Dukes v. Sanofi S.A.

CourtDistrict Court, M.D. Alabama
DecidedJuly 1, 2024
Docket1:23-cv-00648
StatusUnknown

This text of Dukes v. Sanofi S.A. (Dukes v. Sanofi S.A.) is published on Counsel Stack Legal Research, covering District Court, M.D. Alabama primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Dukes v. Sanofi S.A., (M.D. Ala. 2024).

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF ALABAMA SOUTHERN DIVISION

GLENYS DUKES, ) ) Plaintiff, ) ) v. ) CIVIL CASE NO. 1:23-cv-648-ECM ) [WO] SANOFI US SERVICES, INC., et al., ) ) Defendants. )

MEMORANDUM OPINION and ORDER

I. INTRODUCTION This case concerns the chemotherapy drug Taxotere, which until recently was part of a multidistrict litigation where plaintiffs alleged that they developed permanent alopecia after use of the drug. This case, filed by Plaintiff Glenys Dukes (“Dukes”), was then remanded to this Court. Now pending before the Court is Defendants’ Sanofi-Aventis U.S. LLC and Sanofi US Services Inc.’s (“Sanofi”) motion for judgment on the pleadings. (Doc. 29). After reviewing the parties’ submissions, the Court finds that the motion (doc. 29) is due to be granted. The Plaintiff in her response also requests leave to amend her complaint to allege case-specific facts. (Doc. 34). The Court construes this as a motion for leave to amend the complaint. For the reasons stated, that motion (doc. 34) is due to denied. II. STANDARD OF REVIEW A. Motion for Leave to File an Amended Complaint

“A party may amend its pleading once as a matter of course no later than . . . 21 days after serving it.” FED. R. CIV. PRO. 15(a)(1). “In all other cases a party may amend its pleading only with the opposing party’s written consent or the court’s leave.” FED. R. CIV. PRO. 15(a)(2). “[L]eave to amend shall be freely given when justice so requires,” Maynard v. Bd. of Regents of Div. of Universities of Fla. Dep’t of Educ. ex rel. Univ. of S. Fla., 342 F.3d 1281, 1287 (11th Cir. 2003) (citation omitted), but “it is ‘not an automatic

right.’” Reese v. Herbert, 527 F.3d 1253, 1263 (11th Cir. 2008) (citation omitted). The Court may deny leave “where there is substantial ground for doing so, such as ‘undue delay, bad faith or dilatory motive on the part of the movant, repeated failure to cure deficiencies by amendments previously allowed, undue prejudice to the opposing party by virtue of allowance of the amendment, [and] futility of amendment.’” Reese v. Herbert, 527 F.3d

1253, 1263 (11th Cir. 2008) (alteration in original) (citing Burger King Corp. v. Weaver, 169 F.3d 1310, 1319 (11th Cir. 1999)). B. Judgment on the Pleadings “Granting judgment on the pleadings is appropriate when ‘there are no material facts in dispute and the moving party is entitled to judgment as a matter of law.’” Thompson v.

Regions Sec. Servs., Inc., 67 F.4th 1301, 1305 (11th Cir. 2023) (citation omitted). “All facts alleged in the complaint must be accepted as true and viewed in the light most favorable to the nonmoving party.” Douglas Asphalt Co. v. Qore, Inc., 541 F.3d 1269, 1273 (11th Cir. 2008) (citing Cannon v. City of West Palm Beach, 250 F.3d 1299, 1301 (11th Cir. 2001)).

III. JURISDICTION The Court has subject matter jurisdiction over this action pursuant to 28 U.S.C. § 1332. The parties do not contest personal jurisdiction or venue, and the Court concludes that venue properly lies in the Middle District of Alabama. See 28 U.S.C. § 1391. IV. STATEMENT OF FACTS The case before the Court was remanded from the multidistrict litigation In re:

Taxotere (Docetaxel) Products Liability Litigation, No. 2:16-md-2740 (J.P.M.L.) (“the MDL Court”). The Plaintiff filed the instant case on December 9, 2016, and it was remanded to this Court from the MDL Court on November 3, 2023. The operative pleadings consist of the Second Amended Master Complaint (“SAMC”) (doc. 11-4 at 342) and Duke’s First Amended Short Form Complaint (“FASFC”) (doc. 9), which contains

her individual allegations. In granting the plaintiffs’ motion for leave to file the SAMC, the MDL Court ordered Sanofi not to plead in response to the SAMC, and that Sanofi’s answer to the First Amended Master Complaint would be deemed its answer to the SAMC. Doc. 4230, at 2, In re: Taxotere, No. 2:16-md-2740. The following facts, taken in the light most favorable to Dukes, are alleged in the SAMC.

Taxotere is a chemotherapy drug primarily administered to those suffering from breast cancer. Sanofi is a pharmaceutical company involved in the development, testing, manufacturing, labeling, marketing, and selling of Taxotere. The Food and Drug Administration (“FDA”) approved Taxotere for various uses in the 1990s and early 2000s. Initially, hair loss was listed as a “possible side effect” of Taxotere. (Doc. 11-4 at 365). Temporary and reversible hair loss ordinarily results from chemotherapy. Over the years,

however, permanent hair loss, or Permanent Chemotherapy Induced Alopecia (“PCIA”), became a well-documented and studied side effect of Taxotere and began to be reported on by news outlets in 2010. PCIA “is defined as an absence of or incomplete hair regrowth six months beyond the completion of chemotherapy.” (Id. at 378). Alopecia lowers self- esteem and quality of life, and causes anger, anxiety, sadness, and other negative emotional effects.

Meanwhile, according to Dukes, Sanofi continued to mislead consumers as to the serious side effects of Taxotere. For example, Sanofi and its sales associates “cherry picked” positive data, emphasized certain side effects over others, and distributed materials to physicians which were banned by the FDA. In 2015, after Sanofi submitted new information to the FDA about PCIA, updated warnings were added to the drug’s

Patient Counseling Information advising physicians to inform patients of some documented cases of permanent hair loss, but that “in most cases normal hair growth should return.” (Id. at 366). The drug’s label, however, did not mention PCIA. Dukes alleges that she used Taxotere from May 2010 to June 2010. She filed her complaint on December 9, 2016, and then filed her FASFC on May 31, 2017. Under

Question 12 of the FASFC: the “Nature and extent of the alleged injury,” Dukes alleges that she has suffered severe personal injuries, including permanent alopecia, medical expenses, future loss of earnings, mental anguish, and loss of enjoyment of life. (Doc. 9 at 4). Apart from this statement, and when and where the drug was administered, no other case-specific facts are alleged. Dukes brings claims for strict products liability failure to warn (Count One),1 negligence (Count Three), negligent misrepresentation (Count Four),

fraudulent misrepresentation (Count Five), fraudulent concealment (Count Six), and fraud and deceit (Count Seven). V. DISCUSSION A. Motion for Leave to File an Amended Complaint Because it is relevant to deciding the motion for judgment on the pleadings, the Court first turns to Dukes’ motion for leave to file an amended complaint. The MDL Court

stated upon remand to this Court that “[a]ll deadlines for Plaintiffs to amend their individual complaints without leave of court have passed.” (Doc. 12 at 76).2 The Defendants also oppose the motion. (See doc. 35 at 2–6). Dukes seeks leave to amend her complaint to provide “case-specific facts and to avail herself of Alabama substantive law.” (Doc. 34 at 4).

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Dukes v. Sanofi S.A., Counsel Stack Legal Research, https://law.counselstack.com/opinion/dukes-v-sanofi-sa-almd-2024.