Cohen v. American Biltrite Inc. (N.Y. Sup. Ct., Sept. 4, 2018)

Our plain-English summary of Cohen v. American Biltrite Inc. (New York Supreme Court, September 4, 2018).

Steven Cohen sued American Biltrite and other defendants, including Colgate-Palmolive Company, individually and as representative of the estate of his late wife, Sandra Cohen. He claimed she was exposed to asbestos in Cashmere Bouquet talcum powder, made by Colgate-Palmolive, which she used from 1951 to the early 1970s. He claimed this caused her mesothelioma and death. Before trial, he asked the court to bar evidence about FDA regulation of talc and the FDA's view that talc is safe or "generally recognized as safe." The court granted the motion in part. It ruled that what laws govern FDA regulation of talc is a legal question for the judge, so no evidence on it would be admitted. It held that the "generally recognized as safe" label applies only to food additives and new drugs, not cosmetics, and that the similar phrase "generally regarded as safe" could be confused with it. The court also found Colgate-Palmolive's evidence on this point was hearsay. The rest of the motion was denied, leaving plaintiff free to object at trial.

We wrote this summary from the court's opinion with the help of AI. It is not the court's wording, and it is not legal advice. The full opinion is below.

The decision

• Court: New York Supreme Court
• Decided: September 4, 2018
• Citation: 2018 NY Slip Op 51951(U)
• Stage: Discovery or evidence ruling
• State: New York

Outcome. The court granted plaintiff Steven Cohen's motion in part, precluding evidence of what laws govern FDA regulation of talc and evidence that the FDA classified talc as "generally recognized as safe" or "generally regarded as safe", and otherwise denied the motion without prejudice to objections at trial; Colgate-Palmolive lost the ruling in part.

What the court held. The scope of FDA regulation of talc is a question of law, not fact evidence, and the "generally recognized as safe" classification applies only to food additives and new drugs, so references to it (and the similar "generally regarded as safe") lack probative value for cosmetic talc.

Issues decided: Federal Preemption, Trial Procedure and Discovery.

The people and their exposure

• Sandra Florence Cohen: mesothelioma; died

The defendants

• Colgate-Palmolive Company (manufacturer)
• American Biltrite Inc.

The court's opinion

The text below is Google Scholar's copy of the court's opinion, a public record. Numbers in brackets, such as [*921], mark where each page of the printed reporter begins.

2018 NY Slip Op 51951(U)

STEVEN ANDREW COHEN, INDIVIDUALLY and AS PERSONAL REPRESENTATIVE OF THE ESTATE

OF SANDRA FLORENCE COHEN, DECEASED, Plaintiff,

v.

AMERICAN BILTRITE INC., ET AL., Defendants.

190044/2016.

Decided September 4, 2018.

Supreme Court, New York County.

LUCY BILLINGS, J.

Plaintiff sues defendants to recover damages for the decedent Sandra Cohen's exposure to asbestos from talc contaminated with asbestos in the Cashmere Bouquet talcum powder that Sandra Cohen used from 1951 to the early 1970s and that was manufactured by defendant Colgate-Palmolive Company. Plaintiff moves to preclude testimony or exhibits at trial regarding regulation of the safety of talc by the United States Food and Drug Administration (FDA) and regarding its position that talc is safe, "generally regarded as safe," or "generally recognized as safe." 21 U.S.C. § 321(u); 21 C.F.R. §§ 170.3(k), 170.30. For the reasons explained below, the court grants plaintiff's motion in part.

The FDA's regulation of the safety of talc or talcum powder is an issue of law, not fact on which evidence is to be admitted. The parties may cite to the court any federal statutes that require or authorize the FDA to regulate the safety of talc or talcum powder, which the court will consider in determining (1) whether and how, through any regulations, the FDA has regulated these substances' safety and (2) the applicability of any law to the factual evidence introduced. Morris v. Pavarini Constr., 9 NY3d 47, 51 (2007); Bucholz v. Trump 767 Fifth Ave., 5 NY3d 1, 7 (2005); Lopez v. Chan, 102 AD3d 625, 626 (1st Dep't 2013); McCoy v. Metropolitan Transp. Auth., 53 AD3d 457, 459 (1st Dep't 2008). Therefore the court grants plaintiff's motion to the extent of precluding any evidence of what laws apply and what they require or authorize. The court also must preclude evidence if prejudice from introduction of the evidence outweighs its probative value. Salm v. Moses, 13 NY3d 816, 818 (2009); Kish v. Board of Educ. of City of NY, 76 NY3d 379, 384-85 (1990). Plaintiff claims that references to the FDA finding that talc is safe or generally regarded as safe are misleading because those findings relate only to ingestion of talc, not its inhalation or its absorption through mucous membranes that plaintiff claims caused Sandra's Cohen's mesothelioma and death.

Plaintiff suggests that the FDA's authority over the safety of cosmetics is limited because, according to its website, the agency lacks the authority to approve cosmetics before they are marketed. While the court may take judicial notice of information from a government website, LaSonde v. Seabrook, 89 AD3d 132, 137 n. 8 (1st Dep't 2011); Kingsbrook Jewish Med. Ctr. v. Allstate Ins. Co., 61 AD3d 13, 20 (2d Dep't 2009), again, the laws governing the FDA, not its website, establish its regulatory authority over the safety of cosmetics. 21 C.F.R. § 720.1 allows manufacturers' voluntary reporting of their cosmetics' ingredients to the FDA, which is consistent with the website information plaintiff presents, but he fails to identify any statute or regulation that prohibits the FDA from publicizing the safety or the hazards of cosmetic products. The FDA may "cause to be disseminated information regarding food, drugs, devices, tobacco products, or cosmetics in situations involving. . . imminent danger to health or gross deception of the consumer." 21 U.S.C. § 375(b). As Colgate-Palmolive points out, the FDA also must ensure that "cosmetics are safe and properly labeled," 21 U.S.C. § 393(b)(2)(D), but Colgate-Palmolive fails to identify any regulation that actually regulates the safety of talc or talcum powder or how either one must be labelled.

Plaintiff also seeks to preclude evidence of the FDA's findings that talc is "generally recognized as safe," a classification defined by 21 U.S.C. § 321(u) and 21 C.F.R. §§ 170.3(k) and 170.30 that applies only to food additives, 21 U.S.C. § 321(s), and new drugs. 21 U.S.C. § 321(p); United States v. Generix Drug Corp., 460 U.S. 453, 457 (1983); United States v. Rutherford, 442 U.S. 544, 551 (1979). While Colgate-Palmolive relies on deposition testimony by the president of Colgate-Palmolive's talc supplier, that the FDA deemed the supplier's talc to be generally recognized as safe, and a published article reciting the FDA's statement that talc was generally recognized as safe for use in cosmetics, both the testimony and the

article's quotation are inadmissible hearsay. Nor does this evidence specify that it refers to talc used in cosmetics during the period that Sandra Cohen used talc, to show that the evidence is relevant.

The prejudice to plaintiff from other, admissible evidence that Colgate-Palmolive may introduce regarding the FDA's findings that talc is safe, however, is minimal, as plaintiff may present evidence that those findings relate only to ingestion of talc, not its inhalation or its absorption through mucous membranes, and therefore are irrelevant. That evidence is lacking in the current record. Similarly, if the FDA's findings are based on data collected after Sandra Cohen's exposure, the data and conclusions drawn from these data may fail to establish that talc use during the period that Sandra Cohen used talc was safe and be irrelevant and precluded on this basis. Mahai-Sharpe v. Riverbay Corp., 126 AD3d 573, 573 (1st Dep't 2015); Fortich v. Ky-Miyasaka, 102 AD3d 610, 610 (1st Dep't 2013); Kaplan v. Karpfen, 57 AD3d 409, 410 (1st Dep't 2008); Timmins v. Tishman Constr. Corp., 9 AD3d 62, 69 (1st Dep't 2004).

On the other hand, no further evidence is needed to determine that, based on the law, the classification "generally recognized as safe" does not apply to cosmetics. Since the terms "generally regarded as safe" are virtually synonymous and easily confused with that classification, the references to any such terms in this action lack probative value. Therefore the court grants plaintiff's motion to the further extent of precluding evidence that the FDA has found or classified talc or talcum powder to be "generally recognized as safe" or "generally regarded as safe," as well as evidence regarding the FDA's regulation of talc or talcum powder, but otherwise denies plaintiff's motion, without prejudice to his objections at trial.

Sources

• The opinion on Google Scholar
• The opinion on CourtListener
• New York asbestos laws
• New York asbestos exposure sites