Preemption

Stealth Tort Reform: How the Bush Administration’s Aggressive Use of the Preemption Doctrine Hurts Consumers A Center for Progressive Regulation White Paper Examined in the context of relevant Supreme Court In recent months, a flurry of media stories has drawn precedent, it becomes clear that FDA’s recently articulated public attention to the seemingly esoteric topic of the position on preemption stretches the doctrine far beyond Food and Drug Administration’s (FDA) attempts to its appropriate and established bounds. No change in preempt a variety of state tort suits against drug and the relevant statute, regulations or case law has taken medical device manufacturers. Under the direction of place to prompt FDA’s aggressive new stance on FDA Chief Counsel Daniel E. Troy, the agency has preemption. Rather, it appears that the primary submitted briefs in multiple lawsuits, each time motivating concept behind FDA’s pro-preemption briefs supporting the manufacturer’s argument that federal law is the Bush Administration’s tort reform agenda. Already preempts state common law claims. Much of the media FDA’s briefs have prompted some courts to find state coverage has focused on the potential conflicts of interest tort claims preempted, thereby effecting significant raised by Mr. Troy’s previous representation of changes in the law that had not occurred prior to Mr.
companies such as those he now invokes FDA’s power FDA’s amicus briefs represent part of a larger threat While Mr. Troy’s endeavors prior to his appointment that the Bush Administration poses to the crucial role by President Bush as FDA Chief Counsel provide that private tort suits play in supplementing regulatory context to the agency’s recent aggressive push for federal programs aimed at protecting health, safety and the preemption, a much less visible aspect of these activities environment. Recent questions concerning whether is the contribution that his substantive legal arguments FDA appropriately dealt with studies suggesting a link are making to the Administration’s anti-consumer tort between antidepressants and suicidal tendencies highlight reform agenda. Although federal preemption of state the crucial importance of the role and availability of tort common law claims may seem like an obscure issue of recovery as a supplement to regulatory oversight.
little concern to most consumers, Mr. Troy’s vigorous FDA’s Recent Intervention in Private assertion of federal preemption claims threatens to deprive countless citizens of their rights under establishedstate law.
The Bush Administration’s FDA has garnered considerable media attention, as newspapers have run Both the legal arguments raised by Mr. Troy on stories with eye-catching headlines such as: In a Shift, behalf of FDA and the manner in which FDA has come Bush Moves to Block Medical Suits; FDA Stepping Into Liability to weigh in on the preemption question represent a Lawsuits on Side of Drug Makers It Regulates; and FDA’s significant departure from past agency practice. Acting Chief Lawyer Stands Up for the Big Guys.1 These and other in his capacity as the agency’s Chief Counsel, Mr. Troy articles focus on the actions of Daniel E. Troy, President has actively sought guidance from pharmaceutical firms Bush’s appointee to the position of FDA Chief Counsel.
concerning lawsuits in which FDA could play a role in Over the past two years, Mr. Troy’s FDA has filed “friend promoting preemption. Since he assumed the helm of of the court” (amicus curiae) briefs, or statements of FDA’s legal ship, the agency has submitted briefs in five interest, in five private lawsuits involving drugs or medical recent lawsuits involving drugs or medical devices. More devices, four of which were product liability suits brought often than not, FDA has filed those briefs on its own by injured consumers.2 In the briefs, Mr. Troy brings initiative, without being asked to do so by the court.
FDA’s considerable weight to bear in favor of the to safeguard its considerable expertise in regulating the manufacturers’ defense that federal law preempts the content of drug labeling and advertising.”10 Federal preemption is a principle of constitutional Mr. Troy’s articulated rationale for FDA’s law derived from the Supremacy Clause, which provides intervention into private lawsuits represents a that a federal law can supersede or supplant any significant departure from the views on preemption inconsistent state law or regulation.4 In the context of consistently held by the agency during past Mr. Troy’s recent legal briefs, preemption is the asserted Administrations. In 1996, FDA’s Clinton-era Chief authority of the federal government to override the Counsel, Margaret Jane Porter, spoke at an FDLI powers of the states to determine what label warnings seminar.11 Her opening remarks referred to FDA’s “long- (in the case of drugs) or design criteria (in the case of standing presumption against preemption” even in the medical devices) may be required by state legislation or implementation of a section of the FDCA that contains held subject to liability in litigation.5 Put simply, an explicit preemption provision.12 In sharp contrast to preemption causes “the nullification of state actions that Mr. Troy’s stated position that “state courts and juries conflict with or supplement FDA decisions.”6 If a court should not second-guess the agency’s scientific agrees with FDA and the manufacturer that a tort claim determinations,”13 Ms. Porter explained that “FDA’s view is preempted, the court must rule in favor of the is that FDA product approval and state tort liability defendant.7 The import of the preemption doctrine, and usually operate independently, each providing a the reason that Mr. Troy’s amicus briefs have garnered the significant, yet distinct, layer of consumer protection.”14 attention they have, thus becomes clear – if a productmanufacturer can successfully argue that the federal law In addition to the Bush Administration’s drastic preempts plaintiff ’s claim, the lawsuit disappears (and views on the roles of federal regulation, state common precedent to support future assertions of the preemption law and preemption, the agency has moved in a “radical new direction”15 with respect to its involvement inprivate lawsuits. Specifically, Mr. Troy has taken the The benefit of preemption to potential product extraordinary step of seeking out lawsuits in which FDA liability defendants is obvious: it provides a shield against could intervene on behalf of product liability defendants expensive settlements and/or judgments in favor of (i.e., large drug companies) in support of preemption.
plaintiffs. What is less clear is why FDA, the agency At a December 2003 conference on drug and medical charged with regulating to protect the health and safety device litigation for defense lawyers and in-house of consumers, would work so hard to deprive consumers counsel, Mr. Troy told the audience of several hundred injured by the products it regulates of their only remedy.
pharmaceutical attorneys to suggest lawsuits into which At a 2002 legal symposium, Mr. Troy and the Bush the agency might intervene.16 The signed affidavit of a Administration set forth plans for “FDA Involvement in conference participant states that Mr. Troy cautioned Product Liability Lawsuits.”8 At the symposium, held by that since FDA “can’t get involved in every case,” the Food and Drug Law Institute (FDLI), Mr. Troy interested attorneys should make their particular cases maintained that because the federal Food, Drug and Cosmetic Act (FDCA) gives FDA broad authority toregulate the content of labeling for all drugs and Indeed, even prior to Mr. Troy’s appeal at the advertising for prescription drugs, allowing state courts December 2003 conference, his office had responded to and juries to impose additional requirements in conflict pleas from defense counsel in at least two product liability with FDA determinations could require drug firms to cases. During the month of July 2002, when Pfizer faced choose between state and federal compliance and lead a lawsuit alleging that its antidepressant drug Zoloft to inconsistency in drug firms’ communications to caused a patient to commit suicide, one of the company’s physicians and patients about drugs.9 Accordingly, Mr.
attorneys “called Dan Troy and informed him of the Troy declared that FDA would “participate in product case.”18 Within a couple of months, FDA had filed a liability lawsuits brought under state law as necessary brief before the United States Court of Appeals for the Stealth Tort Reform: The Bush Administration, FDA, and Preemption Ninth Circuit, without being asked (by the court) to do Dan Troy’s Legal Arguments in Context Mr. Troy’s own justification for FDA’s aggressive In another case, where a plaintiff sought damages intervention in private lawsuits since his appointment is for injuries allegedly sustained from pacemakers that the agency “only intervenes in private-party lawsuits manufactured by Pacesetter, Inc.,20 the Circuit Court of when it has a significant, direct stake in the outcome and Shelby County, Tennessee denied defendant Pacesetter only files briefs in cases in which the courts have already Inc.’s Motion for Summary Judgment.21 Soon thereafter, ruled against the position the FDA supports.”34 His counsel for Pacesetter wrote to the office of FDA Chief explanation fails to address either why FDA is aggressively Counsel, to remind FDA that motions in the interlocutory seeking out lawsuits in which to intervene or why, in the appeal of the matter were soon due, and that “accordingly, absence of any intervening change in the governing law, FDA’s Motion to Intervene should likewise be submitted the agency’s substantive views on the preemption issue by that time.”22 FDA timely submitted a brief in support have changed so dramatically from FDA’s former “long- standing presumption against preemption.”35 Responding to Mr. Troy’s unprecedented actions, That presumption (now reversed under the guidance Representative Maurice D. Hinchey (D-N.Y.) successfully of Mr. Troy) is consistent with the fundamental principles introduced legislation to cut $500,000 from the office of upon which the doctrine of preemption rests. Time and FDA Chief Counsel’s budget.24 Other veteran observers again, the Supreme Court has articulated the basic canons of FDA confirm Representative Hinchey’s assertions that that should guide judicial evaluation of preemption Mr. Troy’s active pursuit of, and intervention in, private claims. The starting premise is that the States are lawsuits takes the agency in a new direction. Professor independent sovereigns in the United States federal James O’Reilly, University of Cincinnati Law Professor system of government.36 It is a familiar principle of and former FDA counsel, noted that, “FDA is now in constitutional law that powers not delegated to the federal the business of helping lawsuit defendants” and that the government are reserved to the States.37 Among the most practice is “a dramatic change in what FDA has done in basic reserved powers is the police power – the inherent the past.”25 The Public Citizen Litigation Group agrees power of a sovereign to make all laws necessary to that FDA “has not supported preemption of personal preserve the public safety, health and welfare.38 injury claims prior to this administration.”26 Accordingly, the Court assumes “that the historic policepowers of the States were not to be superseded by the In an attempt to defend Mr. Troy’s actions, five former Federal Act unless that was the clear and manifest purpose FDA Chief Counsels27 wrote a letter claiming that “there of Congress.”39 Consequently, “‘[t]he purpose of is ample precedent for the actions that Mr. Troy has Congress is the ultimate touchstone’ in every pre-emption recently been undertaking,” and that his actions are “not case.”40 In the case of the FDCA, the “overriding” radical or even novel.”28 However, as noted in purpose of the statute is to protect the public health, and the Representative Hinchey’s response, the Former Chief Supreme Court has made clear that the Act must be given Counsels cite inapposite legal precedent.29 To a liberal construction consistent with that intent.41 demonstrate by example that Mr. Troy’s active solicitationof lawsuit information from corporate defendants, and There are two major classifications of federal unsolicited intervention in private cases is “not radical preemption, each of which is implicated by Mr. Troy’s or even novel,”30 the Former Chief Counsels cited cases recent rash of amicus briefs. Express preemption occurs where FDA was either the defendant in the case to begin when Congress expressly contemplated the role of the with31 or was asked by the court to submit a brief.32 States and included a statutory provision that explicitly Moreover, in a newspaper article published prior to abrogates state power in a particular area.42 Even when Representative Hinchey’s proposal to penalize the Chief an explicit preemption provision appears in the statute Counsel’s office, Peter Barton Hutt, FDA Chief Counsel under consideration, the Supreme Court has found that in the Nixon Administration, acknowledged that while the presumption against preemption of state police power he supported FDA’s legal position, he “probably wouldn’t mandates a narrow interpretation of the scope of the provision, consistent with “both federalism concerns and the historic primacy of state regulation of matters Though the trial court rejected Pacesetter’s assertion of health and safety.”43 In product liability cases of (and FDA’s support of) the preemption defense, the involving medical devices, the issue before a court matter will be re-visited on appeal.52 Nonetheless, FDA’s charged with deciding whether plaintiff ’s tort claim is brief in Murphree has already succeeded in aiding a federal preempted is the proper scope of an express preemption appeals court to rule in favor of a manufacturer and find provision contained in the statute governing medical a plaintiff ’s tort claims preempted.53 The United States Court of Appeals for the Third Circuit recently held thatthe express preemption clause in the Medical Device In the absence of express preemption, a court may Amendments (MDA) to the FDCA preempted Barbara still find that “a federal statute implicitly overrides state Horn’s state law claim (on behalf of her deceased law either when the scope of a statute indicates that husband, Daniel Horn) against Thoratec Corporation.54 Congress intended federal law to occupy a field The Bush Administration’s assertion of preemption in both medical device and prescription drug cases stretches the doctrine beyond the bounds delineated amicus briefs in prescription drug litigation rely on the ensued, and a disconnection of the HeartMate apparatus more tenuous doctrine of implied preemption. As allowed an air bubble to travel to Mr. Horn’s brain.56 explained more fully below, however, the Bush He then suffered a hemorrhage that rendered him brain Administration’s assertion of preemption in both medical dead.57 Less than four months after he was implanted device and prescription drug cases stretches the doctrine with the HeartMate, Mr. Horn was pronounced dead.58 beyond the bounds delineated by the Supreme Court.
Barbara Horn filed her husband’s state law claims Medical Device Litigation: Murphree v. Pacesetter
against Thoratec in federal court, where she alleged that and Horn v. Thoratec
the HeartMate had been defectively designed and On September 20, 2000, Gary Murphree filed suit manufactured and that Thoratec had failed to warn of against Pacesetter, Inc. in the Circuit Court of Shelby the alleged defects.59 Thoratec moved for summary County, Tennessee.46 Mr. Murphree alleged that the two judgment on the ground that Horn’s claims were expressly pacemakers he had received, both manufactured and later preempted.60 The court agreed, and Horn appealed.61 recalled by Pacesetter, left him with third-degree heart Subsequently, FDA submitted its statement of interest block, a failure of the heart’s electrical signals that can in the Murphree case.62 Early this year, the Third Circuit lead to cardiac arrest.47 After receiving a letter from allowed Thoratec to amend the record on appeal to Pacesetter’s counsel following the court’s denial of include FDA’s brief in Murphree, and approximately one Pacesetter’s motion for summary judgment,48 FDA filed month later it asked FDA to submit a letter brief in the a brief arguing that Murphree’s claim was preempted.49 Horn v. Thoratec appeal.63 The court’s opinion relied In the brief, FDA argued that “the prospect of hundreds substantially on both FDA briefs to reach its conclusion of individual juries determining the propriety of that Horn’s tort claims could not proceed.
particular device approvals, or the appropriate standards In so concluding, the Horn court had to distinguish to apply to those approvals, is the antithesis of the orderly the Supreme Court’s seminal holding in Medtronic, Inc. v.
scheme Congress put in place and charged FDA with Lohr. In that case, the Court held that although Section implementing.”50 Private tort suits, the brief maintained, 360k of the MDA provides for express preemption of would create uncertainty and chaos “for both the certain state law “requirements” governing medical devices, the relevant statutory and regulatory languageevidences “an overarching concern that preemption occur Stealth Tort Reform: The Bush Administration, FDA, and Preemption only where a particular state requirement threatens to courts to preempt state tort claims involving prescription interfere with a specific federal interest.”64 The Lohr drugs. FDA’s actions in this regard are especially Court’s extensive analysis concluded that the statutory remarkable, because (as noted above) the prescription language itself, the overriding purpose of the MDA (to drug portions of the FDCA do not contain a preemption provide for the safety and effectiveness of medical devices provision.75 Indeed, since the statute’s enactment, no intended for human use)65 and the FDA regulations all reported decision ever has held that the FDCA preempts supported the conclusion that the tort claims under common law claims for damages caused by drugs.76 review, including use of defective materials and failure Moreover, in 1933, Congress rejected a suggested to warn,66 were not of the specific nature required in provision in a draft of the original FDCA providing a order to be preempted by the MDA.67 The Supreme federal cause of action for damages because “a common Court reasoned that because the general state common- law right of action (already) exists.”77 Keeping in mind law requirements were not specifically developed “with the maxim that “‘[t]he purpose of Congress is the ultimate respect to” particular medical devices, they were not the touchstone’ in every pre-emption case,”78 and the kind of requirements that Congress and FDA feared Supreme Court’s admonition that the historic police would impede the ability of federal regulators to powers of the States should not be found to be implement and enforce specific federal requirements.68 preempted “unless that was the clear and manifest Ultimately, the Court stated, “given the critical importance purpose of Congress,”79 it becomes apparent that FDA’s of device specificity in our (and FDA’s) construction of arguments in favor of preemption in the prescription § 360k, it is apparent that few, if any, common-law duties have been preempted by this statute.”69 In re Paxil
The Horn court distinguished Lohr first on the basis Presently, a class action lawsuit is pending before a that the federal requirement in question was of greater California federal court, in which dozens of plaintiffs specificity than the provision that was before the Supreme contend that Glaxo SmithKline (GSK) has engaged in Court.70 Turning next to the more analogous state law false advertising by promoting its drug Paxil as “non- requirements at issue, the Third Circuit went to great habit forming.” Paxil is an antidepressant in the class of lengths to diminish the importance of the Supreme medicines known as SSRIs, or selective serotonin Court’s statement that “it is apparent that few, if any, reuptake inhibitors.80 SSRIs treat depression by common-law duties have been preempted” by the MDA’s normalizing levels of the brain chemical serotonin.81 preemption provision.71 FDA’s amicus arguments may have However, SSRIs also have effects on numerous other been especially persuasive in this regard. The court noted parts of the brain’s cellular system.82 the agency’s unequivocal statement that “[s]tate commonlaw tort actions threaten the statutory framework for the In August 2002, the court granted plaintiffs’ request regulation of medical devices,” because tort relief in the for a preliminary injunction barring GSK from continuing form of damages could pressure manufacturers to add to air television commercials claiming that Paxil was “non- warnings that FDA had not approved.72 The court further habit forming.”83 GSK motioned the court to reconsider quoted FDA’s prediction that such “individualized its ruling, and, after asking FDA to file a brief and redetermination of the benefits and risks of a product” considering all arguments, the court lifted the preliminary could harm the public health by “resulting in scientifically injunction.84 In its brief, FDA asserted, among other unsubstantiated warnings and underutilization of things, that Paxil does not cause withdrawal symptoms beneficial treatments.”73 The Murphree court similarly but merely causes a “discontinuation syndrome,”85 and quoted FDA’s professed concern that “such uncertainty that in any event, plaintiffs’ claim was preempted.
as to the status of medical devices would create chaos Although the court ultimately lifted the preliminary for both the regulated industry and FDA.”74 injunction on other grounds,86 it soundly rejected the FDA (and GSK) argued for implied preemption on Beyond pushing the law in a new direction in the the ground that the comprehensive nature of the FDCA, medical device arena, the current FDA is also pressing when taken together with FDA’s expertise, evidences a other SSRIs (such as Prozac) cause suicide and Congressional intent to preempt state law.87 The court determined on each occasion that the scientific evidence found the argument that FDA has exclusive domain over was insufficient to compel a warning linking Prozac to control and regulation of prescription drug suicidal behavior.99 Pfizer therefore argued that advertisements to be unpersuasive.88 The court noted “plaintiff ’s attempt to use state tort law to require that neither FDA nor GSK had cited any case holding warnings that Zoloft causes suicide” conflicted with that the FDCA preempts state law, and noted that “if FDA’s determinations concerning SSRI warnings.100 anything, FDA’s and GSK’s arguments ran contrary to The district court rejected the preemption defense, the grain of other decisions.”89 Judge Marianna Pfaelzer instead finding on a variety of grounds that Pfizer had failed to demonstrate that it would be impossible to FDA’s and GSK’s position vitiates, rather than comply both with FDA requirements and with a state advances, the FDCA’s purpose of protecting the law or decision requiring a stronger warning.101 In a public. That is, FDA and GSK invite the Court separate proceeding, the court granted summary to find that in enacting the FDCA for the judgment to Pfizer on the ground that Ms. Motus was purposes of protecting public health, Congress unable to present any evidence to establish that her not only declined to provide for a private cause husband’s doctor would have acted differently had Pfizer of action, but also eliminated the availability of included a warning about an association between Zoloft Ms. Motus appealed the court’s judgment to the Ninth Circuit, and Pfizer cross-appealed the earlier ruling on Despite the court’s outright rebuff of FDA’s theory, its preemption argument.103 FDA filed an amicus curiae Mr. Troy plans to continue his “fight for the FDA’s brief without being asked to do so by the court, and it supremacy.”91 He has indicated that he intends to raise did so within months of Mr. Troy’s receipt of a phone the argument again before Judge Pfaelzer in the ongoing call from one of Pfizer’s attorneys, requesting that the government file a brief in support of preemption.104FDA’s involvement in the case was especially alarming Motus v. Pfizer
to plaintiff ’s counsel, because before being appointed to Five days after filing its brief in the Paxil litigation, the position of FDA Chief Counsel, Mr. Troy had FDA submitted an amicus curiae brief to the United States represented Pfizer for pay as a private attorney.105 Court of Appeals for the Ninth Circuit93 in a case According to Mr. Troy, since the mandatory recusal period involving another SSRI drug, Zoloft.94 Flora Motus had elapsed at the end of May, he “didn’t see any initially brought the case in state court on behalf of her problem” with filing a brief that supported Pfizer’s husband Victor, who committed suicide approximately one week after commencing to take Zoloft for his In the brief, Mr. Troy and FDA argued that the claims depression.95 Ms. Motus alleged that Pfizer failed to adequately warn of the dangers, contraindications andside-effects of Zoloft.96 After successfully removing the when Zoloft was prescribed for Victor Motus, case to federal court, Pfizer moved for summary any warning, no matter how worded, that could judgment on the ground that the inadequate warning reasonably have been read as describing or alluding to [a causal relation to suicide] wouldhave been false or misleading, and therefore in Specifically, Pfizer argued that FDA had instructed conflict with federal law because there was no it to use certain verbatim text in its labeling that did not (and still is not) scientific support for such a link suicide to the drug but rather warned that the warning. This is not just because FDA had possibility of suicide is inherent in depression.98 rejected any link between Zoloft and suicide Additionally, before and during FDA’s consideration of when . . . the agency approved the drug as a the Zoloft application, the agency considered claims that Stealth Tort Reform: The Bush Administration, FDA, and Preemption treatment for depression. Subsequently, in that Congress intended to effect so sweeping a response to petitions making similar allegations change without even a comment. Rather, the as to the related drug Prozac, FDA found no link agency believes that Congress intended to restrict between antidepressants and suicide.107 preemption to positive enactments (for example,legislation or regulations) that apply to the In addition to arguing for implied preemption on marketing of medical devices within a state, and the basis of actual conflict, FDA raised the over- did not intend to preempt state tort remedies for deterrence argument that it has also advanced in the Murphree and Horn cases108 involving medical deviceclaims: The pre-Bush Administration FDA’s view on the interplay between state tort claims and federal regulation was expressed formally in a brief submitted to an Illinois dissemination of scientifically unsubstantiated court in 1996,114 when FDA asserted that because the warnings, so as to deprive patients of beneficial, federal approval process represents FDA’s endorsement possibly lifesaving treatment, could well frustrate of a minimum standard, federal approval should not the purpose of federal regulation as much as over- displace state common law that may provide additional utilization resulting from a failure to disclose a drug’s scientifically demonstrable adverseeffects.109 What has caused the agency’s views to shift so drastically? The Supreme Court has not decided any case In the end, the Ninth Circuit affirmed the lower that reverses either its reading of the MDA’s preemption court’s ruling that Mrs. Motus had failed to establish proof provision or its mandates on the presumptions that that stronger warnings could have altered her husband’s inform any preemption decision (express or implied).
medical treatment or averted his suicide, and it therefore Congress has not passed any legislation altering the did not address the preemption issue.110 But the story language of the MDA’s preemption provision or adding of FDA’s brief in the case doesn’t end there. Though a preemption provision to the FDCA’s prescription drug FDA may not have succeeded in establishing precedent sections. FDA has not gone through formal in the Ninth Circuit, its amicus brief has been convincing administrative procedures to promulgate a new regulation lower courts to preempt similar tort claims in other that interprets the MDA and/or the FDCA in such a jurisdictions. Two federal district courts in Texas have way as to preempt state tort claims. Stated simply, there found failure to warn claims against Pfizer preempted, has been no intervening change in the law of preemption resting their holdings in large part on FDA’s views as to justify such a drastic reversal by FDA.
FDA’s Shift in Position: A Manifestation of Instead, the Bush Administration’s FDA now argues that the agency’s former view (that federal approvalshould not displace state common law that may provide FDA’s legal briefs in Murphree, Horn, In re Paxil and additional protection to consumers) fails to “take Motus represent a 180-degree shift from the agency’s prior sufficient account of the state-of-the-art risk management position on the preemption issue. After the Supreme principles that FDA currently follows.”116 FDA declared Court’s landmark decision in Medtronic, Inc. v. Lohr, former that “[t]he Government now believes” that the better FDA Chief Counsel Margaret Porter stated that the implementation of the statutory scheme is to focus “not Court’s refusal to find the plaintiff ’s claims preempted only on identifying the risk minimization appropriate for was consistent with FDA’s “long-standing presumption the device, but also on ensuring that the measures selected against preemption.”112 Porter further elaborated, stating do not present their own public health disadvantages.”117 Thus, with no more than a bare assertion that commonlaw tort claims might cause drug and medical device [g]iven the harsh implications of foreclosing all manufacturers to take actions that actually increase risk judicial recourse for consumers injured by to consumers, the Bush Administration has concluded defective medical devices, FDA does not believe that consumers are better off without private legal recourse. For an administration that purports to respect did not require the advice and consent of the Senate, the authority of states, this conclusion has a derisive was seen as a reaction to Senator Kennedy’s protest.124 implicit premise: State court judgments, according to A medical device industry publication voiced the the Bush Administration, are likely to be so erratic and Administration’s hope: “Until Bush is able to place unfounded as to harm the very people they intend to someone in the commissioner’s office who will meet Kennedy’s approval, perhaps Mr. Troy can bring aboutmore regulatory circumspection at the agency.”125 Such a speculative, condescending assertion cannot by itself explain the Administration’s actions.
Indeed, Mr. Troy’s background is rife with themes Consumers are not the constituency that will be made of “regulatory circumspection.” After attending better off by eliminating private legal recourse for injuries Columbia University School of Law, he clerked for sustained by drugs and/or medical devices. Instead, outspoken conservative Judge Robert Bork of the With no more than a bare assertion that common law tort claims might cause drug and medical device manufacturers to take actions that actually increase risk to consumers, the Bush Administration has concluded that consumers are better off up health care costs and impose a huge burden on the drug companies.127 As an associate scholar of legal economy.118 After declaring tort reform an “emergency” studies at the American Enterprise Institute, he argued upon assuming office as Governor of Texas, Mr. Bush that companies that dumped toxics before it was illegal helped to ensure enactment of seven tort reform bills, to do so should not be held liable for the cleanup of including measures that reduced punitive damage such waste.128 Mr. Troy’s greatest anti-regulatory liability and raised the burden of proof for plaintiffs achievement may be his successful argument before the seeking such damages.119 Business groups, many of Supreme Court on behalf of Brown & Williamson which were among Mr. Bush’s largest gubernatorial Tobacco Corporation that FDA has no authority to campaign contributors, had laid the groundwork for the Mr. Troy’s philosophy as FDA Chief Counsel is, in Mr. Troy has helped to advance George W. Bush’s large part, consistent with his conservative views: agencies pro-business, pro-tort reform tradition by establishing should limit their actions to what the law explicitly an “open-door policy” for industry, thereby earning for authorizes them to do.130 Yet in the area of preemption, himself a reputation for being as receptive to industry as Mr. Troy argues consistently for FDA authority well in any FDA Chief Counsel.121 It is no coincidence that excess of what the relevant statutes stipulate, what the FDA’s top legal voice is so closely aligned with the Supreme Court has delineated, and what FDA has Administration’s political agenda. In the summer of 2001, historically asserted. In fact, in that area, he has managed the Bush Administration had settled on Michael J. Astrue to change the entire nature of the Chief Counsel’s office, as its choice for FDA Commissioner.122 Senator Edward converting it from a legal office to an activist policy M. Kennedy, chair of the Senate Committee on Health, Education, Labor and Pensions, opposed Astrue’s Mr. Troy’s enthusiastic endorsements of broad FDA candidacy on the ground that the then Senior Vice- authority in the realm of preemption are best understood President and General Counsel of Transkaryotic as a manifestation of George W. Bush’s continued Therapies, Inc. (a biopharmaceutical company) was too attempts to promote tort reform. The Chief Counsel closely tied to industry.123 President Bush’s appointment has specifically stated that FDA “is deeply immersed in of Mr. Troy to the position of FDA Chief Counsel, which tort reform issues.”132 Jay P. Lefkowitz, former director Stealth Tort Reform: The Bush Administration, FDA, and Preemption of President Bush’s Domestic Policy Council stated that documents from unwilling defendant manufacturers, FDA’s litigation strategy embodies “good health policy question company representatives during depositions and thereby uncover evidence of fraud andmisrepresentation.140 For example, court-ordered In short, FDA’s 180-degree shift from the agency’s discovery allowed counsel for the plaintiffs in the Paxil prior position on the preemption issue represents neither litigation to see raw data on the drug’s safety and efficacy, a response to some intervening change in the law, nor a while FDA saw only the completed write-ups.141 Also reflection of drastically different “state-of-the-art risk obtained in discovery but never seen by FDA were the management principles.”134 The current FDA’s arguments manufacturer’s internal communications about how to – diametrically opposed to the views consistently held by previous FDAs – represent a concerted effort toadvance the Bush Administration’s activist tort reform Past examples of tort litigation uncovering policy agenda. It is precisely for this reason that courts information that FDA failed to find demonstrate just how should regard FDA’s pro-preemption amicus briefs with crucial the role of civil discovery through tort suits can great circumspection. Although an agency’s construction be. It was a trial lawyer, not FDA that discovered that of its own regulations is normally entitled to substantial one of the published clinical studies of thalidomide (the deference by the courts, the fact that FDA’s complete drug prescribed for morning sickness that caused severe about-face has taken place in the absence of any credible birth defects) had been ghost written by an employee of change in legal or factual circumstances significantly the drug’s manufacturer.143 In the state tobacco litigation, private attorneys for the states discovered and made What’s at Stake: Regulation, Tort Law and available for public inspection documents establishing facts that the industry had denied to FDA (and Congress)for decades.144 The Bush Administration’s FDA has vociferously Recent revelations about data demonstrating a link argued that allowing state tort claims against the between SSRI drugs and suicidal behavior underscore manufacturers of drugs or medical devices that FDA has the very real need to protect the role of tort litigation in approved would undermine FDA’s review and approval supplementing FDA’s regulatory efforts. In June 2003, of product labeling. In particular, state tort suits could less than a year after FDA asserted to the United States result in “scientifically unsubstantiated warnings” by Court of Appeals for the Ninth Circuit in the Motus case manufacturers that could, in turn, result in the that its internal review of SSRI data disclosed that “there underutilization of beneficial treatments, to the detriment is no difference in the risk of suicide between those on of consumers.136 This simplistic and speculative SSRI’s and those on placebo,”145 the agency issued a argument, however, fails to address the ramifications of statement recommending that Paxil not be used in eliminating tort remedies and implicitly rests on the children and adolescents for the treatment of assumption that FDA’s “centralized expert evaluation”137 depression.146 The recommendation was based on is based on all relevant data and studies.
“reports of a possible increased risk of suicidal thinking Aside from the harsh consequences to consumers and suicide attempts” in children under the age of 18 who would be left without any means of obtaining compensation for injuries caused by defective prescription In July 2003, FDA asked manufacturers for drugs or medical devices, preemption of tort claims information about pediatric studies of other depression would destroy the vital role that state common-law drugs, including several SSRIs.148 After reviewing the remedies play in supplementing and augmenting federal data, FDA issued a Public Health Advisory to health health and safety regulations.138 Specifically, the tort care professionals, stating that it had not “been able to system is often able to get to the truth in ways that are rule out an increased risk of suicidality” for any of the largely unavailable to regulatory agencies.139 The tort drugs.149 FDA further stated that additional data and system allows trial lawyers, so often vilified by President analysis, as well as a public discussion of available data Bush, to spend the resources needed to obtain and review were needed.150 The public discussion recommended by the Advisory was convened on February 2, 2004, for to disregard studies that indicate that its product causes the purpose of addressing concerns and gathering death or injury if it knows that it may be held liable for information from a variety of sources and perspectives damages caused by that product in the future, and it about the relationship between suicidal behavior and SSRI will not be tempted to hide those studies if it knows drugs.151 Prior to the meeting, FDA scientists met to that a jury may award punitive damages when the cover- discuss the agenda. Dr. Andrew Mosholder, an FDA up is later uncovered. A complete shield from liability drug-safety analyst who studied clinical trials of based on an existing FDA label deprives consumers of antidepressants, stated that he planned to present his the additional incentive that the threat of tort recovery conclusion: young people who took antidepressants were provides to manufacturers. Without the possibility of far more likely to show suicidal tendencies than those damaging information ever being revealed through litigation, manufacturers of drug and medical deviceswould have every incentive to withhold even more such High-ranking officials at FDA, however, decided that Dr. Mosholder would not be permitted to speak abouthis findings.153 Though Dr. Mosholder would attend the In its Motus brief, FDA rested its preemption meeting to make another presentation, upper level argument in large part on the fact that FDA had rejected decisionmakers decided that another FDA official would a link between Zoloft and suicide, and it explicitly argued describe the antidepressant drug data Mosholder had that the agency “found no link between antidepressants and analyzed without offering any conclusion.154 Concerned suicide.”160 Consumers would be harmed, the agency about the reliability of Dr. Mosholder’s conclusions, FDA asserted, by over-warning about a link between SSRI hired researchers at Columbia University to re-analyze drugs and suicidal behavior.161 Two courts relied on FDA’s the same data.155 The Columbia study, completed after arguments to find a plaintiff ’s claims preempted, thus the February meeting, reached conclusions nearly preventing them from using discovery tools to explore the merits of their assertions.162 Despite recentdevelopments, Mr. Troy has stated that FDA has “not In September 2004, after an advisory committee rethought [its] legal views on preemption merely because meeting held as a follow-up to the February 2 meeting, the facts [on SSRIs] change.”163 In the face of a flagrant Dr. Robert Temple, director of FDA’s office of medical failure of the regulatory system, the Bush Administration policy, stated that “we now all believe that there is an continues to believe that whether FDA is right or wrong increase in suicidal thinking and action that is consistent in its conclusions about the dangers of products it across all the drugs.”157 Dr. Temple was one of the regulates, consumers are better off without a legal remedy.
officials who decided to prevent Dr. Mosholder frompresenting the same conclusion in February.158 According to Temple, the data demonstrating the consistent link Mr. Troy’s successes in urging courts to adopt a between antidepressants and suicidal behavior were radically aggressive preemption policy illustrate “how a contained in 15 clinical trials, some of which had been White House can use its administrative and legal powers hidden for years from the public by the drug companies to change the regulatory terrain without taking the often arduous course of asking Congress to change the law.”164 This timely example of the ability of regulated entities The Bush Administration has pursued its tort reform to hide data concerning the very dangers that FDA seeks agenda through arcane legal vehicles that are largely to protect the public against underscores the necessity hidden from public view, and it has enlisted the industry of preserving the tort remedies that the Bush to alert it to chances to do so. Courts should be reluctant Administration is trying so hard to eliminate. Common to accept the flawed and unprecedented statements of law claims hold companies liable for poorly designed this administration’s FDA, and consumers should be and manufactured products, and they can indirectly outraged at these clandestine attempts to erode their influence corporate conduct. A company is not as likely Stealth Tort Reform: The Bush Administration, FDA, and Preemption and Drug Law Institute’s (FDLI) bi-monthly magazine, “was adaptedfrom remarks originally delivered at FDLI’s annual Advertising and * Policy Analyst, Center for Progressive Regulation (CPR), B.A., Promotion Conference, September 11-12, 2002.” Id. at 4.
J.D., University of Maryland. This White Paper is the first in aseries of efforts by CPR to highlight the Bush Administration’s pervasive attempts to consolidate federal power in the area of state 11 Margaret Jane Porter, The Lohr Decision: FDA Perspective and Position, tort law. The author is grateful for the invaluable input and guidance 52 FOOD & DRUG L.J. 7, n a1 (1997) (noting that article is an updated of the following CPR Scholars: Thomas O. McGarity, who holds version of speech presented at FDLI’s seminar “After the Lohr the W. James Kronzer Chair at the University of Texas School of Decision: What You Can Learn to Help Reduce Your Organization’s Exposure Law and is the President of CPR; David C. Vladeck, Associate to Product Liability,” Washington, D.C. (Oct. 8, 1996)). Significantly, Professor of Law and Co-Director of the Institute for Public Ms. Porter opened her remarks at the seminar by noting that “earlier Representation at Georgetown University Law Center (and former versions of the program were billed as an opportunity to learn how Director of the Public Citizen Litigation Group); and Douglas A.
to help reduce manufacturers’ product liability exposure. FDA was Kysar, Assistant Professor of Law at Cornell Law School.
not interested in providing such advice; the program was revised to offer 1 Robert Pear, In a Shift, Bush Moves to Block Medical Suits, N.Y. TIMES, an opportunity to understand product liability exposure.” Id. at 7 July 25, 2004; Robert Cohen, FDA Stepping Into Liability Lawsuits on (emphasis added). Mr. Troy’s markedly different view of the role Side of Drug Makers It Regulates, THE SEATTLE TIMES, May 11, 2004, for FDA can be seen in the way his appearance at a 2003 conference at A2; and Patrick McGann, FDA’s Chief Lawyer Stands Up for the Big for in-house counsel and trial attorneys was billed: Guys, LEWISTON MORNING TRIBUNE, July 31, 2004, at 10A. See also, This roundtable of top defense attorneys and in-house e.g., Anne C. Mulkern, Watchdogs or Lap Dogs? When Advocates Become counsel will provide an insightful update on the preemption Regulators, THE DENVER POST, May 23, 2004, at A-01; Gary Young, doctrine and defense techniques for ensuring the best use of it. Dan FDA Strategy Would Pre-empt Tort Suits; Does it Close Off Vital Drug Troy, Chief Counsel of the FDA, will kick off the Data?, NATIONAL LAW JOURNAL, March 1, 2004, at 1; Jeff Swiatek, discussion by giving his valuable insight into why the FDA FDA Gets Involved in Court Disputes, INDIANAPOLIS STAR, October 20, chooses to file amicus briefs on certain cases . . . and what we’re likely to see next. This dynamic session is sure to be 2 Horn v. Thoratec, 376 F.3d 163 (3rd Cir. 2004); Motus v. Pfizer, 358 F.3d 659 (9th Cir. 2004); Dowhal v. SmithKline Beecham Consumer, 88 Full Agenda for the 8th Annual Conference for In-House and Trial P.3d 1 (Cal. 2004); In re Paxil Litigation, 2002 WL 31375497 (C.D.
Attorneys: Drug and Medical Device Litigation, December 14, 15 & 16, Cal. 2002); and Murphree v. Pacesetter, Inc. et al, No. 005429-00-3 2003, <http://www.americanconference.com/drug/ (Tenn. Circuit Ct.), appeal docketed, No. W2004-01432 (Tenn. Ct.
agenda_full.cfm> (site visited 12/9/2003) (on file with author) 3 See, e.g., Letter Brief of Amicus Curiae United States, 2004 WL 12 See Porter, supra, n. 11, at 7 (referring specifically to FDCA § 521, 1143720, Horn v. Thoratec, 376 F.3d 163; Brief of Amicus Curiae United part of the Medical Device Amendments (MDA) to the FDCA).
States, 2002 WL 32303084, Motus v. Pfizer, 358 F.3d 659; and Brief of Amicus Curiae United States, 2003 WL 23527781, Dowhal v. See Troy, supra, n. 9, at 7.
SmithKline Beecham, 88 P.3d 1.
14 See Porter, supra, n. 11, at 11.
4 BLACK’S LAW DICTIONARY 1197 (7th ed. 1999). See, e.g., Rose v. 15 150 CONG. REC. H5581-04 (daily ed. July 13, 2004) (statement of Arkansas State Police, 479 U.S. 1, 3 (1986) (“[T]he Supremacy Clause invalidates all state laws that conflict or interfere with an Act of Congress (citing Hayfield Northern R. Co. v. Chicago & North See Mulkern, supra, n. 1.
Western Transp. Co., 467 U.S. 622, 627, and n. 4 (1984); Gibbons v. 17 See <http://www.house.gov/hinchey/issues/fda.shtml> (site Ogden, 22 U.S. (9 Wheat.) 1, 211 (1824))).
visited September 2, 2004), quoting from Affidavit of Jessica R.
5 See James T. O’Reilly, A State of Extinction: Does Food and Drug Dart, ¶5, Dusek v. Pfizer, Inc., No. H-02-3559 (S.D. Tex. Feb. 20, Administration Approval of a Prescription Drug Label Extinguish State Claims for Inadequate Warning?, 58 FOOD & DRUG L. J. 287, 288 (2003).
18 Michael Kranish, FDA Counsel’s Rise Embodies U.S. Shift, THE 6 See Young, supra, n. 1.
BOSTON GLOBE, December 22, 2002 (quoting Pfizer attorneyMalcolm Wheeler).
7 See, e.g., Needleman v. Pfizer, Inc., 2004 WL 1773697, *6 (N.D. Tex.
Aug. 6, 2004) (slip op.) (finding plaintiff ’s failure to warn claim Brief of Amicus Curiae United States, Motus v. Pfizer, see supra, n.
preempted and granting summary judgment to Pfizer).
8 See Pear, supra, n. 1.
Kathleen Kerr, Can FDA Seal Be Broken?, NEWSDAY.COM, August 9 Daniel E. Troy, FDA Involvement in Product Liability Lawsuits, UPDATE, Jan.-Feb. 2003, at 4, 7. This article, which appeared in The Food Letter from Michael J. Weber (Feldman Gale & Weber, P.A.) to Paige Taylor (Assoc. Chief Counsel, FDA) (November 25, 2003), available at: < http://www.house.gov/hinchey/issues/fda10.pdf> “Former Chief Counsels’ Letter”).
29 Letter from Hon. Maurice D. Hinchey to Hon. Henry Bonilla, 2 (August 5, 2004), available at <http://www.house.gov/apps/list/press/ny22_hinchey/morenews/080504fda_bonilla.html> (site 23 Statement of Interest of the United States of America, Murphree v. Pacesetter, Inc. et al., No. 005429-00-3 (Tenn. Circuit Ct. Dec. 12,2003), cited and quoted in Horn v. Thoratec Corp., 376 F.3d 163, 171 30 See Former Chief Counsels’ Letter, supra, n. 21.
31 See Weinberger v. Bentex Pharmaceuticals, Inc., 412 U.S. 645 (1973), 24 See 150 CONG. REC. H5581-04, supra, n. 15.
cited by Former Chief Counsels’ Letter, supra, n. 21.
25 See Mulkern, supra, n. 1.
32 See Bernhardt v. Pfizer, 2000 WL 1738645, *1, n.3 (S.D.N.Y. 2000)(noting that “[a]t the Court’s request, the United States has submitted 26 See Cohen, supra, n. 1.
a Statement of Interest”); and Jones v. Rath Packing Co., 425 U.S. 933 27 Each of the five former Chief Counsels are now in private (1977) (inviting the Solicitor General to file brief expressing the practice, working for firms that represent clients in the fields of views of the United States), opinion at 430 U.S. 519 (1977), cited by Former Chief Counsels’ Letter, supra, n. 21. The court’s opinionin the final case cited by the Former Chief Counsels does not reveal Peter Barton Hutt is a partner at Covington and Burling in what, if any, involvement FDA had in the case. See Eli Lilly & Co.
Washington, D.C. See <http://www.martindale.com/xp/ v. Marshall, 850 S.W.2d 164 (Tex. 1993), cited by Former Chief Martindale/Lawyer_Locator/Search_Lawyer_Locator/ Counsels’ Letter, supra, n. 21.
lawyer_search.xml> (site visited 9/21/2004).
33 See Mulkern, supra, n. 1.
Richard A. Merrill also works for Covington & Burling, as of counsel. Id. Covington and Burling’s representative clients Troy: Untitled Enforcement Letters Are Strong Enough to Support include, among others, Eli Lilly, GlaxoSmithKline, Johnson & Enforcement Acts, 10 FDA ADVERTISING & PROMOTION MANUAL, Johnson and Merck. See <http:// MONTHLY BULLETIN, 1, 3 (November 2002).
35 See Porter, supra, n. 11, at 7 (referring specifically to FDCA § 521, default.asp?action=rf&rf=fprofile&fid=3826>, (site visited 9/2/ part of the Medical Device Amendments (MDA) to the FDCA).
36 Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (1996).
Richard M. Cooper is a member of Williams & Connolly LLP, where his fields of expertise include Food and Drug Law. See See U.S.C.A. Const. Amend. X.
<http://www.martindale.com/xp/Martindale/Lawyer_Locator/ 38 See BLACK’S LAW DICTIONARY, supra, n. 4, 1178.
Search_Lawyer_Locator/lawyer_search.xml> (site visited 9/21/ 2004). That firm’s clients include Wyeth, Bayer, and the United Lohr, 518 U.S. at 485, (quoting Rice v. Santa Fe Elevator Corp., 331 States Surgical Corporation, “a leading manufacturer of wound U.S. 218, 230 (1947); Hillsborough County v. Automated Medical closure products and advanced surgical devices . . . .” <http:// Laboratories, Inc., 471 U.S. 707, 715-16 (1985)).
www.wc.com/practice.cfm?practice_ID=15&link=1&pf=1> (site 40 Id. (citing Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516 (1992); Gade v. Nat’l Solid Wastes Management Ass’n., 505 U.S. 88, 96 (1992);Malone v. White Motor Corp., 435 U.S. 497, 504 (1978)).
Nancy L. Buc is a Resident Partner at Buc & Beardsley, a boutiquefirm that specializes in Food, Durg, Medical Device, Biologics and 41 United States v. An Article of Drug . . . Bacto-Unidisk, 394 U.S. 784, Cosmetic Law. See <http://www.martindale.com/xp/Martindale/ Lawyer_Locator/Search_Lawyer_Locator/lawyer_search.xml> 42 See O’Reilly, supra, n. 5, 288.
43 Lohr, 518 U.S. 470 at 485.
Thomas Scarlett is a member of Hyman, Phelps & McNamara,P.C., a mid-size firm that specializes in “[p]ractice before all Courts, 44 Sprietsma v. Mercury Marine, 537 U.S. 51, 64 (2002) (internal citations Government Agencies and International Regulatory Authorities omitted) (quoting English v. General Elec. Co., 496 U.S. 72, 78-79 involving Foods, Drugs, Cosmetics, Medical Devices, Biologics, Pesticides, Controlled Substances and Consumer Products.” See 45 21 U.S.C. §§ 351 et seq.
<http://www.martindale.com/xp/Martindale/Lawyer_Locator/Search_Lawyer_Locator/lawyer_search.xml> (site visited 9/21/ 46 Murphree v. Pacesetter, Inc. et al, No. 005429-00-3 (Tenn. Circuit Ct.), appeal docketed, No. W2004-01432 (Tenn. Ct. App.).
28 Letter from Peter Barton Hutt, Richard A. Merrill, Richard M.
Cooper, Nancy L. Buc and Thomas Scarlett to Hon. Henry 48 Letter from Weber to Taylor, supra, n. 21.
Bonilla (July 15, 2004), 150 CONG. REC. E1505-03 (daily ed. July22, 2004) (letter submitted into record by Rep. Barton) (the Stealth Tort Reform: The Bush Administration, FDA, and Preemption 49 Statement of Interest of the United States of America, Murphree § 360(e)(c). Id. at 164-65. The device at issue in Lohr had received v. Pacesetter, supra, n. 23.
FDA approval through the “substantial equivalence” process setforth in 21 U.S.C. § 510(k). Lohr, 518 U.S. at 480. The Lohr Court found that the generality of the federal requirements imposed under the “substantial equivalence” process made the claim 52 Murphree v. Pacesetter, Inc., No. W2004-01432 (Tenn Ct. App.).
quite unlike a case in which the Federal Government hasweighed the competing interests relevant to the particular 53 Horn v. Thoratec Corp., 376 F.3d 163, 171 n. 13, 178 (3rd Cir. 2004).
requirement in question, reached an unambiguous conclusion about how those competing considerationsshould be resolved in a particular case or set of cases, and implemented that conclusion via a specific mandate on Id. at 501. The Horn court read this language to suggest that “theanalysis would have been significantly different if the device at issue in Lohr had weathered a more exacting federal investigation, such as the PMA process.” Horn, 376 F.3d at 169 (citing Medtronic, 518U.S. at 501).
71 Id. at 174-76. The Third Circuit reasoned that because Justice Breyer wrote separately to emphasize that he was “not convinced 62 Statement of Interest of the United States of America, Murphree that future incidents of MDA preemption of common-law claims v. Pacesetter, supra, n. 23.
will be ‘few’ or ‘rare,’” Lohr, 518 U.S. at 508 (Breyer, J., concurringin part), the appropriate reading of the Lohr decision was not the 63 Third Circuit Asks FDA to Submit Brief in Pending Medical Preemption broad pronouncement made by Justice Stevens that few, if any, Case, BNA PRODUCT LIABILITY DAILY, March 10, 2004. The court common-law duties had been preempted. Rather, the Third Circuit allowed Thoratec to amend the record on appeal by including FDA’s read Lohr to advise that “a court should carefully examine the state filing in Murphree on January 24, 2004 and requested FDA to submit common law claim in order to determine whether that claim would a letter brief on February 27, 2004. Id.
impose a substantive requirement that conflicts with, or adds a greater 64 Medtronic, 518 U.S. at 500. The MDA preemption section burden to, a specific federal requirement.” Horn, 376 F.3d at 174.
The court concluded that “Horn’s general state law claims wouldimpose substantive requirements on [Thoratec] that would conflict § 360k. State and local requirements respecting devices with, or add to, the requirements imposed by FDA involved in the design, manufacturing, fabrication and labeling of the HeartMate.”Id. at 176.
Except as provided in subsection (b) of this section, noState or political subdivision of a state may establish or 72 Id. at 177-78 (quoting Letter Brief of Amicus Curiae United continue in effect with respect to a device intended for (1) which is different from, or in addition to, any 74 Id. at 178 (quoting Statement of Interest of the United States requirement applicable under this chapter to the device, of America, Murphree v. Pacesetter, 7-9).
75 21 U.S.C. §§ 351 et seq.
(2) which relates to the safety or effectiveness of thedevice or to any other matter included in a requirement 76 Brief of Amicus Curiae Public Citizen, 2003 WL 22716063, *13, applicable to the device under this chapter.
Motus v. Pfizer, Inc., 358 F.3d 659 (9th Cir. 2004).
77 See Robert S. Adler & Richard A. Mann, Preemption and Medical Devices: The Courts Run Amok, 59 MO. L. REV. 895 (1994) (citingH.R. 6110, 73d Cong., 1st Sess. Section 25 (1933); S. 1944, 73d Cong., 2d Sess. S24 (1933); Hearings Before a Subcommittee of the Committee on Commerce of the United States Senate on S.
1944, 73d Cong., 2d Sess. 400, 403 (1933)).
78 Id. (citing Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516 (1992); Gade v. Nat’l Solid Wastes Management Ass’n., 505 U.S. 88, 96 (1992); 70 Horn, 376 F.3d at 169-73. Thoratec’s HeartMate had been through Malone v. White Motor Corp., 435 U.S. 497, 504 (1978)).
FDA’s Pre-Market Approval (PMA) process, pursuant to 21 U.S.C.
79 Medtronic v. Lohr, 518 U.S. at 470, 485 (1996) (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947); Hillsborough County v.
Automated Medical Laboratories, Inc., 471 U.S. 707, 715-16 (1985)).
80 See, e.g., Jamie Talan, Paxil Subject of Suit; AG, in First Actionof its Kind, Accuses GlaxoSmithKline of Concealing Details 101 Id. at 1096. The court summarized its findings: About Drug’s Risks, NEWSDAY, June 3, 2004, p. A06.
[S]everal other courts have determined that FDA requirements are minimum standards and that FDAapproval is not a shield to liability; 21 CFR § 314.70(c)(2)(1) permits manufacturers to strengthen warning labels 83 In re Paxil Litigation, 2002 WL 31375497, *1 (C.D. Cal. 2002).
without prior FDA approval; Pfizer has not limited itsattack to any specific warnings; and finally the FDA has not made any statement that Pfizer could not include a strengthened suicide warning. In light of these factors,the Court finds that Pfizer has not established that it would 86 The court lifted the preliminary injunction based largely on FDA’s be impossible to comply simultaneously with FDA explanation of its own consideration of whether the advertisements requirements and with a state law or decision requiring a were misleading. FDA’s “extensive fact finding process engaged in by FDA with regard to Paxil and its approval of Paxil’sadvertisements” changed the court’s “evaluation of Plaintiffs’ likelihood of success on the merits to a degree dictating that the 102 Motus v. Pfizer Inc., 196 F.Supp.2d 984, 999 (C.D. Cal. 2001) preliminary injunction should be denied.” In re Paxil, 2002 WL 103 See Motus III, 358 F.3d at 660.
104 See Kranish, supra, n. 18.
105 Letter from Karen A. Barth (counsel for Flora Motus) to Daniel Troy, Esq., (January 3, 2003) (on file with author); see also Kranish, 90 Id. at *1 (internal citation omitted).
91 See Kranish, supra, n. 18.
92 Matt Fleischer-Black, Cosmetic Advocacy, T Brief of Amicus Curiae United States, supra, n. 3, *21 - *22, Motus III (emphasis in original).
93 FDA’s brief in the Paxil litigation was filed on September 5, 2002.
FDA’s argument that excessively strong warnings could result in In re Paxil, supra, n. 86 at *1. Its amicus brief before the Ninth under-utilization of a treatment were successful in the limited Circuit was filed on September 10, 2002. Brief of Amicus Curiae context presented by the case of Dowhal v. SmithKline Beecham United States, Motus v. Pfizer, 358 F.3d 659, supra, n. 3.
Consumer Healthcare, 88 P.3d 1 (Cal. 2004). In Dowhal, a citizen ofCalifornia filed suit against SmithKline, seeking to force the 94 Motus v. Pfizer, 358 F.3d 659 (9th Cir. 2004) (Motus III). Zoloft is company to include a warning required by the California Health the registered trademark and brand name in the United States for and Safety Code in its labeling of nicotine replacement therapy sertraline hydrochloride, an SSRI. Motus v. Pfizer, 127 F. Supp.2d (NRT) products. Id. at 917-19. The warning required by the 1085, 1088 (C.D. Cal. 2000) (“Motus I”).
California law would have warned that NRT products “contain[] a 95 Motus I, 127 F. Supp.2d at 1086.
chemical known to the State of California to cause birth defects orother reproductive harm.” Id. at 918. FDA did not permit SmithKline to use the stronger warning, however, instead requiring a label that warned that the “medicine is believed to be safer thansmoking. However, the risks to your child from this medicine are 98 The text of the warning FDA instructed Pfizer to not fully known.” Id. at 919. FDA filed an amicus brief in support of preemption. Brief of Amicus Curiae United States, 2003 WL Suicide – The possibility of a suicide attempt is inherent in depression and may persist until significant remission The court concluded that it had no reason to question FDA’s expert occurs. Close supervision of high risk patients should determination that “the risk of harm may be so remote that it is accompany initial drug therapy. Prescriptions for Zoloft outweighed by the greater risk that a warning will scare consumers (sertraline) should be written for the smallest quantity of into foregoing use of a product that in most cases will be to their capsules consistent with good patient management, in benefit.” Id. at 934. However, the court rejected the broader order to reduce the risk of overdose.
arguments raised in FDA’s brief, noting that in most cases FDA Stealth Tort Reform: The Bush Administration, FDA, and Preemption warnings and the California state warnings would “serve the same 125 Id. The position of FDA Commissioner remained vacant from purpose — informing the consumer of the risks involved in use of January 19, 2001 through November 14, 2002, when Mark B.
the product — and differences in wording would not call for federal McClellan was sworn in as Commissioner. <http:// preemption.” Id. In the specific case of NRT use by pregnant www.fda.gov/oc/commissioners/mcclellan.html> (site visited 09/28/2004). In the 14-month period between his ownappointment and that of Commissioner McClellan, Mr. Troy held [T]he FDA warning serves a nuanced goal — to inform at least 50 meetings with representatives of the industries FDA pregnant women of the risks of NRT products, but in a regulates, none of which were memorialized in any way. See way that will not lead some women, overly concerned about those risks, to continue smoking. This creates a conflictwith the state’s more single-minded goal of informing the Dr. Lester M. Crawford Jr., who was appointed deputy commissioner consumer of the risks. That policy justifies federal in February 2002 and headed the agency until McClellan’s appointment, was named to lead FDA as acting commissioner asof March 27, 2004, following Dr. McClellan’s departure. <http:// www.fda.gov/oc/commissioners/mcclellan.html>.
126 See Fleischer-Black, supra, n. 92.
110 Motus III, 358 F.3d at 661.
127 See Mulkern, supra, n. 1.
111 Needleman v. Pfizer Inc., 2004 WL 1773697, *4 (N.D. Tex. Aug. 6, 128 See Kranish, supra, n. 18. Troy’s book, Retroactive Legislation, was 2004) (slip op.) (“[T]he Court places weight on FDA’s unambiguous published under the auspices of the American Enterprise Institute statement [in the Motus brief] that it would view any statement in 1998. See <http://www.aei.org/publications/bookID.223/ describing a relationship between Zoloft use and suicide as “false book_detail.asp> (site visited 09/28/2004).
and misleading” and it would deem any state warning requirementpreempted”); Dusek v. Pfizer, Inc., No. H-02-3559, 12-13 (S.D. Tex.
129 See Kranish, supra, n. 18.
Feb. 20, 2004) (slip op.) (“The Court concludes that the FDA’s 130 See Carey, supra, n. 122.
position as stated in the [Motus] amicus brief that any label suggestingthat Zoloft can cause suicide would be false or misleading provides 131 See Shultz, supra, n. 121.
132 See <http://www.house.gov/hinchey/issues/fda.shtml> (site visited September 2, 2004), quoting from Affidavit of Jessica R.
Dart, ¶6, Dusek v. Pfizer, Inc., No. H-02-3559 (S.D. Tex. Feb. 20, 114 Kernats v. Smith Indus. Med. Sys., Inc., 669 N.E.2d 1300 (Ill. App.
134 See Letter Brief of Amicus Curiae United States, Horn, supra, n.
115 Letter Brief of Amicus Curiae United States, Horn, supra, n. 3, 135 See, e.g., Letter Brief of Public Citizen, Counsel for Appellant, at 3-4, Horn v. Thoratec, 376 F.3d 163, available at <http:// www.citizen.org/documents/HornSurreply4.601.pdf>; see UnitedStates v. Mead Corp., 533 U.S. 218, 228 (2001) (degree of deference due to government depends on, among other things, consistency 119 Richard A. Oppel, Jr. and Jim Yardley, The 2000 Campaign: the and formality of government’s position).
Texas Governor; Bush Calls Himself Reformer; the Record Shows the Label 136 See Letter Brief of Amicus Curiae United States, Horn, supra, n.
May Be a Stretch, THE NEW YORK TIMES, March 20, 2000, at A16.
3, *25-*26; Brief of Amicus Curiae United States, Motus III, supra, 121 See Stacey Shultz, Mr. Outside Moves Inside, U.S. NEWS & WORLD 137 See Letter Brief of Amicus Curiae United States, Horn, supra, n.
REPORT, March 24, 2003 (quoting Wayne Pines, former FDA official and current president of regulatory services and healthcare at 138 See Thomas O. McGarity, Beyond Buckman: Wrongful Manipulation APCO, a Washington, D.C. communications consulting firm.) of the Regulatory Process in the Law of Torts, 41 Washburn L.J. 549, 122 John Carey, Just What the Doctor Ordered for FDA?, BUSINESS 124 James G. Dickinson, Bush Taming FDA? Some Think Not, 141 Young, supra, n. 1. Karen Barth Menzies of the Los Angeles MEDICAL DEVICE & DIAGNOSTIC INDUSTRY, October 2001.
law firm Baum Hedlund represents the plaintiffs in In re Paxil.
143 McGarity, supra, n. 138, at 571 (citing Michael D. Green, Bendectin 151 Transcript of the February 2, 2004 meeting of the and Birth Defects, 78 (1996)).
Psychopharmacologic Drugs Advisory Committee with the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee,12-13, available at: <http://www.fda.gov/ohrms/dockets/ac/04/ 145 Brief of Amicus Curiae United States, Motus III, supra, n. 3, *22.
transcripts/4006T1.pdf> (site visited 09/30/2004).
The brief was submitted on September 10, 2002. Id at *i.
146 FDA Statement Regarding the Anti-Depressant Paxil for the Pediatric Population, June 19, 2003, available at <http://www.fda.gov/bbs/ topics/ANSWERS/2003/ANS01230.html> (site visited 09/02/ 155 Gardiner Harris, FDA Links Drugs to Being Suicidal, THE NEW 147 Id. The statement also included a large block warning in its YORK TIMES, September 13, 2004 at A1.
statement advising that “[d]espite the new possible concerns about the use of Paxil in children, it is essential that patients taking Paxil do not suddenly discontinue use of the drug.” Id. Nine months earlier, FDA’s brief in the Paxil litigation had asserted that the drug did not cause withdrawal symptoms but merely a “discontinuation syndrome.” See Kranish, supra, n. 18. FDA’s brief in the Paxil litigation was filed on September 5, 2002. In re Paxil, supra, n. 86 at Brief of Amicus Curiae United States, supra, n. 3, *21 - *22, Motus III (emphasis in original).
148 Anna Wilde Mathews, Mood Disorder: In Debate Over Antidepressants, FDA Weighed Risk of False Alarm, THE WALL STREET JOURNAL, May25, 2004, at A1. FDA sought the information for Prozac, Zoloft, 162 Needleman v. Pfizer Inc., 2004 WL 1773697, *4 (N.D. Tex. Aug. 6, Luvox, Celexa, Wellbutrin, Effexor, Serzone and Remeron. Id.
2004) (slip op.); Dusek v. Pfizer, Inc., No. H-02-3559, 12-13 (S.D.
Tex. Feb. 20, 2004) (slip op.), supra, n. 111.
149 FDA Public Health Advisory, Reports of Suicidality in PediatricPatients Being Treated with Antidepressant Medications for Major Depressive Disorder (MDD), October 27, 2003, available at <http:// www.fda.gov/cder/drug/advisory/mdd.htm> (site visited 09/02/2004).
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