Author: AboutLawsuits

Health investigators have begun looking into a number of birth defects that have occurred in Kettleman City, a small town in Kings County, California. Residents suspect that the Kettleman City birth defects may be caused by hazardous waste from a nearby chemical disposal facility, which has been looking to expand.

Governor Arnold Schwarzenegger ordered both the California Department of Public Health and the California Environmental Protection Agency (CAL-EPA) to take aggressive action to investigate the environmental and health issues in Kettleman City on Friday. Out of 20 children born in the town of 1,500 between September 2007 and November 2008, five had facial birth defects. Residents also say there have been a high number of miscarriages as well.

The probe was launched after residents protested outside of U.S. EPA headquarters last week.

Chemical Waste Management, Inc. seeks to expand a nearby hazardous waste disposal facility which is already the largest in the western part of the country. Residents were unsuccessful in convincing the Kings County Board of Supervisors to deny the company permission to expand the facility last year.

Chemical Waste Management officials say that they believe their facility meets all state standards and is not playing a role in the recent cluster of birth defects in Kettleman City. Some have suggested that Kettleman City may also be exposed to potential health problems due to diesel emissions or pesticides used on nearby farms. The town is located between San Francisco and Los Angeles on Interstate 5, a major trucking corridor.

“There is nothing more important than the health and safety of the public,” Governor Schwarzenegger said. “My administration is committed to the community of Kettleman City and will use our resources to conduct a thorough investigation to provide these hard-working people with answers and the peace of mind they deserve.”

CAL-EPA and state health officials will present their initial findings on February 9.

Federal regulators are warning that the Bristol-Myers Squib HIV drug Videx appears to be linked to rare liver problems, known as non-cirrotic portal hypertension, which could be fatal for some users.

The Videx side effects warning was issued on January 29 by the FDA. The agency noted that it has received 42 adverse event reports among users of Videx and Videx EC involving the rare, but serious, liver disorder over the last 18 years. At least four of the patients died from bleeding or liver failure on Videx after developing the condition.

Videx (didanosine) is an antiretroviral drug marketed by Bristol-Myers Squib. It was first approved by FDA in 1991. In 2000, the FDA approved a delayed-release version called Videx EC. The drug belongs to a class of medications known as nucleoside analogues, and reduces the growth of HIV.

Non-cirrhotic portal hypertension is the result of restricted blood flow through a major vein in the liver. The blood backs up to veins in the esophagus, which become enlarge and distended. The enlarged veins can sometimes rupture, leading to serious bleeding and, potentially, death.

Despite the risk of Videx liver damage, the FDA says that the drug should stay on the market, because the benefits for HIV patients still outweigh the risks. The FDA is requiring new label warnings, as well as changes to the medication guide to alert users about the potential risk of the Videx side effects. The drug already has been known to cause liver toxicity when combined with some other antiretroviral medications, such as hydroxyurea and ribavirin.

The FDA recommends that doctors with patients taking Videx regularly monitor for signs of portal hypertension.

A fix has reportedly been found for the sticking Toyota gas pedals that have led to the recall of millions of vehicles and been linked to at least 19 deaths caused when Toyota vehicles accelerated out of control.

Toyota Motor Sales U.S.A., Inc. announced a comprehensive plan on Monday to eliminate the excess friction that has caused accelerator pedals to stick on some vehicles. The repair involves the addition of a shim to a part of the pedal assemblage. According to Toyota officials, the shim will prevent a resistance spring from locking up due to friction, which has been the cause of some of the Toyota gas pedal problems.

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.

Toyota officials say that the replacement parts are already being shipped to dealers, who are being trained on how to install the parts correctly. The company says that some dealers will leave their service departments open 24 hours a day to address cars affected by the Toyota recall.

The widespread reports of problems caused by defective Toyota gas pedals has led lawmakers to call for congressional hearings before the House Committee on Oversight and Government Reform on February 10, and the House Energy and Commerce Committee on February 25. U.S. Representative Henry Waxman, the Energy and Commerce committee’s chairman, said the Toyota acceleration problems have been linked to at least 19 deaths over the past 10 years.

In addition to scrutiny by lawmakers, the company faces a growing number of lawsuits over recalled Toyota vehicles connected to the gas pedal problems. There have been at least seven individual lawsuits filed against the company, as well as three Toyota class-action suits.

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

About 646,000 Honda Fit sub-compacts have been recalled, including 141,000 sold in the United States, after a 2-year-old was killed in a car fire in South Africa that is being blamed on the vehicle’s power window system.

The worldwide Honda Fit recall was announced late last week for the 2007-2008 models. The car, known as the Honda Jazz and Honda City in Europe, Africa and Asia, has a malfunctioning power window switch which can overheat when it comes in contact with a large amount of liquid, such as a heavy rainfall.

The switch defect led to a car fire and the death of 2-year-old Vanilla Nurse in Cape Town, South Africa last year. There have been no other injuries or deaths reported in association with the defect.

Honda Motor Co. suggested in a statement Friday that the problem could be linked to water, rain or other liquids entered the driver’s side window and reached the master power window switch. “An overheating switch may cause smoke, melting or potentially, fire,” the statement warned.

The Honda Fit is built in Brazil, China, India, Japan, Malaysia and Thailand. The largest number of the vehicles have been sold in Latin America, which has 229,000 Honda Fits on the road. There are 171,372 in the U.K, where it is known as the Honda Jazz, and there are 141,140 in the U.S. The rest are scattered around the world.

There has been no official recall release from the National Highway Transportation Safety Administration (NHTSA), and owners have been recommended to keep the windows rolled up in rain or snow until they receive an official recall notice. The 2009-2010 model year Honda Fits are not affected by the recall.

Photo courtesy of IFCAR at http://commons.wikimedia.org/

The FDA has required the drug maker Eli Lilly to update the warning label for their popular antipsychotic Zyprexa about potential weight-gain side effects among children.

According to an FDA statement posted on Friday for neuropsychiatric healthcare professionals, Zyprexa side effects can lead to increased potential for weight gain and hyperlipidemia in children ages 13 through 17. The warning also suggests that prescribing doctors may want to look at other medications first, due to Zyprexa health risks for adolescents, which can include high cholesterol and diabetes.

“When deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and hyperlipidemia,” the warning reads. “Clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents.”

The warnings come after an October study published in the Journal of the American Medical Association linked use of Zyprexa to dramatic weight gain among children. The study found that among children between 4 and 19, side effects of Zyprexa resulted in an average weight gain of 18.7 pounds after only 11 weeks. Researchers also found similar problems with other antipsychotics in the same class, with side effects of Seroquel causing children to gain an average of 13.5 pounds, Risperdal causing an average increase of 11.7 pounds and Abilify causing an average weight gain of 9.7 pounds.

In recent years, Eli Lilly has faced a number of lawsuits over Zyprexa in the United States and Canada involving allegations that the drug maker failed to adequately warn about the risk of diabetes and other problems caused by the risk of weight-gain associated with the drug. Lilly has also been accused of fraudulent marketing of the drug for uses that they had not established were safe or effective.

There are currently more than 150 shoulder pump lawsuits filed throughout the United States, according to a recent report in the New York Times.

The cases all involve similar allegations that the use of pain management pumps after arthroscopic surgery destroyed the shoulder cartilage for plaintiffs, leaving them with a lifetime of pain and limitations on the use of their shoulders. The lawsuits could be costly for the medical device manufacturers if the first shoulder pump trial is any indicator.

Earlier this month, a jury in Oregon ordered the maker of the I-Flow On-Q Painbuster shoulder pump to pay nearly $4.75 million to a man who developed the progressive loss of cartilage after using the I-Flow pain pump.

The condition, known as shoulder chondrolysis, has been linked to the intra-articular use of infusion pumps that deliver a combination of pain medications directly into the shoulder during the days after arthroscopic surgery. Although the FDA has never approved the pumps for this purpose, many manufacturers have been accused of encouraging doctors to use shoulder pain pumps instead of oral pain medications.

The condition, known as chondrolysis of the shoulder, has been linked to the intra-articular use of infusion pumps that deliver a combination of pain medications directly into the shoulder during the days after arthroscopic surgery. Although the FDA has never approved the pumps for this purpose, many manufacturers have been accused of encouraging doctors to use shoulder pain pumps instead of oral pain medications.

More than two years after the first published study discussed the problems with shoulder pumps, the FDA required manufacturers of the pumps and the local anesthetics to add new warnings about the risk of chondrolysis in November 2009. The recent warnings were designed to alert healthcare professionals that the use of pain pumps following shoulder surgery to infuse medication directly into the joint increases the risk of chondrolysis, particularly involving the shoulder.

Currently all federal lawsuits over problems with shoulder pumps are being handled as individual claims, without any centralized or coordinated pretrial proceedings. The U.S. Judicial Panel on Multidistrict Litigation denied a request to consolidate the federal cases in August 2008, indicating that the number of different manufacturers of pain pumps and different medications used in the devices made coordination for pretrial litigation not appropriate. However, attorneys representing plaintiffs in the cases have renewed their request to consolidate the federal lawsuits.

Federal investigators from the National Transportation Safety Board (NTSB) have determined that overloading and improper balancing are to blame for a 2009 plane crash in West Virginia that killed six people, including four pilots who were members of a Chicago-area aviation club.

The NTSB findings were released this week, providing further details about the small plane accident that occurred on January 30, 2009. According to a report by the Associated Press, investigators determined that it was the responsibility of the pilot, Wieslaw Dobrzanski, to make sure that the plane’s load and center of gravity were within manufacturer specifications.

Dobrzanski and the five other people on-board were killed when the twin engine Piper PA-34 crashed into power lines as the plane tried to make it to an airport near Huntington, West Virginia on low fuel.

The small plane had a maximum weight limit of 4,570 pounds, but investigators say that the plane weighted 4,902 pounds at takeoff. The weight was also loaded too far to the rear, which threw off the plane’s center of gravity. An overweight and poorly balanced plane can be hampered by performance issues in flight and can potentially face severe problems during takeoff, landing, and maneuvering. The extra weight load can also cause the plane to burn through fuel faster than expected.

Investigators also say that Dobrzanski did not receive a weather briefing, was not certified for instrument flight, and never filed a flight plan.

The plane was flying from Illinois to Florida with four members of the American Polish Aero-Club. The group was headed to Florida on a shopping trip to look at purchasing gliders for the aviation club. Families of two of the crash victims, Stanley Niemiec and his daughter, Monika Niemiec, have already filed a wrongful death lawsuit against the aviation club.

The FDA has scheduled a public meeting for late this month to review review the controversial process used to swiftly approve medical devices, which some say has been overused and allowed dangerous devices to be implanted in patients.

According to a statement released last week, the FDA scheduled a public meeting for February 18. The purpose of the meeting is to discuss challenges facing the agency’s pre-market notification process, also known as the 510(k) process, which allows quick approval of medical devices if they can be shown to be substantially similar to products already on the market. Critics and studies have suggested that the FDA leans too heavily on the process for quick medical device approval, which has led to dangerous and, in some cases, deadly medical devices onto the market.

The meeting will include open comment sessions on issues involving previously approved devices, new technology and scientific evidence, FDA practices in the face of high volumes of submissions, and post-market surveillance.

The hearings come after the release of several studies that have been highly critical of FDA’s ability to adequately investigate medical devices to ensure that they are safe for use in consumers. Two studies, published late last year, found that the FDA does not require enough clinical trials and that it often accepts suspect data at face value.

One study, conducted by researchers from the University of California and published in the Journal of the American Medical Association, found that two thirds of approved devices only went through one clinical trial before being unleashed on the market, and most of those trials involved less than 300 subjects. The other study, conducted by researchers from the FDA and Boston’s Beth Israel Deaconess Medical Center and published in the American Journal of Therapeutics, indicated that about 40% of the studies used to decide what devices are approved lack clear definitions of safety requirements.

In addition, a study by the Government Accountability Office (GAO) released in June found significant shortcomings and a heavy reliance on the 510(k) process. The GAO report identifies gaps in the FDA reviewing process, deficiencies in the agency’s postmarket surveillance, and also found that FDA has not kept up with regular inspections of medical device manufacturing facilities. Many devices which should be put through the more stringent premarket approval process are put through the premarket notification process instead, the GAO found.

The meetings also come as Congress ponders what to do about a 2008 Supreme Court decision in Riegel vs. Medtronic, which determined held that the FDA approval of a medical device can make manufacturers immune from product liability lawsuits for injuries caused by the defective design of their devices. Legislation called the Medical Device Safety Act of 2009 was introduced last year to overturn that decision, but there has been no action on the bill since hearings this summer.

As a consequence of the Supreme Court decision, thousands of pending medical device lawsuits have been dismissed, including cases filed on behalf of thousands of patients injured by the recalled Medtronic Sprint Fidelis defibrillator lead.

A Medtronic Sprint Fidelis defibrillator lead recall was issued on October 15, 2007, after it was discovered that the small wires used to connect defibrillators to the heart was prone to fracture or break. Although the defective design has caused hundreds of people to suffer unnecessary shocks or caused their defibrillator to fail when it was needed to deliver a life-saving jolt, a federal judge ruled earlier this year that patient claims for medical expenses and other compensation are now barred because the FDA approved the design of the device.

The meeting will be held on February 18 from 8 a.m. to 5:30 p.m. at the Hilton Washington, D.C./North Gaithersburg, in Gaithersburg, Maryland. Those wishing to attend the meeting or participate must register by 5 p.m. on February 12. The FDA will accept written or electronic comments until March 5, 2010. The meeting will be also webcast live at http://www.ConnectLive.com/events/fda021810.

A Los Angeles jury has rejected a claim by a former smoker that a tobacco company should be held liable in a mesothelioma lawsuit filed over the use of asbestos filters on cigarettes during the 1950s.

The asbestos lawsuit was brought by Robert Cox against Lorillard, which manufactured Kent cigarettes. Cox was diagnosed with mesothelioma in 2008 and claimed that Lorillard designed a defective cigarette due to the inclusion of the asbestos filters, and failed to warn users of asbestos health risks.

After an eight-week trial, the Los Angeles County Superior Court jury concluded on January 19, that Lorillard was not liable and did not have to warn Cox about the risks associated with asbestos filters. According to a report by The Recorder, the decision was based on expert witness testimony regarding the prevalence of asbestos use in the 1950s and what was believed, at the time, regarding its safety. The defense was banned from presenting evidence that demonstrated the amount of asbestos that could enter the lungs from use of the filters.

Lorillard has successfully defended itself over the use of the asbestos cigarette filters in six lawsuits filed since 2000.

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 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.

A Michigan woman has filed a lawsuit over Yaz, alleging that Bayer’s popular birth control pill caused her to have her gallbladder removed and suffer blood clots that now require her to take medication to avoid clot formation in the future.

The Yaz gallbladder removal lawsuit was filed yesterday in the U.S. District Court for the Eastern District of Michigan by Asia Moore. It will join hundreds of other cases pending against Bayer Pharmaceuticals that involve allegations that the drug maker failed to adequately research the potential side effects of Yaz or warn about the increased risk of gallbladder disease, stroke, heart attack, pulmonary embolism, deep vein thrombosis or sudden death.

Moore’s Yaz case is believed to be the first lawsuit from Michigan, which has a state law protecting drug makers from product liability for medications that have been approved by FDA. According to a statement from the lawyers who filed the case, they believe that Bayer’s conduct with Yaz has been so egregious that it may override the state provision.

According to the complaint, Moore began using Yaz birth control in March 2007. As a result of alleged Yaz side effects, Moore suffered loss of her gallbladder and the formation of blood clots, which have left her facing a lifetime of increased risk that she may suffer a blood clot in the future. In addition, Moore says that she must now take prescription medications to reduce the risk of blood clots from Yaz.

Gallbladder problems from Yaz have been reported among many former users of the birth control. The gallbladder assists the body in the digestive process and stores bile produced by the liver.

Yaz is a newer type of birth control pill, which contains a “fourth” generation progestin known as drospirenone. The progestin is unique to Yaz and Yasmin, which are both manufactured by Bayer. Plaintiffs like Moore allege that there is insufficient data is available to support the safe use of drospirenone, particularly compared with second generation progrestin.

Drospirenone impacts the body’s normal mechanism of regulating a balance between salt and water, which could result in elevated potassium levels. According to Moore’s complaint, this could lead to a condition known as hyperkalemia if potassium levels become too high, which can cause heart rhythm disturbances. If hyperkalemia disrupts the normal rhythm, the flow of blood through the heart can be slowed to the point that it permits a blood clot to form.

Moore’s Yaz gallbladder lawsuit will consolidated in the federal MDL, or multidistrict litigation, which has been centralized in the Southern District of Illinois for all cases against Bayer over problems with Yaz and Yasmin, their other birth control pill which is nearly identical to Yaz.

European Union (EU) medical experts have called for a recall of Meridia, saying that the weight-loss drug’s safety risks outweigh its benefits and that it is too dangerous for public use.

The recommendations by the European Medical Agency’s Committee for Medicinal Products for Human Use came as the FDA warned against use of the drug among patients with heart problems. Marketed as Meridia in the U.S., the sibutramine-based drug is sold in Europe as Reductil, Reduxade, and Zelium. The committee’s recommendations must be approved by the European Commission.

On January 21, the FDA said the drug’s heart risks require that it not be used in patients with a history of cardiovascular disease, such as congestive heart failure, stroke, and hypertension. However, the agency has thus far not indicated whether a Meridia recall will be issued. The consumer group Public Citizen filed a petition with the FDA late last year calling for a Meridia ban, citing additional information from a recent study that found the weight-loss drug may increase the risk of heart attacks, strokes and other cardiovascular problems

Meridia (sibutramine) was approved by the FDA in 1997 as a prescription-only weight loss supplement for obese patients with other risk factors such as diabetes, high cholesterol and controlled blood pressure.

In November 2009, the FDA announced that they were reviewing potential heart problems from Meridia after data suggested that side effects of the drug may cause users to suffer a higher number of cardiovascular events, such as heart attacks, strokes, resuscitated cardiac arrest or death.

The review was announced after FDA began examining data from a 10,000-patient study conducted in Europe known as the Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of Cardiovascular Event (SCOUT). The latest recommendations came after further review of that data.

European medical experts were also consulting the SCOUT data when they came to the conclusion that the drug should be banned.

Product liability lawsuits and wrongful death lawsuits against Toyota Motor Corp. are beginning to mount in the wake of recent gas pedal problems with Toyota vehicles, which have resulted in the recall of more than 5 million cars, pick-up trucks and sports utility vehicles.

Owners have complained that their Toyota vehicles, some of which were sold under the Lexus brand, suddenly began to accelerate out of control, resulting in serious and sometimes fatal accidents.

The problems first gained national attention following an August 2009 accident in California involving an off-duty state trooper and three family members who were killed while driving a Lexus ES 350 on loan from a San Diego dealership.  Minutes before the fatal crash, passengers called police to report that the Toyota-manufactured vehicle was accelerating out of control at speeds as high as 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 hitting another vehicle, falling off an embankment, rolling multiple times and bursting into flames.

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.  Following that recall it was reported by the New York Times that Toyota knew about the potential acceleration problems for more than two and a half years before issuing the recall.

What is believed to be the first class action lawsuit against Toyota over the acceleration problems was filed in November 2009.  In that case, two vehicle owners who experienced problems suggested that the floor mats were not the only cause of the sudden acceleration, alleging that Toyota failed to correct a problem with the throttle control system.  The plaintiffs claimed that the original design for the system, known as the ETCS-i, included a safety feature that would have put the engine into idle mode in case of unintended acceleration.  However, Toyota allegedly decided to sell the vehicles without the feature in 2001.

In late November, Toyota updated their prior floor mat recall to indicate that they will replace the gas pedals on the Toyota and Lexus vehicles that were part of the initial recall.  The company indicated that the gas pedals will be shortened on some models and that the floor surface beneath the pedal will be reconfigured on certain models.  New brake over-ride systems were also included as part of the corrective action, designed to address the problem of some vehicles not stopping when the accelerator and brake and gas pedals are pressed down at the same time.  Toyota indicated that the override feature will be standard on all future models.

Earlier this month, Toyota issued yet another recall for 2.3 million Toyota vehicles, including 600,000 that were not subject to the prior floor mat recall.  The company indicated that they discovered that the accelerator pedals may stick on these Toyota vehicles, which included the Camry, Corolla, Tundra and other models.  The accelerator pedal mechanism was found to mechanically stick in a partially depressed position or return slowly to the idle position in some circumstances.

This week, Toyota took the rare step of halting production and sales for eight different models of vehicles with the gas pedal problems.  The action was taken until a fix for the defect could be finalized.

In the wake of the continuing Toyota accelerator problems, a growing number of lawsuits continue to be filed on behalf of vehicle owners or family members of those who died in a crash when their Toyota vehicle accelerated out of control.  According to a report by Bloomberg News, there have been at least seven individual lawsuits against Toyota and three class-action suits filed so far.

Last week, Joseph Hauter, of Los Angeles County, California, filed a Toyota gas pedal lawsuit against Toyota Motor Company in federal court in Santa Ana, claiming that his 2008 Tundra pickup accelerated out of control while he pulled into a service station

Among the Toyota wrongful death lawsuits filed is a case brought by the family of a woman who was killed in April 2008 when her 2005 Toyota Camry allegedly sped out of control and crashed into a tree at 80 m.p.h.  Another case was filed on behalf of a woman who was killed in an accident in September 2007 when a friend lost control of a 2005 Camry.

Federal regulators have released new guidance to help home owners and inspectors identify which homes are affected by toxic Chinese drywall.

The new Chinese drywall identification guidance was released by the U.S. Department of Housing and Urban Development (HUD) and the U.S. Consumer Product Safety Commission (CPSC) on Thursday. It not only describes how to identify imported drywall problems, but it also describes what evidence is needed for the two agencies to determine that damage to the home was caused by the drywall.

The CPSC reported earlier this month that it has received about 2,702 reports of problems with Chinese drywall from 36 states, as well as the District of Columbia and Puerto Rico. Homeowners complain that the toxic wallboard releases sulfuric odors, causes health problems, and corrodes wiring and appliances. Many of the claims about the imported drywall have been confirmed by laboratory testing.

Home owners and inspectors must be able to see a blackening of copper electrical wiring or air conditioning evaporator coils, and must have had new drywall installed between 2001 and 2008, according to the guidance. There are also a number of criteria homes must meet to ascertain that the problems are caused by the drywall and not the result of some other problem. The criteria are different based on the age of the home.

The guidance and update on the number of complaints comes as a coalition of homeowners has filed a lawsuit seeking to force 14 different insurance companies to cover Chinese drywall damage to their homes. The lawsuit was filed in late November, but announced this month by the WCI Chinese Drywall Trust in the U.S. District Court for the Eastern District of Louisiana.

The trust was formed when WCI Communities, Inc, a Florida-based home builder, went bankrupt under a deluge of Chinese drywall complaints from more than 700 owners of the homes it built between September 2006 and 2008. The lawsuit alleges that a number of  insurance companies have wrongly denied coverage or ignored claims of Chinese drywall property and health damages.

Millions of sheets of toxic drywall were imported from China into the United States between 2004 and 2007, due to a domestic shortage caused by a housing boom and construction following a serious of hurricanes that struck the southeastern United States. The CPSC has confirmed more than 6 million sheets were imported into the country in 2006, and additional temporary support personnel are being brought in to verify more shipments.

Efforts to remove the material have been spotty and expensive. In some cases, contractors have had to strip homes down to the studs, with no guarantee that they have rid the structure of the corrosive gases. There have also been many cases where it was unclear whether problems were the result of Chinese drywall, and in some cases, houses thought to have problems did not have Chinese drywall at all.

A number of homeowners throughout the United States have filed contaminated Chinese drywall lawsuits against manufacturers and distributors. In June, all of the federal drywall litigation was consolidated and centralized in an MDL, or Multidistrict Litigation. The cases were assigned to U.S. District Judge Eldon E. Fallon in New Orleans, who has put the cases on a “fast track,” with trials involving property damage claims set to begin in early 2010.

Proceedings on the first lawsuit are scheduled to begin today in a lawsuit against Taishan Gypsum, a Chinese drywall manufacturer. Representatives of the company have failed to appear for proceedings, and Judge Fallon has found the company in default.

If the lawsuit against the company is successful, it will effectively end their ability to import to the U.S. until they have paid the judgment against them. Their ships and cargo will be seized and sold until they pay, or until the value of the judgment has been reached.

A class action lawsuit has been filed on behalf of hundreds of patients who allegedly received unnecessary coronary stents by a doctor at St. Joseph Medical Center in Towson, Maryland.

The lawsuit was filed Thursday in Baltimore, weeks after St. Joseph Medical Center sent letters to 369 patients notifying them that they may have undergone unnecessary heart surgery to implant coronary stents for clogged arteries that they did not need. All of the cases involve one physician, Dr. Mark Midei, who was named as a defendant together with St. Joseph Medical Center in the class-action suit.

Former St. Joseph stent patients have recently discovered that Dr. Midei told them that they had substantial artery blockages, when they may have only had minimal blockages that did not require stent placement. The discrepancies were discovered when St. Joseph called in other coronary experts to examine the patients’ catheterization films.

The St. Joseph Medical Center class action suit seeks to force the hospital to pay for a review of patient records and to impose certain requirements on the hospital before they can perform stent procedures. However, many lawyers pursuing St. Joseph stent lawsuits indicate that individuals treated by Dr. Midei may be in a better position to investigate their claim and obtain more complete compensation for their damages by pursuing an individual claim.

The first individual lawsuit against St. Joseph over unneeded stents by Dr Midei was filed last week, alleging that the hospital knew the doctor was fraudulently or negligently telling patients that they needed the stent procedures that were not medically necessary and failed to take steps to stop it.

Cardiac catheterization procedures with stent placement, which cost about $10,000.00, are designed to keep open significantly blocked arteries. Typically it is only considered necessary for a stent to be implanted when an artery is at least 70% blocked, with anything under 50% considered “insignificant” and treatable without a stent. Some patients were exposed to the risks associated with stent placement by Dr. Midei when they had blockages as low as 10%.

Dr. Mark Midei headed up the cardiac catheterization unit at St. Joseph Medical Center in Baltimore County until he was stripped of his position and privileges at the hospital last summer amid a federal investigation involving cardiac stent procedures performed at the Towson, Maryland hospital.

A federal judge presiding over the consolidated Digitek litigation, which is centralized in the U.S. District Court for the Southern District of West Virginia, has scheduled the first trial over the recalled heart drug to being in January 2011.

There are currently more than 200 Digitek lawsuits pending in the federal MDL, which all involve similar allegations that Actavis Totowa and their distributors sold over-sized Digitek pills, which caused users to suffer a variety of serious and potentially life-threatening injuries associated with receiving too much of the heart medication.

According to a pretrial order issued Tuesday by Chief Judge Joseph R. Goodwin, the first “bellwether” Digitek trial is scheduled to begin on January 31, 2011. Five cases were selected last month for early trials in the MDL, but the order does not indicate which of those lawsuits will be the first case presented to a jury.

Digitek is a generic version of the drug digoxin, used to treat congestive heart failure, abnormal heart rhythms, atrial flutter and atrial fibrillation. The medication is extremely dose-specific with a narrow therapeutic index. If too little of drug is prescribed it can be ineffective, and if too much is prescribed it can lead to a Digitek overdose, where the drug builds up in the system. This can result in a serious and potentially life-threatening condition known as digitalis toxicity.

In April 2008, Actavis Totowa issued a Digitek recall for all lots of the heart drug after it was discovered that some tablets may have been commercially released that were twice as thick as they were supposed to be. The error potentially exposed thousands of users to a risk of digoxin overdose or poisoning.

According to a December 2008 report released by the non-profit Center for Public Justice, the FDA received reports of at least 667 Digitek overdose deaths tied to the recalled pills between April 2008 and June 2008.

In addition to the cases pending before Judge Goodwin in federal court, there are also many similar lawsuits pending in various state courts. According to an order issued in December, the judges presiding over those state court cases will join Judge Goodwin for a joint hearing in October 2009 to address the scientific and technical issues presented in the Digitek recall lawsuits. Following the joint hearing, each judge will give a seperate ruling as they relate to the cases they are presiding over.

A panel of neurologists is recommending that Botox be used to treat some symptoms of spasticity associated with cerebral palsy, despite prior FDA warnings about the possible risk of serious and life-threatening reactions that have already killed several children who were given the injections off-label to treat the disability.

In an article published in the medical journal Neurology, a panel of experts from the American Academy of Neurology (AAN) published a review of several medications that could potentially be used to treat symptoms cerebral palsy. The article includes recommendations that Botulinum toxin type A, known by the brand name Botox, be used to treat spastic cerebral palsy, which is associated with difficulty moving, or stiff and jerky movements.

Botox, manufactured by Allergan Inc., contains extremely minute quantities of Botulinum Toxin A, which causes muscle paralysis. Although the medication is most commonly known for its cosmetic uses to remove wrinkles, it is also approved treat cervical dystonia, spasms of the eyelids and symptoms of severe underarm sweating. While some other countries, including Canada, have approved Botox for cerebral palsy, the FDA has not granted such approval in the United States.

In February 2008, the FDA issued a public health warning about potential Botox side effects when the medication is used to reduce spasticity among children with cerebral palsy. The agency indicated at that time that the medication had caused a number of hospitalizations and deaths due to paralysis, most frequently among children with cerebral palsy who are typically given a significantly larger dose of the medication.

A Botox “black box” warning was ordered in April 2009, indicating that side effects of Botox could cause potentially life-threatening problems similar to botulism if the medication spreads from the area of the injection to other parts of the body.

The recent recommendations by the American Academy of Neurology refer to FDA’s warning as “isolated cases of generalized weakness resulting in poor outcomes.”

“For children with CP, (Botox) is established as an effective treatment to reduce spasticity in the upper and lower extremities, but there is conflicting evidence regarding functional improvement,” the panel concluded. “The available evidence suggests that (Botox) is generally safe in children with CP. However, severe generalized weakness may occur.”

Allergan Inc. currently faces at least 15 Botox lawsuits that claim that the company hid the risks associated with the drug. Jury selection began this week in the first Botox trial, involving a case brought by the parents of 7-year-old Kristen Spears, a child with cerebral palsy that died in November 2007 after receiving seven shots of Botox. Allergan has argued that the girl’s death was unrelated to her Botox treatments and failed in an attempt to have the lawsuit dismissed late last year.

Over 1,000 CYBEX strollers have been recalled due to the risk of fingertip amputation after a child’s finger was fractured in the stroller’s hinges. This is at least the third stroller recall issued in recent months due to design defects that may pose a risk of finger injury for children or parents.

The CYBEX stroller recall was announced on January 27 by the U.S. Consumer Product Safety Commission (CPSC) and Health Canada after the manufacturer, Regal Lager Inc., received the child injury report. The stroller’s hinge mechanism can amputate or lacerate a child’s finger when folding or unfolding the stroller.

Similar recalls were issued for about one million Maclaren strollers in November 2009 and 1.5 million Graco strollers earlier this month. The Maclaren stroller recall was issued after the manufacturer received at least 12 reports of children having their fingers amputated in their strollers. The Graco stroller recall was issued after five children lost fingertips.

The Regal Lager CYBEX stroller recall only affects about 1,100 strollers in the U.S. and 90 in Canada. The Ruby, Onyx and Topaz models of the CYBEX strollers have all been recalled. All of the models have the word CYBEX printed on the side.

The strollers were sold at department stores and juvenile product stores across the U.S. for between $140 and $260 between August 2009 and November 2009.

Consumers are warned to immediately stop using any of the recalled CYBEX strollers = and to contact Regal Lager for a free hinge cover kit.

About 2,500 Yamaha FX10 snowmobiles have been recalled due to a defect that could cause a loss of steering control, posing a serious risk of an accident that may injure or kill riders.

The Yamaha snowmobile recall was issued on Wednesday by the U.S. Consumer Product Safety Commission (CPSC) and Yamaha Motor Corporation U.S.A. According to the recall notice, a bolt in the right front A arm of the steering assembly can loosen on some vehicles. Although there have been no reports of injuries associated with the product defect, this could riders to lose the ability to control the snowmobile.

Five models of Yamaha 2009 FX10 Snowmobiles are subject to this recall, including:

• FX Nytro, model number FX10Y
• FX Nytro XTX, model number FX10XTY
• FX Nytro RTX, model number FX10RTRY
• FX Nytro MTX, model number FX10MTRY
• FX Nytro RTX SE, model number FX10RTRSY

The snowmobiles were sold by Yamaha dealers nationwide from June 2008 through January 2010 for between $10,000 and $11,000.

Anyone with one of the recalled Yamaha snowmobiles has been urged to stop using the vehicle immediately and contact a dealer to schedule a free repair. The company reports that all registered owners have been sent mail notifications of the snowmobile recall.

This is the second time in less than a year that Yamaha has had to deal with safety issues involving their vehicles. On March 31, 2009, sales were temporarily halted for their Yamaha Rhino ATV, so that safety repairs and modifications could be performed on about 145,000 of the side-by-side vehicles after the CPSC determined that they were prone to rollover even when driven at slow speeds on level terrain.

Yamaha added safety features to the Rhino ATV, such as half doors, additional passenger handholds, and made alterations to the wheel base to improve handling. The company currently faces several hundred Yamaha Rhino lawsuits that are pending throughout the United States on behalf of riders who allege that Yamaha failed to take steps to improve the safety of the vehicles soon enough, resulting in severe or fatal injuries when one of the ATVs rolled over.

The multiple myeloma drug Velcade has been found to increase the risk of liver toxicity and liver damage in patients suffering from moderate to severe liver problems, resulting in a warning to doctors this month that such patients should be started on low doses of the drug.

The warning was issued this month by FDA and Millennium Pharmaceuticals, Inc. in a letter to healthcare professionals (PDF). The prescribing information for the drug has also been changed to recommend low starting doses of Velcade for patients with moderate-to-severe liver problems.

Velcade (Bortezomib) was approved by FDA in 2003 as a second-line injection treatment for multiple myeloma. It was developed by Millennium Pharmaceuticals, Inc. (owned by Takeda) and Johnson & Johnson. In 2008, it was approved as a front-line multiple myeloma treatment. It is also approved as a second-line treatment for mantle cell lymphoma.

The FDA and Millennium warn that the drug is metabolized by liver enzymes, and exposure to the drug is increased in patients with moderate or severe hepatic impairment. Healthcare professionals are recommended to start those patients on lower doses of Velcade than other patients, and then closely monitor them for signs of liver toxicity.

Liver toxicity, or hepatotoxicity, is a form of liver damage caused by chemical exposure. It is responsible for 50% of all acute liver failures and is the most common reason for drugs to be pulled from the market. Liver toxicity can cause liver cell necrosis, hepatitis, vascular lesions and other liver problems.

The federal government has enacted a ban on text messaging for drivers of all large commercial trucks and buses to prevent potentially deadly and catastrophic traffic accidents.

The ban goes into effect immediately, and drivers who violate the ban could find themselves hit with fines of up to $2,750. This law follows a similar prohibition against “texting” by all drivers of federal vehicles that went into effect in December.

The prohibition, announced earlier this month by Transportation Secretary Ray LaHood, comes after a Virginia Tech Transportation Institute study this fall found that tasks that drew the drivers’ eyes away from the road ahead of them significantly increased the risk of an accident. The study was compiled from several driving studies conducted by the institute, and the collected data equaled about six million miles of driving.

Heavy vehicle and truck drivers were 23.2 times more likely than a non-distracted driver to have a truck accident if they were texting, 6.7 times as likely to crash while reaching for, or using, an electronic device, and 5.9 times as likely to have an accident while dialing on a cell phone.

Drivers of light vehicles and cars were at much less risk of having an accident, but still faced a 2.8 times greater risk of crashing while dialing a cell phone than a non-distracted driver and were 1.4 times more likely to crash while reaching for an object and 1.3 times as likely to have an auto accident while talking on the cell phone.

On October 1, Maryland became the 10th state to make it illegal for any driver operating a motor vehicle to send a text message and the 18th state to enact some kind of law restricting text messaging while driving. On the same day, President Barack Obama issued an executive order banning text messaging by federal workers operating government vehicles, or driving their own vehicles on government business. The senate is also weighing new legislation that would force all 50 states to enact texting bans, or potentially lose millions of dollars in federal funding.

In late July, four Democratic Senators introduced legislation that would give states two years to enact new laws banning text messaging and sending e-mail messages while driving. Those states that fail to do so would lose 25% of their highway funding each year they had no such law, until they lost the entirety of their funding. The legislation was introduced as AAA has ramped up efforts calling for a nationwide ban on ‘texting while driving’ and other cell phone-related activities that they refer to as ‘distracted driving.’