Lawyers in our Mass Torts Section have been very busy during the first seven months of 2017. The lawyers in the section will investigate any medication or medical device claim involving catastrophic injury or death. Andy Birchfield is the Section Head, assisted by Melissa Prickett, Section Administrator. The following are some of the drugs and devices lawyers and support staff in the section 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 well-respected Harvard medical doctor 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. J&J has shown no concern for its actions or for the thousands of victims.
Lawyers: Ted Meadows, Danielle Mason and David Dearing
Primary Staff Contacts: Katie Tucker, Gwyn Harris and 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, 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. Our lawyers are currently investigating claims of GI bleeding, hemorrhagic strokes or any other serious or fatal bleeding involving Xarelto®.
Lawyers: Andy Birchfield, David Byrne and Melissa Prickett
Primary Staff Contacts: Susan Harding and Penny Davies
The type of bone cement used during knee replacement surgery affects the outcome of that surgery. High viscosity bone cement (HVC) boasts shorter mixing and waiting times and longer working and hardening phases, meaning surgeons can handle and apply the cement earlier than with low- or medium-viscosity cements. Although HVC may be more convenient to use, there is mounting evidence that the bond it produces is not as strong. Researchers have observed more early failures with the use of HVC, even when used in combination with a previously well-performing implant. Complications associated with knee replacements performed with HVC include loosening and debonding (where the implant fails to adhere to the cement interface on the shin or thigh bone), which requires revision surgery. Other reported problems include new onset chronic pain and instability.
Lawyers: Roger Smith and Liz Eiland
Primary Staff Contact: April Worley
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 Staff 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 diabetic 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.
Lawyer: Danielle Mason and Melissa Prickett
Primary Staff Contact: Penny Davies
Retrievable IVC filters are wire devices implanted in the inferior 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 26, 2012); LFIT Anatomic v40 Femoral Head (recalled August 29, 2016)
• 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 manufactures 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 Staff Contacts: Donna Puckett and Stephanie Dean
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. A multidistrict litigation (MDL) has been created for claims against makers Ethicon and Johnson & Johnson. The MDL will be in the Northern District of Georgia located in Atlanta with Judge Richard W. Story presiding.
Lawyers: Matt Munson and Melissa Prickett
Primary Staff Contact: Penny Davies
Abilify Multidistrict Litigation Approaches 200 Lawsuits
A multidistrict litigation (MDL) has been established for nearly 200 lawsuits filed against Bristol-Myers Squibb and Otsuka Pharmaceutical Co., the makers of Abilify. The U.S. Judicial Panel on Multidistrict Litigation centralized the Abilify MDL in the U.S. District Court for the Northern District for Florida with Judge M. Casey Rodgers presiding. Abilify, the top-selling antipsychotic drug in the U.S., was first approved by the Food and Drug Administration (FDA) in 2002 to treat adults with schizophrenia. It was approved later to treat symptoms of a variety of mental disorders, including bipolar disorder and depression. Lawsuits that have been combined in the MDL involve impulse-control problems the Plaintiff developed while taking Abilify.
Abilify’s label did not mention “gambling” until January 2016. Four months later, the FDA issued a drug safety communication about “compulsive or uncontrollable urges to gamble, binge eat, shop and have sex.” The notice was based on numerous reports from patients who had taken the drug.
In 2007, the drug cost its makers $515 million when, according to the U.S. Department of Justice, the companies settled with state and federal regulators for numerous civil claims including marketing the drug to treat elderly patients with dementia-related psychosis. The previous year, the FDA issued a black box warning cautioning against that particular use of the drug due to an increased risk of death for elderly dementia patients. The companies agreed in 2016 to pay another $19.5 million to 42 states and Washington D.C. to settle additional claims that they improperly marketed and promoted the drug for off-label uses.
Lawyers in the section are currently investigating cases involving Abilify and compulsive gambling. If you have any questions regarding the litigation, or if you would like us to review a potential claim, contact Melissa Prickett, a lawyer in the Mass Torts Section. She can be reached at 800-898-2034 or by email Melissa.Prickett@beasleyallen.com.
Sources: Daily Hornet; U.S. Judicial Panel on Multidistrict Litigation and U.S. Department of Justice
Depuy Synthes Attune Knee System
Knee replacement surgery is considered highly effective for the treatment of degenerative joint disease or arthritis. It is also considered one the most successful surgical procedures in medicine. Implant survival rates are reported at more than 90 percent at 10-19 years of follow-up. With over 600,000 knee implants per year in the United States, the substantial public health impact of total knee replacements is undeniable. In response to the demand for operational efficiency, DePuy Synthes, part of the Johnson & Johnson conglomerate of companies, developed the ATTUNE® Knee System, a novel design total knee arthroplasty (TKA) system. The ATTUNE® Knee System features new designs and lighter innovative patient specific instruments for implant of the prosthesis. In 2013, DePuy Synthes launched the ATTUNE® Knee System on the market.
DePuy Synthes obtained market approval from the FDA based on the representation that the ATTUNE® Knee System was substantially equivalent to prior proven models. DePuy Synthes was not required to establish that the knee system was safe and effective. As a result, arthroplasty patients and the public are experiencing the harm caused by no clinical testing for a product with new features based on the representation as “substantially equivalent” to prior proven models.
Initially, the ATTUNE® Knee System marketing was very successful, resulting in embracement by the medical community. However, within two years, surgeons began encountering high failure rates. In addition, researchers found numerous adverse reports with the U.S. Food and Drug Administration (FDA) of the tibial component failure in the ATTUNE® Knee System. In a June 2017 study, researchers identified similarities in the failures. All revisions in the study had the failure of cement-to-implant.
Several design features were identified as possible reasons for increased failure of this implant including increased constraint of tibial polyethylene, reduced cement pockets in tibia, reduced rotational stabilizers on keel (i.e., all smooth surfaces on tibial fixation surface), and roughness factor on fixed bearing was only 60 versus 220 on the previous generation system (Sigma, DePuy Synthes).
The 2017 study alerted that the failure rate within the FDA database is likely underreported as competing companies cannot provide data on the revision components that they replace. The authors recommended that patients who present with unexplained pain undergo a thorough workup for a painful joint, which includes blood work and imaging and consider the diagnosis of debonding at implant-cement interface.
Lawyers in Beasley Allen’s Mass Torts Section are currently investigating cases involving early knee implant failure with the ATTUNE® Knee System associated with debonding at implant-cement interface. If you or a loved one has experienced complications from knee replacement surgery with the ATTUNE® Knee System, including loosening or debonding of the tibial component, contact Melissa Prickett at 800-898-2034 or by email at Melissa.Prickett@BeasleyAllen.com.
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; 14.9 million patients received 157 million prescriptions for PPIs in 2012.
Our lawyers 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 me 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. Beasley Allen is currently investigating cases involving PPI-induced acute interstitial nephritis.
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: Crystal Jacks
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.
Lawyers: Frank Woodson and Matt Munson
Primary Staff 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 Staff 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. The section is 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.
Lawyers: Navan Ward
Primary Staff Contacts: Donna Puckett and Stephanie Dean
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 U.S. Food and Drug Administration (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 U.S. Food and Drug Administration (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. Our lawyers are currently investigating cases of women who suffered permanent hair loss following Taxotere chemotherapy.
Lawyers: Beau Darley and Melissa Prickett
Primary Staff Contact: Penny Davies
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