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Absence of warning not negligence per se


“Unquestionably, the submissions established that Warner-Lambert’s warnings complied by stating the dangers that were known or reasonably knowable at the time.”

Hon. Charles B. Schudson
Wisconsin Court of Appeals

Even if prescription warnings are inadequate, a plaintiff must prove the inadequacy caused her to keep taking the prescription in order to recover damages, the Wisconsin Court of Appeals held on March 30.

In August 1996, shortly after giving birth, Donna Kurer began using Loestrin, an oral contraceptive. The Loestrin package she received included a “Detailed Patient Package Insert” — an extensive, small-print description of the medication with numerous sections including, “Risks of Taking Oral Contraceptives,” “Warning Signals,” and “Side Effects of Oral Contraceptives.”

None referred to Stevens-Johnson Syndrome (SJS). However, one section of the Detailed Patient Package Insert warned as follows: “If any of these adverse effects occur [sic] while you are taking oral contraceptives, call your doctor immediately[.]” It then listed adverse effects, including “[s]udden severe headache,” “dizziness,” “[d]ifficulty in sleeping, weakness, lack of energy, fatigue, or change in mood (possibly indicating severe depression).”

Another section titled, “Other Side Effects,” advised, “Other side effects may include change in appetite, headache, nervousness, depression, dizziness, loss of scalp hair, rash, and vaginal infections.” Immediately thereafter, concluding the “Other Side Effects” section, the patient package insert warned: “If any of these side effects bother [sic] you, call your doctor or health care provider.”

Another insert advised, “The onset or exacerbation of migraine or development of headache with a new pattern which is recurrent, persistent, or severe requires discontinuation of oral contraceptives and evaluation of the cause.” The insert also advised that other “adverse reactions have been reported in users of oral contraceptives and the association [between the contraceptives and the reactions] has been neither confirmed nor refuted.” Among the listed reactions was “Erythema multiforme,” a group of skin hypersensitivity disorders that includes SJS.

Kurer started feeling “[d]izzy, light-headed, fainty” and started experiencing lethargy, sleepiness, and headaches after taking Loestrin for four months. In December 1996, after two months of these symptoms, she read the entire patient insert, a copy of which had accompanied each of her six monthly doses, and all copies of which she had retained.

What the court held

Case: Kurer v. Parke, Davis & Co., No. 03-0647.

Issue: If a drug manufacturer complies with the minimum FDA warning requirements, can it be negligent per se for failure to warn?

If a plaintiff testifies she continued to take a drug, despite having the side-effects listed in the warning, and had never heard of the condition that caused her injuries, can the manufacturer be held negligent?

Holding: No. Compliance with FDA-required warnings generally forecloses negligence per se.

No. The evidence is clear that, even if the warnings were inadequate, the inadequate warning was not the cause of the injuries.

Counsel: Owen Thomas Armstrong Jr., Milwaukee; Christopher J. Stawski, Milwaukee, for appellant; Kenneth B. Ness, Milwaukee, for respondent.

After reading the warnings, however, Kurer did not immediately call her doctor. She explained, “I guess I just dragged it on, not knowing anything worse would happen to me.”

In February 1997, Kurer was hospitalized, diagnosed with SJS, and is now blind. Kurer brought suit against Parke, Davis & Company and Warner-Lambert Company, alleging failure to warn of the possible Loestrin-SJS connection.

Milwaukee Circuit Court Judge Jeffrey A. Kremers granted summary judgment to the defendants, holding that the warnings were not inadequate as a matter of law, and that Kurer failed to establish that, had she received any additional or different warnings, she would have discontinued her use of Loestrin.

Kurer appealed, but the court of appeals affirmed in a decision by Judge Charles B. Schudson.

Negligence Per Se

The court rejected Kurer’s argument that, by failing to inform about the association between SJS and oral contraceptives, the defendants did not comply with the governing FDA regulations, and was negligent per se.

The court noted that drug labeling is part of a comprehensive regulatory scheme inextricably connected to drug approval, and that an application for approval of a new drug must include “specimens of the labeling proposed to be used for such drug.” 21 U.S.C. 355(b)(1)(F).

The court acknowledged that, although the FDA has prescribed these standards, it has not foreclosed drug manufacturers from adding warnings, and that a drug manufacturer’s compliance with the FDA labeling standards does not preempt state-law claims.

Quoting a federal case, Caraker v. Sandoz Pharm. Corp., 172 F.Supp.2d 1018, 1034-1035 (S.D.Ill.2001), the court iterated, “Liability, irrespective of the Food, Drug, and Cosmetic Act (FDCA), may attach if drug manuf
acturers do not at least request FDA approval of an additional warning as soon as new hazards or elevated risk associations are discovered. … Because there is no indication that Congress and the FDA have attempted to impede what the FDA has referred to as the sophisticat[ed] and complex [ ] private tort litigation in the United States, this Court is right to interpret the FDA standards as minimum ones and to find that drug manufacturers still have a duty to timely disclose new known risks to learned intermediaries, especially because any other interpretation would run contrary to what appears to be an intent to preserve these tort remedies.”

The court held that violations of FDA regulations may constitute negligence per se, citing Lukaszewicz v. Ortho Pharm. Corp., 510 F.Supp. 961, 964 (E.D.Wis.), amended, 532 F.Supp. 211 (E.D.Wis.1981).

In addition, enactment of safety statutes over an activity does not abolish the duty arising under common-law negligence.

Applying the standards, the court found that Kurer failed to make a claim of negligence per se, by failing to establish that the defendants’ warnings failed to comply with FDA standards.

Because nothing established the defendants had any actual or constructive knowledge that Loestrin could cause SJS, the defendants could not have violated FDA regulations by failing to add an SJS warning.

The court concluded, “Unquestion-ably, therefore, the submissions established that Warner-Lambert’s warnings complied by stating the dangers that were known or reasonably knowable at the time.”

Common Law Negligence

Turning to the common law negligence claim, the court also held that Kurer’s evidence was insufficient to survive summary judgment.

While the adequacy of a warning often presents a factual issue for a jury, a claim of negligence requires proof of causal negligence, which the court found lacking.

A plaintiff must establish causation by showing that, if properly warned, he or she would have altered behavior and avoided injury. Mazur v. Merck Co., 742 F.Supp. 239, 262 (E.D.Pa.1990).

Related Links

Wisconsin Court of Appeals

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Case Analysis

However, Kurer stated that she had never heard of anyone having SJS before her own case, did not know what it was, or what the symptoms were. She also admitted that, at the time she suffered her symptoms, she had “no clue” whether additional warnings would have led her to call her physician and stop taking Loestrin.

Kurer further admitted that she read the warning label that mentioned heart attacks, strokes, embolisms, blood clots, and other things that could lead to death or other very severe consequences, but continued to take Loestrin.

The court thus concluded, “regardless of whether … the Loestrin warnings should have distinguished SJS from erythema multiforme and warned of both, the undisputed fact remains: when Kurer suffered her symptoms, her patient insert advised her to call her doctor, and the product insert, in turn, connected such symptoms to erythema multiforme, thus effectively warning of SJS as her doctors then understood it (emphasis in original).”

Accordingly, the court affirmed.

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David Ziemer can be reached by email.

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