Posts Tagged ‘lawsuit’

On June 18, 2009, a federal judge ruled that AstraZeneca, a pharmaceutical company, cannot block testimony by a medical expert that its antipsychotic drug Seroquel is linked to weight gain and diabetes.  Seroquel is an oral medication used to control the symptoms associated with schizophrenia.  Seroquel is AstraZeneca’s second-best-selling drug with $4.45 billion in sales in 2008.

The expert witness, Donna Arnett, is a professor and chairwoman of the epidemiology department at the University of Alabama at Birmingham.  Arnett asserts that Seroquel causes metabolic changes in its users, which can lead to diabetes and weight gain.  She also contends these metabolic changes occur throughout treatment with Seroquel.

AstraZeneca contended that Arnett’s testimony should be quashed, because she cherry-picked data favorable to her position.  However, the federal judge held that it would be up to a jury to decide whether her conclusions are credible or not.  This decision will affect the approximately 6000 cases pending against AstraZeneca in the federal court in Orlando, Florida.  More than 15,000 plaintiffs have sued AstraZeneca in state and federal courts, asserting that the company hid information about Seroquel potentially causing diabetes in its users.  The federal cases are combined in a multidistrict litigation before a federal judge.  The same judge dismissed two Seroquel lawsuits in January 2009, holding that the plaintiffs could not prove that Seroquel contributed to their development of diabetes.

In May 2009, AstraZeneca successfully obtained dismissal of the first Seroquel case in Delaware after the judge excluded expert testimony about the link between Seroquel and the onset of diabetes in the plaintiff.  AstraZeneca hoped that exclusion of Arnett’s testimony would produce favorable outcomes, but the federal judge denied its motion, sparking some hope in Seroquel victims.  If you or a loved one has been injured by Seroquel, you may have a Seroquel lawsuit and should contact a Seroquel lawyer.

Using contact solution correctly and safely is key to keeping your eyes healthy.  For example, not emptying the solution out of your contact lens case after each use could cause serious injures and even blindness from an infection.  Solutions that are not thrown out after use are essentially “dirty” and can contain various bacteria and micro-organism. Using fresh and clean solution each time reduces the risk of getting eye infections.

The FDA recently published an article on the importance of using contact lens solution correctly and safely.  The article discusses the Dos and Don’ts for contact lens wearers, how to prevent eye infections, and the symptoms of eye infections. In January 2009, the FDA assembled a workshop called “Microbiological Testing of Contact Lens Solution Products,” in collaboration with several eye care professional groups.  The workshop’s goal was to gain consensus on test methods for evaluating contact lens solutions and the development of Acanthamoeba keratitis, a rare but serious eye infection.  The FDA also convened a meeting of its Ophthalmic Device Panel in June 2008, to identify ways to improve contact lens safety. The panel gave updated information about keeping contact lens care products safe. Currently, the FDA is revising the guidance document, which specifically addresses the labeling and directions for proper use of contact lens solutions.

The FDA stresses the importance of not using contact lens solution more than once, not using expired solution, and rubbing and rinsing your contacts thoroughly with clean and fresh solution daily. Failure to use contact lenses and solution correctly can cause eye infections.  Both bacterial and fungal infections can lead to serious consequences, such as permanent loss of sight if left untreated.  Bacterial infections are more common than fungal infections, but fungal infections are much more difficult to diagnose and treat.  If left untreated, fungal infections can cause permanent blindness, sometimes within as little as 24 hours.  Symptoms of eye infections include, but are not limited to: discomfort, excess tearing or other discharge, unusual sensitivity to light, itching, burning, and pain.

The FDA became increasingly aware of the potential danger of not monitoring the safety of contact lens solutions closely after the Advanced Medical Optics’ (AMO) voluntary recall of Complete MoisturePlus contact lens solution.  The Center for Disease Control and Prevention identified a link between Complete MoisturePlus and the onset of Acanthamoeba keratitis, which caused blindness in several Complete MoisturePlus users. AMO speculated that improper handling and shipping of Complete MoisturePlus solutions caused this outbreak.

Some people avoid the hassle and dangers of wearing contact lens by opting to get lasik surgery to permanently correct their visions.  However, even though the technology for lasik surgery has improved over the years, there are still risks involved in lasik surgery.  If you or a loved has been injured by lasik surgery, you may have a lasik malpractice lawsuit and should contact a lasik malpractice lawyer today.

On June 17, 2009, the FDA reported the conclusions of its studies on Maxipime, an antibiotic generically known as cefepime.  Maxipime is a Bristol Meyers Squibb drug used to treat infections caused by abdominal surgery and other conditions. A recent published study suggested that patients given the drug might be more likely to suffer deadly complications compared to patients treated with other drugs.  The FDA determined that Maxipime did not increase the rate of death in its users.  The FDA reviewed the study’s data and conducted additional analyses based on additional data, including data provided by Bristol Meyers Squibb.

In a letter it sent to healthcare professionals, the FDA stated that it still approved Maxipime as an appropriate treatment for its approved indications, at least for now.  However, the FDA will continue to investigate into the safety of Maxipime.  As part of its ongoing investigation, both the FDA and Bristol Meyers Squibb are conducting separate studies on Maxipime’s potential link to increased death rates in its users.  The results of these studies will be reported in approximately a year.

Currently, the FDA has not indicated that Maxipime is a dangerous drug, but perhaps as it continues to do further investigations into the drug, it will find contrary information.  If you or loved one has been harmed by a dangerous drug, contact a dangerous drug lawyer today.

Advanced Medical Optics (AMO), a manufacturer of contact-lens solution, concealed complaints it received about the Complete MoisturePlus solutions causing eye infections and blindness. Government documents show AMO received complaints about the solution more than a year before it was recalled, and failed to report the complaints to the FDA as compelled by law. AMO recalled Complete MoisturePlus after the Centers for Disease Control and Prevention identified a link between the solutions and dozens of cases of serious infections called Acanthamoeba keratitis.

Acanthamoeba is a microscopic organism found in water or soil that can cause severe harm when it enters the eye. It usually enters the eye by attaching to a contact lens. Once it enters the eye, it is very difficult to kill, because it seals itself in a protective coating when faced with antibacterial drugs and protects itself from being killed for weeks or even months. If Acantheamoeba is not killed, it damages the eye and may cause blindness. In rare cases, it can even lead to a deadly infection of the brain and spinal cord. Acanthamoeba infections generally occur in, at most, two contact lens wearer per million. With 30 million contact lens user in the U.S., one would expect only 60 people to be infected. However, the figure exploded to more than 100 in 2007 alone.

Beginning in February 2006 and continuing through November of that year, AMO received a number of complaints about people diagnosed with the Acantheamoeba infections after using Complete MoisturePlus contact-lens solutions. However, these reports were not disclosed until June 2007, when the FDA went to investigate AMO’s headquarters regarding the recall. The FDA and CDC insisted that AMO recall the product after finding that contact lens wearers who had the infection were at least seven times more likely to use Complete MoisturePlus than those who did not contact the amoeba. The link between Complete MoisturePlus and Acanthamoeba keratitis is unknown, but AMO surmised it was due to improper handling and shipping of the contact-lens solutions.

Paige Reichardt was a victim of AMO’s misconduct. She became infected in 2005 and had to undergo a series of surgeries to remove her cataract lens, iris, and cornea. Ultimately, her whole eye had to be removed and replaced with a glass prosthetic. In an editorial, she described the pain as a feeling that someone had stabbed her eye with knives. Over 220 other plaintiffs had filed lawsuits against AMO, which is now part of Abbot Laboratories.

AMO’s negligence is a prime example of the devastating results that could occur when a manufacturer fails to take proper precautions in ensuring the safety of its product and properly warn people of the product’s dangers. If you are injured by a dangerous drug or defective medical device, contact a dangerous drug lawyer today.

Christine Golden, a Pennsylvanian woman, was recently awarded a $1.88 million judgment by a Pennsylvanian jury in a medical malpractice lawsuit.  Her husband, Terrence Golden, died after two doctors failed to diagnose his bladder cancer during a time when he could have been potentially saved with proper medical treatment.  Terrence died in January 2009 from the bladder cancer, which Christine alleged could have been treated if doctors had diagnosed it correctly.  It took nearly two years and several visits to a urologist and a pathologist before the bladder cancer was discovered.  The jury found that this medical misdiagnosis led to the death of Terrence.

With cancer, medical misdiagnosis is extremely fatal, because it can deprive a patient of important early treatments, which are less effective when the cancer is at later stages.  Bladder cancer is invasive and often spreads to other organs, as it did in Terrence, when not discovered in its early stages.  If caught early, bladder cancer can even be cured.

Christine sued Terrence’s urologist, Milan J. Smolko, who saw him numerous times between September 2002 and January 2004.  Terrence had complained about urinary problems during those visits.  Smolko had misdiagnosed him with only an inflamed and enlarged prostate without doing any further investigations until July 2003.  At that time, Smolko sent a bladder biopsy to pathologist, Lillian Longendofer, who also failed to identify the problem.  Eventually, Terrence went to another doctor in June 2004, who discovered the bladder cancer, but it was too late.  By that time, the cancer had metastasized to Terrence’s prostate and portions of his urethra.  The doctor removed the affected areas, but the cancer was too advanced to treat completely and as a result, Terrence died in January 2009.

Medical misdiagnosis can lead to serious, even fatal, consequences.  Careless oversights made by doctors can claim lives and deprive people of the chance to live their lives to the fullest.  If you or a loved one has been a victim of medical misdiagnosis or a doctor’s failure to diagnose, contact a medical malpractice lawyer today.

On June 10, 2009, a Food and Drug Administration (FDA) panel supported the use of Seroquel, a mood-stabilizing medicine manufactured by AstraZeneca, in children and adolescent, stating that the drug was “acceptably safe” and useful to treat schizophrenia and bipolar disorder.  At this time, FDA has not officially approved Seroquel for use in children and adolescents.

Seroquel is an oral medication used to control the symptoms associated with schizophrenia.  Seroquel is AstraZeneca’s second-best-selling drug with $4.45 billion in sales in 2008.  AstraZeneca is asking FDA to approve to market Seroquel in patients aged 13 to 17 with schizophrenia, and in patients aged 10 to 17 with bipolar disorder.

Schizophrenia afflicts about 1% or around 2.4 million Americans, specifically those in their late teens and early 20’s. Bipolar disorder is significantly more severe when found in children than adults and is characterized by frequent mood shifts and energy levels. It affects anywhere from 1-3 percent or around 5.7 million Americans.

In 1997, the FDA approved Seroquel for the treatment of schizophrenia.  However, the FDA has also reported that Seroquel has serious side effects when used by adult or elderly patients, including:

• An increased chance of death in elderly person
• Neuroleptic malignant syndrome (NMS), a life-threatening nervous system problem that can cause high fever, muscle stiffness, sweating, a fast or irregular heartbeat, a change in blood pressure and confusion
• An uncontrollable muscle movement condition known as tardive dyskinesia
• High blood sugar and diabetes

Seroquel lawsuits allege that AstraZeneca knew of Seroquel’s side effects, but did not take adequate steps to warn doctors and patients of them.  In addition, the lawsuits also allege that AstraZeneca aggressively marketed and promoted Seroquel for “off label” use, despite not getting FDA approval during that time.

The FDA panel also supports use of another drug Zyprexa, manufactured by Eli Lilly & Co., for use as a second-line treatment, or a second option after other drugs have failed in adolescents, because of concerns about significant weight gain in many adolescent patients.  In schizophrenia studies of Lilly’s Zyprexa, more than 30 percent of adolescents gained weight, compared with just 6 percent of adults. On average, adolescents gained nearly 10 pounds, compared with 6 pounds for adults.  Zyprexa is Lilly’s top-selling drug with $4.7 billion in sales in 2008.  Lilly is seeking FDA’s approval for Zyprexa in patients aged 13 to 17 with schizophrenia, and in patients aged 10 to 17 with bipolar disorder.