YOLANDA FELIX, AS PERSONAL REPRESENTATIVE OF THE ESTATE OF KEVIN FELIX-BAPTISTE, APPELLANT,
v.
HOFFMANN-LAROCHE, INC., ET AL., APPELLEES

Fla. 3d DCA | 1987-09-29
No. 86-1844
Before HENDRY, NESBITT and FERGUSON, JJ.
513 So. 2d 1319 Florida District Court of Appeal, Third District (1987) Positive Treatment
Cited by 8 cases

AI-generated. These summaries, headnotes, and key points are machine-generated and may contain errors or omissions. Always verify against the full opinion text below. Not legal advice.

Synopsis

A pharmaceutical manufacturer's duty to warn prescribing physicians of dangerous side effects is satisfied if the warning is adequate and clear. Here, Hoffmann-LaRoche provided sufficient warnings about Accutane's teratogenic risks to pregnant women, and summary judgment was properly granted because the prescribing physician had independent knowledge of the dangers regardless of any alleged warning deficiency.


Holding

Summary judgment was proper on two independent grounds: (1) the warnings provided to physicians about Accutane's teratogenic risks were adequate as a matter of law, and (2) even if a warning deficiency existed, it could not have been the proximate cause of the plaintiff's damages because the prescribing physician had independent knowledge of the drug's dangers to pregnant women at the time of prescription.


Headnotes

[1] A drug manufacturer owes a duty to warn prescribing physicians of the dangerous side effects of its prescription drugs.

[2] A drug manufacturer is not liable for patient injuries resulting from drug side effects if the warning provided to the medical community is adequate.

Previewing 2 of 5 headnotes on this case. FLexlaw’s editorially structured points of law — every proposition, pinpointed — are reserved for members.

Join FLexlaw to unlock all legal intelligence

Key Quotes

“a drug manufacturer owes a duty to warn prescribing physicians of the dangerous side effects of its prescription drugs. See Macmurdo v. Upjohn Co., 444 So.2d 449 (Fla. 4th DCA 1983); Buckner v. Allergan Pharmaceuticals, Inc., 400 So.2d 820 (Fla. 5th DCA), review denied, 407 So.2d 1102 (Fla.1981); see also Ricci v. Parke-Davis & Co., 491 So.2d 1182 (Fla. 4th DCA), review denied, 501 So.2d 1283 (Fla.1986). If the warning given to the medical community is sufficient, then the drug manufacturer is not liable for injuries sustained by the physician's patients as a result of the side effects of the drugs.”

Establishes the foundational rule that drug manufacturers must warn physicians but are not liable if warnings are adequate.

Previewing 1 of 3 key quotes on this case — the court’s exact language, pinpointed for members.

Join FLexlaw to unlock all legal intelligence

Facts & Procedural History

Kevin Felix-Baptiste's mother, Yolanda Felix, took Accutane (a prescription drug) while pregnant, resulting in birth defects. The drug was prescribed …

The full statement of facts, procedural history, and disposition for this case are member content.

Join FLexlaw to unlock all legal intelligence

© FLexlaw, Inc. — AI-generated enrichments are proprietary. All rights reserved.


Opinion of the Court
PER CURIAM.

PER CURIAM.

We affirm the trial court’s final summary judgment, entered in favor of Hoffmann-LaRoche, Inc., Roche Biomedical Laboratories, Lester M. Wachman, Bindley Western Industries, Inc., Gray Drug Stores, Inc. of Miami, Gray Drug Stores, Inc., and Sherwin Williams Company, for two reasons.

First, a drug manufacturer owes a duty to warn prescribing physicians of the dangerous side effects of its prescription drugs. See Macmurdo v. Upjohn Co., 444 So. 2d 449 (Fla. 4th DCA 1983); Buckner v. Allergan Pharmaceuticals, Inc., 400 So. 2d 820 (Fla. 5th DCA), review denied, 407 So. 2d 1102 (Fla.1981); see also Ricci v. Parke-Davis & Co., 491 So. 2d 1182 (Fla. 4th DCA), review denied, 501 So. 2d 1283 (Fla.1986).

If the warning given to the medical community is sufficient, then the drug manufacturer is not liable for injuries sustained by the physician’s patients as a result of the side effects of the drugs. The warning given was adequate as a matter of law. It is inconceivable that reasonable persons could disagree as to the adequacy of the warnings in conveying to physicians that the prescription drug, Accu-tane, is dangerous to pregnant women and should not have been prescribed. See Goodson v. Searle Laboratories, 471 F.Supp. 546 (D.Conn.1978); Dunkin v. Syntex Laboratories, Inc., 443 F.Supp. 121 (W.D.Tenn.1977); Brick v. Bames-Hines Pharmaceutical Co., 428 F.Supp. 496 (D.D. C.1977); Wolfgruber v. Upjohn, 72 A.D.2d 59, 423 N.Y.S.2d 95 (N.Y.App.Div.1979), aff'd, 52 N.Y.2d 768, 436 N.Y.S.2d 614, 417 N.E. 2d 1002 (1980); see also Upjohn Co., 444 So. 2d at 452 (Hersey, J., dissenting).

Besides using the term “teratogenicity,”1 the package insert accompanying the drug also warned:

Women of child-bearing potential should not be given Accutane unless an effective form of contraception is used, and they should be fully counseled on the potential risk 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 period.

It is also uncontested that the Physician’s Desk Reference gave a similar warning.

Second, even if we accept that a factual issue remains concerning whether the manufacturer breached a duty it owed by failing to provide an adequate warning, such a breach cannot be the proximate cause of Felix’s damages. The prescribing physician testified not only that he understood the warnings but that he had prior knowledge of the teratogenic propensities of Accutane from independent research and reading, and from seminars he had attended. It is unclear from the record whether Yolanda Felix was pregnant when Dr. Greenwald prescribed the drug and it is disputed whether he warned her of the risks involved, but what is clear is that at the time he prescribed Accutane, he was aware of the dangers it posed to pregnant women.

Consequently, the undisputed evidence demonstrates that any inadequacy in the warning provided was not the proximate cause of Felix’s damages and that the defendants were, therefore, entitled to judgment as a matter of law. See Goodson, 471 F.Supp. at 548; Dunkin, 443 F.Supp. at 124.

While we recognize that whether a warning is adequate is usually a jury question, e.g., Ricci, 491 So. 2d at 1182; Macmurdo, 444 So. 2d at 451, summary judgment is proper where, as here, the warning is clear and unambiguous, the injuries arising as a result of the failure to heed the warning are identical to those the warning described, and the undisputed evidence demonstrates that at the time the prescribing physician prescribed the drug, he was completely aware of the dangers it posed. See Goodson, 471 F.Supp. at 546; Dunkin, 443 F.Supp. at 121. Accordingly, the trial court’s final summary judgment is affirmed.

. Dr. Greenwald, the prescribing physician in this case, 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.”


Cases With Similar Vibessemantic neighbors from the corpus


Citator

Cited By

  • Childers v. Hoffmann-LaROCHE, Inc., 540 So. 2d 102 (Fla. 1989)
    …GRIMES, Justice. We review Childers v. Hoffmann La-Roche, Inc., 514 So. 2d 390 (Fla. 3d DCA 1987), in which the district court of appeal affirmed the trial court on the authority of Felix v. Hoffmann-LaRoche, Inc., 513 So. 2d 1319 (Fla. 3d DCA 1987). Because we accepted conflict jurisdiction of Felix, we also have jurisdiction of Childers under article V, section 3(b)(3), of the Florida Constitution. Jollie v. State, 405 So. 2d 418 (Fla.1981). Both the Felix and Childers ca…
  • Felix v. Hoffmann-LaROCHE, Inc., 540 So. 2d 102 (Fla. 1989)
    …GRIMES, Justice. 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 (F…
  • Bogorff v. Kjell Koch, M.D., 547 So. 2d 1223 (Fla. 3d DCA 1989)
    …manufacturer of a prescription drug, Lederle had a duty to warn the medical community of potential side effects resulting from the use of its product. Davis v. Wyeth Laboratories, Inc., 399 F. 2d 121 (9th Cir.1968); Felix v. Hoffmann-LaRoche, Inc., 513 So. 2d 1319 (Fla. 3d DCA 1987), rev. granted, No. 71,633 (Fla. Mar. 18, 1988); Ricci v. Parke-Davis & Co., 491 So. 2d 1182 (Fla. 4th DCA), rev. denied, 501 So. 2d 1283 (Fla.1986); Buckner v. Allergan Pharmaceuticals, Inc., 400 So. 2d 820 (Fla. 5th DCA), rev. de…

Previewing 3 of 5 citing cases — full citator treatment, depth of discussion, and citing context are member features.

Join FLexlaw to unlock all legal intelligence

Authorities Cited

Full citator, related cases, and AI research tools

Open in FLexlaw