2004, Issue 6 With permission from FDLI
Why Is FDA Attacking Injured Consumers?
By Edward J. Parr, Jr.
Since 2001, the Food and Drug Administration (FDA) has intervened in at least five private lawsuits, involving both drugs and medical devices, to advocate the preemption of state product liability claims. FDA has openly shifted its position on express preemption of medical device claims, and has argued in favor of the implied preemption of prescription pharmaceutical claims for the first time in the agency's history. FDA's Chief Counsel has encouraged drug and medical device companies to come to the agency for help in defeating private product liability lawsuits. Is this new direction good policy or bad politics?
Medical Device Preemption
There is no provision in the Federal Food, Drug, and Cosmetic Act (FDCA) that expressly preempts1 state tort laws, except in the Medical Device Amendments of 1976. Under those amendments, section 521 of the FDCA prohibits a state from promulgating any "requirement regarding a medical device intended for human use" that is "different from or in addition to" any requirement of the FDCA.2 The medical products industry has long argued that if any design change or new warning is needed to avoid state tort liability (which they can only know after they lose a lawsuit), then that design change or new warning essentially is a requirement of state law, which should be preempted.
Although circuit courts have split on whether product liability cases involving medical devices reviewed and approved under a premarketing application (PMA) are preempted, a plurality of the Supreme Court in 1996 held in Medtronic v. Lohr that lawsuits involving devices merely granted premarketing clearance—under section 510k of the Medical Device Amendments3— are not preempted.4 In an amicus brief it filed in Medtronic, FDA argued that private suits in state courts are "complementary" to the agency's efforts to keep device companies in compliance with FDA regulations; in fact, in the Fourth Circuit, FDA argued with the plaintiff that Lohr precluded preemption of state law tort claims.5 In 1997, then-Chief Counsel Margaret Jane Porter noted "the agency's longstanding presumption against preemption in implementing section 521 [21 U.S.C. § 360k] of the [FDCA]."6 She went on to say:
The Court, like FDA, refused to find that Congress intended section [360k] to usher in a sweeping preemption of traditional common law remedies against manufacturers and distributors of defective devices. There was a marked absence of such an intent on the part of legislators who were acutely aware of the high-profile product liability litigation involving medical devices. The Court emphasized Why Is FDA Attacking Injured Consumers? by Edward J. Parr, Jr. the importance of not cavalierly preempting state regulation, particularly in fields traditionally left to the states.7
In 2000, the Supreme Court heard a "Pedicle Screw" injury case, which specifically addressed whether there was a state tort cause of action for committing a "fraud on FDA." Even though the Supreme Court struck down the "fraud-on-the-FDA" cause of action in Buckman Co. v. Plaintiffs' Legal Committee, 8 that case arguably was not a preemption case; rather, the Court's decision was consistent with a long line of prior cases holding that there is no private right of action under the FDCA.9 Even in Buckman , FDA did not argue that the plaintiffs' state tort common law claims (e.g., failure to warn adequately) should be preempted.
Since 2000, FDA has changed its position with respect to express preemption under 21 U.S.C. § 360k. Now the agency argues that this statutory section does preempt state tort law claims, admitting this is a "change in views" that "has not been taken lightly … ."10 Recently, the Third Circuit agreed with this modified position, 11 and joined those circuits in which PMA approval for a medical device preempts all state tort claims. Thus, since December 2003, FDA has taken an entirely different view of the FDCA's express preemption provisions; the agency now urges courts to reject state tort law claims—apparently no longer viewing these as "complementary to its own efforts."
Prescription Pharmaceutical Preemption
There is no express preemption provision in the FDCA with respect to prescription pharmaceuticals. The Drug Amendments of 1962 (also known as the Kefauver-Harris Amendments) required, for the first time, that new drugs be reviewed and expressly approved by FDA before they could be marketed in the United States. Section 202 of those Amendments provided that "nothing in the amendments … shall be construed as invalidating any provision of State law … unless there is a direct and positive conflict between such amendments and such provisions of State law."12 Thus, FDA's review and approval of new drugs was never intended to preempt state product liability laws unless there is a "direct and positive conflict." This also is consistent with countless state court opinions holding that regulatory compliance is the "minimum" that can be expected from drug companies.13
In its 1979 drug labeling Federal Register notice, FDA argued that "drug labeling does not always contain the most current information and opinion available to physicians about a drug because advances in medical knowledge inevitably precede formal submission of proposed new labeling by the manufacturer and approval by FDA," that "communication of significant medical information should be encouraged, not restricted," and that "the addition to labeling and advertising of additional warnings … is not prohibited by [FDA's] regulations."14 In fact, FDA cited with approval a state court case holding that a company may have a common law duty to revise its warnings earlier than obtaining FDA approval.
As recently as 2000, in Bernhardt v. Pfizer Inc., when the plaintiff requested that the court order the company/defendant to issue a warning letter, FDA intervened only at the invitation of the court and argued only that it had "primary jurisdiction"—under a doctrine that gives a court discretion to "refer a matter within its original jurisdiction to the appropriate administrative agency if doing so will promote proper relationships between the courts and administrative agencies charged with particular regulatory duties."15 Even in that case, however, FDA was a long way from forcing state litigants out of court altogether and from arguing preemption of all state law tort claims.
FDA shifted its position in 2002. In the In re Paxil Litigation against the SmithKline Beecham Corporation (SKB), plaintiffs claimed that the adverse effect warnings for the drug product were inadequate and sought an injunction to prohibit the company from advertising Paxil as "not habit forming."16 After the court entered a temporary restraining order (TRO) against SKB, FDA filed a brief arguing that, because the agency allegedly had reviewed and approved the Paxil label, all of the plaintiffs' claims—including the personal injury claims—should be dismissed. The court vacated its TRO, but declined to adopt FDA's preemption arguments. In a shift of position, FDA began to argue that courts should not only defer to FDA on labeling issues under the primary jurisdiction doctrine, but also that courts must dismiss entire cases, including injury claims.
In 2002,17 FDA totally shifted directions before the Ninth Circuit Court of Appeals in the Motus v. Pfizer case, in which injuries allegedly were caused by Pfizer's Zoloft® (sertraline).18 FDA abandoned the pretense of conflict preemption and simply argued, without evidentiary support and without ever having made an administrative determination, that the agency would not approve any additional warnings the plaintiffs might argue were necessary and that including them would violate FDA regulations. In other words, FDA argued that the agency's regulations preempted the entire field of drug labeling—precisely what FDA had said, in 1979, it would not do and what the 1962 Amendments prohibit. The Ninth Circuit never reached the preemption issue in Motus and upheld dismissal of the case on other grounds. One federal court has since dismissed another Zoloft® product liability case on conflict preemption grounds, after citing FDA's brief in Motus v. Pfizer.19
Policy or Politics?
Prior to 2001, FDA had long viewed state tort litigation as "complementary" to its own efforts to keep companies in compliance with the agency's regulations. In the current administration, FDA lawyers argue that the agency's standards are both the least and the most that can be expected of drug companies without risking "chaos" for the industry.20 FDA argues—without any clear supporting data—that healthcare providers should not be given too much information about risks because it might deter the use of prescription drugs. And, drug companies that reap billion dollar profits from willful misconduct argue that preemption is necessary to keep down the cost of drugs and to make funds available for innovative research and development. In response, U.S. Representative Maurice Hinchey (D-NY) obtained passage of a budget amendment in July 2004 that would strip $500,000 from the budget of the Office of the Chief Counsel at FDA, arguing that the current Chief Counsel "has taken FDA in a radical new direction, seeking to protect drug companies instead of the public."21
Even though states across the nation have recognized that FDA regulations reflect the minimum that can be expected from drug companies, in the practice of state product liability law, an implicit—and sometimes explicit— presumption already exists in the law that a drug approved by FDA is adequately labeled and is not defective. In every drug product liability lawsuit, the plaintiff bears the burden of rebutting that presumption. Preemption does far more than create a rebuttable presumption; preemption reflects a determination that, because of FDA's actions, the conduct of the manufacturer is unassailable. Thus, a manufacturer who may have been negligent or reckless is nevertheless protected, while injured consumers are left without a remedy; the costs of severe and fatal injuries caused by drug company negligence and misconduct will be borne by patients, their families, public and private health insurers, and state and federal governments.
Pharmaceutical tort plaintiff lawyers support the position that more balanced, truthful, and non misleading information needs to be put in the hands of healthcare professionals; that the fidelity and support of both medical leaders and small-office physicians should not be bought; that the art of medical science must be saved from bias and corruption; and that risk management should be used as a means to reduce adverse experiences, not as a means to reduce liability. Preemption will fund research and stock dividends with profits from the injured, will fuel the corruption of medical science, and will stifle the flow of information to physicians. In the end, preemption will undermine the agency's public health mission by allowing gross misconduct to go undeterred and leaving the victims of corporate misconduct without a remedy. This new agency policy, however, will accomplish only two goals: it will protect the industry from "chaos" and it will serve the political agenda of the current administration.
Mr. Parr is a Partner in the law firm of Ury & Moskow LLC, Washington, D.C.
- There are essentially three levels of preemption: "express" preemption—where Congress expressly states in legislation that a federal law preempts specific state laws; "conflict" preemption—where a valid federal law or requirement conflicts with a state law and, in these situations, federal law prevails; and "implied" or "field" preemption—sometimes considered a type of conflict preemption, where federal laws are so comprehensive in one area that state laws may interfere with the federal scheme, and therefore cannot be enforced.
- 21 U.S.C. § 360k.
- Id. § 360c.
- Medtronic v. Lohr, 518 U.S. 470 (1996).
- See Duvall v. Bristol-Myers Squibb Co., 103 F.3d 324 (4th Cir. 1996).
- Margaret Jane Porter, The Lohr Decision: FDA Perspective and Position, 52 FOOD & DRUG L.J. 7, 7 (1997).
- Id. at 10.
- 531 U.S. 341 (2001).
- Bailey v. Johnson, 48 F.3d 965, 968 (6th Cir. 1995) ("Congress did not intend, either expressly or by implication, to create a private cause of action under the FDCA"); Summit Tech. v. High-Line Med. Instruments, 922 F. Supp. 299, 305 (C.D. Cal. 1996); PDK Labs., Inc. v. Friedlander, 103 F.3d 1105, 1113 (2d Cir. 1997) (plaintiff's suit "represents an impermissible attempt to enforce the FDCA through a private right of action"); Mylan Labs., Inc. v. Matkari, 7 F.3d 1130, 1139 (4th Cir. 1993).
- See Amicus Letter-Brief of the United States, Horn v. Thoratec Corp. (Case No. 02-4597, U.S. Ct. App. 3d Cir., May 14, 2004); see also Statement of Interest of the United States, Murphree v. Pacesetter, Inc., Civ. No. Ct-005429-00-3 (Cir. Ct. Tenn., 13th Dist., Dec. 12, 2003).
- Horn v. Thoratec Corp., Slip Op. at 5 (Case No. 02-4597, U.S. Ct. App. 3d Cir., July 20, 2004).
- Pub. L. No. 87-781, 76 Stat. 780 (Oct. 10, 1962).
- E.g., Hill v. Searle Labs., 884 F.2d 1064, 1068 (8th Cir. 1989); Kociemba v. Searle & Co., 680 F. Supp. 1293, 1299 (D. Minn. 1988) (citing Graham v. Wyeth Labs., 666 F. Supp. 1483 (D. Kan. 1987); Brochu v. Ortho Pharm. Corp., 642 F.2d 652 (1st Cir. 1981); and Salmon v. Parke Davis & Co., 520 F.2d 1359 (4th Cir. 1975)); Mazur v. Merck & Co., 742 F. Supp. 239, 247 (E.D. Pa. 1990); Graham v. Wyeth Labs., 906 F.2d 1399 (10th Cir.), cert. denied, 498 U.S. 981 (1990); Abbot v. Am. Cyanamid Co., 844 F. 2d 1108 (4th Cir. 1988); Tobin v. Astra Pharm. Prods., Inc., 993 F.2d 528 (6th Cir.), cert. denied, 510 U.S. 914 (1993); MacDonald v. Ortho Pharm. Corp., 394 Mass. 131, 139-40, cert. denied, 474 U.S. 920 (1985); Hurley v. Lederle Labs., 863 F.2d 1173 (5th Cir. 1988); Feldman v. Lederle Labs., 592 A.2d 1176 (N.J. 1991).
- 44 Fed. Reg. 37,434, 37,435 et seq. (June 26, 1979).
- Bernhardt v. Pfizer Inc., 2000 WL 1738645 (S.D.N.Y. 2000).
- Memorandum Order, In re Paxil Litig., CV-01-07937 (U.S. Dist Ct. C.D. Ca., Aug. 16, 2002).
- In 2002, FDA also intervened in a state court case brought under California's Proposition 65—Dowhal v. Smithkline Beecham Consumer Healthcare, CV-S1-09306 (Cal. Sup. Ct., Apr. 15, 2004). That case, which also involved many unique legal issues arising from a savings clause in the Food and Drug Administration Modernization Act of 1997 (Pub. L. No. 105-115 (Nov. 21, 1997)), arguably involved issues of direct conflict preemption because the drug companies had failed to include the carcinogenicity warning mandated by "Prop 65" after FDA expressly rejected the companies' requests to include the warning.
- See Motus v. Pfizer Inc., 358 F.3d 659 (9th Cir. 2004).
- Dusek v. Pfizer Inc., Memorandum and Order, Civ. No. H-02-3559 (S.D. Tex., Feb. 20, 2004).
- James T. O'Reilly, A State of Extinction: Does Food and Drug Administration Approval of a Prescription Drug Label Extinguish State Claims for Inadequate Warning?, 58 FOOD & DRUG L.J. 287 (2003).
- Press Release, Office of U.S. Rep. M. Hinchey, Hinchey Amendment to Strip Funds From FDA Counsel's Office Accepted Unopposed (July 13, 2004), available at (last visited Sept. 7, 2004).