The first of more than 1,800 lawsuits against the Johnson & Johnson (J&J) subsidiary DePuy Orthopaedics for alleged injuries stemming from their Pinnacle Acetabular Cup System metal hip implants will be heard in test trials, also known as bellwether trials, on May 6 and July 8, 2013 in Texas.

Bellwether trials involving about 6,000 cases on DePuy’s ASR implants in Ohio will also come to trial in 2013.

Bellwether trials are closely watched by both sides, as they are early indicators of how juries will tend to rule in those and all following cases. The outcomes of bellwether trials often create an incentive for parties to settle. DePuy has recently begun to settle cases over its recalled ASR metal hip implants in Nevada, even before courtroom trials have begun.

These trials are part of Multidistrict Litigation (MDL) where hundreds or thousands of similar cases are consolidated under a single federal judge. MDLs allow plaintiffs’ attorneys to share in pre-trial discovery, but unlike class action suits, allow each case to move forward individually.

In Texas, the Honorable Judge James E. Kinkeade is overseeing more than 1,100 cases concerning the Pinnacle metal hip product, including four just added from California and Maryland. In Ohio, Judge David A. Katz is overseeing more than 6,000 cases concerning DePuy’s ASR metal hip implants.

J&J recalled the DePuy ASR products in August 2010, affecting nearly 100,000 patients nationwide after the National Joint Registry of England and Wales and Australia showed devices in as many as 1 in every 8 patients failed. More recent data suggests the failure rate could be much higher. After the ASR recall, the FDA received complaints that the earlier Pinnacle hip-replacements also were failing.

Unfortunately, the U.S. does not have a joint registry to be able to uncover medical device failures before mass numbers of patients are harmed. It’s sort of a head-in-the sand approach to medical device regulation.

According to the journal Orthopedics, metal-on-metal hip replacement joints have been found to “exhibit increased serum cobalt and chromium ion levels.” According to the journal Chemical Communications, these ions may impact cellular genetic material. Studies also show all-metal hip implants can cause metal poisoning of nearby tissues, and the metal debris has been linked to cancer.

J&J recently settled three ASR cases in Nevada for about $200,000 each, as the pharmaceutical and medical device giant continues to vigorously defend its Pinnacle product.

In June, the Food and Drug Administration (FDA) convened a panel to recommend whether additional warnings were needed for metal hip systems. Because early hip implants were already on the market before the FDA began regulating medical devices in 1976, none of these devices has gone through clinical trials. Manufacturers are only required to show the devices are similar to earlier ones.

The FDA panel is not discussing regulatory changes at this time so it is truly buyer beware.

It’s predicted that the personal injuries patients are suffering from metal debris, repeated revision surgeries, and painful and debilitating infections will eventually force J&J to pay at least $2 billion to settle the ASR product liability cases.

3 responses to “Metal-on-Metal Hip Trials Scheduled for 2013

  1. Cal, I am a client of Brenda Fulmer of the Searcy Group, I did speak at the June 27-28, 2012 FDA panel hearing in DC. The metal on metal resurfacing device, (metal on metal) was approved in 2006,the Smith & Nephew Birminham Hip Resurfacing device. The approval of this device was a blatent farse on the part of the FDA. The minutes of the September 8,2006 meeting held in Washington, DC by the FDA to approve this device will explain my opinion. How a single man, partial inventor of the bHR, Derek McMinn, convinced the FDA to approve this device after the application was first submitted in 2004 is a beyond my imagination. The data was taken from a single controlled patient group ( McMinns )the data from this group was questionable from the start, most of his data was never verified by the FDA, it was hear-say by McMinn at best, the numbers of statistical data was inconsistent through out including marketing of the device by Smith & Nephew. (this can be verified by reading Smith & Nephews marketing of the device. There was never any testing done in the USA, there were serious doubts, questions raised by panel members including comments made from three substituting voters of the panel yet it was approved. McMinn received a financial package worth a reported 100 million pounds for the sale of Midland Medical Technology, a company McMinn was a principal. This company had no real apparent value except for the BHR ??? McMinn even warned Smith & Nephew to be precautious with this device as there were no real long term stats on harm that could be caused to a human being via metal particles entering the human body. (particles caused from the friction of the metal on metal components rubbing together)
    There are fewer bhr victims than the other big manufacturers yet each day goes by and more reports of bhr victims are being published in the USA and UK, Australia, New Zealand etc.
    The biggest crime of all coming from the FDA is they have been talking about more data from the various manufacturers as to metal on metal and adversities for years, they are like a dog trying to catch its tail. They talk a lot, I think to pacify the public yet they do nothing concrete about this nightmare. I heard testimony from big time surgeons, scientist, and victims not to use mom hips, there was no need for them any longer etc, etc. Common sense would look at the decline in useage of mom hips by surgeons, read about the 1000’s of adverse complaints filed with the FDA,and other Governmental bodies both in the USA and abroad, check on revision numbers completed by a few of the larger orthopedic hospitals and take these devices off the market. But market share and rates of returns to the investors are more important than the protection of the quality of life of human beings. How the Church, oil,automobile, Penn State institutions
    and industies are held accountable and the device manufacturers] in some cases are not held accountable (pma-pre-marketing approved devices) is a bigger injustice to mankind then anything else. How the FDA can say in good conscience they are protecting the well being and health of our own USA citizens appears to be a blatant lie.
    The longer folks are kept in the dark on this matter, and the longer these devices remain implanted the greater the damage could result.
    Perhaps had my surgeons known what the medical device manufacturers knew I wouldn’t be in a wheelchair today with little quality of life.
    If this happened in a 3rd world country we would be there tomorrow with help.
    What about the 1000’s of folks in our own country and 1000’s abroad, is the quality of our lives less valuable than market share and returns to the investors ?
    These manufacturers are repeat offenders of the law with kickback payments (used to help market their devices)Smith and Nephew is in court being sued by the USA on a whistle blower case. These companies pay their fines imposed by the goverment like they were paying a traffic ticket and continue doing the same infractions. The settlements being made to some of these victims is nothing more to these manufacturers than paying traffic tickets, they make billions of dollars each year. They save 1000’s of lives, they do give folks a new chance in life HOWEVER that doesn’t make it ok to have a device malfunction, hurting and destroying lives forever.
    What will happen next time, more bad press, more fines, more hearings by the FDA ?
    Time for a major reality check, don’t you think.
    Howard Sadwin

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