A Manhattan federal judge will oversee pretrial procedures regarding allegedly defective prosthetics, the Exactech knee, ankle, and hip implants.
Since 2021, the company has voluntarily recalled hundreds of thousands of these gadgets because, according to its lawyers, “off-specification” device packaging may have caused polyethylene components to oxidize before the end of their stated shelf life. The recalled products included several models of the Optetrak and Truliant knee implants; the Connexion GXL and Acumatch, MCS, and Novation hip implants; and Vantage ankle implants.
The JPML assigned the litigation to U.S. District Judge Nicholas Garaufis of the Brooklyn-based Eastern District of New York, where about one-third of the cases have been filed so far. The Optetrak device was developed at Hospital for Special Surgery in Brooklyn, the plaintiffs noted.
The Search for the “Perfect” Implant
Most joints, especially hip joints, are basically cup-and-socket joints. This configuration allows for an almost complete range of motion.
For many years, all manufacturers focused exclusively on plastic-on-metal implants. These gadgets had metal sockets and plastic cups. These implants were reliable and relatively easy to surgically implant. However, they weren’t very long-lasting. Especially if the patient was physically active, within a few years, the plastic began wearing out.
Therefore, Zimmer, Biomet, and other large implant makers switched to metal-on-metal implants. Manufacturers claimed these gadgets, with their all-metal parts, would last much longer than the old models.
Theoretically, that might have been true, especially if the patient was relatively inactive. But manufacturers failed to account for metallosis, or metal poisoning. Because of this neglect, these detective prosthetics often failed more quickly than their plastic-on-metal predecessors.
With every step, the all-metal parts grinded against one another, releasing microscopic metal fragments into the bloodstream. The body cannot naturally process such particles. So, they build up, usually around the defective prosthetics device. That buildup causes premature device failure. Additionally, unlike the older plastic models, when all-metal models fail, they do so suddenly and catastrophically.
Migratory metallosis could be a problem as well. The metal fragments move to a vital organ, usually the liver or kidney. These metal filing then cause cancer or another serious chronic illness.
Exactech hoped its polyurethane-on-metal implants would be the best of both worlds, with the reliability of plastic and the durability of metal. Once again, in a laboratory, that might have been true.
There’s a difference between a laboratory and the real world. In the 1990s, researchers first identified an oxidation problem. Improper storage causes the polyurethane to oxidize. This process thins the polyurethane, making it more vulnerable to accelerated wear by delamination because of concentrated subsurface stress and fatigue wear.
Legal Options for Victims of Defective Prosthetics
Legally, device manufacturers have a duty to warn customers about known risks. These warnings must clearly appear on product labels. Additionally, these warnings cannot be in Medspeak. They must be in a language the customer understands. If the company negligently failed to include a proper warning, it could be liable for damages.
Negligence cases have a number of moving parts. Primarily, for this reason, a New York personal injury attorney often looks at alternative theories, such as a manufacturing defect, to obtain maximum compensation.
Issues with polyurethane-on-metal implants are tailor-made for manufacturing defect claims. Legally, device makers are responsible for product safety up to the moment the gadget appears on a retailer’s shelf. This responsibility includes adequate storage, not only in a warehouse but also in a semi-truck or whatever delivery vehicle the manufacturer uses.
As mentioned, negligence cases have a number of possible defenses. A defective prosthetics product case usually only has one effective defense, the unforeseeable misuse doctrine, and this defense rarely applies. Basically, the manufacturer must prove the victim misused the device in an unforeseeable way, such as attempting an Evel Knievel-like stunt on an artificial hip.
Other defective product claims hinge on design defects. Arguably, Exactech’s implants had a design defect as well. The polyurethane wasn’t strong enough to take everyday wear and tear, especially if the person was active.
Due to the nature of these cases, defective product claims often include compensatory and punitive damages.
When hip, knee, and other implants fail, the victims usually need expensive revision surgery. Even then, they often lose whatever mobility they had prior to the surgery and they must still deal with chronic pain. Compensation is available for these economic and noneconomic losses. Victims need money to pay medical bills and other injury-related expenses. Additionally, no one should suffer because of someone else’s negligence or misconduct.
As for punitive damages, companies usually know about safety or other device issues, but they don’t address these issues. If a New York personal injury lawyer presents clear and convincing evidence that the company intentionally disregarded a known risk, jurors may award punitive damages. A damage cap may apply in some situations.
Medical device failure victims are entitled to substantial compensation. For a free consultation with an experienced personal injury attorney in New York, contact Napoli Shkolnik PLLC. Attorneys can connect victims with doctors, even if they have no insurance or money.