AP investigation shows thousands of unsafe devices cleared by FDA through streamlined pathway.

In a nearly 3,800-word piece, the AP (11/27) reports the FDA’s declaration it strives to be “first in the world” to approve critical medical devices “mirrored the talking points of the $400 billion medical device industry...and ushered in a series of changes that critics say have allowed manufacturers to seek regulatory approval for high-risk devices using smaller, shorter, less rigorous studies that provide less certainty of safety and effectiveness.” Under Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, “annual new device approvals have more than tripled, while warnings letters to device manufacturers about product safety and quality issues have fallen roughly 80 percent, an Associated Press investigation found.” According to an AP analysis of FDA data, since 2012, “tens of thousands of injury and death reports have been filed in connection with devices that were cleared through a streamlined pathway that minimizes clinical trial testing.” The agency on Monday “proposed changes to the streamlined system that would push manufacturers to incorporate more up-to-date technology into their devices,” but major reforms “could take years to implement.”

NHTSA receives complaints about “death wobble” with Jeep steering wheel.

The Detroit Free Press (11/19, Lawrence, 1.14M) reports the National Highway Traffic Safety Administration has begun to closely examine complaints recently made about what Jeep enthusiasts call the “death wobble,” which Fiat Chrysler Automobiles spokesman Mike Palese referred to as “steering system vibration” in an email, in which Palese also said the matter is not “a safety issue.” The Free Press says the “death wobble” occurs “after a vehicle hits a bump at highway speeds and then the steering wheel begins to shake, sometimes ‘violently.’” The NHTSA said it had received 11 complaints regarding the issue during the previous month.

        Carscoops (11/19, Anderson) reports Jeep said the issue can be fixed by, according to Carscoops, “tightening or replacing loose or worn steering parts, balancing or changing the tires, having a front end alignment or by installing a new steering dampener.” In addition, the NHTSA stated the issue occurs irregularly and is predictable so the vehicle can always remain under control. Reps. Anna Eshoo (D-CA) and Henry Waxman (D-CA) sent a joint letter to the NHTSA, in which they asked why consumers had not been informed about the issue, and that the NHTSA must evaluate the problem. Also reporting is Autoblog (11/19, 261K).

CEOs of Kia, Hyundai decide not to attend Senate hearing on burning car incidents.

KXAS-TV Dallas (11/14, 397K) reports that according to the Senate Commerce Committee, a hearing regarding the various burning car incidents across the country involving Kia and Hyundai vehicles has been cancelled because the CEOs, who were expected to testify, decided not to attend the hearing. Hyundai “told [Dallas’] NBC 5 it appreciated the concerns of the Senate Commerce Committee and had engaged in frequent and transparent dialogue with its staff.” Kia “said it will continue to work with the National Highway Traffic Safety Administration and Congress in a full and transparent manner.” KXAS-TV says, “Both Kia and Hyundai are now requesting ‘a more comprehensive review of non-collision fires among all automakers,’ citing research that the fires are not only limited to their cars.” The Center for Auto Safety is “displeased with the CEOs of Kia and Hyundai for ‘refusing’ to show up and testify before U.S. Senators.”

Honda recalling vehicles with front passenger airbag inflators over risk of explosion during crash.

WCBD-TV Charleston, SC (11/13) reports Honda is “recalling certain model year 2010-2012 Accord, 2010-2015 Crosstour, 2010-2011 Civic, 2010-2011 Civic Hybrid, 2010-2011 Civic NGV, 2010-2011 CR-V, 2014 FCX Clarity, 2010-2013 Fit, 2014 Fit EV, 2010-2014 Insight, and 2010-2015 Pilot vehicles.” The “front passenger airbag inflators in the affected vehicles may rupture when deploying during a crash, according to the NHTSA.”

Deadly Guardrails on U.S. Roadways

A guardrail buckles on impact with a car. The kinked edge of the buckled guardrail speared the driver’s door impaling the driver’s legs. This is a scenario that should not happen on America’s roadways with a safely designed guardrail. These injuries are preventable with a safe design of the guardrail safety system.

What is supposed to be a roadway safety device and help protect vehicles that for whatever reason may leave the roadway, instead, due to a defective design, fails to absorb crash forces, buckles, turning the guardrail into a spear that either pierces the vehicle or causes it to overturn.  The penalty for an inadvertent departure off the roadway or being forced off the roadway should not be serious injury or death from a guardrail.

Anytime a vehicle has left the roadway and impacted a guardrail the attorney evaluating the case should also look at whether or not the guardrail played a role in causing injury to the people inside the vehicle.