Author: AboutLawsuits

  • Toyota Wrongful Death Lawsuit Filed Over Defective Gas Pedal

    Another Toyota wrongful death lawsuit has been filed over a fatal auto accident allegedly caused by the uncontrolled, sudden acceleration of a Toyota Corolla.

    Trina Renee Harris, 34, died in December in Houston, Texas, when her 2008 Corolla blew through a stop sign and ran into a concrete wall. The Toyota model was one of more than 5 million vehicles that have been included in a series of Toyota recalls over the last several months due to problems with sudden acceleration. Her husband, Michael Harris, filed a wrongful death lawsuit in Harris County District Court on February 1 against Toyota, gas pedal manufacturer CTS Corp., and the Fred Haas Toyota World car dealership.

    The mother of two died while her husband, an officer in the U.S. Navy, was on assignment in San Diego after a tour of duty on an aircraft carrier in the Middle East. According to the Toyota product liability lawsuit, the accident was caused by a defective accelerator pedal.

    In September 2009, a Lexus and Toyota 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, including 600,000 that were not subject to the prior floor mat recall due to an actual mechanical problem that was causing some gas pedals to stick. Shortly after, the company stopped production and sales on eight of its most popular vehicles, including the Corolla, Camry, and Tundra. The company has also announced it is recalling nearly 2 million vehicles in Europe and almost 80,000 in China.

    Last week, Toyota announced a fix for the recalled gas pedals, indicating that they will make repairs that eliminate the problems that have caused some accelerator pedals to stick. The repair involves the addition of a shim to a part of the pedal assemblage, which will prevent a resistance spring from locking up due to friction.

    In addition to the gas pedal problems, the Japanese automaker announced this week that they will issue a Toyota Prius recall for about 300,000 of the hybrid vehicless due to brake problems sometime this week. Toyota officials say that the Prius brake problem was caused by the vehicle switching between traditional braking systems and an electronic system that helps recharge the car’s battery. Drivers would feel a moment where the brakes did not appear to be working as the system switched over. The problem was fixed by a software adjustment, the company claims.

    The gas pedal recall has resulted in a slew of Toyota lawsuits. About a dozen class action lawsuits against Toyota have been filed, including eight since the end of January. There have also been several wrongful death Toyota lawsuits, like Harris’s.  Attorneys familiar with the cases say Toyota will likely be hit by an additional three dozen lawsuits in coming weeks.  All of the cases claim that Toyota knew or should have known about the defective gas pedal problems and sold defective and dangerous vehicles to the public.

    As of February 5, Bloomberg News reports that there were about 30 lawsuits over the Toyota accelerator problems.

    The Harris wrongful death lawsuit charges the defendants with gross negligence, and seeks $200 million in compensatory and punitive damages. Toyota has indicated that the true cause of the accident should be determined before the company can respond. Experts from Harris’s legal team and insurance company inspectors are expected to conduct investigations of the wreckage.

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

  • Prempro Verdict for Punitive Damages Reduced by Judge

    A Pennsylvania judge has slashed a jury’s $78.7 million award in a Prempro breast cancer lawsuit, saying that the punitive damage portion of the verdict was excessive.

    In October 2009, a Philadelphia jury awarded Connie Barton $3.7 million in compensatory damages and another $75 million in punitive damages after finding that Wyeth hid the risk of breast cancer from Prempro.

    In an order issued by Judge Norman Ackerman of the Philadelphia Common Pleas Court, the punitive damages award was reduced to $5.62 million. However, the compensatory damage award was left intact and Judge Ackerman added another $1.25 million in interest to the award, bringing the total Prempro verdict to $10.5 million.

    Barton’s case is one of about 9,000 Prempro lawsuits pending against Pfizer’s Wyeth subsidiary. All of the lawsuits involve similar allegations that the drug maker failed to adequately warn about the risk of invasive breast cancer from hormone replacement therapies, and intentionally hid the cancer risk from women.

    Hormone replacement therapy involves the use of hormones and progestins to artificially boost hormone levels in women undergoing menopause due to surgery or in postmenopausal women, to provide relief from symptoms such as hot flashes, irregular menstruation or weight gain.

    In 2002 the National Institutes of Health released the results of studies that found women receiving HRT were at higher risk of breast cancer, strokes and heart attacks. The studies, part of the Women’s Health Initiative, sparked most of the breast cancer lawsuits currently against the company.

  • Tysabri Brain Infection Risk Increases with Number of Infusions: FDA

    The FDA has issued another warning about the risk of brain infections from Tysabri, indicating that the more infusions a patient receives of the multiple sclerosis drug, the higher their risk of contracting progressive mutifocal luekoencephalopathy (PML), a rare and often fatal infection in the brain.

    Healthcare professionals were notified on Friday about this new safety information and label changes about the risk of Tysabri brain infections. The new warnings come after the agency confirmed at 31 cases of PML brain infectiions among Tysabri users.

    Tysabri (natalizumab) is an intravenous injection given every 28 days to treat MS and Crohn’s Disease. Manufactured by Biogen Idec Inc. and marketed with Elan Corp PLC, Tysabri has been shown to prevent relapse, cognitive decline and vision loss associated with MS. Sales of Tysabri bring in about $1 billion annually.

    A Tysabri recall was issued in 2005 after three users developed the rare and life-threatening brain infection, which attacks the central nervous system, damaging and inflaming the white matter areas of the brain. The drug was reintroduced in July 2006 with stronger warnings about the potential PML brain infection side effects of Tysabri and it was only made available under strict usage guidelines.

    PML is believed to be caused by the common JC virus, and side effects of Tysabri may reduce the ability of the immune system to combat the virus.

    Symptoms of PML brain infections from Tysabri could include confusion, blurred vision, speech and movement difficulties, dizziness and loss of balance. In most cases, PML has a very high fatality rate, however, some Tysabri users have had a better prognosis due to early detection and the use of a plasmapharesis treatment, which removes Tysabri from the system rapidly and allows the immune system to fight off the virus.

    Due to the risks of PML, Tysabri is only available in the U.S. after its re-release through a joint FDA and BioGen risk reduction program called Tysabri Outreach Unified Commitment to Health (TOUCH). The TOUCH program monitors each patient for signs of PML or other opportunistic viruses that may strike at patients with lowered immune systems.

    By studying the 31 cases of PML since Tysabri was re-introduced, the FDA has determined that there have been no reports of PML in patients treated for less than 12 months. Patients who have had 24 to 36 infusions in the U.S. have developed PML at a rate of 1 in 1,000. Outside of the U.S., the rate is 1 in 2,000, but the FDA does not know why there is a discrepancy.

    The FDA recommends that doctors take the patient off Tysabri at the first signs of PML.

    The safety warning also contained information about another Tysabri side effect known as Immune Reconstitution Inflammatory Syndrome (IRIS). The condition is rare, causing an inflammatory response in patients who recovered from PML after being taken off Tysabri infusions. IRIS can cause an unexpected decline in their condition. It has not been detected in patients who discontinued Tysabri for other reasons.

  • Medtronic Sprint Fidelis Lead Failure Rates Reportedly As High As 9.2%

    According to new research, the failure rate for recalled Medtronic Sprint Fidelis leads, which are small wires used to connect a defibrillator to the heart, could be twice as high as the manufacturer has claimed.

    A number of prominent medical facilities, including the Mayo Clinic, the University of Rochester and the University of Ottawa, say that Medtronic’s published failure rate of 4.6% for the leads is wrong. According to a new study published in the January edition of the American Journal of Cardiology, the Medtronic Sprint Fidelis lead failure rate at three years was 9.2% at one particular hospital. In addition, researchers found that the failure rate of the leads is increasing as time goes by. 

    A Medtronic Sprint Fidelis recall was issued on October 15, 2007, after it was confirmed that the small wires were prone to fracture or break. At the time of the recall, the leads were already implanted in about 268,000 people. If the defibrillator lead fails, it could result in a massive electrical shock or cause a patient’s cardiac defibrillator not to work when it is needed to deliver a life-saving jolt.

    Researchers performed a retrospective review of 426 lead implants at the University of Rochester to highlight the hazards of the leads fracturing over time. They found that only 90.8% of the leads implanted survived after three years, and concluded that “the hazard of Fidelis lead fracture is increasing exponentially with time and, based on our data, occurring at a higher rate than the latest manufacturer’s performance update.”

    The researchers note that other defibrillator leads have shown no sign of increased failure rate over time, and say that more studies are needed to determine whether the fracture rate will continue to rise or level off over time.

    The findings come after an analysis by UBS Investment Research in late December warned that Sprint Fidelis lead failures could reach as high as 30% over four years. The analysis also suggested that the leads appear more likely to fail in healthier patients.

    Thousands of Medtronic defibrillator lead lawsuits have been filed on behalf of individuals who had the leads implanted, including hundreds who have had the lead fracture. However, most of those suits were dismissed last year due to a 2008 Supreme Court decision in Reigel vs. Medtronic, which was found to protect Medtronic from liability for their defective medical device because it was approved by the FDA.

    While the Sprint Fidelis lawsuits are being appealed, efforts are underway in congress to overturn the Reigel Supreme Court decision with the Medical Device Safety Act of 2009. Senators last held a hearing on the bill in August, at which time the Government Accountability Office (GAO) released a report that determined that the FDA was inadequate to the task of being the sole insurer of medical device safety.

  • Nintendo Wii Injury Reports Growing in Severity

    Reports of injuries associated with the Nintendo Wii appear to be growing in severity as more peripherals have been introduced for the popular game system, requiring users to be more physical.

    According to a letter published in the most recent edition of the New England Journal of Medicine, Karen Eley of Oxford Radcliffe Hospitals NHS Trust in the United Kingdom, details a serious foot injury sustained by a 14-year-old girl while playing the Wii. The girl fell off of her Wii Fit balance board and suffered a fractured foot.

    The incident is just one of a growing number of injuries connected to the Wii, which have included head injuries, dislocated bones and even at least one case of traumatic hemothorax, which involved bleeding in the space between the chest wall and the lung.

    Many of the more severe injuries are related to use of the Wii Fit balance board, which rests two inches off the ground and requires users to quickly adjust their balance while standing on the board to play certain video games. Most commonly, users suffer what doctors call “Wii-knee” which is caused by frequent bending at the knee while using the balance board. In some cases, the injuries have involved the kneecap becoming dislocated. 

    The injuries are not restricted to use by the balance board. The standard Nintendo Wii controller, a wireless remote that is sensitive to hand movements, has been associated with injuries being called Wii-itis by doctors and users.

    As early as 2008, doctors warned about the risk of Nintendo Wii injuries, indicating that they were seeing an alarming number of new injuries by players of the Wii. Most of the injuries were associated with stretched or torn tendons, similar to tennis elbow. Doctors estimated in 2008 that the Wii put an average of 10 users in the hospital every week.

    One of the problems, experts say, is that people using the Wii often do not approach it the same way they would normal physical exercise. They do not stretch first and often play for extended periods of time. Stretching before playing and limiting Wii play time to sessions comparable to doing actual exercise could eliminate many injuries, doctors say.

  • Illinois Medical Malpractice Damage Cap Struck Down by State High Court

    The Illinois Supreme Court has ruled that the state’s cap on damages in medical malpractice lawsuits is unconstitutional and violates the separation of powers between the judicial and legislative branches of the government.

    The 4-2 ruling, issued last Thursday, struck down a law capping non-economic damages in Illinois malpractice cases, which had been in place since 2005. It is the third time that the state’s highest court has ruled against medical malpractice caps.

    Chief Justice Thomas Fitzgerald said that the state’s attempt to override the will of a jury with a cap on malpractice awards in Illinois “runs afoul of the separation of powers clause.” Fitzgerald called the caps, which limited non-economic damages to $500,000 for physicians and $1 million for hospitals, arbitrary and said that the caps did not regard facts or circumstances. Fitzgerald said that the cap eroded the consistency and rationality of the state’s justice system.

    The law was brought to the court on appeal after it was ruled unconstitutional by Cook County Circuit Judge Diane Larsen in an Illinois malpractice suit brought by the family of Abigaile LeBron, an infant girl who suffered brain damage at birth. Larsen, echoing a similar Illinois Supreme Court decision that struck down a 1995 medical malpractice cap, said that the legislature stepped on the jurisdiction of juries and judges by enacting the cap.

    Justices Anne Burke, Charles Freeman, and Thomas Kilbride ruled along with Fitzgerald to reject the ban. Justices Lloyd Karmeier and Rita Garman dissented, referencing health care costs and the needs for reform. Fitzgerald and the majority judges stated that their decisions on constitutionality could not be influenced by those factors, however.

    California was the first state to enact a damage cap in 1975, specifically limiting the non-economic damages in medical malpractice lawsuits. According to the National Conference of State Legislatures, as of 2005 ten states capped recoveries specifically on medical malpractice cases and another 22 have caps that are not limited to medical malpractice. About a dozen states also have caps on punitive damages.

    Similar caps are facing legal challenges in Missouri, Indiana and Georgia.

  • Chantix Attorneys Appointed to Leadership Roles in Federal Litigation

    U.S. District Judge Inge Prytz Johnson, who is presiding over the federal Chantix litigation, has appointed 17 attorneys to serve in leadership roles in the multidistrict litigation (MDL). The Chantix attorneys will perform actions during pretrial proceedings that will benefit all plaintiffs who have filed a Chantix lawsuit in federal courts throughout the United States. 

    In October 2009, the U.S. Judicial Panel on Multidistrict Litigation consolidated all federal lawsuits over Chantix before Judge Johnson in the U.S. District Court for the Northern District of Alabama. The cases include allegations that Pfizer failed to adequately research their medication or adequately warn doctors and patients about the potential psychological Chantix effects, which can include suicide, suicidal thoughts, depression and other abnormal behavior.

    As part of the coordinated pretrial proceedings, Judge Johnson issued an order on February 2 appointing Ernest Cory to serve as Plaintiffs’ Lead Counsel and Joe Whatley Jr. to serve as Plaintiffs’ Liason Counsel. As Lead Counsel, Cory will act as a spokesperson for all plaintiffs at pretrial hearings and in response to inquiries from the court. He wil also submit and argue motions before the court, examine witnesses at hearings and negotiate stipulations and potential Chantix settlement agreements with the defendants, which would apply to all cases. As Liason Counsel, Whatley will receive and distribute orders from the Court and documents from opposing counsel, and assist in the coordination of activities between both parties.

    Together with Cory, four other lawyers were appointed to serve on the Plaintiffs’ Executive Committee and nine attorneys were appointed to serve on the Plaintiffs’ Steering Committee together with Whatley. Jayne Conroy and David Ratner were also appointed to serve as Plaintiffs’ State/Federal Liason Counsel.

    Chantix (varenicline) was approved by the FDA in 2006 as a prescription medication to help people quit smoking. The drug works by reducing the positive feelings that come from cigarettes, blocking the receptors in the brain commonly stimulated by nicotine. However, the drug has been linked to increased risks of suicide and suicide attempts, aggressive behavioral changes and other psychiatric side effects, which have resulted in fatal or catastrophic injuries for many users.

    The FDA has received hundreds of adverse event reports involving Chantix problems, leading to a “black box” warning being added to the medication in June 2009 to warn consumers and the medical community about the potential psychological side effects. Pfizer has also been required to conduct clinical trials providing more data on how often neuropsychiatric symptoms with Chantix occur and what conditions cause them.

    The first status conference in the MDL has been set for February 23, when attorneys from both sides will meet and develop a discovery plan and discuss coordination with courts dealing with Chantix lawsuits at the state level.

    When the Chantix MDL was formed in October, 34 cases were consolidated before Judge Johnson. Since that time, Chantix suicide lawsuits have continued to mount. According to documents filed early last month, an additional 27 complaints have been transferred to the MDL. In addition, Chantix attorneys are continuing to review potential cases, and it is expected that hundreds of additional complaints over Chantix will be filed in the future.

  • Estimated Cost of Mesothelioma Lawsuits for Insurers in U.K. Doubles

    Actuaries in the United Kingdom are doubling earlier predictions about the potential cost of asbestos and mesothelioma lawsuits, estimating that $17.7 billion in asbestos-related claims will be filed between now and 2050.

    The new numbers, provided last month by the U.K. Asbestos Working Party (PDF), is more than twice that of the $7.57 billion estimate it made in 2004. The group, part of the Actuary Profession association, estimated that 90% of all asbestos claims filed with insurance companies will be related to cases of mesothelioma cancer.

    The group said that the number of mesothelioma sufferers who would make claims was underestimated in 2004, when claims from people with mesothelioma only accounted for one-third of all insurance claims. Since then, that percentage has skyrocketed to two-thirds and continues to rise.

    Mesothelioma is a rare form of cancer 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.

    Asbestos was widely used in a variety of manufacturing and construction applications throughout the last century, with use peaking in 1973. Most uses of asbestos were banned in the United States in the mid-1980s. Despite the ban, the U.S. Centers for Disease Control and Prevention says that the number of mesothelioma deaths continues to rise each year due to the latency period, with the number expected to peak in 2010.

    Asbestos litigation is the longest running mass tort in U.S. history, with the first asbestos exposure case 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.

  • Financial Fraud Arbitration Cases Increased 43% in 2009

    The number of plaintiffs filing financial fraud arbitration claims topped 7,000 last year, as more brokers and financial firms were hit with breach of fiduciary duty charges in the wake of the sub-prime mortgage debacle.

    According to statistics released last month by the Financial Regulatory Authority (FINRA), arbitration claims skyrocketed in 2009, increasing 43% over the 4,982 cases filed in 2008. Breach of fiduciary duty was charged in 4,206 of those cases, making it the leading complaint filed last year. Misrepresentation and negligence were the next two most common charges, with 3,408 and 3,405 cases, respectively.

    Mutual funds were the most common target of investor arbitration, with 1,556 claims filed against them. Many attribute the increase in filings to the collapse of the sub-prime mortgage market at the end of 2007. A number of high-profile stockbroker fraud arbitration claims have been won by investors who say that some funds which claimed to be conservative violated their prospectus by investing heavily in sub-prime mortgage financial products.

    FINRA is a non-governmental regulatory body that handles the resolution of disputes between investors and stockbrokers and other financial firms. It was created in July 2007 as a successor to the National Association of Securities Dealers, to arbitrate stock broker fraud claims that can include charges of breach of contract, breach of fiduciary duty, negligence, misrepresentation, unauthorized trading and other claims that investments were improperly handled.

    The new numbers bear out a FINRA report released in July, which estimated that the number of claims would breach the 7,000 mark. In July, FINRA figures noted that investors were winning more cases in 2009. Through May, FINRA arbitration panels ruled in favor of awarding investors 47% of the time, as opposed to 42% during the same period last year. It remains to be seen whether that trend held steady throughout 2009.

  • Ohio Wrongful Death Lawsuit Results in $3.6M Verdict

    An Ohio jury awarded $3.6 million in a wrongful death lawsuit filed by the family of a man who was crushed to death after his truck was overloaded with propane cylinders.

    The verdict was issued Tuesday in the Tuscarawas County Common Pleas Court in favor of the family of Robert L. Romig, Jr., according to a report in the Canton Repository. Romig died on June 20, 2005, after a load of propane cylinders fell on him while he was trying to offload his truck during a delivery. The lawsuit accused Worthington Cylinder Corp., a subsidiary of Worthington Industries of Columbus, of overloading his truck.

    Romig died when he tried to attach a hook for a crane onto one of four tiers of cylinders that were loaded onto his two-level flatbed truck. One of the cradles, loaded with propane cylinders, detached and fell on Romig, crushing him to death. According to the complaint, there should have been only three tiers of cylinders loaded onto the truck.

    During the Ohio trial, a loader who worked for Worthington testified that he saw that the truck was overloaded, and saw that some of the load had created a dangerous overhang, but never informed Romig. The employee said that he knew what had caused the accident as soon as he heard Romig had been killed. The plaintiffs alleged that the company forsook safety in order to get the cylinders loaded onto trucks as fast as possible.

    The lawsuit had been filed by Romig’s wife, Sandra Romig, and on behalf of their four adult children. The jury deliberated less than two hours before reaching the verdict after a three-week trial.

  • NIH to Track Radiation Exposure in Patients’ Medical Records

    In the wake of growing concerns over CT scan radiation exposure and the risk of cancer, federal regulators have announced that they will begin tracking radiation doses given to patients.

    The National Institutes of Health (NIH) says that it’s own doctors will begin recording radiation doses for patients in medical records, according to an announcement in the most recent issue of the Journal of the American College of Radiology. Recording the dosages is expected to help doctors manage the risk of cancer due to radiation exposure over time.

    NIH officials say that while they treat too few patients directly to use the information as a database of medical radiation exposure cancer risk, they hope that other hospitals will follow their lead. Their record-keeping will also not focus on radiation errors, but instead will watch the accumulation of radiation exposure from  a variety of treatments.

    CT scan procedures across the country are under close scrutiny by the FDA after the discovery that a number of patients have suffered radiation overexposure from CT Scans performed incorrectly. The FDA is currently reviewing CT scan procedures nationwide, and released interim guidance for health care professionals and radiologists in December. The guidance advised them to review procedures and CT scan settings, and to be thorough in checking the amount of dosage prescribed for each CT scan patient.

    The recent FDA investigation was sparked by the discovery of CT scan radiation over-exposure problems that may have affected more than 200 patients at Cedars-Sinai Medical Center in Los Angeles last year. Since then, the FDA has uncovered at least 50 more radiation CT errors.

    A recent study by the National Cancer Institute concluded that CT scan radiation could be responsible for as much as 2% of all cases of cancer in the U.S. It is estimated that 29,000 people annually could develop cancer within five years of receiving a scan and about half of those people will die from the cancer.

  • Toyota Prius Brake Problems Reported in Nearly 200 Cars

    Nearly 200 reports of brake problems with the 2010 Toyota Prius have the troubled car company considering a recall of the newest model of their famous hybrid vehicle, even while they are still reeling from the fallout a massive recall that has pulled millions of cars off the road due to Toyota problems with sudden acceleration.

    The Toyota Prius brake issues have been reported by at least 180 drivers from the United States and Japan. Toyota indicates that they have already found the source of the problem in the car’s anti-lock brake system and fixed Prius models sold since late January. However, the Japanese automaker did not inform customers and has not indicated whether a Toyota Prius recall will be issued for the 2010 models sold before the fix was initiated.

    Toyota officials say that the Prius brake problem was caused by the vehicle switching between traditional braking systems and an electronic system that helps recharge the car’s battery. Drivers would feel a moment where the brakes did not appear to be working as the system switched over. The problem was fixed by a software adjustment, the company claims.

    Consumer frustration with Toyota has reached unprecedented heights in recent weeks, as the company has recalled more than 5 million Toyota and Lexus vehicles since September due to problems where the some vehicles were accelerating out of control. The company was reportedly aware of the issues for some time and did not take steps to notify the public until after a high-profile crash in August 2009 gained media attention.

    The Toyota sudden acceleration issues have been blamed on thick floor mats used in some vehicles and sticking gas pedals caused by friction. However, outsiders have been pushing for an investigation of the vehicles electronic acceleration system.

    In September 2009, a Lexus and Toyota 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, including 600,000 that were not subject to the prior floor mat recall due to an actual mechanical problem that was causing some gas pedals to stick. Shortly after, the company stopped production and sales on eight of its most popular vehicles, including the Corolla, Camry, and Tundra. The company has also announced it is recalling nearly 2 million vehicles in Europe and almost 80,000 in China.

    As Toyota class-action lawsuits and product liability lawsuits mount against the company, U.S. officials say they have initiated a new probe into the acceleration problems, focusing in part on the electronics linking the accelerator pedal to the engine. Toyota has ruled out the electronics as a cause of the acceleration problems.

    Transportation Secretary Ray LaHood went as far as recommending recently that Toyota owners park their cars unless they were taking them in to get the accelerator fixed, but later retracted the statement.

    The gas pedal problem got a very public face this week after Apple Inc. co-founder Steve Wozniak came out and admitted that he had experienced a sudden acceleration problem in his 2010 Prius several months ago. Wozniak said his Prius accelerated out of his control to speeds of up to 97 m.p.h. before he was able to regain control of the vehicle. Wozniak said he contacted both federal investigators and Toyota, but no one paid attention to his concerns. Toyota engineers have said they will examine his car and look for the source of the problem.

  • Studies Link Side Effects of Lead Exposure to ADHD in Children

    New research into the causes of attention-deficit hyperactivity disorder (ADHD) seem to suggest that lead exposure could be a contributing factor for up to 30% of ADHD children.

    The findings from two new studies, published in this month’s issue of the journal Current Directions in Psychological Science, suggest that exposure to lead may be the second leading cause of ADHD, after genetics. Researchers said they found a consistent link between elevated lead levels and ADHD signs in children.

    Scientists have been able to account for only about 70% of all ADHD cases through genetics, considered to be the primary cause. However, the cause of the other 30% of cases has been hard to determine.

    The new studies found that children with ADHD had higher blood lead levels than those who do not show signs of the behavioral disorder. Researchers also found that the higher the blood lead levels, the more signs of ADHD were present in children’s behavior. High blood lead levels can also result in lead poisoning. The U.S. Centers for Disease Control and Prevention (CDC) consider 10 milligrams of lead per deciliter of blood to be the level of concern for lead exposure.

    Blood lead levels traditionally considered to be lead poisoning can result in nervous system injury, brain damage, seizures or convulsions, growth or mental retardation, coma and even death. Most cases of elevated lead blood levels in children are caused by exposure to lead paint, which is still present in many older homes throughout the United States. If the paint flakes off the wall, young children could ingest the paint chips or breathe in the dust, causing elevated levels of lead in the blood.

    These latest studies follow on the heels of research published in the last two months that has connected low levels of lead exposure to kidney damage in children, as well as depression and panic disorders in young adults.

  • Boneless Beef Recall: 14,000 lbs. May Have E. Coli Contamination

    About 14,000 pounds of boneless beef products distributed by West Missouri Beef, LLC have been recalled due to the possibility of E. coli food poisoning.

    The boneless beef recall was announced on Tuesday by the US. Department of Agriculture’s Food Safety and Inspection Service (FSIS) after FSIS inspectors found evidence of E. coli O157:H7 contamination at the company’s facility. The meat was distributed by the Rockville, Missouri, company to wholesalers in the Chicago area. There have been no reported illnesses connected to the contaminated beef.

    E. coli O157:H7 bacteria is one of the more common causes of food poisoning in the United States. When left untreated, it can lead to dehydration and potentially life-threatening illness. While most healthy adults recover from food poisoning caused by E. coli within a few weeks, young children and the elderly could be at risk for more severe illness. If the toxin enters the blood stream, E. coli could also lead to kidney failure known as Hemolytic-Urenia Syndrome (HUS).

    The recall affects 14,000 pounds of boneless beef processed between October 26, 2009 and January 13, 2010. Products affected by the recall include combo bins of 2,000 pounds of boneless beef. The bins are marked:

    • 75 1-M, produced October 26, 2009
    • 90 3-D, produced November 25, 2009
    • 90 5-D, produced November 27, 2009
    • 90 2-P, produced December 8, 2009
    • 90 2-R, produced December 8, 2009
    • 90 2-V, produced December 8, 2009
    • 90 3-E, produced January 13, 2010

    Each container is marked with an establishment number of “EST. 5821″ inside the USDA mark of inspection.

    Anyone with questions should contact the company at (660 )598-2045.

    The CDC reports that there are about 76 million cases of food-related illnesses reported every year, with more than 300,000 people hospitalized and 5,000 deaths. There were at least nine major recalls of beef products in 2009.

  • Trial Over Fosamax Jaw Damage Set to Begin April 19 in New York

    A federal judge has denied attempts by Merck & Co. to have a Fosamax lawsuit thrown out, clearing the way for an April 19 trial to move forward involving allegations that the plaintiff developed permanent and debilitating jaw damage from Fosamax side effects.

    The case, filed by Louise H. Maley, will be the second Fosamax trial to reach a jury out of hundreds of cases that are currently pending against Merck involving allegations that they failed to adequately research their osteoporosis drug and warn about the risk of a rare jaw condition, known as osteonecrosis of the jaw.

    A prior trial, involving a lawsuit over jaw damage from Fosamax filed by Shirley Boles, ended in a mistrial last year, after the jury was unable to reach a unanimous verdict. It is anticipated that the Boles case will be retried later this year.

    Both cases were chosen as “bellwether” trials because they would be used to evaluate how juries respond to the evidence in the Fosamax litigation. A third “bellwether” case, involving a lawsuit filed by Bessie Fleming, was dismissed in November, after the Court determined that the plaintiff would be unable to establish that Fosamax caused her jaw damage.

    Merck tried to have Maley’s lawsuit dismissed as well, arguing that she could not show specific causation between Fosamax and jaw injuries that developed after taking the drug for eight years. However, in a ruling issued last week, U.S. District Judge John Keenan disagreed and ruled that Maley has enough evidence to allow the case to be presented to a jury.

    Judge Keenan indicated in his order that Maley’s trial over Fosamax jaw damage will begin on April 19, 2010 at 10:00 a.m. in the U.S. District Court for the Southern District of New York, in Manhattan.

    There are currently more than 900 similar Fosamax jaw damage lawsuits pending against the Merck & Co., and lawyers will be closely watching how the jury in the Maley trial respond to evidence that is likely to be presented throughout many of the other cases.

    Fosamax (alendronate sodium), is a member of a class of drugs known as bisphosphonates, and is prescribed for treatment of osteoporosis. Fosamax was approved by FDA in October 1995, and has been used by more than 20 million people. The drug generated over $3 billion in annual sales for Merck before it became available as a generic last year.

  • Settlements Reached in 18 Las Vegas Endoscopy Clinic Hepatitis C Lawsuits

    A Nevada judge has approved the settlement of 18 hepatitis C lawsuits filed by patients of two Las Vegas endoscopy centers that was shut down in 2008 due to unsafe medical practices that exposed thousands of patients to potential infection.

    The Las Vegas endoscopy clinic settlements, which are for undisclosed amounts with Nevada Mutual Insurance Co., were reported last week by Courthouse News Service. The plaintiffs all claimed that they contracted hepatitis C as a result of unsanitary practices at the Endoscopy Center of Southern Nevada and Desert Shadow Endoscopy Center , including reuse of syringes and vials of medication intended for only single-patient use.

    In February 2008, health officials shut the clinics down after identifying the problems, and over 40,000 former patients were advised by the Southern Nevada Health District to get tested for potentially fatal blood-borne diseases like Hepatitis C or HIV.

    Hepatitis C is an infectious disease that can cause liver damage, including liver failure, cirrhosis and liver cancer. It is technically incurable, but very effective treatment has been able to eradicate the disease in some of those who contract it.

    Attempts to certify a hepatitis C class-action lawsuit on the basis of emotional distress on behalf of thousands of former patients of the clinic failed in 2008, but more than 250 patients who suspect they contracted hepatitis C from the clinic filed individual lawsuits.

    There were concerns among those involved in the litigation about the limited insurance coverage and assets available to satisfy all of the infection lawsuits filed, as it was previously reported that the clinic’s insurance policy was only $3 million.

  • Disney Tinkerbell and Papyrus Greeting Card Jewelry Recall: Lead Risk

    About 426,000 children’s jewelry toys have been recalled due to high levels of lead, including the “Tiny Tink” series of Disney Tinkerbell charms and children’s birthday bracelets sold with Papyrus Brand Greeting Cards.

    The recalls were announced by the U.S. Consumer Product Safety Commission on Tuesday. The Tinkerbell jewelry sets, imported by Playmates Toys, were found to have a metal connector that contained levels of total lead in excess of 300 parts per million. The Papyrus bracelets, imported by Schurman Fine Papers, were found to have paint containing excessive levels of lead. Both toys are in violation of the federal lead paint standard.

    The Disney toy jewelry recall affects 252,000 charms sold with the Tiny Tink and Friends toy jewelry sets. The charms have a metal ring and cylinder that are used to attach them to a the toy necklace, bracelet or key chain. Only the units with metal rings and cylinders are affected by the recall. The recall affects the following products:

    • Tinker Bell’s Lil’ Tinker Bracelet, Item #’s 74634 and 74641, UPC #’s 0 43377 74634 8 and 0 43377 74641 6
    • Rosetta’s Rosebud Key Chain, Item # 74631, UPC # 0 43377 74631 7
    • Silvermist’s Water Lily Necklace, Item # 0 43377 74632 4

    The toys were sold at retailers nationwide from November 2008 through November 2009 for between $6 and $8.

    The Papyrus Brand Greeting Cards bracelet recall affects 174,000 wooden bead bracelets that were sold attached to greeting cards with the words “Happy Birthday To You” on the front. The bracelet is multi-colored and includes a wooden bead shaped like a butterfly. The greeting card includes a UPC number of 734524634013 in the lower right corner, and also has “BD 63401″ and “Jean Card & Gift Company” on the back.

    The greeting cards and bracelets were sold in card stores nationwide and by other retailers from February 2004 through September 2009 for about $7.

    High levels of lead paint in children’s toys is heavily regulated due to the risk of long-term damage that may be caused by lead poisoning. High levels of blood lead levels, which typically result from children ingesting lead paint chips that flakes off the walls of older homes, can result in nervous system injury, brain damage, seizures, growth or mental retardation, coma or even death. However, even low levels of lead exposure have been found to be potentially dangerous.

    Any consumers whose children have these toys should take them away immediately and contact the manufacturers for a replacement or full refund.

  • Wal-Mart Disney Princess and the Frog Necklace Recall: Cadmium Risk

    About 55,000 Disney “The Princess and the Frog” necklaces sold exclusively at Wal-Mart stores have been recalled due to high levels of the toxic substance cadmium.

    The Wal-Mart Disney necklace recall was announced by the U.S. Consumer Product Safety Commission (CPSC) on Friday. The necklaces, imported from China by FAF Inc., of Greenville, Rhode Island, have been found to contain high levels of cadmium, which is toxic if ingested by young children. Although no injuries have been reported in connection with the recalled jewelry, consumers have been urged to immediately take the necklaces away from children.

    Cadmium is a toxic metal that is often a by-product of zinc production. Before its toxicity was understood, it was used as a paint pigment and as corrosion-resistant plating on steel. Cadmium is a known carcinogen and the U.S. Centers for Disease Control and Prevention ranks cadmium as the seventh most hazardous substance in the environment. Cadmium poisoning is considered an occupational hazard in some industrial processes and can cause metal fume fever, pulmonary edema, pneumonitis and death. It has also been found to cause developmental problems in children.

    The “Princess and the Frog” necklace recall affects about 55,000 necklaces, which have pendants shaped either like a crown or a frog attached to a metal link chain necklace. The necklaces come with a crown-shaped jewelry box in packaging that has “Disney” and “The Princess and the Frog” printed on it. The necklaces with the crown have a model number of 4616-4187 and a UPC number of 72783367144. The necklaces with the frog pendant have a model number of 4616-4190 and a UPC number of 7278336147.

    The necklaces were sold at Wal-Mart stores nationwide from November 2009 through January 2010 for $5. The necklaces can be returned to any Wal-Mart store for a full refund or a replacement product.

  • Seroquel Litigation May Cost AstraZeneca $1.2B in Legal Costs: Report

    Litigation over Seroquel could cost AstraZeneca up to $1.2 billion in legal costs between thousands of plaintiffs’ failure-to-warn Seroquel lawsuits and government charges that the popular anti-psychotic drug was marketed illegally.

    The ten-digit price tag for Seroquel litigation was estimated in a January 29 article in the Financial Times. The numbers include a $524 million settlement with the U.S. Attorney’s Office in Philadelphia over alleged off-label promotion of the drug, and the cost of battling about 10,000 Seroquel suits filed by 22,000 plaintiffs who claim that the drug maker failed to adequately warn users about potential side effects that may increase the risk of diabetes, weight gain, hyperglycemia and a rare movement disorder known as tardive dyskinesia.

    To date, AstraZeneca has refused to settle Seroquel cases filed by individual users, indicating that they will defend all lawsuits. However, internal documents produced during the litigation suggest that the drug maker was aware of the potential weight-gain Seroquel side effects and continued to promote the drug as weight-neutral for years after clinical evidence demonstrated significant problems that could lead to diabetes and other injuries. The company has racked up $656 million in legal defense costs fighting the failure-to-warn lawsuits over Seroquel, but expects insurance to reimburse it for $521 million of that. However, with the cases are still being fought, the price tag will continue to climb.

    All federal Seroquel lawsuits are consolidated for pretrial litigation in an MDL, or multidistrict litigation, that is centralized in the U.S. District Court for the Middle District of Florida. In November, U.S. District Judge Anne Conway, who is presiding over the Seroquel MDL, ordered lawyers for both sides to met with a mediator to see if there is any possibility for a Seroquel settlement before as many as 6,000 cases are sent back to the districts where they were originally filed for trial.

    Seroquel (quetiapine fumarate) is an atypical-antipsychotic that is a top selling drug for AstraZeneca, generating nearly $5 billion a year in sales. Approved by the FDA in 1997 for the treatment of schizophrenia, it is also commonly used off-label for treatment of anxiety, obsessive dementia, compulsive disorders and autism. Seroquel has been used by more than 19 million people worldwide.

    In a quarterly report released in October, AstraZeneca noted that it had reached an agreement in principle to settle charges by the U.S. government that it was promoting Seroquel for uses not approved by FDA, which is illegal. While doctors may prescribe drugs to treat any ailment, regardless of their approved use, companies are not allowed to promote those drugs for uses other than those that have received federal approval. The settlement is estimated at about $524 million.

    According to internal company documents uncovered through Seroquel litigation, off-label promotion of the drug has been a key marketing strategy for AstraZenca since at least 2000. During pretrial proceedings in lawsuits involving Seroquel filed by consumers who developed diabetes and other health problems after using the drugs, company papers were released that had the stated objective to “continue to encourage off-label use of Seroquel for the treatment of bipolar disorders through publications presented at major congresses,” even though treatment of bipolar disorders was not approved at the time.

  • Salami Food Poisoning Lawsuits Filed as FDA Links Salmonella to Pepper

    The FDA indicates that tainted black pepper may be the cause of a recent salmonella outbreak that resulted in a salami recall last month. The agency made the tentative announcement as the first salmonella food poisoning lawsuits over the peppered salami were filed against the manufacturer, Daniele International, Inc.

    More than 200 people in 42 states, and the District of Columbia, have fallen ill as the result of a strain of salmonella known as Salmonella Montevideo, which the U.S. Centers for Disease Control and Prevention (CDC) say is likely connected to recalled salami produced by Daniele International.

    On Friday, the FDA indicated that Rhode Island Department of Health inspectors discovered an open container of black pepper at the salami manufacturing facility that was contaminated with a strain of salmonella that genetically matched the strain making people sick nationwide.

    A pepper-crusted salami recall was issued on January 23 for approximately 1.24 million pounds of salami/salame and other Italian sausage products. The recalled salami was sold at Costco and other national retailers under the Daniele, Black Bear, Dietz & Watson and Boars Head labels.

    At least two food poisoning lawsuits have already been filed against Daniele International over sicknesses caused by the tainted salami. The first lawsuit was filed on January 28 on behalf of an Illinois family who says that a three-month-old infant was hospitalized due to salmonella food poisoning from salami at Costco. According to a recent blog post by the law firm Marler Clark, a second salami recall lawsuit was to be filed today by a Missouri man who was hospitalized on January 23 for severe gastrointestinal illness after purchasing contaminated salami at a Walmart store.

    On Monday, Daniele International expanded their salmonella recall by 17,235 pounds after Illinois inspectors found contamination in more unopened packages. The additional recalled items include Daniele Hot Sopressata Calabrese, Daniele Spressata Calabrese and Boar’s Head Brand Hot Sopressata Calabrese. All of the recalled meat has an establishment number of “EST 54″ inside the USDA mark of inspection and weigh between 3 and 3.5 pounds.

    The FDA is currently examining the contaminated black pepper found by Rhode Island inspectors and its supply chain. The agency says it will alert the public if it finds any risks associated with the black pepper. However, the agency says that so far tests for salmonella on other black pepper samples have come back negative.

    Salmonella poisoning 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.