By: Jeff S. Gibson, Attorney
The pharmaceutical and medical device industry seems to be on an endless search for the next advancement to improve patient care and quality of life. Whether existing designs are significantly altered by the addition of new materials or new products are created, the FDA continues its oversight of these devices and provides the final approval to allow these products on the market.
As medical device manufacturers rush to market products designed to help patients experience a better quality of life, incomplete or deficient research and reports required to obtain FDA approval can put patients at risk.
In some cases, the submitted research and clinical trials lack the data necessary to determine the long-term impact of these medical devices. The FDA often relies on adverse event reporting from patients and healthcare providers to identify any trends that would indicate a risk to patients and takes appropriate action to ensure future patient safety. These actions can include product recalls, black-box warnings, and safety notices.
Metal on Metal Hip Implant Injuries
Metal on metal hip implants—with a ball that replaces the head of the femur and a cup that replaces the socket of the hip– are constructed of metal components, have been gaining in popularity over the past several years.
However, it didn’t take long before reports of device failure were being reported to the FDA. As the components rubbed together, metal fragments flaked off the devices. Metallosis is a serious condition caused by a build-up of metal debris in the tissue. This debris can cause swelling, pain, infection, and tissue death if not treated. Severe cases of metallosis can lead to toxic levels of metal in the blood—essentially poisoning the patient.
Stryker Rejuvenate & ABG II recalls
Stryker recalled its Rejuvenate Modular and ABG II modular-neck hip stems in June 2012 over concerns about corrosion and fretting of the metal components. Since the recall, nearly 4,000 lawsuits have been filed against Stryker alleging injuries including metallosis and tissue death.
In November 2014, Bloomberg reported that Stryker agreed to pay more than $1 billion to settle lawsuits related to its Rejuvenate and ABG II hip implant devices without even taking a single case to trial.
DePuy ASR XL Acetabular recall
DePuy faced similar problems as Stryker with its ASR XL Acetabular metal on metal hip implant. Within a few years of being on the market, this device had been the subject of more than 5,000 complaints to the FDAs adverse event reporting system. Patients complained of device failure as metal fragments flaked off the components allegedly causing elevated levels of metal in the blood, severe pain, bone loss, and tissue death or necrosis.
DePuy faces thousands of lawsuits in State and Federal courts. Johnson & Johnson, the parent company of DePuy, has agreed to a $2.5 billion settlement in litigation involving the ASR metal on metal hip implant and is continuing settlement talks.
Zimmer Durom Cup recall
The Zimmer Durom Cup is one piece of a metal on metal hip replacement device. It works in a similar fashion to metal on metal hip implant devices from other manufacturers. Unfortunately, patients who have received the Durom Cup have also complained of many of the same problems as patients with other metal on metal hip implants. Severe pain, swelling, and tissue death are serious complications alleged these patients.
After only a few years on the market, Zimmer suspended sales of its Durom Cup after numerous complaints of device failure and serious injuries. At last count, Zimmer had projected to pay out as much as $600 million in damages to patients who filed lawsuits against the manufacturer for injuries associated with the Durom Cup.
Patient Safety First
Patients and their families can suffer life-long effects when medical device manufacturers put profits ahead of safety. Failure to submit devices to thorough testing and notify the medical community and patients of risks associated with treatment can negatively impact the quality of life for patients. People who have suffered a serious injury as a result of metal on metal hip implants or other dangerous medical devices may be entitled to compensation for their injuries. A knowledgeable product liability attorney can evaluate the claim and explain your legal rights and options, contact us here.