Patients victims of untested medical devices – SFGate.

For four years after she had her hip replaced in 2006, Sandy Rotenberg still had increasing pain, but her doctor kept telling her everything looked normal and prescribed more pain pills.

Then in October 2010, during a visit to get a cortisone shot, a different doctor looking at the El Cerrito woman’s X-ray commented that her implant appeared to be one of the faulty all-metal devices made by Johnson & Johnson‘s DePuy unit that the company had recalled that August.

“I felt sick, terrified, but I also felt relieved,” said Rotenberg, 53, who was born with a hip abnormality that caused early deterioration and arthritis. “I’d been hearing this attitude that was pretty paternalist and made me feel like this hysterical female. In some ways, it was just this huge relief to find out what was wrong.”

Turns out Rotenberg was one of more than 93,000 patients worldwide to be implanted with DePuy’s metal-on-metal replacement hip, known as the articular surface replacement.

Metal-on-metal implants, in which the cup and ball are made of metal, have been on the market for decades. DePuy’s version, marketed to younger patients because it would last longer than conventional hip implants, came on the U.S. market in 2005. It not only failed in many patients but released tiny fragments of metal into the patients’ bodies, causing tissue damage and other complications.

Untested devices

Considered one of the largest device failures in decades, the DePuy debacle highlights a little-known but stunning truth: These devices were cleared by the U.S. Food & Drug Administration without having to be tested in a single human being.

How does that happen? A loophole in FDA rules allow certain high-risk devices, including metal-on-metal hip implants, to bypass pre-market testing requirements if their manufacturers can convince the regulators that their device is “substantially equivalent” to a device already on the market.

A growing number of health experts, lawmakers and regulators are trying to close that gap.

“I don’t think we should have devices on the market until we already know they are safe and effective,” said Dr. Rita Redberg, a UCSF professor of medicine who co-authored an article in the New England Journal of Medicine last month calling for a change in FDA regulations. “Pre-market (clinical) trials would have caught the problem and 93,000 people would not have been implanted with a device that has since been recalled.”

The rule that has allowed certain devices to skirt the process of undergoing potentially lengthy and expensive clinical trials dates to 1976, when the FDA started regulating medical devices, which include everything from heart defibrillators to infusion pumps to toothbrushes.

While the FDA requires implantable heart defibrillators and most other highest-risk devices to go through trials, it created a temporary approval process known as the 510(k) program as a stopgap measure to cover devices the agency had not yet classified for their level of risk.

Loophole never closed

This process would allow the FDA to clear these devices by deeming them similar enough to products already on the market. But the loophole was never closed and a number of devices, including metal-on-metal hip implants, have relied on the rule to get on the market.

The FDA has made several attempts over the years to classify metal-on-metal hips, but never completed the process. The agency restarted the effort on Jan. 18 under new rules passed last year designed to make device classification more streamlined.

For as long as the loophole exists, Dr. Kevin Bozic, chairman of the UCSF’s department of orthopedic surgery, said better monitoring of devices after they are already on the market would help identify problems as they occur.

“There are always going to be devices that fail before there are millions of them out there. What we need to do is find about them earlier in the process,” said Bozic, also chairman of the American Academy of Orthopaedic Surgeons Council on Research and Quality.

Bozic is working to create a registry to track patients who have undergone hip and knee replacements in the United States, a move that could be done independently of federal action.

Meanwhile, the problem persists. And now Johnson & Johnson’s hip replacement device has landed in court. A Southern California jury is hearing evidence in the first DePuy case to reach trial. But many more are expected to follow.

More than 10,000 lawsuits have been filed by patients nationwide who have suffered a range of injuries, with some having to undergo multiple surgeries to try to repair the damage. Financial damages have yet to be determined and will depend on the level of injury.

Many of the lawsuits name two orthopedic surgeons who were on the design team for DePuy’s ASR implant and reportedly received millions of dollars in royalties for their work: Dr. Thomas Schmalzried, who practices in Los Angeles, and Dr. Thomas Vail, an orthopedic surgeon at UCSF. Neither UCSF nor Vail would comment.

Plaintiffs’ accusations

San Francisco attorney Lexi Hazam, whose firm is representing about 160 plaintiffs, said DePuy not only created a product that it did not adequately test, but it also failed to notify doctors, patients and regulators as soon as the problems became apparent.

“Serious flaws with the device became apparent quickly,” said Hazam, a partner with the national plaintiffs’ firm Lieff, Cabraser, Heimann & Bernstein LLP. “The company left the product on the market despite knowledge of these flaws.”

Officials from DePuy, for their part, said they decided on the voluntary recall in 2010 after data showed that 12 or 13 percent of patients in the United Kingdom needed surgery to fix problems with their implants after five years.

“We understand that the August 2010 ASR Hip System recall is concerning for patients, their family members and surgeons,” the company said. “Since the recall decision was made, DePuy has worked to provide patients and surgeons with the information and support they need.”

The help may come too little and too late for patients like Rotenberg.

Not fully recovered

Rotenberg, a librarian at Solano Community College, underwent a second surgery to replace the recalled device in January 2011. Then she had to endure yet another surgery in December 2011 to replace the second device after her damaged tissue prevented her bone and ligaments from adhering to the implant. She expects to have to have that implant replaced in the future.

“My body still doesn’t seem to be healing very well in that I’m still in considerable pain,” she said, adding that she uses a cane to walk more than very short distances. “My husband is still tying my shoelaces because I can’t bend over.”

Rotenberg, who is being represented by Hazam’s firm in a lawsuit against the manufacturer, found it challenging to calculate the financial, physical and emotional toll the six years of pain have taken on her and her family.

“The years I kept going back and saying something’s wrong, they could have let my surgeon know there was a problem. If they had replaced it within a year after the first surgery, I would probably be OK,” Rotenberg said. “The damage just didn’t happen once. It kept getting worse and worse. They knew. They knew even more every day that passed.”

Hip replacement recall

For more information about the problems with metal-on-metal implants and Johnson & Johnson’s DePuy recall: 1.usa.gov/11CosuX.

DePuy has established a toll-free number to help patients with recall-related out-of-pocket expenses, such as co-pays, deductible expenses, lost wages and travel costs. The number is (888) 627-2677.

Victoria Colliver is a San Francisco Chronicle staff writer. E-mail: vcolliver@sfchronicle.com

Read more: http://www.sfgate.com/health/article/Patients-victims-of-untested-medical-devices-4272872.php#ixzz2L0eSlQPq

 

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