Opinion ID: 1375802
Heading Depth: 1
Heading Rank: 3

Heading: does fda compliance reinstate the learned intermediary doctrine?

Text: The question then becomes whether the manufacturer has fulfilled its legal obligation once the warnings are approved by the FDA and transmitted to the user. Basel contends that because it complied with FDA requirements it had no further duty to warn Mr. Edwards. Jurisdictions split on their answer to this question. In MacDonald, 475 N.E.2d at 70, 71, the court held that compliance with FDA regulation did not reinstate the learned intermediary doctrine so as to absolve the manufacturer's liability for inadequate warnings. See also McEwen v. Ortho Pharmaceutical Corp., 270 Or. 375, 528 P.2d 522 (1974)(warnings to physicians were not sufficient even though they met FDA standards). Some courts have held compliance with FDA requirements is sufficient to bring a case back within the learned intermediary rule. In Spychala v. G.D. Searle & Co, 705 F.Supp. at 1033, the federal district court held that the FDA exception undercuts if not abrogates the learned intermediary rule and should be narrowly construed. Likewise, in Lacy v. G.D. Searle & Co., 567 A.2d at 401, 402, the Delaware court found that compliance with FDA regulations and approval of the patient brochure by the FDA satisfied the requirement of a direct patient warning. The case of Medtronic Inc. v. Lohr, ___ U.S. ___, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996) is helpful in coming to a decision. In Medtronic, the United States Supreme Court held that the FDA's regulation of medical devices does not preclude state tort liability. The Court was faced with the question of whether FDA procedures and regulations under the Medical Device Act, 21 U.S.C. Section 360(k), preempted state law liability. Plaintiff brought suit after her pacemaker failed, alleging among other things, that the warnings were inadequate. The manufacturer claimed that federal law preempted any state cause of action. The Court first noted that it has long been within the realm of the individual states, under their police powers, to protect the health and safety of their citizens. Although the federal government has taken an increasingly active role in this arena since the enactment of the Food and Drug Act of 1906, common law actions are not automatically preempted. The Supreme Court continued its preemption analysis by pointing out the two critical presumptions governing this issue: (1) that a state's police power is not superseded by federal law unless there is a clear and manifest expression to the contrary and (2) that the intent of Congress is the ultimate touchstone. Id. Relying on these presumptions, the Court turned to the plaintiff's claims of inadequate warnings accompanying the pacemaker, and held that the adequacy of warnings is a question of state law. Plaintiff's action based on inadequate warning was not precluded by the pervasive federal regulation in the area of medical devices. [3] It has long been the concern of this state to protect the health and safety of its citizens. The Supreme Court has recognized that state concern is warranted and permitted. Medtronic, supra . It is the widely held view that the FDA sets minimum standards for drug manufacturers as to design and warnings. Kociemba, at 1298. We conclude that compliance with these minimum standards does not necessarily complete the manufacturer's duty. Accord Mazur v. Merck & Co., 742 F.Supp. 239, 247 (E.D.Pa.1990)(FDA approved warnings regarding a vaccination did not preclude state tort liability for inadequate warnings); Patten v. Lederle Laboratories, 655 F.Supp. 745 (D.Utah 1987)(compliance with FDA requirements does not bar state law claims for manufacturer design flaws or inadequate warnings). The common law duty to warn is controlled by state law. Kociemba, at 1298-99; Odgers v. Ortho Pharmaceutical Corp. 609 F.Supp. 867 (E.D.Mich.1985); Graham v. Wyeth Laboratories, 666 F.Supp. 1483 (D.Kan.1987); MacDonald v. Ortho Pharmaceutical Corp., 394 Mass. 131, 475 N.E.2d 65 (1985). Even the FDA agrees, as noted by the FDA Commissioner who observed that civil tort liability for failure to warn is governed by state law. MacDonald, at 70, citing 43 Fed.Reg. 4214 (1978). Although the common law duty we today recognize is to a large degree coextensive with the regulatory duties imposed by the FDA, we are persuaded that, in instances where a trier of fact could reasonably conclude that a manufacturer's compliance with FDA labeling requirements or guidelines did not adequately apprise [prescription drug] users of inherent risks, the manufacturer should not be shielded from liability by such compliance. MacDonald, at 70 [4] . It may be that in certain instances compliance with FDA warning procedures will satisfy all state law requirements. But although compliance with FDA standards may prove an effective starting ground, it is not necessarily conclusive. The adequacy of warnings is determined by state law. Our result could improve the safety of prescription drugs by requiring that both standards are met. Mazur, at 248. Oklahoma requires that the manufacturer warn of dangers which are foreseeable and known to the manufacturer. Duane v. Oklahoma Gas & Electric Co., 833 P.2d 284, (Okla.1992). Those warnings must be adequate to inform the user of the dangers associated with the product's use. See Tansy, 890 P.2d at 886; Hutchins v. Silicone Specialties, 881 P.2d 64 (Okla.1993). The manufacturer is not, however, required to warn of obvious dangers. Grover v. Superior Welding, Inc., 893 P.2d 500 (Okla.1995). In the present case it appears the manufacturer clearly had knowledge of the dangers associated with the Habitrol patch; it furnished detailed warnings to the prescribing physicians. However, as to the warnings the late Mr. Edwards received in his Habitrol insert, state products liability law must be applied to determine their adequacy.