Author: AboutLawsuits

The FDA has announced that it is requiring a new “black box” warning to alert patients to the potential dangers of Exjade side effects, an iron-reducing medication made by Novartis AG, which could increase the risk of kidney problems, liver problems and gastrointestinal bleeding.

According to a statement posted Thursday on the FDA MedWatch website, the new label will contain a boxed warning indicating that Exjade may cause renal impairment, including kidney failure, hepatic impairment, including liver failure, and gastrointestinal hemorrhage. Among some reported cases, these problems with Exjade were fatal.

The warnings come approximately five months after the FDA issued an early communication in September 2009 to alert healthcare professionals that they were reviewing the potential side effects of Exjade.

Exjade (deferasirox) is an iron chelating medication manufactured by Novartis for people with chronic anemia and iron overload due to a blood transfusion. It was approved by FDA in November 2005, and generated $531 million in sales in 2008.

In 2007, the FDA warned that the drug could cause kidney failure and had resulted in at least eight deaths. The drug’s warning label was subsequently updated to include risks of kidney failure, blood vessel inflammation, hives, and hypersensitivity.

In the most recent safety review, the FDA looked at adverse event data for Exjade and data from a global safety database. The agency concluded that that older patient suffering from myelodysplastic syndrome (MDS) may face a greater risk when compared to younger patients with other chronic anemias.

MDS is a disorder where the patient’s bone marrow does not create enough normal blood cells, resulting in anemia. Those with MDS often need regular blood transfusions, which can cause a buildup of iron in the blood known as iron overload. Iron overload can cause damage to the heart, liver and other organs.

The new warning suggests that doctors closely monitor patients taking Exjade. In particular, they should watch for changes in creatinine levels, as well as changes in the levels of transaminases and bilirubin.

A Danish scientist is filing a counterclaim against GE Healthcare in response to libel charges originally brought by the company over critical statements the radiologist made about potential side effects of Omniscan, an MRI contrast agent that has been linked to a severe and debilitating injury among some patients, known as nephrogenic systemic fibrosis (NSF). 

Henrick Thomsen, a leading medical scientist and radiologist, has been an outspoken crusader against Omniscan, speaking at medical conferences and writing several papers about the risk of problems from the gadolinium-based contrast agent, which is used to improve magnetic resonance imaging (MRI) scan results.

Thomsen sounded the warning bell about potential risks with Omniscan after noticed that 20 of his patients were suffering from nephrogenic systemic fibrosis, which causes a hardening and thickening of the skin and other tissue throughout the body, severely restricting movement.

GE Healthcare attempted to silence Thomsen through use of British libel laws, but The Guardian reports that the Danish radiologist will file a counterclaim for libel in the ongoing battle

Although all types of gadiolinium MRI contrast agents have been linked to nephrogenic systemic fibrosis, multiple reports have suggested that the risk of NSF is increased with Omniscan.

Nephrogenic systemic fibrosis (NSF), which is sometimes referred to as nephrogenic fibrosing dermopathy (NFD), is a rare condition that is only known to occur after exposure to a gadolinium-based contrast agent (GBCA) among individuals with impaired kidney function. There is no cure for the painful and debilitating disorder, and in many cases it results in death.

The manufacturers of all types of gadolinium-based agents were required by the FDA to add the same “black box” warning in the United States in 2007, indicating that individuals with severe kidney problems could develop NSF. However, many have argued that the warnings about Omniscan side effects should be stronger than those on other available contrast agents, possibly calling for a ban on use of the product in some patients.

Approximately 350 nephrogenic systemic fibrosis lawsuits have been filed in the United States by individuals who developed the condition after receiving a gadolinium-based contrast agent. Out of the five approved contrast agents, Omniscan has been associated with the most cases of NSF, outnumbering the other drugs in proportions that far exceed their market share. It has been estimated that about 75% of all NSF lawsuits involve cases where the plaintiff developed the condition after use of Omniscan, even though GE’s contrast agent only accounts for about 30% of the market share.

Federal regulators have moved to restrict the use of Advair, Symbicort, Foradil and Serevent, after determining that side effects of the asthma drugs may increase the risk of severe asthma problems and death in both adults and children.

On February 18, the FDA indicated that Advair, Symbicort, Foradil and Serevent should never be used alone in the treatment of asthma in children and adults. The agency is contraindicating the drugs for solo use and requiring manufacturers to create risk management strategies to educate and train health care professionals and patients about the risks of using the drugs for long-term asthma treatment.

The decision comes after an FDA analysis of a number of studies on the drugs, which are known as long-acting beta agonists (LABAs). The review was undertaken after studies raised concerns that long-term use of LABAs could cause a worsening of asthma symptoms and death in some users. Foradil, Severent, Symbicort and Advair side effects can mask worsening inflammation in the airways, the FDA determined, and worsening asthma symptoms may not be recognized in a timely manner, potentially leading to severe health risks and death.

Advair (salmeterol and fluticasone) and Serevent (salmeterol) are manufactured by GlaxoSmithKline PLC. Foradil (formoterol) is made by Novartis AG and marketed in the U.S. by Schering-Plough Corp. Symbicort is manufactured by AstraZeneca. Advair is the biggest seller out of the four drugs, with sales of nearly $7 billion annually.

In December 2008, an FDA advisory panel recommended a Foradil and Serevent should no longer be approved for asthma treatment. However the panel did not make the same recommendations for Advair and Symbicort, because the drugs are combination products that include a corticosteroid medication.

The FDA decision on Thursday means that the labels of all four drugs will state that LABAs are contraindicated without the use of an asthma controller medication, like an inhaled corticosteroid. The drugs will also include label warnings indicating that they should be used for the shortest duration possible and then discontinued, and that they should only be considered for long-term asthma treatment by patients whose asthma cannot be adequately controlled by other medications.

In addition to the label changes, the manufacturers will be required to create a risk management strategy (REMS) outlining a plan to minimize the health risks to patients. The companies will have to make a revised medication guide for patients and will have to create education plans to ensure that health care professionals are well-informed about the appropriate use of LABAs.

“The risks of hospitalization and poor outcomes are of particular concern for children,” said the FDA Office of Pediatric Therapeutics Director Dianne Murphy.” Parents need to know that their child should not be on a LABA alone.”

Asthma affects 20 million Americans, including 6.5 million children. It is a chronic disease with symptoms like wheezing, difficulty breathing and spasms, which can severely limit activities and impact quality of life.

The first of more than 1,000 Kugel hernia patch lawsuits has been scheduled for trial to begin on March 25 in the federal MDL.

The case, involving a claim filed by plaintiff John Whitfield, is being used as a “bellwether” trial to help the parties and the court gauge how juries will respond to evidence and witness testimony that may be presented throughout other cases in the litigation. All of the lawsuits involve similar allegations that plaintiffs suffered severe injuries as a result of the defective design of several types of hernia mesh products manufactured by Davol, Inc., a subsidiary of C.R. Bard, Inc.

Four bellwether trials are scheduled throughout the year. The outcome of the cases could set the tone for future Kugel hernia patch trials, and may provided the basis for a settlement or other resolution for the litigation.

All federal Kugel mesh lawsuits have been consolidated and centralized for pretrial proceedings in the U.S. District Court for the District of Rhode Island as part of a multidistrict litigation, or MDL.

Three separate Kugel recalls were issued between 2005 and 2007 for different sizes and models of the patch, due to problems with a plastic ring inside the patch which can break, resulting in injuries like bowel perforation, chronic intestinal fistula and additional surgery to remove the mesh.

According to pretrial scheduling orders issued by the court earlier this month, the Whitfield trial will begin March 25, and counsel must provide proposed jury instructions by March 22, and a complete list of witnesses and exhibits at least 10 days before the trial begins.  

Chief Judge Mary M. Lisi, who is presiding over the cases in the MDL, has urged the parties to attempt to settle the cases before juries are seated. A number of the Kugel patch lawsuit settlements have reportedly already been reached for undisclosed amounts.

A Virginia woman has filed a Botox lawsuit against Allergan, Inc., claiming that injections meant to cure a head tremor caused her to suffer brain injuries, movement disorders and dementia.

The complaint was filed by Cynthia Vandenboom in Richmond City Court, alleging that Allergan failed to warn consumers that Botox side effects can cause serious autoimmune responses, brain injury and botulism. The lawsuit is the latest in a series of claims against Allergan over problems with Botox.

Vandenboom indicates that she was given Botox injections to treat a head tremor. As a side effect of Botox, Vandenboom alleges that she suffered a variety of serious and permanent injuries caused by the injections. She experienced rashes, fever, vomiting, severe pain and confusion shortly after being given the injections. Eventually, she developed autoimmune encephalitis movement disorder, lost some of her cognitive functions and now trouble walking. As a result of the Botox injury, the lawsuit claims that she requires care and help from others to conduct a number of daily activities.

Botox is approved for both cosmetic use to reduce the appearance of wrinkles in the skin and to treat medical conditions such as strabismus (crossed eyes), hyperhidrosis (excess sweating), cervical dystonia (involuntary contractions of the neck muscles) and blepharospasms (involuntary blinking of the eye). However, it also commonly used off-label, such as for treatment of stiff and jerky movements associated with cerebral palsy in children.

Extremely minute quantities of Botulinum Toxin A are contained in Botox, which is the bacteria associated with the muscle paralyzing condition Botulism.

Vandenboom says Allergan should have warned users of the chance that Botox toxin, which the lawsuit describes as being 100 times stronger than cyanide, would migrate outside of the injection area and could cause significant injury. The lawsuit accuses Allergan of product liability, negligence and breach of warranty, and seeks $10 million in compensation and $1 million in punitive damages.

There is currently a Botox trial underway in California, filed on behalf of 15 people who also allege that they suffered severe or fatal side effects from Botox treatments. Among the plaintiffs in the case are the families of two young children who died after Botox injections to treat cerebral palsy.

The FDA warned about potential risks associated with Botox in February 2008, after a number of reports were received involving deaths, breathing problems and other adverse reactions associated with use of Botox. At that time, the FDA indicated that the adverse reactions were most commonly seen among children with cerebral palsy, where the typical dose of Botox injection used is substantially larger than what is normally prescribed for cosmetic purposes.

In August 2009, the FDA announced a new “black box” warning about the risk of Botox problems, including potentially life-threatening botulism-like side effects. The warning now alerts users that the toxin used in Botox and other some other products could spread from the area of the injection to other areas of the body. This could cause botulism symptoms, including life-threatening swallowing and breathing difficulties or death.

The FDA is requiring Novartis Consumer Health, Inc. to change the name of one of its Maalox products due to label confusion that could cause consumers to use the wrong type of medication, potentially leading to harmful Maalox side effects.

In a statement issued Wednesday, the FDA warned about the risk of Maalox problems and announced that Novartis will change the name and label of Maalox Total Relief to avoid confusion with other Maalox products, such as Maalox Advanced Regular Strength and Maalox Advanced Maximum Strength. Maalox Total Relief is a medication intended to treat upset stomachs, nausea and diarrhea, whereas other Maalox products are sold as antacids.

The over-the-counter medications have entirely different active ingredients, with Maalox Total Relief (bismuth subsalicylate) being similar to aspirin. The FDA says that it is concerned that consumers will mistakenly take Maalox Total Relief, thinking that it is an antacid, which could lead to problems from Maalox for some users.

Regular Maalox products have the active ingredients of aluminum hydroxide, magnesium hydroxide and simethicone. They are intended for the relief of acid indigestion, heartburn and gas.

“Maalox Total Relief is not appropriate for individuals with a history of gastrointestinal ulcer disease or a bleeding disorder,’” the FDA warned in a press release. “Maalox Total Relief also should not be taken by children and teens if they are recovering from a viral infection, nor by individuals who are taking certain medications including: oral antidiabetic drugs (OADs), anticoagulation (thinning the blood) drugs such as warfarin (Coumadin) and clopidogrel (Plavix), non-steroidal anti-inflammatory drugs (NSAIDS), and other anti-inflammatory drugs.”

The FDA says Novartis has agreed to change the name of Maalox Total Relief to a new name that does not include the word Maalox, and will also change the label design, which is currently nearly identical to Maalox antacid products. In addition, the company will conduct an educational campaign to highlight the differences between the products for healthcare professionals and consumers.

Novartis will also monitor for adverse events and side effects caused by consumers mistakenly taking Maalox Total Relief when they intended to take one of the company’s antacid products. The new, renamed product will be released in September 2010.

Federal investigators announced the expansion of a salami recall this week, to include another 115,000 pounds of meat that is believed to be contaminated with Salmonella Montevideo. At least 230 people have already reported suffering salmonella food poisoning in connection with the tainted salami.

The USDA Food Safety and Inspection Service (FSIS) announced on Tuesday that inspectors have found contamination in more unopened salami products manufactured by Daniele International, Inc. The company originally issued a pepper-coated salami recall on January 23, for approximately 1.24 million pounds of salami and other italian sausage products.

The latest expansion of the recall includes another 115,000 pounds of salami and sausage products rolled in mozzarella cheese. The products were sold in 8-ounce packages under the Daniele, Dietz & Watson, and Boar’s Head labels. A complete list of the products affected by the salami recall expansion can be found in the FSIS press release.

According to an FDA update on the ongoing investigation into the Salmonella Montevideo outbreak, the U.S. Centers for Disease Control and Prevention have confirmed that at least 230 people in 44 states, and the District of Columbia, have fallen ill from food poisoning.

Salmonella Montevideo infection can cause symptoms such as abdominal cramps, nausea, vomiting, bloody diarrhea and fever. While symptoms tend to resolve within a few days or weeks for most healthy adults, the elderly, young children and those with weakened immune systems may be more susceptible to severe, and potentially life-threatening, infections.

The FDA has said that Rhode Island health inspectors found packages of black pepper in the Daniele processing plant to be tainted with the same strain of salmonella responsible for the illnesses, however the FDA has been unable to confirm that the pepper is the source of the outbreak. The suppliers of the black pepper have voluntarily placed their product on hold while the investigation continues.

At least two Salmonella salami lawsuits have already been filed against Daniele International over sicknesses caused by the tainted meat.

A growing number of complaints over steering problems with Toyota Corolla vehicles has sparked a federal investigation, and may result in yet another Toyota recall. The troubled auto-maker has already recalled millions of vehicles in recent months over defective gas pedals, floor mats and problems with brakes.

The National Highway Traffic Safety Administration (NHTSA) has received about 150 reports from 2009 and 2010 Corolla owners who say they have encountered difficulty steering at high speeds. Last Wednesday, U.S. Department of Transportation officials said that they are planning to open an investigation into the Toyota Corolla steering problems.

The Corolla uses electric-assisted steering, which is a cheaper version of power steering that uses an electric motor to reduce the amount of torque the driver needs to exert on the steering wheel to turn the vehicle. According to federal investigators, Corolla owners have been complaining that they have had times where it suddenly became very difficult to steer the car, as though the system temporarily stopped working.

Toyota officials say that if there is a problem, it is most likely related to the braking system or tires. The company has said that they will recall the vehicle if necessary, but have not yet issued a Toyota Corolla recall.

The Corolla is the second-most popular Toyota model in the United States, with sales of 300,000 vehicles here last year. Only the Toyota Camry sold more. Federal investigators say their investigation could potentially affect 500,000 Toyota Corollas currently on the road.

The spectre of a Toyota Corolla recall comes just before officials from the Japanese automaker are scheduled to appear at a congressional hearing on February 24. The hearing will focus on Toyota acceleration problems linked to problems with gas pedals and floor mats causing vehicles to speed up out of control. The sudden acceleration has resulted in accidents throughout the United States, and at least 34 deaths have been linked to the issue.

In September 2009, a Lexus and Toyota floor mat recall was issued for 3.8 million vehicles that contained certain all-weather floor mats, which Toyota indicated could get stuck under the gas pedals, causing unintended acceleration. In January, Toyota issued another recall for 2.3 million Toyota vehicles due to a mechanical problem that was causing some gas pedals to stick.

U.S. lawmakers say they want to determine how long Toyota knew about the problem before taking action.

The Toyota accelerator pedal recalls have resulted in more than 60 Toyota lawsuits, including over a dozen wrongful death and personal injury claims.

Just this week, a $100 million Toyota wrongful death lawsuit was filed against the company in the 122nd District Court in Galveston, Texas, by the family of Kenneth and Janice Berg. The couple died on February 24, 2009 in Clear Lake City when their 2009 Toyota Camry smashed into a poll. According to the lawsuit, witnesses said it appeared the vehicle suddenly accelerated out of control.

Photo Courtesy of: http://www.flickr.com/photos/danielctw/ / CC BY 2.0

A Baltimore jury has awarded about $10 million in a Maryland mesothelioma lawsuit filed on behalf of a man who developed a rare form of cancer as a result of exposure to asbestos when he was a young child. The asbestos was allegedly carried home by his father when he worked as an engineman on an oil tanker more than 30 years ago.

The verdict was handed down at the end of last month in the Baltimore City Circuit Court on behalf of Leroy Conway, Jr., 45, who sued Baltimore-based ATTRANSCO, who employed Conway’s father between 1974 and 1977. While working in an environment where he would become covered with asbestos dust and asbestos particles, Conway’s father carried asbestos home in his hair and clothes.

Leroy Conway, Jr. alleged that he developed mesothelioma from second hand asbestos exposure when he was about 10 years old.

Mesothelioma is found in the lining of the chest and lung. The only known cause of mesothelioma is asbestos exposure, and it is often not diagnosed for 20 to 40 years after exposure. As a result of the long latency period, the cancer is very advanced when it is diagnosed and life expectancy with the disease is limited.

During trial, the former captain of the ship on which Conway’s father worked testified that ATTRANSCO and the crew of the ship knew there was asbestos exposure, but that the company was unaware of the dangers.

The jury disagreed, swayed by evidence brought by the plaintiff that showed the Occupational Safety and Health Administration (OSHA) began regulating and warning about asbestos exposure as early as 1971, and that asbestos side effects had been documented by industry since the 1940s.

Conway has already had a lung removed due to the illness, and can no longer work. The jury awarded him $9.6 million for pain and suffering, and $636,000 for medical expenses in the Baltimore mesothelioma lawsuit.

Asbestos litigation is the longest running mass tort in U.S. history, with the first asbestos exposure lawsuit filed in 1929. Over 600,000 people have filed lawsuits against 6,000 defendants after being diagnosed with mesothelioma, asbestosis or other asbestos-related diseases.

In recent years, a number of similar lawsuits have been brought by individuals like Conway, who were not directly exposed to asbestos by working around the toxic substance, but by living in the same house as those who came into direct contact. Wives who washed the clothing of their husbands, children who were held by their parents after arriving home from work covered in the fibers, and other similar situations have resulted in successful lawsuits for compensation against the manufacturers of asbestos and products that contain asbestos.

A New Jersey jury has awarded $25.16 million in damages in an Accutane lawsuit, which alleged that the acne drug caused the plaintiff to develop inflammatory bowel disease.

The verdict was handed down this week in a New Jersey Superior Court, following the retrial of a case brought by Andrew McCarrell, 38, of Birmingham, Alabama. McCarrell originally won a $2.62 million award against Roche in 2007, but the company got that verdict overturned and the case was sent back for a retrial.

Roche faces nearly 1,000 lawsuits over Accutane, which has been associated with bowel problems, depression and birth defects. All of the lawsuits include allegations that Roche failed to adequately warn users about potential Accutane side effects. The company has lost all six cases that have gone to trial so far, with verdicts totaling $56 million, according to a report by Bloomberg News. One of those verdicts, with a $7.2 million award, has been overturned by a Florida appeals court.

McCarrell claimed that he contracted inflammatory bowel disease after taking the drug for acne in 1995. He underwent five surgeries and had his colon removed as a result, the lawsuit claimed. The jury awarded him $25 million for compensatory damages and $159,000 for medical expenses.

Roche has said they will appeal the verdict again, arguing that the drug carried a warning about the risk of inflammatory bowel disease. However, jurors told Bloomberg News after the verdict that the label warnings did not clearly indicate the risk.

Accutane has been used by more than 16 million people worldwide since it was first introduced in the early 1980s as a treatment for severe acne. An Accutane recall was issued by Roche in June 2009, citing the cost of defending Accutane injury suits as a factor in the decision to discontinue the medication in the United States.

Adding to the problems with Accutane, Health Canada issued a warning last week about reports of severe skin reactions, including sometimes fatal reaction known as Stevens-Johnson Syndrome from Accutane. At least 66 reports of Accutane skin reactions were identified by Health Canada, including adults and children, with two of the cases resulting in death.

Stevens-Johnson syndrome (SJS) is a severe skin reaction that occurs as a side effect of several medications. It is highly debilitating and causes the skin to burn from the inside out, producing blisters, severe rashes and the skin may begin to separate from the body. When the skin lesions affect more than 30% of the body, the condition is referred to as Toxic Epidermal Necrolysis (TEN). Treatment in a hospital Intensive Care Unit (ICU) or Burn Unit is often required, and the conditions can be fatal in many cases.

The results of a new study suggest that side effects of tamoxifen, a breast cancer drug, can lead to decreased cognitive abilities and memory loss. 

Women who took tamoxifen for a year or more were found to score lower on verbal memory and executive functioning tests, according to researchers at the Netherlands Cancer Institute in Amsterdam. Their results were published this month in the online version of the Journal of Clinical Oncology.

Tamoxifen was first approved by the FDA in 1971 for the treatment of breast cancer. Originally developed by AstraZeneca under the brand name Nolvadex, it is now sold under a variety of brand names, including Istubal and Valodex, and is also sold as a generic. Tamoxifen works by inhibiting the development of estrogen, which is believed to stimulate the spread of breast cancer. As of 2004, it was the largest selling hormone-based breast cancer treatment drug in the world.

Dutch researchers, funded by Pfizer, tested 299 women, including 80 women prescribed tamoxifen and 99 women taking Pfizer’s competing Aromasin (exemestane). They found that tamoxifen users had a statistically significant drop in verbal memory and executive functioning skills when compared to healthy control groups. Aromasin users showed no significant cognitive differences, researchers said.

Executive functioning includes the ability to shift attention between two different parts of a task. Verbal memory is the ability to retain and recall spoken information.

Researchers were at a loss to explain why tamoxifen caused a drop in cognitive abilities, but there have been a number of studies that link estrogen with verbal memory, including a 2004 study by U.S. researchers who found that estrogen boosted long-term memory in men, and other studies that suggest women tend to have better verbal memory skills than their male counterparts.

The results of the new study comes on the heels of other research involving the drug, published in the most recent issue of the British Medical Journal, which found that selective serotonin reuptake inhibitors (SSRIs), like Paxil, can interfere with tamoxifen, reducing or completely mitigating the breast cancer drug’s effects. SSRIs are often prescribed to breast cancer patients to combat depression.

Concerns over the increased risk of heart attacks, blood clots, tumors and death from side effects of Aranesp, Procrit and Epogen have led the FDA to restrict the prescribing of the anemia drugs under a risk evaluation and mitigation strategy (REMS).

Aranesp (darbepoetin alfa), Epogen (Epoetin alfa) and Procrit (Epoetin alfa), known as erythropoiesis-stimulating agents (ESAs), are prescribed to patients with kidney disease, anemia, HIV and cancer to stimulate bones to increase the production of red blood cells. They are also prescribed to patients preparing to undergo major non-heart surgery to reduce the number of transfusions such patients must receive. Amgen manufactures all three drugs, though Procrit is sold and marketed by Johnson and Johnson.

Th medications will now only be available through an FDA-approved risk management program, and Amgen has been required to develop a new medication guide and mandatory special training for any doctor or hospital that wants to prescribe the medications to patients with caner. The decision comes after an FDA official published an editorial in the New England Journal of Medicine last month, indicating that the agency will further examine the side effects of Aranesp, Epogen and Procrit following recent studies that confirmed some of the health risks associated with the drugs and also suggested that they may provide little health benefit.

In 2008, Aranesp sales were $3.1 billion, and Procrit accounted for $2.46 billion in sales. Researchers estimate that by 2002, the drugs were being prescribed to nearly half of all cancer patients.

“FDA required Amgen, the manufacturer of these products, to develop a risk management program because studies show that ESAs can increase the risk of tumor growth and shorten survival in patients with cancer who use these products,” the agency stated in a February 16 safety announcement. “Studies also show that ESAs can increase the risk of heart attack, heart failure, stroke or blood clots in patients who use these drugs for other conditions.”

The risk management program, known as a risk evaluation and mitigation strategy (REMS), will require doctors to undergo a special Amgen training program every three years before they will be able to prescribe either of the three drugs to patients with cancer. Cancer patients using the drugs are of special concern, because some studies indicate that ESAs can stimulate tumor growth. Amgen is required to oversee hospitals and doctors using the drugs as part of a cancer treatment program to ensure they are compliant with all aspects of the REMS.

Health care professionals who do not prescribe the three drugs for cancer uses are not required to undergo the special training, but must provide the updated medication guide to any patient being given any of the drugs to make sure they are aware of the risks associated with use.

A number of studies have suggested that the drugs may increase the risks of heart attack, strokes, blood clots and death, causing sales to drop in recent years. In 2007, the FDA issued a public health advisory regarding the drugs, saying that side effects of the Anemia drugs could increase the risk of injury or death at high doses. The FDA required that the drugs add a “black box warning” alerting patients to the risk of blood clots, strokes, heart attacks and death. The black box warning is the strongest label warning the FDA can require of a medication.

Two studies released this fall raised even more questions about the drugs’ safety and effectiveness. One study, presented at the annual meeting of the American Society of Nephrology in San Diego, concluded that the use of Aranesp increased the risk of stroke and did not reduce the risk of either death or cardiovascular events among diabetes patients with chronic kidney problems and anemia.

Another study conducted by New York-Presbyterian Hospital and Columbia University Medical Center found that the anemia drugs doubled the risk of blood clots by patients using the drugs and have resulted in no detectable decrease in the rate of blood transfusions among cancer patients.

Researchers conducting a study of dietary supplements say that a lack of regulation is resulting in potentially poisonous products being sold to consumers in the United States unchecked. 

The study, published in the latest issue of the Archives of Internal Medicine, was focused on an outbreak of acute selenium poisoning from Total Body Formula, which sickened 201 people in 10 states in 2008. Researchers pointed out that due to current federal regulations, Total Body Formula did not have to go through the stringent approval process required by pharmaceutical manufacturers making drugs to treat specific illnesses.

The FDA issued a recall of Total Body Formula and Total Body Mega Formula, distributed by Total Body Essential Nutrition of Atlanta, after Florida health officials reported 23 cases of selenium poisoning in 2008. Users suffered hair loss, muscle cramps, diarrhea, joint pain and fatigue. Researchers conducting the study were able to find a total of 201 people ultimately affected by the dietary supplement side effects.

The researchers found that the supplement contained 200 times the amount of concentrated selenium indicated on the label. While necessary for cellular functions at low levels, selenium becomes toxic at high doses.

Last year there were several recalls of similar dietary supplements or other homeopathic products not regulated by FDA because they were considered either herbal remedies or did not treat a specific illness. Dietary supplements in particular came under increased scrutiny by federal regulators in the wake of a Hydroxycut recall issued in May 2009, after FDA identified a number of reports where users suffered serious and potentially life-threatening liver damage. In July, the FDA warned consumers not to take dietary supplements which contained ingredients identified as steroids. The agency recommended that anyone taking dietary supplements containing steroids should immediately see a doctor if they showed signs of liver problems.

In June, the FDA issued a Zicam recall for the popular cold remedy’s nasal sprays and gels, saying that the unregulated homeopathic product was causing users to lose their sense of smell. Only after identifying the potential health concerns from post-marketing reports, was the FDA able to tell the manufacturer, Matrixx Initiatives, that they would no longer be permitted to market the products until they submit data establishing the safety and effectiveness.

In the case of the Total Body Formula recall, a number of lawsuits have been filed in federal courts against the manufacturers, which were consolidated and centralized as part of a Total Body Formula multidistrict litigation, or MDL, in the Northern District of Alabama in October 2008.

“Toxic concentrations of selenium in a liquid dietary supplement resulted in a widespread outbreak,” researchers concluded. “Had the manufacturers been held to standards used in the pharmaceutical industry, it may have been prevented.”

A Florida woman has filed a dental malpractice lawsuit against a dentist who she says left part of a metal drill bit in her head for 11 months.

The complaint, filed by Donna Delgado, charges oral surgeon Ralph Eichstaedt with medical malpractice for allegedly leaving an inch-long piece of metal drill bit in her sinuses. According to a report by the Associated Press, Eichstaedt dismissed Delgado’s concerns about not feeling well and the drill bit was not discovered until this past August, about a year after Delgado went to Eichstaedt to have two teeth removed.

Delgado claims that the inch-long piece of drill was left in her maxillary sinus during the removal of the two teeth, causing her a variety of ailments, including numbness in her right side. Delgado, concerned about the recurring problems and numbness on her right side, went to a hospital for emergency treatment, where a magnetic scan done by hospital staff unaware of the drill bit caused it to move, resulting in excruciating pain. Delgado allegedly suffered dizziness, numbness, sinus infections, nosebleeds and pain from the broken drill bit. Doctors discovered the drill bit burr and had it surgically removed.

The dental surgery lawsuit alleges that Eichstaedt could have performed a simple x-ray and detected the piece of metal, but instead, repeated attempts by Delgado to find answers were rebuffed. Both Eichstaedt and the Dental Health Group were named as defendants in the malpractice lawsuit, which is seeking unspecified damages.

Leaving all or part of a surgical tool behind after a medical procedure is rare, but can pose serious and potentially fatal consequences. Precautionary measures like checklists, a count of medical tools, tracking bar codes and radiographic screening after operations can greatly reduce the risk. According to a 2003 report published in the New England Journal of Medicine, there were about 1,500 cases a year in which a surgical tool was left behind after surgery. Approximately 88% of the cases involved a final count that was incorrect.

The difficulty in detecting the surgical mistake has led most states to allow exceptions to the statute of limitations for medical malpractice lawsuits in cases where a foreign object is left behind during surgery.

Lawyers involved in the federal NuvaRing litigation, which includes hundreds of cases filed on behalf of women who allege that they suffered blood clot-related injuries after using the popular birth control ring, are scheduled to meet this week with the judge coordinating pretrial proceedings in the multidistrict litigation (MDL). It is expected that the parties will discuss scheduling of the first “bellwether” trials, which will help gauge how juries will respond to evidence that will be presented in different lawsuits over NuvaRing.

All of the cases involve similar allegations that Organon Pharmaceuticals failed to adequately research their birth control ring or warn that potential side effects of NuvaRing may increase the risk of a blood clot, pulmonary embolism, deep vein thrombosis (DVT), stroke, heart attack or sudden death.

There are currently about 250 cases from federal district courts throughout the United States that have been consolidated into the MDL in the U.S. District Court for the Eastern District of Missouri before District Judge Rodney W. Sipple. In addition, NuvaRing lawyers are continuing to review and investigate potential cases for users of the birth control ring, and it is expected that the number of cases filed will increase dramatically in the coming months.

In an order issued last month, Judge Sippel asked attorneys for plaintiffs and defendants to select 16 NuvaRing lawsuits each to go into a pool of potential bellwether cases for the first phase of the litigation. These cases will undergo additional case-specific discovery so that they can serve as early trials, which will help the parties determine the strengths or weaknesses of their cases, and potentially lead to a NuvaRing settlement or other resolution of the litigation.

Lawyers are set to meet with the court for a scheduling conference on Thursday to set dates for the completion and discovery and to set initial trial dates for the “Phase One” cases. The Court will also address discovery issues for the remaining cases in the MDL and a deposition protocol.

Another scheduling conference has been set for January 4, 2011, to establish deadlines for expert and dispositive motions in the “Phase One” cases.

A new study indicates that diabetic women, particularly those over the age of 65, face an increased risk of a bone fracture from Avandia and Actos. 

The study, published in this month’s issue of the Journal of Clinical Endocrinology & Metabolism, found that the risk of a bone fracture from Avandia and Actos can be as much as 70% higher among women taking one of the diabetes drugs. The bone fracture risk is just one of a number of side effects associated with Avandia, which have led some critics to call for an Avandia recall.

Avandia (rosiglitazone), manufactured by GlaxoSmithKline PLC, and Actos (pioglitazone), manufactured by Takeda Pharmaceuticals North America Inc., are both part of a class of medications known as thiazolidinedione agents, which are used to treat type 2 diabetes by helping control blood sugar levels.

Researchers from Henry Ford Hospital in Detroit, Michigan, looked at more than 19,000 individuals with diabetes who had been prescribed an oral diabetes medication. They found that women, on average, had a 50% higher chance of bone fractures when taking Avandia or Actos, and women over 65 saw their risk increase to 75%. Men did not appear to suffer the same increased risk of fractures from Avandia or Actos. For women, the increased risk began to appear about a year after they began treatment with the drugs.

The new study is just the latest blow for GlaxoSmithKline’s drug, as Avandia side effects have also been linked to an increased risk of heart attacks, congestive heart failure, macular edema, liver failure and death.

In October 2008, the consumer interests group Public Citizen filed a petition with the FDA calling for the drug to be banned, arguing that the risk of problems from Avandia outweigh the potential benefits. The FDA has not yet taken any action on the petition.

Glaxo faces thousands of Avandia lawsuits filed by former users of the drug who allege that the drug company failed to adequately research their medication or warn users about the serious side effects. Federal Avandia litigation has been consolidated into an MDL, or Multidistrict Litigation, for pretrial litigation in the U.S. District Court for the Eastern District of Pennsylvania.

A new Toyota recall has been issued for approximately 8,000 Toyota Tacoma 4WD trucks from the 2010 model year, as they may have defective drive shafts that could cause drivers to lose control of the pick-up trucks. The vehicles will join millions of Toyota and Lexus vehicles recalled in recent months over issues like brake problems and uncontrolled acceleration, which have been linked to dozens of deaths. 

The Toyota Tacoma recall was issued over a manufacturing problem that the auto maker indicates could have caused cracks in the front drive shaft of some of the vehilcles. The cracks could cause the driveshaft to separate and fall from the truck, leading to a loss of control and potential accidents that could cause serious injury or death.

Affected drivers are being asked to bring their vehicles into Toyota dealerships for inspection to ensure their drive shafts show no signs of fracture. Toyota officials say the inspections should take about 10 minutes. The 2010 Toyota Tacoma 4WD trucks affected by the recall were manufactured between December 2009 and early this month.

Last week, the Japanese auto maker announced a Toyota Prius recall and Lexus HS250h recall that affected approximately 437,000 hybrid vehicles sold this year, as a software glitch could cause drivers to experience brake failure.

In September 2009, a Lexus and Toyota floor mat recall was issued for 3.8 million vehicles that contained certain all-weather floor mats, which Toyota indicated could get stuck under the gas pedals, causing unintended acceleration. In January, Toyota issued another recall for 2.3 million Toyota vehicles due to a mechanical problem that was causing some gas pedals to stick.

At least 34 deaths have been associated with the Toyota sudden acceleration problem, according to the most recent data submitted to a database maintained by the National Highway Traffic Safety Administration. Thirteen of those deaths were reported to the government over the last three weeks.

The acceleration problem gained national attention following a fatal accident in California in August, where an off-duty state trooper and three family members were killed while driving a Lexus ES 350 on loan from a San Diego dealership. Minutes before the fatal Lexus crash, passengers called police and reported that the Lexus had accelerated to 120 m.p.h. Witnesses reported that the car’s tires were on fire, which was likely due to the driver slamming on the brakes before slamming into an SUV, falling off an embankment, rolling over multiple times and bursting into flames.

The Toyota accelerator pedal recalls have resulted in more than 60 Toyota lawsuits, including over a dozen wrongful death and personal injury claims.

Photo Courtesy of: http://www.flickr.com/photos/danielctw/ / CC BY 2.0

Federal regulators have released new rules designed to protect students by decreasing the risk of food poisoning from school lunches.

The new initiatives, announced this month by Agriculture Secretary Tom Vilsack, will add new safety and quality requirements to food purchased by the U.S. Department of Agriculture (USDA) for the National School Lunch Program. This will include new food safety purchasing requirements for beef suppliers, better information sharing between federal agencies that handle food safety, new research into school food safety, and a review of meat, poultry and processed egg vendors who provide food to the school lunch program.

One of the reviews will be an evaluation by the National Academy of Sciences (NAS), which will look at the Agricultural Marketing Service’s (AMS) ground beef purchasing program. The NAS will review the scientific validity of AMS’s technical requirements.

While most health adults fully recover within a few weeks from food poisoning, which most commonly involve E. coli contamination or salmonella bacteria, young children face an increased risk of severe illnesses from consuming the same foods. This could lead to dehydration, hospitalization, kidney failure or even death.

“Nothing is more important than the health and well-being of our nation’s school children,” Vilsack said in a USDA press release. “We must do everything we can to ensure that our kids are being served safe, high quality foods at school.”

The new initiatives follow a GAO report released in September that found many school lunch programs across the country were not notified of food recalls in a timely fashion after contaminated peanut butter products and vegetables were linked to food poisoning outbreaks. Although no specific reports of illness have been identified, the notification breakdown resulted in children in some schools being served food that had been recalled days or weeks earlier.

The GAO report concluded that U.S. Department of Agriculture’s (USDA) Food and Nutrition Service (FNS), which oversees federal school meals programs, does not always ensure that states and schools received timely and complete notification about suspect food products provided to schools. It suggested that changes could be made to the process that would reduce the risk of school children being exposed to contaminated products that have already been recalled.

Rep. George Miller, chairman of the House Education and Labor Committee, called for a probe of the school lunch program following the GAO report and an E. coli outbreak in New England last fall that sickened 20 children who ate contaminated hamburgers from South Shore Meats at an environmental camp in Massachusetts. No school lunches were connected to the outbreak.

Calling tanning beds, the “cigarettes of our time,” congressional lawmakers have introduced new legislation in an attempt to lower the risk of cancer from tanning beds. 

The new bipartisan bill, the Tanning Bed Cancer Control Act, was introduced in late January by U.S. Representatives Carolyn Maloney (D-New York) and Charlie Dent (R-Pennsylvania). The bill would allow federal regulators to set controls on the amount of ultraviolet radiation emitted by tanning beds as well as set limits on the amount of time users can use the devices.

The legislation comes as the FDA is preparing for public hearings next month on the tanning bed risk of cancer. The FDA could potentially reclassify tanning beds as a more serious type of medical device that would require more stringent regulation. Currently, tanning beds are classified as Class I medical devices, the same classification as bandages.

Tanning beds have been the focus of increased scrutiny by lawmakers and regulators after a decision by the World Health Organization (WHO) last year to list tanning beds as known carcinogens, placing them in the same category as cigarettes and arsenic. A study released by WHO in July 2009, determined that the use of tanning beds before the age of 30 increases the risk of skin cancer by 75%. Previously, they had been classified as “probable” carcinogens.

“Tanning beds are the cigarettes of our time: cancer-causing and poorly regulated,” Rep. Carolyn Maloney said in a press release. “Through education and improved regulation, we can save lives.”

Rep. Dent said that melanoma had impacted his own family, and that the proposed legislation would ensure that the beds are properly labeled and that standards are updated to minimize health risks.

Some studies have shown that the use of tanning beds by young adults results in eight times the risk of developing melanoma, a deadly form of skin cancer once found mainly in the elderly, but which has increasingly become a problem for younger adults. The American Cancer Society says that melanoma, the most dangerous form of skin cancer, is diagnosed in about 69,000 Americans each year and causes about 8,650 deaths annually. Less dangerous, but more common, basal and squamous cell carcinomas affect more than one million Americans each year and cause about 2,000 deaths annually.

Both the FDA and the Indoor Tanning Association say that one of the major problems is people who go too often and overexpose themselves to ultraviolet radiation, hoping to get a better tan. The FDA says once a week will give people the same results as going three times per week. However, the ITA says that it does not believe there is any new science which would justify more stringent FDA regulations.

An automobile product liability lawsuit has been filed against General Motors Corporation by a California woman who suffered severe head injuries when the seat of a Chevrolet Tahoe collapsed during a rear-end accident.

The Chevy Tahoe lawsuit was filed by Wendy Leigh Yates in Stanislaus County’s California Superior Court in late January, against General Motors and Sexton Chevrolet of Manteca, California. The complaint alleges that the 2007 Chevrolet Tahoe was defectively designed and manufactured, allowing the passenger seat to collapse during an October 2007 crash.

According to the complaint, Wendy Leigh Yates was a passenger in a Chevy Tahoe being driven by her daughter, Brittany Yates, when it was rear-ended by another vehicle on October 18, 2007. As a result of the impact, the passenger seat where Wendy Leigh Yates was sitting broke and collapsed backward, causing Yates to slide out of her shoulder restraint and hit her head on the rear passenger compartment. She suffered multiple skull fractures, resulting in permanent injuries and seizures.

A traumatic brain injury is one of the leading causes of death and permanent disability world wide, with 1.4 million people suffering head trauma injuries each year. Automobile accidents are a leading cause of head trauma, accounting for approximately 20% of all traumatic brain injuries. Victims often requiring extensive medical treatment and permanent around-the-clock care.

The product liability lawsuit alleges that GM knowingly sold a defective vehicle to consumers and failed to warn them of the safety risks. The lawsuit claims GM knew, or should have known, that the vehicle’s safety features would fail in relatively low impact accidents, resulting in the risk of severe injury to occupants. The litigation claims that GM’s own test footage shows that the seats can fail and cause the occupant to fall back, striking their head. The suit also alleges that GM’s own testing shows that the seat belt would not properly hold the passenger in place when the seat failed.

The claim seeks an unspecified amount for economic damages, medical expenses, loss of earning capacity, pain and suffering for Yates and her daughter. It also seeks compensation for her husband, Gavin Yates, on the grounds of loss of consortium.