Attorneys expect a wave of lawsuits following DePuy Synthes’ decision to pull tens of thousands of its elbow implants off the market. Dozens of reports have claimed the DePuy Synthes Radial Head Prosthesis system loosened or dislocated, requiring surgery to repair it.
If you were injured as a result of an elbow replacement, you may be eligible for compensation.
Lawyers have already been hearing from patients who were injured when their DePuy Synthes elbow implants failed prematurely. The U.S. Food and Drug Administration had received dozens of reports of serious problems with the device before the company decided to take it off the market in December 2016.
By then, the elbow replacements had already been implanted in thousands of patients.
Lawsuits over DePuy elbow replacements are still in the early stages. No major trials have taken place and no verdicts or settlements have been announced so far.
However, DePuy Synthes’ market withdrawal of its Radial Head Prosthesis System implants could be an indication of lawsuits to come. Such large recalls often indicate a large number of lawsuits could result as people suffer complications from a faulty or defective device.
People who received a DePuy Synthes Radial Head Prosthesis System and who have suffered these complications have started talking to lawyers about seeking compensation for their injuries.
Lawsuits over the DePuy Synthes elbow replacement will likely involve those complications that led DePuy to pull the devices off the market in the first place. DePuy elbow lawsuits may claim: Loosening, Dislocation, and Revision Surgery.
Between 2014 and the time of the recall in December 2016, the FDA had received more than 40 reports of the DePuy Synthes Radial Head Prosthesis System loosening. Repairing the complication required further surgery.
Lawsuits filed over defective or faulty medical devices usually fall under products liability law. To file a lawsuit, people have to show that the device had a defect and the company didn’t do enough to protect people who received it.
There have been no major verdicts or settlements yet involving the DePuy Synthes Radial Head Prosthesis System elbow replacement. But because so many of the devices were removed from the market, attorneys expect there could be a large number of lawsuits filed over the device.
Lawsuits over elbow implants have been fairly rare overall. Most joint-implant lawsuits have involved hips or knees. Verdicts and settlements in other DePuy joint replacement lawsuits have totaled nearly $6 billion in recent years.
More than 18,000 people filed lawsuits over the two models of DePuy hips involved in these recent lawsuits.
There are currently no class-action lawsuits over the DePuy Radial Head Prosthesis System. Class actions are generally impractical for medical device lawsuits. Instead, individual lawsuits are sometimes combined in a multidistrict litigation (MDL). Both class actions and MDLs allow people to pool resources and move their cases more quickly through the legal process, but there are some important differences.
Some state courts also have their own versions of MDLs, allowing several lawsuits filed in those courts to be combined into a single action.
The FDA’s 510(k) process allows a company to market certain medical devices if they can simply show that the product is “substantially similar” in safety and effectiveness to other devices already on the market.
The DePuy Synthes Radial Head Prosthesis System was approved through the 510(k) process in June 2011. DePuy and Synthes merged that year, but Synthes had developed the elbow implant and shepherded it through the FDA approval process.
Synthes had presented the device as substantially similar to two other elbow implants already on the market. The surface of the device, critical for attaching to the bone and potentially important in the device loosening, was compared in Synthes’ application to 10 other existing medical devices.
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