Lexi Hazam summarized the charges Evans and Mechaley have brought against DePuy: “DePuy was aware its ASR hip implant was failing at a high rate, yet continued to manufacture and sell the product to unsuspecting physicians and patients.”

The complaint alleges a current failure rate of thirteen percent of all DePuy ASR hip implants. However, evidence indicates that the true failure rate may rise much higher than thirteen percent.

The New York Times recently reported that Dr. Art Sedrakyan, a researcher at Weill Cornell Medical College of Cornell University, used data collected in other countries to predict that “tens of thousands” of U.S. patients will experience device failure in the coming decade.

The National Joint Registry of England and Wales has found a forty nine percent failure rate within six years of ASR hip implantation. 40,000 U.S. patients received DePuy ASR hip implants before Johnson & Johnson’s 2010 recall – in the coming decade, many of these still-young devices may prematurely fail, and the U.S. may catch up to the British forty nine percent failure rate.

In an interview with a Knoxville television station, Lieff Cabraser attorney Todd Walburg stated the Yaris “had not been recalled by Toyota, even though it had the same kind of electronic throttle system as the other vehicles that had been recalled.” The complaint alleges:

“The subject 2008 Toyota Yaris was not equipped with a brake override system, also known as smart-throttle technology. Ironically, earlier models of the Toyota Yaris that were sold in Europe were equipped with the Bosch brake override system. Toyota elected not to use the Bosch brake override system in the vehicles that it sold in the United States. ”

Learn why Toyota is legally responsible for the damage and injuries cause by its cars suddenly accelerating.

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.”

Patton and her entire family have suffered from the Fosamax and Boniva prescriptions she has taken since 2001. Patton took Fosamax from 2001 to 2006, and took Boniva from 2006 to 2010. Doctors prescribed Fosamax and Boniva, both bisphosphonate drugs, to slow bone loss and combat Patton’s osteoporosis.

However, long term use of these drugs has actually been found to cause brittle bones and to increase the risk of atypical bone fractures. On December 10, 2010, Patton suffered a subtrochanteric femoral fracture while walking up steps. This aptypical femur fracture has been devasting for Patton and her family. Patton noted, “My husband now does a lot of the work I used to do. The accident changed a good part of my life; it put a lot of extra burden on my family.”

Lieff Cabraser attorney Kent Klaudt announced that Reba Patton and her husband Patrick Patton have filed a lawsuit against Fosamax manufacturer Merck&Co., and against Boniva manufacturer GlaxoSmithKine, LLC. Klaudt said, “Merck and GlaxoSmithKline, as alleged in the complaint, concealed and continue to conceal their knowledge of bisphosphonates’ lack of long-term benefits and dangers to Mrs. Patton and other patients.”

To learn more about Fosamax, Boniva and other bisphosphonate drugs, as well as victims’ rights, visit our Bone Drugs and Femur Fractures information page.

The CPSC is aware of “at least 33 cases where children swallowed loose magnets and required emergency surgery.” It is recommended that if a child has swallowed magnets, they seek immediate medical attention. Symptoms of magnets in the intestines include abdominal pain, nausea, diarrhea and vomiting.

Some toys containing small, powerful magnets, such as Magtastik and Magnetix Pre-School Magnetic Toys, have already been recalled because of the dangers they pose to children. The CPSC urges parents to keep all small magnetic toys away from children and to regularly check their childrens’ toys for missing or dislodged magnets. Learn more about Lieff Cabraser’s representation of parents whose children have been injured by dangerous and defective children’s toys.

Join us for a free showing with director Susan Saladoff of

HOT COFFEE

Thursday, November 10th, 12:30 p.m.
Palace Hotel, Gold Room
2 New Montgomery Street
San Francisco, CA

Space is limited.
Please RSVP to HotCoffeeSF@lchb.com

About Hot Coffee

The documentary reveals what really happened to Stella Liebeck, the Albuquerque woman who spilled coffee on herself and sued McDonald’s, while exploring how and why the case garnered so much media attention, who funded the effort and to what end. First-time filmmaker and former public interest lawyer Susan Saladoff uses this infamous case to investigate what’s behind the push for tort reform – which threatens to restrict the legal rights of everyday citizens and undermine the entire justice system.

Hot Coffee challenges viewers to reexamine their beliefs that the courts are flooded with frivolous lawsuits that lead to “jackpot justice.” The documentary shows how Americans are giving up their Constitutional rights without knowing it by voting for limitations on damages or agreeing to mandatory arbitration embedded in the fine print of contracts and waiving their right to a jury trial.

Susan Saladoff, director of “Hot Coffee The Movie”, appeared on the October 25, 2011 Colbert Report to discuss the civil justice system and tort reform. It is a informative interview wherein Ms. Saladoff explains tort reform and discusses the myth of frivolous lawsuits that everyone should see and share.

As described in a review by the Washington Post, “Unlike so many documentaries these days, ‘Hot Coffee’ is refreshingly unadorned or manipulated for artistic or tear-jerking effect. It winnows down complicated legal arguments and anecdotal cases with compassion and clarity.”

Sponsored by

Lieff Cabraser Heimann & Bernstein, LLP
Girard & Gibbs, LLP
Consumer Attorneys of California
Public Justice

Democratic lawmakers believe that examining these two medical devices can provide insight into the regulation of medical devices. The Congressmen write, “Both items are examples of devices that were found to be associated with major health problems after being approved or cleared by the FDA. As such, we believe they could provide important lessons about the device clearance and approval process as well as the adequacy of our postmarketing safety system.” The DePuy metal-on-metal hip implant was approved through the FDA’s 510(k) process, which does not require clinical data and approves new devices deemed substantially equivalent to devices already on the market. The stent was approved “under a humanitarian exemption that lets a maker bypass full premarket approval when the condition affects fewer than 4,000 people.”

After using Simply Thick to feed their premature baby daughter, the Umphress’ infant developed life-threatening necrotizing enterocolitis (NEC), an intestinal condition with a 25% mortality rate and which imposes lifelong injuries on survivors. The Umphress’ daughter, after being airlifted to Children’s Hopsital in Albuquerque and receiving two blood transfusions over a period of twenty days, is now stable but continues to suffer from NEC.

The FDA issued a warning in May 2010 that Simply Thick may cause NEC and that it should not be fed to premature infants. In June 2011, Simply Thick, LLC issued a voluntary recall of Simply Thick thickening gel manufactured at a particular processing plant. By July 2011, the product was released back to the market but is now accompanied by a warning not to feed Simply Thick to premature infants.

Read the full article at Las Cruces Sun-News. Learn more about the Simply Thick recall and victim’s rights.

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.