Toyota owners, there is a new problem facing yet another popular Toyota brand, the Toyota Corolla.  Driver complaints of  power steering related problems are causing Toyota to consider a recall of the very popular subcompact Toyota Corolla. 

This potential new recall may come in addition to the Toyota recall of approximately 8.5 million vehicles worldwide due to floor mat hazards, sticking gas pedals, and braking problems. Toyota has yet to disclose the vehicle model year(s) or regions that may be affected.

Reports show that the most recent Data from the National Highway Safety Administration (NHTSA), puts the alleged death toll due to Toyota vehicles at 34 deaths since 2000, with the numbers continuing to rise.

According to Toyota quality controls executive, Shinichi Sasaki, Corolla drivers may feel as if they were losing control of their ability to steer. Sasaki also mentioned that a link between the Corolla’s possible steering problems might involve the vehicle’s braking system or tires.

Word of this new issue comes on the heels of Toyota President Akio Toyoda’s statements regarding the forthcoming U.S. Congressional meeting. During a recent news conference, Mr. Toyoda stated that he does not plan to appear before the Congressional committee scheduled for February 24. Rather, he stated that he wanted to remain focused on improving the quality and image of his company on a global scale.

Toyota owners continue to address complaints to Federal safety officials about the potential problems. With approximately 100 reported complaints regarding the possible steering trouble, Toyota is poised to take yet another blow to its already tarnished image. When will this saga end?

In addition to decreases in the company’s image and stock value, news of this potential new recall, in conjunction with the other worldwide recalls, continues to draw legal woes for Toyota. According to the Financial Times, Toyota is facing a multitude of class action lawsuits in the United States that may cost the automaker billions of dollars. Experts estimate that more than 40 suits have been filed against Toyota under federal and state law. Claims reportedly involve wrongful death, personal injuries, property damage, and more.

Toyota is working to determine the source of the Corolla complaints and has not ruled out the possibility of issuing yet another recall.  Toyota sold roughly 1.3 million Corollas worldwide in 2009, making it the best-selling car in the world.

To read more on Toyota's latest woes regarding the looming Toyota Corolla stering probe and possible recall, click on the following links to New York Times, CNN,  Financial Times (Registration Required) and the WSJ Blog.

Drivers of the popular gasoline-electric hybrid – a vehicle not currently involved in any recall – face the possibility of up to a one-second lag in braking time. CNN reported that “Toyota officials describe the problem as a ‘disconnect’ in the vehicle’s complex anti-lock brake system (ABS) that causes less than a one-second lag [in braking]. With the delay, a vehicle going 60 mph will have travelled nearly another 90 feet before the brakes begin to take hold.”

The National Highway Traffic Safety Administration confirmed more than 100 Prius driver complaints in connection with the braking problem.  The Washington Post reported that 77 Prius driver complaints were filed to Japanese government officials involving the Hybrid's braking problems, not including the 14 additional complaints logged since July 2009.

Although it is unclear whether any relation exists between this accident and the newest 77 complaints, the fact remains that Toyota’s reputation of safety and engineering excellence has taken a considerable hit in the recent weeks.  Toyota can only hope for a silver lining to come soon.

According to the FDA’s warning letter on Yaz,  the sponsored links were:

“Misleading because they make representations and/or suggestions about the efficacy of YAZ [and other drugs made or marketed by Bayer], but fail to communicate any risk information associated with the use of these drugs.”

The letter went on to state that the sponsored links for YAZ did not adequately communicate Yaz side effects, and failed to use the required established name of the drug. Because of the aforementioned reasons, the FDA found Bayer’s Internet marketing of YAZ to be in violation of the Federal Food, Drug, and Cosmetic Act in addition to FDA regulations.

It is important to note that the risk information associated with using YAZ excluded by Bayer in the sponsored links includes the possibility of:

• Blood Clots
• Deep Vein Thrombosis
• Hypertension
• Gallbladder Disease
• Stroke
• Heart Attack
• Other Ailments

The FDA’s warning letter stated that Bayer’s omission of YAZ’s risk information is “particularly concerning” because the oral contraceptive has a Boxed Warning. According to the FDA:

“Drugs that have special problems, particularly ones that may lead to death or serious injury, may have this warning information displayed within a box in the prescribing information. This is often referred to as a ‘boxed’ or ‘black box’ warning.”

This warning from the FDA is just another troubling example of Bayer’s failure to communicate the risks associated with using YAZ. In addition to this warning, the FDA has found other facets of Bayer’s marketing campaign involving YAZ to be misleading, including several broadcast television advertisements released in 2008.

Because the makers of YAZ have repeatedly failed to communicate the risks associated with the oral contraceptive, you may be entitled to file a civil claim. As a YAZ-induced injury victim, you may be able to receive compensation for your medical costs, loss of wages, and more. If you have suffered any serious injuries as a result of taking Yaz, you may want to contact an experienced personal injury attorney to discuss your specific matter.

Toyota Motor Sales U.S.A., Inc. (TMS), announced today, that the company has developed a safe solution to the risk of sudden, unwanted acceleration. The Japanese automaker indicated that its engineers created and thoroughly tested the solution: a small steel pedal reinforcement assembly designed to eliminate excess friction. Toyota reports that it has commenced shipping the parts to dealers, and expects the millions of affected vehicles to undergo repair as soon as possible.

According to Toyota, this sticking occurred (or can occur) because of excess friction resulting from normal vehicle operation. The company indicates that the pedal reinforcement assembly will eliminate the excess friction that caused the accelerators to stick in rare instances.

At the end of January, the company recalled over 4 million cars from eight vehicle models due to the risk of sudden acceleration caused by the accelerator sticking in a partially open position. In an unprecedented move, the Japanese automaker also halted production to resolve the problem safely and effectively. With Toyota’s announcement comes an apology from top brass, and a hope that the solution will begin to restore customers’ faith in the brand.

Toyota Motor Sales (USA) president and Chief Operating Officer, Jim Lentz, commented on the situation:

“Nothing is more important to us than the safety and reliability of the vehicles our customers drive. We deeply regret the concern that our recalls have caused for our customers and we are doing everything we can – as fast as we can – to make things right.  Stopping production is never an easy decision, but we are 100% confident it was the right decision. We know what’s causing the sticking accelerator pedals, and we know what we have to do to fix it. We also know it is most important to fix this problem in the cars on the road.

The Toyota saga continues with the National Public Radio report Toyota Apologizes, Releases Details On Plan To Fix Gas Pedals.  In a continuing story, NPR's  All Things Considered, co-host Melissa Block spoke with Toyota's Jim Lentz this afternoon on how a driver should handle the situation, of a gas pedal getting stuck.

Lentz is quoted in the interview as giving listeners the following advice:

The Driver should put both feet on the break, press hard, shift the transmission into neutral, and pull off the road.

Click on the following link to hear the All Things Considered interview with Toyota President Jim Lentz
 
Click on the following link to view more from Toyota on the accelerator pedal recall issue.

Click on the following link to see the Toyota PSA on the accelerator issue given by Jim Lentz..

The Toyota vehicles involved in the recent accelerator recall include:

• 2009-2010 RAV4 (Certain models)
• 2009-2010 Corolla (Certain models)
• 2009-2010 Matrix
• 2005-2010 Avalon
• 2007-2010 Camry (Certain models)
• 2010 Highlander (Certain models)
• 2007-2010 Tundra
• 2008-2010 Sequoia

As we mentioned in a previous LaBovickInjuryLawBlog article on the Toyota accelerator recall, owners  and drivers of the above mentioned Toyota models to contact their local Toyota dealer or to contact Toyota directly, if they are having issues. Safety measures and precautions should be taken to avoid any serious car accident.

Huber needles used in implanted ports to withdraw blood, inject medications, and other solutions

The U.S. Food and Drug Administration (FDA) announced a Class I recall of certain infusion set needles used in the treatment of chronically ill patients and others. Products included in the recall are the following all manufactured by the Japan-based Nipro Medical Corporation for Exelint International Corporation.

Exel/Exelint Huber needles

Exel/Exelint Huber Infusion Sets

Exel/Exelint “Suretouch+ [plus.”

The recall comes in response to inspections of Japanese Nipro facilities carried out in October 2009. These inspections found that the needles, used to access under skin ports designed for repeated access to veins, “cored” in approximately 60 to 72 percent of tests. According to the FDA, coring means that the silicone cores (or silvers) of the needles were cutting and dislodging the under skin ports when inserted, causing the ports to leak in certain cases.

In a news release about the recall, the FDA stated that:

“At this time, the FDA has not received any adverse event reports related to silicone foreign bodies released in patients from Huber needle coring. The agency received only reports of port leakage. However, because it may be very difficult for clinicians to associate adverse patient outcomes with the use of defective Huber needles, there may be under-reporting of events.”

Needles involved in the recall were manufactured between January 2007 and August 2009. According to the FDA, this recall includes more than 2 million units in distribution nationwide.

The affected needles have lot numbers beginning with the following, along with a catalogue number of product code:

“07”

“08”

“09”

 For more information, please read the following articles on the Class I FDA recall for Needles

FDA’s New Release about Recall: FDA Announces Class I Recall of Certain Infusion Set Needles
 

CNN Health Article  on Recall: FDA recalls more than 2 million needles used in port implants

According to Honda, the recall was to correct a faulty master power window switch, which could allow water to enter the switch and cause a fire. New York Times reports that three cases of fire due to the defective master switch were reported, including two in the U.S. and one in South Africa.

A statement released by Honda about the recall indicated that:

"Under some severe operating conditions, water, rain, or other liquid may enter the driver's window and reach the master power window switch, resulting in impaired function of the switch.” The statement went on to add that, "An overheating switch may cause smoke, melting or, potentially, fire."

Honda’s recall involves models sold around the world, including North America, South America, South Africa, and Asia. However, a Honda spokesperson indicated that the recall does not include Fit/Jazz and City units sold in Japan. Honda’s Fit is the company’s best-selling car in that country.

This latest recall by Honda comes just days after rival automaker Toyota halted sales and recalled millions of vehicles worldwide due to the threat of unintentional acceleration.

We strongly recommend all Honda Fit/Jazz or City vehicle owners to contact their dealer, or call Honda Automotive Customer Service at 1-800-999-1009.

For more information on the latest Honda recall, please click on one of the following links:

NY Times Article:  Honda Recalls Cars, Citing Defect

Wall Street Journal article: Honda Announces Worldwide Recall Of 646,000 Fit Cars

Honda South Africa’s Press Release about the recall:

Toyota anticipates stopping North American vehicle production lines for the week of February 1 to “assess and coordinate activities.” This production halt will affect Toyota manufacturing facilities in Kentucky, Indiana, Texas, and Canada.

The accelerator pedal recall and sales suspension affects eight models, including:
 

• 2009-2010 Corolla
• 2009-2010 Matrix
• Certain 2007-2010 Camry
• 2005-2010 Avalon
• 2009-2010 RAV4
• 2010 Highlander
• 2008-2010 Sequoia
• 2007-2010 Tundra

Bob Carter, Toyota Division General Manager and Group Vice President  stated the following:

"Helping ensure the safety of our customers and restoring confidence in Toyota are very important to our company. This action is necessary until a remedy is finalized. We’re making every effort to address this situation for our customers as quickly as possible.”

It is important to note that this recall is in addition to the carmaker’s ongoing recall of certain Toyota and Lexus vehicle lines due to the threat of pedal entrapment caused by “incorrect or out of place accessory floor mats.”

A Toyoya spokesperson reported that no confirmed deaths could be traced to the defect. However, Toyota’s stunning decision to halt sales and production are a clear indication of the serious nature of the situation.

For more information on the most recent Toyota recall click on the following links: Toyota, Washingtonpost,  CNNMoney.com and The New York Times.

We encourage Toyota vehicle owners with the affected models to contact their local Toyota Dealer or to contact Toyota directly at 800-331-4331.

Toyota Motor Sales, U.S.A., has recalled approximately 2.3 million vehicles to correct sticking accelerator pedals on specific Toyota Division models. This action is not related to the on-going recall of approximately 4.2 million Toyota and Lexus vehicles to reduce the risk of pedal entrapment by incorrect or out of place accessory floor mats. Approximately 1.7 million Toyota Division vehicles are subject to both separate recall actions.

“Our investigation indicates that there is a possibility that certain accelerator pedal mechanisms may, in rare instances, mechanically stick in a partially depressed position or return slowly to the idle position. Consistent with our commitment to the safety of our cars and our customers, we have initiated this voluntary recall action.”

Toyota owners should take note that the following Toyota vehicles are affected by the accelerator pedal recall

• 2009-2010 RAV4,
• 2009-2010 Corolla,
• 2009-2010 Matrix,
• 2005-2010 Avalon,
• 2007-2010 Camry,
• 2010 Highlander,
• 2007-2010 Tundra,
• 2008-2010 Sequoia

The condition is rare, but can occur when the pedal mechanism becomes worn and, in certain conditions, the accelerator pedal may become harder to depress, slower to return or, in the worst case, stuck in a partially depressed position.

In the event that a driver experiences an accelerator pedal that sticks in a partial open throttle position or returns slowly to idle position, the vehicle can be controlled with firm and steady application of the brakes. The brakes should not be pumped repeatedly because it could deplete vacuum assist, requiring stronger brake pedal pressure. The vehicle should be driven to the nearest safe location, the engine shut off and a Toyota dealer contacted for assistance.

Toyota owners who have questions or concerns should contact the Toyota Customer Experience Center at 1-800-331-4331.

For more information on other toyota recalls, click on the following link:Toyota Recalls
 

The affected Cleviprex lots are 61-978-DW, 61-979-DW, and 61-980-DW, Exp. 01/2010; 68-404-DJ, 68-405-DJ, and 68-406-DJ, Exp. 08/2010; 69-830-DJ, 63-385-DJ, 63-386-DJ, and 63-266-DJ, Exp 03/2011; and 64-453-DJ, Exp. 04/2011. No other lots are affected by this recall.

The Medicines company is cooperating with the U.S. Food and Drug Administration on this recall.
The particulate matter comprises sub-visible inert stainless steel particles of around 2.5 microns.
There are no known complaints or reports of adverse events related to this issue regarding Cleviprex ®

For medical inquiries, adverse event reporting or quality issues related to Cleviprex, please contact The Medicines Company Medical Information at 1-888-977-6326 Monday to Friday 8:00am-5:30pm EST or cleviprexrecall@themedco.com

Consumers with any adverse reactions associated with the use of Cleviprex may also report this to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website.

The stock for MDCO closed at $8.04, down .08 shares from previous trading.
 

In an Associated Press article, The New York Times reports finding from researchers at the University of California, San Francisco. This article shares alarming patterns of how the FDA frequently gave their seal of approval for heart devices based on foreign research in small groups of patients. In a further twist, common standards and protocols for device studies were lacking such as clear goals and randomization. One can't help but wonder, who is looking out for the American public, if the FDA's testing has such fundamental flaws.

Scientific American, author, Cynthia Graber states the following in her podcast transcript, in response to the JAMA article.

"We like to think that medical equipment implanted in our bodies undergoes rigorous testing before it’s put inside a person

These recent turn of events, further underscores the need to pass the Medical Device Safety Act (MDSA), according to the American Association for Justice (AAJ). Since the hotly debated Supreme Court Decision in Riegel v. Medtronic, medical device product liability has been front and center in the debate on FDA approved devices and who should be held accountable.

AAJ President Anthony Tarricone eloquently states the following in support of the Medical Device Safety Act  (HR. 1346 / S. 540)

"Passage of the Medical Device Safety Act is critical for patient safety, especially when medical devices have not gone through rigorous premarket testing and post-market monitoring.”

I have several loved ones and friends that drive a Toyota. Therefore I am genuinely concerned about this recent recall issue. A few months ago, we shared information on our blog regarding the Toyota Mat Recall.

I started to think about the following:

Here is the big game: Before anything: BLAME THE VICTIM. BLAME THE VICTIM. NEVER ADMIT FAULT. BLAME THE VICTIM.

It is the same old story: “The accident wasn’t our fault, it was driver error!” BLAME THE VICTIM.

But eventually the statistics add up. Eventually the big corporation must face the facts. Your car is messed up. Your drug is defective. Your medical device is malfunctioning.

When will these corporations learn and be more responsible about Consumer Safety?

I am delighted that we have a justice system that allows us to hold companies accountable.

Toyota issued the following Recall information on their website, regarding the accelerator pedal:

Toyota Motor Sales, U.S.A., Inc. (TMS) announced today details of the vehicle-based remedy to address the root cause of the potential risk for floor mat entrapment of accelerator pedals in certain Toyota and Lexus models. Toyota issued a consumer safety advisory on September 29 on this issue and has, as an interim measure, commenced the mailing of safety notices to certain Toyota and Lexus owners on October 30.

The models involved are: 2007 to 2010 MY (model year) Camry, 2005 to 2010 MY Avalon, 2004 to 2009 MY Prius, 2005 to 2010 MY Tacoma, 2007 to 2010 MY Tundra, 2007 to 2010 MY ES350, 2006 to 2010 MY IS250, and 2006 to 2010 MY IS 350

Toyota's quick fix to this problem is to  shorten gas pedals by three-quarters of an inch, starting in January. In certain instances, they will take padding from the floor to prevent the pedals from getting stuck on floor mats.

Toyota Announces Details of Remedy to Address Potential Accelerator Pedal Entrapment - Toyota Advisory to consumers 

According to this ruling, an FDA approval for a generic drug does not does NOT preempt claims against the drug makers for failing to warn consumers of known risks.  Justices in this case,  included: Hon. Roger L. Wollman - Sioux Falls, SD, Hon. Diana E. Murphy, Minneapolis, MN and Hon. Kermit E. Bye - Fargo, ND

In Mensing v. Wyeth, the Eighth Circuit's decision concluded with the following:

Mensing has stated a viable claim against the generic metoclopramide manufacturers. Far from prohibiting them from taking steps to warn
their customers of new safety hazards, federal law requires such action. For the
reasons stated we reverse the judgment in favor of the generic manufacturers but
affirm the judgment as to the name brand manufacturers.

Arthur Bryant, Executive Director, Public Justice and the Public Justice Foundation made an excellent point when he recently shared the following message: 

The Eighth Circuit emphasized that generic manufacturers, like name-brand drug companies, "bear primary responsibility for their drug labeling at all times." Lawsuits like Ms. Mensing's, the court said, do not "obstruct the purposes and objectives" of federal drug regulation "in any way." Instead, they help achieve the "fundamental" purpose of federal regulation-ensuring that "all marketed drugs remain safe."

Click here to read the Court Opinion on Mensing v. Wyeth, Inc.

We are headed in the right direction of improving drug safety and holding pharma giants, both brand and generic, accountable for their actions.

Time will tell what impact this decision has on the future of generic pharmaceuticals.

Patients with advanced kidney failure who cannot excrete the chelated form of gadolinium fast enough, nephrogenic systemic fibrosis (NSF) may result. An additional risk factor is acidosis, elevated acid levels in body fluids, a condition often found in end-stage renal patients.

Patients who undergo angioscopic diagnostic procedures may be exposed to up to three times the usual amount of gadolinium. Cardiac patients often have renal insufficiencies due to prolonged elevations in blood pressure. Those most at risk of developing gadolinium NSF are those who have acute or chronic renal insufficiency, often part of the pre-operative stages of a liver transplant.

First noticed in 1997, gadolinium NSF is characterized by a thickening and hardening of skin and connective tissues. Thickened and inflexible skin can interfere with the range of movement in extremities, sometimes resulting in an inability to walk. Internal organs and connective tissue can be seriously damaged, impinging on the function of organs or restricting the movement of areas like the diaphragm, key in the breathing mechanism. Damage may begin appearing within two days to 18 months. Extensive organ damage may result in death.

The first strong association between the use of GBCA and NSF was described in a Danish Medicines Agency press release in May 2006.

In 2007, Yale University’s Dr. Phillip Kuo, MD, PhD, a world-renowned expert on NSF, and his colleagues began recommending hemodialysis of kidney patients with a few hours of undergoing a gadolinium-assisted MRI procedure. Kuo recommended at least two sessions of hemodialysis with the first 24 hours of this particular diagnostic test. In subsequent reports, a renal transplant was shown to arrest or even partially reverse the ravages of NSF.

In order to alert physicians to the hazards associated with gadolinium, the U.S. Food and Drug Administration began asking manufacturers in 2009 to include warnings on their gadolinium-based product labels.

Common types of Product Defects include:

"Marketing Defects," such as missing or inadequate warnings and/or instructions, which may prevent the consumer from knowing how to safely use the product. A good current example of this is the Birth Control Pill YAZ or Yasmin.

• "Design Defects," where the product is manufactured exactly as intended, but the product itself is deemed unreasonably dangerous when used as intended or in a foreseeable manner. A good example of this is the Ford Pinto from the 70's. 

• "Manufacturing Defects," when a particular version of a product is defective and does not conform to the manufacturer's design due to some error in the manufacturing process.

Negligence is an area that looks at several scenarios including the following: 
• Exercise of reasonable care in making sure the product would not cause injury if used properly. ;
• Design, Marketing, and/or Manufacturing that attributed to the defect of the product; and
• Direct and proximate cause of the defect/breach of duty,that injured the claimant.

A Strict Liability claim involves asking the claimant Is show that the product was unreasonably dangerous for its intended use. Also, it is usually required to show that  the defect existed at the time the product left the control of the defendant against whom liability is sought, which caused the  injury.

Damages are seen as an effective measure to force a manufacturers to make safe products in the beginning. In most instances, an injured party is entitled to recover damages for the lass suffered due to the injury caused by the defective product. Sometimes, a victim may be able to receive punitive damages to discourage the guilty party from doing something like this in the future.  

Click on the following links to learn more on defective products, defective drugs  and products liability.

The first lawsuit against Pfizer, in regard to Neurontin, to be heard before the court was the case of Susan Bulger, the 39-year old woman that committed suicide. After the first day of trial, the lawsuit brought against Pfizer by Ms. Bulger’s family was dropped after an anonymous donor agreed to provide monies to the family with the stipulation that the monies be put into a trust for Ms. Bulger’s daughter. The family determined that this would be in the best interests of the child and chose not to proceed with their lawsuit. The court dismissed the case. The attorneys for Pfizer continue to assert that there is no evidence that Neurontin increases or causes suicidal thought or behaviors. However, no real answer has been provided to this question. With the first lawsuit being so quickly dismissed, the mysteries and unanswered questions regarding Neurontin may have to wait to be discovered and answered until further lawsuits come before the courts.

It appears that with so many other lawsuits pending against Pfizer regarding Neurontin that this story is long from over. If Neurontin truly is a potentially dangerous drug, the public needs to be made aware of this before more innocent people are affected.  Attorneys on both sides of the arena seem ready and willing to share their perspectives and evidence with the courts and their juries. How this legal saga is going to play out is anyone’s guess. At this point, there are still more questions than answers. It is important to note that in 2004, Warner-Lambert paid $430 million in to settle allegations involving Neurontin related to off label marketing, in a case handled by the Justice Department. 

Click here to read more on the Neurontin case from Bloomberg.

Pfizer's stock closed at $16.07 today.

Stay tuned...

The Federal Motor Vehicle Safety Standards (FMVSS) and regulations with which automobile manufacturers must comply were first enacted by the National Highway Traffic Safety Administration, in March 1967 to provide manufacturers with guidelines regarding minimum safety performance requirements. Since 1967, new standards have been added and existing standards have been amended. These changes have been necessary due to the evolution and expansion of automobile manufacturing.  In 1973, FMVSS 216 was enacted. According to the U.S. Department of Transportation, FMVSS 216 “specified requirements for roof crush resistance over the passenger compartment.” The intent of FMVSS 216 was to provide protection to individuals involved in rollover crashes by ensuring that automobile manufacturers adhered to federal roof standards. In April 2009, FMVSS 216 was amended to provide better protection for those involved in rollover crashes and extended the standards applicability to both heavier trucks and sport utility vehicles (SUV).

The National Highway Traffic Safety Administration (NHTSA) reports that more than 280,000 rollover accidents are reported each year. As a result of these accidents, approximately 10,000 individuals are killed on a yearly basis. Many of these fatal accidents involve SUVs and trucks. Until the 2009 amendment to FMVSS 216, most SUVs and trucks were exempt from federal roof standards. According to the Insurance Institute for Highway Safety’s Status Report the amendment will begin being phased-in in the year 2012, and all automobile manufacturers will be expected to comply with the amendment by the year 2017. This means that all passenger cars, trucks and SUVs up to 10,000 pounds will be subject to federal roof standards. These standards will apply to both the driver and the passenger side of the vehicle’s roof.

The National Highway Transportation Safety Commission reports that only 2 percent of accidents involve rollovers, but these accidents account for approximately 33 percent of all vehicle related fatalities. In Florida, approximately 25 percent of motor vehicle fatalities were the result of rollover crashes in 2007 according to the Traffic Safety Performance (Core Outcome) Measures provided by the NHTSA. In 2007, Georgia (31%), Alabama (40%), and California (29%) all had higher percentages of rollover fatalities than Florida, and New York (17%), Michigan (19%), and Mississippi (19%) had lower percentages of rollover fatalities than did Florida. The Insurance Institute for Highway Safety’s Status Report predicts that 135 lives will be saved each year by the amendment to FMVSS 216.

The changes that FMVSS 216 will require automobile manufacturers to make in the production of vehicles up to 10,000 pounds will mean that the roofs of cars, trucks, and SUVs will be even sturdier than they have been in the past. Not only will the driver side be able to withstand greater impact but the passenger side will be able to withstand greater impact as well. Proponents of the amendment to FMVSS 216 feel that this change has been long overdue and that by updating and improving the federal roof standards individuals will be more likely to survive a rollover crash.
 

• Hydroxycut Regular Rapid Release Caplets
• Hydroxycut Caffeine-Free Rapid Release Caplets
• Hydroxycut Hardcore Liquid Caplets
• Hydroxycut Max Liquid Caplets
• Hydroxycut Regular Drink Packets
• Hydroxycut Caffeine-Free Drink Packets
• Hydroxycut Hardcore Drink Packets (Ignition Stix)
• Hydroxycut Max Drink Packets
• Hydroxycut Liquid Shots
• Hydroxycut Hardcore RTDs (Ready-to-Drink)
• Hydroxycut Max Aqua Shed
• Hydroxycut 24
• Hydroxycut Carb Control
• Hydroxycut Natural

If you have taken these products and are experiencing side effects, contact your doctor. It is better to err on the side of caution and discontinue use of the product. This could help save your life and prevent fatal results.

The lawsuit stemmed from a discovery of unsafe levels of lead paint found in Mattel toy products that were on store shelves between September 2006 and August 2007. According to the CPSC, nearly 100 varied items were included in the lawsuits, representing several million individual pieces. Mattel issued a recall for the products, which included such popular toy brands as Barbie, Doggie Day Care, Dora the Explorer, and Polly Pocket. Other toys that were recalled included items associated with characters from Sesame Street and the movie Cars.

Parents have every right to feel anxiety about high levels of lead in toys. The CPSC says that lead in paint can cause irreversible brain damage, increased blood pressure, decreased muscle coordination, nerve damage, and reproductive harm in both children and adults. Parents who fear that their children may have been exposed to lead based paint should arrange for lead poisoning screening. Early treatments may reverse the effects of lead poisoning, while prolonged exposure to lead or lack of adequate care may cause permanent damage.

Though some parents have vowed to only allow their children to use organic, unpainted toys, this is an effective but unnecessary step at lead exposure prevention. In order to decrease the contact children may have to possible lead based toys, parents should stay abreast of all product recalls. The CPSC keeps an updated list of all recalled toys at on the Consumer Products Safety Commission website under recalls. Parents should check this site regularly if they are at all concerned about possible lead contamination. Parents should also frequently examine toys and remove those that have chipped or peeling paint, as ingested or inhaled lead is the chief cause of damage. Parents should also attempt to keep children from biting or sucking on painted toys.
 

Raptiva, marketed in the U.S. by San Francisco Pharma manufacturer, Genentech, is a once-weekly injection approved for adults with moderate to severe plaque psoriasis.  Approved by the FDA in 2003, the drug showed no cases of PML in clinical trials. Reports indicate that nearly 3,000 patients were treated with the drug during the clinical trials. The medication was administered to 218 people for one year or more, over 900 patients for six months and 2,400 patients for three months. Approximately 46,000 people worldwide have been treated with Raptiva, since 2003.

Late last year, the FDA, approved a Black Box warning label change of the drug Raptiva in October 2008. The new FDA Box warning stated that using Raptiva could increase the risk for infection. Genentech manufacturer of Raptiva, has been ordered by the FDA, to investigate the effects and likelihood of PML being contracted while taking Raptiva.

Since the FDA's recent advisory, Genentech has taken steps to notify users and medical professionals about the risks of taking Raptiva, by outlining specific risks on the website and sending warning letters to patients and health care providers. Unfortunately, all of this is a little too late for the victims that died, possibly due to using Raptiva for treatment of  psoriasis. According to reports, they were using Raptiva for at least three years.

The FDA has vowed to “take appropriate steps” to ensure that the treatment benefits of Raptiva outweigh the heightened potential risk of contracting PML. Further, the FDA is informing health care providers what to look for in PML cases. They have issued a warning to physicians that they may see more cases of PML. In addition, they  are directly informing Raptiva patients of the risks involved with using the psoriasis medication and describing the symptoms of PML. Hopefully, these proactive measures will help prevent more deaths. 

 

According to the 80 page decision that was delivered by Justice Stevens,

Directly injecting the drug Phenergan into a patient’vein creates a significant risk of catastrophic consequences-quences. A Vermont jury found that petitioner Wyeth, the manufacturer of the drug, had failed to provide an Adequate-quate warning of that risk and awarded damages to re-spondent Diana Levine to compensate her for the amputation of her arm. The warnings on Phenergan’s label had been deemed sufficient by the federal Food and Drug Administration (FDA) when it approved Wyeth’s new drug application in 1955 and when it later approved changes in the drug’s labeling .The question we must decide is whether the FDA’s approvals provide Wyeth with a complete defense to Levine’s tort claims. We conclude that they do not.

The majority decision, authored by Justice Stevens, unequivocally rejected the pharmaceutical defendant’s arguments that the FDA regulatory scheme preempted state law failure-to-warn claims and outlined the real world limitations of FDA powers. This decision will have implications in pharmaceutical product liability claims for decades to come. Also joining Justice Stevens were Supreme Kennedy, Sorter, Ginsberg, Beyer, and Thomas. It was not surprising that the three dissenters included, Chief Justice Roberts, Ali to and Scalar. 

It is important to note that this Br yer and Thomas clarified their vote by also writing an opinion in addition to Justice Stevens.  This solidified their strong belief in their sentiments that manufacturers can't hide behind the FDA approval and not be vigilant in issuing necessary warnings and safety precautions. The Supreme Court held: (1) the FDA’s regulatory scheme exists in harmony with state law failure-to-warn claims; (2) the controversial 2006 FDA preamble regarding preemption is entitled to no deference; and (3) it is the manufacturer, not the FDA, which has the duty to warn consumers about side effects. As the Supreme Court reasoned, “State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly.” (Slip op., at 23.)

This case illustrates that tragic facts make bad law. The Court holds that a state tort jury, rather than the Food and Drug Administration (FDA), is ultimately responsible for regulating warning labels for prescription drugs. That result cannot be reconciled with Geier v. American Honda Motor Co., 529 U. S. 861 (2000), or general principles of conflict pre-emption.

Alito goes on to pose the hypothetical question:  "is it the FDA or a jury in Vermont— that has the authority and responsibility for determining the “adequacy” of Phenergan’s warnings?"

There is so much to discuss in this 80 page decision.   Over the next few days we will go into the decision more on this blog, to highlight more important points in this opinion. As Civil Justice Prosecutors, we are pleased with the Court's decision in Wyeth v. Levine.