In an attempt to insulate drug and device manufacturers from the flood of tort liability in the latter half of the twentieth century, many states adopted “safe-harbor” statutes. These safe-harbor provisions created the presumption that a drug or device manufacturer was not liable for injuries in tort if the FDA approved the drug or device as “safe and effective” and the drug or device and labeling complied with the FDA’s approval. Yet, some states allowed plaintiffs to rebut that presumption if the manufacturer “withheld information from or misrepresented information” to the FDA.
In 2001, the United States Supreme Court ruled that state law “fraud-on-the-FDA” claims were preempted as the state law claims “inevitably conflicted with the [FDA’s] responsibility to police fraud consistently with the Administration’s judgment and objectives.” Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 350 (2001).
At first, the Buckman decision seemed to indicate that such “withholding or misrepresentation” exceptions would also be preempted as the Sixth Circuit applied the Buckman analysis to reach that result. See Garcia v. Wyeth, 385 F.3d 961 (2004).However, a circuit split was soon created when the Second Circuit upheld such an exception as valid. Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2006).
The Second Circuit distinguished Buckman on three grounds. First, the Second Circuit concluded that the cornerstone of the Buckman decision—an absence of the presumption against preemption because states did not have an historical interest in policing fraud against federal agencies—did not apply because states had a traditional interest in protecting the health and safety of its citizenry through common law tort actions. Second, plaintiffs’ claims for recovery were founded in the common law duty of care rather than a new “fraud-on-the-FDA” claim. Finally, proof of “fraud-on-the-FDA” was not an element of the claim but an affirmative defense. Finding preemption where no element of the claim was at issue would stretch preemption far beyond its historical application.
An evenly-divided U.S. Supreme Court, with the Chief Justice abstaining, failed to reverse the Second Circuit in Warner-Lambert v. Kent, 128 S. Ct. 1168 (2008). In 2012, the Fifth Circuit sided with the Sixth Circuit. See Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372 (2012).
A recent district court opinion arising out of the Third Circuit continues that split as The Honorable Robert Kugler of the United States District Court for the District of New Jersey adopted the Second Circuit’s reasoning. As the Third Circuit has not had the opportunity to rule on this split, appellate review of Tigert v. Ranbaxy Pharmaceuticals, Inc., No. 12-00154 (Dec. 18, 2012) will hold important ramifications for what defenses are available to Defendants in three states where mass tort litigation is at home.
More plaintiffs’ attorneys have adopted the recent trend of alleging that pharmaceutical companies must distribute “Dear Doctor” letters or otherwise affirmatively call attention to label changes to satisfy their duty to warn prescribers besides merely updating the package insert with new warnings. The Eighth Circuit recently gave Plaintiffs’ argument support by upholding a Minnesota jury verdict finding that a drug manufacturer failed to warn a doctor despite the warning appearing in the package insert. Schedin v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., No. 11-317, 2012 WL 5971181 (Nov. 30, 2012).
In 2005, Dr. John Beecher prescribed John Schedin, who was 76 at the time, the drug Levaquin and a concomitant corticosteroid. The package insert warned that Levaquin could cause ruptures of the Achilles tendon and was amended in 2001 to also warn that the risk could be increased in patients receiving corticosteroids, especially in elderly patients. Schedin suffered an Achilles tendon rupture and sued Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJP), the company that marketed the drug.
The package insert and the Physician Desk Reference both included the warning regarding corticosteroids and the elderly. The risk of tendon rupture was listed in the Warnings section of the label but was not required to appear in a boxed warning until 2008, after Schedin’s injury. The sales representative testified that her common practice was to discuss labeling changes with prescribers but her notes from meetings with Dr. Beecher did not reference discussion of the warning and the sales aids she used at the time did not mention the risk of tendon rupture. Dr. Beecher testified that he was not aware of the risk associated with corticosteroids and the elderly and would not have prescribed Levaquin had he known of the risk.
Schedin argued that OMJP’s duty to warn obligated it to call prescriber’s attention to changes in the labeling through “Dear Doctor” letters or efforts by sales representatives. The jury returned a verdict for the Plaintiff despite the appearance of the warning in the package insert, the amendment of the PDR to reflect the warning, and the testimony regarding the sales representatives’ common practice to discuss labeling changes.
The Eighth Circuit acknowledged that many other jurisdictions held that pharmaceutical manufacturers satisfied their duty to warn as a matter of law if the warning appeared in the package insert and the PDR. However, as Minnesota courts had not addressed the issue, the Eighth Circuit held that there was sufficient evidence for a jury to find that OMJP had not adequately communicated the increased risk to prescribers.
The procedural posture limits the dangers this opinion poses to pharmaceutical companies. However, the Eighth Circuit highlighted that OMJP should have known that its warnings were inadequate due to the continued receipt of adverse events of tendon rupture in elderly patients prescribed concomitant corticosteroids after the label was amended in 2001. Further, the Court repeatedly described the warning as buried in a 15 page document of small type. These emphasized facts and the lack of weight given to the sales representative’s testimony confirm that pharmaceutical companies must carefully mange label changes, both in active litigation and to prevent future litigation.
The FDA has historically prohibited pharmaceutical companies from engaging in “off-label” promotion of its products. The Food, Drug, & Cosmetic Act also criminalizes misbranding by pharmaceutical companies. Misbranding occurs when a drug’s label does not provide instructions to allow for the safe use of intended indications. The FDA typically will not permit package inserts to provide information regarding off-label uses. Thus, the FDA interprets promotion of off-label uses as an intended indication and without these proper accompanying instructions, the action constitutes misbranding. Pharmaceutical manufacturers and their employees can be charged with misdemeanor and felony offenses and can be sanctioned with as much as three years’ imprisonment or a $10,000 fine.
While numerous pharmaceutical manufacturers have argued that this criminal prosecution violates their and their employees’ rights to free speech, the FDA has not altered its policy. Yet, the Second Circuit recently held that the FDA’s criminal prosecution of pharmaceutical manufacturers and their representatives for truthful, non-misleading speech promoting an FDA-approved pharmaceutical product unconstitutionally encroaches upon the First Amendment. U.S. v. Caronia, No. 09–5006–cr, 2012 WL 5992141 (2d Cir. Dec. 3, 2012).
The Second Circuit applied heightened scrutiny to the FDA’s prosecution and concluded first, that the government’s band did not directly advance its interest and second, that the government’s prohibition was not narrowly tailored to achieve its interest. The FDA claimed that its interest in the regulation was to promote the integrity of the approval process and limit the public’s exposure to unsafe or ineffective products. However, the Second Circuit reasoned that because physicians are allowed to prescribe approved drugs for off-label uses, the FDA’s ban did not limit off-label use or protect the public. Further, by stifling the flow of truthful communication, the FDA prohibition denied prescribers and patients important information about that product, including safety information. Finally, the FDA’s actions also were not narrowly tailored as the FDA could prohibit off-label uses, cap off-label prescriptions, or launch educational campaigns to achieve its interests more narrowly.
The FDA is expected to appeal the decision by either petitioning for en banc review by the Second Circuit or for a grant of certiorari by the Supreme Court. Until appellate options are exhausted, the FDA is unlikely to alter its regulations concerning off-label promotion. If the FDA is forced to change its regulatory scheme, pharmaceutical manufacturers will likely still need to be vigilant that communications could not be construed as “untruthful” or “misleading” to escape disciplinary action by the FDA.
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The BSCR Drug and Device Blog examines topics and legal developments of interest to the drug and device industry. Learn more about co-editors Angela Higgins and Allison Lee, and our Drug and Device practice.
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