We begin with the news that the Drug and Device Law Rock Climber has a new puppy.   He is six months old and already over 60 pounds – a rescued Australian Shepherd mix.  He is also white with blue eyes, a color pattern linked to deafness in dogs and cats.  And he is totally deaf, which the Climber knew before she adopted him.   (She prepared with impressive research on teaching dogs hand signals)  We kept him for a couple of days last week, and we can report that he is beautiful and sweet and cuddly.   He is also huge, bursting with energy, and bent on puppy-esque destruction.  And totally deaf.  So when he began shredding our new area rug, our usual sophisticated discipline technique – screaming bloody murder – had about as much success as you might imagine.

In contrast, the relators in today’s qui tam False Claims Act case were perfectly capable of hearing courts’ repeated admonitions.  But they chose to ignore them, and they (deservedly) paid with their case.   But we get ahead of ourselves.

In United States ex. rel Nargol and Langton v. Depuy Othopaedics, 2021 U.S. Dist. LEXIS 234782 (D. Mass. Nov. 10, 2021), the relators alleged that the defendant illegally promoted and sold hip implant devices “that fell outside FDA-approved manufacturing specifications, causing false claims to be submitted to Medicare and Medicaid.”  Nargol and Langton, 2021 U.S. Dist. LEXIS 234782 at *1.  The unsavory origin of this case has its roots in two hip implant MDLs in which both relators, who immodestly describe themselves as “two of the most prominent experts in [metal-on-metal hip implant] surgical technique and engineering technology,” worked with the plaintiffs.  One was a testifying expert, the other, while “not formally retained, . . . consulted with plaintiffs’ counsel and experts, received remuneration for his time and efforts, and had access to materials that would not . . . have been available to someone who was not associated with the litigation.”  Id. at *3-5.

Beginning in 2012, plaintiffs’ counsel in those MDLs provided both would-be relators with confidential documents that were produced by the MDL (and current) defendant and subject to a protective order.  The relators hired a consulting company to perform a statistical analysis of measurements of explanted hip devices.  Relying on that analysis, the relators filed their FCA complaint in May 2012.   Two years later, the relators belatedly disclosed to the court that the complaint included confidential information subject to the MDLs’ protective orders.   The judge granted the relators leave to amend to remove the confidential material and required both relators to execute affidavits swearing, on penalty of perjury, that the amended complaint did not violated the MDL protective orders.

In 2015, admitting that they had provided confidential documents to states and to the U.S. government between 2012 and 2014, the relators asked the judge presiding over one of the MDLs to relieve them of the obligation to comply with that MDL’s protective order.  The judge refused, instead emphasizing:

 Allowing modification of the Confidentiality Order rewards the [relators] for using confidential information which would not have been available to them absent their special employment.  If the Court agreed with the [relators’] request, these retained experts would be free to use the knowledge they obtain during this litigation for their own benefit.  This result is unacceptable.

Id. at *8 (internal punctuation and citation omitted).

In March 2021, the defendant moved to dismiss the amended complaint, arguing that the relators had violated both MDLs’ protective orders and two judges’ orders by once again including confidential MDL information in their FCA Complaint through the consulting company’s analysis.  The defendant argued that the relators had supplied the consulting company with measurements of explanted components rounded to five decimal places, and that that data existed only in confidential documents the defendant had produced.

In opposition, the relators claimed that they were able to convert publicly-available data to arrive at their calculations and described the ostensible steps in the conversion.  Then, in a later filing, they recited an entirely different account of how they arrived at their measurement data.  Finally, they equivocated about their method in an affidavit.  However, the court denied dismissal, stating that the defendant had “failed to establish that any information in the [Complaint] that previously may have been restricted was not in the public domain” at the time the Complaint was filed.  Id. at *27-28.

The defendant moved for reconsideration, arguing that the court had committed an error of law by shifting the burden of proof onto the defendant, and that the relators were unable to point to any public source of the measurement data.  The court ordered the defendant to provide the documents it alleged to be proprietary and that contained the data, rounded to five decimal places, contained in the consultant’s report.  It ordered the relators to explain how they were able to calculate the data, rounded to five decimal places, from public sources.

And the relators had no satisfactory explanation.  The court stated, “Because relators have provided limited details to fill out the narrative, the court must supply details on its own, including through the use of adverse inferences.  Relators are unable to prove that the Head measurements are public.  In addition, their attempts to back into the measurements through mathematical contortions . . . lack credibility . . . .” Moreover, while the relators refused to disclose what documents the plaintiffs’ counsel had provided to them, they provided the consulting company with “precise measurements for the [device head]” within days of receiving those documents.  Id. at *32.  The court concluded:

The court therefore draws the adverse inference that one of the materials [the relators] received from plaintiffs’ counsel in the . . . MDL in November 2013 was a [device head] drawing.   In addition, the court draws the adverse inference that relators took the [head] diameter and tolerance levels from this drawing to determine the [data] that they then provided to [the consultant].  This information was confidential and subject to a protective order that [the relators] signed before receiving it, and it remains confidential today.   As a result, inclusion of allegation derived from that information in the . . . complaint was in violation of the . . . MDL protective order, [an earlier judge’s] order, and this court’s order.

The court struck the allegations related to the device head from the complaint.  But it went further.  The defendant asked the court to dismiss the entire complaint pursuant to Fed. R. Civ. P. 41(b), which allows a defendant to move for dismissal if a plaintiff fails to comply with a court order.  The court stated:

By including allegations which rely on confidential information in their . . . complaint, relators violated the protective order in the . . . MDL and two court orders in this case. . . . Not only have relators violated those orders, they have done so repeatedly over the course of this nearly decade-long litigation, evidencing a pattern of disregarding orders from this and other courts.  Repeated attempts by this court and others to hold relators to their obligations have proven futile, making dismissal the most important sanction, particularly when the court cannot trust that the remaining allegations of the . . . complaint are untainted.

Id. at *36.  The court concluded, “. . . [D]ismissal is necessary and appropriate in this case because relators’ misconduct has been willful, extreme, and extended, and because the court cannot discern an appropriate alternative sanction.”  Id. at *40 (internal punctuation and citation omitted).

A correct result, obviously, and we shudder at the implications a contrary decision would have carried, permitting unscrupulous plaintiff-side MDL experts to disseminate protected information, with impunity, for their own gain.   We are delighted at the demise of this distasteful narrative, and we hope it will serve as a cautionary tale.

We wish all of you a holiday season filled with health, peace of mind, and happiness.  Stay safe out there.