CVN screenshot of plaintiff attorney Thomas Fraysse (left) and defense attorney Richard Carroll (right) delivering their opening statements
Riverside, CA - The first trial among hundreds of lawsuits stemming from the alleged use of counterfeit spinal implants began Wednesday in California state court, and the proceedings are being webcast gavel-to-gavel by Courtroom View Network.
An attorney for plaintiff Derika Moses accused Riverside Community Hospital of “gross negligence” in allowing doctors to use supposedly imitation metal screws in her spinal fusion surgery, but an attorney for the hospital argued the FDA never determined the screws were counterfeit, and that Moses fully consented to the procedure.
The trial is being closely watched, due to being the first civil case to go before a jury among the many lawsuits initially paused in the wake of a sprawling federal criminal investigation of the alleged use of counterfeit spinal implants in a number of California hospitals.
The full trial, expected to take a number of weeks to complete, is being webcast gavel-to-gavel by CVN.
During his opening statement, plaintiff attorney Thomas Fraysse of Knox Ricksen LLP repeatedly told jurors that Derika Moses had “counterfeit hardware” implanted in her spine following an on-the-job injury, and that administrators at Riverside Community Hospital knew doctors were using supposedly non-FDA approved devices in violation of hospital policies.
“They knew the material they were putting into Derika Moses back was not approved as safe and effective by the FDA,” Fraysse said.
He explained to jurors how the provider of the spinal screws in question, Spinal Solutions LLC, was cut off by their supplier U&I Corporation following a legal dispute. Fraysse told the jury Spinal Solutions responded by obtaining screws from a small private manufacturer who allegedly fraudulently labeled the devices with fake U&I branding, characterizing the screws a “crude copies of a genuine product.”
Neither company is a defendant in the current trial, which only involves Riverside Community Hospital.
Fraysse said Moses had to have the implants removed five years after her initial surgery, and that her adverse reaction to the implants rendered her “totally disabled” and requiring a “boatload” of medication. He did not ask for a specific amount of damages in his opening, but his use of the term “gross negligence” suggests the possibility of both compensatory and punitive awards.
Attorney Richard Carroll of Carroll Kelly Trotter & Franzen representing Riverside Community Hospital, argued that hospital staff upheld “their end of the bargain” and should not be held responsible for the actions of surgeons that he characterized as independent contractors.
In addition to telling jurors that the hospital did its due diligence in obtaining Moses’ fully informed consent for the surgery, he repeatedly took issue with the claim the screws in question were not approved by the FDA, suggesting that “off label” use for drugs and medical devices is both a common and legally acceptable practice.
He also pushed back against claims the hospital failed to perform an investigation into the alleged use of counterfeit materials, arguing that the hospital properly relied on an outside investigation by the FDA that Carroll said did not raise any red flags that could serve as the basis for halting operations like the one Moses underwent.
“They didn’t issue a recall, and they didn’t issue a safety alert,” Carroll said. “That was good enough for Riverside Community Hospital.”
The full trial, taking place before Riverside Superior Court Judge Harold Hopp, is expected to take weeks to complete and will feature extensive fact and expert witness testimony. CVN’s gavel-to-gavel coverage, available both live and on-demand, will continue for the duration of the proceedings.
The case is captioned Derika Moses v. Healthsmart Pacific Inc., case number CVSW1400002 in Riverside County Superior Court.
E-mail David Siegel at dsiegel@cvn.com