A Jacksonville, Florida man has filed a lawsuit against medical device provider, Tracpatch Health Inc. The lawsuit was filed by Robert C. Hovey in the Middle District of Florida.
According to Hovey, Tracpatch Health Inc. knowingly marketed a hip replacement system known as the Consensus Hip System despite it being defective and dangerous to patients who opted for this device.
In the lawsuit, Hovey blames Tracpatch Health Inc. for marketing the Consensus Hip System as being well-designed, effective, and having certain advantages over other hip replacement products on the market. Instead, Hovey details that “the Consensus Hip System was defective and unreasonably dangerous because it is unreasonably prone to cause fretting and/or corrosion.”
In search of a hip replacement system for his damaged natural hip, Hovey opted for the Consensus Hip System because of what it touted it could provide. However, after undergoing surgery and receiving his new artificial hip system, Hovey explains that he began to experience fretting and corrosion of the device which ultimately led to heavy metal poisoning. As a result of his experience and the corrosion process, Hovey no longer had a skeletal connection between his leg and his torso. He was left with a medical phenomenon known as catastrophic disassociation.
Hovey details in his lawsuit that he did not know about the lack of premarket testing the Corrosion Hip system should have undergone. According to the lawsuit, the Consensus Hip System was greenlit by the Food and Drug Administration under Section 510(k) of the Food, Drug, and Cosmetic Act. Because of this, the hip system did not have to undergo any clinical studies in order to receive clearance from the FDA. The lawsuit explains that because the product followed this pathway for availability to consumers, the Consensus Hip System was able “to avoid clinical study and any testing for safety or efficacy.”
Hovey contends that had he known about the device’s “poor design and material choices” and that implementing it would “lead to micro-motion, fretting, corrosion and ultimately the total failure of the implant,” he would not have opted for the device.
The complaint relies on several legal theories, including strict liability failure to warn, strict liability design and manufacturing defect, negligence, and breach of warranty. Hovey is seeking damages, litigation fees, a trial by jury, and any other relief that the Jury might deem applicable.
