In an Oct. 16 ruling, Judge Steven Rau lambasted the company for using “shenanigans” in slow-rolling the discovery process. The lawsuit accuses Boston Scientific of defrauding the FDA by not reporting alleged defects in its Cognis cardiac resynchronization therapy defibrillator and Teligen implantable cardioverter defibrillator, which caused insecure connections between the leads and headers they attached to.
Boston was made aware of the issue after launching the devices in Europe, and upon U.S. launch it allegedly engaged in a strategy of minimizing medical device reports to the FDA covering the defects. When the company released revised versions of the devices, it called the revisions modifications and not corrections, according to the complaint. Boston Scientific then issued a recall for the original devices in mid-2009.
The whistleblower, Dr. Steven Higgins, amended the complaint after it was dismissed in September 2017 and the discovery process began in the spring of 2018. It soon went awry and after a year’s worth of back-and-forth, the parties were still arguing about it, according to court documents.
At issue is which Boston employee was aware of communications with the FDA over the Cognis and Teligen devices. The company initially indicated that one employee was to be deposed as part of discovery for their knowledge of the communications, but after that employee said in a deposition that they were not involved with the FDA, Boston named a second employee as having that knowledge. The company argued that Higgins should have known that the second employee had knowledge relevant to the case from the roughly 400 out of 30,000 documents in discovery that mentioned them.
In his Oct. 16 ruling, Rau wrote that that the lengthy qui tam whistleblower process would have made Boston well aware that the second employee should have been included early in the discovery process. The judge accused Boston of hiding its intention to use the second employee as a witness until the final moments of discovery. Rau ordered Boston to “provide all the discovery it withheld in its shell game with the identities of its newly-disclosed witnesses” within 14 days of the ruling.
He also barred Boston from “using any documents or testimony to support its defenses or refute relator’s claims at any future proceeding in this matter, including summary judgment and trial, if it cannot affirmatively show that said documents or testimony was produced to relator in the normal course of discovery or in response to this order,” he wrote, ordering the company to cover the Higgins’ costs for the motion on sanctions and any discovery costs that follow from it.
On Wednesday, Boston filed an objection to Rau’s order, saying it did not deliberately withhold any witness names and blamed Higgins’ “incredibly condensed deposition schedule” for its adding the witness at the close of discovery. The witnesses were “no secret,” Boston contended, calling Rau’s accusation of foot-dragging “unsupported, speculative and contrary, in material respects, to what the record provides.”
Boston said the monetary sanctions Rau imposed were punitive, and that the judge had damaged the company’s reputation. “The sanctions award should be reversed and the comments critical of BSC and its counsel stricken,” the company added.
Boston also said that Higgins’ “delays in resolving open issues and his back-loading of discovery, including depositions,” were to blame for all the discovery difficulties. In his Oct. 16 order, Rau also took Higgins to task for backloading discovery.
“But relator was essentially fighting with a blindfold on because of Boston Scientific’s discovery actions,” Rau wrote. “The bully and the victim should not be punished equally when the arbiter is called in.”
Boston has asked for a hearing on its objections to Rau’s order.