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Dangerous Drugs and Medical Devices
Dangerous Drugs
Many drugs on the market, both prescribed and over-the-counter, have harmful and even deadly side effects. FDA (Federal Drug Administration) approval does not guarantee that a drug is safe for consumers. Sometimes dangerous drugs are recalled but sometimes they remain on the market despite their risks. At Diamond~Massong, we understand the medical and legal complexities unique to these cases. Examples of dangerous drugs include:
Accutane
Accutane has been around under various names and makers since it was approved by the FDA in 1982. It has been used by more than 16 million people worldwide as a treatment for acne. In June 2009, Hoffman-LaRoche recalled the drug, citing the cost of defending Accutane injury lawsuits as a factor in its decision. By the time Accutane was recalled, LaRoche was facing nearly 5,000 lawsuits involving the drug. The company was well aware the product was dangerous but knowingly hid that fact from physicians.
Three common illnesses have been linked to Accutane:
- Ulcerative colitis (UC). This is a chronic inflammation of the digestive tract, accompanied by ulcers on the lining of the large intestine and rectum. Signs of UC are similar to Crohn’s disease and include abdominal pain and diarrhea. Treatment to manage UC is available although there is no known cure. A study published in the American Journal of Gastroenterology found that Accutane quadruples the risk of developing UC.
- Inflammatory Bowel Disease (IBD). This is a condition involving inflammation of the gastrointenstinal tract, which leads to ulcers and bleeding. Steroids are often prescribed to treat IBD but when they are not effective, surgery may be necessary.
- Crohn’s Disease. This debilitating disease involves inflammation of the digestive tract. It is accompanied by abdominal pain, severe diarrhea, vomiting, and weight loss. The disease is treatable but there is no known cure.
In addition to the pain and suffering associated with these diseases, the cost of treatment can be substantial. If you or a loved one are suffering from one of these serious conditions, Diamond~Massong can discuss your case.
Actos
Actos is a drug commonly prescribed to help treat Type 2 diabetes. The FDA warns that use of the drug at higher cumulative doses for long periods of time may increase the risk of bladder cancer. The manufacturer, Takeda Pharmaceuticals, continues to defend the drug but has agreed to include the potential bladder cancer risk on bottle labels. It is currently sponsoring a study to specifically assess the risk of bladder cancer due to frequent Actos use.
Actos belongs to a class of prescription drugs known as thiazolidinediones, which help reduce insulin resistance, a common problem in those afflicted with Type 2 diabetes. It is available in three different dose levels, and the one you take depends on your specific case of diabetes.
If you have taken Actos and developed bladder cancer, Diamond~Massong understands your concerns and is able to assist.
Chantix
Chantix is a drug used to help patients quit smoking. It was approved by the FDA in 2006 after an accelerated review process. It works in two ways: (1) It blocks nicotine from stimulating brain receptors so cigarettes do not give users the dopamine release they get when smoking, which makes smoking less appealing; and (2) It stimulates the release of small amounts of dopamine to help decrease the desire for nicotine because the body is already getting some level of dopamine.
Although Chantix is effective, it has several negative side effects that can lead to serious medical problems and even death. The FDA has required Pfizer, the drug’s manufacturer, to add information to the warning label about a possible increased risk of suicide, suicidal thoughts, and abnormal behavior seen among users of the drug. Diamond~Massong is reviewing potential claims from those who have committed or attempted suicide; who have been diagnosed with new onset diabetes, Stevens Johnson Syndrome (SJS), a serious skin disease, or Toxic Epidermal Necrolysis (TEN); who have suffered a heart attack following use of the drug; or who have suffered severe physical injury or death from an accident caused by seizures, blackouts, vision disturbances, or other sudden problems.
Fosamax
Since 1995, millions of older women have taken drugs called bisphosphonates, including the popular Fosamax, to stop the progression of osteoporosis, a condition that causes bones to become thin and brittle after menopause. Sadly, strong evidence has shown that the long-term use of Fosamax or its generic equivalent alendronate pose significant health risks. Some women who have taken the drug for five years or more have experienced unusual femur fractures during normal everyday activities without apparent cause.
The femur bone is one of the largest and strongest in the body, known to withstand almost any jolt. Common causes of femur fractures are falls, car accidents, or severe osteoporosis. In 2008, the FDA pressured Merck, which manufactures Fosamax, about constant reports of femur fractures. After more than a year, Merck simply added femur fractures to the list of the drug’s possible side effects, but important concerns about this risk were never fully disclosed to the public or to doctors who continue prescribing the drug.
Fosamax and its equivalent drugs continue to be prescribed for menopausal women, although extended use in some women may actually affect their ability to regenerate new bone and increase their risk of developing fractures. The FDA has now developed recommendations for doctors and patients about the risks and side effects of bisphosponates based on mounting results of clinical trials and ongoing studies.
Diamond~Massong encourages women to make informed decisions about osteoporosis drugs by learning more. One good resource is Bone Health and Osteoporosis: A Report of the Surgeon General (2004)
We are reviewing cases involving women who have suffered unusual, spontaneous femur fractures linked to the osteoporosis drugs Fosamax, Boniva, and Actonel.
SSRI Antidepressants – Paxil and Zoloft
Paxil and Zoloft are two of the most successful antidepressant drugs on the market. They are used to treat major depression and social-anxiety disorders. Unfortunately, use of these drugs during pregnancy, especially during the first trimester, has been linked to a wide array of serious birth defects such as congenital heart defects; persistent pulmonary hypertension (PPH); clubfoot; neural tube defects (brain and spinal cord); omphalocele (abdominal wall defects); cleft lip and cleft palate; limb defects (arms and/or legs); anal atresia (complete or partial closure of the anus); and craniosynostosis (skull defects).
The financial burden and emotional suffering associated with these birth defects are enormous. Diamond~Massong can assist victims of SSRI antidepressants in getting the compensation they deserve.
Pradaxa
Approved by the FDA in October 2010, Pradaxa is a drug used to reduce the risk of strokes and blood clots in people who have atrial fibrillation, a common heart rhythm abnormality. It is in a class of drugs known as “blood thinners” and is marketed as a more convenient choice than traditional treatment with Warfarin (Coumadin) because it is easier to dose, requires less monitoring, and is more effective at preventing clots. In patients using Warfarin, Vitamin K injections can stop internal bleeding. However, there is no available measure to stop bleeding in patients using Pradaxa, which significantly increases the odds that a bleeding event will turn fatal.
In response to numerous reports of fatal bleeds involving Pradaxa, the FDA ordered the manufactuer to change its warning label to reflect the lack of a reversal agent. The original label included no such warning. The FDA is currently evaluating the reports of bleeding deaths and whether the rate is higher than what was seen in the drug’s clinical trials.
If you have suffered a hemorrhagic stroke, gastrointestinal bleeding, or other serious or fatal bleeding involving Pradaxa, please call us.
See examples of our dangerous drugs and medical devices cases.
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