As we have written previously, Andy Birchfield heads up the Mass Torts Section in our firm and Melissa Prickett serves as the Section Administrator. Currently, we have 21 lawyers and 69 staff personnel in the section and they have all been very busy. From time to time, I feel that giving a summary covering some of the Section’s current activities would be useful to our readers. I will now attempt to do just that and hopefully some, if not all, of the information will be of interest. Lawyers and staff in Mass Torts are currently investigating and/or litigating the following:
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. More will be mentioned about Actos below.
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. 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 successfully removing all of the mesh. Currently, we are investigating cases involving mesh manufactured by American Medical Systems, Bard, Boston Scientific, Caldera, 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 over 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 mothers were taking an SSRI, Wellbutrin or Effexor during pregnancy.
Lawyer: Roger Smith
Primary Staff Contact: Linda Reynolds
Approved by the FDA in October 2010, Pradaxa (Dabigatran) is marketed by Boehringer Ingelheim Pharmaceuticals, Inc., to reduce the risk of strokes and blood clots in people who have atrial fibrillation, a common heart rhythm abnormality. Pradaxa is in a class of anticoagulant medications known as “blood thinners.” Pradaxa is a direct thrombin inhibitor. It prevents the formation of blood clots by counteracting the effects of thrombin, which is responsible for clotting. Boehringer Ingelheim Pharmaceuticals markets Pradaxa as the preferred blood thinner. According to Boehringer, it is easier to dose, requires less monitoring, and is more effective at preventing clots compared to Warfarin (Coumadin). However, unlike Warfarin, Pradaxa’s anticoagulation effect cannot be reversed with vitamin K, significantly increasing the odds that a bleeding event will turn fatal.
To date, there have been significant numbers of fatal bleeds reported to the FDA. The lack of a reversal agent is believed to be the cause of the significant number of bleeding-related adverse events. While various reports have linked 260 bleeding deaths to Pradaxa, Boehringer, in an official statement on November 2, 2011, linked about 50 bleeding deaths to Pradaxa, which Boehringer asserted is consistent with expectations from the Pradaxa clinical trials. Earlier this year, the FDA required Boehringer to modify the Pradaxa warning label to reflect the lack of a reversal agent, which, amazingly, had not been included in the original warnings. The FDA is currently evaluating the reports of bleeding deaths and investigating whether the rate of severe bleeding reports is higher than what was seen in the Pradaxa clinical trials. At this point, there is no black box warning for Pradaxa.
We are currently investigating claims of GI bleeding, hemorrhagic strokes or any other serious or fatal bleeding involving Pradaxa.
Lawyer: Roger Smith
Primary Staff Contacts: April Worley and Linda Reynolds
Metal-on-Metal Hip Replacement
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.
Lawyers: Navan Ward and Melissa Prickett
Primary Staff Contacts: Janet Welch and Donna Puckett
Fosamax® (alendronate sodium), manufactured by Merck, is in a class of drugs called bisphosphonates. Fosamax® is commonly used in tablet form to prevent and treat osteoporosis in post-menopausal women. Recently the Journal of Oral and Maxillofacial Surgeons reported a link between bisphosphonates and a serious bone disease called Osteonecrosis of the Jaw (ONJ). Osteonecrosis is a disfiguring and disabling condition of the jaw bone that causes infection and rotting of the jaw bone. Typical presentation of Osteonecrosis is pain, soft-tissue swelling and infection, loosening of teeth, drainage, and exposed bone. Symptoms may occur spontaneously, or at the site of previous tooth extraction. Recently, Fosamax has been linked to low-energy femur fractures in people taking Fosamax for three or more years.
Lawyers: Chad Cook, Leigh O’Dell and Russ Abney
Primary Staff Contact: Tabitha Dean
Gardasil, manufactured by Merck Sharp & Dohme Co., is aggressively marketed as a vaccine that prevents cervical cancer. In fact, it is a vaccine to prevent four types of the sexually transmitted disease, HPV (human papillomavirus). Gardasil is said to protect against four types of HPV, two of which are associated with cervical cancer. These two types of HPV are present in only 3.2% of the cases. At this time, Gardasil has not been proven to prevent cervical cancer. Scientific data indicates that the vaccine may not last longer than five years, if that long. The drug is indicated for young women and men from the age of nine years old up to 26 years old, though the vaccine is primarily given to girls.
The Vaccine Adverse Event Reporting System has over 21,000 reports of adverse events related to the administration of this vaccine including more than 90 deaths. Serious adverse events include multiple sclerosis, blindness, Guillain-Barré Syndrome, lupus, rheumatoid arthritis, paralysis, blood clots and death. The vaccine is recommended for young girls in their early teens. Parents should proceed with caution before allowing their daughters (and sons) to be vaccinated. We are currently investigating cases with documented use of Gardasil and a diagnosis of multiple sclerosis, Guillain-Barré Syndrome, blindness, lupus, paralysis, rheumatoid arthritis and death.
Lawyer: Leigh O’Dell
Primary Staff Contact: Melisa Bruner
Contact us today for a free legal consultation with an experienced attorney.
Fields marked *may be required for submission.
If you would like to subscribe to the Jere Beasley Report digital edition, simply visit our Subscriptions page and provide the necessary information or call us at 800-898-2034.
Attorney Advertising - Prior results do not guarantee a similar outcome.