Mass Torts - Monday, August 11, 2008 15:00 - 0 Comments

Mass Tort Update

We are constantly being asked about what is going on in our firm’s Mass Torts Section. Lawyers in the Section are currently investigating a number of drugs and medical devices, and are involved in litigation with a number of them. I will give a brief summary of what the Section is doing at present.

Avandia®
Avandia, which is widely used to treat patients with Type II diabetes mellitus, has been associated with a significant increase in the risk of myocardial infarction and an increase in the risk of death from cardiovascular causes.  Frank Woodson and Roger Smith are the primary lawyers who are handling Avandia cases for the section.
 
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. Leigh O’Dell and Chad Cook are the primary lawyers in the section who are handling Fosamax cases.
 
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, 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. Ben Locklar and Russ Abney are the primary lawyers handling Gadolinium cases for the Section.
 
 
Guidant Heart Devices
In July of 2005, the FDA announced the recall of implantable defibrillators and pacemakers manufactured by the Guidant Corporation.  These devices are surgically implanted in persons who have a type of heart disease that creates the risk of a life-threatening heart arrhythmia (abnormal rhythm).  Some of the risks associated with the defibrillators are deterioration of wires and their inability to deliver therapy.  One of the risks associated with the pacemakers is that a hermetic sealing component used in the subset of devices may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemaker case.  We are currently investigating claims involving these types of recalled devices. Ted Meadows and Russ Abney are the primary lawyers in the section handling Guidant Heart Device cases.
                              

Medtronic Heart Devices
On April 16, 2004, the FDA announced the recall of numerous implantable defibrillators manufactured by Medtronic, Inc., which were implanted in 1997 and 1998.  These devices are considered a Class I recall, which is the highest priority recall.  In addition, another recall was issued by the FDA on February 10, 2005, for additional Medtronic defibrillators whose batteries were manufactured between April 2001 and December 2003.  We are currently investigating claims involving the particular recalled devices. Ted Meadows and Russ Abney are the primary lawyers in the section handling Medtronic Heart Device cases.

Medtronic Heart Device Lead Wire
On October 15, 2007, the Food and Drug Administration issued a Class I Recall involving the Medtronic, Inc., Sprint Fidelis® Defibrillator Leads, model numbers 6930, 6931, 6948 and 6949.  This recall specifically relates to those leads manufactured from September 2004 through October 15, 2007.  This action does not affect Medtronic pacemaker patients.
 
In March 2007, Medtronic reported two primary locations where chronic conductor fractures have occurred on Sprint Fidelis leads. Those are at: the distal portion of the lead, affecting the ring electrode and near the anchoring sleeve tie-down, affecting the helix tip electrode, and occasionally the high voltage conductor.  High voltage conductor fractures could result in the ability to deliver defibrillation therapy.  Anode or cathode conductor fractures may present increased impedance, oversensing, increased interval counts, multiple inappropriate shocks, and/or loss of pacing output.  The potential for defibrillation lead fracture to result in or contribute to inappropriate shocks or death has been reported.  As of October 4, 2007, there have been approximately 268,000 Sprint Fidelis leads implanted worldwide.  Based on current information regarding the 268,000 implanted leads, Medtronic has identified five patient deaths in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor.  We are currently investigating claims involving the particular recalled leads. Ted Meadows and Russ Abney are the primary lawyers handling Medtronic Heart Device Lead Wire cases for the Section.
        

Hormone Replacement Therapy
For years, women have taken Hormone Therapy (HRT) 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 handling claims against the manufacturers of HT medications.  Ted Meadows, Melissa Prickett and Russ Abney are the primary lawyers handling Hormone Replacement Therapy cases for the Section.

OrthoEvra
OrthoEvra is a hormone contraceptive available in a transdermal patch.  OrthoEvra is manufactured by Ortho McNeil (a subsidiary of Johnson & Johnson).  Recently the FDA disclosed that excessive levels of estrogen delivered by the birth control patch can cause serious injuries and even death.  According to the FDA women who use the patch are exposed to 60% more estrogen than those who are taking the pill, therefore increasing their risk of a serious adverse event.  Injuries or death claims involving OrthoEvra would likely be based on the following criteria: Documented use of OrthoEvra at the time of injury and significant adverse event(s) including blood clots, pulmonary embolism, heart attack, stroke, deep vein thrombosis, and/or death. Chad Cook is the primary lawyer handling OrthoEvra cases for the Section.
 
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®.  We are handling cases on behalf of children born with birth defects to a mother who has documented use of Paxil® during pregnancy.  Chad Cook is the primary lawyer who is handling Paxil cases for the Section.
 
 
Permax® and Dostinex®
These drugs are prescribed in the treatment of Parkinson’s disease and other neurological problems such as restless leg syndrome (RLS).  In a recent New England Journal of Medicine study, a statistically significant percentage of those who used these drugs for more than one year developed the potentially serious complication of valvular heart disease (VHD).  Valvular heart disease is typically diagnosed by a painless and non-invasive test called an echocardiogram that uses sound waves to determine if the valves of the heart are functioning properly.  In many cases, valvular heart disease does not immediately result in symptoms, so if someone has taken either of these drugs, we would suggest that they speak to their physicians about having such a test.      

At this point in time, it appears that the only Parkinson’s related drugs with a demonstrated association with valvular heart disease are Permax® (also prescribed generically as pergolide mesylate) and Dostinex® (also prescribed as generically as cabergoline).  These two drugs are chemically related to the diet drug “Fen-phen”, which was also related to the development of valvular heart disease and another very rare condition call Primary Pulmonary Hypertension (PPH). Navan Ward is the primary lawyer in the section handling Permax and Dostinex cases.
 
 
ReNu MoistureLoc®
ReNu MoistureLoc®, manufactured by Bausch & Lomb, is a solution used to clean contact lens.  Bausch & Lomb announced on April 10, 2006, that it was suspending shipments of this contact solution and retailers were urged to remove the solution from their shelves.  Reports of fungal keratitis infections in users of this have been reported in contact lens wearers who use ReNu with MoistureLoc®. Chad Cook is the primary lawyer handling ReNu MoistureLoc cases for the section.

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 more rapid 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 a joint following shoulder surgery has been linked to a severe condition called Postarthroscopic Glenohumeral Chondrolysis (“Chondrolysis”), in which the cartilage of the shoulder joint 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. Ted Meadows and Russ Abney are the primary lawyers in the Section handling pain pump cases.

Rice Litigation
Genetically modified rice – LL601 and LL604 – has been discovered in the U.S. rice crop, causing significant loss of revenue to U.S. farmers and threatening the success of U.S.-grown rice on the world market.  LL601 and LL604 are types of genetically-modified rice developed, manufactured, and tested by Bayer CropScience.  Bayer allowed the unapproved rice to contaminate conventional rice varieties.  At the time neither LL601nor LL604 were approved for human consumption.  Rice from farms in a five-state region – Arkansas, Mississippi, Missouri, Louisiana, and Texas – has tested positive for LL601 and LL604.  Rice farmers have suffered losses due to crop contamination, lost revenue, and additional costs associated with complying with state and federal efforts to eradicate the contaminated rice.   We are currently investigating potential claims of farmers from Arkansas, Mississippi, Missouri, Louisiana, and Texas who produced or sold rice at any point from 2003 to the present. Frank Woodson and Leigh O’Dell are the primary lawyers who are handling these cases.
 

Stevens-Johnson Syndrome
Stevens-Johnson syndrome is an allergic 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. 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. Frank Woodson is the primary lawyer handling SJS cases for the Section.
 
 
Trasylol
Trasylol is used to reduce blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass surgery who are at an increased risk for blood loss and blood transfusion.  Trasylol was manufactured by Bayer Pharmaceuticals and was approved by the FDA in 1993.  On February 8, 2006, the FDA issued an advisory warning to doctors of the potential for renal toxicity and on November 5, 2007, the FDA and Bayer agreed to temporary marketing suspension of Trasylol.  We are investigating potential Trasylol claims involving death after undergoing a coronary artery bypass procedure or kidney failure requiring dialysis or transplant. Frank Woodson is the primary lawyer handling Trasylol cases for the Section.
 
 
Viagra
Viagra is a drug manufactured by Pfizer used to treat erectile dysfunction.  We are currently investigating cases involving partial or complete blindness caused by non-arteritic ischemic optic neuropathy (NAION).  This is a condition in which blood supply is reduced to the optic nerve causing permanent nerve damage. Chad Cook is the primary lawyer in the Section handling Viagra cases.

Vioxx, Celebrex & Bextra
Vioxx, Celebrex and Bextra are popular and heavily-advertised arthritis drugs commonly referred to as a non-steroidal anti-inflammatory drug (NSAIDS). As you know, Vioxx was taken off the market in September 2004. Bextra was taken off the market in April 2005. Celebrex, which is still on the market, currently carries a black-box warning on its label.
 
Vioxx, Celebrex and Bextra have all been associated with an increased risk of cardiovascular events such as heart attacks and strokes. These drugs are classified as COX-2 inhibitors. COX-2 inhibitors, like older NSAID drugs such as ibuprofen and naproxen, work to decrease swelling in affected joints. However, unlike older NSAIDs that also caused irritation to the lining of the stomach by inhibiting the Cox-1 enzyme, it is theorized that COX-2 inhibitors only block the COX-2 enzyme, leaving the stomach protecting COX-1 alone. Published data calls the beneficial advantages of these drugs into question, and raises questions about “serious cardiovascular events” related to this class of drugs. We are currently litigating heart attacks, stroke and death cases involving Celebrex and Bextra. As you know, the Vioxx cases have been resolved and we are busying completing that settlement. We aren’t taking any more Vioxx cases.
 

Andy Birchfield, Leigh O’Dell, Roger Smith, Frank Woodson, Ben Locklar, Melissa Prickett, Navan Ward, Chad Cook and Russ Abney are all working on these cases.
 
Zithromax
Zithromax (azithromycin), manufactured by Pfizer, is a popular antibiotic used most often to treat respiratory infections, while also used to treat skin infections and some sexually transmitted diseases. Zithromax is taken once daily, usually two to five days under normal dosage.  The most serious types of health problems that have been attributed to Zithromax include liver damage resulting in death or liver transplant surgery. The symptoms for liver damage may include yellow eyes, abdominal pain, nausea, clay colored stools, and dark urine.  Recent warnings have been added to the label regarding abnormal liver function, jaundice, necrosis, hepatic (liver) failure and death, which have been reported by persons taking this drug. Chad Cook and Frank Woodson are the primary lawyers in the Section handling these cases. 

Hopefully, the above information will answer some of the questions we have been getting concerning the Mass Torts Section’s activities. In addition to the primary lawyers mentioned for a drug or medical device, once a case is taken, a trial team is put together at an early stage so that preparation for trial can get started. It’s been very busy in this Section and based on what we have learned in litigation, I don’t see things slowing down any time soon.