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GlaxoSmithKline Lamictal Recall Lawsuit                                      

GlaxoSmithKline Recall of Lamictal 200mg Tablets

Lamictal Side Effects Class Action LawsuitPharmaceutical company GlaxoSmithKline has recalled two batches of Lamictal (lamotrigine) 200mg tablets after an issue related to delayed dissolution is discovered. The Medicines and Healthcare Products Regulatory Agency of the United Kingdom has issued a Class 2 drug alert on the matter, which necessitates action for pharmacy level recall within 48 hours.

The delayed dissolution of the Lamictal 200mg tablet is unlikely to impact plasma concentrations in patients who have already taken tablets from these batches. However, there is still risk that some of the patients experience a reduction in efficacy after receiving these particular tablets. The risk is pegged at very low and the numbers of such patients are also expected to be small.

The issue is only limited to Lamictal 200mg tablets of GlaxoSmithKline with the batch numbers PJ1925 and PJ1926. These are in distribution since November 2010 and expiry date mentioned on them is August 31, 2013. No other batch of the GlaxoSmithKline-made Lamictal 200mg tablets, dose forms, and the overall strength of Lamictal drug stand affected by this issue.

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Ford F-150 Pickup Trucks Recall

Ford Motor Co has agreed to expand the recall of F-150 pickup trucks after receiving numerous

complaints from customers about unexpected deployment of airbags, caused by a possible short-

circuit. The recall impacts about 1.2 million vehicles produced between 2004 and 2006. The recall is

an expansion of the earlier recall of 144,000 F-150 pickup trucks, which includes 16,000 Lincoln Mark

LT vehicles as well.

Ford was forced to issue the recall of its F-150 pickup trucks after the National Highway Traffic

Safety Administration reported 269 incidents of inadvertent airbag deployment, including 60 cases

of injuries to drivers. According to the NHTSA, no other vehicle recall was the result of such a large

number of incidents, making it the most "ever recorded in any inadvertent airbag deployment

investigation or recall."

Despite numerous incidents of injuries to drivers, Ford continues to deny that the problem could

pose unreasonable risk to the vehicle occupants. However, it has eventually agreed to recall F-150,

the company’s best-selling vehicle, after the NHTSA intimated its concerns over safety of the vehicle

occupants, especially drivers, due to inadvertent deployment of front-seat airbags.

The Problem

Numerous incidents have been reported when the front -seat airbags, which are programmed

to deploy as a result of vehicle collision, deployed unexpectedly, even without the vehicle being

involved in any collision. However, the airbags are not supposed to inflate while the vehicle is idle or

being driven at 60 mph.

According to the federal safety regulators, the problem is caused due to the improper positioning of

a wire located in the steering wheel during the assembling of the vehicle, which makes it vulnerable

to short-circuit. Independent experts are of the view that the wiring in F-150s made prior to 2006

wear down easily, causing the airbag deployment without warning.

2011 Ford Recalls

This is the fourth recall by Ford in the last three months. Earlier recalls were primary due to fuel tank

leaks, faulty door handles, and electronic shortage. On March 16, 2011, Ford issued two recalls for

manufacturing errors causing electrical issues and fuel leaks. Around 35,000 vehicles were recalled

in the United States and Canada for electrical short-circuit and fuel leaks. Besides, Ford volunteered

to repair 23,688 Ranger pickup trucks of 2010 model for possible fuel leaks in the engine.

Early February, the auto giant informed owners of its Explorer SUV, produced between July and

December 2010, about the presence of safety problem related to the second row of seats. The

manual reclining mechanism in the seats was far below the acceptable federal safety standards.

Later, the company recalled some of the 14,737 vehicles repaired in December for re-inspection

of software. The recalled vehicles included Edge SUVs, Lincoln MKX, and Super Duty pickups. Ford

acknowledged that it had failed to properly inspect the body control modules during the December

recall.

2010 Ford Mustang, Hybrid Recall

Ford recalled its entire 2010 Mustang line in February 2010 after it was found that the vehicle

was "way too smoking." The company issued a public apology stating that the car was unfit for the

American public. The production line was also closed.

A bulletin issued by Ford the same year urged the owners of its hybrid cars, Fusion and Mercury

Milan, to ask dealers for a free software reprogramming. The existing software was found to be

causing brake malfunction.

2009 Ford Cruise Control Fire Recall

In October 2009, Ford agreed to recall 4.5 million vehicles after it was reported that a faulty switch

caused some fire incidents, thus risking lives. It was the biggest ever recall by the Detroit-based

auto giant. All these vehicles, mostly Ford Windstar, Excursion, F-Super Duty, Econoline, Ranger,

and Mazda B-series, produced before 2003, had Texas Instruments’ cruise control deactivation

switch. It was reported that the switch was prone to hydraulic fluid leakage and overheating, which

could cause fire even if the ignition switch was turned off. This was the eighth such recall by Ford,

thus taking the total number of vehicles recalled due to similar problems to 16 million for the past

10 years. The switch problem was linked to deaths and injuries in 550 fire incidents. The federal

regulators received 1,500 complaints and Ford faces dozens of lawsuits in this regard.

2007 Super Duty Recall

In March 2007, Ford recalled about 37,000 new F-Series Super Duty diesel trucks after reports of

tailpipe fires. It was reported that the diesel particulate filter was prone to catching fire after fuel

leakage. Ford was forced to issue the recall after a Texas driver narrowly escaped from the fire that

engulfed his vehicle. Following the incident, the company also changed battery cable in more than

10,000 vehicles as a precautionary safety measure.

2005 Recall for Engine Stalls

Ford was forced to recall over 100,000 vehicles of Super Duty, Excursion, and Econoline line after it

received numerous complaints from customers in June 2005. It was reported that faulty wiring on

the vehicles caused them to suddenly stall without warning. It was also found that once the vehicle

got stalled, drivers experienced problems in restarting them.

2000 Tire Recall

In May 2000, Ford Motor decided to recall 6.5 million tires supplied by Firestone for its Explorer SUV.

The federal regulators began investigating after numerous incidents of tire shredding were reported,

which caused 300 accidents and claimed 46 lives. As a result, the then Ford CEO Jacques Nasser was

forced to resign. A year ago, the company was forced to issue a recall of tires in 16 countries after

several complaints of tread separation were reported.

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Zyprexa Lawsuit

 

 

Zyprexa Side Effects Lawsuit

Zyprexa Side Effects LawsuitZyprexa by Indiana-based pharma major Eli Lilly is atypical antipsychotic medication useful for the treatment of psychotic conditions, including schizophrenia and bipolar disorder. Approved in 1996, the drug raked $5 billion in annual sales last year. However, Zyprexa has been linked to diabetes, disorders caused by nervous system breakdown, and metabolic disorders in patients. The drug is also harmful for fetus and may cause defective birth – infants born with nervous system and respiratory disorders.

Zyprexa Complaints and Warnings

The FDA has received around 400 reports of diabetes caused by Zyprexa use. The British and Japanese national drug regulators have also identified serious hyperglycemia and diabetes cases caused by the drug. In November 2001, an article in the Journal of the American Medical Association was the first to report the possible association between the drug and hyperglycemia in adolescents. The FDA staff review in December 2001 also echoed the same apprehensions.

A study conducted by Duke University Medical Center in 2002 reported that patients taking Zyprexa are susceptible to ketoacidosis, a serious complication induced by diabetes. The research identified 300 Zyprexa-linked diabetes cases, including 100 patients with ketoacidosis, 22 with fatal pancreatitis, and 20 deaths caused by Zyprexa side effects. The British Medical Journal also reported extensively on the diabetes risk to schizophrenia patients taking Zyprexa.

The Japanese Ministry for Health and Welfare and the nodal medicine control agency in the United Kingdom immediately issued warnings highlighting diabetes-related complications from the drug. The British National Formulary also recommended gradual recall of the drug citing acute withdrawal syndrome associated with it.

In 2003, the FDA asked manufacturer Eli Lilly to strengthen the label warnings on Zyprexa. The new product information alerted consumers and doctors of diabetes related potentially fatal side effects. In 2004, the U.K. Committee on the Safety of Medicines called for restrictions on prescribing Zyprexa to elderly patients with dementia. In December 2006, a report in New York Times claimed Eli Lilly made subtle attempts to play down reports on the health risks of Zyprexa. It cited several internal communications in the company on the possible diabetes side effects observed during the trial but never published or reported to the FDA.

Zyprexa Side Effects

Diabetes and Metabolic Side Effects:

Zyprexa carries a greater risk of inducing and aggravating diabetes compared to other antipsychotic medication. It affects the metabolic process, promotes fat deposition, decreases insulin sensitivity, and increases triglyceride levels. The drug makes our body obtain energy from fat. As a result, carbohydrates remain unutilized in the body. This leads to development of insulin resistance. The drug also increases appetite leading to binge eating, weight gain, acidosis, hypoglycemia, hypokalemia, and hyponatremia. Diabetes patients are at the risk of ketoacidosis accumulation of glucose and carbohydrates in the body

Nervous System Problems:

Zyprexa overdose causes somnolence and neuroleptic malignant syndrome. The disorder, which causes autonomic dysfunction, muscle rigidity, and altered cognitive performance, has above 20 percent mortality rate. The drug also develops sleep-related eating disorder, acute withdrawal symptoms, insomnia, hypertonia, emotional lability, agitation, and facial paralysis.

Cardiovascular Side Effects:

The common side effects include

tachycardia and hypertension. The post-marketing studies have reported congestive heart failure, hemorrhage, atrial fibrillation, cerebrovascular accident, and pulmonary embolus linked to the drug. Elderly patients with dementia are at greater risk of death due to heart failure caused by Zyprexa.

Gastrointestinal Side Effects:

Zyprexa leads to flatulence, increased appetite, frequent dry mouth, constipation, and increased salivation. Other side effects, such as dysphagia, gastroenteritis, mouth ulceration, periodontal abscess, and rectal hemorrhage, have also been reported. The FDA has also received a few complaints of Zyprexa -induced acute pancreatitis.

Hepatic Side Effects:

A 78 year-old woman, who had no prior lever problem, reportedly developed severe hepatic side effects within 13 days of taking Zyprexa. The drug has also been linked to rare side effects, such as hepatitis, mixed liver injury, and liver fatty deposit.

Respiratory Side Effects:

Zyprexa infection causes pneumonia and other fatal respiratory problems in elderly patients. Asthma, apnea, increased cough, dyspnea, hypoxia, voice alterations, lung edema, and fatal lower respiratory tract infection have also been reported.

Other Zyprexa Side Effects:

Ocular problems attributed to Zyprexa include amblyopia, abnormal vision, cataract, eye hemorrhage, and ocular muscle abnormality. The drug can lead to hematologic disorders, resulting in anemia, leukocytosis, leukopenia, and thrombocythemia. Zyprexa musculoskeletal side effects include extremity pain, arthritis, and osteoporosis.

Zyprexa Lawsuit

Eli Lilly faced the first Zyprexa class action lawsuit in 2004, seeking compensation for all those who had suffered from the side effects of the drug. In September 2008, a New York federal judge allowed another class action to proceed. The plaintiffs, third party payors, accused the manufacturer of selling the drug at high prices, overstating its benefits, and hiding the Zyprexa side effects. In November, an Ontario court certified another Canadian class action seeking recovery of the money the consumers had paid for the drug purchase. It cited the sufferings the consumers had undergone due to failure of Eli Lilly to inform about the drug side effects.

In 2005, Lilly announced that it would set up a $700 million fund to settle 18,000 personal injury Lawsuit. In 2007, it paid $500 million to 12,000 plaintiffs, who claimed to have developed diabetes after taking Zyprexa. There are still 1,200 Lawsuit awaiting trial or settlement in the United States. The Canadian class action is to cost a whopping $900 million to the pharma major. In 2009, Eli Lilly was fined $1.4 billion for illegally marketing and promoting off-label use of Zyprexa.

 

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Mesh Lawsuit Settlement

C.R Bard has agreed to a settlement amount of $184 million dollars to settle the majority of kugel mesh lawsuits filed against the company as a result of faulty surgical mesh products manufactured by its subsidiary Davol Inc., makers of the Kugel mesh.

The multi-million  dollar settlement reached in federal court and disclosed in Bard's second quarter filing will be allocated for and distributed to roughly 2,600 patients who were injured by the companies Davol mesh products including the Kugel mesh.

For more information please contact the lead attorney handling defective mesh lawsuits by submitting your case here.

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Optimark Side Effects Lawsuit

 

Optimark Side Effects Lawsuit

Tyco Healthcare’s Optimark is one of the five gadolinium-based contrast agents approved by the FDA for contrast enhancement during MRI scans of the brain, spine, and liver. The drug administered by intravenous injections facilitates visualization of lesions responsible for abnormal vascularity in patients. The drug has been linked to a fatal risk for those with impaired renal function. According to research reports and post-marketing survey, gadolinium-based contrast agents put kidney patients at the risk of Nephrogenic Systemic Fibrosis (NSF), a progressive disorder that results in limited mobility and death.

Optimark Warnings

The FDA approved Optimark in December 1999. The drug was advertised as an alternative to Bayer AG's Magnevist and GE Healthcare’s Omniscan, two well-known MRI contrast agents in the market. However, the FDA issued a public advisory in June 2006 informing patients and medical practitioners about Optimark side effects on kidney patients following reports of fatal Nephrogenic Systemic Fibrosis associated with gadolinium-based contrast agents.

In May 2007, the FDA ordered for "Black Box" warning on four gadolinium-based contrast drugs, including Optimar, following a staff review. The changed labels alerted patients with chronic renal insufficiency and liver problems about fatal side effects of the drug. The federal regulator cited 35 cases of fatal skin diseases in patients who took the drug. In November 2009, the federal regulator named Optimax among the top three gadolinium-based contrast agents associated with the highest risk of Nephrogenic Systemic Fibrosis skin disorder. In December 2009, a panel of experts appointed by the FDA called for tighter restrictions on Optimark. The FDA issued a drug safety communication on September 9, 2010

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