Chapman v. Walmart, Inc. (In re Acetaminophen - ASD-ADHD Prods. Liab. Litig.)
| Decision Date | 20 April 2023 |
| Docket Number | 22md3043 (DLC),22mc3043 (DLC),22cv8830 (DLC) |
| Parties | IN RE: Acetaminophen - ASD-ADHD Products Liability Litigation This Document Relates To: Chapman et al. v. Walmart, Inc. et al., 22cv8830 |
| Court | U.S. District Court — Southern District of New York |
APPEARANCES:
For plaintiffs: Keller Postman LLC Ashley C. Keller Watts Guerra LLC Mikal C. Watts The Lanier Law Firm W. Mark Lanier
For defendant Johnson & Johnson Consumer Inc.: Barnes & Thornburg LLP Sarah E. Johnston Skadden, Arps, Slate, Meagher & Flom LLP Jessica Davidson Miller
This Opinion addresses a motion to dismiss in this multidistrict products liability litigation ("MDL"). Cherise Chapman, individually and on behalf of her minor child D.C (together, "Plaintiffs"), has sued Johnson & Johnson Consumer Inc. ("JJCI") and Walmart, Inc. ("Walmart"; collectively, "Defendants") alleging that her child has autism spectrum disorder ("ASD") and attention-deficit/hyperactivity disorder ("ADHD") because Chapman used the Defendants' acetaminophen products while pregnant. The Plaintiffs allege that the Defendants violated the law of Nevada when they failed to warn of the risks of prenatal exposure to acetaminophen. For the following reasons, JJCI's motion to dismiss on the ground of preemption is denied.
The following facts are drawn from the Plaintiffs' short form complaint ("SEC") and the master complaint in this MDL that the SFC incorporates by reference to the extent they are relevant to JJCI's motion to dismiss on the ground of preemption. The facts are taken as true for the purposes of this motion.
Chapman resides in Nevada. While pregnant, Chapman took Tylenol Extra Strength ("Tylenol"). Chapman's child was born in 2015 and has ASD and ADHD. Chapman asserts that, had she been warned about the risk of ASD and ADHD, she would have taken less Tylenol or not taken it at all.
JJCI manufactures Tylenol. Acetaminophen has long been marketed as the only safe over-the-counter ("OTC") pain reliever for pregnant women. At the time Chapman took Tylenol, the label contained one warning related to pregnancy: "If pregnant or breast-feeding, ask a health professional before use." (Emphasis in original.) There was no specific warning about the risk of ASD or ADHD.
Several scientific studies have found prenatal exposure to acetaminophen to be associated with ASD and ADHD in children. The first cited study is from 2013. More studies followed.
On September 23, 2021, a group of 91 scientists, clinicians, and public health professionals published a "Consensus Statement." Ann Z. Bauer et al., Paracetamol Use During Pregnancy -- A Call for Precautionary Action, 17 Nature Revs. Endocrinology 757 (2021). In the Consensus Statement, the authors note:
A growing body of experimental and epidemiological research suggests that prenatal exposure to paracetamol (N-acetyl-p-aminophenol (APAP), otherwise known as acetaminophen) might alter fetal development, which could in turn increase the risks of certain neurodevelopmental, reproductive and urogenital disorders. . . . [W]e believe we know enough to be concerned about the potential developmental risks associated with prenatal APAP exposure and therefore call for precautionary action. Id. at 758-59. Among the "adverse neurodevelopmental outcomes" the Consensus Statement identifies are ASD and ADHD. Id. at 762. The signatories conclude:
[W]e believe the combined weight of animal and human scientific evidence is strong enough for pregnant women to be cautioned by health professionals against its indiscriminate use, both as a single ingredient and in combination with other medications. We recommend that APAP should be used by pregnant women cautiously at the lowest effective dose for the shortest possible time. Long-term or high-dose use should be limited to indications as advised by a health professional. Packaging should include warning labels including these recommendations.
On June 7, 2022, the Plaintiffs filed this action in the U.S. District Court for the District of Nevada. On October 5, the Judicial Panel on Multidistrict Litigation consolidated this action with others asserting claims that prenatal exposure to acetaminophen causes ASD and ADHD in children and transferred the cases to this Court under 28 U.S.C. § 1407. On November 14, motions to dismiss two actions within the MDL on the ground of preemption were denied. In re Acetaminophen - ASD-ADHD Products Liability Litigation, No. 22md3043 (DLC), 2022 WL 17348351 (S.D.N.Y. Nov. 14, 2022) ("November Opinion").
At the November 17 initial pretrial conference, a schedule was set for the filing of two master complaints: one naming JJCI and the other naming Retailer Defendants. On December 16, the MDL plaintiffs filed the master complaint against JJCI.
On January 20, 2023, Chapman filed her SFC, and on February 3, timely amended it. The SFC asserts Nevada state law claims against JJCI, to wit, claims for strict liability for failure to warn, strict liability for design defect due to inadequate warnings and precautions, negligence, negligent misrepresentation, breach of implied warranty, and violation of Nevada's consumer protection laws.[1]
On February 10, JJCI moved to dismiss all of the SFCs filed against it, including Chapman's.[2] The motion became fully submitted on March 17.
The Retailer Defendants also moved to dismiss all the SFCs filed against them. Separate Opinions will address those motions.
JJCI asserts that federal law preempts the Plaintiffs' state law claims. A multidistrict litigation transferee court "applies the substantive state law, including choice-of-law rules, of the jurisdiction in which the action was filed." Desiano v. Warner-Lambert & Co., 467 F.3d 85, 91 (2d Cir. 2006) (citation omitted). This action was filed in Nevada.
Nevada has adopted the "most significant relationship test" from the Restatement (Second) of Conflict of Laws for choice-of-law decisions in tort actions. General Motors Corp, v. Eighth Judicial Dist. Ct. of State of Nev, ex rel. County of Clark, 134 P.3d 111, 116 (Nev. 2006). Based on the facts asserted in the SFC, it appears that Nevada has the most significant relationship to this litigation. It alleges that the Plaintiffs reside in Nevada. Nevada's tort laws will be applied here. To be clear, no party has argued that the choice of law inguiry will affect the preemption analysis, and nothing that follows suggests that it should.
Under Nevada law, a failure to warn claim consists of the following elements: "(1) the product had a defect which rendered it unreasonably dangerous, (2) the defect existed at the time the product left the manufacturer, and (3) the defect caused the plaintiffs injury." Motor Coach Indus., Inc, v. Khiabani by and through Rigaud, 493 P.3d 1007, 1011 (Nev. 2021) (citation omitted). "[T]he lack of a warning functions as the relevant [product] defect." Id.
At the heart of the Plaintiffs' complaint is the assertion that JJCI had a duty under state law to warn of the risks of prenatal exposure to acetaminophen. JJCI asserts that this state law duty is preempted by regulations promulgated by the Food and Drug Administration ("FDA") that govern how OTC drugs are manufactured and marketed to consumers and by the prohibition in the Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301-399g ("FDCA"), on misbranding. Before discussing the jurisprudence on preemption, it is helpful to review the FDA regulatory scheme for new drugs and OTC drugs generally and the federal regulation of acetaminophen.[3]
"The federal government regulates the manufacture, labeling, and sale of pharmaceuticals pursuant to the" FDCA Gibbons v. Bristol-Meyers Squibb Co., 919 F.3d 699, 707 (2d Cir. 2019). No drug can enter interstate commerce "unless [the] FDA determines that it is generally recognized as safe and effective ("GRAS/E") for the particular use described in its product labeling." Nat. Res. Def. Council, Inc, v. U.S. FDA, 710 F.3d 71, 75 (2d Cir. 2013) (). Once a drug is deemed GRAS/E, it is a "central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times." Wyeth v. Levine, 555 U.S. 555, 570-71 (2009).
The FDCA prohibits "the introduction into interstate commerce of any" misbranded drug. 21 U.S.C. § 331(a). Under the FDCA, a drug is misbranded "if its labeling is false or misleading in any particular" or does not bear "adequate warnings . . . against use . . . where its use may be dangerous to health." Id. § 352(a)(1); (f)(2). The misbranding prohibition is enforced through administrative, civil, and criminal actions. See id. §§ 332-33; 371-72. The FDA has "complete discretion" to decide when the FDCA's enforcement provisions should be exercised. Heckler v. Chaney, 470 U.S. 821, 835 (1985).
"In the 1930's, Congress became increasingly concerned about unsafe drugs and fraudulent marketing," and it enacted the FDCA. Wyeth, 555 U.S. at 566. "The FDCA's most substantial innovation was its provision for premarket approval of new drugs." Id. A new drug is defined as:
any drug . . . the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed,
recommended, or suggested in the labeling thereof . . .
21 U.S.C. § 321(p)(1). "[A] manufacturer seeking federal approval to market a new drug must prove that it is safe and effective and that the proposed label is accurate and adequate." PLIVA, Inc,...
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