Mass Torts Update - Thursday, February 9, 2012 7:54 - 0 Comments

Mass Tort Update

Our Mass Torts Section has been very busy over the past year with that activity has carried over into the New Year. Andy Birchfield heads up the section and Melissa Prickett serves as the Section Administrator. Currently, we have 16 lawyers and 66 staff personnel in the section. I will give a summary of the Section’s current activity. Lawyers and staff in the Section are currently investigating and/or litigating the following:

Actos®

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

Transvaginal Mesh

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.

Lawyer: Leigh O’Dell
Primary Staff Contact: Melisa Bruner

Antidepressants
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 mother was taking an SSRI during pregnancy.
Lawyer: Roger Smith
Primary Staff Contact: April Worley

Chantix®

We are investigating claims of suicide or attempted suicide resulting in permanent injury involving Chantix. Chantix (USA) or Champix (European and other countries), known generically as varenicline, is marketed by Pfizer as a prescription medication used to treat smoking addiction.

Lawyer: Frank Woodson
Primary Staff Contact: Cathy Perry

Crestor®

Crestor (Rosuvastatin) is a popular prescription medication used to reduce the amount of cholesterol in the blood. Crestor, which is manufactured by AstraZeneca, was approved for use by the U.S. Food and Drug Administration (“FDA”), in August of 2003. Since that time, there have been several warnings issued by the FDA relating cholesterol lowering drugs (i.e. – statins) and serious adverse events.

A 2009 study, published in The Lancet, suggested that statins such as Crestor cause serious heart muscle problems, including cardiomyopathy. Cardiomyopathy, which means “heart muscle disease,” is a deterioration of the heart muscle. Patients may experience difficulty breathing, swelling of the feet or ankles, rapid heartbeat and other symptoms. The Lancet article explained that the study’s results “might be a reduction in the concentration of coenzyme Q10 or ubiquinone, which is known to be caused by statins.”
Our firm is currently investigating claims involving Crestor use and cardiomyopathy.

Lawyer: Chad Cook
Primary Staff Contact: Tabitha Dean

DePuy Hip Replacements

Johnson & Johnson, in conjunction with its DePuy Orthopaedics subsidiary, announced at the end of August 2010 that it is recalling parts used for hip replacements. At issue is the high rate of repeat surgeries needed by people who have received the parts. An estimated 93,000 people will be affected by Johnson & Johnson’s latest product recall. Affected hip replacement parts involved in the recall include the DePuy ASR XL Acetabular System and the DePuy ASR Hip Resurfacing System. Patients who reported problems in the first five years and had revision surgery 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.

We would like to review any cases involving individuals who have had a DePuy hip device 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 Pair and Donna Puckett

EBIce® Cold Therapy Cases

These cases involve injuries caused by cryo-therapy devices typically prescribed by orthopedic surgeons and podiatrists after a surgical procedure. “Cold Therapy” is used by a physician or podiatrist in order to minimize pain and swelling related to the surgery. With no or very little instruction and essentially no warnings, a patient uses the device by placing the pad on the affected area, fills the ice chest with ice and water and the circulating pump inside the ice chest circulates cold water through the tubes and cooling pads. Without instruction the patient, thinking that more cooling is better, will subject the skin and underlying nerves around the affected area to very cold temperatures. Injuries resulting from these devices can be dramatic and typically fall into two categories, nerve-only damages and skin injury with nerve damage. The skin injury with nerve damage cases will have visible injuries like frost bite.

Lawyer: Russ Abney
Primary Staff Contact: Amy Brown

Fosamax®

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.

Femur Fracture Criteria: Documented use of Fosamax® for three years or longer with diagnosed low energy femur fractures.

Lawyers: Chad Cook, Leigh O’Dell and Russ Abney
Primary Staff Contact: Tabitha Dean

Gadolinium

The U.S. Food and Drug Administration (FDA) recently asked manufacturers of all Gadolinium-based contrast agents to include a new boxed warning on the product label. These contrast agents are used to enhance the quality of magnetic resonance imaging (MRI) and can place patients at risk for developing a potentially fatal disease known as Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD). People who develop NSF or NFD may experience a thickening of the skin and other organs, which can limit their ability to move or extend joints, and can lead to significant pain and even death. Other problems may include dark patches on the skin that appear rough and hard with raised plaques or papules, which are elevations of the skin. Joint and bone pain, as well as swelling of the feet and hands have also been reported. The FDA first warned about NSF and NFD associated with Gadolinium in June of 2006 and again in December of 2006. As of April of 2007, the FDA had received a considerable number of additional cases involving these conditions.

There are five Gadolinium-based contrast agents which are FDA-approved. One is the Omniscan Contrast Dye, manufactured by GE Healthcare. It is designed for intravenous use in MRI for the brain and the spine. In a recent study, five of the nine patients diagnosed with NSF received an MRI involving Omniscan Contrast Dye. Other studies have shown similar results. The other Gadolinium-based agents include OptiMARK, Magnevist, MultiHance and Prohance. Manufacturers of these products include Bayer Schering Pharma, GE Healthcare, Tyco Healthcare and Bracco Diagnostic, Inc. We are currently evaluating these Gadolinium-based contrast agents involving patients who have developed nephrogenic systemic fibrosis or Nephrogenic Fibrosing Dermopathy.

Lawyer: Roger Smith
Primary Staff Contact: Linda Reynolds

Hormone Therapy

For years, women have taken Hormone Therapy (HT) to reduce the symptoms of menopause. Studies now show that HT medications such as Prempro and Premarin can increase the risk of breast cancer, ovarian cancer, stroke and heart disease. We are currently investigating potential claims against the manufacturers of HT medications. There are a number of cases set for trial in several states over the next few months and others will soon be set. We currently have 660 cases either filed or soon to be filed.

Lawyers: Ted Meadows, Melissa Prickett, Russ Abney, Navan Ward James Lampkin, Danielle Mason and Matt Teague
Primary Staff Contacts: Katie Tucker and Gwyn Harris

Keppra Generic

Keppra (generic name levetiracetam) is an anti epileptic drug. It is used to treat seizures in adults and children. There is growing evidence that switching from the brand-name Keppra to the generic form of Keppra (levetiracetam) can cause an increased rate of seizure. Many individuals report going seizure-free for years and then having a seizure shortly after switching to the generic drug. For anticonvulsant drugs, small variations in concentrations between the brand-name formulation and the generic formulation can cause toxic effects and seizures when taken by patents with epilepsy. A single breakthrough seizure due to a change in the amount of medication that is delivered can have devastating consequences, including loss of driver’s license, injury, and even death. We are currently investigating cases where individuals have suffered breakthrough seizures, injury or death after switching from the brand-name Keppra to the generic (levetiracetam) form of Keppra.

Lawyer: Roger Smith
Primary Staff Contact: Linda Reynolds

Paxil®

Paxil® (paroxetine) is an anti-depressant manufactured by GlaxoSmithKline. Recently Public Health Advisories have been issued for Paxil® regarding an increased risk of heart birth defects, persistent pulmonary hypertension (PPHN), omphalocele (an abnormality in newborns in which the infant’s intestine or other abdominal organs protrude from the navel) or craniosynostosis (connections between sutures-skull bones, prematurely close during the first year of life, which causes an abnormally shaped skull) in children born to mothers exposed to Paxil®.

Criteria: Children born with birth defects to a mother who has documented use of Paxil® during pregnancy.

Lawyer: Roger Smith
Primary Staff Contact: April Worley

Pain Pumps

Pain pumps are portable and often disposable pain management devices which continuously administer local anesthetic through a catheter to a surgical wound site for several days following surgery to decrease post-operative pain and assist in earlier rehabilitation. A “Y-connector” accessory is sometimes available so that the pain pump can be used on multiple wound sites. Examples of pain pump manufacturers include Stryker, I-Flow, CME McKinley, Breg, Medical Flow Systems, Baxter and Sgarlato Labs.

Recently, the use of pain pumps to administer medication directly into the glenohumeral joint space following shoulder surgery has been linked to a severe condition called Postarthroscopic Glenohumeral Chondrolysis (“Chondrolysis”), in which the cartilage of the humeral head and the glenoid space of the shoulder process has been destroyed and lost. The destruction of the shoulder cartilage can be attributed to the application of anesthetic medication directly into the joint space via the pain pump catheter. In 2003, it appears that some pain pump manufacturers may have increased the anesthetic dosing capacity of their pain pumps, which may have hastened the onset of Chondrolysis in some patients.

Chondrolysis symptoms usually present between six weeks and six months following surgery and include increased shoulder pain and stiffness, loss of cartilage, decreased range of motion, loss of shoulder joint space, crepitus in the shoulder and loss of strength. Patients suffering from Chondrolysis are usually unable to complete their post-surgical physical therapy due to pain. Whatever the patient’s condition was prior to his or her shoulder surgery, the post-operative diagnosis of Chondrolysis is typically much worse. Ultimately, complete shoulder replacement surgery (acromioarthroplasty) could become necessary in order to eliminate the painful and debilitating symptoms of Chondrolysis.

Lawyer: Frank Woodson
Primary Staff Contact: Cathy Perry

Reglan®

Reglan is used to treat gastrointestinal disorders such as heartburn caused by reflux. The FDA recently required a black box warning linking Reglan and Tardive Dyskinesia. Symptoms of tardive dyskinesia include involuntary and repetitive movements like tongue thrusting, eye blinking and head jerking as well as involuntary movements of the fingers. These symptoms are rarely reversible with no known treatment. Those at increased risk for developing Tardive Dyskinesia are the elderly, especially older women, and people who have taken the drug for a long period of time. The FDA has advised physicians to avoid long term use of Reglan and recommends treatment not exceed three months. Reglan is available in formulations including tablets, syrups and injections.
Criteria: Documented use of Reglan with a diagnosis or symptoms of Tardive Dyskinesia.

Lawyers: Chad Cook and Danielle Mason
Primary Staff Contact: Tabitha Dean

Stevens- Johnson Syndrome

Stevens-Johnson syndrome 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 under age 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: Cathy Perry

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, DVT, or gallbladder removal.

Lawyer: Roger Smith
Primary Staff Contacts: Linda Reynolds and April Worley