Preempting the preemption defense.

Troubled when you hear that victims of defective products have been thrown out of court on federal preemption grounds? This article contains strategies that should innoculate state law tort claims from preemption defenses and enable plaintiffs to get to trial or demand a higher settlement.

The Supreme Court of the United States has been skeptical of claims by corporate defendants that consumer protection laws enacted by Congress in the 1960s and 1970s were intended to immunize defendants from state law tort claims. The Court has rejected the most ambitious of these arguments--that federal regulation of medical devices, railroad safety, airline rates, and cigarette labels ousts the entire field of state tort law.(1)

Despite these consumer victories, the preemption defense has made some disturbing incursions in recent years. Unable to obtain tort "reform" in Congress, corporate defendants have achieved relief through the back door by convincing some courts that Congress intended to preempt some avenues of compensation for injured consumers.

For example, courts have held that the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)(2) bars a claim that a manufacturer failed to warn of proper precautions in the application of dangerous pesticides. These courts have cited a provision of the law that preempts states and localities from regulating pesticide labels approved by the Environmental Protection Agency (EPA).(3)

Courts have come to similar conclusions concerning the preemptive effect of the Federal Hazardous Substances Act (FHSA).(4) It prescribes general warnings for certain household goods such as cleaning agents, solvents, and children's products. Defendants complying with FHSA have thus escaped liability even where they knew of certain health hazards, but did not warn of them on the product label.(5)

Finally, despite the Supreme Court's 1996 no-preemption ruling in Medtronic, Inc. v. Lohr,(6) construing the preemption provision of the federal Medical Device Amendments (MDA),(7) some lower federal courts continue to find preemption of tort claims against medical device manufacturers. For example, because the medical device at issue in the Medtronic case was marketed under an abbreviated Food and Drug Administration (FDA) approval process,(8) a few courts have held that tort claims concerning devices marketed under other, more rigorous FDA approval processes are preempted.(9)

Other courts have disagreed, holding that Medtronic generally requires a no-preemption finding regardless of how the device reached the market.(10) We believe that the latter approach is the correct one,(11) as does the FDA. The agency has issued a proposed regulation stating that its marketing approval for a medical device does not preempt products liability claims that may arise concerning that device.(12)

Even if the medical device preemption battle ends in success, it will not be resolved overnight. And preemption remains a problem for consumers seeking compensation for injuries caused by a wide range of potentially dangerous products. In our view, therefore, plaintiff attorneys need to develop strategies for litigating their cases in a world where preemption exists.

Developing strategies

The remainder of this article focuses on two strategies that we believe generally insulate state tort claims from dismissal on preemption grounds.

First, regardless of the scope of preemption, a claim asserting state law tort liability premised on violations of federal statutory or regulatory requirements should never be preempted. Put differently, because many federal preemption provisions preempt only those state requirements "different from, or in addition to" federal requirements,(13) a tort claim premised on state law duties that are the same as federal requirements is not preempted.

Such a claim can often be pled under state law as both a strict liability and a negligence cause of action. However, liability based on violation of a statute or regulation is most commonly referred to as negligence per se, and we will therefore use this terminology.

Second, many federal preemption provisions seek to displace state law with respect to only one set of characteristics of the product. For instance, the preemption provision of the Public Health Cigarette Smoking Act of 1969 concerns only labeling and advertising of cigarettes. Thus, as the Supreme Court has held, tort claims premised on state law duties other than a duty to warn (e.g., fraudulent conduct by cigarette manufacturers) are not preempted.(14) Plaintiff lawyers must carefully review the relevant federal preemption provision and, if possible, plead causes of action unrelated to the subject matter Congress sought to preempt.

Before turning to these strategies in greater detail, we note three preliminary points. First, these strategies assume that there is some preemption of state law tort claims, an assumption that, in most instances, should not be made. For instance, as noted above, there is little, if any, preemption of tort claims involving medical devices. Thus, we urge plaintiffs' counsel to continue to press all reasonable no-preemption arguments.

Second, even where the defense is partially viable, use of these strategies drives a huge hole in that defense. For example, the standards under federal consumer protection legislation are usually stated in such broad terms that a negligence per se claim premised on those requirements would often not diminish the strength of the plaintiff's case. Put another way, jury instructions based on federal requirements would tend to mimic state common law duties and thus not differ substantially from standard jury instructions applicable in tort cases generally.

Third, we focus below on preemption involving medical devices, pesticides, and hazardous substances. Our strategies, however, can be used to thwart preemption defenses arising from a wide range of federal consumer protection statutes, including those involving airlines,(15) flammable fabrics,(16) and railroad safety,(17) to name a few.

Viability of the negligence per se theory

In Medtronic, the Supreme Court unanimously held that the MDA does not preempt state common law claims of negligent manufacturing and labeling when those claims are based on violations of federal law and regulations. At issue was a class III medical device that was placed on the market because the FDA deemed it "substantially equivalent" to a device already on the market.

The reasoning in Medtronic that justifies the unanimous holding that plaintiffs can sue under state law to enforce federal requirements, however, is based on the "different from, or in addition to" language of 21 U.S.C. [sections] 360k(a). The reasoning is not at all linked to the "substantial equivalency" procedures. Therefore, Medtronic directly applies to a range of other federal statutes with similar preemption provisions, such as FIFRA and FHSA.

Medical Devices. The MDA preempts state "requirement[s]" that are "different from, or in addition to," federal requirements applicable to medical devices,(18) The Supreme Court's ruling permitted all the plaintiffs' state common law negligence claims to go forward against the pacemaker manufacturer, although the Court was deeply divided on the question of whether a common law cause of action for damages is a preempted "requirement" within the meaning of the preemption provision.(19)

An oft-overlooked feature of Medtronic, however, is the Court's unanimous holding that state common law actions for damages are not preempted when those common law duties "parallel federal requirements,"(20) --that is, when "they seek damages for [a defendant's] alleged violation of federal requirements."(21) Such common law actions do not impose "requirements" that are "different from, or in addition to," federal requirements because "[t]he presence of a damages remedy does not amount to the additional or different `requirement' that is necessary under the statute."(22)

Accordingly, the Court permitted the Lohrs' state law claims for negligent manufacturing and labeling to go forward insofar as they alleged violations of federal requirements--dismissal of these claims was improper, even if it might eventually "be necessary as a matter of Florida law to prove that [Medtronic's] violations [of Florida common law duties] were the result of negligent conduct, or that they created an unreasonable hazard for users of the product."(23)

It should not be necessary to allege violation of federal standards in the complaint.(24) However, courts have frequently, and erroneously, dismissed negligence per se claims that were not specifically pleaded as arising out of violations of federal law. Thus, no one should risk being bounced from court for failing to plead the case with the specificity that some courts require.

The complaint should allege that the defendant violated state law (e.g., was negligent) in failing to abide by MDA standards, and a state law claim for negligence should allege the facts of the particular case that constitute a violation of federal regulations. The following sample MDA allegations are by no means comprehensive, but they illustrate the point:

1. Negligence claim for an "adulterated" device: "Defendant was negligent, under the common law of the state of [ ], in the manufacture, design, and testing of the XYZ pacemaker implanted in the plaintiff, insofar as the device was adulterated within the meaning of the federal Food, Drug, and Cosmetic Act, 21 U.S.C. [sections] 351."(25)

2. Negligence per se for defective manufacture of a medical device: "Defendant was negligent, under the common law of the state of [ ], in the manufacture of the XYZ pacemaker implanted in the plaintiff, insofar as the defendant failed to meet the requirements for the manufacture of a medical device under the federal Food, Drug, and Cosmetic Act."

3. Negligence per se for defective manufacture of a medical device, specifically citing the MDA's good manufacturing regulations: "Defendant was negligent, under the common law of the state of [ ], in the manufacture of the XYZ pacemaker implanted in the plaintiff, insofar as defendant failed to meet the requirements for the manufacture of a medical device under the federal Food, Drug, and Cosmetic Act and applicable federal regulations, including but not limited to 21 C.F.R. Part 820."

4. Negligence per se for defective manufacture of a medical device, specifically citing a particular MDA good manufacturing regulation that the plaintiff contends was violated: "Defendant was negligent, under the common law of the state of [ ], in the manufacture of the XYZ pacemaker implanted in the plaintiff, insofar as defendant failed to meet the federal regulatory requirements for the training of its personnel under 21 C.F.R. [sections] 820.25."

5. A state law claim premised on violation of FDA's labeling rules: "Defendant was negligent and/or strictly liable in failing to warn the plaintiff of the dangers of its XYZ pacemaker, insofar as its labeling did not meet the requirements of applicable federal regulations, including but not limited to 21 C.F.R. [sections] 801.109."

FIFRA. FIFRA's preemption section provides that states "shall not impose or continue in effect any requirements for labeling or packaging in addition to or different from those required under this act."(26) Even before Medtronic, the Fourth Circuit recognized that plaintiffs could bring what amounted to a state law negligence per se claim for violating some FIFRA-created duties.(27)

Medtronic confirms the correctness of this holding. One state court has relied on the case to rule that FIFRA does not preempt state law claims for failure to comply with federal requirements.(28)

A particularly powerful negligence per se claim relates to inadequate labeling. FIFRA makes unlawful the sale or distribution of "misbranded" pesticides. These are pesticides whose labels contain false or misleading statements or lack directions for use and warnings that are adequate to protect health and the environment.(29)

If a pesticide manufacturer knows or should know of an unreasonable environmental risk posed by its product, the manufacturer is required to revise its labeling to reflect the risk(30)--indeed, EPA approval of a label is not a defense to an EPA enforcement action for misbranding.(31) Because Medtronic permitted the Lohrs' state law failure-to-warn claims to go forward insofar as they alleged violations of federal law,(32) similar "misbranding" claims also state a claim under state law for violations of FIFRA.

One caveat is proper in these cases: The Fourth Circuit has twice held that FIFRA preempts a state negligence per se cause of action alleging that the language of an EPA-approved label failed to warn adequately of risks associated with a pesticide.(33) The court reasoned that even if such actions alleged a violation of federal requirements, they were preempted because they effectively would require a manufacturer to give a warning that was "in addition to or different from" the warning on the EPA-approved label.(34) In light of Medtronic's holding that a plaintiff can sue for failure to warn under state law for violation of MDA labeling duties, however, these Fourth Circuit cases are no longer tenable. This is particularly so since, in both cases, the Fourth Circuit ignored the pesticide manufacturer's continuing duty under FIFRA not to sell or distribute "misbranded" pesticides.

FHSA. The preemption provision of FHSA states:

[I]f a hazardous substance or its packaging is

subject to a cautionary labeling requirement

under [the act] designed to protect against a

risk of illness or injury associated with the substance,

no state or political subdivision of a

state may establish or continue in effect a cautionary

labeling requirement applicable to

such substance or packaging and designed to

protect against the same risk of illness or injury

unless such cautionary labeling requirement

is identical to the labeling requirement

under [the act].(35)

As with the MDA, we do not believe this preemption provision reaches products liability damages actions, but rather was intended solely to preempt state labeling requirements for hazardous substances that are not identical to federal labeling requirements.(36) In any event, Medtronic should permit a plaintiff to bring a state law cause of action for failure to comply with FHSA labeling requirements.(37)

One pre-Medtronic FHSA case(38) illustrates the possibilities that Medtronic has opened up for state law causes of action that impose duties that are "identical to"(39) or "parallel"(40) FHSA labeling requirements. That particular case arose out of a paint-stripping product whose label was regulated by FHSA.

The plaintiff sued under an Ohio statute providing that a product is defective due to inadequate warnings or instructions under certain conditions:

1. if the manufacturer knew or should have known of the risk associated with the product and failed to provide a warning or instruction; and

2. if the manufacturer failed to provide a warning or instruction that a manufacturer exercising reasonable care would have provided, in light of the likelihood that the product would cause the injury for which the plaintiff seeks compensation and in light of the likely seriousness of that harm.(41) The complaint alleged that the warning label was inadequate under this provision of state law.(42)

Comparing the duties imposed by the state statute and those imposed by FHSA labeling regulations--FHSA requires a label to contain "an affirmative statement of the principal hazard or hazards" and "precautionary measures describing the action to be followed or avoided"(43)--the court permitted the claim to go forward: "[A] products liability action for inadequate labeling of a hazardous substance covered' by the FHSA brought pursuant to state law that imposes labeling requirements identical to the requirements of the FHSA is not preempted."(44)

Critically, the key to the court's decision that FHSA does not preempt the state law claim was not the fact that Ohio had a positive statute setting forth the manufacturer's standard of care (after all, a common law standard of care would have served just as well), but rather that the manufacturer's duties under state law and under the FHSA labeling statute were identical and were stated at the same high level of generality.(45)

Countering likely responses of defendants. When confronted with anti-preemption arguments under all these statutes, defendants typically have two responses. Both are without merit.

First, defendants argue that permitting plaintiffs to sue under state law to enforce federal requirements circumvents the rule that the MDA, FIFRA, and FHSA provide no private right of action for damages.(46) This argument, however, was made--and rejected--in Medtronic itself.

There, citing the fact that the FDA has authority to enforce the MDA,(47) Medtronic contended that it was "most unlikely that Congress intended to foreclose private enforcement of federal norms but to allow states to permit such private enforcement of identical norms under state law."(48)

The Supreme Court unanimously rejected this argument, holding that "[i]t is clear that the Lohrs' allegations may include claims that Medtronic has, to the extent that they exist, violated FDA regulations," and that rather than being inconsistent with the MDA, a state law remedy "merely provides another reason for manufacturers to comply with identical existing 'requirements' under federal law."(49) Indeed, it would be illogical to forbid a state law cause of action for violations of federal requirements because such a prohibition would render the doctrine of negligence per se a nullity.

Second, defendants typically contend that it would undermine the federal regulatory scheme to have state courts and juries "second-guessing" federal agency interpretations of the statute and decisions about manufacturers' compliance with federal law. Precisely this argument was made by the manufacturer in Medtronic.(50)

In permitting plaintiffs to sue under state law to enforce federal requirements, the justices were so underwhelmed by this argument that they rejected it without even specifically mentioning it. And that is because the meaning and purpose of Medtronic--and of negligence per se--is to permit judges and juries to interpret federal law and regulations, which is something they do every day in enforcing federal law.

For example, criminal violations under federal statutes are enforced by judges and juries, often leading to large fines and imprisonment. This argument reveals a distrust of the courts--particularly the state courts--that is hostile to federalism, a central postulate of which is that state and federal courts have co-equal responsibility for enforcing federal law.(51)

Pleading to avoid the preempted subject matter

A second way to avoid preemption is to plead causes of action that avoid entirely the preempted subject matter. This strategy is effective when faced with statutes, such as FIFRA and FHSA, that preempt only some topics of state law.

FIFRA. FIFRA preempts only "different" or "addition[al]" state requirements that relate to "labeling or packaging."(52) The statute does not preempt any state law that does not involve the adequacy of the pesticide's labeling or packaging. Thus, even cases that have held that FIFRA preempts labeling-based failure-to-warn claims have held that other state law claims--such as negligent design, negligent testing, negligent manufacture, and strict liability--that are unrelated to labeling or packaging are not preempted by FIFRA.(53)

Claims of safety or effectiveness made by a defendant for a pesticide, such as in advertisements, are also actionable under theories such as negligence, fraud, and misrepresentation if the claims "substantially differ" from "claims made for [the pesticide] as part of the statement required in connection with its [EPA] registration."(54) Furthermore, a claim for breach of any express warranty that the manufacturer voluntarily places on the label and that is not mandated by FIFRA is not preempted, even if the EPA has approved the label.(55)

FHSA. FHSA preempts only state "cautionary labeling requirement[s]" that are not "identical" to cautionary labeling requirements required by FHSA.(56) Thus, as with FIFRA, claims that do not relate to labeling, such as strict liability claims and implied warranty claims that are based on design defect rather than inadequate warnings, are not preempted.(57)

Countering likely responses of defendants. When a plaintiff pleads in the ways described above to avoid the preempted subject matter, defendants usually respond by arguing that the claims are "really" disguised warning or label-based claims. With respect to some claims, this is true.

For example, a design defect claim based on the theory that a product was unreasonably dangerous because it was not accompanied by adequate warnings is a label-based claim. On the other hand, design defect claims based on defects other than inadequate warnings are not preempted by federal preemption provisions that address only labeling.(58)

Therefore, if the plaintiff's theory of the case is based on products liability, the plaintiff lawyer should counter the argument by pointing out that, whatever the name given to the claim--be it negligent testing, design defect, defective manufacture--the essence of the claim is that the product should not have been marketed with the characteristics that it had when the plaintiff was injured.

Similarly, if the plaintiff's theory of the case is express warranty or fraud, the plaintiff lawyer should assert that these causes of action have nothing to do with whether the defendant warned the plaintiff, but, rather, in the case of express warranty, whether the defendant contractually promised something apart from the label,(59) or, in the case of fraud, whether the defendant violated a general duty not to deceive, a duty that is unrelated to the label.(60)

Consistent with the views of the Supreme Court, plaintiff lawyers have a range of pleading tools to avoid federal preemption. If the strategies that are set forth in this article are followed, counsel should succeed in thwarting preemption defenses in cases involving medical devices, pesticides, hazardous substances, airline rates, railroad safety, flammable fabrics, and beyond.(61)

Notes

(1.) See Medtronic, Inc. v. Lohr, 116 S. Ct. 2240 (1996) (medical devices); American Airlines, Inc. v. Wolens, 513 U.S. 219 (1995) (airline rates); CSX Transp., Inc. v. Easterwood, 507 U.S. 658 (1993) (railroad safety); Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992) (cigarette labels).

(2.) 7 U.S.C. [subsections] 136-136y (1994).

(3.) See, e.g., Papas v. Upjohn Co., 985 F.2d 516, 518 (11th Cir.), cert. denied, 510 U.S. 913 (1993); Worm v. American Cyanamid Co., 5 F.3d 744, 747-48 (4th Cir. 1993) (Worm II).

(4.) 15 U.S.C. [subsections] 1261-1278 (1994).

(5.) See, e.g., Comeaux v. National Tea Co., 81 E3d 42 (5th Cir. 1996); Moss v. Parks Corp., 985 F.2d 736 (4th Cir. 1993).

(6.) 116 S. Ct. 2240.

(7.) 21 U.S.C. [sections] 360k(a) (1994).

(8.) Medtronic, 116 S. Ct. 2240, 2246-48.

(9.) See, e.g., Mitchell v. Collagen Corp., 126 F.3d 902 (7th Cir. 1997), cert. denied, 118 S. Ct. 1300 (1998).

(10.) See, e.g., Ojav. Howmedica, Inc., 111 F.3d 782, 789 (10th Cir. 1997); Kernats v. Smith Indus. Med. Sys. Inc., 669 N.E.2d 1300 (Ill.App.Ct.), appeal denied, 675 N.E.2d 634 (Ill. 1996), later proceeding, 117 S. Ct. 1690 (1997).

(11.) See Brian Wolfman & Allison Zieve, Litigating-Pre-Emption Issues After Medtronic Inc. v. Lohr, 11 TOXICS L. REPORTER (BNA) 296 (Aug. 7, 1996); see also Robert B. Leflar & Robert S. Adler, The Preemption Pentad: Federal Preemption of Products Liability Claims After Medtronic, 64 TENN. L. REV. 691 (1997).

(12.) Medical Devices; Preemption of State Product Liability Claims, 62 Fed. Reg. 65,384 (1997) (to be codified at 21 C.F.R. [sections] 808.1(d)(11)& (12)) (proposed Dec. 12, 1997).

(13.) See, e.g., 21 U.S.C. [sections] 360k(a) (1994) (MDA); 7 U.S.C. [sections] 136v(b) (1994) (FIFRA).

(14.) See Cipollone, 505 U.S. 504, 527-29.

(15.) See, e.g., Wolens, 513 U.S. 219.

(16.) See, e.g., Wilson v. Bradlees of New England, Inc., 96 E2d 552, 556-59 (1st Cir. 1996), cert. denied, 117 S. Ct. 1083 (1997).

(17.) See, e.g., Easterwood, 507 U.S. 658, 665-73.

(18.) See 21 U.S.C. [sections] 360k(a) (1) (1994).

(19.) Compare Medtronic, 116 S. Ct. 2240, 2251-53 (Stevens, J., with three justices concurring); with id. at 2259-61 (Breyer, J., concurring in part and concurring in the judgment); and id. at 2263-64 (O'Connor, J., with three other justices, concurring in part and dissenting in part).

(20.) Id. at 2255; accord id, at 2261 (Breyer, J., concurring in part and concurring in the judgment).

(21.) Id. at 2264 (O'Connor, J., concurring in part and dissenting in part).

(22.) Id. at 2255; accord id. at 2261 (Breyer, J., concurring in part and concurring in the judgment) and at 2264 (O'Connor, J., concurring in part and dissenting in part).

(23.) Id. at 2255.

(24.) See National Bank of Commerce v. Kimberly-Clark Corp., 38 F.3d 988, 992 n.2 (8th Cir. 1994).

(25.) See Cosmo v. Medtronic, Inc., 925 F. Sup. 602, 606-09 (N.D. Ind. 1996).

(26.) 7 U.S.C. [sections] 136v(b) (1994) (emphasis added).

(27.) See, e.g., Worm v. American Cyanamid Co., 970 F.2d 1301, 1308 (4th Cir. 1992) (Worm I).

(28.) Romah v. Hygienic Sanitation Co., 705 A.2d 841 (Pa. Super. Ct. 1997).

(29.) See 7 U.S.C. [subsections] 136(q)(1)(A), (F) & (G), 136j(a)(1)(E) (1994).

(30.) See id. [subsections] 136(q), 136d(a)(2).

(31.) See id. [subsections] 136(q)(1)(A), 136a(f)(2).

(32.) 116 S. Ct. 2240, 2255-56; accord id, at 2261 (Breyer, J., concurring in part and concurring in the judgment) and at 2264 (O'Connor, J., concurring in part and dissenting in part).

(33.) See Lowe v. Sporicidin Int'l, 47 F.3d 124, 128-30 (4th Cir. 1995); Worm II, 5 F.3d 744, 748.

(34.) See Worm II, 5 F.3d 744, 748.

(35.) 15 U.S.C. [sections] 1261 note (b)(1)(A) (1994) (emphasis added).

(36.) FHSA's general labeling requirements are set out at 15 U.S.C. [sections] 1261(p).

(37.) See Moss, 985 F.2d 736, 740-41 & n.2.

(38.) Jenkins v. James B. Day & Co, 634 N.E.2d 998 (Ohio 1994).

(39.) 15 U.S.C. [sections] 1261 note [sections] (b)(1)(A) (1994).

(40.) Medtronic, 116 S. Ct. 2240, 2255.

(41.) Jenkins, 634 N.E.2d 998, 1002-03 (quoting Ohio Rev. Code [sections] 2307.76(A)(1)).42. Id. at 1003.

(43.) 15 U.S.C. [sections] 1261(p)(1).

(44.) Jenkins, 634 N.E.2d 998, 1005.

(45.) Id. at 1004.

(46.) See, e.g., Bailey v. Johnson, 48 F.3d 965, 967-68 (6th Cir. 1995).

(47.) See 21 U.S.C. [sections] 337 (1994).

(48.) Brief for Cross-Respondent Medtronic, Inc., at 43, Medtronic, 116 S. Ct. 2240 (Nos. 95-754, 95-886), 1996 WL 144167, at *43 (U.S. Mar. 29, 1996).

(49.) Medtronic, 116 S. Ct. 2240, 2255; accord id. at 2261 (Breyer, J., concurring in part and concurring in the judgment) and at 2264 (O'Connor, J., concurring in part and dissenting in part).

(50.) Brief for Cross-Respondent Medtronic, Inc., 1996 WL 144167, at *44-46.

(51.) See Gulf Offshore Co. v. Mobil Oil Corp., 453 U.S. 473, 477-78 (1981); Atlantic Coast Line R.R.v. Brotherhood of Locomotive Eng'rs, 398 U.S. 281, 295-96 (1970).

(52.) 7 U.S.C. [sections] 136v(b) (1994).

(53.) See Worm I, 970 F.2d 1301, 1307; Burke v. Dow Chem. Co., 797 F.Supp. 1128, 1141-42 (E.D.N.Y. 1992).

(54.) Lowe, 47 F.3d 124, 130 (quoting 7 U.S.C. [sections] 136j(a)(1)(B)(1994)).

(55.) Kawamata Farms, Inc. v. United Agri Prods., 948 P.2d 1055, 1077-80 (Haw. 1997); Walker v. American Cyanamid Co., 948 P.2d 1123, 1127-28 (Idaho 1997).

(56.) 15 U.S.C. [sections] 1261 note [sections] (b)(1)(A) (1994).

(57.) Wallace v. Parks Corp., 629 N.Y.S.2d 570 (App. Div. 1995); Lee v. Boyle-Midway Household Prods., Inc., 792 F.Supp. 1001, 1007 (W.D. Pa. 1992).

(58.) See, e.g., Lee, 792 F. Supp. 1001, 1007.

(59.) See, e.g., Cipollone, 505 U.S. 504, 525-27; Wolens, 513 U.S. 219, 229.

(60.) See Cipollone, 505 U.S. 504, 527-29; see also id. at 542-44 (Blackmun, J., concurring in part, concurring in the judgment in part, and dissenting in part).

(61.) If you need assistance from PCLG on preemption issues, call [phone] or send an e-mail to [e-mail]. PCLG's website, www. citizen.org, includes briefs and other materials on federal preemption.

Brian Wolfman, a staff attorney at Public Citizen Litigation Group (PCLG), Washington, D.C., was one of the plaintiffs' attorneys in Medtronic, Inc. v. Lohr. Douglas L. Stevick is PCLG's 1997-98 Abraham Fuchsberg Fellow.