Over the last decade, Gordon says, manufacturers hungry to expand sales, rushed to market with defective, untested, failure-prone devices that are having a devastating impact on patients, doctors, health insurance companies and the health care system as a whole.
“Based on what I have seen over the last decade, I would have to be bedridden before I would consider having a hip implant,” says Gordon, an attorney with Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor, P.A. in Florida.
Gordon will be speaking at the Mass Torts Made Perfect convention in Las Vegas this week on what he calls a “health crisis” brought on by defective hip implants.
Metal-on-metal marketing plan
In 2001, about 100,000 hip implants were being used primarily for older patients. But, beginning around 2001, medical device manufacturers like DePuy went forward with metal-on-metal implants that were projected to double the lifespan of the hip replacements, from 15 to 30 years. The increased longevity of the devices made them suitable for younger patients.
“Without any scientific evidence, the industry convinced the entire orthopedic medical community that this device could be put in younger and younger people. It was a marketing plan to sell three to four times as many devices and if you look at the data, you can see that by 2010 they were selling 300,000 to 400,000 devices because they were now viable for people in their 50s, 40s and even 30s,” says Gordon, who is part of the lead council committee in the recent litigation against Stryker, one of the several hip implant replacement companies currently facing legal action.
“As it turns out, the metal-on-metal hip implant does not last longer,” says Gordon. “Generally, they last two to four years. Most case studies show a hip implant is good for 27 to 44 months. Certainly there are people whose devices last five to seven years, but it is rare for these devices to last anywhere close to the 15 years that their predecessors got, much less the 20 to 40 years doctors were led to believe.”
The National Joint Registries
As part of his evidence to support his claims, Gordon points to the National Joint Registries (NJRs) that are kept in Britain, Australia and Europe, where the DePuy ASR and other hip replacement devices were also sold.
“Because of the NJRs,” says Gordon, “the implant failures became readily apparent. Apart from the anecdotal evidence that we see and hear about, it was obvious from the NJR data that there was a statistically significant number of failures.”
Failure rates range from 10 to 50 percent, depending on which company made the device.
“This all started with DePuy and the ASR hip implant debacle,” says Gordon.
Other companies followed between 2001 and 2010 with similar metal-on-metal implants, and it soon became clear that there were problems with the Zimmer Durom Cup implants, the Pinnacle, the Smith and Nephew hip implant, and the Stryker hip implants.
“You have no idea how many orthopedic surgeons I know that are so unhappy with these devices,” says Gordon. “Their patients come back to them with extreme problems. The failure rate of these implants is so high that it has created a crisis of unhealthy and unhappy people in the health care system. Meanwhile, the device companies move on to the next product while the public, the health care system, doctors, health insurers are saddled with huge costs and serious problems.”
You can sense Gordon’s outrage after seeing so many people hobbled by hip implants.
“I have been representing clients for many years and what they have gone through is unnecessary,” he says. “If the devices had not gone to market the way they did, tens of thousands of people would have been saved a lot of suffering.”
The metallosis effect
The most common problems with the metal-on-metal hip replacements are reactions to the metal debris created by the grinding of the metal cup and ball.
“The problems range from a condition called metallosis, which essentially means any kind of inflammation caused by a reaction to the metal particulate, all the way to aseptic lymphocytic vasculitis-associated lesions,” says Gordon. “Tissue, bone, muscle react to the corrosion and particulate and metal debris.
“There are some hip implants that are titanium; however, it is mostly the cobalt chromium ions that are ionizing off of the cobalt head or cup and then picked up by lymphocytes and other cells and spread through the patient’s body, causing a severe localized reaction that results in muscle and tissue death.
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“The doctors can only do so much to rebuild the muscle tissues. People are left with a severe gait disturbance called Trendelenburg gait, or an Abductor Lurch caused by severe weakness in the lower limb muscles. They generally walk with a cane or a walker,” says Gordon, who has represented dozens and dozens of clients in personal injury cases against hip implant manufacturers over the years.
Recently, some health care providers are refusing to provide coverage in cases where the hip implant was defective, leaving patients on the hook for medical costs related to repairing the damage done by hip replacements. They are left with only one option to try and recoup - litigation against the manufacturer.