Congress Schedules Hearings to Beef up NHTSA

The New York Times (4/30, Maynard) reports that Congressional hearings will begin next week on the Motor Vehicle Safety Act of 2010, which would strengthen NHTSA regulators’ power and “require automakers to install a series of safety features on their vehicles.” The planned legislation “includes many of the proposals discussed in hearings this winter” on Toyota’s recall crisis. The Times notes that House Energy and Commerce Chairman Henry Waxman “has begun circulating a draft of the proposal to committee members and has scheduled a subcommittee hearing on the measure for next Thursday.”

Committee Faults FDA for Not Pursuing Heparin Contamination Leads

The Wall Street Journal (4/30, B7, Mundy) reported that, according to an investigation conducted by the House Energy and Commerce Committee, the Food and Drug Administration did not pursue leads which could have fingered those responsible in China for playing a role in the contaminated heparin crisis two years ago. Committee members Rep. Joe Barton (R-TX) and Rep. Mike Burgess (R-TX) sent a letter to the FDA in which they spelled out findings from the investigation and said that it has not pressed the government of China regarding Chinese companies involved.

LaHood Comments on Toyota Fine

According to the Bloomberg News (4/23, Keane, Hughes), Transportation Secretary Ray LaHood said Toyota Motor Corp.’s “payment of a $16.4 million fine showed it accepted responsibility for breaking a law requiring automakers to notify regulators of safety defects.” LaHood said “paying the fine is more important than Toyota’s statement denying US allegations it broke the law by failing to alert regulators within five days of discovering vehicle accelerator pedals could stick.” LaHood said, “Paying the fine is, I think, the determining factor that they acknowledge they were in violation of the law.”

NHTSA Official Warned About Toyota’s Electronic Throttle Control

According to the  New York Times (4/21, Jensen), in late 2003 NHTSA investigator Steve Chan ”concluded that the newly adopted drive-by-wire gas pedals of Toyota Camrys might be a cause of unintended acceleration.” Chan “was looking into sudden-acceleration complaints about Camrys from the 2002-3 model years. The inquiry was prompted by what he saw as an increase in sudden acceleration complaints in 2003.” Chan determined that one possible cause was “a software problem” in the engine control module. “‘Last but not least,’ Mr. Chan wrote, was the drive-by-wire throttle system, which replaced the traditional cables with electronics in the 2002 model.” The Times adds that there is “no proof that the agency acted on Mr. Chan’s report, said Allan Kam, an official at the safety agency from 1975 to 2000, at which time he retired as the senior enforcement attorney.”

Toyota to Pay NHTSA Fine

The USA Today (4/19, O’Donnell) reported that Toyota will agree to pay a record $16.4 million fine “for late reporting of a defect that led to unintended acceleration.” Toyota’s move does not release it from any criminal or civil liability.

The AP (4/19, Thomas) notd that the fine is “the largest civil penalty imposed on an automaker by the government.”

Conclusion of Toyota Investigation Unlikely Before Summer

 The Detroit Free Press (4/16, Gardner) reported that NHTSA Administrator David Strickland said that federal investigators “are looking at a variety of potential solutions to the unintended acceleration issue at the root of Toyota’s recall of nearly 6 million vehicles in the US, but won’t know more about the problem’s cause until this summer at the earliest. . . . A task force of NASA scientists is looking at the possible influence of electromagnetic interference, software coding and cosmic rays on electronic engine controls. They are expected to report their finding to NHTSA this summer. Another group from the National Academy of Science has started a 15-month research project looking at similar issues.”

Dennis Quaid Advocate for Hospital Safety

The USA Today (4/13, Rubin) reported that, according to actor Dennis Quaid, “When a crash happens, it’s so public. … No one is going to fly on their airplanes unless they have that trust.” Yet, “when a mistake occurs in a hospital, the public might never hear about it. Although an estimated 100,000 Americans die each year because of medical errors, their deaths are scattered over thousands of hospitals, ‘where people die anyway,’ Quaid said. ‘It doesn’t get the same type of attention.’”

The USA Today also reported that, since “Quaid’s 10-day-old twins were twice given an adult dose of the blood thinner heparin,” he “has become the self-described ‘frontman’ for a campaign to improve patient care with the implementation of ‘safe practices’ as simple as hand-washing and the use of technologies such as bar codes to match medications to patients.”

Byetta May Be Tied to Increased Cancer Risk

Bloomberg News (4/10, Larkin) reported that reported that “Amylin Pharmaceuticals Inc. and Eli Lilly & Co.’s long-acting Byetta (exenatide) may be tied to increased cancer risk, a top US regulator said, raising concerns that the experimental diabetes drug may need strict warnings.” The “data on intravenous dosing and a once-weekly version of Byetta‘seem to give a similar signal’ as cancers seen in rodent studies of Novo Nordisk A/S’s competing Victoza (liraglutide), said Curtis Rosebraugh, head of the Food and Drug Administration’s Office of Drug Evaluation II, in a Jan. 25 memo posted on the agency’s website.”

Byetta (exenatide) is a Type II diabetes drug approved by the FDA in April 2005 to help to reduce blood sugar levels.  The drug is used to control blood sugar levels and is part of a class of medications known as incretin mimetics, which imitate natural hormones that lower blood glucose levels.

FDA drug safety reviewers have already expressed concerns that Byetta may be linked to kidney failure and a possible increased risk of pancreatitis.  In November 2009, the FDA issued a warning indicating that they received at least 78 post-marketing reports involving Byetta kidney problems, with 62 of those reports involving kidney failure. 

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Toyota Lawsuits Consolidated in California Court.

Lawsuits against Toyota Motor Corp. related to sudden acceleration will be consolidated in a federal court in Santa Ana, California.   According to Bloomberg News (4/10, Fisk) Toyota is facing at least 177 consumer and shareholder lawsuits seeking class-action status and at least 57 individual suits claiming personal injuries or deaths caused by sudden acceleration incidents. All the class actions and most of the individual suits were filed after September, when Toyota began the first of several recalls related to inadvertent acceleration.

Toyota Recall

The CBS Evening News (4/7, story 7, 0:25, Rodriguez) reported that, according to internal Toyota emails, “company executives wrestled with how to deal with sticking accelerator pedals. In January, five days before announcing a massive recall, an American vice president wrote ‘we are not protecting our customers by keeping this quiet,’ and ‘the time has come to not hide on this one.’ ”

Toyota told European distributors about sticky gas pedals weeks before informing NHTSA. The Associated Press (4/8, Thomas, Margasak) reported that the documents reveal that “long before Toyota told US regulators about sticking accelerator pedals, [it] warned its distributors throughout Europe about similar problems.” US complaints “were rising at the end of 2009. The documents show that weeks earlier its European division issued technical information ‘identifying a production improvement and repair procedure to address complaints by customers in those countries of sticking accelerator pedals, sudden rpm increase and/or sudden vehicle acceleration.’ The AP noted that “LaHood cited the warnings to the other countries” in announcing the decision to levy the record $16.4 million fine against Toyota.