As I have mentioned previously, Andy Birchfield heads up our Mass Torts Section. We currently have 25 lawyers and 66 support staff in this Section. The Section also has eight contract lawyers and 16 contract staff workers who are helping the firm with cases in the Section. Melissa Prickett, a lawyer in the Section, serves as Section Administrator and she helps to coordinate all of the activity in the Section. Melissa is assisted by Penney Davies, her Administrative Assistant, who helps with coordination of all Section activities.
Everybody in the Section – lawyers and support staff – has been very busy over the past several weeks. At present, a number of important projects are underway. 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 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 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, David Dearing and Brittany Scott
Primary Staff Contacts: Katie Tucker, Gwyn Harris and Amy Brown
The U.S. Food and Drug Administration (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 Ethicon/Johnson & Johnson.
Lawyers: Leigh O’Dell and Chad Cook
Primary Staff Contacts: Tabitha Dean and Melisa Bruner
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 in 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®.
Lawyers: David Byrne and Melissa Prickett
Primary Staff Contacts: Susan Harding and 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 infection 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
Essure® is a permanent birth control device manufactured by Bayer Healthcare. The device consists of two small nickel alloy coils, which are implanted through the vagina into the fallopian tubes. Scar tissue forms around the coils, preventing sperm from reaching the eggs. Since its approval in 2002, 750,000 Essure® devices have been implanted. Adverse events reported with Essure® include migration, leading to perforation of the fallopian tube or uterine wall or embedment in other organs, often requiring hysterectomy or surgical removal; allergic reactions; severe pain; and infection.
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.
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.
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 who took Lipitor consistently for at least two months and was diagnosed with diabetes while taking Lipitor (or within six months of last dosage of Lipitor).
Lawyers: Frank Woodson and Matt Munson
Primary Staff Contact: Renee Lindsey
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:
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.
Lawyers in the Section 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
Mirena® is an 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.
Lawyers: Roger Smith and Liz Eiland
Primary Staff Contact: April Worley
The Power Morcellator is a surgical instrument used to divide and remove masses during hysterectomies, fibroid removal and other laparoscopic surgeries. The device is inserted through small incisions and removes tissue after aggressively cutting and shredding it. The device can put women at increased risk for a number of deadly uterine cancers. According to FDA analysis, 1 in 350 women undergoing surgical treatment for fibroids has an unsuspected uterine sarcoma that cannot be reliably detected before surgery. During power morcellation, there is a chance pieces of tissue may be left behind. If the tissue is malignant, cancer may be spread. The FDA issued a safety alert in April 2014 discouraging the use of these devices in uterine and fibroid removal procedures.
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 pepticulcers and gastrointestinal reflux disorders, and are available both as prescription and over-the-counter drugs. 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. Lawyers in the section are currently investigating PPI induced acute interstitial nephritis cases.
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
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.
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, DVT, pulmonary embolism and prostate cancer.
The Bellwether discovery process is ongoing against the manufacturers of Androgel with trials expected to start in 2017. The Defendants failed to adequately warn about risks of stroke, deep vein thrombosis, pulmonary embolism and cardiovascular injury and improperly marketed their drugs as a remedy for a series of age-related conditions rebranded as “Low T.” The testosterone lawsuits were centralized under federal multidistrict litigation (MDL) last year to help streamline pretrial discovery, and are being overseen by Judge Matthew Kennelly.
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. We 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.”
Lawyers in the Section will be glad 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.
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.
If you need more information on any of the projects discussed above, contact the lawyer listed as the contact for the particular project at 800-898-2037. You can also call or email Melissa Prickett, the Section Administrator, at 800-898-2034 or Melissa.Prickett@beasleyallen.com. She will be glad to put you in touch with a lawyer.
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