Case 2:16-md-02740-JTM-MBN Document 13062 Filed 07/14/21 Page 1 of 8
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` UNITED STATES DISTRICT COURT
`EASTERN DISTRICT OF LOUISIANA
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`IN RE: TAXOTERE (DOCETAXEL)
`PRODUCTS LIABILITY
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`LITIGATION
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`This document relates to:
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`Elizabeth Kahn, 16-17039
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`MDL No. 16-2740
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`SECTION: “H” (5)
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`ORDER AND REASONS
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`Before the Court is a Motion for Reconsideration on Warnings Causation
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`(Doc. 12536). On May 26, 2021, the Court held oral argument on the Motion.
`For the following reasons, the Motion is DENIED.
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`BACKGROUND
`Plaintiffs in this multidistrict litigation (“MDL”) are suing several
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`pharmaceutical companies
`that manufactured and/or distributed a
`chemotherapy drug, Taxotere or docetaxel,1 that Plaintiffs were administered
`for the treatment of breast cancer or other forms of cancer. Among these
`companies are Defendants sanofi-aventis U.S. LLC and Sanofi U.S. Services
`Inc. (collectively, “Sanofi” or “Defendants”). Plaintiffs allege that the drug
`caused permanent alopecia, or permanent hair loss. Plaintiffs bring claims of
`failure to warn, negligent misrepresentation, fraudulent misrepresentation,
`and more. The first bellwether trial was held in September 2019, and the
`second is set for August 23, 2021.2
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`Plaintiff Elizabeth Kahn is the designated plaintiff for the second
`bellwether trial. In its Order and Reasons dated April 7, 2020 (Doc. 9888) (the
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`1 Docetaxel is the generic version of Taxotere.
`2 The second trial was continued due to the COVID-19 pandemic.
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`“Order”), the Court ruled on Sanofi’s Motion for Summary Judgment Based on
`Warnings Causation as to Kahn.3 Applying the learned intermediary doctrine,
`the Court considered whether a different warning in the Taxotere label would
`have changed the prescribing decision of Kahn’s oncologist, Dr. Carl Kardinal.
`The Court considered whether Dr. Kardinal would have warned Kahn of a risk
`of permanent alopecia had he known of it, and the Court considered “how
`patient choice then would have steered the conversation and the ultimate
`prescribing decision.”4 The Court cited testimony from Dr. Kardinal saying
`that he would have told Kahn of such a risk and would have discussed other
`options with her had she not wished to take Taxotere. Then, the Court cited
`testimony from Kahn saying that if she was told that Taxotere carried a risk
`of permanent hair loss, she would have asked about other options. Based on
`this, the Court found that there was a genuine issue of fact on causation.
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`In the instant Motion, Sanofi now asks the Court to reconsider its Order
`based on a recent Fifth Circuit decision. Plaintiff opposes the Motion.
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`LEGAL STANDARD
`A motion to reconsider an interlocutory order is governed by Federal
`Rule of Civil Procedure 54(b), which states that “any order or other decision,
`however designated, that adjudicates fewer than all the claims or the rights
`and liabilities of fewer than all the parties does not end the action as to any of
`the claims or parties and may be revised at any time before the entry of a
`judgment adjudicating all the claims and all the parties’ rights and liabilities.”
`“Under Rule 54(b), ‘the trial court is free to reconsider and reverse its decision
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`3 The Court granted the Motion in part and dismissed Plaintiff’s redhibition claim. Sanofi
`seeks reconsideration only insofar as the Court denied the Motion.
`4 Doc. 9888 at 4.
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`for any reason it deems sufficient, even in the absence of new evidence or an
`intervening change in or clarification of the substantive law.’”5 “‘[T]he power
`to reconsider or modify interlocutory rulings is committed to the discretion of
`the district court, and that discretion is not cabined by the heightened
`standards for reconsideration governing final orders.’”6
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`LAW AND ANALYSIS
`Sanofi argues that the Fifth Circuit has now established the causation
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`standard relevant to this litigation. Sanofi avers that the dispositive question
`is whether the physician would have changed his prescribing decision had he
`been given a different warning, and Sanofi asserts that the Fifth Circuit
`rejected the notion that the inquiry should consider how patient choice would
`have steered the conversation between the patient and her doctor.
`The Court finds no reason to reverse its original decision. As set forth in
`the Order at issue, under Louisiana law, failure to warn claims involving
`prescription drugs are subject to the learned intermediary doctrine.7 Under the
`doctrine, the manufacturer of a prescription drug “has no duty to warn the
`patient, but need only warn the patient’s physician.” 8 In other words, a
`manufacturer’s duty runs only to the physician—the learned intermediary.9
`The Fifth Circuit has held that there is a two-prong test governing
`inadequate warning claims under the Louisiana Products Liability Act (LPLA)
`when the learned intermediary doctrine is applicable:
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`5 Austin v. Kroger Texas, L.P., 864 F.3d 326, 336 (5th Cir. 2017) (quoting Lavespere v.
`Niagara Mach. & Tool Works, Inc., 910 F.2d 167, 185 (5th Cir. 1990)).
`6 Id. (quoting Saint Annes Dev. Co. v. Trabich, 443 F. App’x 829, 831–32 (4th Cir. 2011)).
`7 Grenier v. Med. Eng’g Corp., 99 F. Supp. 2d 759, 765 (W.D. La. 2000) (applying Louisiana
`law), aff’d, 243 F.3d 200 (5th Cir. 2001).
`8 Willett v. Baxter Intern., Inc., 929 F.2d 1094, 1098 (5th Cir. 1991).
`9 Grenier, 99 F. Supp. 2d at 766.
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`First, the plaintiff must show that the defendant failed
`to warn (or inadequately warned) the physician of a
`risk associated with the product that was not
`otherwise known to the physician. Second, the plaintiff
`must show that this failure to warn the physician was
`both a cause in fact and the proximate cause of the
`plaintiff’s injury.10
`Regarding the second prong, the law is well established that, to prove
`causation, “the plaintiff must show that a proper warning would have changed
`the decision of the treating physician, i.e. that but for the inadequate warning,
`the treating physician would not have used or prescribed the product.”11
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`As Sanofi notes, the Fifth Circuit recently issued a ruling relating to a
`case in this MDL—June Phillips v. Sanofi U.S. Services, et al.12 Applying the
`learned intermediary doctrine in the chemotherapy context, the court noted
`that while “[t]he decision to use a drug in a particular circumstance rests with
`[both] the doctor and the patient,”13 a causation analysis must focus on “the
`prescribing physician’s decision to prescribe the drug.”14 The court wrote:
`[T]o the extent that patient choice is relevant, that
`relevance is cabined to helping us decide whether [the
`plaintiff’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 [the physician’s]
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`10 Stahl v. Novartis Pharmaceuticals Corp., 283 F.3d 254, 265–66 (5th Cir. 2002) (internal
`citation omitted).
`11 Willett, 929 F.2d at 1099. See also Pellegrin v. C.R. Bard, 2018 WL 3046570, at *4 (E.D.
`La. June 20, 2018).
`12 In re Taxotere (Docetaxel) Prods. Liab. Litig. (June Phillips v. Sanofi U.S. Services, et al.),
`No. 20-30405, 2021 WL 1526429 (5th Cir. Apr. 19, 2021).
`13 Id. at *3 (quoting Calhoun v. Hoffman-La Roche, Inc., 768 So. 2d 57, 59 n.1 (La. App. 1 Cir.
`2000), writ denied, 765 So. 2d 1041 (La. 2000)).
`14 Id. The Court acknowledges the clarification from the Fifth Circuit in Footnote 4 of its
`opinion, providing that the question is not “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.” Id. at *3 n.4.
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`prescribing decision would have been different had he
`known that Taxotere’s associated risk of alopecia was
`potentially permanent rather than temporary.15
`Against this backdrop, the Fifth Circuit considered the facts before it.
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`First, the court considered whether a warning regarding permanent
`alopecia would have altered the physician’s risk-benefit assessment of
`Taxotere or his opinion that Taxotere was the best treatment for Phillips, the
`plaintiff. 16 The court answered no to both. 17 Next, the court considered
`whether there was any evidence that the plaintiff “might have steered the
`conversation in such a way that [her oncologist] would have changed his
`prescribing decision had he known that the risk of alopecia associated with
`Taxotere was potentially permanent rather than temporary.” 18 The court
`found “no indication that [the plaintiff] investigated or asked about
`alternatives that might avoid the abnormal hair growth or hair loss.” 19
`Instead, the court found that the plaintiff “‘put her faith in [her physician],’
`and consented to treatment.”20 Finding insufficient evidence to create an issue
`of fact on causation, the court affirmed summary judgment for Sanofi.21
`With this guidance in mind, the Court now turns to Plaintiff’s oncologist,
`Dr. Kardinal. Like the oncologist in Phillips, Dr. Kardinal testified that if the
`Taxotere label had warned of permanent alopecia, this would not have changed
`his chemotherapy recommendation for Plaintiff Kahn.22 He testified, however,
`that such a risk “would have to be included in the discussion” with a patient.23
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`15 Id.
`16 See id. at *4.
`17 See id.
`18 Id. at *4.
`19 Id.
`20 Id.
`21 See id. at *5.
`22 Doc. 9300-9 at 15.
`23 Doc. 9422-4 at 13.
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`He testified unequivocally that “if [Sanofi] stated that the incidence of
`permanent hair loss were X percent or whatever, those things should be made
`known to the patient.”24 Dr. Kardinal further stated that if a patient did not
`wish to take Taxotere because of such a risk, he would have discussed other
`options with her. He stated that paclitaxel is an adequate alternative to
`Taxotere in terms of its efficacy,25 and the Court has found no evidence in the
`record suggesting that paclitaxel was unsuitable for Plaintiff Kahn. This is
`distinguishable from Phillips, in which the identified alternatives were not
`suitable for the plaintiff due to her age and pre-existing heart conditions.26
`Now, like the Fifth Circuit, the Court considers whether there is any
`evidence that Plaintiff Kahn “might have steered the conversation in such a
`way that [her oncologist] would have changed his prescribing decision had he
`known that the risk of alopecia associated with Taxotere was potentially
`permanent rather than temporary.” 27 According to Kahn’s testimony, Dr.
`Kardinal told Kahn that her hair loss would be temporary, and a certain nurse
`assured Kahn of this.28 Kahn testified as follows:
`A:
`[O]ne day, during one of my early visits with Dr.
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`Kardinal and the clinical trial nurse, my
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`husband and I were waiting in the waiting room
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`. . . . And [the nurse] says, I want you to meet
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`someone. I have another patient here . . . , and I
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`want you to see how her hair is growing back.
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`And your hair is going to grow back exactly like
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`24 Doc. 9300-9 at 18.
`25 Doc. 9422-4 at 13–14.
`26 See Phillips, 2021 WL 1526429 at *4 (“[T]hese 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.’”).
`27 Id.
`28 Doc. 9422-6 at 18, 32–33.
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`that, too. You’re going to have a full head of hair
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`when you’re finished with chemotherapy.
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`Q: Who said that to you?
`A: My clinical trial nurse.
`Q: What was her name?
`A: That would have been Shevonda.29
`As this Court noted in its original Order, Plaintiff Kahn testified that if instead
`she “was told that Taxotere could have caused permanent hair loss, [she] would
`have asked what [her] other options were.”30 Notably, when Kahn was given
`options regarding her initial treatment, she chose not to have a mastectomy;
`instead, she chose to see if chemotherapy would shrink her tumor, which it did,
`thereby allowing her to have a lumpectomy instead.31 This is relevant to “the
`importance she places on her appearance,”32 and this further suggests that
`Kahn would have explored her options with Dr. Kardinal.
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`Considering the evidence, the Court finds that there are fact issues for
`the jury to decide regarding whether Dr. Kardinal, after discussing with
`Plaintiff Kahn the risks and benefits of her viable treatment options, would
`have changed his decision to prescribe Taxotere to her.
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`CONCLUSION
`foregoing
`the
`for
`Accordingly,
`reasons, Sanofi’s Motion
`Reconsideration on Warnings Causation (Doc. 12536) is DENIED.
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`for
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`29 Id.
`30 Doc. 9888 at 5. See also Doc. 9422-6 at 33. Kahn’s deposition testimony suggests that
`because she was assured her hair loss would be temporary, she did not ask about any
`options that would avoid permanent hair loss. Id. at 37.
`31 Doc. 9888 at 5.
`32 Phillips, 2021 WL 1526429, at *3.
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`New Orleans, Louisiana this 14th day of July, 2021.
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`JANE TRICHE MILAZZO
`UNITED STATES DISTRICT JUDGE
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