F.D.A. Internal Reports Recommend Avandia Be Withdrawn From Market

There is a fierce debate going on within the Food and Drug Administration regarding the drug Avandia.  According to the New York Times, recent internal reports from the Food and Drug Administration recommend that Avandia (a drug used to treat Type 2 diabetes) be removed from the market.  The reports indicate that people who use Avandia needlessly suffer heart attacks and heart failure each month and say that if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month.   Avandia was linked to 304 deaths during the third quarter of 2009.  It is expected that an advisory committee within the FDA will debate the drug further this spring and summer and will then make a final decision regarding the drug and whether or not it should be sold.

Avandia is manufactured by GlaxoSmithKline and was once one of the best-selling drugs in the world.  In 2006 alone, sales were $3.2 billion.

Toyota Begins Shipping New Accelerator Pedals

Today, Toyota Motor Corp. announced that its accelerator pedal supplier began shipping newly designed pedals to dealers to fix the company's sticky gas pedals that have required 4.2 million vehicles to be recalled.  According to reports, federal regulators did not object to Toyota's repair plans.  A more detailed announcement by Toyota is expected to be made Monday.

In the meantime, contact the Toyota Customer Experience Center at 1-800-331-4331 if you have questions about your vehicle. The Toyota Customer Experience Center hours are: Mon.–Fri. 5:00 am-6:00 pm PST, Sat. 7:00 am-4:00 pm PST.

Toyota Extends Recall And Suspends Sales Over Accelerator Problem

Yesterday, Toyota Motor Corporation extended its recall from last fall and added an additional 2.3 million vehicles to the recall list over problems with accelerators in a number of its most popular vehicles.  Toyota also suspended sales and stopped production of a number of the models subject to the recall until a fix can be implemented. The accelerator problem has been linked to a number of motor vehicle accidents throughout the country involving serious injuries and deaths to occupants.

This has been a public relations nightmare for Toyota that is not getting any better as each day passes.  While Toyota has told federal investigators that it thinks a friction problem in its accelerator pedal mechanisms may make the pedal "harder to depress, slower to return, or, in the worst case, mechanically stuck in a partially depressed position", CTS Corp, the supplier that makes the devices for Toyota, said in a statement Wednesday that the friction problem accounts for fewer than a dozen cases  stuck accelerators and, "in no instance did the accelerator actually become stuck in a partially depressed condition".   

The Toyota vehicles subject to the recall include the following makes and models:

  • 2009-2010 RAV4
  • 2009-2010 Corolla
  • 2009-2010 Matrix
  • 2005-2010 Avalon
  • 2007-2010 Camry (except hybrids)
  • 2010 Highlander (except hybrids)
  • 2007-2010 Tundra
  • 2008-2010 Sequoia
No Lexus Division or Scion vehicles are affected by the new recall. Also not affected are Toyota Prius, Tacoma, Sienna, Venza, Solara, Yaris, 4Runner, FJ Cruiser, Land Cruiser, Highlander hybrids and Camry hybrids, which will remain for sale.
 

According to Toyota, if you experience a sticking accelerator pedal while driving, you should take one of the following actions:

• If you need to stop immediately, the vehicle can be controlled by stepping on the brake pedal with both feet using firm and steady pressure. Do not pump the brake pedal as it will deplete the vacuum utilized for the power brake assist.
• Shift the transmission gear selector to the Neutral (N) position and use the brakes to make a controlled stop at the side of the road and turn off the engine.
• If unable to put the vehicle in Neutral, turn the engine OFF. This will not cause loss of steering or braking control, but the power assist to these systems will be lost.
• If the vehicle is equipped with an Engine Start/Stop button, firmly and steadily push the button for at least three seconds to turn off the engine. Do NOT tap the Engine Start/Stop button. 
• If the vehicle is equipped with a conventional key-ignition, turn the ignition key to the ACC position to turn off the engine. DO NOT remove the key from the ignition as this will lock the steering wheel.  

Customers who have any questions or have experienced any issues with their accelerator pedals should visit Toyota.com, contact the Toyota Customer Experience Center at 1-800-331-4331, or call their local Toyota dealer.

Texas Supreme Court Now Requires E-Submission

The Texas Supreme Court has posted an order on its website which now requires parties to submit electronic copies of all petitions, responses and replies filed with the Court in all cases.  The order will become effective February 15, 2010.

Previously, the Court had only asked for electronic courtesy copies of filings in cases for which it requested briefs. The new order requires parties to e-mail copies of documents to the Supreme Court clerk, scebriefs@courts.state.tx.us, on the same day they file the original paper documents.  Because the parties will still have to file paper documents, submitting an electronic copy of the document does not constitute filing the document.  

Click here to view the Court's order on its website. 

Hertz Corp. v. Friend: Where Is A Nationwide Company's "Principal Place of Business" For Purposes of Diversity Jurisdiction?

This Tuesday, November 10, the U.S. Supreme Court will hear arguments in Hertz Corp. v. Friend (08-1107), a case that will address how you determine where a nationwide company's "principal place of business" is located for purposes of diversity jurisdiction under 1332(c). 

The Court has not previously had an opportunity to address this issue because motions to remand granted by federal district courts are, generally, not subject to appellate review.  However, the Hertz case involves a class action filed in California.  Under the new 2005 Class Action Fairness Act (CAFA), remand orders are subject to appellate review and the Court will have an opportunity to address an issue that could have a sgnificant impact on where lawsuits can be filed and maintained in the future. 

Hertz, a Delaware corporation with its corporate headquaters in New Jersey, argues its "principal place of business" is in New Jersery.  The Plaintiffs argue a "multi-factor approach" should be considered by federal courts and, when doing so, points to California as being Hertz' "principal place of business" because California is far and away the state where Hertz conducts most of its business.  The federal disctrict court and the Ninth Circuit agreed with the Plaintiffs.  The U.S. Supreme Court granted Hertz' petition for certiorari on June 8, 2009.

Sina Kina of the Stanford Law School has done a great job summarizing the case further, which can be reviewed by going here.

NHTSA Investigation Reveals Other Potential Factors Leading to Fatal Lexus Crash

On September 29, I wrote about a fatal crash that occurred this past August near San Diego, California that led Toyota to recall approximately 3.8 million vehicles.   According to investigators, the 2009 Lexus ES 350 being driven by a California Highway Patrol Officer  as a loaner vehicle from a Lexus dealership accelerated to as fast as 100 mph before striking another vehicle, launching off an embankment, rolling several times and bursting into flames.  Four people died in the crash.  Just before the crash occurred, a 911 call from one of the vehicle's passengers told police the vehicle had no brakes and that the accelerator was stuck.  Investigators believed the driver's side floor mat was the culprit. 

The National Highway Traffic Safety Administration's investigation into the California crash is  revealing  more potential factors in the cause of the crash than just the design of the driver's side floor mat., including the following:

  • The driver's side floor mat was made for the Lexus RX400h SUV, not the Lexus ES350.
  • The Lexus at issue had a keyless ignition, which uses a start/stop button to start and stop the engine. There is no traditional key to turn if you need to shut the engine off in an emergency. In the case of the ES350, the button needs to be held for three seconds before it will turn off the engine if the car is in gear. Toyota says it considered this a safety feature to prevent the engine from turning off if the button were pressed accidentally. However, the NHTSA report points out that the Lexus at issue was traveling 100 mph—that’s the equivalent of traveling one and a half football field in three seconds.  Also, NHTSA pointed out that there is no instruction near the dashboard that tells owners or operators about how to shut down the engine by holding it down for three seconds..

The initial report filed by the NHTSA can be reviewed by going here.

AstraZeneca Settles Seroquel Claims For $520 Million

According to the New York Times,  AstraZeneca  has agreed to settle two federal investigations and two whistle-blower lawsuits for a total of $520 million over the sale and marketing of its psychiatric drug Seroquel.  The names of the whistle-blowers and other details regarding the investigations remain under seal in federal court.

Due to aggressive marketing by AstraZeneca, Seroquel had been used for children and the elderly for uses not approved by the Food and Drug Administration. Seroquel had been the top selling antipsychotic drug in the United States, with sales exceeding $17 billion since 2004.

AstraZeneca has been served with approximately 14,444 product liability lawsuits over Seroquel.  Through discovery in some of those cases, Plaintiff's counsel Ed Blizzard says an internal email message from a company official  regarding Study 15 stated "a great 'smoke and mirrors' job"  had been done on a "buried" study in 1997, the year Seroquel was approved by the FDA.

Toyota Hit With Temporary Restraining Order

In what appears to be the first case in Texas to be filed against Toyota seeking to reopen previously settled product liability cases, Judge T. John Ward, who presides over the United States District Court, Eastern District of Texas, Marshall Division, signed and entered a temporary restraining order against Toyota Motor Corporation, Toyota Motor Sales, USA, Inc. and several in-house counsel for Toyota regarding document retention related to Toyota motor vehicles. 

The temporary restraining order arises out of a civil RICO complaint filed in Judge Ward's court by Raul Lopez, a plaintiff who previously settled a personal injury case with Toyota years ago.  Mr. Lopez filed a RICO complaint on September 25 seeking to reopen his case after Dimitrious Biller, a former in-house attorney for Toyota, filed a federal lawsuit in California alleging Toyota has illegally withheld and destroyed evidence in hundreds of rollover injury and death cases over  the past several years. 

The temporary restraining order issued by Judge Ward yesterday orders Toyota, and essentially anyone who works for or with Toyota, to:

  1. Issue litigation holds on all documents in any form pertaining to any make, model or year platform vehicle;
  2. Issue litigation holds on all documents in any form pertaining to any non-production vehicle evaluation pertaining to product liability or crashworthiness issues;
  3. Issue litigation holds on all documents in any form pertaining to research projects that involve issues related to product liability or crashworthiness issues;
  4. Issue litigation holds on all documents that are presently or will be subject to any type of document retention policy;
  5. Issue litigation holds on all documentation and all communications sent to outside Counsel, outside experts, or outside contractors.

Judge Ward also set a show cause hearing  for October 7, 2009, at 1:30 pm, for Toyota to show why the temporary restraining order should not be converted to a preliminary injunction.

The style of the case is Raul Lopez, et. al. v. Toyota Motor Corporation, et. al., Cause No. 2:09-CV-292.

 

Toyota Recalls 3.8 Million Vehicles

Today, Toyota Motor Sales, USA announced it was recalling approximately 3.8 million vehicles to address problems with removable floor mats that could cause the accelerator to become stuck and lead to a crash.  This recall is the largest recall in Toyota's history.

According to the National Highway Traffic Safety Administration, the federal government has received notice of 102 incidents involving Toyota vehicles where the accelerator became stuck while being operated.  While it is not clear how many of the 102 reported incidents resulted in injuries or deaths to occupants, Toyota spokesperson Irv Miller stated "[a] stuck open accelerator pedal may result in very high vehicle speeds and make it difficult to stop a vehicle, which could cause a crash, serious injury or death."  Transportation Secretary Ray LaHood stated "this is an urgent matter" and warned owners of affected vehicles to remove the floor mats from the driver's side immediately.

This past August near San Diego, a 2009 Lexus ES 350 being driven by a California Highway Patrol Officer accelerated to 120 mph before striking another vehicle, launching off an embankment, rolling several times and bursting into flames.  Four people died in the crash.  Just before the crash occurred, a 911 call from one of the vehicle's passengers told police the vehicle had no brakes and that the accelerator was stuck. Investigators believe the floor mat may be to blame for the incident.

 

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Mitsubishi Recalls 2010 Endeavor For Defective Airbags

Mitsubishi has recalled 531 Endeavor model vehicles from the 2010 model year as a result of certain vehicles having potentially defective airbags. Specifically, the recall results from the retainer bracket for seat-mounted airbags on both the driver and passenger side airbags being incorrectly welded. If the faulty welding condition exists in a vehicle, the side airbags may not deploy correctly in a side impact crash, possibly resulting in serious injury to an occupant.

The vehicles involved were manufactured by Mitsubishi between May 26 and July 28, 2009.  Mitsubishi began notifying owners within the last week and issued a "stop sale"  on all 2010 Endeavors until all potentially effected vehicles can be inspected.

Any of the recalled vehicles will be inspected by a Mitsubishi dealer and repaired at no charge to the customer.  Customers can contact the Mitsubishi Customer Relations Department at 1-888-648-7820.