A federal circuit court has rejected attempts by Pennsylvania medical device makers to unseal records that were part of a grand jury investigation that resulted in officials from those companies pleading guilty to unlawful off-label marketing.
The device maker Synthes and its subsidiary Norian Corp. had sought the documents in an effort to impeach the testimony of a witness expected to testify in two wrongful death civil lawsuits that are ongoing in California.
A unanimous three-judge panel of the U.S. Court of Appeals for the Third Circuit ruled Sept. 8 that, along with possibly revealing the “essence of what [took] place in the grand jury room,” the device makers’ argument that the materials could undermine a witness’ credibility did not outweigh the importance of keeping the investigative proceedings confidential.
“The interest in secrecy in this case remains high. Synthes is hoping to use grand jury materials to undermine the credibility of Dr. [Paul] Nottingham, a key witness during the grand jury proceedings, and to impliedly shift blame for the death of his patient to him, away from Synthes,” Judge Julio Fuentes, who wrote the court’s nonprecedential opinion, said. “This is precisely the kind of ‘future retribution’ that could chill the candor of future grand jury witnesses.”
Neither James Smith of Blank Rome, who represented Synthes, nor assistant U.S. attorney Mary Crawley returned calls seeking comment.
According to Fuentes, Synthes manufactured and marketed bone cement products beginning in the late 1990s. The U.S. Food and Drug Administration approved of the devices being used as general bone filler, but expressly did not approve them to be used in spines, Fuentes said, adding that the FDA further required a warning label saying the cement should not be used in spines.
However, “despite this clear directive from the FDA,” Synthes marketed the bone cement for use in spinal procedures, Fuentes said.
According to Fuentes, the off-label use led to several patient deaths and spurred a criminal investigation, which in 2009 came before a grand jury.
After the grand jury proceedings, the government charged Synthes and the company’s executives with conspiracy to defraud the federal government, and charged Synthes with criminal violations of the Food, Drug and Cosmetic Act, Fuentes said. The defendants pleaded guilty to the charges, Fuentes said, and, according to media reports, the executives received prison time.
In 2014, estates of two people who died during spinal surgeries that involved using Synthes’ bone cement filed a wrongful death suit in California state court against Synthes and several executives, Fuentes said. His opinion did not include the names of these plaintiffs, or the venue in California where their cases were filed.
According to Fuentes, during discovery, Dr. Paul Nottingham, a physician who treated one of the plaintiffs, testified that he remembered being told by a Synthes sales representative and a company executive that the bone cement had been approved for use in vertebroplasties.
Synthes then petitioned the federal court in Pennsylvania to unseal documents they claimed would undermine Nottingham’s testimony.
Fuentes, however, determined that the U.S. district court did not abuse its discretion when it denied the company’s efforts, and further said there were other possible avenues the company could use to possibly uncover testimony counter to Nottingham’s.
“Dr. Nottingham testified that he spoke to two people at Synthes about the FDA status of the bone cement,” Fuentes said. “Surely those individuals may be able to shine some light on what occurred.”