Court Opinion

ID: 4226340
Source: CourtListenerOpinion
Date Created: 2017-12-06 21:00:37.013682+00
Date Added: 2024-06-11T14:42:44.417442
License: Public Domain

NOT FOR PUBLICATION

                    UNITED STATES COURT OF APPEALS
                                                                            FILED
                            FOR THE NINTH CIRCUIT
                                                                            DEC 06 2017
                                                                         MOLLY C. DWYER, CLERK
                                                                          U.S. COURT OF APPEALS
In re: INCRETIN-BASED THERAPIES                  No.   15-56997
PRODUCTS LIABILITY LITIGATION,
______________________________                   D.C. No.
                                                 3:13-md-02452-AJB-MDD
JEAN ADAMS, On Behalf of Herself and
All Other Similarly Situated Plaintiffs,
                                                 MEMORANDUM*
              Plaintiff-Appellant,

 v.

MERCK SHARP & DOHME CORP.,
FKA Merck & Co. Inc.; et al.,

              Defendants-Appellees.

                   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

                                            2
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

      1
        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 (9th
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.
                                           3
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

                                           4
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

                                          5
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

      2
         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.
                                           6
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’

                                           7
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.

                                           8
      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.

                                          9