Under the Act, if a medical device was approved under the expedited 510(k) process, “which now requires companies only to show their devices are smilar to those already on the market,” the FDA could require post-market studies to determine safety. The FDA could also grant partial device approval for devices approved under the 510(k) process, pending futher saftey studies.

In addition to introducing post-market safety legislation, the Senators have also sent investigative letters to five medical device manufacturers, requesting information on their post-market surveillance of products.

Senator Grassley’s press release states, “Letters were sent to Johnson & Johnson, for its DePuy metal-on-metal hip implant…Medtronic for its Infuse product; Boston Scientific for Guidant’s defibrillators; CR Bard for vaginal and hernia mesh products; and, Zimmer Holdings for its knee replacements.”

Transvaginal mesh was approved as a moderate risk device under the FDA’s controversial 510(k) process. The FDA’s 510(k) process allows for a medical device to be approved for market without clinical data if it is deemed “substantially equivalent” to products already on the market. This “substantially equivalent” approval condition has been criticized as overly lax and responsible for public health nightmares such as DePuy’s recalled ASR hip implant.

Transvaginal mesh failures were cited in the U.S. Institute of Medicine’s July review of the FDA’s medical device approval and their recommendation that the process be replaced with a stricter system. Opponents of transvaginal mesh allege that the mesh products, currently classified as moderate risk devices, expose patients to higher risks than non-mesh products, and ask that transvaginal mesh be recalled and reclassified as a high risk device.

Previously reported in Bloomberg, the FDA issued a transvaginal mesh safety warning in July 2011, stating that it has received “1,503 reports of complication associated with the material from January 2008 to December 2010.” It is in response to these widespread reports of complications that the FDA is considering a change in risk classification.

The CPSC reports 65 incidents “resulting in two deaths and 34 victims who were hospitalized with second and third degree burns of the face, chest, hands, arms or legs.”

To see a complete list of fuel gel manufacturers that have recalled their products and to submit a complaint, please visit Lieff Cabraser’s Firepot Fuel Gel Recall information page.

The Consumer Product Safety Commission says the electrical cords on the monitors can be dangerous for babies if placed too close to their crib

More than 40 different models of handheld, digital and color monitors, are being recalled by Summer Infant. The monitors were sold at major retailers between 2003 and 2011. Going forward, the company will provide new on-product warning labels and instructions about monitor placement.

For more information on model numbers of recalled monitors, consumers can contact Summer Infant at 800-426-8627.

Lieff Cabraser currently represents parents whose children have been injured from defective health and baby care products. If your child has been injured from a defective product, we welcome you to contact a Lieff Cabraser defective product attorney. We will review your claim in confidence without charge or obligation.

The chemical, naphthalene, has already been banned in the European Union as a chemical harmful to children. The naphthalene-filled mothballs are used as a preservative for storing clothing and other articles susceptible to damage from mold or moth larvae.

The Australian Pesticides and Veterinary Medicines Authority issued a report stating that more than 100 infants are treated annually to overcome the adverse effects of the toxic mothballs.

Kathleen Recinos of Panorama City, was killed Dec. 19, 2008, when a 2009 Toyota Scion driven by her boyfriend, Brian Martinez, “suddenly and unexpectedly accelerated,” crossed into oncoming traffic on Tampa Avenue in Northridge, California, and struck two oncoming vehicles, according to the lawsuit, filed in federal court in Santa Ana. Recinos was pregnant at the time and Martinez was also killed in the accident.

Lieff Cabraser represents the parents in the wrongful death lawsuit. The complaint alleges that electronic throttle control systems contained in many Toyota models are faulty and have caused hundreds of crashes. The parents also faulted Toyota for failing to include a brake override system that would have cut off the accelerator if the brake and gas pedals were applied simultaneously.

Read the full story on the LA Times website. You can also read a copy of the complaint filed in the case or read more about the lawsuit and similar Toyota sudden acceleration incidents.

The drop-side cribs have come under scrutiny in recent years because of malfunctioning hardware that can lead to the drop-side rail partially detaching from the crib.  When this happens, it can creat a dangerous “V” -like gap between the mattress and side rail where a babie can become entrapped and suffocate.

As part of their new standard, the CPSC plans to vote on this week a more rigorous safety testing for cribs.

Lieff Cabraser currently represents parents whose children have been injured by defective cribs.  Learn more about the crib recalls.

DaimlerChrysler appealed a jury’s 2008 verdict awarding $5.08 million to the family, but Friday’s ruling by the 4th Circuit Court of Appeal rejects the company’s claim that the judge presiding over the trial made several errors. The couple initially assumed the 1999 accident had been caused by leaving the car in reverse, but they sued in 2001 after receiving a call from a Los Angeles Times reporter investigating similar “park-to-reverse” complaints about Jeep Grand Cherokees.

A three-judge panel from the 4th Circuit rejected the company’s claim that the suit should be thrown out because the Guillots missed a deadline for suing. The couple didn’t have “the appropriate information to file a claim at the moment the accident occurred,” the court said. A “vehicle defect was never suspected by the investigating officer, and Mr. Guillot blamed himself for the accident for two years,” the ruling says. The court also concluded the jury’s award wasn’t excessive.

Scott Nealey of Lieff Cabraser, a lawyer for the Guillots, said the couple was “extremely pleased” with the court’s ruling. “The most important thing for them was just the vindication of the jury’s verdict,” he said, adding that the company had blamed them for the accident and claimed it was “all their fault.”

Persons who have been injured in accidents involving faulty transmissions, or family members of loved ones who have died, have filed lawsuits against Chrysler and other manufacturers for the injuries they suffered. Lieff Cabraser represents victims of park to reverse defects.

On April 30, 2010, the United States Consumer Product Safety Commission announced the recall of thousands of Simplicity cribs due to suffocation and strangulation dangers. The current recall includes seven Simplicity crib models sold at Wal-Mart Stores Inc., Target Corp., Babies R Us and other national stores. The Simplicity recall includes all full-sized cribs with tubular metal mattress-support frames, which can bend or detach, causing the mattress to collapse and creating a space that a baby can roll into, become trapped in and suffocate.

According to the CPSC, at least one child became trapped in his Simplicity crib and suffocated in 2008. The company at large has been subject to about a dozen recalls since 2005 with links to 13 crib deaths.

Graco Crib Recall

On April 30, 2010, the CPSC recalled 217,000 Graco dropside cribs manufactured by LaJobi. The agency confirmed that there have been 99 complaints of dropside problems with the cribs. The recall is the result of hardware failures in the wood cribs. According to news reports the dropside (the side of the crib that moves up and down) can break or detach, resulting in a dangerous gap between the crib mattress and crib side that creates the risk of suffocation or strangulation.

As she traveled down the highway, the Prius suddenly accelerated and went out of control. The Prius slammed into a Subaru Forester that was delivering mail on the side of the highway. The passenger side of the Prius struck the rear of the Forester with so much force that John Donoghue was killed in the passenger seat. The vehicle continued off the highway and eventually stopped only when it ran into a snow drift.

In addition to the devastating loss of her husband, Mrs. Donoghue suffered serious injuries of her own, including head trauma, a fractured shoulder, a broken jaw, and a collapsed lung.

Today, Mrs. Donoghue filed a lawsuit in Federal court against Toyota seeking compensation for injuries to herself and for the death of her husband.

Why Toyota Is Liable For Sudden, Acceleration Accidents

Since 2001, the electronic throttle system in most Toyota vehicles, including the 2006 Toyota Prius driven by Jacquelyn Donoghue, has relied on sensors, microprocessors and electronic motors instead of a mechanical linkage, such as steel cable, to connect the accelerator pedal to the engine throttle plate.

Millions of Toyota vehicles were not equipped with a safety feature, known as ‘brake-to-idle’ override that is found in many other vehicles. This feature enables drivers to override the electronic throttle and control the vehicle in the event of a sudden unintended acceleration.

“The complaint charges that Toyota’s failure to incorporate a brake-to-idle safety device in the Prius driven by Jacquelyn Donoghue played a direct role in the death of her husband John Donoghue,” stated Robert J. Nelson of the national plaintiffs law firm Lieff Cabraser Heimann & Bernstein, LLP, which is representing Mrs. Donoghue.

If you would like to learn more about your legal rights visit US Auto Injury Law.com’s Toyota and Lexus sudden acceleration accidents page.