Because of the many contacts our lawyers are having relating to Mass Torts Litigation, I will set out some of the drugs and medical devices that we are handling. The lawyers in the Section will investigate any medication or device claim involving catastrophic injury or death. The following are some of the drugs and medical devices the lawyers are currently working on:
The FDA has approved updated warning labels for Actos, a prescription medication used to treat Type 2 diabetes. The updated label states that Actos usage for more than one year may cause bladder cancer. Actos, manufactured by Takeda, has been under FDA review since September 2010. In June 2011, the FDA issued a warning for Actos, while at the same time, drug regulators in France and Germany suspended use of the drug. We are currently investigating claims involving usage of Actos, Actoplus Met, Actoplus Met XR, Duetact and bladder cancer.
Lawyer: Roger Smith
Primary Staff Contact: April Worley
The FDA has issued an updated safety communication warning doctors, health care professionals and patients that the placement of surgical mesh through the vagina to treat pelvic organ prolapse and stress urinary incontinence may present greater risk for the patient than other non-mesh procedures. This is also called transvaginal mesh (TVM). According to the FDA, reported complications from the transvaginal placement of the mesh include erosion of the mesh into the vaginal tissue, organ perforation, pain, infection, painful intercourse and urinary and fecal incontinence. Often women require surgery to remove the mesh. In some cases, this can require multiple procedures without successful removing all of the mesh. Currently, we are investigating cases involving mesh manufactured by American Medical Systems, Bard, Boston Scientific, Caldera, Coloplast and Johnson & Johnson.
Lawyers: Chad Cook and Leigh O’Dell
Primary Staff Contacts: Tabitha Dean, Melisa Bruner and Kim Owen
SSRI-antidepressants such as Celexa, Lexapro, Luvox, Paxil, Prozac and Zoloft are prescribed to treat depression. Studies in the last several years have shown an increased risk of heart birth defects in children born to mothers who took SSRI-antidepressants in the first trimester. Most of the cardiac defects observed in these studies were atrial or ventricular septal defects, conditions in which the wall between the right and left sides of the heart does not completely develop. We are currently investigating claims of birth defects involving children whose mother was taking an SSRI, Wellbutrin or Effexor during pregnancy.
Primary Staff Contact: Linda Reynolds
Byetta®, Januvia®, Janumet® and Victoza®
These drugs are used to treat Type 2 diabetes. They have been prescribed to millions of people in the United States. Since approving the medications, the FDA has issued several warnings about links between them to complications related to pancreatic diseases. Recent studies have linked these two drugs to acute pancreatitis and pancreatic cancer. We are currently investigating claims of pancreatitis, pancreatic cancer and thyroid cancer.
Lawyers: David Dearing or Melissa Prickett
Primary Staff Contacts: Nancy LeGear or Penny Davies
GraunFlo® 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 increase in the risk of cardiopulmonary arrest and sudden cardiac death. The manufacturer, Fresnius 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.
Lawyer: Frank Woodson
Primary Staff Contact: Renee Lindsey
Lipitor, a statin drug to treat high cholesterol, 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 25. Of the 153,840 women evaluated, more than 10,000 had developed Type 2 diabetes by the end of the study.
Criteria: Injured is female; took Lipitor consistently for at least two months; Injured was diagnosed with diabetes while taking Lipitor, or within six months of last dosage of Lipitor; Body Mass Index (BMI) of 30 or less at time of diabetes diagnosis; Injured has no or limited family history of diabetes.
The JPML has granted consolidation of lawsuits involving the cholesterol lowering medication Lipitor in the USDC in South Carolina. U.S. District Judge Richard M. Gergel, based in Charleston, will serve as the judge for the MDL. On March 28, 2014 Judge Gergel appointed Plaintiff lawyers to lead the litigation. Frank Woodson from our firm was appointed as one of the lawyers to serve on the Plaintiffs’ Steering Committee.
The lawsuits allege that women receive little, if any, benefit from Lipitor while subjecting them to the risk of diabetes. There are several hundred lawsuits filed across the country that will be transferred to Judge Gergel’s Court. Our firm looks forward to working with the other members of the PSC on these cases.
Metal-on-Metal Hip Replacements
Metal-on-Metal hip replacement manufacturers have been under heavy scrutiny in the past few years regarding the dangers of their metal on metal hip devices. The main hip devices under scrutiny are:
Johnson & Johnson/DePuy: ASR Total Hip Replacement and ASR Resurfacing System hip (Recalled on August 24, 2010);
Johnson & Johnson / DePuy: Pinnacle metal-on-metal hip;
Zimmer: Durom Cup hip;
Stryker: Rejuvenate and ABG II Stems (Recalled on July 4, 2012);
Biomet: M2a and 38 Diameter hips,
Wright: (a) Conserve, (b) Dynasty, (c) Lineage and (d) Profemur (femur fracture) hips; and
Smith and Nephew: R3 Liner hips (Recalled on June 1, 2012).
Metal-on-metal hip patients from the above manufacturers have similarly reported problems after their initial implant surgery resulting in revision surgery. All have reported a variety of symptoms, including pain, swelling and problems walking. These symptoms are normal for patients following a hip replacement, but can be a sign that something is wrong if they continue or come back frequently. Additionally, metal debris spreading in the hip area has been reported due to the metal-on-metal friction involved from the metal components moving together.
Our lawyers would like to review any cases involving individuals who have had any of the above metal on metal hip devices implanted and all individuals unsure of the type of hip device implanted if the person has had revision surgery, or the person is experiencing hip pain, hip swelling or difficulty walking.
Lawyers: Navan Ward and Melissa Prickett
Primary Staff Contacts: Janet Welch and Donna Puckett
Mirena® is an intrauterine device (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.
Primary Staff Contact: Linda Reynolds
Risperdal® is an atypical antipsychotic drug used to treat schizophrenia and certain problems caused by bipolar disorder and has been linked to the development of gynecomastia in boys and young men. Gynecomastia is a condition that causes boys to grow breasts.
Lawyer: James Lampkin
Primary Staff Contact: Ann Easley
Stevens- Johnson Syndrome
Stevens-Johnson Syndrome (SJS) is an immune complex hypersensitivity reaction that can be caused from an infection or immune response to drugs. It is a severe expression of a simple rash known as erythema multiforme. SJS is also known as erythema multiforme major. It affects all ages and genders including pediatric populations. The most severe form of SJS is toxic epidermal necrolysis (TENS). SJS occurs twice as often in men as in women. Most cases of SJS appear in children and young adults younger than 30. Females with SJS are twice as likely as males to develop TENS, and have an even higher chance if taking a category of drugs known as NSAIDs, non-steroidal anti-inflammatory drugs.
Lawyer: Frank Woodson
Primary Staff Contact: Renee Lindsey
Johnson and Johnson has known for decades that its talcum products, such as Shower to Shower baby powder, can cause ovarian cancer. But J&J has failed to warn women of the risk of using these products in the genital area. A Harvard medical doctor says that he has studied the link between talc and cancer for 30 years and believes talc is the likely cause for as many as 10,000 cases of ovarian cancer each year.
Lawyer: Ted Meadows
Primary Staff Contact: Katie Tucker
Testosterone Replacement Therapy
Testosterone Replacement Therapy 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. 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. We are currently investigating claims of heart attack, stroke and prostate cancer.
Lawyer: Matt Teague
Primary Staff Contact: Heather Hall
Yaz, Yasmin, Ocella or Beyaz
Yaz is a combination birth control pill containing drospirenone and ethinyl estradiol. It is marketed not only as a contraceptive pill, but as a proven treatment for premenstrual dysphoric disorder (PMDD), a condition with severe emotional and physical premenstrual symptoms. Yaz is also marketed as an effective treatment for moderate acne. However, studies indicate that Yaz poses a particular heath hazard because one of its two primary ingredients, drospirenone, is a diuretic, which can cause an increase in potassium levels in the blood and lead to hyperkalemia, which causes heart rhythm disturbances that can cause blood clots leading to sudden cardiac death or pulmonary embolism or strokes. Diuretics can also cause significant problems with the gallbladder, leading to gallbladder removal. Criteria: Documented use of Yaz with a diagnosis of heart attack, stroke, pulmonary embolism or DVT.
Primary Staff Contacts: Linda Reynolds and April Worley
Zimmer NexGen Knee Replacements
Since 2003, more than 150,000 Zimmer NexGen Flex-Knee implants have been sold. Several different components used as part of the Zimmer NexGen Flex-Knee replacement system have been associated with increased risk of complications, including pain, swelling, loosening of component parts, and the need for follow-up/revision surgery. Several prominent surgeons want a Zimmer NexGen knee replacement recall to be issued. At a March 2010 conference of the American Academy of Orthopedic Surgeons, two knee surgeons presented data suggesting that the Zimmer NexGen Flex-Knee failure rate could be as high as 9 percent, and that the actual number of complications that require revision surgery could be even higher. The lead author of the study, Dr. Richard Berger, described the failure rate of the Zimmer NexGen CR-Flex Porous Femoral Component as “unacceptably high.”
Our lawyers would like to review any cases involving individuals who have had a Zimmer NexGen knee device implanted, or individuals unsure of the type of knee device implanted, if that individual has had revision surgery.
We will discuss in the next section some of the more recent happenings around the country relating to the Mass Torts Litigation. There have been a number of significant happenings in this most important area of concern. I do not anticipate a slow down in this litigation anytime soon.
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