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.

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.”

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.”

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 scientific group, the Institute of Medicine, is scheduled to release a report on Friday that could propose a tougher approval process for a wide range of devices like hip implants, hospital pumps and external heart defibrillators. The report, commissioned by the Food and Drug Administration, comes after several well-publicized recalls in recent years of devices that have failed in thousands of patients, causing numerous injuries.

But a business group and others have taken the highly unusual step of making a pre-emptive strike, arguing that the report is biased. That attack began even before the study panel finished its review, and has intensified in recent weeks.

Read the full story on the New York Times website.

Lieff Cabraser represents patients across America who have been injured or suffered due to defective medical devices, including metal hip implants.

Infuse has been widely used in spinal fusion procedures since 2002. While Medtronic lists sterility as a possible side effect, Medtronic-paid research attributed it to a particular surgical technique, rather than the product itself.

The type of spinal fusion at issue is known as an anterior lumbar fusion, a procedure performed on about 80,000 patients a year in this country. Infuse is used in about half of those procedures, and men make up about half of the patients who undergo spinal fusions.

The Spine Journal study, authored by Stanford University surgeon Dr. Eugene J. Carragee, found that men treated with Infuse developed a condition that causes temporary or permanent sterility at a far higher rate than men who received a bone graft, another material that is used to fuse spinal vertebrae.

On June 22, 2011, U.S. Senators Max Baucus and Chuck Grassley requested that Medtronic produce records related to Infuse, citing concerns:

“Side effects of Infuse or similar bone growth products developed by Medtronic may have been unreported or underreported in the clinical literature.”

Click here to learn more about the Infuse spine product and its side effects.

Following his hip replacement surgery in 2007, John Chisnell of Raleigh, North Carolina, suffered great pain and agony due to the failure of his Durom Cup, manufactured by Zimmer, Inc., to properly attach to his hip bone. The pain was constant and significantly limited his mobility and ability to engage in sports and physical activities as well as interfering with his work.

“The pain went on for so long, both the incapacitation from having a bad hip–it went on for over two years before having revision surgery, and now my legs have mismatched length,” stated Chisnell. “The implant never healed the way it was advertised.  It put my life on hold for two years.  It is just wrong for Zimmer to market such a device.”

In January 2010, Chisnell underwent revision surgery to replace the faulty Durom Cup.  The revision surgery has resulted in Chisnell’s left leg being one-half inch longer than his right leg, causing him continued pain to the present.

Learn more about the Zimmer hip recall lawsuits.

William Kokoszka, a 54 year-old Connecticut resident, has filed a personal injury lawsuit against Zimmer Inc., for extreme pain and injuries due to a defective artificial hip manufactured by Zimmer.

In each case, the patient experienced excruciating pain following implantation of the Zimmer Durom Cup and all have, or soon will, be forced to undergo a painful revision surgery.

“At my age, I wanted to continue my active lifestyle, including spending time with my family, working with my charities, traveling with my husband, and being able to perform basic daily activities,” stated Renee Donnelly, age 74, of Paradise Valley, Arizona, one of the patients that filed a lawsuit. “However, once I was implanted with the defective Durom Cup, my life became very limited.”

“I used to lead a very fulfilling and active lifestyle, traveling abroad, exercising regularly, volunteering, and working in my garden. Now, my life is so limited due to the pain that the defective Durom Cup implant has caused me,” stated plaintiff Karen Hoggarth, age 54, of Westerville, Ohio. “I can’t even walk up the stairs without pain.”

“The quality of life physically and mentally, today and in the future, for myself and my family has been permanently damaged by the defective Zimmer Durom Cup I received in 2006,” added William Kokoszka, another plaintiff from Meriden, Connecticut. “Zimmer should be accountable for its negligence and disregard for the safety of patients implanted with the Zimmer Durom Cup.”

Zimmer Durom Cup Lawsuits

The Durom Cup was first sold in the nation in 2006 and was implanted in over 12,000 patients over a two year period. The estimated failure rates of the Durom Cup ranges between 20% and 30%.

After the Durom Cup was introduced in the United States, Zimmer began receiving complaints from physicians that the artificial hip was failing. “Despite warnings from leading orthopedic surgeons, Zimmer continued to aggressively market the Durom Cup in 2007 and into 2008, blaming surgeons for the growing failure rate,” stated attorney Wendy R. Fleishman of the national law firm Lieff Cabraser Heimann & Bernstein, LLP.

Learn more about the Zimmer Durom Cup and defective hip implant lawsuits.

Walter Thomas, a 63-year-old retired manufacturing plant supervisor, may be left with a permanent limp, he alleges in a personal injury lawsuit filed against Zimmer Inc, the manufacturer of his faulty artificial hip implant.

Thomas, a 63-year-old retired manufacturing plant manager, endured agonizing pain for months, many hip dislocations, two revision surger

ies, and has been left with a potentially lasting limp due to Zimmer’s allegedly defective hip implant.

“This has been a very trying time in my life for me and my family,” Thomas stated.  “When my artificial hip was implanted in May of 2007, I was hoping for a quick recovery.  Never did I think that I would have to endure two additional surgeries, three hip dislocations which resulted in trips to the Emergency Room, several weeks of physical therapy, and the frightening prospect of being permanently handicapped because of Zimmer’s faulty product.  To me, this lawsuit is about holding Zimmer accountable for what they did to me.”

“Zimmer’s belated suspension of sales of its defective product was too little, too late for Mr. Thomas and for countless other folks, who needed safe and effective hip implants to restore their ability to sit, stand and walk without excruciating pain” stated Thomas’ attorney Mark P. Chalos of national law firm Lieff Cabraser Heimann & Bernstein, LLP.
“Now, those same men and women suffer from pain worse than before the ‘fix’ to their hips, and some, like Mr. Thomas have permanent limps. Zimmer should do right by Mr. Thomas and his family.”

Learn more about Durom Cup injuries and the rights of victims.

Todd Lovelace, a 45-year old truck driver from Elizabethtown, Kentucky, received a Zimmer Durom Cup in May 2008 as part of hip replacement surgery on his left hip. After months of great pain, agony, difficulty walking and bearing weight, he was compelled to undergo a second surgery to remove the defective cup in December 2008. Lovelace stated, “It’s ruined my life. I’m in chronic pain and have lost my job as a result of this defective device.”

In December 2007, the Durom Cup was implanted in Christine Walker, a 53-year old former registered nurse from West Palm Beach, Florida. She too suffered months of great pain and agony, necessitating her to stop working. In December 2008, her Durom Cup was removed. “I believed that after my hip replacement I would return to my career in nursing and to my active lifestyle with my husband of thirty-seven years. Instead, I live every minute of every day in pain and worry, with the loss of my career, how much more I am going to lose.”

“The complaint estimates that upwards of 24% of patients that received the Durom Cup will be forced to undergo revision surgery,” plaintiffs’ counsel Wendy R. Fleishman commented. “It is long past the time for Zimmer to formally recall the Durom Cup and take responsibility for the extreme pain and injuries its defective product has caused thousands of patients across America.”

Learn more about Zimmer Durom Hip defects and the rights of people injured by the Durom Cup.