Lawyers in our Mass Torts Section have been very busy. In fact, Andy Birchfield, who heads up this Section, says the lawyers and support staff are busier than ever. Andy has put together a tremendous group in the Section. 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 devices our lawyers and support staff are currently working on:
Johnson and Johnson has known for decades that its talcum products, such as Shower to Shower and 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 2,200 cases of ovarian cancer each year.
Lawyers: Ted Meadows, Danielle Mason and David Dearing
Primary Contacts: Katie Tucker, Gwyn Harris or Amy Brown
Approved by the FDA in 2011, Xarelto® is one of the newest blood thinners on the market. It is manufactured by Janssen Pharmaceutical (a subsidiary of Johnson & Johnson) and co-marketed by Bayer Healthcare. It is prescribed to prevent blood clots in patients suffering from atrial fibrillation, pulmonary embolism, deep vein thrombosis and stroke, and patients who have recently undergone hip or knee replacement surgery. Since its approval, it has been linked to hundreds of injuries and deaths. We are currently investigating claims of GI bleeding, hemorrhagic strokes or any other serious or fatal bleeding involving Xarelto®. I will write in more detail on the Xarelto litigation below.
Lawyers: David Byrne and Melissa Prickett
Primary Contacts: Susan Harding or Penny Davies
3MTM Bair Hugger
The 3MTM Bair Hugger is a forced hot air warming blanket, used primarily to help maintain a patient’s body temperature during surgery. The 3MTM Bair Hugger pushes warm air through a flexible hose into a blanket draped over a patient. However, warming blankets can recirculate contaminated air over a patient’s body, including over an open surgical site. This may result in infections like MRSA or sepsis. In particular, patients undergoing knee or hip replacement surgery are at risk of infections deep in the joint, which is very difficult to treat. Complications from these infections include hospitalization, implant revision surgery, limited mobility, permanent disability, amputation and death.
Lawyer: Melissa Prickett
Primary Contact: Penny Davies
Approved in March 2013, Invokana® (canagliflozin) is an SGLT2 Inhibitor used to treat adults with Type 2 diabetes, manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. SGLT2 inhibitors work by preventing high blood sugar by helping the patient’s kidneys remove excess sugar through their urine. In May 2015, the U.S. Food and Drug Administration (FDA) issued a warning the drug has been linked to cases of ketoacidosis, a serious condition where there is too much acid in the blood. Complications of diabetic ketoacidosis include difficulty breathing, nausea/vomiting, abdominal pain, confusion and unusual fatigue or sleepiness. The condition can lead to diabetic coma and/or death.
Lawyers: Danielle Mason and Melissa Prickett
Primary Contact: Penny Davies
Retrievable IVC filters are wire devices implanted in the vena cava, the body’s largest vein, to stop blood clots from reaching the heart and lungs. These devices are used when blood thinners are not an option. Manufacturers include Bard, Cook and Johnson & Johnson. While permanent IVC filters have been used since the 1960s with almost no reports of failure, retrievable IVC filters were introduced in 2003, promoted for use in bariatric surgery, trauma surgery and orthopedic surgery. Risks associated with the retrievable IVC filters include migration, fracture and perforation, leading to embolism, organ damage and wrongful death.
Metal-on-Metal Hip Replacements
Metal-on-Metal hip replacement manufacturers have been under heavy scrutiny over 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, and
• Wright: (a) Conserve, (b) Dynasty, (c) Lineage and (d) Profemur (femur fracture) hips.
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 will 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.
Lawyer: Navan Ward
Primary Contacts: Donna Puckett and Stephanie Dean
Proton Pump Inhibitors
Proton pump inhibitors (PPIs) were introduced in the late 1980s for the treatment of acid-related disorder of the upper gastrointestinal tract, including peptic ulcers and gastrointestinal reflux disorders, and are available both as prescription and over-the-counter drugs. Popular PPIs include Prilosec, Prevacid, and Nexium. Use of PPIs has increased in the U.S. from 3.4 percent to 7.0 percent among men and from 4.8 percent to 8.5 percent among women from 1999-2000 to 2011-2013, according to the National Health and Nutrition Examination Survey, and 14.9 million patients received 157 million prescriptions for PPIs in 2012.
We are currently investigating cases involving PPI use and Acute Interstitial Nephritis (AIN), which is a condition where the spaces between the tubules of the kidney cells become inflamed. Case reports have linked PPI use to AIN as early as 1992, and observational studies in 2014 and 2015 provided further evidence of the link between PPIs and AIN. The injury appears to be more profound in individuals older than 60. While individuals who suffer from AIN can recover, most will suffer from some level of permanent kidney function loss. In rare cases individuals suffering from PPI-induced AIN will require kidney transplant. Our lawyers are currently investigating PPI-induced acute interstitial nephritis cases.
Lawyers: Roger Smith and Liz Eiland
Primary Contact: April Worley
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 Contact: Crystal Jacks
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 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.
Lawyers: Frank Woodson and Matt Munson
Primary Contact: Renee Lindsey
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. Lawyers in the section are currently investigating claims of heart attack, stroke, DVT, pulmonary embolism and prostate cancer.
Lawyer: Matt Teague
Primary Contact: Heather Hall
A preliminary study indicates that 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 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. Our lawyers are currently looking at cases involving men who are taking or have taken Viagra and were diagnosed with melanoma.
Zimmer NexGen Knee Replacement
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 will 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.
Manufactured by GlaxoSmithKline, Zofran® (ondansetron) was approved to treat nausea during chemotherapy and following surgery. Zofran® works by blocking serotonin in the areas of the brain that trigger nausea and vomiting. Between 2002 and 2004, GSK began promoting Zofran® off-label for the treatment of morning sickness during pregnancy, despite the fact the drug has not been approved for pregnant women and there have been no well-controlled studies in pregnant women. The FDA has received nearly 500 reports of birth defects linked to Zofran®. Birth defect risks include cleft palate and septal heart defects.
Taxotere is a chemotherapy drug that belongs to a family of drugs called taxanes. Taxotere is administered intravenously and is approved to treat breast cancer and other forms of cancer. In 2007, manufacturer Sanofi-Aventis touted the efficacy results of a clinical study involving Taxotere, but failed to inform the FDA, health care providers, and the public that a number of patients taking Taxotere experienced permanent hair loss. While hair loss during chemotherapy is a well-known side effect, patients undergoing chemotherapy with Taxotere were not warned that they could potentially experience permanent hair loss, which is a devastating condition, particularly for women. In December 2013, the FDA announced that it had ordered Sanofi-Aventis to change Taxotere’s label to warn patients of the risk of permanent hair loss. We are currently investigating cases of women who suffered permanent hair loss following Taxotere chemotherapy.
Lawyers: Beau Darley and Melissa Prickett
Primary Contact: Penny Davies
Physiomesh is a flexible polypropylene mesh used for hernia repair, designed to reinforce the abdominal wall to prevent future hernias. However, Physiomesh is actually linked to a higher rate of hernia recurrence than other similar meshes. In May 2016, Ethicon issued a voluntary recall of its product, citing unpublished data that showed that people who underwent hernia repair with Physiomesh were more likely to need future surgeries than patients treated with competitor products. Other potential complications include organ perforation, mesh migration, bacterial infection, sepsis, and even death.
In addition to the lawyers listed as primary contacts, there are other lawyers working on these projects. While I only named the primary contacts, if you have difficulty reaching the contact lawyer named for a specific project, contact Melissa Prickett at 800-898-2034 or by email at Melissa.Prickett@beasleyallen.com. She will make sure you are contacted by a lawyer who is knowledgeable about your specific request.
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