Johnson & Johnson's Quality Catastrophe

After 50-plus product recalls in 15 months, the $60 billion company is fighting to clear its once-trusted name

Jamie Chung

By David Voreacos, Alex Nussbaum and Greg Farrell

In the split second after the blast, Lance Corporal Cody Perkins thought he was still sitting in his unit's Humvee, enveloped in blinding dust kicked up by the roadside bomb. It was only when he slammed with shattering force onto the pavement that the 20-year-old U.S. Marine realized he'd been ejected from the rolling vehicle and thrown into the air.

Perkins's commanding officer was killed in the November 2005 incident outside Haditha, Iraq, and two other Marines were injured. Perkins came away with scrapes, bruises, and a fractured femur, or thigh bone. After emergency surgery in Iraq, the Mississippi native was transported back to the U.S., where surgeons implanted screws to fuse the broken bone.

That failed, leaving Perkins hobbled. A military surgeon, Dr. Keith Holley, told him that his best option was a so-called metal-on-metal prosthetic hip made by DePuy Orthopaedics, a unit of Johnson & Johnson (JNJ). The new hip was being promoted as tough and durable—and thus perfect for younger, physically active patients like Perkins. On Dec. 13, 2006, Dr. Holley implanted DePuy's ASR XL Acetabular System in the soldier at the Navy Medical Center in San Diego.

Perkins never regained the mobility he had before the injury, but he was able to resume full-time work. By late 2009, however, while he was working as a Marine criminal investigator at California's Camp Pendleton, it started—muscle fatigue at first, which led to shin splints, followed by pain in his hip that radiated up to his back and down to his knees. Soon he was unable to sleep through the night. "It's always uncomfortable," he says. "There's never a completely pain-free day."

The cause of his trouble, his current physician Dr. Richard Conn says, isn't a complication from his original injury but the replacement hip. Perkins has been told he'll need to undergo "revision" surgery to replace the ASR hip with another implant—a highly invasive procedure with a heightened risk of infection and joint dislocations down the road. It's also likely to render him unable to pass the Marines' rigorous annual physical fitness test.

"I wanted to retire out of the Marine Corps," says Perkins, who has earned two Purple Hearts. "But there's no way that can happen ... not a chance."

Now a sergeant based at North Carolina's Marine Corps Air Station Cherry Point, Perkins has joined more than 1,000 other people who are suing Johnson & Johnson over its DePuy ASR implants, seeking damages for medical costs, lost wages, and pain and suffering.

On Aug. 26 last year, DePuy announced a voluntary recall for two types of ASR hips, including the one in Perkins's leg, but only after 93,000 had been implanted in patients worldwide, including 37,000 in the U.S. J&J; says DePuy withdrew the hips for safety reasons, while denying in court papers that the devices are defective. Announcing the voluntary recall, it cited unpublished 2010 data from the U.K. showing that within five years, 13 percent of ASR XL hips failed and needed to be replaced, and 12 percent of the similar ASR Hip Resurfacing System failed. (The U.S. doesn't collect numbers on hip failure rates.) All types of implants are susceptible to post-operative problems; Australia's registry for joint implants says 3.3 percent of all implants fail after five years. But the stats DePuy cited for the recall—three to four times that norm—now appear sadly optimistic. On Mar. 9 the British Orthopaedic Assn. and the British Hip Society said preliminary data put the ASR XL's failure rate in the U.K. as high as 49 percent after six years.

The new report adds weight to plaintiffs' lawyers predictions that thousands more patients will file similar lawsuits. Case after case describes patients in pain and immobilized by joint dislocations, infections, and bone fractures. Their claims are backed by surgeons who say metal debris from the hips, made from a cobalt-and-chromium alloy, causes tissue death around the joint and may increase the amount of metal ions in the bloodstream to harmful levels. "There's so much metal, it's toxic to the tissues," says Dr. William Jiranek, a professor at Virginia Commonwealth University School of Medicine in Richmond and an orthopedic surgeon who has removed ASR hips.