Jean Adams v. Merck Sharp & Dohme Corp. ( 2017 )

  •                            NOT FOR PUBLICATION
                        UNITED STATES COURT OF APPEALS
                                FOR THE NINTH CIRCUIT
                                                                                DEC 06 2017
                                                                             MOLLY C. DWYER, CLERK
                                                                              U.S. COURT OF APPEALS
    In re: INCRETIN-BASED THERAPIES                  No.   15-56997
    ______________________________                   D.C. No.
    JEAN ADAMS, On Behalf of Herself and
    All Other Similarly Situated Plaintiffs,
    FKA Merck & Co. Inc.; et al.,
                       Appeal from the United States District Court
                          for the Southern District of California
                       Anthony J. Battaglia, District Judge, Presiding
                          Argued and Submitted October 3, 2017
                                  Pasadena, California
    Before: GRABER, MURGUIA, and CHRISTEN, Circuit Judges.
                 This disposition is not appropriate for publication and is not precedent
    except as provided by Ninth Circuit Rule 36-3.
          Plaintiff-Appellant Jean Adams and other plaintiffs in this consolidated,
    multidistrict litigation appeal the district court’s determination that their state-law
    claims were preempted under Wyeth v. Levine, 
    555 U.S. 555
     (2009). We have
    jurisdiction pursuant to 28 U.S.C. § 1291. We do not decide whether the
    defendants met their burden under Levine’s “clear evidence” test because we hold
    the district court misapplied Buckman Co. v. Plaintiffs’ Legal Committee, 
    531 U.S. 341
     (2001), in two ways: first, the district court relied on Buckman to
    impermissibly circumscribe discovery; and second, the district court relied on
    Buckman to deem the plaintiffs’ newly discovered evidence “irrelevant” to the
    court’s preemption analysis at the summary judgment stage. Either of these errors
    would independently warrant reversal.
          1. In Buckman, the plaintiffs were injured by the use of orthopedic bone
    screws in their spines and claimed that the defendant, a consulting company that
    assisted the screws’ manufacturer to secure regulatory approval, made fraudulent
    representations to the Food and Drug Administration (FDA). Id. at 343. The
    Supreme Court held the plaintiffs’ state-law claims were impliedly preempted by
    federal law.1 Id. at 348. The Court ruled that the plaintiffs’ state-law “fraud-on-
    the-FDA” claims “inevitably conflict[ed] with the FDA’s responsibility to police
    fraud consistently with the Administration’s judgment and objectives,” id. at 350,
    and reasoned, “were plaintiffs to maintain their fraud-on-the-agency claims . . . ,
    they would not be relying on traditional state tort law which had predated the
    federal enactments” in question, id. at 353; “[o]n the contrary, the existence of
    these federal enactments is a critical element in their case.” Id.
          Conversely, in Stengel v. Medtronic Inc., we held the plaintiffs’ state-law
    failure-to-warn claim was not preempted. 
    704 F.3d 1224
    , 1233 (9th Cir. 2013) (en
    banc), cert. denied, 
    134 S. Ct. 2839
     (2014). We explained that because the
    plaintiffs’ claim “rest[ed] on a state-law duty that parallel[ed] a federal-law duty”
    and was “independent of the FDA’s pre-market approval process that was at issue
    in Buckman,” Buckman did not control and the plaintiffs’ claims were not
            The federal law at issue in Buckman, Stengel v. Medtronic Inc., 
    704 F.3d 1224
     (9th Cir. 2013) (en banc), and McClellan v. I-Flow Corp., 
    776 F.3d 1035
    Cir. 2015), was the Medical Device Amendments to the Food, Drug, and Cosmetic
    Act (FDCA). We have previously suggested that the reasoning and policy of these
    decisions also applies to drugs. See Gaeta v. Perrigo Pharm. Co., 
    630 F.3d 1225
    1234 (9th Cir. 2011) (distinguishing Buckman but giving no indication that
    Buckman’s rule was inapplicable to preemption with respect to drug claims),
    vacated on other grounds, 
    565 U.S. 973
     (2011). We therefore assume without
    deciding that Buckman would also preempt state-law fraud-on-the-FDA claims
    concerning drugs.
    preempted. Id.; see also McClellan v. I-Flow Corp., 
    776 F.3d 1035
    , 1040–41 (9th
    Cir. 2015) (holding the plaintiff’s state-law failure-to-warn claims against the
    manufacturer of an infusion pump were not fraud-on-the-FDA claims preempted
    under Buckman because the claims “did not arise solely by virtue of” federal law,
    and because there was “no suggestion that Congress intended to displace
    traditional tort law by making all policing of medical labels and warnings the
    exclusive province of the FDA”).
          2. Here, the district court first relied on Buckman to circumscribe discovery.
    Though it acknowledged that “this is not a case like Buckman that is predicated
    upon a fraud-on-the-FDA basis,” the district court perceived that the plaintiffs
    “invoke[d] allegations of misreporting and under-reporting as a justification for
    additional discovery, and as pertinent to a preemption defense.” The court
    concluded that the plaintiffs were asserting “fraud-on-the-FDA type allegations”
    that were preempted by Buckman, and decided that the discovery they sought,
    which included adverse event source documents and databases, was irrelevant to
    whether federal law preempted the plaintiffs’ state-law failure-to-warn claims.
          First, we disagree with the district court’s characterization of the plaintiffs’
    state-law claims as “fraud-on-the FDA type allegations.” The plaintiffs asserted
    common-law failure-to-warn claims arising from a state-law duty that paralleled an
    FDCA-imposed duty, as was the case in Stengel and McClellan, where we found
    the state-law claims not to be preempted. Stengel, 704 F.3d at 1233; see also
    McClellan, 776 F.3d at 1040–41. The discovery the plaintiffs sought was directly
    relevant to whether any causal connection existed between incretin use and
    pancreatic cancer. The plaintiffs did argue that it would not be unduly burdensome
    to produce the data they requested because the defendants were required to collect
    and submit it to the FDA, but the duty the plaintiffs claim the defendants breached
    was the parallel common law duty to warn, not a duty arising from the FDCA. As
    pertinent to the defendants’ preemption affirmative defense, whether it would have
    been possible for the defendants to comply with both their common law duty to
    warn and the federally imposed reporting obligations is a separate issue that cannot
    be resolved without knowing what information was available to the defendants.
    See Levine, 555 U.S. at 573. Neither Buckman’s holding nor what the district court
    termed the “policy underlying Buckman” can be read to preclude discovery of
    evidence relevant to the plaintiffs’ state-law failure-to-warn claims. See Stengel,
    704 F.3d at 1233.
          The district court also ruled the request to compel production of the
    defendants’ adverse event source documents and databases was unduly
    burdensome. The plaintiffs sought the “source files” for each pancreatic cancer
    event known to the defendants. Such files have been produced in pharmaceutical
    litigation of this sort, it is undisputed that the defendants already maintained these
    databases, and here, the volume of the requested data was limited. Defendants
    established only that producing the files to the plaintiffs would require the
    relatively modest task of redacting identifying information of patients and
    reporters.2 The cost estimate provided to the district court included the cost of
    producing the source files of both pancreatic cancer and pancreatitis. This figure
    therefore overestimated the cost required to produce the pancreatic cancer files
    alone. Thus, the defendants failed to show that complying with the plaintiffs’
    discovery request would be unduly burdensome, and it was an abuse of discretion
    to deny the plaintiffs’ motion to compel production for this reason. We reverse the
    district court’s discovery orders that were premised on its misapplication of
    Buckman, specifically: (1) the denial of the plaintiffs’ motion to compel production
    of adverse event source documents and databases; and (2) the denial of the
    plaintiffs’ motion to compel production of the defendants’ foreign regulatory files.
          3. The district court also relied on Buckman to preclude its consideration of
    “new safety information” the plaintiffs uncovered in the discovery they were
             The number of pancreatic cancer adverse events (and the corresponding
    number of source files the defendants would need to produce) appears to be
    relatively low according to the FDA’s adverse event database.
    allowed to conduct, including a signal assessment completed by Health Canada and
    evidence from animal studies and clinical trials. The defendants argue the district
    court considered and rejected the plaintiffs’ “new safety information” as non-
    material. In its summary judgment order, the district court enumerated the “new
    safety information” that the plaintiffs proffered, but also unambiguously stated that
    it “maintain[ed] its position as set forth in previous orders regarding the relevance
    of this data to the Court’s conflict preemption analysis,” reiterated its view that
    “Buckman [was] implicated by Plaintiffs’ defense to the clear evidence standard,”
    and concluded that the “new safety information” did not constitute “persuasive or
    appropriate considerations in analyzing the clear evidence standard” (emphasis
    added). These statements strongly suggest that the court deemed the new safety
    information irrelevant at the summary judgment stage. Further, in its discussion of
    the materiality of the “new safety information,” the district court stated, “it remains
    unclear whether the FDA considered this information, and if it did not, whether
    this data would have altered the FDA’s conclusion” (emphasis added).
    Uncertainty about whether the FDA considered the “new safety information” and
    whether it would have altered the FDA’s conclusion establishes that a disputed
    issue of material fact should have prevented entry of summary judgment on the
    defendants’ preemption claim. As the district court correctly noted, the parties’
    experts disputed whether the “new safety information” would have been material
    to the FDA’s analysis.
          4. Finally, we hold the district court abused its discretion by partially
    disqualifying the plaintiffs’ regulatory expert. The district court’s order correctly
    observed that Dr. Fleming’s exposure to confidential information could not be
    “entirely documented” by discoverable information such as meeting minutes, but
    failed to account for the fact that this was the only evidence the defendants offered
    to show they had disclosed to Dr. Fleming information relevant to the current
    litigation. The defendants did not submit testimony or a declaration of anyone at
    Novo Nordisk who could attest to whether or how any information provided to Dr.
    Fleming was relevant to the current litigation, and Dr. Fleming averred that in
    reaching his opinions and preparing his report for this litigation, he did not rely on
    any information, confidential or otherwise, that he obtained from his consulting
    relationship with Novo. Without more, the defendants did not meet their burden of
    showing “specific and unambiguous” disclosures required to trigger
    disqualification, Hewlett-Packard Co. v. EMC Corp., 
    330 F. Supp. 2d 1087
    , 1094
    (N.D. Cal. 2004) (emphasis added). The district court abused its discretion by
    partially disqualifying Dr. Fleming.
          As an independent ground for disqualifying Dr. Fleming, the district court
    concluded that he was a “competitor” under the court’s protective order. The
    parties stipulated to the terms of the protective order, Dr. Fleming’s involvement
    with Exsulin did not violate its express terms, and the defendants acknowledge that
    the drug being developed by Dr. Fleming’s company was not a prescription
    medication. The district court’s order concluded that “Plaintiffs’ argument
    distinguishing between a manufacturer and a developer presumes a meaningful
    difference in the context of the protective order,” but the record does not show that
    the defendants were required to carry their burden of showing the distinction was
    not meaningful. The district court abused its discretion by partially disqualifying
    Dr. Fleming as a “competitor” under the stipulated terms of the protective order.
          VACATED and REMANDED.