Thousands of Americans have been struggling with defective hip replacement devices ¬†not knowing that they would cause serious problems after they underwent hip replacement surgery. But the manufacturer knew and sold them anyway, according to lawsuits filed recently in cases against DePuy Orthopaedics, a division of Johnson & Johnson.
How did the device get on the American market in the first place?
The Food and Drug Administration approved DePuy’s ASR XL Acetabular System in ¬†2005 without requiring it to undergo clinical trials, according to a March 2010 report in The New York Times about this Johnson & Johnson product. ¬†¬†
A hip replacement will usually last 15 years. But the ASR System has a 13 percent failure rate in less than five years. It was used in approximately 37,000 hip replacement surgeries in the U.S. Now, its victims must endure another total hip replacement, called revision surgery, ¬†to remove and implant another device. Victims have no other medical option to stop the pain and suffering caused by the defective Johnson & Johnson product. ¬†¬†¬†¬†¬†
After 30 years of representing the injured, personal injury attorney Jim Adler knows how big insurance companies, corporations, ¬†manufacturers, property owners and refineries try to take advantage of those they have hurt. ¬†
“It’s a war. On one side is a victim who is fighting for his or her very life against a big company that wants to give them nothing. Not only has this innocent person been hurt, he or she often has ongoing pain and may end up disabled for life,” Adler says.
Adler notes that the ASR System is particularly dangerous because it can dislocate, and chip or break bones as it wears out, causing more damage to the body. It can also release toxic metal debris into the blood stream. Although DePuy says it will pay for victims’ revision surgeries, doctor visits and medical testing, Adler says the company should also pay for victims’ pain and suffering. ¬†
“The ASR implant is a metal-on-metal device. As it wears, it can generate large amounts of metallic debris, leading to high levels of metal in the blood. The long term effects on the body are still being studied. But we already know it can cause painful cysts, groin pain, death of tissue in the hip joint and bone loss,” Adler added. ¬†¬†
The ASR Hip System also has a design flaw that makes it hard to implant at the proper angle. An American doctor who was one of its co-developers told the New York Times, in an article published on March 9, 2010, that the ASR cup could be “more of a challenge to implant than competing cups” because it is “shallower” than similar devices. ¬†
DePuy is also reportedly marketing two other systems that violate the Federal Food Drug and Cosmetics Act. According to Internet news reports, The FDA sent a warning letter to DePuy on August 19, 2010 about its TruMatch Personalized Solutions System, used to produce custom surgical guides and its Corail Hip System used in arthorplasty surgery of the hip. An FDA expert charged the company is only approved to market the Corail system for cementless use and that it violated the law when it marketed the “solutions system” without prior approval. ¬†¬†
Adler said the August 2010 FDA warning about those two products raises even more doubts about DePuy’s integrity. He urges anyone suffering after a hip implant to see a doctor to determine if it is a DePuy ASR Hip System. If so, a personal injury lawyer like Adler should be consulted. Johnson & Johnson and DePuy are already facing an i ncreasing number of ASR Hip System lawsuits across the United States.¬†