You are here: Home / 2010 / Archives for March 2010

Toyota Had a “Game Plan” in 2007

March 19, 2010 By

Toyota had a “game plan” in 2007 to avoid a major vehicle recall for disputes involving unintended acceleration. Instead, Toyota was able to implement a mere floor mat recall, reports the Washington Post.

The National Highway Traffic Safety Administration (NHTSA) became interested in Toyota floor mats in March 2007, after five complaints concerning Toyota’s 2007 Lexus ES350, writes the Post. Three were crashes. That summer, the agency widened its investigation to the 2007 Camry after one of those vehicles careened out of control in San Jose, killing the driver of another vehicle. According to the Post, a floor mat was apparently attributed to that crash. Also, consumer complaints and insurance statistics began to mount for unintended-acceleration in Toyotas.

An internal NHTSA memo revealed investigators thought  “something about the throttle pedal or floorpan design lends itself to easier jamming than other models produced in the past.” According to the Post, they speculated the problem might also include the Prius, Camry and Avalon, and could occur when either Toyota-made or after-market floor mats were in a vehicle.

The Post said Toyota had a “game plan” for the inquiry and eshewed the NHTSA’s findings. The mega automaker insisted that no danger existed if consumers correctly installed the proper Toyota floor mats; thus, there were no defects and reason for a recall. In the end, Toyota would agree to pull only one kind of floor mat that affected fewer than 55,000 cars, said the Post.

In a presentation for Toyota North America’s president, Yoshimi Inaba, two years later, the limited recall was considered a “win” for the world’s largest automaker. According to the Post, Toyota bragged it had saved $100 million by postponing findings of a defect.

That came to an end this past fall, after the highly publicized death of a California Highway Patrolman and family members. Toyota finally acknowledged accelerator pedals in 12 different model floor plans needed modification to prevent floor mats from entrapping the accelerator. Unfortuneately, a total of 20 more deaths had occurred…all connected to unintended acceleration.

Filed Under: Accidents, Product Liability

Johnson & Johnson Finally Responds to Warning Letter

March 19, 2010 By

Johnson & Johnson procrastinated too long before recalling offensive smelling Tylenol and other over-the-counter drugs, said  the Food & Drug Administration(FDA) so last January, the agency sent J & J’s unit McNeil Consumer Healthcare a warning letter stating such. Now the mega company says it has implemented measures to prevent a repeat occurrence.

The FDA letter detailed: manufacturing violations, quality problems, accusations that McNeil did not quickly identify the problem source, did not conduct a comprehensive investigation and failed to notify authorities in a timely manner, thus extending consumer product exposure. Deborah Autor, chief of compliance in FDA’s drug office, said McNeil knew about the odor problem in September 2008, but did not inform the agency until September 2009. Strangely, the FDA does not have authority to force a drug company to issue a recall.

Last November, McNeil pulled 5 lots of Tylenol Arthritis Pain Caplet 100 count bottles, with the distinctive red EZ-OPEN CAP because of musty odor complaints also associated with nausea, stomach pain,vomiting and diarrhea. In December, the recall was increased to comprise all product lots. The list of recalled items was again expanded in January to include about 50 million bottles of Tylenol, Rolaids, Benedryl and St. Joseph’s Aspirin.

McNeil blamed the strange odor on contamination by a chemical called 2,4,6-tribromoanisole. The source is thought to be the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials. The health effects of this compound have not been well researched but McNeil said that so far, all reported adverse reactions have been non-serious and temporary.

Earlier this week, the FDA posted McNeil’s response to their warning letter on its Web site. In a letter dated February 5, McNeil said it is taking corrective and preventive actions to improve its quality assurance systems. Among other things, the company said it has changed the way it reviews consumer complaints so it can readily identify problems and take action more effectively, the letter said. Also, McNeil plans to conduct a comprehensive quality management assessment and was altering its investigative procedures.

An official for the FDA told The New York Times that it was in the process of reviewing the McNeil letter. “Our primary concern is protecting public health by determining what occurred and why it occurred, and ensuring that the company takes the needed corrective actions as stated in the agency’s warning letter,” said Richard Friedman, the director of manufacturing and product quality at the agency’s center for drug evaluation and research.

How long does it take to read and review a letter?

Filed Under: Defective Drugs

Chinese Drywall Test Case Begins in New Orleans

March 18, 2010 By

Yesterday, a Louisiana family’s Chinese drywall nightmare was described during opening statements in the first contested Chinese drywall trial in New Orleans federal court.  This test trial case, known as a bellwether, is intended to help ascertain property damage issues in other cases against manufacturers.

More than 2,000 families currently have claims pending in the Chinese drywall multidistrict litigation before U.S. District Judge Eldon Fallon. This first bellwether case was filed on behalf of Tatum and Charlene Hernandez of Mandeville, Louisiana, and names Knauf Gips and Knauf Plasterboard Tianjin Co. as lead defendants. Judge Fallon presides without a jury.

The family claims that their home was ruined by tainted Chinese drywall. They settled into their house in 2006, but since then, family members have suffered from headaches and respiratory problems. The family remains in the toxic home because they are unable to afford both rent and a mortgage. As with many similiar situations, their homeowners’s claim was denied and the builder has been less than helpful.

Knauf acknowledges that its drywall was defective but the company disputes the remediation amount sought by the Hernandez family. Business Week reports that all parties in the suit agree that removing and replacing drywall, moldings, carpets, a granite countertop, electrical switches and outlets are necessary, but claims such as wiring, appliances, personal property and repair costs are in dispute.

Judge Fallon will determine the nature and the scope of the remediation and also repair costs. Drywall health issues will be dealt with later in the litigation. These decisions should help set values that will guide settlement discussions in future cases.

Since late 2008, the Consumer Products Safety Commission (CPSC) has received approximately 3,000 reports from residents in 37 states, the District of Columbia, and Puerto Rico regarding toxic Chinese drywall. Gases emitted from the wallboard are blamed for significant property damage, including HVAC systems, smoke detectors, electrical wiring, metal plumbing components, and other household appliances. These gases also produce a sulfurous odor that permeates homes, and cause metals, including air conditioning coils and even jewelry, to corrode. People living with Chinese drywall complain of eye, respiratory and sinus problems that could be associated with the gases.

Environmental Protection Agency tests last summer revealed that Chinese-manufactured drywall had elevated levels of strontium sulfide, as well as several organic compounds affiliated with acrylic paint production that were not found in U.S.-made drywall samples. In November, results of CPSC tests of 51 homes confirmed that the presence of hydrogen sulfide is the essential component that causes copper and silver sulfide corrosion found in Chinese drywall homes. Federal investigators are wary when discussing health risks from exposure to drywall gases.

Filed Under: Chinese Drywall

Gyrus Ear Device Removed in Class I Recall

March 18, 2010 By

The Food & Drug Administration (FDA), in cooperation with Gyrus ACMI, Inc., has issued a Class I recall notice for Micron Bobbin Vent Tube T, 1.27 mm. The implanted recalled device is for ventilation or drainage of the middle ear.

Class I recalls are the FDA’s most serious type and involve situations when there is a reasonable probability that product use will cause serious adverse health consequences or death.

This call back involves devices with Catalog (REF) Number 145281-ENT, Lot Number MH136952. Note: The specific products were manufactured only on December 17, 2009 and distributed only on December 22, 2009. The reason for this action is the possibility that these particular devices are not sterilized.

On January 4, 2010, Gyrus ACMI notified their customers about the recall and on January 27, sent a follow-up letter to customers and implanting surgeons with a problem description and instructions for product return.

As usual, patients should discuss any relevant concerns with their physicians. Contact Gyrus ACMI at 1-800-773-4301 with further questions.

Health care professionals and consumers can report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch: The FDA Safety Information and Adverse Event Reporting Program1 either online, by regular mail, or by FAX.

-

Filed Under: Defective Medical Devices

Toyota Admits Some Matrix and Corolla Vehicles Could Stall

March 18, 2010 By

Toyota has admitted that engines in more than 1 million Corolla and Matrix vehicles could stall, but no worries, since the problem is not “an unreasonable risk” to safety. They contend the cause is computer flaws, reports the Detroit Free Press.

Since last November, the National Highway Traffic Safety Administration (NHTSA) has been exploring 2006 Corolla and Matrix stalling concerns because the agency had received 26 reports of that happening. In various situations, drivers said they had no warning while some reported the engine was difficult to restart or continued stalling. Fortunately, no injuries or crashes resulted. writes the Free Press.

The NHTSA had received a total of 76 related reports by the beginning of this month; one incident was a fire and some stalls occurred in intersections or highway merging, said the Free Press. Not “an unreasonable risk”to safety?

The affected vehicles are 2005 through 2007 model years Corolla and Matrix, which Toyota blames two suppliers for physical faults in engine control units during production.

The world’s largest auto maker sent a letter to the NHTSA, stating it “does not believe that the alleged defect creates an unreasonable risk to motor vehicle safety.” The letter continues that a dashboard warning light would appear and also, estimated the stalls would affect only 0.8% of the models throughout 10 years. The Free Press writes that if the NHTSA accepts Toyota’s assessment that stalling isn’t a safety risk, the company could remedy the problem in various ways without an official recall.

Since last fall, Toyota has recalled over 8 million vehicles worldwide for situations involving unintended acceleration. The NHTSA has received more than 2,000 accusations of sudden, unintended acceleration with Toyota and Lexus vehicles, resulting in more than 50 deaths and hundreds of accidents since 2000. Toyota has blamed the problems on faulty floor mats and defective accelerator pedals, but many contend an inferior electronic throttle control system is the culprit. In February, Toyota pulled more than 400,000 hybrid vehicles, including the 2010 Prius and the Lexus HS250h, for malfunctioning breaks.

Suspicions have recently heightened as dozens of Toyota owners who had recall repairs, complain they are still experiencing unintended acceleration. Although the Corolla and Matrix stalling dilemma is the latest plague challenging Toyota’s long-standing reputation for quality and reliability, undoubtedly, it won’t be the last.

Filed Under: Accidents, Product Liability
« Older Posts