A disabled veteran from Wisconsin has sent a letter to Congressman Reid Ribble requesting a Congressional Hearing before Congress over concerns of regulatory malfeasance at the FDA that led to the metal-on-metal hip replacement debacle. Metal hip devices were allowed to remain on the market without medical providers having any guidelines on how to monitor 500,000 Americans for the periprosthetic and systemic complications of chrome-cobalt metallosis.

The disabled vet received a metal-on-metal hip implant in 2010, and complained of groin pain almost immediately after being implanted with the premarket approval (PMA) hip implant. It is devastating to think that the FDA was formed to protect and ensure the quality of our lives. Yet, the FDA has granted manufacturers of premarket approval medical devices full immunity from patient lawsuits. These same medical devices were not required to undergo any clinical testing.

Some people may be wondering what all the fuss is about with regards to premarket metal-on-metal hip implants. The problem originates from the dismal laws written around the FDA, particularly the 510 (k) clearance loopholes. (The appalling vaginal mesh medical disaster is problematic of the same loophole.) If a medical device manufacturer can convince the FDA that some medical device is “substantially equivalent” to another similar device already on the market, then it is approved without any actual testing to verify if the product is safe or not, under that loophole. For this reason, the Institute of Medicine recommended the 510 (k) be abolished, which investigated 510 (k) clearance at the request of the FDA.

No doubt when you have such a dismal system in place, where medical devices can be approved merely because the manufacturer says its product is similar to another product already on the market – another product that might also be harmful to patients – then there is no end to the types of useless and dangerous medical devices that can be approved by the FDA. The FDA does deserve credit for proposing new regulation that removes metal-on-metal hips from the 510 (k) process.

A Chicago jury has reached its verdict in the second DePuy ASR trial in favor of the defendant DePuy Pharmaceuticals. The verdict comes after a month long trial in Cook County Circuit Court, according to court records [Strum vs DePuy(2011-L-009352,Cook County IL Circuit Court)]. Although this is a disappointing verdict, other plaintiffs can potentially be awarded millions of dollars in future DePuy ASR lawsuits.

According to an article written by Cal Warriner, most Americans are unaware that anywhere from 75 to 90 percent of medical devices pass through the 510(k) gate to approval in the U.S. and these are the same devices that are failing in England, Australia and worldwide, as those countries often follow the U.S. lead to approval.

Warriner notes only three metal-on-metal resurfacing hip implants went through the FDA’s premarket approval (PMA) process and were required to provide clinical data to prove safety before they were approved in the U.S. The Birmingham Hip Resurfacing was finally approved in the U.S. in 2006 after initially being denied. It joins the Conserve Plus by Wright Medical, approved by the FDA after a PMA in 2009, and the Cormet by Corin in 2007 – all resurfacing devices.

Unfortunately for the patients who discover after the fact that they are experiencing complications with these PMA devices, they cannot hold the manufacturer accountable due to a U.S. Supreme Court Decision, Riegel v. Medtronics, which gave medical device manufacturers immunity in court if their product received FDA approval.

A second state court trial over the ASR implant is already underway in Illinois just days after a California jury order Johnson & Johnson to pay $8.3 million in damages to a retired Montana prison guard. Opening statements began March 11, 2013, in Cook County Superior Court in Chicago in the case of plaintiff Carol Strum against J&J’s DePuy Orthopedics subsidiary.

Carol Strum, 54, an Illinois nurse whose DePuy ASR hip implant failed after three years, requiring her to undergo a second surgery to replace the device. Jurors were told by Strum’s attorney in an opening statement that “the ASR design flaws caused it to shed chromium and metal debris” into the tissue surrounding Strum’s hip. Her attorney asserts “DePuy knew that the design flaws in this device could cause it to shed those particles into patients, causing tissue death, high blood metal ion levels and the need for the serious and unnecessary second surgery before Carol Strum ever had the ASR put into her body.”

Strum’s attorney further told jurors that while DePuy executives discovered the device flaws in 2008 and commissioned a redesigned project, which was scrapped and the device remained on the market for another two years. The company never once mentioned the device’s risks to the doctors they sold the products to prior to issuing a global recall in August 2010. Her attorney acknowledged, “If they had, we would not be here today.”

A California jury awarded a Montana man $8.3 million in damages on Friday. The panel did not award punitive damages and rejected the Plaintiffs claim DePuy failed to adequately warn of risks associated with the implant. The jury declined to issue punitive damages, saying Johnson & Johnson’s subsidiary DePuy orthopedics unit, which made and marketed the all-metal device, did not act with fraud or malice. The Articular Surface Replacement (ASR) metal-on-metal implant was later recalled mid-2010.

In a statement, Johnson & Johnson described the verdict as mixed and plans to appeal the damage award. The company continues to dispute that the ASR was defectively designed. A second trial is expected to begin on Monday in Chicago, with other cases expected to proceed later this year.

More than 55,000 people undergo revision surgeries in the United States each year to replace loose, painful, infected or dislocated hip implants. No doubt hip revision surgeries are complicated, painful, and even dangerous in some cases given the mortality rate increases to 2.5 percent from one percent for the original surgery. The goal for surgeons is to relieve pain, restore mobility, and remove damaged, worn out or recalled implants.

Patients often find they have little choice as they need to surgically repair the hip to function normally again, despite the potentially long-lasting complications and suffering for revision surgery patients.

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