author: SCHUDSON, J.

text:
    Donna Kurer, Dylan F. Kurer, and Dawson W. Kurer, Plaintiffs-Appellants, v. Parke, Davis & Company, and Warner-Lambert Company, Defendants-Respondents.
    Court of Appeals

      No. 03-0647.

      Oral argument January 6, 2004.

    Decided March 30, 2004.

    2004 WI App 74
    (Also reported in 679 N.W.2d 867.)

      On behalf of the plaintiffs-appellants, the cause was submitted on the briefs of O. Thomas Armstrong of Quarles & Brady LLP, of Milwaukee. There was oral argument by O. Thomas Armstrong.

    On behalf of the defendants-respondents, the cause was submitted on the brief of Kenneth B. Ness of Terschan, Steinle & Ness, of Milwaukee. There was oral argument by Kenneth B. Ness.

    Before Fine, Schudson and Curley, JJ.

       Petition to review denied 6-8-04.

   SCHUDSON, J.

¶ 1. Donna Kurer and her children, Dylan and Dawson ("Kurer"), appeal from the circuit court order granting summary judgment and dismissing their action against Parke, Davis & Company and Warner-Lambert Company (collectively, "Warner-Lambert"). Kurer argues that the court erred in concluding that her summary judgment submissions failed to establish that Warner-Lambert was negligent per se for failing to warn that her oral contraceptive, Loestrin®, was a possible cause of Stevens-Johnson Syndrome ("SJS"), and for failing to inform her that Loestrin® could cause headaches and other symptoms of SJS, necessitating its discontinuance. Alternatively, Kurer argues that, at the very least, the submissions established a material factual issue of whether Warner-Lambert was negligent for failing to provide sufficiently clear and emphatic warnings that, she maintains, would have caused her to call her doctor and discontinue Loestrin®.

¶ 2. We conclude that the warnings accompanying Loestrin® were adequate as a matter of law and, therefore, that the circuit court correctly concluded that Warner-Lambert was not negligent per se. Additionally, we conclude that Kurer's summary judgment submissions failed to establish the requisite causal nexus between the alleged inadequate warnings and her injuries. Accordingly without addressing any other issue, see Gross v. Hoffman, 227 Wis. 296, 300, 277 N.W. 663 (1938) (only dispositive issue need be addressed), we affirm.

I. BACKGROUND

¶ 3. In August 1996, shortly after giving birth, 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 SJS. Two sections of the Detailed Patient Package Insert, however, provided information of importance to this appeal.

¶ 4. The "WARNING SIGNALS" section began by stating: "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," "difficulty in sleeping, weakness, lack of energy, fatigue, or change in mood (possibly indicating severe depression)."

¶ 5. The "SIDE EFFECTS OF ORAL CONTRACEPTIVES" section included a subsection titled, "Other Side Effects," which 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."

¶ 6. Also accompanying the Loestrin® package was a second, more extensive insert, often referred to as a "product package insert." In that insert, under the "WARNINGS" section, was a subsection, "Headache," which 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 product 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, according to the summary judgment submissions, included SJS.

¶ 7. According to her deposition, Kurer started feeling "[d]izzy, light-headed, fainty" and started experiencing lethargy, sleepiness, and headaches after taking Loestrin® for four months. And, 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. After reading the warnings, however, Kurer did not immediately call her doctor; instead, she read material about the first year of a baby's life, conferred with friends and family members, and concluded that her symptoms were postpartum and/or premenstrual. She explained: "So I guess I just dragged it on, not knowing anything worse would happen to me."

¶ 8. In February 1997, after new symptoms had developed and others had become more severe, Kurer was hospitalized and ultimately diagnosed with SJS from which she has suffered terrible consequences, including blindness. Kurer testified that had she been warned of the possible connection between her symptoms and SJS, she would have stopped taking Loestrin®. Consequently, Kurer brought claims based on Warner-Lambert's Alleged failure to warn of the possible Loestrin®-SJS connection.

¶ 9. Granting summary judgment, the circuit court concluded, in part, that: (1) the warnings accompanying Loestrin® were adequate as a matter of law; and (2) the submissions failed to establish that, had Kurer received any additional or different warnings, she would have discontinued her use of Loestrin®. We agree.

II. DISCUSSION

¶ 10. Summary judgment methodology is well known and need not be repeated here. See Wis. Stat. § 802.08(2); Grams v. Boss, 97 Wis. 2d 332, 338-39, 294 N.W.2d 473 (1980). Although we value a circuit court's analysis, our review of its grant or denial of summary judgment is de novo. Green Spring Farms v. Kersten, 136 Wis. 2d 304, 315-17, 401 N.W.2d 816 (1987). Here, on the issues we address, we conclude that the circuit court's analysis was sound and its conclusions were correct.

A. The Arguments

¶ 11. Kurer's essential premise, as phrased in her brief to this court, is that by "failing to inform [her] about the association between SJS and oral contraceptives," Warner-Lambert "did not comply with governing FDA regulations." She anchors her arguments in regulations of the Federal Food, Drug and Cosmetic Act that mandate that the contents of the "patient package insert for an oral contraceptive drug product" warn of "risks ... associated with the drug's use," 21 C.F.R. § 310.501(c)(2), of "the most serious side effects," § 310.501(c)(7), and of "other serious adverse reactions and potential safety hazards that may result from the use of oral contraceptives," § 310.501(c)(8). She contends, therefore, that the Loestrin® patient insert should have warned of SJS, and that its failure to do so constituted negligence per se. Alternatively, she contends that, "at the very least, whether Warner-Lambert was negligent in failing to warn [her] about SJS presents an issue of fact for the jury."

¶ 12. In a closely related argument, Kurer also addresses SJS symptoms, contending that under these same FDA regulations, Warner-Lambert was negligent per se "in failing to tell [her] to discontinue Loestrin® if she experienced recurrent and/or persistent headache [s]." And again, alternatively, she maintains that this at least presents a jury issue "particularly in view of the fact that Warner-Lambert told prescribing physicians, via the product package insert, that Loestrin® must be discontinued in such circumstances."

¶ 13. In support of her arguments, Kurer directs our attention to: (1) the difference between the warnings to consumers in the patient insert and to doctors in the product insert, and the latter's emphasis on recurrent headaches; and (2) the failure of either the patient insert or the product insert to specifically warn of SJS. Kurer maintains that had she been properly warned, she would have sought assistance from her physician promptly and, therefore, could have discontinued using Loestrin® and prevented the harm she suffered.

¶ 14. Warner-Lambert responds that "all of the necessary package inserts and warning labels had to be submitted [to] and approved" by the United States Food and Drug Administration, and that the FDA had not authorized any warning for SJS. Warner-Lambert explains that no such warning had been authorized because "prior to Kurer's case the FDA had never received an Adverse Event Report alleging that any oral contraceptive manufactured by any pharmaceutical company was possibly associated with SJS." Therefore, Warner-Lambert maintains, its warnings were not only adequate, but, as a matter of law, could not have warned of SJS except to the extent that the patient insert advised of certain symptoms, and to the extent that the product insert advised of the possible association of such symptoms with erythema multiforme.

¶ 15. On this legal point, as we will explain, Warner-Lambert is incorrect. Warner-Lambert also argues, however, that: (1) it did warn Kurer to call her doctor if she suffered symptoms, including bothersome or severe headaches; (2) it did advise her doctor of the possible association of such symptoms with erythema multiforme, which, Warner-Lambert maintains, included SJS; and (3) Kurer's submissions establish that an additional, specific warning of SJS would not have made any difference. On these critical factual points, Warner-Lambert is correct.

B. The Regulations and their Relationship to the Common Law

¶ 16. Drug labeling is part of a comprehensive regulatory scheme inextricably connected to drug approval. See Hurley v. Lederle Labs., 863 F.2d 1173, 1179 (5th Cir. 1988) (discussing 21 C.F.R. §§ 1, 201). 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). Grounds for refusing an application may include the failure to provide evidence supporting the "proposed labeling," § 355(d)(1), or the agency's "fair evaluation" that the proposed labeling is "false or misleading in any particular." § 355(d)(7). Approval, once granted, may be withdrawn based on "new information" leading to a "fair evaluation" that the labeling is "false or misleading in any particular." § 355(e)(3). The "content and format of labeling" is strictly prescribed. See 21 C.F.R. § 201.57 (detailing the requirements for prescription drugs and/or insulin).

¶ 17. Manufacturers of "oral contraceptive drug products" not only must satisfy the requirements for drug labeling generally, they also must inform consumers of "the benefits and the risks involved in their use" in the "patient package insert... required to be placed in or accompany each package dispensed to the patient." 21 C.F.R. § 310.501(a); see also 21 U.S.C. §§ 352, 355 (providing that the FDA regulates the labeling of oral contraceptives, including patient inserts). The patient inserts must contain "[a] warning regarding the most serious side effects of oral contraceptives," 21 C.F.R. § 310.501(c)(7), "[a] statement of other serious adverse reactions and potential safety hazards that may result from the use of oral contraceptives," § 301.501(c)(8), and "[a] statement concerning common, but less serious side effects which may help the patient evaluate the benefits and risks from the use of oral contraceptives," § 301.501(c)(9).

¶ 18. Contrary to Warner-Lambert's argument, however, although the FDA has prescribed these standards, it has not foreclosed drug manufacturers from adding warnings. Drug manufactures can strengthen warnings or petition for additional warnings when new risk information arises. See 21 C.F.R. § 314.70(c)(2)(i); Motus v. Pfizer, Inc., 127 F. Supp. 2d 1085, 1093-94 (C.D. Cal. 2000); Caraker v. Sandoz Pharm. Corp., 172 F. Supp. 2d 1018, 1033-34 (S.D. Ill. 2001). Thus, even after approval, a drug manufacturer can add warnings without prior FDA approval. See Caraker, 172 F. Supp. 2d at 1034. The FDA clarifies this in the preamble to its drug labeling regulations:

The Commissioner . . . advises that these labeling regulations do not prohibit a manufacturer, packer, rela-beler, or distributor from warning health care professionals whenever possibly harmful adverse effects associated with the use of the drug are discovered. The addition to labeling and advertising of additional warnings, as well as contraindications, adverse reactions, and precautions regarding the drug, or the issuance of letters directed to health care professionals (e.g., Dear Doctor letters containing such information) is not prohibited by these regulations.
In considering these regulations in a product liability case, at least one court has held that an NDA [New Drug Application] holder may have a duty to add a warning before FDA approval of a supplemental application.

44 Fed. Reg. 37,434, 37,447 (1979) (citing McEwen v. Ortho Pharm. Corp., 528 P.2d 522 (Or. 1974)); see also 21 C.F.R. 314.70(c)(2)(i) (2000); 44 Fed. Reg. 37,434, 37,447 (1979) (explaining that this regulation permits the addition to the drugs labeling or advertising of information about a hazard without advance approval of the supplemental application by FDA).

¶ 19. Further, a drug manufacturers compliance with the FDAs labeling standards does not preempt state-law claims.

Until 1965, the FDA regulations applicable to drugs prohibited companies from adding warnings or other information without prior approval. These regulations were amended in 1965, allowing labeling changes related to safety to be placed into effect at the earliest possible time, the goal of which was for drug manufacturers to enable prompt adoption of such changes. 30 Fed. Reg. 993 (1965). Liability, irrespective of the Food, Drug, and Cosmetic Act (FDCA), may attach if drug manufacturers do not at least request FDA approval of an additional warning as soon as new hazards or elevated risk associations are discovered. These options for conveying additional risk information are not prohibited but encouraged.
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.
In enacting the FDCA, Congress enacted no general preemption provision. While Congress did enact such a provision for things like medical devices, it chose not to with respect to prescription drugs. Thus, the normal practice Congress employs when it is attempting to carve out areas of preemption was specifically not done with respect to prescription drugs.

Caraker, 172 F. Supp. 2d at 1034-35 (citations, footnotes, and parentheticals omitted).

¶ 20. In Wisconsin, violations of FDA regulations may constitute negligence per se. See Lukaszewicz v. Ortho Pharm. Corp., 510 F. Supp. 961, 964 (E.D. Wis.), amended, 532 F. Supp. 211 (E.D. Wis. 1981). Further, it is a "well-established rule that the enactment of safety statutes or legislation giving a commission jurisdiction over a certain activity does not abolish the duty arising under common-law negligence." Kemp v. Wisconsin Elec. Power Co., 44 Wis. 2d 571, 579, 172 N.W.2d 161 (1969) (citing Schulz v. Chicago, Milwaukee, St. Paul, Pac. R.R. Co., 260 Wis. 541, 51 N.W.2d 542 (1952)). Indeed, as our supreme court has explained:

[A] safety statute merely establishes a minimum standard of care and the conduct, even though sanctioned or in conformity with the statute, is not thereby necessarily relieved of conforming to the common-law requirements of ordinary care. In any event the establishment of a statutory definition of negligence per se does not thereby result in a preemption of the entire negligence question. There remains the question of possible common-law negligence.

Hoffmann v. Wisconsin Elec. Power Co., 2003 WI 64, 12, 262 Wis. 2d 264, 664 N.W.2d 55 (quoted source omitted). Moreover, a "statute does not change the common law unless the legislative purpose to do so is clearly expressed in the language of the statute." Id., 13 (quoted source omitted); see also Fuchsgruber v. Custom Accessories, Inc., 2001 WI 81, 25, 244 Wis. 2d 758, 628 N.W.2d 833 ("To accomplish a change in the common law, the language of the statute must be clear, unambiguous, and peremptory") (citations omitted).

¶ 21. As numerous courts have concluded, FDA regulations do not preempt the imposition of state common law liability for failure to warn claims. See, e.g., Feldman v. Lederle Labs., 592 A.2d 1176, 1192 (N.J. 1991) ("[W]e find nothing in the federal scheme to support the assertion that manufacturers of prescription drugs and antibiotics who literally comply with [FDA regulations] must be immune from state tort liability for injuries caused by their products."); Mazur v. Merck Co., 142 F. Supp. 239, 247 (E.D. Pa. 1990) ("[M]ere compliance with an FDA suggestion, or for that matter, regulation or order, does not mean that state tort law becomes irrelevant.... State tort law is intended to supplement federal regulation...."); cf. Medtronic, Inc. v. Lohr, 518 U.S. 470, 486-87 (1996) (Stevens, J., writing for himself and Justices Anthony M. Kennedy, David H. Souter, and Ruth Bader Ginsburg) (negligence and strict liability claims for failure to warn about risks of a medical device were not preempted by federal regulations). "FDA approval is not a shield to liability. FDA regulations are generally minimal standards of conduct unless Congress intended to preempt common law, which Congress has not done in this area." Hill v. Searle Labs., 884 F.2d 1064, 1068 (8th Cir. 1989) (citations omitted). "An FDA determination that a warning is not necessary may be sufficient for federal regulatory purposes but still not be sufficient for state tort law purposes." Wells v. Ortho Pharm. Corp., 788 F.2d 741, 746 (11th Cir. 1986),

C. Application of the Law to the Facts of this Case

¶ 22. Although compliance with FDA standards generally will foreclose negligence per se, see Lukaszewicz, 510 F. Supp. at 964; see also Mazur, 742 F. Supp. at 257-58, such compliance, as we have explained, does not preclude a finding of negligence. And although negligence per se and negligence are distinguishable, in this case our analyses of them eventually merge because Kurer is specifically arguing that the patient insert warnings were not clear and emphatic enough to satisfy the FDA requirements for a patient insert for an oral contraceptive. See ¶ 17, above.

¶ 23. To support her claim of negligence per se, Kurer must establish that Warner-Lambert failed to warn in a manner that complied with the FDA standards. She has failed to do so. The submissions do not establish that Warner-Lambert knew that Loestrin® could cause SJS. Without any actual or constructive knowledge of this alleged adverse effect, Warner-Lambert cannot be said to have violated FDA regulations by failing to add an SJS warning. Unquestionably, therefore, the submissions established that Warner-Lambert's warnings complied by stating the dangers that were known or reasonably knowable at the time.

¶ 24. To support her claim of negligence, Kurer must establish that Warner-Lambert breached its duty to warn, and that the breach caused her injuries. See Gracyalny v. Westinghouse Elec. Corp., 723 F.2d 1311, 1316-17 (7th Cir. 1983) (claim of negligence, unlike claim of strict liability, requires plaintiff to prove specific acts of causal negligence); Dippel v. Sciano, 37 Wis. 2d 443, 459-60, 155 N.W.2d 55 (1967). With respect to the adequacy of a warning, the initial inquiry under both strict liability and negligence analyses is the scope of the manufacturer's duty to provide a warning. Gracyalny, 723 F.2d at 1318. Although the adequacy of a warning often presents a factual issue for a jury, that is not always so. Compare id. at 1321, with Alvarado v. Sersch, 2003 WI 55, 29, 262 Wis. 2d 74, 662 N.W.2d 350 (summary judgment in negligence is proper where no reasonable jury, properly instructed, could find defendant was negligent). We, like the trial court, conclude that Kurer failed to establish either any inadequacy in the warnings or any causal link between an alleged inadequacy and her injuries.

¶ 25. A plaintiff who has established both a duty and a failure to warn must also establish causation by showing that, if properly warned, he or she would have altered behavior and avoided injury. Mazur, 742 F. Supp. at 262; see also Staymates v. ITT Holub Indus., 527 A.2d 140, 147 (Pa. Super. Ct. 1987) (evidence must support a reasonable inference that the existence of an adequate warning may have prevented the injury). Even in the event that a warning is inadequate, proximate cause is not presumed. Mazur, 742 F. Supp. at 262. Absent proof that a more complete or explicit warning would have prevented Kurers use of Loestrin, she cannot establish that Warner-Lambert's alleged failure to warn was the proximate cause of her injuries.

¶ 26. Kurer stated that she had never heard of anyone having SJS before her own case. And Kurer's expert explained that in order for a warning to make a difference, it must be easily and readily understood. Kurer ultimately 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®. At her deposition, she testified:

Q [I]n December, [you read] the warning label.
A Yes.
Q And it talked about heart attacks, strokes, embolisms, blood clots, and other things that could lead to death or other very severe consequences. And in December you knew those things could be a possible consequence for continuing to use the Loestrin, correct?
A Correct.
Q And knowing these possible severe consequences which could lead to death, paralysis!,] blindness, things like that, you still elected to take — continue taking the Loestrin, correct?
A Correct.
Q Do you have any idea on a percentage basis how much more likely it is to have any of these things that we just talked about occur as a result of using oral contraceptive[s] versus the probability of or possibility of having a situation where you did with SJS?
A No clue.
Q So you don't know it's more likely, less likely, anything like that?
A No.
Q Okay. Did it concern you that you could have a heart attack, blood clot, embolism, a stroke while using the Loestrin?
A I never heard of anyone having it.
Q Okay. You never heard of anyone having SJS before, correct?
A Exactly.
Q And if SJS had been placed on the package insert, would that have necessarily stopped you from continuing to take that Loestrin?
A With the symptoms? Yes. I would have stopped.
Q Okay. Why would that have prevented you from taking it more?
A Because when I had this rash, and had my ringing in the ears, if I would have read that on the birth control pills, I would have pertained it to it, and I would have stopped taking it.
Q If we could go back to what your knowledge was, at that time, from December to February. I believe, before, you said that you never heard of SJS before, erythema multiforme before, erythema multiforme major before, or TENS [Toxic Epidermal Necrolysis] before you went in the hospital at St. Luke's. Correct?
A Correct.
Q Okay. So if you never heard of these things, and even if the SJS had been mentioned on the package insert, that really wouldn't have changed your thought process or decision to keep on using the Loestrin, would it?
[Plaintiffs counsel]: I'm going to object to that question because she testified to just the opposite before. She indicated if she'd seen any symptoms, or read about them, she would have stopped taking it immediately. I thought she just said that.... Unless I'm misunderstanding your question.
[Defense counsel]: No. I appreciate that. That's why I had the preface there that I wanted to go back to your knowledge at the time.
[Plaintiffs counsel]: You mean December.
[Defense counsel]: Yes.
[Donna Kurer]:
A You can't ask me that now. I have no clue. If you're asking me that now, I'm going to say no, I wouldn't have took [sic] it.
[Defense counsel]:
Q Okay. But, at the time, you did not know what SJS was, correct?
A No.
Q And you wouldn't have known what any of the symptoms of SJS -
A No.
Q Okay. And if you never heard of anyone else having SJS, and not knowing what it was, if that had been on the package insert, is it fair to assume that you would have kept on taking the Loestrin?
A I have no clue.

¶ 27. Although Kurer now insists that she would have called her doctor, her submissions provide no support. After all, it is undisputed that she had many of the symptoms listed on the patient insert, including headaches that bothered her, but that she did not call her doctor as the patient insert instructed.

¶ 28. Still, maintaining that the warnings fell short, Kurer attempts to attach significance to the differences in the patient insert warnings between: (1) "sudden severe headache" and merely bothersome headaches; and between (2) the advice to call a doctor "immediately" and the less emphatic advice to merely call. See ¶¶ 4-5, above. Her attempt fails. Under the exact warnings, only if a patient suffers no headache at all, or no bothersome headaches, does the patient insert fail to advise a call to the doctor. Clearly and repeatedly, the patient insert warns patients to call their doctors in the event of headaches, whether severe or merely bothersome.

¶ 29. Moreover, Kurer's attempt fails to account for the patient insert's equally clear warnings to call doctors about other symptoms she suffered, including some associated with erythema multiforme, which, according to the submissions, included SJS. The report of Rodney Richmond of the Institute for Pharmaceutical Care, on which Kurer heavily relies, does not alter the analysis. While detailed and impressive, and while maintaining that "[biased upon a clinical consensus statement published in 1993, SJS is a skin reaction that is discreetly different from erythema multiforme," and "[t]herefore ... should he treated as such with respect to characterizing potential drug-induced adverse events," the report cannot counter the critical, undisputed understandings of Kurer's doctors.

¶ 30. Roger Lalich, M.D., the obstetrician/gynecologist who prescribed Loestrin® for Kurer, did not clarify whether he understood the relationship between erythema multiforme and SJS at the time he prescribed the contraceptive. However, based on what he had reviewed in preparation for the August 14, 2002 deposition in this case, he had come to understand that SJS "was part of that [erythema multiforme] syndrome." And Charles Brummitt, M.D., Kurer's treating physician, considered erythema multiforme to "come in major and minor forms," the more serious of which was "the Stevens-Johnson's form." Therefore, regardless of whether the FDA or Warner-Lambert should have embraced scientific information such as that forming the basis for Richmond's opinion, and regardless of whether, as a result, 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 multi-forme, thus effectively warning of SJS as her doctors then understood it.

¶ 31. We reject Kurer's assertion, articulated in her reply brief, that "Warner-Lambert asks the Court to immunize it from any liability for failing to warn [her] about recurrent and persistent headache, as well as SJS, because it allegedly provided adequate warnings to [her] prescribing physician, Dr. Lalich." That is not what Warner-Lambert has asked, and that is not what this court has done. If the patient insert in this case had said nothing about the very symptoms. Kurer suffered, and instead simply placed all the warnings in her doctor's hands, this could have been a very different case.

¶ 32. Clearly, therefore, while Kurer's circumstances are tragic, Warner-Lambert's warnings were adequate as a matter of law, and the summary judgment submissions failed to establish that Kurer would have heeded a different warning. The circuit court correctly granted summary judgment.

By the Court. — Order affirmed.

       Stevens-Johnson Syndrome is:
      a severe form of erythema multiforme ... characterized by [bullous lesions] on the oral mucosa, pharynx, anogenital region, and conjunctiva; target-like lesions and fever. The patient may be unable to eat or properly close the mouth.... The eyes may become very painful[, and conjunctivitis with swelling and pus] may make it impossible for the patient to open them.... The conjunctival lesions may leave [residual corneal scarring]. The condition is occasionally fatal.
      The MeRCk Manual of Diagnosis and TheRapy 825 (17th ed. 1999).

       For simplicity, this opinion will refer to the two types of inserts as the "patient insert" and the "product insert." Additionally, we note the existence of a third insert, the "Brief Summary Patient Package Insert." This third insert, however, has not become a factor in this appeal.
      Typically, while the patient insert goes with the oral contraceptive to the patient, the product insert may be retained by the physician and/or may go to the patient, depending on the circumstances of the drug's distribution. In this case, however, whether Kurer had knowledge of the product insert is immaterial to her challenges to the adequacy of the warnings in the patient insert.
      Nevertheless, because our discussion ultimately will also involve consideration of the contents of the product insert in this case, we note that the information in a product insert corresponds to that contained in the Physicians Desh RefeRence (PDR).
      The [PDR] is an annual publication compiling product information about pharmaceuticals. The information is provided by the drug manufacturers and is approved by the [Food and Drag Administration]. Each year the PDR and its supplements are sent free of charge to licensed physicians in the United States and abroad. A typical entry includes the trade name and chemical name of the drag, a description of the drug, indications and contraindications for its use, warnings, adverse reactions, administration and dosage, and information on managing and adjusting the dosage of the drag.

        Garvey v. ODonoghue, 530 A.2d 1141, 1144 n.4 (D.C. 1987).

       We recognize, however, that while the summary judgment submissions suggest no dispute about Kurer's diagnosis or the tragic harm she suffered, they do refer to considerable dispute about whether Loestrin® causes SJS, or caused her SJS.

       21 C.F.R. 310.501, provides in pertinent part:
      Patient package inserts for oral contraceptives.
      (a) Requirement for a patient package insert. The safe and effective use of oral contraceptive drug products requires that patients be fully informed of the benefits and the risks involved in their use. An oral contraceptive drug product that does not comply with the requirements of this section is misbranded under section 502 of the Federal Food, Drug, and Cosmetic Act. Each dispenser of an oral contraceptive drug product shall provide a patient package insert to each patient (or to an agent of the patient) to whom the product is dispensed, except that the dispenser may provide the insert to the parent or legal guardian of a legally incompetent patient (or to the agent of either). The patient package insert is required to be placed in or accompany each package dispensed to the patient.
      (b) Distribution requirements. (1) For oral contraceptive drug products, the manufacturer and distributor shall provide a patient package insert in or with each package of the drug product that the manufacturer or distributor intends to be dispensed to a patient.
      (c)Contents of patient package insert. A patient package insert for an oral contraceptive drug product is required to contain the following:

        (2) A summary including a statement concerning the effectiveness of oral contraceptives in preventing pregnancy, the contraindications to the drugs use, and a statement of the risks and benefits associated with the drugs use.
      (7) A warning regarding the most serious side effects of oral contraceptives.
      (8) A statement of other serious adverse reactions and potential safety hazards that may result from the use of oral contraceptives.
      (9) A statement concerning common, but less serious side effects which may help the patient evaluate the benefits and risks from the use of oral contraceptives.

       We note that the preamble refers to "warning health care professionals" and, therefore, might not seem to apply to patient inserts. Indeed, at oral argument, Warner-Lambert maintained that the federal regulations precluded an oral contraceptive manufacturer from including any additional warning in its patient insert. Pressed to identify which regulations, however, Warner-Lambert conceded that it could not.
      Our research reveals that on May 25, 1989, the FDA revoked the "guideline texts of professional and patient labeling for ... oral contraceptive drug products," and did so in order "to enable manufacturers and others to receive the most current [medical] information available to the agency in the most timely manner possible." See 54 Fed. Reg. 22,585, 22,587 (1989), 54 Fed. Reg. 22,624, 22,624 (1989). In fact, 21 C.F.R. § 310.501(f) encourages manufactures to supplement approved applications. It provides:
      Requirement to supplement approved application. Holders of approved applications for oral contraceptive drug products that are subject to the requirements of this section are required to submit supplements under § 314.70(c)[, governing new drug approval,] of this chapter to provide for the labeling required by this section. Suck labeling may be put into use without advance approval by the Food and Drug Administration.

      (Emphasis added.) Moreover, 21 C.F.R. § 314.70(c), which addresses "Supplements for changes that may be made before FDA approval," provides that "[c]hanges [to] labeling" may be made "[t]o add or strengthen a contraindication, warning, precaution, or adverse reaction." Id. None of these regulations is limited to warnings to health care providers alone; all apparently allow for additional warnings to patients. Thus, Warner-Lambert has pointed to nothing, and we have found nothing, that supports its contention that federal law prevents it from modifying labeling directed to patients in order to warn patients of potential hazards of oral contraceptives. Moreover, as we explain in the main body of this opinion, FDA approval of patient-directed warnings does not preempt state-law claims.

        See also Caraker v. Sandoz Pharm. Corp., 172 F. Supp. 2d 1018, 1033 (S.D. Ill. 2001) ("FDA's drug labeling decisions impose only 'minimum' standards that are open to supplementation by state law through a jury's verdict enforcing a manufacturer's common law duty to warn .... Because there is no evidence that either Congress or the FDA intended on scrapping state products liability claims based on a failure to warn ..., it is reasonable to find that the FDA has imposed a minimumas opposed to conclusivestandard of safety."); Mazur v. Merck Co., 742 F. Supp. 239, 247 (E.D. Pa. 1990) ("[M]ere compliance with an FDA suggestion, or for that matter, regulation or order, does not mean that state tort law becomes irrelevant. First, compliance with an FDA regulation may establish that the manufacturer met the appropriate minimum standards of due care, but compliance does not necessarily absolve the manufacturer of all liability. Manufacturers must meet state safety requirements, whether codified or embodied in the common law, in addition to satisfying the initial FDA requirements.") (citation omitted); Kociemba v. G.D. Searle Co.,
        680 F. Supp. 1293, 1299 (D. Minn. 1988) ("The mere fact that the [drug] received FDA approval does not, by itself, indicate that Congress impliedly intended to preclude state tort actions against prescription drug manufacturers. This is especially true in light of the widely held view that FDA regulation of prescription drugs establishes minimum standards, both as to design and warning."); Edwards v. Basel Pharm., 933 P.2d 298, 302 (Okla. 1997) ("It is the widely held view that the FDA sets minimum standards for drug manufacturers as to design and warnings. We conclude that compliance with these minimum standards does not necessarily complete the manufacturers duty.") (citation omitted); Savina v. Sterling Drug, Inc., 795 P.2d 915, 931 (Kan. 1990) ("[Regulations imposed by the FDA are minimal standards. A drug company is not prohibited from providing additional warnings and additional information that is not required by the FDA.").

       Information and advice to a patient contained in a patient insert, in combination with more specific information and advice to a doctor contained in a product insert, may achieve the best balance between telling patients so little as to leave them unwarned and so much as to leave them overwhelmed. See Catherine A. Paytash, Note, The Learned Intermediary Doctrine and Patient Package Inserts: A Balanced Approach to Preventing Drug-Related Injury, 51 Stan. L. Rev. 1343, 1368-71 (1999) (advocating such a hybrid-model as the best approach to promoting safe and effective prescription drug therapy). As Warner-Lambert suggests:
      The FDA's intent, via all of these labeling regulations and restrictions, is to make the labeling a realistic reflection of what is needed in order to make intelligent decisions. The ultimate objective is meaningful summarization of responsible data, while avoiding sensory overload. With this objective in mind, the FDA has not authorized any oral contraceptive manufacturer to specifically warn about SJS.

        To put this in practical terms, consider the inserts in this case. The patient insert consists of two very long, small-print pages with numerous sections. The product insert, with a similar format and font, is three times as long. It is reasonable to surmise, therefore, that the FDA's regulatory scheme anticipates a patient-physician partnership — that is, a warning system alerting patients to symptoms and leading them to contact their doctors who, better informed, take appropriate action. This, in fact, was the circuit court's view. Granting summary judgment, the court observed:
      I believe that the hybrid approach that I think is appropriate here is one that says, ["]Look, with respect to the physicians, you have to advise them of certain things that include even more rare conditions that maybe are specifically appropriate to your patient, maybe aren't!,] and we are going to rely on you to decide how much of that information you should pass on to your patient.!"] . . .
      But there is another set of information that we know should go directly to the patient perhaps ... more general information to put them on notice that, !"L]ook, there [are] some things you should watch out for, some primary symptoms to be aware of that you might want to talk to your health care provider about and we are going to require you do that.!"]
      This hybrid approach, however, has not been accepted by those courts embracing the "learned intermediary doctrine." They focus on the product insert — the warnings provided to doctors, not patients — to determine whether compliance with FDA standards shields a drug manufacturer from liability for failure to warn. See, e.g., Taurino v. Ellen, 579 A.2d 925, 928-29 (Pa. Super. Ct. 1990).
      Other courts, however, explain why such absolute adherence to the learned intermediary doctrine may be particularly inappropriate for oral contraceptives. Often dispensed through clinics, and often prescribed for extended time periods, oral contraceptives often come with little patient-physician interaction. Thus, these courts observe, warnings to doctors in product inserts may provide little if any meaningful warning to the consumer. See, e.g., MacDonald v. Ortho Pharm. Corp., 475 N.E.2d 65, 69-71 (Mass. 1985).
      Although the parties debate how the learned intermediary doctrine affects this appeal, we need not make that determination given the bases on which we have resolved this case.


source: Caselaw Access Project

author: SHIRLEY S. ABRAHAMSON, C.J.

license: Public Domain

text:
    State of Wisconsin, Plaintiff-Appellant, v. Todd M. Jadowski, Defendant-Respondent.
    Supreme Court

      No. 03-1493-CR.

      Oral argument April 27, 2004.

    Decided June 10, 2004.

    2004 WI 68
    (Also reported in 680 N.W.2d 810.)

      For the plaintiff-appellant the cause was argued by Sandra L. Nowack, assistant attorney general, with whom on the briefs was Peggy A. Lautenschlager, attorney general.
    For the defendant-respondent there was a brief by Richard Hahn and Holden & Hahn, S.C., Sheboygan, and oral argument by Richard Hahn.

   SHIRLEY S. ABRAHAMSON, C.J.

¶ 1. This is an appeal from an order of the Circuit Court for She-boygan County, L. Edward Stengel, Judge. Todd M. Jadowski, the defendant, faces prosecution on one count of sexual intercourse with a person who has not yet attained the age of 16 years contrary to Wis. Stat. § 948.02 (1999-2000). The circuit court granted the defendant's motion to introduce evidence of the victim's intentional misrepresentation of her age.

¶ 2. This case comes before the court on certification by the court of appeals pursuant to Wis. Stat. § (Rule) 809.61. The court of appeals certified the following questions:

(1) Is a minor sexual assault victim's intentional misrepresentation of his or her age a defense to a charge brought under Wis. Stat. § 948.02(2)?
(2) If not, do Wis. Stat. §§ 939.23, 939.43(2), and 948.02(2) deny an accused his constitutional rights under the Fourteenth Amendment to the United States Constitution?
¶ 3. We answer the questions as follows:
(1) Wisconsin Stat. § 948.02(2) read in conjunction with Wis. Stat. §§ 939.23 and 939.43(2) precludes a defense predicated on a child's intentional misrepresentation of her age. On the basis of the text of the statutes, the history and purpose of the statutes, and the practical requirements of law enforcement, and despite the severe penalties imposed, we conclude that no affirmative defense of the victim's intentional misrepresentation of his or her age exists in a prosecution under Wis. Stat. § 948.02(2). We decline the defendant's invitation to engraft such an affirmative defense onto § 948.02(2). Accordingly, we further conclude that the circuit court erred in ruling to admit the evidence the defendant proffered. If an accused's reasonable belief about the victim's age, based on the victim's intentional misrepresentation of age, is not a defense, then neither evidence regarding the defendant's belief about the victim's age nor evidence regarding the cause for or reasonableness of that belief is relevant. Therefore, evidence of the defendant's reasonable belief about the victim's age or the victim's intentional misrepresentation of her age is inadmissible in the guilt-determination phase of a criminal proceeding to support the defendant's asserted affirmative fraud defense to the crime.
(2) The statutes do not violate an accused's rights under the Fourteenth Amendment to the United States Constitution.

¶ 4. We therefore reverse the order of the circuit court and remand the cause to the circuit court for further proceedings consistent with this decision.

I — I

¶ 5. For purposes of this appeal, the facts are not in dispute. On April 15, 2002, the State filed a complaint against the 35-year-old defendant, alleging that on April 3, 2002, he had sexual intercourse with a person below the age of 16 in violation of Wis. Stat. § 948.02(2). The victim was born on September 13, 1986, making her about five and a half months shy of her 16th birthday on the date of the alleged assault.

¶ 6. Prior to trial the defendant moved to admit evidence that the victim fraudulently induced him to believe she was an adult. The circuit court held an evidentiary hearing on the motion. The defendant made an offer of proof that the victim was a chronic runaway; that the victim used what appeared to be a state-issued identification card showing her to be 19 years old; that the victim told the defendant and others that she was 19 years old; that the victim appeared to be 19 years old; and that the victim maintained in the defendant's presence that she was old enough to work as an exotic dancer.

¶ 7. The circuit court ruled that evidence of the victim's fraud was admissible under Wis. Stat. § 904.04 as relevant to the "issue of intent on behalf of the alleged victim as well as the absence of mistake or accident."

¶ 8. The State timely filed a motion for reconsideration, which the circuit court denied. The State sought leave to appeal the order admitting this evidence. The court of appeals granted leave to appeal and then certified the cause to this court as an issue of first impression.

¶ 9. The first issue requires us to decide whether a minor sexual assault victim's intentional misrepresentation of his or her age is a defense to a charge brought under Wis. Stat. § 948.02(2). This court decides questions of statutory interpretation independently of the circuit court and court of appeals, but benefiting from their analyses.

¶ 10. The second issue requires us to determine the constitutionality of statutes. The question of constitutionality is a question of law that we decide independently of the circuit court or court of appeals, but benefiting from their analyses. Statutes are presumed to be constitutional. A party challenging a statute's constitutionality must ordinarily demonstrate that the statute is unconstitutional beyond a reasonable doubt.

l-H l-H HH

¶ 11. The first issue we address is whether a minor sexual assault victim's intentional misrepresentation of his or her age is a defense to a charge under Wis. Stat. § 948.02(2). The defendant asserts that his reasonable belief about the victim's age based on the victim's fraud regarding her age should be a defense to a charge under § 948.02(2). We read Wis. Stat. § 948.02(2) with § 939.23 and § 939.43(2) to preclude a defense predicated on a child's intentional misrepresentation of her age.

¶ 12. Section 948.02(2) governs second-degree sexual assault of a child and provides that "[w]hoever has sexual contact or sexual intercourse with a person who has not attained the age of 16 years is guilty of a Class BC felony." The defendant and the State agree that the State must prove only two elements for a conviction: that the accused had sexual contact or intercourse with the victim, and that the victim was under the age of sixteen. The defendant asserts, however, that a victim's intentional misrepresentation of her age is an affirmative defense to the crime.

¶ 13. The issue, then, is whether the statutes allow an affirmative defense predicated on the victim's intentional misrepresentation of his or her age.

¶ 14. Wisconsin Stat. § 939.23, governing criminal intent as an element for crimes, provides guidance in determining whether an accused's reasonable belief about a victim's age based on the victim's intentional misrepresentation is a defense.

¶ 15. Section 939.23 addresses criminal intent as an element of all crimes in chapters 939 to 951. When criminal intent is an element of a crime, the statute uses one of several words or phrases, such as "intentionally," "know," or "believe." The sexual assault offense in the case at bar (§ 948.02(2)) does not contain any of the words or phrases denoting criminal intent.

¶ 16. Even if Wis. Stat. § 948.02(2) included a word of criminal intent like "intentionally" or "know," the State would not have to prove an accused's knowledge of the age of the minor. Section 939.23(6) expressly provides that criminal intent "does not require proof of knowledge of the age of a minor even though age is a material element in the crime in question."

¶ 17. Thus the sexual assault statute in the case at bar read in conjunction with Wis. Stat. § 939.23(6) does not require an actor to know the victim's age and does not set forth an actor's reasonable (but erroneous) belief about the victim's age as a defense.

¶ 18. An actor's ability to raise mistake regarding his belief about the age of a minor as a defense is explicitly negated in Wis. Stat. § 939.43(2). The general rule about mistake, set forth in § 939.43(1), is that "[a]n honest error, whether of fact or of law other than criminal law, is a defense if it negatives the existence of a state of mind essential to the crime." The exception to this general rule applies here: "A mistake as to the age of a minor ... is not a defense."

¶ 19. The defendant acknowledges that Wis. Stat. §§ 948.02(2), 939.23, and 939.43(2) prohibit an actor from raising mistake about the age of the minor as a defense to the charge of sexual assault. The defendant reasons that although these statutes prohibit the defense of mistake, they do not prohibit an actor from raising the affirmative defense of a victim's intentional misrepresentation about her age. The defendant distinguishes the defense of mistake from the defense of fraud. He asserts that he, as a victim of fraud, is not in the same position as an accused who is mistaken about the victim's age or who commits an honest error. The defendant urges that he was not mistaken about the victim's age; he was defrauded by the victim.

¶ 20. The defendant's affirmative defense of fraud is premised in part upon Wis. Stat. § 939.45, governing privilege as a defense to prosecution for a crime. The defendant relies on § 939.45(6), the "catch-all" provision of the privilege statute. The catch-all provision states that the defense of privilege can be claimed "[w]hen for any other reason the actor's conduct is privileged by the statutory or common law of this state." The defendant does not explain, however, upon what statute or common law rule he is relying under the catch-all privilege statute.

¶ 21. The crux of the defendant's position is that this court should engraft an affirmative defense of fraud onto Wis. Stat. § 948.02(2) even though the text of the statutes renders an actor mistaken as to a child's age liable for the crime. We are not persuaded that any reason exists for this court to perform such a task. We agree with the State that § 948.02(2) is a strict liability crime with regard to knowledge of the child's age. Numerous indicia point to the conclusion that no affirmative fraud defense is part of or should be read into § 948.02(2) and that the defendant's proposed affirmative defense is contrary to the policy adopted by the legislature.

¶ 22. First, an examination of Wis. Stat. § 948.02(2) in the broader context of chapter 948, Crimes Against Children, demonstrates that the legislature has, in certain statutes, created an affirmative defense of reasonable cause to believe that the child had attained the age of 18 years. See, for example, Wis. Stat. § 948.11(2) (c), pertaining to exhibition of harmful materials to a child, and § 948.05, pertaining to sexual exploitation of a child. Inclusion of this "reasonable cause to believe" affirmative defense in some child exploitation provisions in chapter 948 but not in others supports the conclusion that the legislature did not intend to include this affirmative defense in § 948.02(2). Because the legislature did not expressly create the "reasonable cause to believe" defense in § 948.02(2), this court should not read it into the statute.

¶ 23. Second, Legislative Council drafting documents of the 1950-1953 criminal code, since which time Wis. Stat. §§ 939.23 and 939.43(2) have remained essentially the same, are replete with evidence that the drafters intended to impose strict liability on an actor regardless of the actor's knowledge or belief about a child's age in child sexual assault cases.

¶ 24. Third, the purpose of Wis. Stat. § 948.02(2) is furthered by not engrafting onto the statute the affirmative defense proposed by the defendant. The statute is based on a policy determination by the legislature that persons under the age of sixteen are not competent to consent to sexual contact or sexual intercourse. The statute is intended to protect children. The state has a strong interest in the ethical and moral development of its children, and this state has a long tradition of honoring its obligation to protect its children from predators and from themselves. The statutes are designed to impose the risk of criminal penalty on the adult, when the adult engages in sexual behavior with a minor.

¶ 25. Fourth, engrafting the defendant's proposed defense onto the statute undermines the policy of protecting minors from sexual abuse and would raise practical law enforcement problems. Age is difficult to ascertain, and actors could often reasonably claim that they believed their victims were adults. The requirements of practical law enforcement support a conclusion that Wis. Stat. § 948.02(2) is a strict liability statute with regard to the age of the victim.

¶ 26. Fifth, the traditional approach, originally accepted in virtually every state and still accepted in many jurisdictions, is to impose strict liability regarding the age of the victim no matter how reasonable the defendant's belief that the victim was old enough to consent, and no matter that the belief is based on the victim's own representations. The need for or desirability of providing a mistake or fraud defense regarding the age of the victim has been subject to debate. Professor LaFave, to whom this court often turns for assistance, concludes that in more recent times the issue of such a defense has been recognized as "a policy matter that ought to be specifically addressed in the statutory definition of the crime."

¶ 27. Historically, the penalty imposed under a statute has been a significant consideration in determining whether a statute should be construed as dispensing with mens rea. Criminal liability without criminal intent almost always has involved statutes that impose only fines or short jail sentences. Indeed, some courts have justified the imposition of criminal liability without requiring proof of scienter in part because the offenses did not bear the same punishments as "infamous crimes" and questioned whether imprisonment was compatible with the reduced culpability required for such regulatory offenses.

¶ 28. The severe penalties for violation of Wis. Stat. § 948.02(2) stand in sharp contrast to the less severe penalties at issue in other strict liability offenses. The maximum penalty for a conviction under Wis. Stat. § 948.02(2) is a $10,000 fine or 30 years imprisonment or both. In addition to these penalties, an individual convicted of violating § 948.02(2) is subject to registration as a sex offender, including annual registration requirements. The offender is subject to the provisions of Wis. Stat. ch. 980 governing commitments of sexually violent persons. As a felon, the individual would also lose his or her right to possess a firearm, to hold an office of public trust, and to vote.

¶ 29. The severe penalties for violation of Wis. Stat. § 948.02(2) support an inference that the legislature did not intend to impose strict liability regarding knowledge of the age of the victim. Yet this inference drawn from the severe penalties is outweighed by the other factors we have set forth.

¶ 30. On the basis of the text of Wis. Stat. § 948.02(2) read in conjunction with §§ 939.23 and 939.43(2), the history and purpose of the statutes, and the practical requirements of law enforcement, and despite the severe penalties imposed, we conclude that no intentional misrepresentation defense exists in a prosecution under Wis. Stat. § 948.02(2). We decline the defendant's invitation to engraft an affirmative defense for fraud onto § 948.02(2).

¶ 31. Accordingly, we further conclude that the circuit court erred in ruling to admit the evidence the defendant proffered. If an accused's reasonable belief about the victim's age, based on the victim's intentional misrepresentation, is not a defense, then neither evidence regarding the defendant's belief about the victim's age nor evidence regarding the cause of or reasonableness of that belief is relevant. Therefore, evidence of the defendant's belief about the victim's age or the victim's intentional misrepresentation of her age is inadmissible in the guilt-determination phase of a criminal proceeding to support the defendant's asserted affirmative fraud defense to the crime.

IV

¶ 32. We turn to the second issue: If an accused is not allowed an affirmative defense that his reasonable belief about the victim's age was caused by her intentional misrepresentation of her age, do Wis. Stat. §§ 948.02(2), 939.23, and 939.43(2) deny an accused his constitutional rights under the Fourteenth Amendment to the United States Constitution? We conclude that the statutes do not violate the defendant's constitutional rights.

¶ 33. The defendant argues that these statutes are unconstitutional on the following due process grounds: The statutes are vague, they are overbroad, and they violate the defendant's right to substantive due process.

¶ 34. The defendant's argument on vagueness is that without the fraud defense no actor knows with certainty when he commits the crime of sexual assault of a child. The defendant does not argue that he was unaware of the illegality of engaging in sexual intercourse with a 15-year-old. Rather, he argues that an actor of normal intelligence does not know that his conduct with a particular individual is forbidden because of the difficulty of ascertaining the age of the individual. The defendant asserts that unless he can introduce evidence of a reasonable mistake as to the age of the victim, caused by the victim's intentional misrepresentation of age, the statute is unconstitutionally vague.

¶ 35. In examining a legislative act for vagueness, we must determine whether the statute is sufficiently definite to give reasonable notice of the prohibited conduct to those who wish to avoid its penalties and to apprise judges and juries of standards for the determination of guilt.

¶ 36. Upon reading Wis. Stat. § 948.02(2), we conclude that the statute is clear and precise. The prohibited conduct is engaging in sexual intercourse with a child under the age of 16 years. The text is not rendered vague by the difficulties that might attach to an actor's attempt to ascertain whether the person is at least 16 years old. We are not persuaded that Wis. Stat. § 948.02(2) is unconstitutionally vague.

¶ 37. The defendant's next argument is that his right to intimate association is protected by the due process clause of the Fourteenth Amendment and that Wis. Stat. § 948.02(2) is unconstitutionally overbroad and violates substantive due process. The overbreadth and substantive due process challenges overlap, and we shall treat them together.

¶ 38. The defendant contends that the statute is overbroad and violates substantive due process because its language is so sweeping that its sanctions may be applied to conduct that the state is not permitted to regulate.

¶ 39. The defendant concedes that the government has a significant interest in protecting children and regulating sexual contact between minors and adults and agrees with the court of appeals decision in State v. Fisher that the state's significant interests in protecting children trumped Fisher's right to a privacy interest in having sexual intercourse with another person.

¶ 40. The defendant argues, however, that because Wis. Stat. § 948.02(2) does not allow a defense based on the victim's intentional misrepresentation about her age, the statutes impermissibly chill his exercise of his legitimate prerogative to have sex with young women who are of the age of consent. The defendant argues that the circumstances in this case, that is, the victim's intentional misrepresentation, provide a very narrow and necessary exception to the criminalization of sexual contact between minors and adults.

¶ 41. The crux of the defendant's constitutional argument is that he is being held criminally liable for a felony with severe penalties when, if given the opportunity, he could prove himself morally blameless. He is morally blameless, he asserts, because he was fraudulently induced by the minor to have a reasonable belief that she was of age.

¶ 42. Substantive due process protects citizens against arbitrary or wrongful state actions, regardless of the fairness of the procedures used to implement them.

¶ 43. It is a fundamental principle of law that an actor should not be convicted of a crime if he had no reason to believe that the act he committed was a crime or that it was wrongful. An intent requirement was the general rule at common law. The absence of a mens rea requirement in a criminal statute is a significant departure from longstanding principles of criminal law.

¶ 44. Nevertheless, strict liability crimes, that is, crimes defined without any culpable state of mind, are known at law. In general, when strict liability is imposed, the actor is deemed to have had sufficient notice concerning the risk of penal sanction inherent in the proscribed activity that it is not unjust to impose criminal liability without the necessity of proving moral culpability. "[T]he existence and content of the criminal prohibition in these cases are not hidden; the defendant is warned to steer well clear of the core of the offense (as in the statutory rape case)." Adults are well aware of the strict liability aspect of statutory rape laws.

¶ 45. The legislature has broad powers to promote the public welfare and to create criminal offenses and impose punishment. A state legislature is free to define a criminal offense and a state may bar consideration of a particular defense so long as the result does not offend "some principle of justice so rooted in the traditions and conscience of our people as to be ranked as fundamental."

¶ 46. The strict liability crime of statutory rape, in which the victim's apparent maturity is not a defense, is a recognized exception to the general rule requiring mens rea in criminal statutes. Traditionally, according to the weight of authority, "mistake as to age" has not been a defense against the charge of statutory rape. This rule is still followed in many jurisdictions.

¶ 47. Furthermore, strict liability regarding the age of the minor furthers the legitimate government interest in protecting children from sexual abuse by placing the risk of mistake on the adult actor.

¶ 48. The long history of statutory rape as a recognized exception to the requirement of criminal intent and the well accepted legislative purpose for omitting scienter undermine the defendant's argument that Wis. Stat. § 948.02(2) offends principles of justice deeply rooted in our traditions and conscience.

¶ 49. We acknowledge that there has been movement away from strict liability for statutory rape in recent years. Under the Model Penal Code, for example, the defense of mistaken belief should be available when the critical age is more than 10 years of age. The theory is that the policies underpinning strict liability seem less compelling as the age of the minor increases; an accused who mistakenly but reasonably believes such a partner is above the critical age should have a defense because he "evidences no abnormality, no willingness to take advantage of immaturity, no propensity to corruption of minors."

¶ 50. Because the legislature's forbidding a reasonable mistake of age defense in statutory rape cases (whether the mistake is induced by intentional misrepresentation or otherwise) has a significant historical derivation and is widespread, and because of judicial deference to the legislature's discretion in the exercise of its police powers, we conclude it is not violative of due process for the state legislature to forbid a defense of fraud or reasonable mistake about the age of the victim.

¶ 51. In sum, we conclude that the plain language of Wis. Stat. § 948.02(2), read in conjunction with Wis. Stat- §§ 939.23 and 939.43, precludes a defense predicated on a child's intentional misrepresentation of her age. We also conclude that the statutes do not violate the defendant's rights under the Fourteenth Amendment to the United States Constitution. Accordingly, we reverse the order of the circuit court and remand the cause for further proceedings consistent with this decision.

By the Court. — The order of the circuit court is reversed and the cause is remanded to the circuit court.

       All references to the Wisconsin statutes are to the 1999-2000 version unless otherwise indicated.

       We use "intentional misrepresentation" and "fraudulent misrepresentation," and "fraud" interchangeably.

       Wisconsin's rules of evidence define relevant evidence as "evidence having any tendency to make the existence of any fact that is of consequence to the determination of the action more probable or less probable than it would be without the evidence." Wis. Stat. § 904.01.

       The parties disagree about the extent of the circuit court's order admitting evidence. The State maintains that the circuit court's order was limited to evidence presented at the motion hearing. The defendant argues that the circuit court's order also applied to information in his written offer of proof. We need not resolve this dispute in light of our holding.

         State v. Randall, 192 Wis. 2d 800, 824, 532 N.W.2d 94 (1995).

         Norquist v. Zeuske, 211 Wis. 2d 241, 250, 564 N.W.2d 748 (1997).

        Aicher ex rel. LaBarge v. Wis. Patients Comp. Fund, 2000 WI 98, ¶¶ 18-20, 237 Wis. 2d 99, 613 N.W.2d 849.
      When a statute implicates First Amendment rights, the State has the burden of proving beyond a reasonable doubt that the statute is constitutional. State v. Zarnke, 224 Wis. 2d 116, 124-25, 589 N.W.2d 370 (1999) (citing State v. Thiel, 183 Wis. 2d 505, 523, 515 N.W.2d 847 (1994); City of Madison v. Baumann, 162 Wis. 2d 660, 668-69, 470 N.W.2d 296 (1991)).
      This often-used language of proof beyond a reasonable doubt is perhaps more pertinent to an evidentiary burden of proof in criminal cases than to a burden imposed on a party on a question of law. The burden of proof language recognizes the deference due to the legislature. See, e.g., Davis v. Grover, 166 Wis. 2d 501, 564 n.13, 480 N.W.2d 460 (1992) (Abrahamson, J., dissenting); Guzman v. St. Francis Hosp., 2001WI App 21, ¶ 4 n.3, 240 Wis. 2d 559, 623 N.W.2d 776.

       Wis JI — Criminal 2104 (2002).

       Wisconsin Stat. § 939.23(1) provides as follows:
      When criminal intent is an element of a crime in chs. 939 to 951, such intent is indicated by the term "intentionally", the phrase "with intent to", the phrase "with intent that'', or some form of the verbs "know" or "believe".
      Wisconsin Stat. § 939.23(2) and (3) define the words "know" and "intentionally" in the criminal code as follows:
      (2) "Know" requires only that the actor believes that the specified fact exists.
      (3) "Intentionally" means that the actor either has a purpose to do the thing or cause the result specified, or is aware that his or her conduct is practically certain to cause that result. In addition, except as provided in sub. (6) [knowledge of the age of a minor], the actor must have knowledge of those facts which are necessary to make his or her conduct criminal and which are set forth after the word "intentionally."

       Wis. Stat. § 939.23(6).

       Wis. Stat. § 939.43(1).

       Wis. Stat. § 939.43(2).

        See, e.g., Flores v. State, 69 Wis. 2d 509, 511, 230 N.W.2d 637 (1975) (mistake as to age of minor is not a defense); Hughes v. State, 55 Wis. 2d 477, 481, 198 N.W.2d 348 (1972) (same); Kelley v. State, 51 Wis. 2d 641, 648, 187 N.W.2d 810 (1970) (same); State v. Lentowski, 212 Wis. 2d 849, 853-54, 569 N.W.2d 758 (Wis. Ct. App. 1997) (same).

       The defendant relies on United States v. United States District Court, 858 F.2d 534 (9th Cir. 1988), to support his position. In this federal case, the Ninth Circuit Court of Appeals engrafted a reasonable mistake of age defense onto a statute proscribing the production of materials depicting á minor engaged in sexually explicit conduct, reasoning that the First Amendment required a reasonable mistake of age defense and that congressional intent was to uphold the statute. The present case is not a First Amendment case, and it is not necessary for the court to read any language into these statutes to preserve their constitutionality.

       This court has frequently been asked to decide whether a statute creates a strict liability crime, that is, whether a statute includes intent (scienter) as an element of the crime when the statute does not explicitly refer to scienter. See, e.g., State v. Danforth, 129 Wis. 2d 187, 385 N.W.2d 125 (1986); State v. Stanfield, 105 Wis. 2d 553, 314 N.W.2d 339 (1982); State v. Collova, 79 Wis. 2d 473, 255 N.W.2d 581 (1977).
      In making this determination a court considers the following factors: (1) the language of the statute; (2) the legislative history of the statute; (3) the seriousness of the penalty; (4) the purpose of the statute; and (5) the practical requirements of effective law enforcement. State v. Stoehr, 134 Wis. 2d 66, 76, 396 N.W.2d 177 (1986) (citing Collova, 79 Wis. 2d at 478-80; Stanfield, 105 Wis. 2d at 560-61).

        State v. Polashek, 2002 WI 74, ¶ 30, 253 Wis. 2d 527, 646 N.W.2d 330 (inclusion of mental state in one section tends to indicate a deliberate legislative choice to exclude a mental state from another section).

        See Judiciary Committee Report on Criminal Code, Wisconsin Legislative Council Report, vol. Y Bill No. 100A at 20, 21, 35 (1953).

        State v. Fisher, 211 Wis. 2d 665, 674, 565 N.W.2d 565 (Ct. App. 1997).

        See Judiciary Committee Report on the Criminal Code, Wisconsin Legislative Council Report, vol. VII at 33 (1953).

        See, e.g., 2 Wayne R. LaFave, Substantive Criminal Law § 17.4(c) at 650 (2d ed. 2003); Colin Campbell, Mistake or Lack of Information as to Victim's Age as Defense to Statutory Rape, 46 A.L.R. 5th 499, 509-18 (1997 & Supp. 2004).
      Several jurisdictions have, however, adopted a defense based on the reasonable belief of an accused about the age of the minor by judicial decision or statute. Campbell, 46 A.L.R. 5th at 518-20.

        See, e.g., Larry W Myers, Reasonable Mistake as to Age: a Needed Defense to Statutory Rape, 64 Mich. L. Rev. 105 (1965-66) (arguing that "the time has come for more liberal and realistic laws" that permit a reasonable mistake as to age defense to a charge of statutory rape); Catherine L. Carpenter, On Statutory Rape, Strict Liability, and the Public Welfare Offense Model, 53 Am. U.L. Rev 313 (2003) (urging reconsideration of the imposition of strict liability in statutory rape cases); Michelle Oberman, Regulating Consensual Sex with Minors: Defining a Role for Statutory Rape, 48 Buff. L. Rev. 703 (2000) (suggesting various revisions to statutory rape laws).

       2 LaFave, supra note 20, § 17.4(c) at 650.

        See, e.g., United States v. X-Citement Video, Inc., 513 U.S. 64, 71 (1994); Staples v. United States, 511 U.S. 600, 616 (1994).

       See Staples, 511 U.S. at 616.

        See Staples, 511 U.S. at 617 (citing Tenement House Dep't v. McDevitt, 109 N.E. 88, 90 (N.Y. Ct. App. 1915)).

        See Staples, 511 U.S. at 617 (citing People ex rel. Price v. Sheffield Farms-Slawson-Decker Co., 121 N.E. 474, 477 (N.Y. Ct. App. 1918)).

       Effective February 1, 2003, the offense became a Class C felony with a penalty of a fine not to exceed $100,000 or imprisonment not to exceed 40 years or both. Wis. Stat. § 939.50(3)(c) (2001-02).

        See Wis. Stat. § 301.45.

        See Wis. Stat. § 941.29.

        See Wis. Const. Art. XIII, § 3(2).

        See Wis. Const. Art. Ill, § 2(4)(a). For restoration of civil rights, see Wis. Stat. § 304.078.

       Wisconsin's rules of evidence define relevant evidence as "evidence having any tendency to make the existence of any fact that is of consequence to the determination of the action more probable or less probable than it would be without the evidence." Wis. Stat. § 904.01. Except as provided by law, relevant evidence is generally admissible; evidence that is not relevant is inadmissible. Wis. Stat. § 904.02.

       Although the briefs refer to Article I, § 8 of the state constitution, no state constitutional argument separate from a federal constitutional argument is made and we therefore do not address the state constitutional issue.

        See, e.g., United States v. Lanier, 520 U.S. 259, 267 (1997); Baumann, 162 Wis. 2d at 676-77 (citing State v. Zwicker, 41 Wis. 2d 497, 507, 164 N.W. 2d 512 (1969), citing Landry v. Daley, 280 F. Supp. 938 (N.D. Ill. 1968)).
      The due process clause of the Fourteenth Amendment requires that a criminal statute be declared void when it is so vague that "men of common intelligence must necessarily guess at its meaning and differ as to its application." Connolly v. Gen. Constr. Co., 269 U.S. 385, 391 (1926).
      For a discussion of the void-for-vagueness doctrine, see 1 LaFave, supra note 20, § 2.3.

        City of Milwaukee v. Wilson, 96 Wis. 2d 11, 19, 291 N.W.2d 452 (1980).

        Fisher, 211 Wis. 2d at 674-75.

       Professor Packer commented on the inappropriateness of the criminal sanction in the absence of scienter as follows:
      [To] punish conduct without reference to the actor's state of mind is both inefficacious and unjust. It is inefficacious because conduct unaccompanied by an awareness of the factors making it criminal does not mark the actor as one who needs to be subjected to punishment in order to deter him or others from behaving similarly in the future, nor does it single him out as a socially dangerous individual who needs to be incapacitated or reformed. It is unjust because the actor is subjected to the stigma of a criminal conviction without being morally blameworthy. Consequently, on either a preventive or retributive theory of criminal punishment, the criminal sanction is inappropriate in the absence of mens rea.

      Packer, Mens Rea and the Supreme Court, 1962 Sup. Ct. Rev. 107, 109. See also Model Penal Code § 2.05 comment (Official Draft & Revised Comments 1985).

        Thorp v. Town of Lebanon, 2000 WI 60, ¶ 45, 235 Wis. 2d 610, 612 N.W.2d 59 (quoting County of Sacramento v. Lewis, 523 U.S. 833, 846 (1998)).
      For a discussion of substantive due process, see 1 LaFave, supra note 20, § 3.3.

        Morissette v. United States, 342 U.S. 246, 251 (1952).

       For example, courts have held that if an accused knowingly possessed a hand grenade, it is no defense to argue that the accused was not aware that the device in question was subject to regulation, but if accuseds owned firearms that are in technical violation of a regulation, they may avail themselves of a "mistake of fact" defense. See Staples, 511 U.S. at 610-11; United States v. Freed, 401 U.S. 601, 609 (1971).

        United States v. Wilson, 159 F.3d 280, 296 (7th Cir. 1998) (Posner, C.J., dissenting).

       "Sixteen will get you twenty!" is a common exclamation expressing the widespread awareness of statutory rape laws and the strict liability aspect of the offense.

        Pauly v. Keebler, 175 Wis. 428, 439, 185 N.W. 554 (1921). The legislature's authority to define an offense includes the power to exclude the element of knowledge from its definition. Lambert v. California, 355 U.S. 225, 228 (1957).

        Montana v. Egelhoff, 518 U.S. 37, 43 (1996) (quoting Patterson v. New York, 432 U.S. 197, 201-02 (1977)).

        Morissette, 342 U.S. at 251 n.8. See also X-Citement Video, 513 U.S. at 72 n.2.

        See, e.g., 2 LaFave, supra note 20, § 17.4(c) at 650; Campbell, supra note 20, at 508-09.

       Campbell, supra note 20, at 509.

        See United States v. Ransom, 942 F.2d 775, 777 (10th Cir. 1991), cert. denied, 502 U.S. 1042 (1992); Garrison v. Elo, 156 F. Supp. 2d 815, 832 (E.D. Mich. 2001).

       A minority of states allow some form of a "belief about age" defense by judicial decision or by statute. See, e.g., People v. Hernandez, 393 P.2d 673 (Cal. 1964) (apparently the first case to allow the defense; ruling on lenity grounds).
      Wisconsin has explicitly rejected the Hernandez case. See Kelley, 51 Wis. 2d at 649.
      For a discussion of the jurisdictions that have allowed some form of the defense, see Collins v. Mississippi, 691 So. 2d 918, 923 (Miss. 1997); Campbell, supra note 20, passim. For a list of states that have revised their statutes to allow the defense, see Model Penal Code and Commentaries § 213.6(1) cmt. 2, n.10 (Official Draft & Revised Comments 1985).

        Model Penal Code § 213.6(1) (Official Draft & Revised Comments 1985).

        Model Penal Code § 213.6, cmt. 2 at 415 (Official Draft & Revised Comments 1985).
      Many of the cases upholding the constitutionality of statutory rape involve an adult's sexual contact with a much younger person than the crime described in Wis. Stat. § 948.02(2).

       For cases upholding the constitutionality of statutory rape as a strict liability offense, see, e.g., Ransom, 942 F.2d at 776-77; Nelson v. Moriarty, 484 F.2d 1034, 1035-36 (1st Cir. 1973); People v. Green, 514 P.2d 769, 771 (Colo. 1973); State v. Tague, 310 N.W.2d 209, 212 (Iowa 1981); Garnett v. State, 632 A.2d 797, 803-05 (Md. 1993); State v. Stokely, 842 S.W.2d 77, 81 (Mo. 1992); State v. Moore, 253 A.2d 579, 581 (N.J. 1969); Guinyard v. State, 195 S.E.2d 392, 396 (S.C. 1973); State v. Martinez, 52 P.3d 1276, 1280-82 (Utah 2002).
      For cases concluding that an accused has the right to proffer the defense, see, e.g., State v. Guest, 583 P.2d 836, 838-39 (Alaska 1978) (due process requires that the defendant be allowed to introduce evidence regarding mistake as to age); Perez v. State, 803 P.2d 249, 250-51 (N.M. 1990) ("While a child under the age of thirteen requires the protection of strict liability, the same is not true of victims thirteen to sixteen years of age. We recognize the increased maturity and independence of today's teenagers and, while we do not hold that knowledge of the victim's age is an element of the offense, we do hold that under the facts of this case the defendant should have been allowed to present his defense of mistake of fact.").
      Analysis of the constitutional issue is also found in dissenting opinions in cases in which the majority opinion upheld the constitutionality of a strict liability statutory rape statute. See, e.g., State v. Silva, 491 P.2d 1216 (Haw. 1971) (Levinson, J., dissenting) (arguing that fairness requires that the pertinent statute be construed as permitting the affirmative defense of reasonable mistake as to age); Owens v. Maryland, 724 A.2d 43 (Md. 1999) (Bell, C.J., dissenting) (arguing that due process requires that an accused be allowed an affirmative defense predicated on reasonable mistake about age); Garnett v. State, 632 A.2d 797 (Md. 1993) (Bell, C.J., dissenting) (same).