Florida Injury Lawyer Blog

The popular diabetes drug Avandia has been reported to cause hundreds of heart attacks each month and has also been linked to heart failure. According to a Senate report and as reported by The New York Times, the U.S. Food and Drug Administration (FDA) is urging a recall on Avandia because of the health risk associated with the drug. The reports state that heart failure and heart attacks suffered as a result of Avandia would be prevented if diabetes patients were instead given the drug Actos.

The Senate report says GlaxoSmithKline, the manufacturer of Avandia, was aware of Avandia's health risks for years but did not tell the public. In 2007, The Journal of the American Medical Association challenged Avandia's safety. The same year, a scientific study published in the New England Journal of Medicine showed a 43% higher risk of a heart attack from using Avandia. The pharmaceutical giant stood by its product, saying it was safe. Not too long after the study, the FDA added a black box warning of Avandia's heart attack risks.

Avandia (Rosiglitazone) has been on the market since 1999 for the treatment of Type 2 diabetes. GlaxoSmithKline continues to stand by its product, claiming there is no link between Avandia and heart attacks. However, the drug is estimated to have induced nearly 100,000 heart attacks in the 11 years it has been on the market.

Continue reading "FDA Urges Avandia Recall, Diabetes Drug Linked to Heart Problems" »

Heparin manufacturers, including Baxter International, Inc., are facing mounting lawsuits alleging that a known 2008 contamination of the anticoagulant caused severe injuries and deaths. Lawsuits addressing the defective drug are being filed in state and federal courts. The federal court cases are being transferred to multi-district litigation in the Northern District of Ohio.

Heparin is a blood thinner (anticoagulant) used to prevent blood clots in veins, arteries, and lungs, which is often used prior to surgery or as a coating for medical devices. In 2008, the U.S. Food and Drug Administration (FDA) identified an increase in the number of deaths and adverse events, such as anaphylactic-type reactions (allergic reactions) and acute hypotension (extremely low blood pressure), associated with Heparin use. Scientists identified a contaminate in the Heparin described as oversulfated chondroiton sulfate which mimicked heparin activity and eluded routine testing. Because of the contamination, the FDA adopted a new standard for testing Heparin in 2009.

Baxter and other manufacturers began recalling suspected contaminated Heparin in 2008. Investigations have shown that the problem may stem from Chinese producers of crude heparin. A key ingredient in Heparin is made from pig intestines in China because of the large number of available animals. Although the source of the contamination has not yet been determined according to reports, some lawsuits are alleging that the China production facilities did not meet U.S. regulation and were not inspected or approved by the FDA.

Continue reading "Contaminated Heparin Injury Lawsuits Continue to Mount for Manufacturers" »

The U.S. Food and Drug Administration (FDA) recently announced that it would require Humira and other tumor necrosis factor (TNF) blocker prescription medications to include its strictest warning on both the packaging and prescribing information for the potentially dangerous drugs. The 'boxed warning' or 'black box warning' is now required after analysis of adverse medical incident reports submitted to the FDA showed an increased risk of lymphoma and other cancers with the use of TNF blockers such as Humira, Enbrel, Remicade and Cimzia in children and young adults. The FDA is requiring that manufacturers warn doctors and patients of the increased risk of leukemia, as well as new-onset psoriasis, on the TNF blocker packaging.

TNF blockers such as Humira, Enbrel, Remicade and Cimzia are used to treat children and young adults with Juvenile Idiopathic Arthritis (also known as Juvenile Rheumatoid Arthritis), Crohn's disease and other diseases. The drugs work by suppressing the immune system to block the tumor necrosis factor which causes inflammation and immune system related diseases.

The black box warning for TNF blockers comes after approximately 30 reports of cancer in children and young adults under the age of 18 taking TNF blockers were reported to the FDA between 1998 and April 2008. The concern included the development of lymphoma (cancer of the cells in the immune system) and other cancers such as leukemia, melanoma and solid organ cancers in children taking TNF blockers such as Humira, Enbrel, Remicade and Cimzia. In August 2009, the FDA announced that it had tracked 48 malignancies from 2001 through 2008 associated with the use of TNF blockers in children after an average of 30 months of treatment. The FDA will continue to investigate and analyze data from long-term studies of the potentially dangerous drugs.

Continue reading "Humira, Other TNF Blockers Linked to Cancer in Children" »

Paxil is an antidepressant manufactured by GlaxoSmithKline which is used to treat a variety of psychological disorders including depression, obsessive compulsive disorder, anxiety, and other mental issues.  Paxil is a member of a group of drugs known as selective serotonin reuptake inhibitors (SSRI) and is used to balance serotonin levels in the brain.  However, since Paxil's introduction on the market in 1993, the potentially dangerous drug has been plagued with complaints of serious adverse medical events including an increase in suicide rates and attempts, addiction, and birth defects.

According to reports, Glaxo has paid nearly $390 million for suicide death and attempts attributed to Paxil.  The family of a Valparaiso, Indiana, boy who killed himself shortly after he started taking Paxil recently settled their suit against Glaxo for an undisclosed amount.  In that case and other suicide cases, Glaxo has attempted to blame the suicides on the underlying depression and not the drug itself.  However, Glaxo has reportedly settled 150 Paxil-related suicide cases and 300 Paxil-related suicide attempt cases.

Paxil has also been linked to severe birth-defects in children whose mothers took the antidepressant while pregnant.  In October, a Philadelphia jury found that Glaxo negligently failed to warn doctors of Paxil's risk to pregnant women and found that Paxil caused the heart defect in the three-year-old boy involved in the case.  The jury awarded the family $2.5 million in compensatory damages including future medical care.  According to reports, this case was the first of some 600 lawsuits against Glaxo for failing to warn of Paxil's dangers to pregnant women.  Glaxo has reportedly settled 10 other birth-defect cases to date.

Paxil has also been accused of causing addiction and severe withdrawal effects for those attempting to quit the drug.   According to reports, Glaxo has settled nearly 3,200 cases involving addiction-related complaints and complications.

Continue reading "Paxil Lawsuits Costing Manufacturer Approx. $1 Billion" »

The U.S. Food and Drug Administration (FDA) has refused to back down from a warning letter sent to Zicam manufacturers, Matrixx Initiatives, Inc., regarding the potential dangers of its over-the-counter cold medication.  In June 2009, the FDA warned consumers that three Zicam products -- Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Nasal Swabs, Kids Size (discontinued product) -- were associated with 130 reports of the loss of sense of smell (also known as anosmia).  According to the FDA, the loss of sense of smell reportedly occurred after the first dose of the drug, but is also known to occur after multiple doses.

The potentially dangerous Zicam products contain zinc gluconate (labeled "zincum gluconicum") as the active ingredient.  The FDA warns on its website that although these products are marketed to reduce the duration and severity of the common cold, the products have not been shown to be effective in doing so.  Consumers are advised not to use the potentially dangerous drugs for any reason and to throw away any remaining product.  Matrixx Initiatives has since pulled the products in question from the market, but the FDA fears that unknowing consumers will use products still stored in their medicine cabinets.

In the June 2009 warning letter, the FDA accused Matrixx Initiatives of failing to provide any data to establish that Zicam Cold Remedy intranasal products are safe and effective for the uses identified in their labeling.  On the contrary, the FDA said that there is published scientific literature that evidences various salts of zinc can damage olfactory function in humans.

Continue reading "FDA Sticks to Zicam Cold Remedy Warning Letter on Loss of Smell" »

Ironically, 71-year-old Shirley Boles took Fosamax (the brand name for alendronate) to increase her bone density, but instead the Walton Beach, Florida woman found her jawbone deteriorating, her teeth loosening, and her gums turning black. This condition resulting in jawbone death is known as osteonecrosis of the jaw (ONJ).

Boles took Fosamax from 1997 to 2006 and asserts that Merck, the manufacturer, failed to warn doctors about the relationship between the drug and ONJ. There are now approximately 900 plaintiffs participating in the class action against Merck. This first lawsuit is being heard this month in the US District Court in Manhattan.

A study performed at the University of Southern California School of Dentistry and reported in the Journal of the American Dental Association (Jan. 1, 2009) found that 1 in 23 of the 208 patients studied taking alendronate had active ONJ. Researchers noted that even short-term use of alendronate was correlated with ONJ in some patients after certain dental procedures.

According to an article in USA Today (March 13, 2005) the chairman of the division of oral and maxillofacial surgery at the University of Miami, Robert Marx, stated that he knew of 40-50 cases of ONJ nationwide in patients who had taken Fosamax.

Continue reading "Florida Woman First Fosamax Multidistrict Litigation Plaintiff" »

The U.S. Food and Drug Administration (FDA) has ordered manufacturers of the promethazine hydrochloride injection to include a black box warning regarding potential dangers associated with the administration of the drug.  Promethazine hydrochloride was formally manufactured by pharmaceutical giant Wyeth under the name Phenergan.  Promethazine is used to treat nausea, vomiting, and pain after surgery and anesthesia, as well as allergy symptoms, motion sickness, and other ailments.

According to the FDA, the warning only applies to the injectable form of the drug which presents a serious risk of tissue damage if improperly administered.  The FDA warns that gangrene and other tissue injuries can be caused by administering promethazine in an artery or under the skin.  Because Phenergan, or promethazine, can potentially leach out of a vein and damage surrounding tissue during intravenous administration, the drug should be injected deep into muscle according to the FDA.

The black box warning label ordered for promethazine follows a March 4, 2009, U.S. Supreme Court decision in the landmark case Wyeth v. Levine.  In Levine, Diana Levine, a musician, had her arm amputated after Phenergan was injected into her vein using the "IV-push" method, entered her artery, and caused gangrene.  A state jury found that Wyeth failed to provide adequate warning of the dangers of such administration and awarded Ms. Levine $6.7 million in compensatory damages.  Wyeth appealed claiming that federal law pre-empted Levine's claim because the warning label had been approved by the FDA and it would be impossible to comply with both state and federal law.  The Supreme Court found against Wyeth and upheld the state court decisions in favor of Ms. Levine.

Continue reading "FDA Orders Black Box Warning for Generics of Wyeth's Phenergan" »

Bayer's drug trasylol, also known under the generic name aprotinin, was widely administered during heart surgery to control bleeding, but research indicates that it may be responsible for a multitude of deaths.

A 2006 study in the New England Journal of Medicine reported that trasylol increased patients' risks of kidney failure, heart attack, and stroke. The researchers concluded that the drug accounted for $1 billion in annual dialysis costs as a result of the 10,000 to 11,000 cases of kidney failure attributed to its use.

Additional studies in the United States and Canada revealed that patients receiving trasylol incurred a much higher death rate than those who had received other drugs

According to a report on CBS News' 60 Minutes, trasylol was given to 52-year-old Joseph Randone in January 2008 to decrease the bleeding risk during what should have been routine heart valve replacement surgery. Shortly after the surgery, he suffered two heart attacks and kidney failure. Eventually, his legs had to be amputated, his eyes sewn shut, and a pacemaker implanted in his heart before his eventual death. His surgeon indicated that he believed trasylol caused the complications.

Bayer allegedly concealed information from one of its own studies about the dangers of using trasylol during an FDA advisory hearing in September 2006. In the face of mounting evidence of the drug's adverse effects, the FDA requested in November 2007 that Bayer stop sales. However, it was not until May 2008 that Bayer recalled any remaining supply of the drug from the market.

On April 25, 2008, Bayer announced that 78 trasylol lawsuits were filed. The first trasylol trial consolidated in a multidistrict litigation is now scheduled to begin on January 18, 2010 in the U.S. District Court for the Southern District of Florida.

Continue reading "Trasylol Increases Death Rate Among Heart Surgery Patients" »

The U.S. Food and Drug Administration (FDA) recently alerted consumers to instances of liver damage associated with the prescription diet pill Xenical and the over-the-counter diet pill Alli.  Both Alli and Xenical contain the chemical orlistat which is used to block the absorption of fat in the intestines.  According to the FDA, there have been 32 reports of serious liver damage, including six cases of liver failure, from people taking orlistat.

The FDA advises people taking prescription drugs containing orlistat to contact their physicians immediately if they experience any signs associated with liver damage.  Symptoms of possible liver injury include:

• weakness or fatigue
• fever
• jaundice (yellowing of the skin or the whites of the eyes)
• brown urine
• abdominal pain
• nausea
• vomiting
• itching
• light-colored stool
• loss of appetite

Although the FDA has stated there is no definite association between liver injury and orlistat, they continue to investigate the relationship between the reported cases of liver injury and the drug.

Continue reading "Diet Pills, Alli & Xenical, May Cause Liver Damage" »

Propylthiouracil (PTU) was recently cited in a safety warning released by the U.S. Food and Drug Administration (FDA).  According to the warning, reports to the Adverse Event Reporting System show an increase risk of patients suffering hepatotoxicity with propylthiouracil when compared to another hyperthyroidism drug, methimazole.  There have been 32 cases of serious liver damage associated with propylthiouracil in both adults and children according to the FDA including 13 reported deaths and 11 liver transplants in patients taking PTU.

Propylthiouracil is an oral antithyroid drug used to treat Graves' disease by suppressing the creation of thyroid hormones.  Propylthiouracil is generally considered only as an alternative to methimazole if a patient is allergic to methimazole or is pregnant.  According to the FDA, doctors are instructed to carefully consider the risks of using or switching to propylthiouracil to treat patients with hyperthyroidism and closely monitor all patients taking the drug for liver damage.

Signs of Potential Liver Damage:

• fatigue
• weakness
• yellowing of the skin or eyes (jaundice)
• abdominal pain
• itching
• easy bruising
• loss of appetite
  

Patients taking propylthiouracil and experiencing any symptoms of potential liver damage should seek immediate medical advice. 

Continue reading "Graves' Disease Drug, Propylthiouracil, May Increase Risk of Liver Damage" »

The U.S. Food and Drug Administration (FDA) recently released an "Early Communication" concerning the asthma drug, Xolair.  According to the report, patients taking Xolair have a disproportionate increase in heart failure, arrhythmias, enlarged hearts, stroke, and other vascular conditions compared to patients not taking the drug.  Xolair, also known as Omalizumab, is an injected medication used to treat moderate to severe asthma that cannot be controlled by inhaled corticosteroids.

Xolair was approved by the FDA in 2003 and now accounts for $517 million in revenues for its manufacturer, Genentech.  Genentech merged with the international pharmaceutical behemoth, Roche, in March.  Genentech and Roche have both had recent setbacks with drugs such as Xolair and Accutane.  Accutane was recently pulled from the market and Xolair received a black box warning in 2007 for the potential risk of anaphylaxis.

Although the FDA advises patients to continue to take Xolair as prescribed and refrained from issuing prescribing changes, it continues to investigate the potential causal connection between the drug and the reported adverse health risks.  The final results of the study are anticipated to be available to the FDA in 2012.

Continue reading "Study Shows Asthma Drug, Xolair, May Increase Heart Failure Risk" »

The drug company, Roche, has pulled its acne medication, Accutane, from U.S. markets citing economic reasons and stiff competition from generic competitors. The removal comes, however, amidst numerous jury verdicts against the drug company for failing to warn of the medication's dangerous side effects. In 2007, a Florida jury found against Roche in the amount of $7 million for failing to warn of potential health risks. The removal of Accutane adds U.S. markets to a list of eleven other countries that have also seen the potentially dangerous drug removed from circulation.

According to reports, nearly 13 million people have taken Accutane since its release in the early 1980s. There are currently 5000 personal injury suits involving Accutane stemming from Roche's failure to warn of potential inflammatory bowel disease. Other serious safety concerns surround Accutane including causing psychosis, depression, suicidal thoughts and actions, birth defects, miscarriage, and premature birth.  Cases involving the dangerous health risks of Accutane continue to be litigated across the United States.

Continue reading "Acne Drug, Accutane, Pulled from Market" »

The U.S. Food and Drug Administration (FDA) announced today that it will require manufacturers of drugs containing propoxyphene, such as Darvocet and Darvon, to include boxed warnings on their products which emphasize the risk of death and injury from overdose associated with the drug. This action comes after a British study and other data linked propoxyphene and fatal overdoses. The FDA is also requiring that manufacturers provide information with the drug stressing the importance of taking the medication as directed.

According to reports, the FDA refused to order a phased withdrawal of the potentially fatal drug from the market, despite an advisory panel's decision in favor of removing the product from circulation. Rather, the FDA decided to require further safety studies of the product to determine the effects of propoxyphene at higher than recommended doses.

Critics of the drugs argue that propoxyphene, a member of the group of drugs known as opioids and used to treat mild to moderate pain, poses a greater risk of addiction and fatal overdose than warranted by its arguable benefits. An estimated 21 millions prescriptions for propoxyphene-containing drugs were written in 2007 and reports indicate that 503 deaths were associated with the drug Darvon including 20% from suicides.

Continue reading "Potentially Dangerous Drug Darvocet Gets Black Box Warning" »

The U.S. Food and Drug Administration (FDA) has warned that antiepileptic (or anti-seizure) drugs such as Topamax, Lamictal, and Lyrica can increase the risk of suicidal thoughts and behaviors.  Because these drugs are so widely used throughout the United States, the warnings pose an intriguing question as to who is responsible to warn and monitor the patients that take these potentially deadly medications and when a failure to either warn or monitor becomes medical malpractice.

Generally, when speaking of prescriptions drugs, the manufacturer's duty to warn of potential risks and side-effects is limited to adequately advising the prescribing doctor of any risk that may result from the patient's use of the drug.  This is because the prescribing doctor acts as a "learned intermediary" and considers both his understanding of the patient's condition and the potential risks of a drug when making a decision to either prescribe the drug or not.  However, the knowledge the doctor has available to him is not static and changes when new tests and studies become available as seen in the case of antiepileptic medications.  Failing to inform patients already prescribed a certain medication of newly discovered risks associated with that drug may result in medical malpractice.

Doctors have a duty to disclose the risks associated with medications or courses of treatment.  This duty can include explaining to the patient what is at stake when taking the medication, any alternatives, what goals the doctor is attempting to achieve, and the risk of the treatment and the risk of no treatment at all.  Florida law requires doctors to explain the serious risks and the possibility of serious harm taking the drug entails so that an intelligent choice can be made by the patient by balancing the possible risks and the possible benefits.  Therefore, when new risks are made known to the doctor by the manufacturer or other source, the argument can be made that it is medical malpractice not to inform the patient of the new risk so that they may make an informed and intelligent decision based on the new information.

Doctors also have a duty to monitor their patients during their course of treatment.  Obviously, a failure to monitor a patient prescribed a drug that increases suicidal thoughts and behaviors could be deemed malpractice.  It is important for the prescribing medical professional to closely monitor a patient taking antiepileptic medications to ensure the risks of suicidal behavior do not begin to outweigh the benefits of the drug.  Failure to properly monitor a patient could have devastating effects including death or serious injury.
  

Continue reading "Potential Medical Malpractice for Prescriping Drugs That Increase Suicidal Thoughts" »

Florida residents should immediately stop using the potentially defective dietary supplement, Hydroxycut, according to the U.S. Food and Drug Administration (FDA) which recently warned of serious injuries associated with the product across the U.S.  The FDA has tracked 23 cases of people reporting health complications after taking Hydroxycut including jaundice, liver damage, seizures, cardiovascular disorders, and rhabdomyolysis.  One death linked to the dietary supplement has also been reported to the FDA.

Dietary supplements are not regulated by the FDA until after they have reached the market.  Unlike prescription drug manufacturers, dietary supplement makers are self-regulated and responsible for ensuring their products are safe and effective and contain the proper warnings prior to coming on the market.  Once on the market, the manufacturers are responsible for reporting known health hazards caused by their product, and the FDA takes action against products found to be harmful or adulterated.  Hydroxycut is the latest in a long line of dietary supplements tracked by the FDA found to either cause serious health issues or contain undeclared, active pharmaceutical ingredients.

If you have the associated symptoms or develop new symptoms after taking Hydroxycut, you should see your doctor as soon as possible.

Continue reading "Dangerous Diet Pill Hydroxycut Causes Injury And Death" »