Feinberg v Colgate-Palmolive Co.

[*1] Feinberg v Colgate-Palmolive Co. 2012 NY Slip Op 50515(U) Decided on March 22, 2012 Supreme Court, New York County Heitler, J. Published by New York State Law Reporting Bureau pursuant to Judiciary Law § 431. This opinion is uncorrected and will not be published in the printed Official Reports.

Decided on March 22, 2012
Supreme Court, New York County

Arlene Feinberg and JACOB FEINBERG, Plaintiffs,

against

Colgate-Palmolive Co., et al., Defendants.



190070/11



Attorneys for Plaintiff:

ROBERT KOMITOR, ESQ.

AUDREY P. RAPHAEL, ESQ.

JAMES M. KRAMER, ESQ.

Levy Phillips & Konigsberg

DIOGENES P. KEKATOS, ESQ.

Seeger Weiss

Attorneys for Defendant:

ADAM M. ABENSOHN

CHRISTINE CHUNG, ESQ.

Quinn Emanuel

Sherry Klein Heitler, J.

In this personal injury action, defendant Colgate-Palmolive Co. ("Colgate") moves pursuant to CPLR § 3211(a)[FN1] to dismiss plaintiffs' claim that Colgate failed to provide plaintiff Arlene Feinberg ("Plaintiff") with an adequate warning of the hazards associated with asbestos on the label for its Cashmere Bouquet talcum powder product on the ground that Plaintiff's claim is preempted by federal law. For the reasons set forth below, the motion is denied.

BACKGROUND

Plaintiff Arlene Feinberg has mesothelioma. Among other things she alleges that she was exposed to asbestos from the use of Colgate's Cashmere Bouquet talcum powder from approximately 1950 through the late 1980s.[FN2] She testified that during that period she used the product at least once a day after she showered. It is undisputed that during the nearly four [*2]decades in which she used the product, it did not contain any warning regarding the health hazards associated with asbestos.

The Federal Food, Drug, and Cosmetics Act (the "Act" or "FDCA") was enacted in 1938, in part to prohibit the "adulteration or misbranding of any food, drug, device, tobacco product, or cosmetic in interstate commerce" as well as the manufacture of "any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded." See 21 U.S.C.A. §§ 331(b), (g). The Act was amended in 1997 to add a preemption provision ("Preemption Clause") for the labeling and packaging of cosmetics. See 21 U.S.C.A § 379s(a).[FN3]

Colgate asserts that this provision preempts Plaintiff's common law failure to warn claim in this action, both expressly and impliedly. Colgate further argues that Plaintiff's claim should be dismissed by reason of the primary jurisdiction doctrine. In opposition, Plaintiff argues that Colgate's motion must be denied since the Preemption Clause is not retroactive in its application and because Colgate never provided the Food and Drug Administration ("FDA") with its own [*3]test results showing that its Cashmere Bouquet talcum product contained asbestos. Plaintiff further contends, among other things, that the FDA has never issued any binding regulation on the labeling of cosmetic talc that arguably could preempt or conflict with her common law failure to warn claim.

DISCUSSIONI.Retroactivity

Colgate's motion must be denied because it seeks to apply the 1997 Preemption Clause to events that had their genesis more than 45 years before it existed, and which ceased to occur almost twenty years before Congress sought to legislate the labeling of cosmetic products.

The Preemption Clause may not be applied retroactively. In the first instance, it does not contain a retroactivity provision. This is critical given the historical fundamental requirement that retroactivity should not be read into a statute unless the law expressly provides for such relief or necessarily requires it. See Landgraf v USI Film Prods., 511 U.S. 244, 265 (1994) ("the presumption against retroactive legislation is deeply rooted in our jurisprudence, and embodies a legal doctrine centuries older than our Republic"); Majewski v Broadalbin-Perth Cent. Sch. Dist., 91 NY2d 577, 584 (1998) ("It is a fundamental canon of statutory construction that retroactive operation is not favored by courts and statutes will not be given such construction unless the language expressly or by necessary implication requires it"); see also Jacobus v Colgate, 217 NY 235, 240 (1916) ("It takes a clear expression of the legislative purpose to justify a retroactive application").

Nor is there any implication from the plain language of the statute that the legislature intended it to be applied retroactively. In this regard, Colgate relies on 21 U.S.C.A. § 379s(a), which bars the states from establishing or "continu[ing] in effect" any packaging or labeling requirements applicable to cosmetic products that is different from, in addition to, or otherwise not identical to the Act's requirements. No matter how strained an interpretation that Colgate would impose on this language, it does not express Congressional intention of retroactivity. It is clear to this court that this statutory language evinces an intention to prohibit the imposition of new requirements by the States that would differ from or conflict with federal requirements, and to bar the continuing application of any conflicting State requirements that may have existed before the Preemption Clause came into effect. This language cannot be interpreted to reach back to extinguish any legitimate claims that arose from the use of cosmetic talc products prior to 1997. Such an interpretation would invade existing rights and expectations in derogation of the cardinal rule against retroactivity. See Landgraf, supra, at 269, 280. Indeed, the language of the savings clause of the statute (21 U.S.C.A. § 379s[d], which provides, "Nothing in this section shall be construed to modify or otherwise affect any action or the liability of any person under the product liability law of any State") demonstrates Congressional intent not to impair such preexisting rights.

Colgate relies primarily on Zeran v America Online, Inc., 958 F. Supp. 1124 (E.D. Va.) aff'd 129 F.3d 327 (4th Cir. 1997) in which a technician initiated a state law negligence action against an internet service provider for attaching the technician's name and telephone number to distasteful slogans. The service provider filed a motion for judgment on the pleadings alleging that the technician's state tort action was preempted by section 230 of the Communications [*4]Decency Act. See 47 U.S.C.A. § 230.[FN4] With regard to the retroactive effect of that preemption provision, the court held that "such clear statutory language cannot reasonably be construed to mean that only some causes of action may be brought, namely those concerning events arising before the enactment of the CDA." Zeran, supra, 958 F. Supp. at 1136. However, the Zeran court conceded that Congress had "expressed its intent with respect to retroactivity more directly in other circumstances." Id. More importantly, the language of the Preemption Clause in this case is completely different from that discussed in Zeran (47 U.S.C.A. § 230), so much so that it is not inconsistent to accord the two preemption statutes different temporal applications. See Landgraf, supra, p. 291.

The court is not persuaded by Colgate's invocation of the canon of statutory construction expressio unius, exclusio alterius ("the express mention of one thing excludes all others") for the proposition that 21 U.S.C.A. § 379s(e) provides the only exception to the preemption provision found in 21 U.S.C.A. § 379s(a). The carve out found in § 379s(e) means only that notwithstanding the provisions of the Preemption Clause, the States may continue to prospectively enforce requirements different from those set forth therein so long as their adoption is by public initiative or referendum. That Congress expressly carved out from section 379s all state requirements adopted by public initiative or referendum prior to 1997 does not mean that all other requirements, both prospective and retroactive, should be preempted.

Colgate's argument that the Preemption Clause bars any claims that accrued after it went into effect does not change this fact. In this respect, Colgate relies on New York's CPLR 214-c, which sets forth a three year statute of limitations within which to bring an action from the date of discovery of the latent effects of exposure to toxic substances, including asbestos.[FN5] By passing CPLR 214-c, the New York legislature adopted "a rule of accrual keyed to the discovery of the manifestations or symptoms of the latent disease that the harmful substance produced.'" Giordano v Market America, Inc., 15 NY3d 590, 603 (2010) (quoting Wetherill v Eli Lily & Co., 89 NY2d 506, 514 [1997]). This is so because, due to the long latency period of asbestos-related diseases, claims of the vast majority of asbestos-victims would be time-barred years, if not decades, before they ever knew they had been injured due to such exposure. In fact, it is not uncommon for the latency period for asbestos-related diseases to be 40 or 50 years.

Although Plaintiff's claim may have accrued upon the manifestation of her disease, and after the 1997 Preemption Clause went into effect, the advent of her injuries is not relevant to the question of whether Colgate owed and/or breached its duty to warn Ms. Feinberg of the hazards [*5]associated with asbestos during the years that it manufactured and sold its product. The time period that Plaintiff actually used the product, that is, from the 1950s through the late 1980s, was decades before the Preemption Clause existed. See Kaiser Aluminum & Chem. Corp. v Bonjorno, 494 US 827, 855 (1990, Scalia, J., concurring) ("principle that the legal effect of conduct should ordinarily be assessed under the law that existed when the conduct took place has timeless and universal appeal.")

It is important to consider that CPLR 214-c and the Preemption Clause were enacted to govern two completely different fields. New York's legislature enacted CPLR 214-c in part to ensure that those individuals who were injured as a result of their earlier exposure to asbestos received their day in court. The Preemption Clause, on the other hand, was enacted by Congress to ensure uniformity in the labeling of cosmetic products. Surely Congress did not intend to abrogate asbestos-related tort actions when it passed the FDCA, nor is there any indication that the state legislature considered the effect of CPLR 214-c in the context of cosmetic labeling requirements. As Colgate would apply them, the interplay of these statutes would have a profoundly unjust impact on the parties' rights, however unintended. Fundamental notions of fairness dictate that this result not be allowed. Cf. Landgraf, supra; see also McKinney's Cons Laws of NY, Book 1, Statutes § 145 ("A construction which would make a statute absurd will be rejected").

Colgate's alleged wrongful conduct occurred before the Preemption Clause went into effect. Therefore, it is clear that the FDCA does not apply in this case, and on this ground alone Colgate's motion to dismiss must be denied in its entirety.[FN6]

II.Express Preemption

Colgate also argues that Plaintiff's common law action is expressly preempted. See 21 U.S.C.A § 379s(a). However, there is nothing to show that the FDA ever issued a formal, binding regulation regarding the content labeling of cosmetic talc products. Absent this critical component, there is no preemption.

By way of background, it is well recognized that the Supremacy Clause (US Const, art VI, cl 2) "may entail pre-emption of state law either by express provision, by implication, or by a conflict between federal and state law." Balbuena v IDR Realty LLC, 6 NY3d 338, 356 (2006). Express preemption involves an explicit statement by Congress that prohibits state governments from enacting laws in a specific area. See Lee v Astoria Generating Co., L.P., 13 NY3d 382, 391 (2009). Pertinent to this concept is section 379s(a) of the Preemption Clause, which provides in relevant part:

[N]o State or political subdivision of a State may establish or continue in effect any requirement for labeling or packaging of a cosmetic that is different from or in addition to, or that is otherwise not identical with, a requirement specifically applicable to a particular cosmetic or class of cosmetics under this Act . . . . (emphasis added)

Colgate's arguments regarding the preemptive effect of section 379s(a) in the circumstances of this case fail in multiple respects. [*6]

As there are no published "requirement[s] specifically applicable" to cosmetic talc, preemption is not triggered. While the Act does not expressly define "requirement" as it relates to the Preemption Clause (See e.g., 21 USCA § 321), the FDA's own publication entitled "The Food and Drug Administration's Development, Issuance, and Use of Guidance Documents" (62 Fed. Reg. 8961-01 [Feb. 27, 1997]) (the "Report") is instructive. The Report was published in response to a concern from Congress that the FDA had been relying less and less on developing its policies through formal, binding mechanisms and was instead relying on informal policy statements (see S. Rep. No. 105-43, at 26). The majority of the Report focuses on the definition and use of "guidance documents."[FN7] Significantly, among other things, the Report advises that "guidance documents" do not include any "communications or actions taken by individuals at FDA or directed to individual persons or firms." 62 Fed. Reg, supra, at 8961. It also rejects the notion that "guidance documents" should be interpreted to "announce[] a regulatory expectation." Id. The Report obliges the FDA to "spot check its staff to ensure that unofficial' guidance documents or other means (such as speeches) are not being used to first transmit to a broad public audience new or different regulatory expectations that are not readily apparent from the applicable statute or regulations." Id. at 8962. It recognizes that the "only binding requirements are those set forth in the statute and FDA's regulations" and that "in order to bind the public, FDA must (with limited exceptions) follow the notice and comment rulemaking process." Id. at 8963.

This is particularly relevant, where as here, Colgate relies almost exclusively on a July 1986 letter by the FDA's then Acting Associate Commissioner for Regulatory Affairs directed only to one Mr. Phillippe Douillet in response to that individuals' November 1983 petition which requested that cosmetic talc be labeled with an asbestos warning statement. The FDA response letter recites in relevant part (Defendant's exhibit 5):

FDA recognizes that asbestos inhalation over extended periods is hazardous to humans. The agency is also aware that some cosmetic talc produced in the 1960's and early 1970's did contain asbestiform minerals. However, your petition has not persuaded us that the cosmetic talc that is presently being produced contains significant amounts of asbestiform minerals. (emphasis added).

* * * *

Consequently, we find that there is no basis at this time for the agency to conclude that there is a health hazard attributable to asbestos in cosmetic talc. Without evidence of such a hazard, the agency concludes that there is no need to require a warning label on cosmetic talc.

* * * *

This denial is without prejudice to the future filing of a petition on this matter, accompanied by [*7]all relevant data in support of the petition.

In all practicality, this letter does not have the binding effect that Colgate would attach to it. The letter is neither a formal regulation nor a guidance document. 62 Fed. Reg., supra at 8961. It was issued only to Mr. Douillet and focused only on talc products that were available in the mid 1980s. The FDA response letter was neither made available to the public nor was it ever subject to the notice and comment process required by the Administrative Procedure Act. See 5 USC § 553. In fact, Colgate itself found the letter only after having made a Freedom of Information Law request. Moreover, the letter expressly provides that the FDA's denial of Mr. Douillet's request was without prejudice, which strongly implies that the letter was not intended to have any preclusive effect.

At best, the letter is an expression of the FDA's informal opinion at the time. The non-binding nature of such an opinion letter is most clearly exhibited by reference to the treatment given to "private letter rulings" by the Internal Revenue Service, as described in Amergen Energy Co., LLC ex rel. Exelon Generation Co., LLC v United States, 94 Fed. Cl. 413, 418 (2010):

Private letter rulings, like certain other written determinations issued by the IRS, "may not be used or cited as precedent." 26 U.S.C. § 6110(k)(3) (2006). Most courts, therefore, do not find private letter rulings, issued to other taxpayers, to be of precedential value in deciding the tax claims before them. See, e.g., Lucky Stores, Inc. & Subsidiaries v. Comm'r, 153 F.3d 964, 966 n. 5 (9th Cir. 1998) ("Taxpayers other than those to whom such rulings or memoranda were issued are not entitled to rely on them.")

Similar to an IRS private letter ruling, the FDA's letter response to Mr. Douillet's request was minimalist at its core and cannot be read to have any kind of binding or precedential value in respect of any one other than the particular petitioner and certainly not the general public.

Colgate also relies on the decision in Dowhal v SmithKline Beecham Consumer Healthcare, 88 P.3d 1, 11 (Cal. 2004). In that case, an individual citizen challenged the failure of several companies that manufactured, marketed, and distributed over-the-counter nicotine replacement therapy products as aids to stop smoking to place certain health warnings that were mandated on such products by California Law. Prior to the suit, one of the defendant manufacturers had sought permission from the FDA to change the label for its product to add such warnings, which the FDA denied. The court dismissed plaintiffs' claims, holding that by denying the manufacturer's request, the FDA had established a federal policy that effectively barred all warnings on nicotine replacement products.

The Dowhal case is factually distinguishable from the case at bar. Dowhal addressed an existing California statute rather than the common law product liability claim at issue here, which both statutes clearly permit (compare 21 USCA § 379s(d) with Cal. Health & Safety Code § 25249.6). Furthermore, there is nothing in the Dowhal decision to show that thecourt ever considered the FDA's own published policy on guidance documents. See 62 Fed. Reg. 8961-01.As a matter of sound policy, this court should not accord the 1986 response letter the broad precedential value Colgate seeks to invest it with. It does not seem just to require an unpublished letter, the very existence of which was known only to the writer and the one individual to whom it was written, to bind the entire country in terms of the cosmetic talc [*8]industry. Moreover, such a concept runs afoul of section (c) of the Preemption Clause, which defines the scope of the preemption as referring to "any specific [state] requirement relating to the same aspect of such cosmetic as a requirement specifically applicable to that particular cosmetic or class of cosmetics under this chapter for packaging or labeling . . . ." (21 USCA § 379s[c]).

Whether or not the FDA response letter relied on by Colgate would constitute a binding expression of the FDA's policy on the labeling of cosmetic talcs, the fact is that in this case Ms. Feinberg used Cashmere Bouquet for more than 30 years prior to the filing of the Douillet petition and the FDA's response thereto. Nothing in the response letter indicates that the FDA's position in that letter applied retroactively, or that the agency even considered the manufacture or sale of talc products during the 1950s, 1960s, or 1970s in rendering same. By contrast, the FDA acknowledged therein that cosmetic talc products contained asbestos in the 1960's and 1970's. See defendant's exhibit 5, supra, p. 9. What is important for purposes of this motion is that the FDA had not implemented any labeling requirement for cosmetic talcs and had not made an informed choice whether to implement any labeling requirement for cosmetic talcs during the relevant time period when Ms. Feinberg used Cashmere Bouquet talcum powder.

III.Implied Preemption

If Congress' intention to preempt state law is not found to be express, a federal statute may nevertheless preempt state law by implication. See Wyeth v Levine, 555 US 555 (2009); see also Balbuena, supra, 6 NY3d at 356. Such implied preemption takes two forms. "The first, referred to as field preemption, occurs if federal law so thoroughly occupies a legislative field as to make reasonable the inference that Congress left no room for the States to supplement it." Balbuena, supra, at 356 (internal quotation marks omitted). The second, referred to as conflict preemption, occurs "where compliance with both federal and state regulations is a physical impossibility . . . or where the state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress." Id., citing Ray v Atl. Richfield Co., 435 U.S. 151, 158 [1978]).

Colgate relies on Pliva, Inc., et al., v Mensing, 564 US ___ , 131 S. Ct. 2567, 180 L. Ed. 2d 580 (2011), which appears to be the latest Supreme Court decision to address implied federal preemption of state tort claims in the context of FDA labeling requirements. In Pliva, the FDA had issued a labeling requirement regarding "Reglan," the brand name of a drug used to treat digestive tract problems. The plaintiffs were prescribed the generic form of the drug, "metoclopramide," which contained the same labeling information as that approved by the FDA for the brand name.[FN8] By 2009 the FDA had ordered a black box warning for Reglan concerning the dangers associated with its long-term use. Plaintiffs suffered severe neurological reactions from taking the generic form of the drug and brought state tort claims against the manufacturers of metoclopramide for failing to adequately warn them of such danger. The basis for the plaintiffs' claims was that the warning labels for the generic drug were inadequate and that the manufacturers had a duty to strengthen their warning labels under the FDA's "changes-being-[*9]effected" process. Pliva, supra, at 2575.

The Supreme Court found that the FDA's federal labeling requirement preempted the plaintiffs' state law claims against the manufacturers of the generic drug because it would have been impossible for the manufacturers to change their warning labels without violating the federal requirement that the warning on a generic drug must match the warning on the brand name version. The Court held that because the FDA "prevented the Manufacturers from independently changing their generic drugs' safety labels . . .[i]t was not lawful under federal law for the Manufacturers to do what state law required of them." Id. at 2570, 2578.

Colgate's reliance on Pliva in the circumstances of this case is misplaced. The Pliva Court instructed that "the question for impossibility' is whether the private party could independently do under federal law what state law requires of it." Id. at 2579. In this case, there is no competing federal requirement, and therefore Colgate could have warned talc consumers consistent with state product liability law regarding the hazards associated with asbestos. Where, as here, there are no federal requirements, public or otherwise, with which Colgate or any other talc manufacturer was required to comply, there is no issue of impossibility.

Colgate also mistakenly relies on Geier v American Honda Motor Co., Inc., 529 U.S. 861 (2000), in which the Supreme Court concluded that plaintiffs' claims against a car manufacturer were impliedly preempted by a federal Department of Transportation ("DOT") ruling. In Geier, the plaintiffs sued to recover for personal injuries on the ground that the defendant failed to install airbags in its cars. In its defense, the defendant relied on a DOT decision in which it declined to require airbags in all 1987 model cars and instead opted for manufacturers to phase in the use of passive restraints over time. The court dismissed plaintiffs' case, holding that any duty to install airbags "presented an obstacle to achieving the variety and mix of devices that the federal regulation sought"' Wyeth, supra, at 580 (quoting Geier, supra, at 881).

In so holding, the Geier Court had the benefit of several material facts that do not obtain in this case. For one, the DOT had enacted a formal rule and had publicly adopted a detailed plan to phase in the passive restraint devices that it required. In addition, the Geier Court had the benefit of the DOT's input confirming its intention that state law necessarily interfered with its regulation and its explicit assessment that the likely impact of allowing state law claims would be to undermine federal law. The FDA's 1986 response letter to the 1983 Douillet petition does not come close to the DOT's public record establishing a binding regulation by which persons may direct their actions. This example alone dictates that the FDA response letter is not entitled to any equivalent deference, which shortcoming is not at all surprising given that such response letter was neither subject to comment nor made available to the public.

Nor is Colgate's reliance on the recent Supreme Court decision in National Meat Ass'n v. Harris, 565 U.S. ____, Slip Op. No. 10-224 (U.S. Jan. 23, 2012) persuasive.[FN9] The federal provision at issue in National Meat Ass'n, supra, is the Federal Meat Inspection Act ("FMIA"), 21 U.S.C.A. §§ 601 et seq., which "regulates a broad range of activities at slaughterhouses to ensure both the safety of meat and the humane handling of animals" in interstate and foreign commerce. Id., Slip Op. at 1. "The FMIA also regulates slaughterhouses serving an exclusively [*10]intrastate market in any State that does not administer an inspection system with requirements at least equal to those' of the [FMIA] . . . . Because California has chosen not to adopt such an inspection program, the FMIA governs all slaughterhouses in the State . . . § 623(a)." Id., Slip Op. at 1, n. 1. To implement the FMIA, extensive regulations governing the inspection and treatment of animals and other aspects of slaughterhouse operations have been promulgated. The regulations which prescribe humane methods for handling non-ambulatory and sick or diseased animals are detailed and comprehensive. The Department of Agriculture's Food Safety and Inspection Service ("FSIS") employs many thousands of trained inspectors, investigators and veterinarians to implement, investigate and enforce the FMIA's requirements. Id., Slip Op. at 2.

In response to a 2008 undercover video released by the Humane Society of the United States that showed California slaughterhouse workers dragging, kicking and electro-shocking sick and disabled cattle in an effort to move them, the California legislature strengthened a pre-existing state statute governing the treatment of non-ambulatory animals for application to its FMIA regulated state slaughterhouses (see Cal. Penal Code Ann. § 599[f]). It imposed a maximum penalty for violation of such state prohibitions of one year in jail and a $20,000 fine (see Cal. Penal Code Ann. § 599[h]). A trade association that represented meat packers and processors and operators of swine slaughterhouses sued the State of California to enjoin the enforcement of § 599(f) against the slaughterhouses on the ground that the FMIA preempts the application of § 599(f).

The Supreme Court unanimously held that "[t]he FMIA's preemption clause sweeps widely €" and in so doing, blocks the applications of § 599f challenged here. The clause prevents a State from imposing any additional or different €" even if non-conflicting €" requirements that fall within the scope of the Act . . . . In essence, California's statute substitutes a new regulatory scheme for the one the FSIS uses. Where under federal law a slaughterhouse may take one course of action in handling a nonambulatory pig, under state law the slaughterhouse must take another." Id., Slip Op. at 6.

The preemption provision at issue in National Meat Ass'n is similar to the Preemption Clause at issue in the case at bar. The National Meat Ass'n provision sets forth, in relevant part: " Requirements within the scope of this [Act] with respect to premises, facilities and operations of any establishment at which inspection is provided under . . . this [Act] which are in addition to, or different than those made under this [Act] may not be imposed by any State.' 21 U.S.C. § 678." Id., Slip Op. at 4.[FN10]

The National Meat Ass'n preemption provision also includes a saving clause which sets forth that it "shall not preclude any State . . . from making requirement[s] or taking other action, consistent with this [Act], with respect to any other matters regulated under this [Act]...." Id., Slip Op. at 4, n.3. (Emphasis added). [*11]

Colgate suggests that the highly similar statutory text in National Meat Ass'n to the Preemption Clause at issue here requires preemption of all state action in this case, "even if non-conflicting." (Letter submission dated January 25, 2012, Faith Gay, Esq.). However, the preemption language of 21 U.S.C.A. § 678 iswhere any similarity of National Meat Ass'n to this case ends. National Meat Ass'n focuses on a state's direct action in the positive enactment, whether conflicting or not, of public laws which penalize the state's slaughterhouses for noncompliance therewith in an area comprehensively regulated and vigilantly overseen in the public arena by the FMIA. In this case we have a private state common law products liability claim based on Colgate's alleged failure to warn of the dangers associated with asbestos in the sale of its Cashmere Bouquet talc in an unregulated arena for the packaging and labeling of such products. If there is no federal regulation to begin with, there can be no conflict. Moreover, while the FMIA saving provision makes a general reference to "other matters regulated under this [Act]", the saving clause in the case at bar expressly permits Plaintiff's products liability claims (see 21 U.S.C.A. § 379s[d]). Finally, in light of the lack of federal regulation of the particular issue herein, it can hardly be said that Plaintiff's claim amounts to state action "in addition" to federal regulation. It is unreasonable to suggest that anything is "in addition" to something that does not exist. In light of such distinguishing features, this court declines to adopt the holding of National Meat Ass'n, supra, in relation to this case.

Plaintiff correctly submits that this case is analagous to Wyeth v Levine, supra. In Wyeth, the plaintiff was administered an injection of "Phenergan," a drug which can cause a patient to develop gangrene if it enter's the patient's artery. The Phenergan label warned of this danger, but did not warn of the increased danger if administered through an intravenous-push injection, as opposed to standard intravenous-drip methods. The existing label was deemed sufficient by the FDA. The plaintiff sued under Vermont state law alleging that the defendant failed to warn of the higher risks associated with the IV-push injection. The defendant argued that this cause of action was preempted by federal law insofar as the FDA had found Phenergan's warning label to be sufficient.

The Wyeth Court found "no merit in this argument, which relie[d] on an untenable interpretation of congressional intent and an overbroad view of an agency's power to pre-empt state law." Id. In the end, the Wyeth Court rejected the defendant's arguments, because, among other reasons, there was strong evidence indicating that Congress did not intend to impliedly preempt state tort law. Id. at 575, quoting Bonito Boats, Inc. v Thunder Craft Boats, Inc., 489 U.S. 141 (1989) ("The case for federal pre-emption is particularly weak where Congress has indicated its awareness of the operation of state law in a field of federal interest, and has nonetheless decided to stand by both concepts and to tolerate whatever tension there [is] between them").

More important, the Wyeth Court found compelling that it had "no occasion . . .to consider the pre-emptive effect of a specific agency regulation bearing the force of law." Wyeth, supra, 555 US at 580 (emphasis added). Here, too, there is no specific agency regulation bearing the force of law that would serve to preempt warnings on the dangers of asbestos in cosmetic talcs. (See Part II, supra). In light of all of the above, Colgate's argument that requiring a warning on its talc products would obstruct the purposes and objectives of the FDA's labeling requirements is without merit and, accordingly, its contention that Plaintiff's failure to warn [*12]claim is impliedly preempted by federal law is without merit.

IV.Primary Jurisdiction

Colgate also moves for dismissal based on the primary jurisdiction doctrine, which "applies where a claim is originally cognizable in the courts, and comes into play whenever enforcement of the claim requires the resolution of issues which, under a regulatory scheme, have been placed within the special competence of an administrative body." Heller v Coca-Cola Co., 230 AD2d 768, 769 (2d Dept 1996). While deferral is not statutorily required, courts may "still apply the doctrine as a prudential matter." Schiller v Tower Semiconductor, Ltd., 449 F.3d 286, 294 (2d Cir. 2006).

No "fixed formula exists" for applying the primary jurisdiction doctrine, but the Second Circuit has generally considered four factors (Id):

(1) whether the question at issue is within the conventional experience of judges or whether it involves technical or policy considerations within the agency's particular field of expertise;

(2) whether the question at issue is particularly within the agency's discretion;

(3) whether there exists a substantial danger of inconsistent rulings; and

(4) whether a prior application to the agency has been made.

None of these factors favor dismissal of this case on primary jurisdiction grounds. In particular, because this and other courts regularly preside over asbestos-related litigation in large numbers across the country, the courts are plainly competent to handle matters like the case at bar. See In re Methyl Tertiary Butyl Ether Products Liability Litigation (MTBE I), 175 F. Supp. 2d 593, 617 (SDNY 2007) ("Referral of an issue to an agency on the grounds of primary jurisdiction is inappropriate when the issue in question is a purely legal one . . or turns on a factual matter requiring no technical or policy expertise"). Further, as Plaintiff points out, it is questionable whether the FDA would even address the matter as the Cashmere Bouquet product at issue is no longer on the market.

The Second Department's decision in Heller, supra lends no support to defendant's argument. In that case, plaintiffs sued several soft drink manufacturers alleging that the artificial sweetener Aspartame had a short shelf-life, causing canned beverages to become spoiled, stale, or tasteless. The plaintiffs sought to compel the defendant manufacturers to disclose the expiration dates on all of its diet soft drink products. The trial court "deferred the issues presented concerning the appropriateness of the labeling of beverages containing Aspartame and the use of Aspartame in aged soft drinks to the FDA ", which had previously issued a formal regulation concerning the use of Aspartame as a sweetener. Id. at 769-70. The court emphasized that the FDA had a special expertise to evaluate Aspartame as a food additive, and that requiring a "use by" label would disrupt national uniformity in the labeling of soft drinks. Id. at 770. Here, because the FDA issued no labeling regulation for cosmetic talc, there is no reason to assert that Plaintiff's personal injury claim will have the same effect.

CONCLUSIONThe court has considered all of defendant's remaining arguments and finds them to be without merit. Accordingly, it is hereby

ORDERED that Colgate-Palmolive Co.'s motion to dismiss Plaintiff's failure to warn [*13]claim is denied in its entirety.

This constitutes the decision and order of the court.



DATED: FEBRUARY 22, 2012

_____________________________________

Sherry Klein Heitler

J.S.C. Footnotes

Footnote 1:It appears that defendant is relying on subdivision (7) of CPLR 3211(a), which allows for dismissal where "the pleading fails to state a cause of action."

Footnote 2:Plaintiff's videotaped deposition was taken on June 2, 2011.

Footnote 3:21 U.S.C.A. § 379s, entitled "Preemption for labeling or packaging of cosmetics," provides:

(a) In general. Except as provided in subsection (b), (d), or (e) of this section, no State or political subdivision of a State may establish or continue in effect any requirement for labeling or packaging of a cosmetic that is different from or in addition to, or that is otherwise not identical with, a requirement specifically applicable to a particular cosmetic or class of cosmetics under this Act, the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.).

(b) Exemption. Upon application of a State or political subdivision thereof, the Secretary may by regulation, after notice and opportunity for written and oral presentation of views, exempt from subsection (a) of this section, under such conditions as may be prescribed in such regulation, a State or political subdivision requirement for labeling or packaging that

(1) protects an important public interest that would otherwise be unprotected;

(2) would not cause a cosmetic to be in violation of any applicable requirement or prohibition under Federal law; and

(3) would not unduly burden interstate commerce.

(c) Scope. For purposes of subsection (a) of this section, a reference to a State requirement that relates to the packaging or labeling of a cosmetic means any specific requirement relating to the same aspect of such cosmetic as a requirement specifically applicable to that particular cosmetic or class of cosmetics under this chapter for packaging or labeling, including any State requirement relating to public information or any other form of public communication.

(d) No effect on product liability law. Nothing in this section shall be construed to modify or otherwise affect any action or the liability of any person under the product liability law of any State.

(e) State initiative. This section shall not apply to a State requirement adopted by a State public initiative or referendum enacted prior to September 1, 1997.

Footnote 4:7 U.S.C.A. § 230(e)(3) provides that "[n]othing in this section shall be construed to prevent any State from enforcing any State law that is consistent with this section. No cause of action may be brought and no liability may be imposed under any State or local law that is inconsistent with this section."

Footnote 5: Such period begins to run from the "date of discovery of the injury by the plaintiff or from the date when through the exercise of reasonable diligence such injury should have been discovered by the plaintiff, whichever is earlier." CPLR 214-c(2).

Footnote 6:In this respect, it is therefore unnecessary for the court to consider Plaintiff's estoppel argument at this juncture.

Footnote 7:The FDA defined the term "guidance documents" to mean: "(1) Documents prepared for FDA review staff and applicants/sponsors relating to the processing, content, and evaluation/approval of applications and relating to the design, production, manufacturing, and testing of regulated products; and (2) documents prepared for FDA personnel and/or the public that establish policies intended to achieve consistency in the agency's regulatory approach and establish inspection and enforcement procedures." 62 Fed. Reg., supra at 8961.

Footnote 8:The FDA interprets 57 Fed. Reg. 17961 (1992) to require a generic drug's labeling to be the same as the brand name drug product's labeling because the brand name product is the basis for the generic product's approval for use by the FDA. Pliva, supra, at 2575.

Footnote 9:Colgate presented this case to the court by letter dated January 25, 2012, after the initial submission date. Plaintiff responded by letter dated January 30, 2012.

Footnote 10:As set forth above, the Preemption Clause at issue in this case (21 U.S.C.A. § 379s[a]) provides, in relevant part: "[N]o State. . . may establish or continue in effect any requirement for labeling or packaging of a cosmetic that is different from or in addition to, or that is otherwise not identical with, a requirement specifically applicable to a particular cosmetic or class of cosmetics under this

Act . . . ."