin or Melissa Prickett at 800-898-2034 or by email at James.Lampkin@beasleyallen.com or Melissa.Prickett@beasleyallen.com.
Metal-on-Metal Hip Replacement parts – The FDA has ordered a review of all metal-on-metal hip implants due to mounting patient complaints. Problems with the metal-on-metal devices include loosening, fracturing and dislocating of the device caused by inflammation in the joint space. We are investigating all cases involving metal-on-metal hip implants, including the DePuy Orthopaedics ASR XL Acetabular System and the DePuy ASR Hip Resurfacing System, recalled in August 2010; the Smith & Nephew R3 Acetabular System, recalled in June 2012; the Stryker Rejuvenate and ABG II modular-neck stems, recalled in July 2012; the DePuy Pinnacle, the Zimmer Durom Cup, the Wright Conserve, and the Biomet M2A and M2A-Magnum hip replacement systems, which have not been recalled. Reported problems include pain, swelling and problems walking. Contact Navan Ward at 800-898-2034 or by email at Navan.Ward@beasleyallen.com.
GranuFlo – GranuFlo® and NaturaLyte® are products used in the dialysis process. On June 27, 2012, the FDA issued a Class 1 recall of GranuFlo® and NaturaLyte®. A Class 1 recall is the most serious FDA recall, reserved for situations in which the FDA deems “there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. Use of these dialysis products has been linked to an increased risk of cardiopulmonary arrest and sudden cardiac death. The manufacturer, Fresenius Medical Care, was aware of the dangers and injuries associated with these products but failed to warn patients and doctors until 2012. We are currently investigating death claims as well as claims of heart attack, cardiopulmonary arrest or any other serious injury. Contact Frank Woodson at 800-898-2034 or by email at Frank.Woodson@beasleyallen.com.
Mirena – Mirena® is an IUD that was originally approved by the FDA as an intrauterine contraceptive. It was later approved as a treatment for heavy menstrual bleeding. It works by slowly releasing a low dose of levonorgestrel (a synthetic progestin hormone) directly into the uterus. Serious adverse side effects and potentially life-threatening complications have been reported following the implantation of the device. These complications include organ perforation, migration of the IUD to outside the uterus, expulsion of the IUD, and embedment in the uterus, among others. Contact Roger Smith at 800-898-2034 or by email at Roger.Smith@beasleyallen.com.
Byetta, Januvia, Janumet and Victoza – These are drugs from a class known as incretin mimetics that are used to treat Type 2 diabetes. The FDA approved Byetta in 2005, Januvia in 2006, Janumet in 2007 and Victoza in 2010. These drugs have been prescribed to millions of people in the United States. Since approving the medications, the FDA has issued several warnings about links between Byetta, Januvia, Janumet and Victoza to complications related to pancreatic diseases. Recent studies have linked these drugs to acute pancreatitis and increased risk of pancreatic cancer. We are currently investigating claims of thyroid cancer and pancreatic cancer. Contact David Byrne at 800-898-2034 or by email at David.Dearing@beasleyallen.com.
If you have any difficulty reaching the lawyers mentioned for any of the projects mentioned above, and your need is urgent, you can contact Melissa Prickett, the Section Administrator, at 800-898-2034 or by email at Melissa.Prickett@beasleyallen.com. She will have the appropriate lawyer contact you.
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