Following the massive DePuy hip replacement recall, Senators Charles Grassley (R-Iowa), Richard Blumenthal (D-Conn.) and Herb Kohl (D-Wis.) have introduced legislation to help protect patients from being exposed to dangerous medical devices and to ensure that recalls are conducted promptly when a company learns that a device is defective.
This bipartisan bill authorizes the FDA to require post-market clinical studies for medical devices such as hip implants, that could have serious safety risks. The bill also gives the FDA the ability to require manufacturers to conduct safety studies after a device is approved through the expedited 510(k) process, the regulatory loophole that allowed the DePuy ASR to be sold in the United States.
“This reform legislation should be part of the reauthorization of the medical device user fee law next year,” Grassley said. “The reforms incorporate well-founded recommendations from the Government Accountability Office and reflect the value of having a robust post-market surveillance operation in the FDA. Important information can be learned about product safety after a device is on the market, and when there are problems, the sooner the response, the better.”
“Unsafe medical devices pose severe dangers to patients and impede approval of new, safe devices – causing significant costs to our economy as well as health,” said Blumenthal. “This bill will help protect people from dangerous unsafe medical devices by demanding more consumer safeguards, improving recall management, avoiding costly recalls, and preventing irreversible injury to patients. By removing unsafe devices from the market more quickly and efficiently, we’re preserving a faster approval track for safe and effective products to reach patients.”
“Faulty medical devices, especially those implanted in the body, can have disastrous health impacts on patients,” Kohl said. “This legislation will help ensure that FDA can act quickly and decisively when there’s a problem, and that the drive toward getting new technologies to market won’t come at the risk of patient safety.”
The three Senators also sent investigative letters to five companies, including Johnson & Johnson / DePuy. The Senators have requested details about DePuy’s post-market surveilance of the ASR implant, and how and when it decided to recall the ASR from the market. The letter said:
As the Special Committee on Aging’s recent oversight hearing detailed, effective post-marketing surveillance practices allow companies to recognize problems with medical devices in a timely fashion, preventing expensive recalls later, and can also save lives and prevent unnecessary suffering.
HIP IMPLANT RECALL CLAIMS
We currently represent people from across the country and around the world who had a DePuy ASR hip implant or a metal-on-metal Pinnacle hip implant that failed. If you or a loved one suffered an injury caused by a metal-on-metal hip implant, you may be entitled to recover damages in a lawsuit against the manufacturer.
ABOUT OUR HIP IMPLANT RECALL ATTORNEYS
We have an unparalleled depth of knowledge about hip implant litigation that comes from years representing orthopedic companies. For example, the firm’s partner, Brian Devine, worked for years at Sulzer Medica, a global manufacturer of hip and knee implants. As its Assistant General Counsel, Brian was responsible for all of the firm’s product liability cases worldwide. When the company suddenly had to recall several thousand hip and knee implants in December 2000, Brian was given lead responsibility for managing the resulting avalanche of litigation. He managed thousands of individual cases and directed attorneys in almost every state in the country. He then took a leading role in negotiating a nationwide class-action settlement which provided $1 billion in compensation to those who were injured by Sulzer Medica’s hip and knee implants.
Brian now uses his experience to help victims who are injured by orthopedic products. His legal and medical knowledge combined with the unique perspective he gained while working for a medical device company makes him a formidable adversary. Brian’s skill as an advocate is best proven by his results. In the last few years alone, he has recovered more than $20 million for a wide variety of clients. He has scored five victories in excess of $1 million, and his largest victory is a $3.7 million settlement on behalf of a single client.
We have offices in San Francisco, California. We represent injured persons nationwide through our network of experienced and dedicated attorneys.
Our description of your legal rights is not intended to constitute legal advice and is not intended to imply that any product is defective. That can only be determined through a case-specific investigation. This site is not affiliated in any way with any manufacturer of hip implants.
