Following a two-week bench trial before New Mexico Judge Nan G. Nash, medical device manufacturer Zimmer Inc. has been ordered to pay more than $2 million to a New Mexico man for a defective Zimmer hip implant with an “unreasonably dangerous design.”
In February 2010, Michael Brian McDonald, an Albuquerque economist at the University of New Mexico, then in his sixties, was suffering right hip pain that was preventing him from his usual tennis and golf. That June, McDonald received the MTLK implant. Initial recovery went well, but by May 2011, McDonald suffered from extreme hip and groin pain and loss of flexibility, resulting in two corrective surgeries that October and November, during which the doctor implanted two new prostheses and replaced the cobalt-chromium head with a ceramic head. In his lawsuit, McDonald argued that the implant’s combination of different metals creates an unreasonable risk of metallic debris, which can ultimately lead to metallosis, a build-up of metal in the soft tissues. McDonald also accused Zimmer of failing to test the device adequately.
Zimmer’s dual modular hip implant, the M/L Taper Hip Prosthesis with Kinectiv Technology (“MLTK”), is comprised of multiple components, including a cobalt-chromium head, titanium neck and stem. Zimmer has sold over 148,000 of the implants since the device was introduced to the United States market in 2007.
In a 27-page decision, Judge Nash ruled that the defective design and insufficient testing caused likely permanent harm to the plaintiff, resulting in “metallosis,” or a buildup of cobalt debris harming the hip joint and contaminating blood.
“It is never appropriate to design a hip implant system that would create an unreasonable risk of injury to the health or safety of a patient … It is more probable than not that Plaintiff will need a third, more complicated revision surgery in the future. This surgery will cost approximately $250,000 and will involve removal of all of the implant components for a period of 2-3 months to try and kill the infection, during which Plaintiff will be wheelchair bound. If the infection can be successfully eradicated, another hip prosthesis will be implanted, necessitating the same type of physical therapy and recovery period as the first two revision surgeries … In designing the MLTK, Defendants knew that the use of dissimilar metals can result in a higher potential for corrosion and that wear debris from a junction of two dissimilar metals had been documented to be toxic and harmful to the human body.”
In determining the damages of $2.027 million, Judge Nash apportioned it into $1 million for past and future pain and suffering, $480,000 for lost enjoyment of life, and the rest for past and future medical expenses, lost household services, and out-of-pocket expenses, including another revision surgery.
The judge traced the product defect to Zimmer’s testing its components in isolation, but not their interactions together, which would have determined their potential harm. Regardless, Judge Nash ultimately decided that Zimmer had “exercised ordinary care in the designing and testing of the MLKT.” In fact, she even ruled that Zimmer had adequately warned healthcare practitioners about the risk of metal corrosion.
However, Judge Nash ruled that Zimmer could still be held liable under the doctrine of strict liability, which does not take the issue of negligence into account. Judge Nash reasoned that Zimmer should be held liable for releasing a product that creates an unreasonable risk of injury, whether or not their design and testing process could be considered reasonable. “If a device is throwing off or creating so much metal debris and corrosion that it causes metallosis,” she said, “that is not an acceptable risk of harm.”
Strict liability, also known as “absolute liability,” is liability incurred for causing damage or harm to life, limb, or property without the necessity of proving intent or negligence. When pursuing a legal action for liability, the plaintiff must generally prove that the defendant was somehow at fault, whether by negligence or direct fault, for the damages incurred by the plaintiff. The law, however, recognizes there are certain circumstances that are so inherently dangerous or hazardous, that there is no need for the plaintiff to prove direct fault or negligence.
In civil law, a tort is an intentional or negligent act, a civil wrong, as opposed to a criminal act, which causes harm to another. A tort is the basis for a civil lawsuit, and includes such acts as negligence, assault, intentional infliction of emotional distress, and products liability. A strict liability tort holds a person or entity responsible for unintended consequences of his actions. Some circumstances or activities are known to be fundamentally dangerous, so when something goes wrong, the perpetrator is held legally responsible.
Fault in strict liability cases is not an issue. Therefore, proving that an injury or damages occurred, and that they occurred as a result of the plaintiff’s activities or product, becomes the focal point of any civil lawsuit on a strict liability tort. To be successful in making a products liability claim under strict liability, the plaintiff must prove that there was a defect in the product when it left the defendant’s possession. He must also prove that he was a logical and foreseeable user of the product who used the product as it was intended. Additionally, the plaintiff must prove that he was injured by use of the product, and that it was caused by the product’s defective nature.