A federal judge in Minnesota this week lambasted Boston Scientific (NYSE:BSX) “shenanigans” in slow-rolling the discovery process in a whistleblower lawsuit lodged over two of its cardiac rhythm management devices, imposing sanctions for the conduct.
The lawsuit accused 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 US launch it 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 began to go awry and after a year’s worth of back-and-forth the parties were still arguing about it, according to court documents. In an Oct. 16 ruling, Judge Steven Rau leveled sanctions against Boston Scientific and expressed his displeasure with the other side’s conduct as well.
“This case is what happens when you cross an approach to discovery à la Inspector Clouseau with a corporate lawyer caricature found in cartoon caption contests,” Rau wrote. “Not even the one-eyed man would be king over this disaster.
“While both parties share the blame as to certain discovery woes, defendant Boston Scientific’s discovery actions throughout this case have tiptoed the line of permissible, albeit discouraged, behavior. Now, with the discovery end in sight, Boston Scientific has crossed the line into sanctionable conduct. It must be awarded its just deserts [sic] for these efforts,” he wrote.
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.
Rau was having none of it, writing 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 court is convinced that Boston Scientific intended to use [the second employee] as a witness and hid that information until the final moments of discovery,” Rau wrote. “Boston Scientific cannot go through an entire government investigation and the entire discovery period with the qui tam relator then feign ignorance as to which witnesses and what documents are important to the claims that have been considered the whole time. Such a conclusion is absurd, and Boston Scientific knows it.”
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 Oct. 16 ruling.
“The court will not countenance further shenanigans from Boston Scientific. Therefore, Boston Scientific is barred 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.
“Throughout this case, Boston Scientific has displayed a profound lack of deference to the court and the rules of procedure. Despite the court’s regular attempts to guide the parties through discovery, Boston Scientific has exhibited a lack of professionalism and courtesy. Boston Scientific must pay the cost of the unadvisable strategy which lead to the discovery violations discussed herein,” Rau wrote.
Higgins did not escape his displeasure, either.
“To be fair, the court is unhappy with relator’s conduct through discovery. While the prospect of endless motion practice is not appealing to the court or the parties, this case begged for early motions to reign in Boston Scientific’s lethargic discovery compliance,” Rau wrote. ” Relator should have been more diligent in calling out Boston Scientific’s absurdity. But even more so, relator should not have backloaded discovery in the manner he did, particularly given the volume of documents that were likely to be at issue in a qui tam case aimed at a heavily regulated medical device manufacturer. But relator was essentially fighting with a blindfold on because of Boston Scientific’s discovery actions. The bully and the victim should not be punished equally when the arbiter is called in.”
