Archive for September, 2013

Bloomberg Reports Settlement Talks in Mesh Cases

Bloomberg is reporting that C.R. Bard, Endo Health Solutions, Boston Scientific, Cook, and Coloplast are in what Judge Goodwin described a “behind the scenes” settlement talks.  Johnson and Johnson (J&J) is reportedly NOT participating.

Bard was held liable in two jury verdicts so far.  In July 2012, Bard lost an Avaulta case in a California jury trial and was ordered to pay Christine Scott and her husband over $5 million.  On August 15, 2013, the company was ordered to pay $2 million to Donna Cisson after a jury verdict.  Shortly thereafter, it settled a case in West Virginia (Queen vs. Bard and on September 13, 2013 reportedly settled Melanie Virgil’s case that was set for trial in New Jersey on September 26, 2013.

Bard’s implants have been targeted in more than 12,000 cases, while Boston Scientific said in an August regulatory filing; it faces more than 12,000 suits over its vaginal devices.  Endo’s American Medical Systems Inc. unit faces about 13,500 vaginal-mesh claims between state and federal suits, and Coloplast and Cook face about 1,000 claims combined.  J&J faced 12,250 pelvic mesh claims through June 30, according to a regulatory filing.

C.R. Bard took a $275.1 million litigation charge earlier in 2013 year related to the lawsuits, an action that led to a sizable net loss.

In February 2013, Linda Gross won $11.11 million in her lawsuit against Johnson & Johnson’s Ethicon brand over its Prolift vaginal mesh product.  Gross had 18 surgeries.  The New Jersey jury found that J&J failed to warn patients and doctors about the risks of its mesh products and made fraudulent misrepresentations.  Based on the Bloomberg report, it is too early to know if the settlement talks will continue let alone lead to a resolution.

Click here to read the full article: Bard, Vaginal-Mesh Makers, Said to Be in Settlement Talks

If you would like more information, check the video below, go to our website, or contact us at 1-800-481-1615 or email us.

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Toyota and Nissan Issue Recalls for Over 1.5 Million Worldwide

2008 Toyota Sienna

2008 Toyota Sienna

On September 26, 2013, Toyota and Nissan announced two separate recalls that will affect over 1.5 million vehicles worldwide.  Toyota will be recalling 615,000 Sienna minivans in the United States.  The reason for the recall is that the minivan can shift out of park even if the driver is not depressing the brake pedal.  This defect increases the threat of the vehicle rolling away without the driver knowing.  The models affected are the 2004-2005 and the 2007-2009 vehicles.  The 2004-2005 were manufactured from January 10, 2003, through August 10, 2005.  The 2007-2009 models were manufactured from manufactured February 20, 2007, through December 12, 2008.

Toyota will mail initial notifications to owners beginning in late October 2013.  When the parts become available, owners will be sent a second notice and dealers will replace the shift lock solenoid, free of charge.  Owners may contact Toyota at 1-800-331-4331.

Click here to read the full New York Times article: Nissan and Toyota Issue Recalls for About 1.5 Million Vehicles Worldwide

Nissan will be recalling 908,000 vehicles worldwide due to defective accelerator sensors.  Because of the defective accelerator sensors, the vehicles affected could lose power and stall out.  To fix the problem, the accelerator pedal assembly must be replaced and the system reprogrammed.  In the United States, 98,000 of the Nissan 2006-10 Infiniti M models will be affected.  These automobiles were manufactured from April 4, 2004, through October 5, 2010.

Nissan will notify owners, and dealers will replace the accelerator pedal assembly and reprogram the engine control module, free of charge. The recall is expected to begin in early November 2013. Owners may contact Nissan at 1-800-647-7261.

Click here to read the full CBS News article: Nissan, Toyota recalling 1.5M vehicles

Recently, Toyota recalled over 1 million Toyota and Lexus models due to rear suspension, loose bolt, and overheating problems.

Americans rely on their car manufactures to provide a safe well-designed vehicle.  Sadly, that is not often the case.  The Auto Defect Attorneys at the Brandi Law Firm has successfully represented many people injured from defective Toyotas, Fords, Chrysler, Nissan, GM products and numerous other manufacturers and suppliers.  Often times, people involved in accidents do not examine the issues of defective vehicle design nor whether the car was truly crashworthy – does it contain the appropriate crash protection.  If you or a loved one has been injured in an auto crash, our attorneys at the Brandi Law Firm are available to consult with you.  Please contact our office at 800-481-1615 or email us.

Trademark Notice

Toyota is a registered trademark of Toyota Motor Corporation.  The use of this trademark is solely for product identification and informational purposes. Toyota Motor Corporation is not affiliated with this website, and Toyota Motor Corporation has no affiliation with the Brandi Law Firm.  Nothing on this site has been authorized or approved by Toyota Motor Corporation.

Nissan is a registered trademark of Nissan Motor Corporation.  The use of this trademark is solely for product identification and informational purposes. Nissan Motor Corporation is not affiliated with this website, and Nissan Motor Corporation has no affiliation with the Brandi Law Firm.  Nothing on this site has been authorized or approved by Nissan Motor Corporation.

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Another Plaintiffs Actos verdict, Another Verdict Thrown Out by Trial Judge

On September 26, 2013, a jury in Baltimore, Maryland, found that Takeda Pharmaceutical Co. did not properly warn Diep An, an ex-U.S. Army translator, and his doctor about the risks of its Actos diabetes drug and ordered the company to pay more than $1.7 million in damages.  Jurors also found that An, a thirty year smoker was contributorily negligent, and under Maryland Law, the Judge immediately threw out the verdict.  The case is An v. Nieberlein, 24-C12003565, Circuit Court for the City of Baltimore, State of Maryland.

For Actos users and for Takeda, this means two juries have found Actos to be defective, have inadequate warnings, and be the contributing factor to its user’s cancers.  However, for reasons unrelated to the conduct of Takeda, but solely due to legal issues, two trial judges overturned the verdicts allowing Takeda to temporarily dodge the Juries inevitable findings of fault.

In An, the case was overturned due to the vagaries of Maryland law as it relates to contributory negligence of the user, where if a Plaintiff is even one percent at fault , the Plaintiff cannot recover.  This issue was most recently upheld by the Maryland Court of Appeal in a 5-2 vote on July 9, 2013.  Only Maryland, Virginia, Alabama, North Carolina and the District of Columbia still have the law while 46 states use a comparative negligence system that reduces the damages an injured person can receive in proportion to his or her degree of fault.

On April 26, 2013, a Los Angeles jury heard similar evidence and found against Takeda and assessed damages at $6.5 million (Cooper v. Takeda Pharmaceuticals America Inc., CGC-12-518535, California Superior Court, Los Angeles), but Judge Kenneth Freeman granted a post trial motion to overturn the verdict.  First, Judge Freeman granted Takeda’s motion to exclude the opinions of Plaintiff’s causation expert Dr. Norm Smith that Actos was a substantial factor in specifically causing Mr. Cooper’s bladder cancer.  With no opinion to support that finding remaining in the case, the Court then granted Takeda’s motion for non-suit, throwing out the verdict.

In September 2010, the FDA ordered a safety review of Actos.  The FDA is continuously reviewing the results of an ongoing ten-year study of the long-term risk of bladder cancer in approximately 193,000 diabetic patients taking Actos.  Takeda officials previously said that the study FDA officials reviewed are continuing and final results are expected in 2014.  A significantly increased risk of bladder cancer has been seen among patients from this group who take the highest doses of Actos (more than 28,000 mg) and who take Actos for longer than one year.  Compared to patients never having taken Actos, taking Actos for longer than one year was associated with a forty percent higher risk of bladder cancer.

A European study by the French Medicines Agency found a 22 percent higher risk of bladder cancer in approximately 155,000 patients taking Actos from 2006 to 2009, compared to 1.3 million patients not taking the drug.  The risk was highest in patients taking a cumulative Actos dose of 28,000 mg or more during the study period.  Authorities responded to the evidence of bladder cancer risk by recalling Actos in France and Germany.

We continue to believe that Actos is a likely cause and substantial factor in the bladder cancer patients we represent and that ultimately Takeda will be held responsible.  If you or a loved one has been diagnosed with bladder cancer and took the diabetes drug Actos, you may have a claim for your injuriesThomas J. Brandi and the Brandi Law Firm are leaders in nationwide pharmaceutical litigation for decades and are now representing clients who have suffered bladder cancer related to Actos use and filed suits on their behalf. For a free consultation call us at 1-800-481-1615 or email us or go to our website for further information about Actos.

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California Supreme Court Victory for Generic Fosamax Users

On September 25, 2013, the California Supreme Court denied the generic Fosamax manufacturers petition for review thereby upholding the June 13, 2013 Court of Appeal decision allowing people injured by generic Fosamax to go forward in the Courts and hold the generic manufacturers responsible.  In denying the generic manufacturers Petition, the Supreme Court let stand the June 13, 2013 the California Court of Appeal, Fourth Appellate District, Division Three ruling that people who used the generic Fosamax were not preempted by Federal law and the decision in PLIVA, Inc. v. Mensing (2011) 131 S.Ct. 2567, but could proceed against manufacturers of generic version for failure to adequately warn of safety issues regarding the products (Teva Pharmaceuticals USA, Inc, et al vs. Superior Court of Orange County, OLGA PIKERIE, Real Party In Interest, G047134).

In Mensing, a 5-4 decision authored by Hon. Clarence Thomas, the US Supreme Court ruled that any claim a generic drug company should have used stronger warnings than those approved for use on the equivalent brand name drug are preempted by federal law.  The court also held that a state could not require a generic drug manufacturer to provide information on its label in addition to information required on the brand name drug’s label, as that would make it impossible for the generic drug manufacturer to comply with both its duty under federal law to match the brand-name label and any claimed duty under state law to do more.  As a result of this impossibility, such a state requirement would be preempted by federal law.

The practical effect of Mensing is, to quote the dissenting opinion of Justice Sotomayor, at 2581;

“As a result of today’s decision, whether a consumer harmed by inadequate warnings can obtain relief turns solely on the happenstance of whether her pharmacist filled her prescription with a brand-name or generic drug.  The Court gets one thing right: This outcome “makes little sense.”

However, in the case of Olga Pikerie, the California Court stated: “In this case, in contrast, plaintiff alleged that the brand‑name drug label was updated, but the generic drug manufacturers failed to update their products’ labels accordingly.  In other words, the generic drug labels did not match the brand‑name drug label.  Consequently, we conclude, plaintiff’s claims in this regard are not preempted by federal law.”

Fosamax was under patent protection to Merck until 2008.  Fosamax was heavily marketed following its introduction to the consumer market in 1999.  Millions of patients were prescribed Fosamax to treat or prevent Osteoporosis, especially in women going through menopause.  However, there are potential dangerous side effects of Fosamax that Merck & Company (manufacturer of Fosamax) failed to alert the public about, especially atypical femur fractures.  For many, what was designed to make you stronger actually made you weaker.

This decision will allow countless people who suffered atypical femur fractures on Fosamax or its generic equivalent to hold the manufacturers accountable.  The Brandi Law Firm continues to represent a number of people who used Fosamax or its generic equivalent and suffered atypical femur fractures.  We believe that ultimately Merck and the generic manufacturers will be held accountable in these cases.  If you would like more information, check the video below or go to our website, or contact us.

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Honda Recalls 374,000 Vehicles due to Air Bag Defect

Honda has announced that it will recall 374,000 vehicles to fix an airbag defect.  The problem is an electrical issue that could cause air bag deployment when there is no collision.  This recall affects 318,000 Honda Odyssey minivans from the 2003 and 2004 model years, and 56,000 Acura MDX sport-utility vehicles from 2003.

Click here to read the full Wall Street Journal article: Honda Recalls 374,000 Vehicles Whose Airbags Might Inflate Unexpectedly 

Honda will begin notification in late October.  To fix the defect, Honda will install a filter next to the air bag system.  Owners can contact Honda and Acura at www.recalls.honda.com and www.recalls.acura.com or by calling 800-999-1009 for Honda and 800-382-2238 for Acura.  Honda’s recall numbers are JC2 (Honda Odyssey) and JC3 (Acura MDX).

This is not the first time Honda has had to recall automobiles for air bag issues.  Back in April 2013, 4 Japanese automakers including Honda had to recall over 3 million vehicles due to improperly manufactured and installed air bags inflators that caused the airbag to deploy abnormally during a crash.

Americans rely on their car manufactures to provide a safe well-designed vehicle.  Sadly, that is not often the case.  The Auto Defect Attorneys at the Brandi Law Firm has successfully represented many people injured from defective Toyotas, Fords, Chrysler, Honda, GM products and numerous other manufacturers and suppliers.  Often times, people involved in accidents do not examine the issues of defective vehicle design nor whether the car was truly crashworthy – does it contain the appropriate crash protection.  If you or a loved one has been injured in an auto crash, our attorneys at the Brandi Law Firm are available to consult with you.  Please contact our office at 800-481-1615 or email us.

Trademark Notice

Honda is a registered trademark of Honda Motor Corporation.  The use of this trademark is solely for product identification and informational purposes. Honda Motor Corporation is not affiliated with this website, and Honda Motor Corporation has no affiliation with the Brandi Law Firm.  Nothing on this site has been authorized or approved by Honda Motor Corporation.

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DePuy September 23, 2013 Bellwether Trial Continued

On September 20, the Honorable David Katz presiding over the DePuy bellwether case, Ann McCracken v. DePuy Orthopaedics, Inc., et. al., Case No. 11 dp 20485, continued the trial 90 days from September 24, 2013 “in the interest of justice”.  According to the Order, the Judge continued the trial so that the parties could complete the scheduling of expert witnesses and pretrial discovery.

Approximately 93,000 DePuy ASR were subject to a global recall and over 10,000 cases are pending in California and the MDL.  Potentially thousands more wait on the horizon.  Thousands of hip implant recipients have experienced pain, dislocation, fracture, toxic poisoning, and were forced to have revision surgery to remove the defective DePuy ASR.

The lawyers at the Brandi Law Firm are representing a number of people with cases pending against the manufacturer of the DePuy ASR in the California JCCP, the MDL, and people who were injured by the DePuy Pinnacle.  Please contact the DePuy hip replacement failure attorneys at the Brandi Law Firm today (1-800-481-1615 or email us) to talk with a Johnson & Johnson DePuy ASR recall lawsuit attorney.

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Bard Settles Another Vaginal Mesh Suit

On September 13, 2013, Bard settled Melanie Virgil’s claims that Bard’s Avaulta Plus insert caused urinary problems.  The case, Virgil v. C.R. Bard Inc. (BCR), ATL-L6917-10, Superior Court of New Jersey Law Division, Atlantic County (Atlantic City), was scheduled to go to trial on September 26.  According to the complaint, Virgil, a junior high school music teacher in Colorado, sued Bard after her transvaginal mesh device began to erode.  Virgil needed three surgeries to address urinary problems created by the insert.

Click here to read the full Bloomberg article: Bard Said to Settle Vaginal-Mesh Case Set for Trial

Bard has lost two jury trials, has settled a third case after a jury selected, and now has settled a fourth before trial commenced.  Bard faces more than 8,000 claims over the Avaulta insert.

Over 23,000 women have filed suits detailing their injuries from the mesh inserted in them.  We believe that ultimately the cause of their injuries will be shown to be the defects in the mesh products and the absence of appropriate warnings.  If you would like more information, check the video below, go to our website, or contact us at 1-800-481-1615 or email us.

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Another LabCorp Whistleblower Suit Unsealed

Hunter Laboratories of Campbell, CA and its chief executive Chris Reidel filed a whistleblower suit against Laboratory Corp of America Holdings (LabCorp) and Quest Diagnostics alleging the two giants gouged Medicaid system by billing the state system significantly higher amounts than they bill private insurers.  Originally filed in State court in December 2007, the case was removed to federal court and unsealed in August 2013 (Hunter Laboratories LLC v. Quest Diagnostics et al 13 -cv-01129, U.S. District Court, Eastern District of Virginia (Alexandria)).  According to Bloomberg News, “A similar case brought by Hunter and Riedel accusing Quest of overcharging Medi-Cal, the Medicaid program in the state of California, was settled in 2011 for $241 million.”  A similar case is pending against LabCorp and Quest in Georgia.

Click here to read the full Bloomberg News article: Quest Diagnostics Sued for Defrauding Virginia Medicaid

On September 11, 2013, FierceMedicalDevices reported that “While the Virginia case is likely alarming to other state payers, the feds have long been concerned that Medicare is being bilked by diagnostics companies.  According to an Inspector General report released over the summer, the likes of Quest and LabCorp overcharged Medicare by about $910 million for common lab tests in 2011, as private insurers paid between 18% and 30% less than the federal government.”

Click here to read the full article: Quest, LabCorp Defrauded Medicaid, Lawsuit Says

LabCorp is also being sued in San Francisco Superior Court (No. CGC-12-518072) to prevent LabCorp for improperly changing screening codes on laboratory orders resulting in higher payments by consumers.  While preventative screening laboratory work is generally free of charge under many health care plans, LabCorp’s actions of changing the codes results in consumers being responsible for co-payments and charges, which are then pursued by LabCorp.

If you have any information regarding this practice or wish any information, please contact us at bjm@brandilaw.com or 800-481-1615.

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Studies Show Increased Risk with da Vinci Robot Procedures

In a study published in the prestigious Journal of Obstetrics and Gynecology (Green Journal) covering 804,551 benign hysterectomies in the United States in 2009 and 2010, patients undergoing surgeries using robots (including da Vinci robot) were more likely to have pneumonia post surgery, had the same complication rate as no robotic surgery, and paid $2500 more for their procedures than non robotic surgery.  Of the 804,551 surgeries, 20% were laparoscopic and 5.1% robotically assisted.  Among minimally invasive hysterectomies, the use of robotic hysterectomy increased from 9.5% to 13.6%.  The group of researchers is from the University of Texas Southwestern Medical Center.

Click here to read article: Intuitive’s Surgical Robots Slammed in Another Study

Click here to read the abstract: Comparison of Robotic and Laparoscopic Hysterectomy for Benign Gynecologic Disease

In a second study in the Journal for Healthcare Quality, published August 27, 2013, researchers at John Hopkins concluded that robotic surgery complications are grossly under-reported.  The researchers note that 1,400 surgical robots were installed in U.S. hospitals as of 2011, a jump of 600 over the previous four years and that more than 1 million robotic surgeries have been performed in the U.S. since 2000, but hospitals only reported 245 complications to the FDA (including 71 deaths).  And the low number comes even as procedures using surgical robots jumped over 400% in the U.S. between 2007 and 2011, the researchers note.

According to trade publication FiercePharma, “They looked at reporting of adverse events to the FDA from Jan. 1, 2000 to Aug. 1, 2012, plus legal judgments, news media reports and court records, and then cross-referenced to see if everything matched.  What they found: eight cases weren’t appropriately reported to the FDA.  Five of those were never filed with regulators at all, and two were only filed after the press reported the specific cases first.

And while complications such as excessive bleeding were reported, there were other problems that may not have been reported correctly, or at all, the researchers speculate.  For example, they note that surgeons can accidentally cut the aorta during robotic surgery because they can’t feel how firm it is.  But, the data was unclear as to whether this would be reported as a surgeon or device-related problem. Also, they cite a previous study in which nearly 57% of surgeons surveyed anonymously said that they had to convert to laparoscopic or open surgery after the robotic device malfunctioned.  And it is unclear how, or if, those errors are reported with the FDA.”

The study looked at 245 events reported to the FDA, including 71 deaths and 174 non-fatal injuries as well as data from other sources.

Click here to read the full article: Johns Hopkins: Robotic surgery Complications Grossly Underreported

The da Vinci revenue is the primary source of revenue for its manufacturer, Intuitive Surgical, Inc.  Stock prices have dropped from $583 in February 2013 to $385 on September 9, 2013.  The da Vinci robot machine-made by Intuitive Surgical Inc. was first FDA approved in 2000 for adult and pediatric use in urologic surgical procedures, gynecologic surgical procedures, as well as other procedures.  The robot costs in excess of one million dollars.  Intuitive based in Sunnyvale, CA, outside of San Francisco, is the only company whose surgery system is cleared for soft tissue procedures that include general surgery, prostrate operations, and gynecological surgery.

If you are a patient considering a da Vinci robot surgery, you may wish to ask your doctor about alternatives for your particular problem. If you or a loved one has been injured from a procedure involving the da Vinci robot, and wish more information about your legal rights, you can contact the lawyers at the Brandi Law Firm (1-800-481-1615 or email us).

Trademark Notice

Da Vinci is a registered trademark of Intuitive Surgical Inc.  The use of this trademark is solely for product identification and informational purposes.  Intuitive Surgical Inc. is not affiliated with this website, and Intuitive Surgical Inc. has no affiliation with the Brandi Law Firm.  Nothing on this site has been authorized or approved by Intuitive Surgical Inc.

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Toyota Announces Three Recalls Affecting Over 1 Million Vehicles

Toyota Hybrid

Toyota announced three separate recalls that will affect over 1 million Toyota and Lexus models.  Toyota has recalled over 780,000 Toyota RAV4 sport utility vehicles and Lexus HS 250h autos because the rear suspension arm will loosen over time and develop damage to the rear tire rod.  This damage will eventually lead to a failure, which could cause the vehicle to lose control.  The model years affected are from 2006 through 2011 for both vehicles that were manufactured from October 2005 through September 2010.  This is the second time Toyota has had to recall these vehicles for the same problem.  The first recall occurred in August 2012 where Toyota attempted to correct the problem, but failed.  According to the New York Times, Toyota told dealers that because of a limited number of parts, not all vehicles will be repaired until next February.

Click here to read the full New York Times Article: Toyota Recalls Vehicles a Second Time

Toyota will notify owners, and dealers will inspect the tie rods and replace any that have rust or corrosion on the alignment adjustment threads.  All owners will receive notification of the recall, with most receiving second notifications when parts are available in their area.  This recall supersedes Toyota and Lexus recall 12V-373.  All vehicles that have been inspected and remedied under the previous recall need to be re-inspected and have the appropriate remedy applied.

Another recall affects 133,000 2006-2010 Toyota Highlander Hybrid SUVs and Lexus RX 400h vehicles from 2006-2008 are being recalled due to overheating problems.  Certain transistors within these hybrid cars could be damaged during regular use.  This heat damage could cause the car to lose power and steering capabilities.

Toyota will notify owners, and dealers will replace the part.  The recall is expected to begin in late September 2013.  Vehicles that had the part previously replaced under recall 11V-342 are not affected by this campaign.

Click here to read the full USA Today article: Toyota Recalls Hybrids for Heat, Lexus Cars for Engines

The final recall affects 102,000 Lexus IS 350, IS 350C, and GS 350 vehicles.  The model years in this recall are from 2006 to 2011.  This recall was issued, because certain bolts that were installed in timing controlled mechanisms can become loose while driving.  If the bolts continue to loosen, the vehicles affected can stop completely while in use.  The manufacturer has not yet provided a notification schedule for this recall.

Detailed information is available to customers at www.toyota.com/recall and www.lexus.com/recall and by calling the Toyota Customer Experience Center at 1-800-331-4331.

Last month, Toyota recalled 342,451 Tacoma Access Cab vehicles due to a defect in the rear seat belts installed.

Americans rely on their car manufactures to provide a safe well-designed vehicle.  Sadly, that is not often the case.  The Auto Defect Attorneys at the Brandi Law Firm has successfully represented many people injured from defective Toyotas, Fords, Chrysler, Nissan, GM products and numerous other manufacturers and suppliers.  Often times, people involved in accidents do not examine the issues of defective vehicle design nor whether the car was truly crashworthy – does it contain the appropriate crash protection.  If you or a loved one has been injured in an auto crash, our attorneys at the Brandi Law Firm are available to consult with you.  Please contact our office at 800-481-1615 or email us.

Trademark Notice

Toyota is a registered trademark of Toyota Motor Corporation.  The use of this trademark is solely for product identification and informational purposes. Toyota Motor Corporation is not affiliated with this website, and Toyota Motor Corporation has no affiliation with the Brandi Law Firm.  Nothing on this site has been authorized or approved by Toyota Motor Corporation.

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