Posted with permission of TRIAL (March 2007) TRIAL • Fighting preemption • March 2007 • Volume 43, Issue 3 Copyright American Association for Justice, formerly Association of Trial Lawyers of America. Why preemption proponents are wrong

Corporate defendants’ claim that the effect of state tort actions is equivalent to state positive law has no merit. The reality is that consumer protection can be guaranteed only when tort remedies work in tandem with federal regulation.

BRIAN WOLFMAN

he basic idea of federal preemp- because, for instance, these products seeking damages on the ground that the tion is easily stated: It is a con- have been approved for marketing by a plaintiff’s injuries were caused by the Tstitutionally mandated principle federal agency harms both the injured device’s defective design or inadequate that demands that federal law trumps people and society generally. labeling is also preempted. state law when the two confl ict or in In other words, is the effect of posi- the rare instances when a federal law is An unsound theory tive law (in this case, a state’s positive so comprehensive that there’s no role law requirement that a product not be The theoretical basis that defendants left for state law to fi ll. But in practice, marketed) the same as a jury’s damag- offer for preemption of state tort law courts have often had diffi culty applying es verdict (in this case, a state’s award is not fi rmly established in preemption the principle. of damages based on a design defect)? doctrine. I don’t mean the detailed com- For plaintiff lawyers, preemption is This is an important question because an ever-present worry. When your cli- parison between a particular federal reg- defendants have relied heavily on the ent has been injured by a defective car, ulatory regime and the state tort claims argument that positive law and com- truck, medical device, boat, tobacco asserted in a particular case. There, as mon law damages exert the same regu- product, pesticide, or mislabeled drug, the case law shows, the devil is in the latory effect and that when positive law or has been victimized by a bank or details.2 I am referring to defendants’ ef- is preempted, common law should be as other lending institution, the defendant forts to equate the effect of tort law—of well. will probably assert that federal law pre- empts your client’s state law damages Defendants have relied heavily on the argument claim. You can expect this argument no matter how weak the federal regulatory that positive law and common law damages exert scheme or how attenuated the connec- the same regulatory effect and that when positive tion between that scheme and the harms your client suffered or the state law law is preempted, common law should be as well. duties under which your client seeks a remedy.1 state law damages actions—with posi- Does the Supreme Court buy into But defendants’ and tort “reformers’” tive state regulation. this equivalence between positive state pro-preemption arguments do not refl ect For example, assume that a fed- regulation and a jury’s award of damag- current preemption doctrine as estab- lished by the courts. A common—and eral agency has approved the market- es? To put it mildly, the Court has been false—argument for preemption, for ex- ing of a particular medical device as it unpredictable. ample, is that state tort law necessarily is currently designed, manufactured, Its fi rst statement on this topic was interferes with federal regulatory objec- and labeled and that a state’s ban on in the labor law context, in San Diego tives. the marketing of this device would be Building Trades Council v. Garmon.3 Moreover, preemption of state tort preempted on the ground that it would Garmon involved a business’s attempt law is a bad idea. Immunizing the mak- confl ict with federal law. The question, to prevent union picketing by bringing a ers of products that cause injury simply then, is whether a state law tort suit suit under California law seeking an in- junction and damages. In an early stage In 1992, the Court seemed to change to warn. of the litigation, the Supreme Court ruled course. A plurality opinion in the fa- In responding to the tobacco in- that the injunctive relief was preempted mous tobacco liability case, Cipollone dustry’s arguments that the 1965 act by the National Labor Relations Act.4 v. Liggett Group, Inc., relied on the preempted state law damages claims The Court also rejected the attempt to language from Garmon quoted above based on the industry’s failure to warn, impose damages under California law: and concluded that the Public Health the Court seemed to reject the Garmon Cigarette Smoking Act of 1969, which viewpoint as a general, overarching jus- [State] regulation can be as effectively requires specifi c warnings on cigarette tifi cation for preemption: “[T]here is no exerted through an award of damages as packages, preempted some, but not all, general, inherent confl ict between feder- through some form of preventive relief. tort claims based on a failure to warn al preemption of state warning require- The obligation to pay compensation can 8 be, indeed is designed to be, a potent about the dangers of smoking. ments and the continued vitality of state 11 method of governing conduct and control- This section of the Cipollone deci- common law damages actions.” ling policy. Even the states’ salutary effort sion was premised in part on particular The internal tension in Cipollone carried over to a 1996 medical device The Supreme Court has said it is ‘perfectly rational’ preemption case, Medtronic v. Lohr.12 A plurality opinion, again authored by for Congress to preempt state positive law but not Justice Stevens, suggested that a ratio- nal Congress could (and did) treat state common law claims, which ‘perform an important common law damages actions differ- remedial role in compensating accident victims.’ ently from positive state law,13 while the dissenters and one concurring justice generally equated the two.14 to redress private wrongs or grant com- language of the 1969 act that purported- pensation for past harm cannot be exerted ly pointed in the direction of preemption to regulate activities that are potentially of common law duties.9 But it also relied Divining congressional subject to the exclusive federal regulatory intent scheme.5 on Garmon’s claim that damages liabil- ity can have, and is intended to have, the Although the Supreme Court’s con- Garmon was not a products liability same effect on the defendant’s future fusion on this score runs deep, it is im- case, and federal labor laws, unlike most conduct as would positive state regula- portant to mention three rulings from federal statutes that regulate consumer tion. Since then, defendants in products the Court that directly challenge the products and services, authorize mone- liability and similar cases have relied on premise that positive law and damages tary remedies. Garmon thus presented a this language from Garmon and Cipol- liability are the same for preemption different situation from the medical de- lone ad nauseam, in an effort to show purposes. First, in Goodyear Atomic vice example above because neither the that state tort law and state positive law Corp. v. Miller, the Court considered relevant federal regulatory statute nor have the same regulatory effect—that is, whether an Ohio administrative agency any other federal law provides a means that they are inherently the same. could, consistent with federal preemp- to compensate people harmed by medi- But not so fast. In the majority por- tion principles, award additional work- cal devices.6 tion of the Cipollone decision—which ers’ compensation benefi ts based on Nevertheless, it is easy to see why addressed the preemptive effect of an violations of state safety standards at preemption-seeking defendants rely so earlier version of the cigarette-labeling a federally owned, privately operated 15 heavily on Garmon. Its exclusive focus law (the 1965 Federal Cigarette Label- nuclear production facility. on tort damages as a regulatory, rather ing and Advertising Act)—just a few The Court held that the additional award was not preempted. Acknowledg- than a compensatory, tool is useful to paragraphs above the endorsement of ing that state positive law safety require- defendants seeking to equate positive Garmon, the same justice who wrote ments might be preempted, the Court law with tort law. the plurality opinion, Justice John Paul viewed damages liability as fundamen- But Garmon arose in a context quite Stevens, said something quite different: tally different: different from modern tort law, and even that the 1965 act, because of its particu- after Garmon, the prevailing assumption lar wording, preempts “only positive Congress’ reluctance to allow direct state in the courts was that regulatory stan- enactments by legislatures or adminis- regulation of federal projects says little dards and state compensation schemes trative agencies that mandate particular about whether Congress was likewise concerned with the incidental regulatory 7 occupied separate spheres. Indeed, until warning labels” and “not . . . common effects arising from the enforcement of a the 1990s, the Supreme Court had never law damages actions.”10 The Court held workers’ compensation law, like Ohio’s, held a state law tort claim preempted that although the 1965 act preempted that provides an additional award when the by federal regulation, at least not where state positive law labeling requirements, injury is caused by the breach of a safety regulation. The effects of direct regula- federal law itself did not provide a right it did not preempt any state damages ac- tion on the operation of federal projects of action for damages. tions, even those premised on a failure are signifi cantly more intrusive than the incidental regulatory effects of such an ad- itive law, it has not expressly touted tort protector of its citizens’ health and safe- ditional award provision. [The] appellant law’s remedial function. And tort law’s ty.23 may choose to disregard Ohio safety regu- lations and simply pay an additional work- ability to compensate the injured is one In short, once the overarching justifi - ers’ compensation award if an employee’s way that tort law and positive adminis- cation for tort preemption is gone, pre- injury is caused by a safety violation. We trative law requirements differ funda- emption proponents must come up with believe Congress may reasonably deter- mentally. some other, more case-specifi c, justifi - mine that incidental regulatory pressure is acceptable, whereas direct regulatory au- Finally, in Bates v. Dow Agrosci- cation. They no longer have a knockout thority is not.16 ences, a 2005 case about whether the punch. Federal Insecticide, Fungicide, and Ro- A typical express preemption provi- The last sentence, which suggests denticide Act preempts state tort claims, sion goes something like this: Preemp- that Congress had thought about the dif- the Court overruled the pro-preemption tion occurs where a state law “require- ferences between “incidental regulatory position of nearly every federal circuit ment” confl icts with a federal positive pressure” and “direct regulatory author- and about 30 state appellate courts.19 law “requirement.”24 That language, ity,” seems a misstatement. Like most The Court confronted an express pre- standing alone, doesn’t tell the courts federal regulatory statutes—even those emption provision that preempts state much about whether state tort law is or that expressly preempt state law—the law “requirements” when they differ is not preempted. If anything, because statutes relevant in Goodyear Atomic from, or add to, federal regulatory re- the federal law “requirement” is indis- had said nothing about preemption of quirements.20 In holding that most (and putably a positive regulatory require- state law monetary liability. In reality, possibly all) of the plaintiff’s claims ment, it makes sense to think of the state the Court was saying that positive law were not preempted, the Court ex- law “requirement” as being one of posi- and damages liability do not exert the plained that a positive law “requirement tive law as well.25 same regulatory effect and that a reason- is a rule of law that must be obeyed; an And these ambiguous provisions sit able Congress, if it had thought about event, such as a jury verdict, that merely smack-dab in the middle of statutes en- the question, would not have equated motivates an optional decision, is not a acted in the 1960s and 1970s to improve the two in confronting the issue present- requirement.”21 The Court was making consumer safety and health or fi nancial ed by the case. the point that positive regulation has a security, such as the Medical Device Nor can the Garmon formulation be much more direct effect on conduct than Amendments or the National Traffi c squared with two more-recent Supreme does a damages award. and Motor Vehicle Safety Act, to name Court forays into tort preemption. In Why are these cases important? Be- but two. And those statutes contain not Sprietsma v. Mercury Marine, which cause if the basic theoretical justifi ca- a word—not a single word—suggesting considered a preemption argument tion for preemption—equating state that what Congress was really doing was based on the Federal Boat Safety Act positive law and state tort law—is not enacting massive tort “reform” more ex- (FBSA), a young woman died tragically really a part of the legal landscape, then pansive than the express tort “reform” when she fell overboard and was struck defendants have only two things on statutes that Congress has been repeat- by a boat’s propeller blades.17 One of the questions the case presented was wheth- To the extent that tort law exerts regulatory effect er a state common law claim premised on a boat manufacturer’s failure to in- on a drug maker, it does so only after repeated suits, stall a propeller guard was preempted settlements, and fi ndings of liability; even then by the FBSA’s express preemption pro- vision—which, according to the manu- the cause-and-effect relationship is rarely clear. facturer, preempted all positive law and common law regarding boat safety. which to hang their hats: highly ambigu- edly unwilling to enact over the last 20 The Court rejected that argument. It ous express preemption provisions cre- years.26 noted that it is “perfectly rational” for Congress to preempt state positive law ated by Congresses that were striving to Let’s take one possible illustration of but not “common law claims, which— increase protections for consumers, or, such a claim’s implausibility. Is it pos- unlike most administrative and legisla- even less plausibly, claims of implied sible that the Medical Device Amend- tive regulations—necessarily perform preemption arising from the interstices ments to the Food, Drug, and Cosmetic an important remedial role in compen- of federal law.22 Act27—sponsored by Sen. Edward Ken- sating accident victims.”18 Neither of these assertions should nedy (D-Mass.) and passed in 1976 by This statement is important because, fare well if the courts consistently ap- an overwhelmingly Democratic post- generally, even when the Court has re- ply the presumption against preemption Watergate Congress in response to fused to fi nd tort claims preempted and of state law, which is said to apply with medical device tragedies such as the has challenged the notion that tort law particular force in tort cases because of Dalkon Shield saga28—were intended to exerts the same regulatory effect as pos- the state’s traditional role as the prime eliminate the right to recover under state law for injuries caused by defective duct of the regulated industry. has a nonregulatory component—com- FDA-approved medical devices? Some Contrast that direct regulatory power pensation—that is virtually never a people may believe that tort preemption with the tort system. Large industry play- component of the U.S. administrative is a good thing, but they can’t seriously ers generally react slowly, and some- law system. To put it another way, feder- believe that it arises from an enactment times not at all, to liability pressures. al agencies that regulate virtually never like the Medical Device Amendments. Most instances of liability are absorbed compensate. As Kennedy bluntly put it, “The leg- without a change in the manufacturer’s Unfortunately, much modern preemp- islation is written so that the benefi t of conduct, or at least the kind of change tion doctrine and many legal academics, the doubt is always given to the con- that a regulator could bring about swift- intrigued by the theoretical regulatory sumer. After all, it is the consumer that ly. As the District of Columbia Circuit effect of tort as a means of social con- pays with his health and life for medical has recognized, the imposition of dam- trol, have not focused on the compensa- device malfunctions.”29 ages liability does not legally compel the tory component. Yet the principal pur- pose of tort law—particularly in a world Even those inside the FDA have raised serious where, at least in theory, the agencies are already accomplishing their regula- questions about the agency’s ability to achieve its tory function—is compensation. Compensation is what distinguishes mission. FDA employees have expressed alarm at the tort system from the modern regula- the improper pressure they felt to approve drugs. tory state. That is not to say that the cre- ation and perpetuation of tort duties are not intended to have an effect on future defendant to alter its future conduct.32 A practical question conduct. They are. But, at the very least, To the extent that tort law exerts a The doctrinal playing fi eld regarding regulatory control and compensation regulatory effect on a drug manufac- preemption is therefore wide open. The are major goals of tort law. That being turer, it does so only after repeated suits, next question, then, is a practical one: so, why should the compensation prin- settlements, and fi ndings of liability— Does equating positive law with tort ciple give way to the regulatory prin- law work as a practical matter? In other and even then the cause-and-effect rela- ciple when there is a perceived “regula- words, does the equation make empiri- tionship is rarely clear. In many instanc- tory” confl ict between tort law and the cal sense? That’s an easy one, and the es, even after an onslaught of lawsuits, administrative state? And why shouldn’t answer is no. the manufacturer holds out for a long the plaintiff’s interest in compensation As a matter of regulatory impact, it time—or forever. The Supreme Court prevail, particularly given the current is a huge leap from the proposition that put this well in Goodyear Atomic, when political reality, in which federal law tort law is meant to (and does to some it said that “the effects of direct regula- provides neither comprehensive health degree) have a regulatory effect, to the tion on the operation of federal projects care nor accident insurance? proposition that its impact is equivalent are signifi cantly more intrusive than the Given these political defi ciencies and to direct, positive law regulation. incidental regulatory effects of such an the relatively weak regulatory effect of 33 When the FDA, for instance, wants to additional award provision.” tort, the compensation principle should get a food, drug, or device off the mar- Of course, there is some symbiosis trump the regulation principle, at least ket, it can do so swiftly. It can actually here. The regulatory system exerts pres- in the absence of the most direct types seize products, like David Kessler did sures on the tort system and vice versa, of confl ict between federal law and state with misbranded orange juice when he both exert fi nancial and political pres- law (for instance, where federal law for- fi rst became FDA commissioner.30 It can sure on politicians and industry, and bade boat propeller guards, and the state deny regulatory approval; it can impose both are capable of publicizing informa- law tort claim was premised on a duty advertising restrictions; it can demand tion that would otherwise stay locked to provide one,34 or where federal law data. The Food, Drug, and Cosmetic away in corporate fi le cabinets. But that prohibited air bags, and the state law tort Act gives industries the right to oppose doesn’t alter the basic truth: There is no claim was premised on a duty to require agency action, but as a practical matter, reason to build a body of legal literature them35). In this regard, one conception the agency generally can exert its posi- and judicial doctrine on the equivalency of strict products liability—in which tive law priorities with great force. between tort and direct regulation when the law acknowledges that even social- Of course, agencies often do not that equivalency is not remotely accu- ly benefi cial products can cause grave exercise their full regulatory authority rate. harm and allows those products on the because of indifference, insuffi cient re- market but compensates those who are sources, lack of political will, or “cap- Compensatory role injured—is perfectly consistent with a ture” by the regulated industry.31 But Against this background, there are regulatory system that seeks, but can federal agencies, if they wish to do so, two reasons why tort preemption is gen- never fully achieve, optimal health and have the ability to quickly alter the con- erally a bad idea. First, the tort system safety benefi ts.36 The regulatory system is not intend- preemption, but to show why preemp- propriately exclude or alter technical in- ed to prevent all harm, nor could it—and tion would do violence to public safety formation or my conclusions in an FDA this is the second reason why preemp- and to the agency’s mission. To put it scientifi c document.”44 tion is generally a bad idea. Regulation mildly, the FDA’s preemption plea is ill- Similarly, in a 2003 survey by the is meant to balance risks and benefi ts timed. Recently, two independent gov- FDA’s parent agency, the Department (with the knowledge that injuries will ernment reports have described the dan- of Health and Human Services, 18 per- occur) in a highly imperfect system, gerous shortcomings in FDA oversight cent of FDA physicians and scientists where regulators depend almost ex- of drug safety. who responded reported pressure to rec- clusively on profi t-motivated sellers to First, in a report issued in March ommend that drugs be approved, even submit all available, relevant data—data 2006, the Government Accountability when they had reservations about the that changes over time, as new informa- Offi ce concluded that the drugs’ safety, effectiveness, or quality, tion emerges after a product is marketed and 66 percent lacked confi dence that to the public. FDA lacks clear and effective processes the agency “adequately monitors the for making decisions about, and provid- Even if we assume that tort law ex- ing management oversight of, postmarket safety of prescription drugs once they erts some regulatory pressure—and I safety issues. The process has been limited are on the market.”45 do—why wouldn’t we want it to do so? by a lack of clarity about how decisions Rezulin, Lotronex, Celebrex, Vioxx, The Supreme Court itself has seemed are made and about organizational roles, Zoloft, Prozac, and Accutane are among insuffi cient oversight by management, and to answer that question affi rmatively, data constraints.41 the many drugs that have required post- understanding both that tort law does approval labeling changes to add or not exert the same regulatory effect as And more recently, a National Acad- strengthen warnings. Several were re- positive law and that it can apply use- emies Institute of Medicine report, moved from the market entirely. ful pressure where the regulatory system prepared at the FDA’s request, found The labeling changes were due, at fails to achieve its full purposes.37 that the drug safety system is impaired least in part, to information and pressure A present-day example helps il- by “serious resource constraints that derived from the tort system. As a 2002 lustrate the serious concerns raised by weaken the quality and quantity of the medical journal article noted, “Many a system that would tolerate both tort science that is brought to bear on drug serious [adverse drug reactions] are preemption and regulatory failure. In a safety; an organizational culture in [the discovered only after a drug has been regulatory preamble accompanying a FDA] that is not optimally functional; on the market for years. Only half of new FDA rule concerning drug labeling, and unclear and insuffi cient regulatory newly discovered serious [adverse drug the agency has claimed that its labeling authorities particularly with respect to reactions] are detected and documented rules preempt state tort claims based on enforcement.”42 in the Physicians’ Desk Reference [the a drug manufacturer’s failure to warn.38 In other words, the agency maintains The Supreme Court recognizes that tort law does that the principal type of state law dam- ages claim raised by people injured by not exert the same regulatory effect as a positive drugs has been silently obliterated by federal law—silently, because no fed- law and can apply useful pressure where the eral statute or regulation remotely sug- regulatory system fails to achieve its full purposes. gests such a result. As a legal matter, the FDA’s view seems like a stretch for a Even those inside the agency have doctors’ drug-labeling bible] within sev- host of reasons, not the least of which is raised serious questions about the FDA’s en years after drug approval.”46 that when Congress was considering the With all that said, do we really want legislation that became the Food, Drug, ability to achieve its mission. In two re- to override the tort system? Do we real- and Cosmetic Act in 1938—the legis- cent surveys, FDA employees expressed ly want a system where imperfect regu- lation that authorizes the FDA to issue alarm at the improper pressure they felt latory agencies, all too often infl uenced labeling rules in the fi rst place—it “re- to approve new drugs. by the regulated industries, must do the jected a provision in a draft of the origi- In one survey, released by the Union job on their own, while those who are nal (FDCA) providing a federal cause of of Concerned Scientists last summer, injured have no means of compensation? action for damages because ‘a common 60 percent of FDA employees who re- To ask those questions is to answer them. law right of action [already] exists.’”39 sponded knew of situations “where As my colleague Allison Zieve and I commercial interests have inappropri- BRIAN WOLFMAN is director of the have elsewhere explained, the FDA’s ately induced or attempted to induce the Public Citizen Litigation Group in preemption position has no legal support reversal, withdrawal, or modifi cation of Washington, D.C. The group litigates and is not entitled to judicial deference.40 FDA determinations or actions.”43 Eigh- preemption cases at all levels of the My point for present purposes is not teen percent agreed that “I have been federal and state courts. Wolfman can to undermine the FDA’s legal claim to asked, for nonscientifi c reasons, to inap- be reached at [email protected]. Notes by judges and juries. . .[,] suggesting that the pre- rity/FDA-Survey-Brochure.pdf (accessed Feb. 5, 1. For a discussion of strategies for defeat- empted ‘requirements’ established or continued by 2007). ing a preemption defense based on identifying states also refer primarily to positive enactments 44. Id. of state law.”). differences between the purpose of the relevant 45. U.S. Dept. of Health & Human Servs., federal regulatory scheme and the purpose of the 26. See e.g. Robert S. Adler & Richard A. Off. of Inspector Gen., FDA’s Review Process for relevant state common law, see Brian Wolfman & Mann, Preemption and Medical Devices: The New Drug Applications—A Management Review Douglas L. Stevick, Preempting the Preemption Courts Run Amok, 59 Mo. L. Rev. 895, 940-42 & 12, 19 (Mar. 2003), www.oig.hhs.gov/oei/reports/ Defense, TRIAL 54 (July 1998). nn. 185-89 (1994). oei-01-01-00590.pdf (accessed Feb. 5, 2007). 2. See e.g. Bates v. Dow Agrosciences, 544 27. Pub. L. No. 94-295, 90 Stat. 539 (1976). 46. Karen E. Lasser et al., Timing of New U.S. 431, 437-42 (2005); Medtronic, Inc. v. Lohr, 28. See e.g. Medtronic, 518 U.S. at 475-76 Black Box Warnings and Withdrawals for Pre- 518 U.S. 470, 475-80 (1996) (plurality). (plurality); Adler & Mann, supra n. 26, at 912 & scription Medications, 287 JAMA 2215, 2218 3. 359 U.S. 236 (1959). n. 84. (2002). 4. Id. at 238. 29. 121 Cong. Rec. 10688 (1975); see gen- 5. Id. at 247. erally Food & Drug Law Inst., An Analytical Legislative History of the Medical Device Amend- 6. See Medical Device Amendments to the ments of 1976 (Daniel F. O’Keefe Jr. & Robert A. Food, Drug, and Cosmetic Act, Pub. L. No. 94- Spiegel eds., 1976). 295, 90 Stat. 539 (1976) (codifi ed chiefl y at 21 U.S.C. §§360c-360k (2000)). 30. Warren E. Leary, Citing Labels, U.S. Seizes Orange Juice, N.Y. Times A18 (Apr. 25, 7. See e.g. Silkwood v. Kerr-McGee Corp., 1991). 464 U.S. 238, 251-53 (1984); Hurley v. Lederle Laboratories, 863 F.2d 1173, 1176-78 & n. 2 (5th 31. For a comprehensive review of these Cir. 1988); Osburn v. Anchor Laboratories., Inc., problems at an agency particularly indifferent 825 F.2d 908, 911-13 (5th Cir. 1987); Ferebee to its safety mission, the Federal Motor Carrier v. Chevron Chem. Co., 736 F.2d 1529, 1539-43 Safety Administration, see Stephen Labaton, As (D.C. Cir. 1984); Feldman v. Lederle Laborato- Trucking Rules Are Eased, a Debate on Safety ries, 479 A.2d 374, 390-91 (N.J. 1984). Grows, N.Y. Times A1 (Dec. 3, 2006), http://se- lect.nytimes.com/search/restricted/article?res=F5 8. 505 U.S. 504, 521 (1992) (quoting Gar- 0F15FC345A0C708CDDAB0994DE404482 (fee mon, 359 U.S. at 247). required) (accessed Feb. 5, 2007). 9. Id. 32. See e.g. Ferebee, 736 F.2d at 1541. 10. Id. at 519. 33. 486 U.S. at 185. 11. Id. at 518. 34. Sprietsma, 537 U.S. 51. 12. 518 U.S. 470. 35. Geier v. Am. Honda Motor Co., 529 U.S. 13. Id. at 486-89. 861 (2000). 14. Id. at 504-05 (Breyer, J., concurring), 36. See William Lloyd Prosser et al., Prosser 510 (O’Connor, J., Rehnquist, C.J., Scalia, J., & & Keeton on Torts 536-37, 692-93 (4th ed., West Thomas, J., concurring in part and dissenting in 1984); Clarence Morris, Morris on Torts 240-41 part). (2d ed., Foundation Press 1980). 15. 486 U.S. 174 (1988). 37. See e.g. Bates, 544 U.S. at 451 (quoting 16. Id. at 185-86. Ferebee, 736 F.2d at 1541-42). 17. 537 U.S. 51 (2002). 38. 71 Fed. Reg. 3922, 3933-3936 (Jan. 24, 2006). 18. Id. at 64. The Court also rejected the manufacturer’s argument that the plaintiff’s com- 39. Adler & Mann, supra note 26, at 924 & mon law claim was impliedly preempted by the n. 130. Coast Guard’s supposed safety-based opposition 40. Allison M. Zieve & Brian Wolfman, The to propeller guards or by the FBSA more gener- FDA’s Argument for Eradicating State Tort Law: ally. Id. at 64-70. Why It Is Wrong and Warrants No Deference, 21 19. 544 U.S. 431, 441 (2005). Toxics Law Rep. 516 (2006) & 34 Prod. Safety & Liab. Rep. 308 (2006). See also Louis M. Bograd, 20. 7 U.S.C. §136v(b) (2000). Taking on Big Pharma—and the FDA, on page 30 21. Bates, 544 U.S. at 445. of this issue. 22. See e.g. Medtronic, 518 U.S. at 487 (plu- 41. U.S. Govt. Accountability Off., Improve- rality). ment Needed in FDA’s Postmarket Decisionmaking 23. Id. at 485. and Oversight Process, Highlights GAO-06-402 24. See e.g. 7 U.S.C. §136v(b) (2000) (pes- (Mar. 2006), www.gao.gov/new.items/d06402.pdf ticides); 21 U.S.C. §360k(a) (2000) (medical de- (accessed Feb. 5, 2007). vices). 42. Inst. of Med., The Future of Drug Safety: 25. See e.g. Medtronic, 518 U.S. at 489 (plu- Promoting and Protecting the Health of the Pub- rality) (21 U.S.C. §360k “refers to ‘requirements’ lic, S-4 (Sept. 22, 2006), http://iom.edu/?id=37339 many times throughout its text. In each instance, (accessed Feb. 5, 2007). the word is linked with language suggesting that 43. Union of Concerned Scientists, Voices of its focus is device-specifi c enactments of positive Scientists at the FDA: Protecting Public Health law by legislative or administrative bodies, not Depends on Independent Science (2006), www. the application of general rules of common law ucsusa.org/assets/documents/scientific_integ-