Johnson & Johnson is challenging findings from several research studies published in the British Medical Journal (BMJ) which question the safety of all-metal hip implants. Johnson & Johnson, along with its subsidiary DePuy Orthopedics, is currently facing thousands of lawsuits in the U.S. and around the world in connection with injuries allegedly caused by its now-recalled ASR all-metal hip implants.
In February 2012, investigations editor Deborah Cohen published a piece in the British Medical Journal evaluating the overall safety of metal-on-metal hip implants. As part of her investigation, Ms. Cohen looked at research data to determine what risk the metal hips posed to patients in terms of side effects associated with metal poisoning, the potential link between cancer risk and metal hips and the overall revision rate data, which suggested a significantly high failure rate for these types of artificial hips. Upon completion of her investigation, Ms. Cohen concluded that despite being aware of the potential dangers to consumers posed by all-metal hip implants, Johnson & Johnson and DePuy continued to aggressively market these devices.
Representatives for Johnson & Johnson and DePuy responded to Ms. Cohen’s assertions by calling them “alarmist” and claiming that they were factually inaccurate. Ms. Cohen has since fired back, stating that her report was necessarily alarming because it portrayed an accurate portrait of the current state of medical device regulation. The DePuy ASR hips, which were pulled off the market in a massive worldwide recall in 2010, were approved in the U.S. under the Food and Drug Administration’s 510k rule. Under this system, a device can be approved without additional safety testing if the manufacturer can prove that it is similar to another product that is already on the market. Johnson & Johnson used its own Pinnacle all-metal hip as the predicate device for the ASR hips. While the Pinnacle hip has not been recalled, it has since been linked to numerous reports of complications similar to those associated with the ASR metal hips.
Approximately 93,000 ASR hips were affected by the 2010 recall. A New York Times article published earlier this year suggested that Johnson & Johnson was aware of problems with the ASR hips for as long as a year before the recall was issued. The Times has also reported that Johnson & Johnson continued to market an ASR hip resurfacing system to health care professionals overseas for as long as a year after the device’s FDA approval application was rejected in the U.S. Johnson & Johnson has continued to maintain that it was unaware of the potential for problems with these devices.
Patients in the U.S. and abroad who have experienced pain, swelling, tissue damage, loss of mobility or other complications after receiving an ASR or Pinnacle hip are encouraged to speak with an experienced DePuy hip attorney regarding their rights. As the December trial date for the first DePuy ASR lawsuit nears, it’s expected that more claims will be forthcoming.
NadrichCohenLLP