Court Opinion

ID: 4678704
Source: CourtListenerOpinion
Date Created: 2021-04-20 00:00:41.615539+00
Date Added: 2024-06-11T08:03:46.139608
License: Public Domain

Case: 20-30405     Document: 00515827361         Page: 1     Date Filed: 04/19/2021

           United States Court of Appeals
                for the Fifth Circuit
                                                                          United States Court of Appeals
                                                                                   Fifth Circuit

                                                                                 FILED
                                                                             April 19, 2021
                                  No. 20-30405                              Lyle W. Cayce
                                                                                 Clerk

   In re: Taxotere (Docetaxel) Products Liability
   Litigation
   _________________________________________

   June Phillips,

                                                            Plaintiff—Appellant,

                                      versus

   Sanofi U.S. Services, Incorporated, formerly known as
   Sanofi-Aventis U.S., Incorporated; Sanofi-Aventis,
   U.S., L.L.C.,

                                                         Defendants—Appellees.

                  Appeal from the United States District Court
                     for the Eastern District of Louisiana
                           USDC No. 2:16-CV-15397

   Before King, Smith, and Haynes, Circuit Judges.
   Per Curiam:
         Plaintiff-appellant June Phillips asks us to reverse the district court’s
   grant of summary judgment on her failure-to-warn claim asserted against the
   manufacturers of Taxotere, a chemotherapy medication. Specifically,
   Phillips argues that Taxotere’s manufacturers failed to provide an adequate
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                                    No. 20-30405

   warning of potentially permanent hair loss, which caused her injuries. But,
   on this record, it is beyond any genuine dispute that a warning of the risk of
   permanent hair loss—as opposed to temporary hair loss—would not have
   affected the prescribing physician’s decision to prescribe Taxotere.
   Therefore, under Louisiana law, Phillips cannot establish causation, and her
   failure-to-warn claim against Taxotere’s manufacturers fails as a matter of
   law. We AFFIRM.
                                         I.
   A.     Factual Background
          In August 2013, plaintiff-appellant June Phillips, at the age of seventy-
   five, developed an aggressive form of breast cancer that spread through her
   body. Years before, Phillips had been diagnosed with dyslipidemia, diffuse
   arterial sclerotic plaquing, and paroxysmal atrial tachycardia, all cardiac
   conditions pre-existing her breast cancer diagnosis.
          To help treat her breast cancer, Phillips underwent a surgery on
   October 9, 2013. During that surgery, Phillips’s doctors discovered that her
   cancer had metastasized, or spread, to her lymph nodes. And when tests were
   run on her tissue, her doctors established that her cancer was HER2+, PR+,
   and ER+. Put simply, Phillips’s cancer was aggressive, and presented a high
   risk—about a fifty-percent chance—of recurrence.
          As a follow-up to her surgery, Phillips was referred to an oncologist,
   Dr. Scott Sonnier. On October 28, 2013, Dr. Sonnier reviewed her lab results
   and communicated to Phillips that her cancer had spread and that it was
   aggressive and likely to recur. Dr. Sonnier told Phillips that chemotherapy
   following surgery was the main treatment used to eliminate cancer and would
   improve her chances of “disease-free survival or living without recurrence.”
   Specifically, Dr. Sonnier recommended, and ultimately prescribed,
   “adjuvant TCH in addition to adjuvant hormonal therapy and post

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   lumpectomy radiation therapy.” TCH is a Taxotere-based chemotherapy
   treatment that aims to reduce the risk of cancer recurrence.
           At that time, the warning for Taxotere—a main component of
   TCH—did not include any mention of a risk of permanent alopecia, or
   potentially permanent hair loss. But Dr. Sonnier nevertheless discussed
   TCH’s potential side effect of temporary alopecia, and indicated that
   Phillips’s hair would likely fall out but might grow back with a different
   texture, color, and thickness. Phillips did not ask Dr. Sonnier about
   alternative treatments in light of this risk, and she consented to the treatment
   in November 2013.
   B.      Procedural Background
           Defendants-appellees Sanofi U.S. Services, Inc., and Sanofi-Aventis
   U.S., L.L.C., (collectively, Sanofi) manufacture, sell, distribute, or hold
   regulatory approval for certain prescription chemotherapy medications,
   specifically Taxotere, commonly used to treat breast cancer patients. As we
   mentioned, Taxotere was a main component of the TCH treatment Phillips
   received following her surgery.
           Phillips’s appeal arises out of multidistrict litigation pending in the
   Eastern District of Louisiana (“the MDL”). The MDL—which
   encompasses Phillips’s case 1—was formed when, in October 2016, the
   Judicial Panel on Multidistrict Litigation centralized numerous actions
   involving allegations related to Sanofi’s failure to warn patients that Taxotere

           1
             To be clear, however, Phillips’s case is not part of a class action lawsuit, or a
   single, representative proceeding. Cf. In re Vioxx Prod. Liab. Litig., 650 F. Supp. 2d 549,
   558 (E.D. La. 2009) (“[T]he underlying actions in an MDL remain individual in nature
   while a class action is a representative proceeding.”).

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   might cause permanent hair loss. In re Taxotere (Docetaxel) Prods. Liab. Litig.,
   220 F. Supp. 3d 1360, 1361 (J.P.M.L. 2016). 2
           Before the district court, the MDL plaintiffs have collectively filed a
   Second Amended Master Complaint. They allege that Sanofi knew that
   Taxotere causes permanent hair loss and failed to warn patients of that side
   effect. On May 31, 2017, Phillips filed her individual Short Form Complaint
   bringing eleven claims against Sanofi. She did not assert any claims against
   Dr. Sonnier.
           The only claim at issue on appeal 3 here is Phillips’s claim that Sanofi
   failed to warn of the risk of permanent alopecia associated with Taxotere in
   accordance with Louisiana law.
           Sanofi filed a motion for summary judgment—in Phillips’s case
   only—asserting that Phillips could not establish the requisite causation for
   her failure-to-warn claim to survive as a matter of law. The district court
   granted this motion. After conferral, all of Phillips’s remaining claims were

           2
             As of March 2021, more than 12,500 actions were pending in this MDL, including
   Phillips’s case. U.S. Judicial Panel on Multidistrict Litigation, MDL Statistics and Report:
   Distribution of Pending MDL Dockets by District (Mar. 15, 2021), available at
   https://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-
   March-15-2021.pdf
           3
             Here, summary judgment was filed in Phillips’s individual case, as is sometimes
   done in the context of an MDL. See Douglas Smith, The Myth of MDL Settlement, 107 KY.
   L. J. 467, 478 n.62 (2019) (collecting examples of lower courts’ rulings on individual
   summary judgment motions). The challenge before us does not arise in the context of an
   omnibus dispositive motion filed to resolve common questions in the MDL in whole or in
   part. See, e.g., In re Lipitor (Atorvastatin Calcium) Mktg., Sales Pracs. and Prods. Liab. Litig.
   (No II) MDL 2502, 892 F.3d 624, 649 (4th Cir. 2018) (affirming grant of summary judgment
   in product liability actions involving statins); In re Zoloft (Sertraline Hydrochloride) Prods.
   Liab. Litig., 858 F.3d 787, 800 (3d Cir. 2017) (affirming summary judgment on all claims).

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   dismissed, the district court entered final judgment in her case, and this
   appeal followed.
                                          II.
          Our review of a district court’s grant of summary judgment is de novo,
   and we view all facts, and the inferences to be drawn from them, in the light
   most favorable to the non-movant. Kariuki v. Tarango, 709 F.3d 495, 501 (5th
   Cir. 2013).
          “The court shall grant summary judgment if the movant shows that
   there is no genuine dispute as to any material fact and the movant is entitled
   to judgment as a matter of law.” Fed. R. Civ. P. 56(a); Celotex Corp. v.
   Catrett, 477 U.S. 317, 322 (1986). “[T]he substantive law will identify which
   facts are material.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986).
          “[A] dispute about a material fact is ‘genuine’ . . . if the evidence is
   such that a reasonable jury could return a verdict for the nonmoving party.”
   Id.; see Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587
   (1986). The movant has the initial burden of demonstrating the absence of a
   material fact issue. St. Paul Ins. Co. v. AFIA Worldwide Ins. Co., 937 F.2d 274,
   279 n.6 (5th Cir. 1991). If it satisfies that burden, the non-movant must
   identify specific evidence in the summary judgment record demonstrating
   that there is a dispute of material fact concerning the essential elements of its
   case for which it will bear the burden of proof at trial. See
   Fed. R. Civ. P. 56(a), (e); Celotex, 477 U.S. at 324.
                                         III.
          The only claim that Sanofi moved to have resolved on summary
   judgment in this case was Phillips’s failure-to-warn claim, and the district
   court’s resolution of this claim, under Louisiana law, is the only issue before
   us here.

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          Pursuant to the Louisiana Products Liability Act, a plaintiff asserting
   a failure-to-warn claim must prove: (1) a manufacturer’s failure to adequately
   warn the prescribing physician of a risk associated with the product that the
   physician did not otherwise know about, and (2) that the failure to warn was
   the cause in fact and the proximate, or legal, cause of the plaintiff’s injury.
   Kampmann v. Mason, 921 So. 2d 1093, 1094, 1096 (La. App. 5 Cir. 2006)
   (citing La. Stat. Ann. § 9:2800.57 (West 2013)).
          An adequate warning is one that “would lead an ordinary reasonable
   user . . . to contemplate the danger in” the use of the product.
   La. Stat. Ann. § 9:2800.53(9) (West 2013). Under the “learned
   intermediary doctrine,” however, a patient’s physician acts as an informed
   intermediary between the drug company and the patient. Brown v. Glaxo, Inc.,
   790 So. 2d 35, 38-39 (La. App. 1 Cir. 2000), writs denied, 785 So. 2d 827 and
   785 So. 2d 832. Thus, a drug manufacturer has a duty to warn the prescribing
   physician, rather than the patient, of potential risks associated with the use
   of the drug. Mikell v. Hoffman-LaRoche, Inc., 649 So.2d 75, 79-80 (La. App. 1
   Cir. 1994).
          To prove causation in this context, a “plaintiff must show that a
   proper warning would have changed the decision of the [prescribing]
   physician, i.e. that but for the inadequate warning, the [prescribing] physician
   would not have used or prescribed the product.” Willett v. Baxter Int’l, Inc.,
   929 F.2d 1094, 1099 (5th Cir. 1991); accord Sharkey v. Sterling Drug, Inc., 600
   So. 2d 701, 711 (La. App. 1 Cir. 1992), writs denied, 605 So.2d 1099 and 605
   So.2d 1100.
          Phillips argues that the focus of our inquiry should be “how patient
   choice . . . would have steered the conversation and the ultimate prescribing
   decision.” And, certainly, under Louisiana law, “[t]he decision to use a drug
   in a particular circumstance rests with [both] the doctor and the patient.”

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   Calhoun v. Hoffman-La Roche, Inc., 768 So. 2d 57, 59 n.1 (La. App. 1 Cir.
   2000), writ denied, 765 So. 2d 1041.
           But, as we have established, a causation analysis in a failure-to-warn
   claim asserted against a drug’s manufacturer (the only claim at issue here) is
   focused on the prescribing physician’s decision to prescribe the drug. Willett,
   929 F.2d at 1099; accord Sharkey, 600 So. 2d at 711. So, to the extent that
   patient choice is relevant, that relevance is cabined to helping us decide
   whether Phillips’s evidence—including that of other available treatments
   and the importance she places on her appearance—is sufficient to introduce
   a genuine dispute of material fact as to whether Dr. Sonnier’s prescribing
   decision would have been different had he known that Taxotere’s associated
   risk of alopecia was potentially permanent rather than temporary. 4 It is not.
           First, as a general matter, Dr. Sonnier testified that the additional
   warning regarding permanent alopecia has not materially altered his risk-
   benefit assessment of Taxotere. Further, Dr. Sonnier testified that alopecia
   is, and has been, a common and widely known side effect of “Taxotere and
   other chemotherapy drugs.” The “specific type of alopecia” appears on this
   record to have had no effect on Dr. Sonnier’s prescribing decision, and this
   supports the conclusion that Sanofi’s alleged failure-to-warn could not have
   been the cause of Phillips’s injury. Cf. Cooper v. Sams, 628 So. 2d 1181, 1190
   (La. App. 3 Cir. 1993), writs denied, 632 So. 2d 766, 632 So. 2d 767 (affirming

           4
               The district court has indicated in this case and others that “[b]ecause the
   chemotherapy decision-making process is unique” the question is “whether and how the
   doctor would have advised the patient of the risk of permanent alopecia associated with
   Taxotere, whether the patient would have inquired about other options, what the doctor
   would have recommended, and what decision the plaintiff would have ultimately made.”
   See, e.g., In re Taxotere (Docetaxel) Prod. Liab. Litig., No. 16-15607, 2019 WL 2995897, at *7
   (E.D. La. July 9, 2019). Under Louisiana state law, we find no support for this proposition
   and no occasion to deviate from binding caselaw to apply this standard.

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   a grant of summary judgment where a failure to warn “could not have caused
   [a patient’s] injuries . . . because [the prescribing physician] already knew
   of . . . those dangers”) (emphasis added).

          Second, when it comes to Phillips in particular, Dr. Sonnier repeatedly
   testified that a Taxotere label warning of potentially permanent hair loss—as
   opposed to temporary hair loss—would not have changed his decision to use
   the Taxotere-based chemotherapy to treat Phillips’s breast cancer. For
   example, he was asked directly: “If someone with Ms. Phillips’s medical
   history came [to] you today with the same tumor type, same medical history,
   would you make the same recommendation for her treatment?” “Yes,” he
   replied. This was so because of Phillips’s age—seventy-five—and her pre-
   existing cardiac conditions, along with the fact that Phillips’s cancer carried
   a high risk of recurrence.
          When Dr. Sonnier prescribed TCH, he identified alternatives,
   specifically Anthracycline-based therapies. But these alternatives to the
   Taxotere-based TCH carried a risk of cardio toxicity and are not
   recommended for use in those over the age of sixty-five. In light of the fact
   that Phillips was seventy-five and had pre-existing heart conditions, Dr.
   Sonnier did not prescribe these alternatives. Dr. Sonnier testified that had
   Phillips asked to undergo an Anthracycline-based therapy instead of TCH,
   he “[didn’t] think it would have been okay with [him],” and he “would not
   give it.”
          Certainly, as Phillips indicates, the record reflects that there were
   available treatment options beyond those carrying a risk of cardio toxicity.
   These treatments, however, were less efficacious and would “not have
   reduced her risk[] of recurrence to the same degree as TCH.” Phillips has
   not identified any testimony from Dr. Sonnier that these were adequate to
   help treat her aggressive cancer, let alone that a warning of potentially

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   permanent hair loss—as opposed to temporary hair loss—would have led Dr.
   Sonnier to prescribe these instead of TCH. Cf. Sharkey, 600 So.2d at 711
   (finding causation where a physician “testified unequivocally” that an
   adequate warning against the use of aspirin in children would have prevented
   him from advising his patient to give her child an aspirin). 5
           Third, it is clear that Dr. Sonnier and Phillips discussed the risk that
   Dr. Sonnier was aware of all along—that is, the risk of temporary alopecia
   and abnormal hair regrowth. Although Phillips now argues that her
   “appearance is unmistakably important to her,” there is no indication that
   Phillips investigated or asked about alternatives that might avoid the
   abnormal hair growth or hair loss. Dr. Sonnier did not present TCH to her as
   one of many viable options; rather, after explaining why available alternatives
   were inadequate, he stated that “[TCH] is the therapy that we do.” In turn,
   she “put her faith in [him],” and consented to treatment. In other words,
   important to her as her appearance may be, on this record, there is little
   evidence that Phillips might have steered the conversation in such a way that
   Dr. Sonnier would have changed his prescribing decision had he known that
   the risk of alopecia associated with Taxotere was potentially permanent
   rather than temporary.
           The       “judge’s        inquiry,       [at    the      summary         judgment
   stage] . . . unavoidably asks whether reasonable jurors could find by a
   preponderance of the evidence that the plaintiff is entitled to a verdict.”

           5
             To the extent Phillips now challenges Dr. Sonnier’s judgment in prescribing
   TCH, a failure-to-warn claim against drug manufacturers (the only claim at issue here) is
   not the proper vehicle for that challenge. See generally Cobb v. Syntex Lab’ys, Inc., 444 So.
   2d 203 (La. App. 5 Cir. 1983) (describing the relationship between the duties of a physician
   and those of a drug manufacturer and holding that a patient could not recover from a drug
   manufacturer for an injury allegedly sustained from taking its drug where, inter alia,
   warnings were adequate).

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   Anderson, 477 U.S. at 252. At most, Phillips’s points about the existence of
   non-Anthracycline alternative therapies and her testimony about how she
   might have steered the conversation amount to a “scintilla of evidence in
   support of [her] position.” Id.
          Hence, at this stage of the litigation, this evidence is “insufficient,”
   id., to create a genuine dispute of material fact as to whether a warning that
   Taxotere caused potentially permanent—as opposed to temporary—
   alopecia would have changed Dr. Sonnier’s prescribing decision, see Willett,
   929 F.2d at 1099 (affirming a grant of summary judgment where “[t]he
   plaintiff . . . failed to present any specific evidence that this additional risk
   would have changed [the prescribing physician’s] decision”). To the
   contrary, on this record, it is beyond any genuine dispute that “an adequate
   warning . . . would have been futile under the circumstances.” Sharkey, 600
   So. 2d at 711.
                                         IV.
          Because Phillips has failed to introduce sufficient evidence to enable a
   reasonable jury to find that Sanofi’s alleged failure to warn of the risk
   permanent—as opposed to temporary—alopecia in connection with the use
   of Taxotere was the actual and proximate cause of her injuries, we AFFIRM
   the district court’s grant of summary judgment.

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