Court Opinion

ID: 6934687
Source: CourtListenerOpinion
Date Created: 2022-07-24 00:24:50.917468+00
Date Added: 2024-06-11T16:07:23.697703
License: Public Domain

BARKETT, Circuit Judge,
concurring in part, and dissenting in part:
I agree with the majority’s conclusion that the plaintiffs’ evidence established sufficient causation to support a verdict against Armour. I believe the majority errs, however, in concluding that reversal is warranted because of the jury instruction given regarding the learned intermediary defense. The majority’s error, in my judgment, lies in confusing matters of law and matters of fact. An error in jury instructions is reversible where the appellate court is left with “a substantial and ineradicable doubt” as to whether the jury was properly guided in its deliberations regarding both the law and the issues. Pate v. Seaboard R.R., Inc., 819 F.2d 1074, 1080-81 (11th Cir.1987). I do not believe such doubt exists here.
The relevant law, 21 C.F.R. § 201.57(e) (1982), is unusually clear and' precise. It provides that pharmaceutical companies “shall” revise labeling to include a warning as soon as there is “reasonable evidence” of an association of serious adverse reactions and potential safety hazards with a drug.1 The *1196instruction given was a correct statement of the law. The instruction correctly required Armour to demonstrate that Dr. Barbosa possessed the same reasonable evidence of associated risk that Armour possessed. Armour, at a minimum, legally had to have reasonable evidence to issue the warning. Thus, to be a learned intermediary and to possess the same evidence of associated risk that Armour had, Dr. Barbosa, at a minimum, had to have reasonable evidence of the risk.
The majority confuses matters of law and matters of fact by requiring evidentiary support for inclusion of the reasonable evidence standard in the learned intermediary instruction. However, as noted, the legal standard contained in the instruction was properly determined by the district court as a matter of law; the only factual matter for the court was whether defendant had adduced sufficient evidence to support the giving of the instruction. See Bank South Leasing, Inc. v. Williams, 778 F.2d 704, 707 (11th Cir.1985) (defense instruction warranted where evidence sufficient for jury to find in favor of defense based on instruction).2
Even if one accepts the majority’s view that inclusion of the reasonable evidence standard required evidence that Dr. Barbosa knew the legal definitional requirements for an FDA warning, Dr. Barbosa’s testimony would seem to be precisely the “factual basis in the record” that the majority claims is needed to support the instruction given. Dr. Barbosa’s testimony plainly supports the conclusion that he knew the import of warnings from drug companies.3 Moreover, as a mat*1197ter of judicial notice,4 it is beyond doubt that Dr. Barbosa, as a board-certified pediatric oncologist, would have been aware that reasonable evidence was required before a warning could be issued.5
In addition, Armour’s argument ignores not only the law but the public policy behind the law. Armour argues, and the majority implicitly accepts, the proposition that Dr. Barbosa must be a learned intermediary simply because “all of the medical evidence which plaintiffs contended disclosed this risk to Armour was as equally available to Dr. Barbosa as it was to Armour.” If doctors had to independently investigate the properties of all the medicines they use, a drug company would never be required to warn, and there would be no need for the comprehensive framework of federal law controlling the use of medicines or the FDA regimen regulating drug warnings.6
The underlying rationale of all the cases in which drug companies are required to warn physicians is that although drug companies and clinical physicians both work in the medical field, the drug company is the entity expected to have specific expertise in the use of a product by virtue of its focused research on the product. Thus, although a physician will be generally aware of the properties of a drug he or she administers, he or she will not be expected to have the same technical expertise in the scientific study of the drug as the manufacturer has, notwithstanding that the body of medical evidence about the drug may theoretically be “equally available” to everyone in the medical field. When a physician does have that specific information and has been warned of the hazards of the drug, then, of course, a specific drug company warning would be superfluous. For example, in Felix v. Hoffman-LaRoche, Inc., 540 So.2d 102 (Fla.1989), the physician testified that he fully understood the warnings and also had prior knowledge of the hazardous nature of the drug. As a result, the Florida *1198Supreme Court reasoned that the drug manufacturer could not be penalized for the failure of the doctor to impart knowledge concerning the dangers of the drug of which the doctor had been warned and was aware. Id. at 105. We do not have such a situation here.
Because the learned intermediary instruction correctly stated the law and adequately presented the issue, I have no doubt that the jury was properly guided in its deliberations on the defense. Even accepting the majority’s approach, I believe that the evidentiary record and judicial notice support the propriety of the instruction given.
For these reasons, I respectfully DISSENT.

. The regulation states in pertinent part:
Specific requirements on content and format of labeling for human prescription drugs.
(e) "Warnings”: Under this section heading, the labeling shall describe serious adverse reactions and potential safety hazards, limitations in use imposed by them, and steps that *1196should be taken if they occur. The labeling shall be revised to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug; a causal relationship need not have been proved.
21 C.F.R. § 201.57(e) (1982) (emphasis added).

. Bank South, upon which the majority relies, simply provides that evidence must exist in the trial record to support the giving of an affirmative defense instruction. Bank South, 778 F.2d at 707. It does not discuss the content of an instruction.

. Dr. Barbosa's testimony demonstrates that he was intimately acquainted with the warnings from drug companies and with the information that such warnings are used to convey:
Q: How are you kept informed about new hazards or side effects which may come to light associated with a particular pharmaceutical product?
A: Well, if there’s a significant hazard or side effect, usually the pharmaceutical company takes care of immediately notifying us.
Q: What sort of volume of materials do you receive from pharmaceutical companies each week?
A: It's really variable. Sometimes nothing during the week, some other weeks several mailing [sic],
Q: How are they usually delivered?
A: It depends on the urgency of the situation. There's usually what they call a Dear Doctor letter [sic] is called a mailgram or in the envelope you will see the sign "URGENT— important information for the practice inside, read it.”
Q: Let me just show you an envelope that you provided me. Is this similar to what you receive [sic] a Dear Doctor letter in in [sic] appearance?
A: Yes, sir. Here’s a red star; the starting [sic ] medical jargon is “URGENT.”
Q: Well, let's talk about the particular years 1982 through 1985. If during those years some new hazard arose associated with a particular pharmaceutical product, how would you expect to find out about it?
A: It would depend on the urgency of the situation. If a situation was serious enough to warrant immediate attention, you would expect that the pharmaceutical company would be in immediate touch with us.
Q: By what means?
A: Either by personal visit or by the means just showed.
Q: Are you speaking about this type of letter?
A: Yes, sir.
Q: How often do you read the Dear Doctor letters that arrive at your office?
A: Letters like the one I just showed, I open them immediately, sir.
Q: Why?
A: Because they [sic] supposed to bring urgent or very important information.
Moreover, the trial record contains testimony by Dr. Barbosa in which he clearly states that he would have ceased treating Jason with concentrate had he received such a warning letter or visit from Armour:
Q: Okay. Let me ask you this question, Doctor: Back in July of 1983 when Jason got his first concentrate from you, if you had received a written warning from Armour Pharmaceutical Corporation indicating that there was a potential AIDS risk associated with its factor VIII concentrate product, how would that have impacted your care and treatment of Jason?
A: It would have changed the care, sir.
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Q: We know Jason received six injections of non-heat treated concentrate in the last half of *11971983. Had you received a warning of a possible risk of AIDS transmission via concentrate from Armour prior to giving those injections, would you have given them?
A: No.
Q: What would you have done?
A: Given ciyoprecipitate.

. Even ignoring Dr. Barbosa's conspicuous testimonial evidence, this court must take judicial notice of certain facts not explicitly discussed by the trial court. Under Rule 201 of the Federal Rules of Evidence, "[a] judicially noticed fact must be one not subject to reasonable dispute in that it is either (1) generally known within the territorial jurisdiction of the trial court or (2) capable of accurate and ready determination by resort to sources whose accuracy cannot reasonably be questioned.” Fed.R.Evid. 201(b). Moreover, "judicial notice may be taken at any stage of the proceedings, whether in the trial court or on appeal." 56 F.R.D. 183, 206. As this court has recently recognized, "[ajppellate courts have a special need to resort to facts not found in the record. When the question before the court is not merely the rights of the parties, but the interests of others who may be affected by the rule the court makes to govern the case, it would be foolish for the court to rely only on the evidence the parties have chosen to prove below.” Nipper v. Smith, 39 F.3d 1494, 1498 n. 1 (11th Cir.1994) (en banc) (quoting 21 Charles Alan Wright & Kenneth W. Graham, Jr., Federal Practice and Procedure: Evidence § 5102, at 462 (1977)).

. It cannot be reasonably disputed that Dr. Bar-bosa, as a specialist in pediatric hematology-oncology, would be acquainted with the warning letters of drug companies and with the evidentia-ry standards that cause such warnings to be issued. In this regard, the trial record plainly indicates that Dr. Barbosa was a medical doctor, licensed to practice medicine by the state of Florida. It also indicates that he was nationally licensed, that is, he was "board certified" in pediatric hematology-oncology, had the largest pediatric hematology practice in Florida and probably the fourth largest in the southeastern United States, and, as the majority observes, was the Medical Director of the Department of Hematology-Oncology at All Children's Hospital in St. Petersburg, Florida. When physicians are licensed in this way, they are licensed to work with medicines, including state-controlled pharmaceutical products such as factor VIII concentrate and ciyoprecipitate. They are so licensed in part because the state has found them to be proficient in the usage of drugs and medicines and knowledgeable about their regulation by the FDA; absent such proficiency and knowledge, one simply cannot be a practicing clinician in Florida or any other state. As it happens, Dr. Barbosa "demonstrated” in the trial testimony cited in the foregoing that he is knowledgeable about regulatory practices as regards blood clotting products. But even if he had not, it would have been implicit in the recitation of his credentials.

. See 21 U 21 C.F.R. §§ 301 et seq.; 42 U.S.C. § 262; 21 C.F.R. § 200.5 (1994); § 201; id. § 601.12.