It’s All in the Hips: Metal-on-Metal Hip Replacements and the Law

Michael GrossmanOctober 12, 2016 7 minutes

Medical science rose in part from a need and desire to combat and cure human frailty, and has made tremendous strides toward its effective treatment. For instance, many companies have devoted considerable resources to the creation of prosthetic devices and orthopedic implants to replace failing joints.

One often-replaced area is the ball-and-socket joint system that connects the pelvis to a femur, the upper thigh-bone (to be less insufferably academic, that's your hip). Years of grinding the head of your femur against the natural cup of your hip joint can lead to excessive pain and degradation of the joint. It gets very hard to walk on a system that is no longer able to bear your body weight, and it is often a doctor's recommendation that a patient in this position undergo a hip replacement procedure. In many such cases, a metal femoral component (the "ball") and acetabular receiver (the "socket") replace the worn-down elements to keep the patient moving. These pieces can be made of a variety of metals, including chromium, cobalt, nickel, titanium, and molybdenum. Cobalt and chromium seem to be the most common composition.

Regrettably, the technology and materials used in hip replacements are not without their drawbacks, and medical studies suggest they may be creating just as many problems as they purport to solve. Our injury attorneys look at the ongoing litigation against the manufacturers of these "metal-on-metal" hip replacements, and the options people may have if injured in such a way.

Who Makes Hip Replacements?

Patients who find themselves in need of a prosthetic hip do not lack for options. Many companies make the femoral and acetabular components that are combined into artificial hip joints, which end up looking like the graphic below (not that its appearance is really key to its application).

Metal on Metal hip implant components

Among the companies that develop and distribute artificial hips are some big names--at least in the health care industry:

  • Encore Medical ("Encore"), now a subsidiary of California-based DJO Surgical.
  • Zimmer Holdings Inc. ("Zimmer"), maker of a number of implants and components.
  • Smith & Nephew RLC, a UK-based manufacturer with a number of marketed implants.
  • Stryker Corp. ("Stryker"), considered a global leader in medical equipment and orthopedics.
  • Wright Medical Technology ("Wright"), a leader in implant manufacturing since 1950.
  • Biomet Orthopedics ("Biomet"), maker of knee, hip, shoulder, and other implants. Bought by Zimmer in 2014, now called Zimmer Biomet.
  • DePuy Orthopedics ("DePuy"), a branch of Johnson & Johnson. Yes, that Johnson & Johnson.

Regrettably, these names have all become familiar to members of the legal profession as well. Personal injury and products liability attorneys have received scores of complaints from people who have suffered injuries after receiving these hip implants.

What are the Hazards of Metal-on-Metal Hips?

One of the biggest problems of these implants is their tendency to create unwanted debris that pollutes the body. When the metal "ball and socket" of a conventional hip implant grind together (this is called "fretting"), the friction of the elements creates tiny particles of cobalt and chromium, which then accumulate around the joint. Over time, these particles irritate tissues in the hip, causing inflammation, swelling, fluid build-up, and soft-tissue growths (pseudotumors), virtually all of which cause considerable pain and immobility. The cobalt and chromium particles can also gradually build up in the bloodstream, causing a severe complication known as metallosis (metal poisoning). This can lead to a variety of life-threatening systemic complications in other areas of the body.

The performance records of these devices are also somewhat tarnished by regular reports of operational failures--without the natural ligaments that hold the femur to the acetabulum, the implant's components have an increased chance of separating. In short, the ball pops out of the socket, and without that connection the implant cannot function. The devices are also known to increase the risk of bone fracture and infection in the areas surrounding the implant site, and some of the manufacturers' products also have excessive breakage rates of the acetabular cup, also called the shell. All told, the track records of these implants are less than stellar.

To be clear: The prostheses serve a necessary purpose, and benefit many patients who suffer from debilitating hip problems. With that said, the failure rate of many models of hip replacement are a cause for concern, and many patients who have suffered such failures are seeking compensation for the pain and expense of undergoing revision or replacement surgeries.

Current Litigation Example: DePuy and Johnson & Johnson

At this time, DePuy and its parent company Johnson & Johnson are already facing the third of their bellwether trials, which are the claims picked to be tried before the bulk of the filed claims are examined. This is an important measure because it grants all involved parties a picture of "how the winds are blowing" with respect to the overall case. Manufacturers often decide whether to settle out of court with plaintiffs based on the outcome of the trials. Seven plaintiffs with allegedly-failed DePuy Pinnacle Hip Implants were consolidated in Dallas, part of Texas' Northern District, and the trial commenced last week.

An earlier bellwether resulted in DePuy paying for a Texan jury's verdict in favor of the plaintiffs, to the tune of $502 million. It was determined that the company was liable for products that failed prematurely and released metal particulate into patients' systems, causing significant pain and suffering and requiring repeated surgical corrections. The Pinnacle was determined to have a number of shortcomings that DePuy had not properly addressed, opting instead to make use of the FDA's 510(k) "Fast Track" approval system. DePuy successfully bypassed much of the normal quality control requirements by alleging that its product was functionally equivalent to many others on the market that had already undergone scrutiny. The Pinnacle underwent no clinical trials before its release to the market.

In an effort to prevent similar manipulations of the system, the FDA later revised its approval requirements for metal-on-metal hip implants to require clinical trials. They also advised physicians that MOM hip systems should only be used if other artificial hip implants are not viable or available.

These cases are the inevitable outcome of more than 8,000 federal product liability suits filed by people with adverse effects from the implants. That was the approximate tally as of July 2016. As of 2011, these claims were consolidated into a Multi-District Litigation, or MDL, in Texas' Northern District Court.

DePuy has also taken heat in the past when it was shown in 2013 that the company was aware for several years prior that another of its implant procedures, the Articular Surface Replacement (ASR) hip system, was shown not to live up to the company's claims of increased durability and mobility than prior devices. Corporate records discovered during these trials revealed that before it initiated a recall in 2010, DePuy was already aware that over 40 percent of implanted ASR devices would fail within 5 years.

While the DePuy MDL is taking up much of the spotlight at the moment, the other listed manufacturers have been forced to issue recalls on a number of their own in-house products. They also face similar litigation from patients who were injured by the implants.

What Do I Do If I Have a Hip Replacement Injury?

If you are suffering infection, pain, inflammation, and/or immobility after having hip replacement surgery, it is possible that your hip implant is experiencing a malfunction. I am not a doctor and have no way of knowing your unique medical history, so don't take that as gospel truth--consult your health care provider as soon as possible.

Should it be confirmed that your hip implant is the source of your damages, you may be entitled to compensation. A skilled products liability attorney will be able to prove that your injuries are based on the manufacturer's negligence, and will assist you in securing recompense for your pain and suffering, as well as any medical expenses you accrued trying to address those issues.

An attorney will need to prove a few things in order to successfully pursue a liability claim on a plaintiff's behalf. Based on the requirements of Texas product liability claims, the plaintiff will need to demonstrate that the defendant breached their duty to keep the plaintiff safe. This is not difficult to prove; manufacturers make products under the implicit assumption that they will not bring harm to end-users who make reasonable use of those products. That is, if the item is used within its parameters and for its intent, it is fair to assume that it will not hurt the person or persons making use of it. If it does--contaminated food, guns that jam or backfire, artificial hips that harm more than they help--it signifies that the product was incorrectly made, which is a breach of its maker's duty to consumers.

If breach of duty is discovered, the attorney must then show that the flaw in the product was the proximate cause of the plaintiff's injuries. Again, this is not terribly difficult to demonstrate, though defense attorneys will most likely examine a patient's medical history to see if any previous health conditions might have paved the way for malfunction or infection. If the patient has any autoimmune disorders or problems with bone density, defense could effectively argue that these compromises in the patient's health may well have contributed to the infection or bone breakage that occurred around the implant site. They would not be arguing that no one was at fault, necessarily, but rather would be attempting to pass the responsibility away from their product to the surgeon who did the work, or the facility where it was performed. An effective defense would lessen or even eliminate the company's liability for the plaintiff's injury.

If no such prior medical history is present--no susceptibility to the conditions that occurred once the hip was implanted--medical records should pretty clearly indicate that the hip was the source of the injury. Before the surgery, Patient X did not have metallosis, and afterward, he did. Examining what happened between these two states, we find the introduction of a large, friction-intensive metal device in Patient X's hip. A few deft slices with Occam's Razor, and a good personal injury attorney will prove causation.

Hip Replacement Is A Valuable Medical Procedure.

As I said earlier, compared to the alternative of simply enduring a disintegrating hip joint, a prosthetic hip is a solid alternative. All surgery has risks, but in many cases it is the best possible alternative to suffering with things as they are. Many of the listed firms are investigating alternatives to the current composition of the implants to avoid some of the complications currently experienced by patients. Metal-on-plastic and ceramic hip replacement systems are also available, though not without their own share of hazards.

That does not excuse the ones who acted with foreknowledge of those complications, though. They stand accused of aggressively marketing and distributing products with proven flaws for the sake of profits, and of allegedly trying to ignore or bury reports that would negatively impact their bottom lines. These companies are perhaps not doing the best job they could of double-checking their work, and that certainly is not right. It's why these lawsuits exist, really; people deserve to be made whole if they are sold a bill of goods that causes just as much pain, if not more, than the condition it set out to solve.

Pain and suffering, coupled with the medical bills and lost wages from surgeries and down-time, need to be paid for somehow, and it is only just that their cause provide their remedy.