Dunn v. Sanofi-Aventis U.S. LLC

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MAGGIE DUNN, Plaintiff, v. SANOFI-AVENTIS U.S. LLC, et al., Defendants.

CIVIL No. 3:23-cv-649-ECM [WO]

United States District Court, M.D. Alabama, Eastern Division

May 7, 2024

MEMORANDUM OPINION AND ORDER

EMILY C. MARKS CHIEF UNITED STATES DISTRICT JUDGE

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 Maggie Dunn, was then remanded to this Court. Now pending before the Court is Defendants' Sanofi-Aventis U.S. LLC and Sanofi U.S. Services Inc.'s (“Sanofi”) motion for judgment on the pleadings. (Doc. 24). After reviewing the parties' submissions, the Court finds that the motion is due to be granted.

II. STANDARD OF REVIEW

“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 November 25, 2017, 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. 9-4 at 342) and Ms. Dunn's Short Form Complaint (“SFC”) (doc. 1), 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 Ms. Dunn, are alleged in the SAMC.

Taxotere is a chemotherapy drug primarily administered to those suffering from breast cancer. Sanofi is 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. 9-4 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.” (Doc. 9-4 at 378). Alopecia lowers self-esteem and quality of life, and causes anger, anxiety, sadness, and other negative emotional effects.

Meanwhile, 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.” (Doc. 9-4 at 366). The drug's label, however, did not mention PCIA.

Ms. Dunn alleges that she used Taxotere from August 7, 2012 to October 28, 2012. Ms. Dunn filed her SFC on November 25, 2017. Under Question 12 of the SFC: the “Nature and extent of the alleged injury,” Ms. Dunn alleges that she “continues to suffer and will suffer from disfiguring permanent alopecia as a result of receiving chemotherapy with Taxotere.” (Doc. 1 at 4). Apart from this statement, and when and where the drug was administered, no other case-specific facts are alleged. Ms. Dunn 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

The Plaintiff first contends that the Defendants' motion is not ripe because the pleadings are not closed. The Defendants, however, have filed an answer. Doc. 961, In re: Taxotere, No. 2:16-md-2740. Further, all deadlines to amend complaints have passed, (doc. 10 at 76), and this Court previously denied the Plaintiff's motion for leave to file an amended complaint (doc. 32). Thus, the pleadings are closed, and the motion is ripe for review. See Filo Am., Inc. v. Olhoss Trading Co., 321 F.Supp.2d 1266, 1267 (M.D. Ala. 2004) (“Once the answer was filed, the pleadings were closed[.]”).^[2]

The Defendants argue that Ms. Dunn did not plead her fraud claims with the particularity required by Rule 9(b), and that her claims are time-barred. The Court addresses each of the Defendants' arguments in turn.

A. Fraud Claims Under Rule 9(b)

Ms. Dunn brings three claims sounding in fraud: fraudulent misrepresentation, fraudulent concealment, and fraud and deceit. The Defendants argue that Ms. Dunn did not plead these claims with the particularity required by Rule 9(b). Under Rule 9(b), “[i]n alleging fraud . . ., a party must state with particularity the circumstances constituting fraud ....” FED. R. CIV. P. 9(b). To satisfy Rule 9(b), the complaint must set forth

(1) precisely what statements were made in what documents or oral representations or what omissions were made, and (2) the time and place of each such statement and the person responsible for making (or, in the case of omissions, not making) same, and (3) the content of such statements and the manner in which they misled the plaintiff, and (4) what the defendants obtained as a consequence of the fraud.

Young v. Grand Canyon Univ., Inc., 57 F.4th 861, 875 (11th Cir. 2023) (citation omitted).

After the Defendants in the previous MDL proceedings moved to dismiss the fraud claims in the Master Complaint for failure to plead with particularity, the MDL Court acknowledged in an August 30, 2017 hearing before Judge Engelhardt that “a master complaint could not possibly be expected to include every case-specific detail such as a particular misleading statement made by a particular sales representative to the physician of an individual plaintiff.” Hearing Transcript, Doc. 823, at 22, In re: Taxotere, 2:16-md-02740. Indeed, the allegations in the SAMC “are not enough to satisfy the who, what, when, where, and how required by Rule 9(b)” as it concerns Ms. Dunn specifically. Young, 57 F.4th at 876; see Maxwell v. Sanofi-Aventis U.S. LLC, 2023 WL 7115575, at *2 (N.D. Ala. Oct. 27, 2023). Thus, the Court considers both the SAMC and the Plaintiff's SFC in deciding the sufficiency of the pleadings. Hearing Transcript, Doc. 823, at 22, In re: Taxotere, 2:16-md-02740.

The MDL Court then ruled that “specific allegations, particularly with respect to fraud, should be perfected within the short form complaints filed in the individual member cases.” (Id. at 23).^[3] Ms. Dunn, however, did not amend her complaint to perfect her allegations of fraud. Ms. Dunn did not allege what statements mislead her, at what time and place the statements were made, or who made the statements. The only information specific to Ms. Dunn are the dates she was administered Taxotere, and that it was administered in Alabama. Consequently, the Court finds that Ms. Dunn's claims of fraud are due to be dismissed for failure to plead with particularity.

B. Statute of Limitations

The Defendants next argue that Ms. Dunn's remaining claims are time-barred. Ms. Dunn's negligence and failure to warn claims are subject to a two-year statute of limitations. Bush v. Ford Life Ins. Co., 682 So.2d 46, 47 (Ala. 1996) (per curiam) (“The statute of limitations applicable to a negligence claim is two years.”); ALA. CODE 1975, § 6-2-38(1) (“All actions for any injury to the person or rights of another not arising from contract and not specifically enumerated in this section must be brought within two years.”); McKenzie v. Janssen Biotech, Inc., 295 So.3d 617 (Ala. 2019) (applying two year statute of limitations to failure to warn claims). Under Alabama law, the “statute of limitations begins to run when the cause of action accrues, which . . . is the date the first legal injury occurs.” Ex parte Abbott Lab'ys, 342 So.3d 186, 194 (Ala. 2021) (citing Ex parte Integra LifeSciences Corp., 271 So.3d 814, 818 (Ala. 2018)). Further, “[a] cause of action accrues as soon as the claimant is entitled to maintain an action, regardless of whether the full amount of the damage is apparent at the time of the first legal injury.” Id. at 194 (citing Chandiwala v. Pate Constr. Co., 889 So.2d 540, 543 (Ala. 2004)).

The SAMC defines PCIA “as an absence of or incomplete hair regrowth six months beyond the completion of chemotherapy.” (Doc. 9-4 at 378). The Defendants contend that applying the alleged...