Smith & Nephew Inc. is asking a Maryland federal court to throw out claims from patients who received its hip implant devices before October 2009, saying none of them have alleged the company had information about potential defects that would have affected their use before then.
The company argued for the removal of 307 plaintiffs from the multidistrict litigation consolidated in Maryland, saying their claims fail because they predate when the company should have allegedly been on notice of any defects.
The MDL comprises hundreds of suits from patients who say they were implanted with the company’s Birmingham Hip Resurfacing, or BHR, implants and suffered injuries related to them breaking down and metal entering their bloodstreams.
While failure-to-warn claims regarding the physicians and patients have already been dismissed from the MDL, Smith & Nephew said the only remaining theory for failure-to-warn claims is that it failed to warn the U.S. Food and Drug Administration about the alleged defects.
The plaintiffs in the MDL point to ad hoc reports in foreign registries, which found higher rates of revision or replacement for female patients and patients with smaller femoral heads, as putting Smith & Nephew on notice of the alleged defects, but the company argued it only received that information starting in October 2009.
As a result, any claims from those who were implanted with the devices prior to that date can’t stand, as the plaintiffs haven’t shown any evidence the company knew of a defect or failed to report it to the FDA, or that any such reporting would have changed their doctors’ decisions to use the implants.
Other communications from earlier, such as a “Dear Doctor” letter in May of that year, accurately reflected the information the company had at the time, and thus can’t support a claim it was hiding information from its customers or the FDA.
The company argued other claims, such as the breach of warranty and negligent misrepresentation claims, are preempted, and the punitive damages claims should be thrown out because of the other claims’ failure, and also because there’s no evidence the company acted intentionally, maliciously or recklessly in making and marketing the devices.
In August, Smith & Nephew avoided damages in a bellwether trial in the MDL, with the jury finding the plaintiff was not entitled to a payout despite finding the company had made negligent misrepresentations about the device.