Felix v. Hoffmann-LaRoche, Inc.
| Decision Date | 23 February 1989 |
| Docket Number | No. 71633,HOFFMANN-L,71633 |
| Citation | 540 So.2d 102,14 Fla. L. Weekly 73 |
| Parties | , 14 Fla. L. Weekly 73, Prod.Liab.Rep. (CCH) P 12,063 Yolanda FELIX, etc., Petitioner, v.aROCHE, INC., et al., Respondents. |
| Court | Florida Supreme Court |
Jeffrey P. Kaiser of the Law Offices of Jeffrey P. Kaiser, Miami Lakes, for petitioner.
Mercer K. Clarke of Kelley, Drye & Warren, Miami, and Smathers & Thompson, Miami, for respondents.
Alan C. Sundberg, Tallahassee, and A. Broaddus Livingston and Sylvia H. Walbolt, Tampa, of Carlton, Fields, Ward, Emmanuel, Smith & Cutler, P.A., amicus curiae for G.D. Searle & Co.
We review Felix v. Hoffmann-LaRoche, Inc., 513 So.2d 1319 (Fla. 3d DCA 1987), because of apparent conflict with Tampa Drug Co. v. Wait, 103 So.2d 603 (Fla.1958); Ricci v. Parke Davis & Co., 491 So.2d 1182 (Fla. 4th DCA), review denied, 501 So.2d 1283 (Fla.1986); MacMurdo v. Upjohn Co., 444 So.2d 449 (Fla. 4th DCA 1983); and Lake v. Konstantinu, 189 So.2d 171 (Fla. 2d DCA 1966). Jurisdiction is based on article V, section 3(b)(3), of the Florida Constitution.
This was a suit for the wrongful death of a child attributed to the ingestion of Accutane by his mother during pregnancy. Accutane is a drug prescribed for serious and disfiguring cases of acne which was approved for marketing in the United States by the Food and Drug Administration in 1982. The mother took the drug late in 1982 while she was pregnant upon the prescription of her physician. The child was born with severe birth defects which led to his early demise.
A critical issue in the case was whether the manufacturer of the drug furnished adequate warnings of the dangers of using the drug during pregnancy. The relevant text of the package insert at that time stated:
CONTRAINDICATIONS: Teratogenicity was observed in rats at a dose of isotretinoin of 150 mg/kg/day. In rabbits a dose of 10 mg/kg/day was teratogenic and embryotoxic, and induced abortion. There are no adequate and well-controlled studies in pregnant women.
Because teratogenicity has been observed in animals given isotretinoin, patients who are pregnant or intend to become pregnant while undergoing treatment should not receive Accutane. Women of childbearing potential should not be given Accutane unless an effective form of contraception is used, and they should be fully counseled on the potential risks to the fetus should they become pregnant while undergoing treatment. Should pregnancy occur during treatment, the physician and patient should discuss the desirability of continuing the pregnancy.
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Women of childbearing potential should be instructed to use an effective form of contraception when Accutane therapy is required. (See CONTRAINDICATIONS AND WARNINGS.)
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PREGNANCY: Category X. See "CONTRAINDICATIONS" section.
Dr. Greenwald prescribed Accutane to the mother for a cystic acne condition of her face and shoulders which had persisted for many years. He characterized Accutane as a miracle drug for people with acne. Dr. Greenwald testified that he understood the warnings which accompanied the drug and said that "category X" meant that the drug should not be used during pregnancy. He also stated that he had prior knowledge of the teratogenic propensities of Accutane from independent research and reading and from seminars he had attended. He defined "teratogenicity" as "the ability of something to turn out a teratogen" and the term "teratogen" as "a mutant, deformed something--a deformed part, a deformed being, a deformed person, a monster, if you will, something very abnormal." Dr. Greenwald testified that he warned the mother against the use of Accutane if she were to become pregnant. The mother denied having received such a warning.
The trial judge entered summary judgment in favor of those defendants which were involved in the manufacture and distribution of Accutane. The Third District Court of Appeal affirmed and gave two reasons for its decision. First, the court held that the warning provided by the drug manufacturer was adequate as a matter of law. Second, the court reasoned that any inadequacy in the warning could not have been the proximate cause of the damages because the mother's physician knew of the drug's inherent dangers and when it should not be taken.
At the outset, it is clear that the manufacturer's duty to warn of Accutane's dangerous side effects was directed to the physician rather than the patient. Buckner v. Allergan Pharmaceuticals, Inc., 400 So.2d 820 (Fla. 5th DCA), review denied, 407 So.2d 1102 (Fla.1981). This is so because the prescribing physician, acting as a "learned intermediary" between the manufacturer and the consumer, weighs the potential benefits against the dangers in deciding whether to recommend the drug to meet the patient's needs. Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1276 (5th Cir.), cert. denied, 419 U.S. 1096, 95 S.Ct. 687, 42 L.Ed.2d 688 (1974). Furthermore, there is no contention that the warning given in this case contained any misstatements. While there have been subsequent incidents of children born with birth defects after their mothers ingested Accutane, there had been no Accutane related teratogenicity in human infants prior to the ingestion of the drug in this case.
The asserted basis for conflict in this case is the district court's conclusion that the warning given was adequate as a matter of law. In Tampa Drug Co. v. Wait, a man had died as the result of using carbon tetrachloride to clean the floors of his home. The main issue before the Court was the adequacy of the warning to consumers on the jug which contained the carbon tetrachloride. The Court held that the conflicting evidence in the record concerning the adequacy of the warning justified submitting that issue to the jury for determination. Citing Wait as authority, several subsequent district courts of appeal decisions have employed language which can be read to say that the adequacy of drug warnings is invariably a jury question. Ricci; MacMurdo; Lake.
Thus, petitioner...
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...cases where there was no evidence that a different warning would have changed the physician's behavior. See Mason, 27 So.3d at 77; Felix, 540 So.2d at 105. In case, however, Dr. Avey did not testify that an adequate warning would have had no effect on his interactions with Davis. To the con......
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In re Testosterone Replacement Therapy Prods. Liab. Litig.
...cases where there was no evidence that a different warning would have changed the physician's behavior. See Mason, 27 So.3d at 77; Felix, 540 So.2d at 105. In case, however, Dr. Avey did not testify that an adequate warning would have had no effect on his interactions with Davis. To the con......
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...on several cases to support its argument. See E.R. Squibb and Sons v. Farnes, 697 So.2d 825, 827 (Fla.1997) ; Felix v. Hoffmann–LaRoche, Inc., 540 So.2d 102 (Fla.1989) ; Higgins v. Forest Labs., 48 F.Supp.3d 878 (W.D.Va.2014).In response, Bennett argues summary judgment is inappropriate bec......
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Krstic v. Sofregen Med. Inc.
...whether to recommend the [medical device] to meet the patient's need [("the learned intermediary doctrine")].Felix v. Hoffman-LaRoche, Inc., 540 So.2d 102, 105 (Fla. 1989); see also Beale v. Biomet, Inc., 492 F. Supp. 2d 1360, 1367-38 (S.D. Fla. 2007) (applying the learned intermediary doct......
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CHAPTER § 9.03 The Learned-Intermediary Doctrine
...(Del. 1989). District of Columbia: Mampe v. Ayerst Labs., 548 A.2d 798, 801 n.6 (D.C. 1988). Florida: Felix v. Hoffmann-LaRoche, Inc., 540 So.2d 102, 104 (Fla. 1989). Georgia: McCombs v. Synthes, 587 S.E.2d 594, 595 (Ga. 2003). Hawaii: Craft v. Peebles, 893 P.2d 138, 155-56 (Haw. 1995). Ida......