US Pharm. 2008;33(5):70-74.
The sorcerer leaves his
apprentice alone in the workshop tidying up. But the apprentice soon tires of
sweeping, so he enchants a broomstick to do it for him, using magic that he
has not yet fully learned. Soon the magic broom is spewing water all over the
floor, and the room begins to flood. The sorcerer returns, sees what is
happening, and breaks the spell, all the while rebuking the apprentice for
trying something he was not qualified to do.
A strange thing happened a short while ago. The United States Supreme Court ended up deciding a case by a 4-4 tie vote.1 That was quite a difficult task considering there are nine justices. But it occurred because Chief Justice John Roberts recused himself from the case, a controversy involving a defendant corporation in which he held significant stock. The effect of such a tie is that the decision from the Court of Appeals stands unchanged.
This might not be so remarkable in ordinary situations, but this case involved something that could have a very dramatic effect on litigation throughout the nation. It has sparked great interest in legal circles around the country for the past few years. The smart money was betting on the direct opposite outcome. At issue was whether the regulatory scheme for new drug approvals established by the Federal Food, Drug, and Cosmetic Act should preempt state product liability laws when injured plaintiffs sue a pharmaceutical company, alleging that they were harmed by a "defect" in a drug even though the FDA approved a New Drug Application after finding the drug safe and effective for its intended purposes.
The argument, embraced by Pharmaceutical Research and Manufacturers of America (PhRMA) and other drug companies, goes something like this: Before marketing a new drug, the manufacturer must submit the medication to years of testing and amass significant evidence that the drug is safe and effective to the satisfaction of the FDA. Having garnered that "seal of approval" from the federal government and then manufacturing, labeling, and marketing the drug in accordance with strict government standards, the manufacturer should not be subject to the whims of a state jury in product liability cases where the plaintiff asserts that there is something wrong with the drug, usually in the form of failure by the manufacturer to warn of foreseeable risks that are not included within the drug labeling. Were this doctrine to be adopted by the courts, this would mean a virtual end to nearly all drug product lawsuits, and those who claim to have been harmed by the effects of a drug would not be able to seek redress of their damages in a court of law.
The only problem with this "federal preemption" assertion is that Congress never voiced intent to preempt state laws in the Federal Food, Drug, and Cosmetic Act as originally adopted in 1938 or in any of the numerous amendments to the law over its long history. Congressional intent to preempt state law must be expressed in some form for the doctrine to operate. So far, very few courts have interpreted the act to contain anything that would even imply a congressional objective to wipe out a significant area of American jurisprudence. But this pesky little detail is not stopping the FDA from claiming that it does indeed have the authority to preempt contrary state laws.
The notion that the FDA has inherent authority to claim preemptive powers surfaced initially on December 22, 2000, in a Notice of Proposed Rulemaking.2 However, it was not until 2001, when Daniel Troy was appointed general counsel to the FDA, that the preemption steamroller took on serious proportions. Some argue that this was a political appointment signaling that the administration intended to impose its corporate-friendly agenda on the federal agency.3
Both before and after his stint with the FDA ended in 2004, Troy was paid handsomely by PhRMA companies representing their interests at the FDA and elsewhere. While he served as general counsel, the FDA began doing something it had not done previously: it started showing up in state drug product liability lawsuits filing amicus briefs taking sides with the defendant drug companies and arguing, in an unprecedented move, that the state lawsuits were preempted by the FDA. Troy argued that the lawsuits impermissibly interfered with the FDA's authority to regulate drugs by letting judges and jurors second-guess decisions regarding labeling and drug approvals recommended by scientific experts working for or on behalf of the FDA.
This is all the more surprising given that a prior general counsel, Margaret Porter, asserted that "FDA product approval and state tort liability usually operate independently, each providing a significant, yet distinct, layer of consumer protection." 4 She also noted that the agency has had a long-standing policy against preemption because "even the most thorough regulation of a product such as a critical medical device may fail to identify potential problems presented by the product. Preemption of all such [product liability] claims would result in the loss of a significant layer of consumer protection."5
Nevertheless, in 2006, the FDA issued a final rule governing the content and format of drug product labeling. 6 In this amended regulation, the FDA announced that the labeling requirements preempt state law claims that impose additional or different requirements. It specifically said that state drug product liability litigation is preempted by the FDA regulations. It also stated that such state claims undermine federal law "when state laws purport to compel a firm to include in labeling or advertising a statement that the FDA has considered and found scientifically unsubstantiated."7
Facts of the Case
The case subject of this debate originates with Michigan plaintiffs' claims that they were harmed after taking the drug Rezulin (troglitazone).8 The drug, which was manufactured by Parke-Davis/Warner-Lambert (now Pfizer), was approved by the FDA in 1997 for treatment of type 2 diabetes. Soon after it was marketed, reports started coming in documenting severe liver toxicity. The manufacturer agreed to a series of four label changes requested by the FDA between 1997 and 1999 and to limit marketing of the drug only for individuals who were not well controlled by other available medications. On March 21, 2000, the FDA asked the manufacturer to remove the product from the market.9
In 1995, the Michigan legislature amended its product liability law to immunize drug manufacturers from injury claims allegedly caused by an FDA-approved medication. The immunity provision has an exception and does not apply if the defendant "intentionally withholds from or misrepresents to the U.S. FDA information concerning the drug that is required to be submitted under the Federal Food, Drug, and Cosmetic Act and the drug would not have been approved, or the U.S. FDA would have withdrawn approval for the drug if the information were accurately submitted."10
Trial Court Ruling
This so-called "fraud on the FDA" exception to otherwise outright immunity had been discussed in a few other cases with mixed results. In this case, however, the federal trial court dismissed the lawsuit because there was no evidence that the defendants misrepresented or withheld information in obtaining FDA approval for the drug. The judge also determined that the fraud immunity exception in the Michigan statute was impliedly preempted by the Federal Food, Drug, and Cosmetic Act. He reasoned that if the plaintiffs covered by the Michigan statute were able to litigate claims of fraud on the FDA in individual personal injury suits, whether in state courts or in federal courts, the potential would exist for the FDA's personnel to be drawn into those controversies on a case-by-case basis over and over again. Concluding that this would generate "a wholly impractical situation," the judge held that "the exception in the Michigan statute is preempted."11
Court of Appeals Decision
The court started its opinion with the broad observation that "it has long fallen within the province of states to safeguard the health and safety of their citizens" and that "consonant with the historic primacy of state regulation of these matters, the power of states to govern in this field is considerable and undisputed." Succinctly put, the court stated, "The question presented by this appeal is whether federal law preempts traditional common law claims that survive a state's legislative narrowing of common law liability through a fraud exception to that statutory limitation."12
The court went on to note that throughout American history, there has been a presumption against federal preemption of state laws involving traditional tort liability. The court stated, "Until and unless Congress states explicitly that it intends invalidation of state common law claims merely because issues of fraud may arise in the trial of such claims, we decline to read general statutes like the Federal Food, Drug, and Cosmetic Act as having that effect." In coming to this conclusion, the court quoted a U.S. Supreme Court decision: "Particularly in [circumstances] in which Congress has ‘legislated...in a field which the States have traditionally occupied,' we start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress." 13
As to the preemption language that was included in the revised labeling rule ("state drug product liability litigation is preempted by the FDA regulations"),14 the court stated:
Although any statement by a federal agency carries persuasive weight, the FDA's recent pronouncement does not ultimately affect our analysis in this case. First, the FDA's statement seemingly concerns only preemption of state laws that impose additional labeling requirements. Appellants' claims rest on far broader allegations, e.g., defective design and manufacturing. Second, even to the extent that the FDA's statement might bear peripherally on the claims asserted in this case, it is not clear what, if any, deference would be owed to the FDA's view. Assertions of implied preemption arguably originate in [congressional] statutory ambiguity as to which an agency's interpretations may be accorded deference. But, whatever deference would be owed to an agency's view in contexts where a presumption against federal preemption does apply, an agency cannot supply, on Congress' behalf, the clear legislative statement of intent required to overcome the presumption against preemption.
Summarizing these views, the court then quoted language from an earlier U.S. Supreme Court decision: "Agencies may play the sorcerer's apprentice but not the sorcerer himself." 15 In conclusion, the court stated:
Because we find that a presumption against preemption applies in the instant case, we are bound also to conclude that, absent a clear statement from Congress, the common law claims preserved by Michigan's immunity exception cannot be preempted by federal law. Accordingly, an FDA statement to the contrary--even if the one it issued could be treated as such--could not alter our conclusion that Congress did not intend to preempt traditional and preexisting common law claims
While the 4-4 split in the U.S. Supreme Court that allowed the Court of Appeals decision to stand might be good news for the Michigan plaintiffs in the case at hand, this might not remain a long-lived precedent on the subject. The U.S. Supreme Court has agreed to take up another drug product liability case involving a preemption issue.16 In this case, the plaintiff sued the manufacturer of Phenergan (prometh azine) when she was severely injured and her arm had to be amputated after the drug was injected directly into an artery. She successfully argued in a state lawsuit that the defendant was negligent for failing to warn against the known dangers of direct intravenous-push injection. The defendant argued that the court should have dismissed the case because the claims are preempted by federal laws. The Supreme Court of Vermont held that the FDA regulations do not preempt the state's product liability laws. Obviously, this will be the main focus of the case when it comes before the U.S. Supreme Court.
Of what importance are drug product liability claims to pharmacists and why should we care if the courts do eventually hold that the FDA regulations preempt state lawsuits against drug makers? The potential interest is great. In our litigious society, when a patient is hurt after using a drug product, the tendency of the plaintiff's lawyers are to take a shotgun approach to a lawsuit--sue everybody in sight and see what happens. Liability might stick to one or more of the defendants. When it comes to drug injury litigation, there are often a number of parties for the plaintiff to take aim at: the physician who prescribed the medication, the pharmacist who dispensed it, the nurse who administered it, the health system or organization where any of these players are employed or have privileges, and the manufacturer of the medication.
Now imagine that the defendant with the deepest pockets, the drug company, is taken out of this equation because the courts conclude that maybe the "sorcerer's apprentice" can do magic after all and immunize the drug company through the preemption doctrine. Injured plaintiffs are still going to be looking for defendants that can be made to pay. Let's say that in any given case maybe there is only the prescriber and the pharmacist to look at for potential damages. Maybe the drug company cannot be held liable for failing to warn against a known hazard, but more and more frequently courts are saying pharmacists may be liable for not warning about known risks. And, of course, there is nothing out there that says a pharmacist only has to warn about information in FDA-approved labeling. In the Vermont case, the court stated that the FDA labeling requirements establish only a floor, not a ceiling. So if a drug company can be held liable for not warning about known risks that the FDA does not address, so too could a pharmacist.
For years pharmacists have been clamoring to be recognized as drug experts. However, do not be surprised if somebody wants to hold you liable for not exercising that expertise. The better advice might just be to make sure those malpractice policy premiums are paid and kept up to date. That, and maybe keep your own sorcerer around.
1. Warner-Lambert v. Kent, Slip Op No. 06-1498 (March 3, 2008), 128 S. Ct. 1168, 2008 U.S. Lexis 2235.
2. Proposed FDA rule preempts state product liability laws. NCLS News. January 13, 2006. http://22.214.171.124/programs/press/2006/pr060113.htm. Accessed March 28, 2008.
3. Mencimer S. Daniel Troy's poison
pill. Mother Jones. March 7, 2008.
2008/03/daniel-troy-fda-preemption.html. Accessed March 28, 2008.
4. Porter MJ. The Lohr decision: FDA perspective and position. Food Drug Law J. 1997;52:7-11. As quoted in: Bogard LM. Taking on big pharma--and the FDA: the fight against federal preemption is far from over, but some courts have rejected drug company claims that an FDA preamble should be granted sweeping deference. Trial. March 1, 2007. http://goliath.ecnext.com/coms2/gi_0199-6362272/Taking-on-big-pharma-and.html. Accessed March 28, 2008.
5. Id. See also note 3, supra.
6. 71 FR 3922 (January 24, 2006).
7. Id. At 3935.
8. See note 1, supra.
9. Rezulin to be withdrawn from the market. HHS News.March 21, 2000. www.fda.gov/bbs/topics/NEWS/NEW00721.html. Accessed March 28, 2008.
10. MCL § 600.2946(5)(a).
11. Desiano v. Warner-Lambert , 467 F3d 85, 2006 U.S. App Lexis 25108. Decided October 5, 2006, cert granted, 128 S. Ct. 31, 168 L. Ed.
13. Medtronic v. Lohr, 518 U.S. 470, 485, 116 S. Ct. 2240, 135 L. Ed. 2d 700 (1996).
14. See note 6, supra.
15. Alexander v. Sandoval, 532 U.S. 275, 291, 121 S. Ct. 1511, 149 L. Ed. 2d 517 (2001).
16. Levine v. Wyeth, 2006 Vt
107, 2006 Vt Lexis 306 (Supreme Court of Vermont, decided October 7, 2006);
cert granted, 128 S. Ct. 1118, 2008 U.S. Lexis 1100 (January 18, 2008).
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