Expert Witnesses Cannot Use Discovery Information to Launch Own Qui Tam Action; United States District Court for the District of Massachusetts No. 12-10896-MPK, U.S. ex rel. Dr. Antoni Nargol & Dr. David Langton v. DePuy Orthopaedics Inc., et al.
The district court affirmed another court’s confidentiality order precluding the relators from using any information they gained as expert witnesses in prior litigation to support their qui tam action. The relators had previously served as expert witnesses in numerous personal injury lawsuits against the defendants and asserted that the information they learned in that capacity suggested the defendants had misled the FDA into approving a medical device and thereby violated the FCA. However, the relators were bound by a confidentiality order preventing them from using any information provided by the defendants during discovery in those cases, and were required to remove any reference to this information in their second amended complaint. The relators argued that the defendants voluntarily provided the documents during discovery and tacitly approved their use in this case, but the court disagreed, finding no overt permission from the defendants.
Relators Dr. Antoni Nargol and Dr. Robert Langton brought a qui tam action against DePuy Orthopaedics Inc., DePuy Inc., and Johnson & Johnson Services Inc., alleging healthcare fraud in connection to the defendants’ manufacture of various metal-on-metal hip replacement devices.
The relators’ second amended complaint alleged that, over a five-year period, DePuy illegally promoted and sold a significant number of MoM devices that fell outside FDA-approved manufacturing specifications, causing false claims to be submitted to Medicare and Medicaid.
At issue in these proceedings was the role the relators played as expert witnesses during litigation against DePuy involving a similar hip replacement device. Previously, a confidentiality order was approved to govern the relators’ use of information they learned from DePuy while providing their expert testimony.
The relators moved for clarification of the protective order and for additional discovery. They also moved to an order permitting the production and disclosure of confidential information to potential co-counsel. The defendants moved to strike portions of the amended complaint and to dismiss the case. The defendants also moved for a determination of the relators’ claims of privilege and to compel discovery.
In their complaint, the relators described themselves as two of the most prominent experts in MoM surgical technique and engineering technology, and noted their frequent use of DePuy’s devices. According to the relators, in 2007, they discovered significantly greater metal ion concentrations in the bloodstream of patients who had used DePuy devices, in comparison to patients who had used competitors’ devices. By 2010, DePuy was subject to some 10,000 personal injury and product liability lawsuits in relation to these devices.
The relators served as expert witnesses or provided other expert assistance in many of these cases. In this regard, the relators obtained information about DePuy subject to other courts’ protective or confidentiality orders, including one that expressly prohibited the relators from sharing or using the information they received in their capacities as expert witnesses in this qui tam litigation and from sharing the information with any government entities.
The information the relators learned during their time as expert witnesses formed the basis of their FCA lawsuit. During their preparation for their expert testimony, the relators combined their own personal knowledge with the information they learned from the confidential DePuy documents and concluded that DePuy had violated the FCA. The information they learned directly from DePuy was incorporated into their first complaint, but removed after a previous judge concluded the complaint was tainted by the information subject to the confidentiality order.
After the relators filed their second amended complaint, DePuy successfully moved to dismiss, but the First Circuit vacated a portion of the decision, returning some of the claims to district court.
The relators’ remaining claims alleged that DePuy provided devices that, due to latent manufacturing defects, materially deviated from the design specification of the FDA-approved device. To obtain an accelerated premarket approval, DePuy had attested that its device was substantially equivalent to an FDA-approved device.
The defendants did provide the relators with all the discovery it produced in prior litigations, including information subject to confidentiality orders the relators received as expert witnesses. The government also received this information from the relators for their investigation. The relators argued the production of the materials during discovery amounted to DePuy’s permission to use the information, and the defendants disagreed.
According to DePuy, the relators provided confidential information to a consultant they hired to perform various statistical analyses relating to the troubled implants. In response, the relators argued they had not used any confidential information to plead or otherwise prosecute the complaint. However, according to DePuy, the relators admitted providing confidential information to their consultant, and therefore the results of that analysis were irrevocably tainted and must be stricken. Further, the defendant argued that without the analysis, the SCA no longer contained any assertions concerning the rate of DePuy’s alleged noncompliance with manufacturing specifications, and therefore the case must be dismissed.
The defendants also argued the relators failed to respond to numerous discovery requests regarding their relationship with the consultant and the protocols, steps, and processes used to measure and analyze the MoM devices. DePuy argued this information was necessary to determine whether the relators violated the confidentiality order; to determine whether relator Langton’s data can be validated; and to vet the statistical analyses.
The court held that the confidentiality order remained binding on the relators. The relators asked the court to conclude that DePuy’s agreement to produce the documents in discovery amounted to the defendants’ permission to use the information during litigation. The court disagreed, finding the previous court order clear on the prohibition on the use of any information gleaned from the relators’ access to DePuy as expert witnesses. The court also found that numerous communications from DePuy made it clear the defendants never intended to allow the relators to use this information in the present litigation. The court found no case law to support the relators’ argument that DePuy’s production of the discovery constituted permission to use the discovery going forward.
Though the court found little First Circuit case law evaluating whether the court could modify another court’s order, the court found that equity demanded the order remain binding. According to the court, allowing the relators to use this confidential information would create distrust between parties exchanging confidential information in future, similar litigation. The court found it likely defendants would hesitate before sharing any confidential discovery materials if the plaintiffs’ experts could then use their positions of trust to launch additional litigation.
The court also held the defendants were entitled to receive back from the relators any discovery materials covered by the confidentiality order. The relators argued that it was a double standard to prohibit them from using the documents they received in their capacity as expert witnesses, while simultaneously requiring them to produce that very information for the defendants’ use, but the court was not persuaded. The court also permitted DePuy to depose the relators’ consultant for the limited purpose of determining what information was produced and when. The court noted that the confidentiality order did not create any boundary on the relators’ obligation to produce responsive documents and reasoned that it would be nonsensical to withhold DePuy’s own information from the defendants. Rather, knowing which confidential documents were provided to the consultant—if any—would enable the defendants to determine if the relators violated the order.
