Florida Products Liability Lawyers
A number of drugs have been noted to cause tissue damage. Tissue damage includes injury to the muscles, bones, tendons, ligaments, cartilage, and skin. Patients are often surprised to learn of the unexpected adverse side effects of drugs because these side effects are not always highlighted in the meager warnings written by third parties on drug store receipts or provided by prescribing physicians and surgeons.
Perhaps the best examples of muscle damage are rhabdomyolysis and myopathies which is muscle damage associated with statin drugs. These drugs are some of the most widely prescribed medications for the treatment of elevated cholesterol and lipid levels. The statin class of drugs (also known as HMG-CoA reductase inhibitors) was first introduced in the United States in 1997, and now includes a number of single as well as combination medications, in both brand name and generic formulations:
- Advicor (niacin extended-release/lovastatin)
- Altoprev (lovastatin extended-release)
- Caduet (amlodipine and atorvastatin)
- Compactin (mevastatin)
- Crestor (rosuvastatin)
- Lescol (fluvastatin)
- Lipitor (atorvastatin)
- Livalo (pitavastatin)
- Mevacor (lovastatin)
- Pravachol (pravastatin)
- Simcor (niacin extended-release/simvastatin)
- Vytorin (ezetimibe/simvastatin)
- Zocor (simvastatin)
All of these cholesterol-lowering drugs are known to cause damage to a patient’s muscles. In its extreme form, this muscle damage is known as rhabdomyolysis, and involves a massive release of myoglobin into the bloodstream due to a breakdown of skeletal muscle. The symptoms of rhabdomyolysis include extreme weakness (especially in the quadriceps muscles), muscle pain, vomiting, confusion, and dark brown urine (due to the presence of excess myoglobin). This statin-induced tissue damage can lead to arrhythmia, kidney failure, heart failure, and death. The condition can be easily diagnosed through urinalysis or blood tests to detect the presence of creatine kinase (CK) or myoglobin. Your bad drug attorney at Searcy Denney knows that patients with rhabdomyolysis usually require hospitalization and IV fluids, and may need to undergo dialysis for renal failure. Rhabdomyolysis patients also often require a short-term stay in a rehabilitation unit or nursing home as well as physical therapy to help restore their muscle strength and mobility.
Bayol (also known as cerivastatin) was another drug that was part of the statin class of drugs, but was recalled from the market in August of 2001 after 31 patients died due to Baycol-induced muscle injuries. For many years, the statin drug Crestor has been the subject of concerns relating whether that it may be more likely to cause rhabdomyolysis, kidney failure, cardiomyopathy (enlarged heart), and liver failure than other statins. More recently, there have been concerns about the safety of Zocor. I n June of 2011 a Safety Alert from the FDA noted an enhanced risk of severe muscle damage, including rhabdomyolysis, in patients taking high doses of Zocor, especially during the first year of ingestion.
In a terrible twist of irony, several drugs and medical devices used to treat patients with bone-related medical problems have been noted to cause additional harm to the bones of these patients. Perhaps the most striking examples of these issues would be with regard to the bisphosphonate class of drugs as well as metal-on-metal hip implants.
Bisphosphonate drugs are used to treat osteoporosis, metastatic bone disease, Paget’s disease, and other conditions. The drugs are taken by millions of patients, especially post-menopausal women. This class of drugs includes a number of popular oral and injectable osteoporosis medications, including Fosamax, Boniva, Actonel, Reclast, and others. The manufacturers of these osteoporosis drugs include many leading pharmaceutical manufacturers, such as Merck, Novartis, Proctor & Gamble, Sanofi-Aventis, Warner Chilcott, and Roche. The drugs can be taken daily, weekly, monthly, or even once a year. The drugs Aredia and Zometa are administered through IV to patients undergoing chemotherapy. These drugs have been widely marked for nearly two decades primarily to enhance the bone health, not only in patients with documented osteoporosis but also as a preventative measure in patients who are perhaps at-risk to develop osteoporosis in the future or who have been noted to have osteopenia (a condition that may be a precursor to the development of osteoporosis). Unfortunately, over the past decade, researchers have discovered a number of safety issues associated with these osteoporosis drugs. They have formed evidence that the drugs actually weaken some bones while providing, at best, only short-term improvement in the strength of other bones in the body. Defective drug attorneys warn that many patients have developed jaw osteonecrosis, where the drug has weakened the jaw bone and made it more susceptible to both serious infections and osteomyelitis, neither of which are easily treated. The same osteoporosis drugs have been noted to cause essentially a fossilization of long bones in the body, with resulting atypical femur fractures in patients. These patients have experienced a broken leg (sometimes bilateral fractures) associated with little trauma but due to drug-induced weakening of the internal structures of their leg bones. These safety issues, which arose long after wide-scale marketing of the drugs, have led to a shift in the conventional wisdom with regard to whether these osteoporosis drugs should be as widely used as well as whether they should be prescribed for periods of time in excess of four years.
Bone damage is also a major concern amongst patients who have been implanted with metal-on-metal hip implants. These products, which are manufactured by Stryker, Zimmer, DePuy, Biomet, Smith & Nephew, and others, have been aggressively marketed to younger patients, who often have experienced destruction of their joints due to injuries or long-term use of steroid medications. Over the past few years, the safety of these devices has come into question after numerous reports of implant loosening, systemic poisoning, and of damage to patients’ bones. One device, the DePuy ASR metal-on-metal hip implant, has been “recalled.” Concerns remain regarding the safety of other metal-on-metal implants that have not yet been recalled.
Tendon and Ligament Damage
It is hard for patients to imagine that an antibiotic prescribed to treat an upper respiratory infection could result in tendon ruptures and permanent disabilities. Drug injury lawyers reveal that unfortunately, tendon and ligament damage is a side-effect of an entire class of antibiotics known as fluoroquinolones. This class of antibiotics includes a number of popular medications, including Cipro, Proquin, Factive, Avelox, Floxin, Noroxin, and Levaquin. Levaquin remains on the market even though there have been lawsuits pending for several years now against it s manufacturers for failure to provide adequate warnings of the risks of tendon ruptures, especially Achilles tendon ruptures, from use of this drug. The Levaquin litigation focuses on the failure of the drug manufacturer Ortho-McNeil, a division of Johnson & Johnson, to warn that Levaquin was more likely to cause tendon ruptures than other drugs the same class, especially in elderly women and those patients who were also taking steroids.
Chondrolysis is a condition in which articular cartilage is destroyed. Articular cartilage covers the areas of bones that come in contact with other bones and acts as a lubricant during movement of the joint, reducing friction and protecting bones from wear.
Over the past decade, a number of orthopedic surgeons caused unintended harm to their patients through the use of external infusion pain pumps. Unsuspecting physicians had no idea that the medical device manufacturers who were aggressively marketing these devices had been denied approval by the FDA for use of the pump and attached catheter within the joint space.
Disposable pain pumps are used in connection with joint surgeries, mostly involving the shoulder and knee, and are worn by the patient for only a few days after surgery. A catheter is attached to an external pain pump and left inside the joint space for up to five days following the surgery. Your Florida product liability lawyer explains that the pain pump would then infuse the joint space where surgery had just been performed with anesthetic drugs. Surgeons were told that pumping pain medications directly into the joint space would provide superior pain relief over the narcotic medications that are routinely prescribed after surgery. The pain pump manufacturers failed to inform doctors that they had known for years that anesthetic drugs (such as Marcaine and bupivacaine) are toxic to cartilage. By pumping these drugs into a tight joint space in high volumes following the surgery, the pain pumps set in motion a destructive process known as chondrolysis where the previously-healthy cartilage lining the joint becomes necrotic and dies after coming into contact only briefly with the drugs.
Chondrolysis (also known as Post-Arthroscopic Glenohumeral Chondrolysis [PAGCL) is a condition that did not exist prior to the use of pain pumps several years ago, and it leads to devastating complications for patients. Many patients who experience chondrolysis are young athletes who had relatively minor arthroscopic repair or stabilization procedures. After surgery they developed joint pain, stiffness, and loss of motion. Most patients with chondrolysis require numerous additional surgical procedures, and suffer significant complications and inability to regain full mobility of their joints.
One of the most significant injuries that a patient can suffer due to a drug reaction is Stevens Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN). These life-threatening hypersensitivity reactions often start with a seemingly mild rash soon after a new medication has been ingested. Within hours this rash progresses and causes sloughing of the skin in most affected patients. The same Stevens Johnson Syndrome or Toxic Epidermal Necrolysis process also causes significant internal problems, including ulcers in the mucosal passages, arrhythmia, and kidney failure. Unfortunately, many prescribing physicians are ill-informed about the potential for SJS and TEN reactions, and often fail to identify and aggressively treat the conditions in their early stages. A myriad of prescription and over-the-counter drugs are known to cause Stevens Johnson Syndrome and Toxic Epidermal Necrolysis, with new ones being discovered each year. The recall of Bextra, a popular arthritis medication manufactured by Pfizer in 2005, was one of the largest and most expensive drug recalls and was necessitated by the discovery of a risk of hypersensitivity reactions, including SJS and TEN, after FDA approved and use by millions of patients.