Under the Radar – Wyeth v. Levine and the Stealth Revision of Regulatory Rulebooks that Could Preclude Scores of State-Level Tort Claims
By Ross A. Hammersley
The U.S. Supreme Court is poised to radically alter state law tort liability in a manner which could increase the scrutiny of—and possibly malpractice litigation against—physicians everywhere. In the matter of Wyeth v. Levine (Case No. 06-1249), which will be decided before next summer, the Court will tackle the issue of whether the FDA’s approval of the warning language used on prescription drug labels pre-empts state law “failure to warn” claims brought against pharmaceutical manufacturers.
The argument advanced by petitioner, Wyeth Pharmaceuticals, boils down to an assertion that it should be impossible for a pharmaceutical company to be held liable for what a jury determines to be an inadequate drug label, since the language of that label was approved by the FDA. Despite evidence suggesting that the FDA’s approval of Wyeth’s drug Phenergan was arguably based on incomplete or inadequate data, Wyeth argues that FDA approval should preempt state law “failure to warn” claims such as the one brought in this case.
Should the Court rule in favor of Wyeth and decide that tort claims against drug manufacturers are preempted by a drug’s label—even if the existing wording of that label is inadequate—there could be a profound impact on physicians and health law practitioners throughout the country. Foreclosing this long-standing avenue of relief for injured patients could lead to an increase in medical malpractice litigation against physicians prescribing these drugs. Such a ruling would also remove a strong incentive for manufacturers to correct and update inadequate labels over time, and could lead to a severe decrease in consumer confidence in the ability of the FDA to protect patients from faulty medical drugs or devices.
Wyeth Pharmaceuticals was sued by Diana Levine, a Vermont musician who, in response to continuing symptoms of headache-related nausea, received an injection of Wyeth’s Phenergan. The label which Wyeth submitted for marketing, and which the FDA approved, included a general warning that intravenous administration of the drug (through either “IV drip” or “IV push” methodology) could result in “inadvertent arterial injection and gangrene.” However, the label failed to distinguish the level of risk as between these two different intravenous methods of administration, despite the fact that IV push administration carried a significantly higher level of risk than did IV drip. Unfortunately, it was one such IV push arterial injection which allegedly caused Levine to develop severe tissue deterioration and gangrene in her right arm (leading to its amputation below the elbow and the negligence suit against Wyeth).
Levine alleged, and a Vermont jury agreed, that Wyeth had violated the Food, Drug and Cosmetic Act of 1938 (FDCA) and a state-law duty to warn by failing to include in its labeling for Phenergan “‘adequate warnings’ against ‘unsafe dosage or methods or duration of administration or application.’” Specifically, Levine argued that as early as the 1970’s Wyeth was aware or should have been aware of severe adverse health effects—including multiple amputations—caused by another anti-nausea drug, Pfizer’s Vistrol. Based on those incidents, Pfizer voluntarily removed IV push injection from the accepted administration methodologies for Vistrol. Levine argued that Wyeth had an obligation to follow a similar course with Phenergan, including a voluntary alteration of the language on Phenergan’s label so as to ban the IV push procedure completely. Finally, Levine further argued that Wyeth failed to present the evidence of the unreasonable risk of “inadvertent arterial injection” associated with IV-push administration of Phenergan to the FDA.
In contrast, Wyeth argued that the FDA’s approval of the Phenergan label precluded Wyeth from making any unilateral revisions to the label’s content, and that the FDA’s labeling requirements preempt suits like Levine’s for two reasons: (1) that Wyeth could not possibly comply with the common law determinations of individual states while contemporaneously complying with the FDA’s labeling requirements; and (2) that state failure-to-warn liability, despite compliance with federal labeling requirements, conflicts with the federal objectives of the FDCA. Therefore, Wyeth has asked the Court to set aside the jury’s award to Mrs. Levine and rule that the FDA’s “approval of a prescription drug’s labeling preempts state-law ‘failure-to-warn’ claims.”
Medical devices and drugs may meet the minimum requirements of the FDCA and applicable regulations while still posing a risk to patients or doctors in unforeseen circumstances or when used for an “off-label” purpose (i.e., a use inconsistent with the express language approving or authorizing the use of a device or drug). As such, throughout the seventy year history of the Act state tort liability and damages have been described as “serv[ing] a complementary purpose to direct government regulation” by providing compensation for injuries and alerting the public to the risks and hazards posed by drugs and medical devices that fall through the cracks of federal oversight. (David C. Vladeck, The Emerging Threat of Regulatory Preemption (January 2008)(unpublished white paper for the American Constitution Society)).
Although Wyeth contends that there is a conflict between the labeling requirements of the FDCA and state law tort claims, an amicus (“friend of the court”) brief filed by former FDA Commissioners Dr. Donald Kennedy and Dr. David A. Kessler refutes this assertion, stating that “until 2002, failure-to-warn litigation was seen by both Congress and FDA as an important adjunct to federal regulation.” Members of Congress similarly filed a brief in support of Levine establishing that state tort suits have been considered complementary to the FDCA by the courts, the FDA and Congress for such a long period of time that this jointly held understanding has become “well-embedded.”
While the outcome of the Wyeth case remains to be determined, if the Supreme Court issues a decision favoring Wyeth there are likely to be several foreseeable consequences to both the drug approval process and health law generally.
First, Phenergan will certainly not be the last drug that obtains FDA approval only to have its safety called into question by the discovery of unforeseen risks and hazards. In fact, the New England Journal of Medicine recently published a timeline for four such drugs that followed a similar track of initial agency approval followed by subsequent discovery of a variety of drug safety problems (Rosiglitazone, Rofecoxib, Dexfenfluramine and Aprotinin). Furthermore, the Journal points out that FDA approval often involves only “short-term efficacy studies, not long-term safety studies,” noting that the FDA is forced to base its approval decisions on manufacturers’ own disclosures and revelations because the agency itself has no subpoena power. A ruling in favor of Wyeth could result in a continuation of inadequate and likely incomplete information on drug safety being provided by manufacturers to both doctors and patients, despite the “approval” of a drug’s label by the FDA. As demonstrated by the voluntary recall of Vioxx (Rofecoxib), the consequences on consumer and professional confidence could be severe.
Second, shorn of their ability to take legal action against drug manufacturers when the risks associated with such drugs are manifested, another potential impact of a ruling in favor of Wyeth at the Supreme Court could be an increase in malpractice suits against the physicians who administered the drugs causing the injury or harm to the patient.
Third, the shift from viewing state tort actions as complementary to, rather than in conflict with, regulation as noted by Drs. Kennedy and Kessler is unfortunately not unique to the FDA. In what some scholars have referred to as “stealth tort reform,” or “preemption by preamble,” several federal agencies (including the FDA) are now adding language to the preambles of notices in the Federal Register which assert that otherwise routine regulatory actions will now be considered to preempt state law tort claims in a broad and, until recently, unprecedented fashion. If all such tort claims are considered to be preempted, it will be a major reversal of the long-standing and well-settled framework in which state law tort claims serve as a complement to federal regulatory actions.
Not only would a ruling in favor of Wyeth have enormous economic consequences for the pharmaceutical industry, but the reasoning behind this argument could also be extended to a whole host of regulated industries. This is conceivably why the U.S. Chamber of Commerce described the Wyeth case in the Wall Street Journal as “the business case of the century.” Therefore, it is clear that the outcome of this case should be closely monitored, not only by doctors and health care professionals, but also by the business community and the public at large, in order to see just how far this preemption argument will be taken. Although federal health and safety regulations have operated for decades in concert with civil remedies at the state level, this delicate balance could be upset by a ruling in favor of Wyeth before the end of this Supreme Court term.
Ross Hammersley is an associate attorney at Frank, Haron, Weiner and Navarro, PLC. His practice involves representation of individual physicians, health care professionals, home health agencies and other health care entities in a variety of areas relating to health law and regulations.
The U.S. Supreme Court is poised to radically alter state law tort liability in a manner which could increase the scrutiny of—and possibly malpractice litigation against—physicians everywhere. In the matter of Wyeth v. Levine (Case No. 06-1249), which will be decided before next summer, the Court will tackle the issue of whether the FDA’s approval of the warning language used on prescription drug labels pre-empts state law “failure to warn” claims brought against pharmaceutical manufacturers.
The argument advanced by petitioner, Wyeth Pharmaceuticals, boils down to an assertion that it should be impossible for a pharmaceutical company to be held liable for what a jury determines to be an inadequate drug label, since the language of that label was approved by the FDA. Despite evidence suggesting that the FDA’s approval of Wyeth’s drug Phenergan was arguably based on incomplete or inadequate data, Wyeth argues that FDA approval should preempt state law “failure to warn” claims such as the one brought in this case.
Should the Court rule in favor of Wyeth and decide that tort claims against drug manufacturers are preempted by a drug’s label—even if the existing wording of that label is inadequate—there could be a profound impact on physicians and health law practitioners throughout the country. Foreclosing this long-standing avenue of relief for injured patients could lead to an increase in medical malpractice litigation against physicians prescribing these drugs. Such a ruling would also remove a strong incentive for manufacturers to correct and update inadequate labels over time, and could lead to a severe decrease in consumer confidence in the ability of the FDA to protect patients from faulty medical drugs or devices.
Case Background
Wyeth Pharmaceuticals was sued by Diana Levine, a Vermont musician who, in response to continuing symptoms of headache-related nausea, received an injection of Wyeth’s Phenergan. The label which Wyeth submitted for marketing, and which the FDA approved, included a general warning that intravenous administration of the drug (through either “IV drip” or “IV push” methodology) could result in “inadvertent arterial injection and gangrene.” However, the label failed to distinguish the level of risk as between these two different intravenous methods of administration, despite the fact that IV push administration carried a significantly higher level of risk than did IV drip. Unfortunately, it was one such IV push arterial injection which allegedly caused Levine to develop severe tissue deterioration and gangrene in her right arm (leading to its amputation below the elbow and the negligence suit against Wyeth).
Levine alleged, and a Vermont jury agreed, that Wyeth had violated the Food, Drug and Cosmetic Act of 1938 (FDCA) and a state-law duty to warn by failing to include in its labeling for Phenergan “‘adequate warnings’ against ‘unsafe dosage or methods or duration of administration or application.’” Specifically, Levine argued that as early as the 1970’s Wyeth was aware or should have been aware of severe adverse health effects—including multiple amputations—caused by another anti-nausea drug, Pfizer’s Vistrol. Based on those incidents, Pfizer voluntarily removed IV push injection from the accepted administration methodologies for Vistrol. Levine argued that Wyeth had an obligation to follow a similar course with Phenergan, including a voluntary alteration of the language on Phenergan’s label so as to ban the IV push procedure completely. Finally, Levine further argued that Wyeth failed to present the evidence of the unreasonable risk of “inadvertent arterial injection” associated with IV-push administration of Phenergan to the FDA.
In contrast, Wyeth argued that the FDA’s approval of the Phenergan label precluded Wyeth from making any unilateral revisions to the label’s content, and that the FDA’s labeling requirements preempt suits like Levine’s for two reasons: (1) that Wyeth could not possibly comply with the common law determinations of individual states while contemporaneously complying with the FDA’s labeling requirements; and (2) that state failure-to-warn liability, despite compliance with federal labeling requirements, conflicts with the federal objectives of the FDCA. Therefore, Wyeth has asked the Court to set aside the jury’s award to Mrs. Levine and rule that the FDA’s “approval of a prescription drug’s labeling preempts state-law ‘failure-to-warn’ claims.”
Litigation and Regulations Working In Concert
Medical devices and drugs may meet the minimum requirements of the FDCA and applicable regulations while still posing a risk to patients or doctors in unforeseen circumstances or when used for an “off-label” purpose (i.e., a use inconsistent with the express language approving or authorizing the use of a device or drug). As such, throughout the seventy year history of the Act state tort liability and damages have been described as “serv[ing] a complementary purpose to direct government regulation” by providing compensation for injuries and alerting the public to the risks and hazards posed by drugs and medical devices that fall through the cracks of federal oversight. (David C. Vladeck, The Emerging Threat of Regulatory Preemption (January 2008)(unpublished white paper for the American Constitution Society)).
Although Wyeth contends that there is a conflict between the labeling requirements of the FDCA and state law tort claims, an amicus (“friend of the court”) brief filed by former FDA Commissioners Dr. Donald Kennedy and Dr. David A. Kessler refutes this assertion, stating that “until 2002, failure-to-warn litigation was seen by both Congress and FDA as an important adjunct to federal regulation.” Members of Congress similarly filed a brief in support of Levine establishing that state tort suits have been considered complementary to the FDCA by the courts, the FDA and Congress for such a long period of time that this jointly held understanding has become “well-embedded.”
Potential Impacts of Regulatory Preemption
While the outcome of the Wyeth case remains to be determined, if the Supreme Court issues a decision favoring Wyeth there are likely to be several foreseeable consequences to both the drug approval process and health law generally.
First, Phenergan will certainly not be the last drug that obtains FDA approval only to have its safety called into question by the discovery of unforeseen risks and hazards. In fact, the New England Journal of Medicine recently published a timeline for four such drugs that followed a similar track of initial agency approval followed by subsequent discovery of a variety of drug safety problems (Rosiglitazone, Rofecoxib, Dexfenfluramine and Aprotinin). Furthermore, the Journal points out that FDA approval often involves only “short-term efficacy studies, not long-term safety studies,” noting that the FDA is forced to base its approval decisions on manufacturers’ own disclosures and revelations because the agency itself has no subpoena power. A ruling in favor of Wyeth could result in a continuation of inadequate and likely incomplete information on drug safety being provided by manufacturers to both doctors and patients, despite the “approval” of a drug’s label by the FDA. As demonstrated by the voluntary recall of Vioxx (Rofecoxib), the consequences on consumer and professional confidence could be severe.
Second, shorn of their ability to take legal action against drug manufacturers when the risks associated with such drugs are manifested, another potential impact of a ruling in favor of Wyeth at the Supreme Court could be an increase in malpractice suits against the physicians who administered the drugs causing the injury or harm to the patient.
Third, the shift from viewing state tort actions as complementary to, rather than in conflict with, regulation as noted by Drs. Kennedy and Kessler is unfortunately not unique to the FDA. In what some scholars have referred to as “stealth tort reform,” or “preemption by preamble,” several federal agencies (including the FDA) are now adding language to the preambles of notices in the Federal Register which assert that otherwise routine regulatory actions will now be considered to preempt state law tort claims in a broad and, until recently, unprecedented fashion. If all such tort claims are considered to be preempted, it will be a major reversal of the long-standing and well-settled framework in which state law tort claims serve as a complement to federal regulatory actions.
Conclusion
Not only would a ruling in favor of Wyeth have enormous economic consequences for the pharmaceutical industry, but the reasoning behind this argument could also be extended to a whole host of regulated industries. This is conceivably why the U.S. Chamber of Commerce described the Wyeth case in the Wall Street Journal as “the business case of the century.” Therefore, it is clear that the outcome of this case should be closely monitored, not only by doctors and health care professionals, but also by the business community and the public at large, in order to see just how far this preemption argument will be taken. Although federal health and safety regulations have operated for decades in concert with civil remedies at the state level, this delicate balance could be upset by a ruling in favor of Wyeth before the end of this Supreme Court term.
Ross Hammersley is an associate attorney at Frank, Haron, Weiner and Navarro, PLC. His practice involves representation of individual physicians, health care professionals, home health agencies and other health care entities in a variety of areas relating to health law and regulations.