Opinion ID: 2341867
Heading Depth: 1
Heading Rank: 7

Heading: failure to give learned intermediary instruction

Text: On the products liability claim, Sandoz tendered the following instruction with its proposed jury instructions: Sandoz has no duty to provide warnings directly to Mrs. Gunderson, but only to Dr. Armstrong. Therefore, in order for plaintiffs to prevail, you must be satisfied from the evidence that Sandoz provided an inadequate warning to Dr. Armstrong regarding the risk of seizure purportedly associated with Parlodel. Otherwise, you will find for Sandoz. The trial court declined to give the above instruction to the jury. The court instructed the jury as follows relative to Sandoz's duty to Mrs. Gunderson as a consumer of Parlodel: You will find for the Plaintiffs, ... if you are satisfied from the evidence as follows: A. As manufactured by Defendant Sandoz, the drug Parlodel was unreasonably dangerous for the use of the drug's ultimate users, including Plaintiffs' decedent,... A product is unreasonably dangerous if it creates such a risk of injury to a potential user that an ordinarily prudent manufacturer of pharmaceutical products, being fully aware of the risks, would not have placed or kept the product on the market.... Approximately three months after the trial in the case at bar, this Court rendered its decision in Larkin v. Pfizer, Inc., 153 S.W.3d 758, 762 (Ky.2004), wherein we adopted the learned intermediary doctrine from the Restatement (Third) of Torts: Prods. Liab. § 6(d)(1) (1998). This doctrine, which is an exception to the general rule that a manufacturer's duty to warn of any risks or dangers inherent in the product runs to the ultimate consumer, relieves the prescription drug manufacturer from liability to the ultimate consumer if it provides an adequate warning about the drug to the prescribing physician. Id. at 764. As to what constitutes an adequate warning, the Larkin Court stated: An adequate warning has been defined as one sufficient to apprise the general practitioner as well as the unusually sophisticated medical man of the dangerous propensities of the drug. It is incumbent upon the manufacturer to bring the warning home to the doctor. Several cases have held that a package insert may be sufficient for the warning to be adequate as a matter of law. The warning may also be adequate if posted in the Physician's Desk Reference. Id. at 764-65 (citations and internal quotations omitted). Sandoz argues that the information in the package insert for Parlodel and in the Physician's Desk Reference, as well as Dear Doctor letters it sent directly to doctors, constituted an adequate warning to Dr. Armstrong of the dangers of Parlodel, thus entitling it to the tendered jury instruction on the learned intermediary doctrine. In affirming the trial court's refusal to give the learned intermediary rule instruction, the Court of Appeals ruled that a specific instruction on the doctrine's application in the case was not required under Ford Motor Company v. Fulkerson, 812 S.W.2d 119, 123 (Ky.1991) (rejecting a fact-specific instruction in products liability case in favor of general instruction stating liability in terms of Restatement (Second) of Torts § 402A). In our view, whether an instruction on the learned intermediary doctrine was required in the present case was not a question of whether a general or fact-specific instruction was warranted, as in Fulkerson . Rather, it was an issue of adequately and accurately instructing the jury on the law of the case. See Shewmaker v. Richeson, 344 S.W.2d 802, 806 (Ky.1961). If the evidence supported application of the learned intermediary doctrine in the instant case, it was error for the trial court to not submit a learned intermediary instruction because the instructions, as given, did not give the jury an opportunity to find whether Sandoz provided an adequate warning to Dr. Armstrong of the risks associated with Parlodel, which would have precluded a judgment against Sandoz under the law. The package insert for Parlodel and the Physician's Desk Reference (PDR) information on Parlodel at the time of Mrs. Gunderson's prescription both provided the following warning: While hypotension during the start of therapy with Parlodel ... occurs in some patients, 50 cases of hypertension have been reported, sometimes at the initiation of therapy, but often developing in the second week of therapy. Seizures have been reported in 38 cases (including 4 cases of status epilepticus), both with and without the prior development of hypertension occurring mostly in postpartum patients up to 14 days after initiation of treatment. Fifteen cases of stroke during Parlodel ... therapy have been reported mostly in postpartum patients whose prenatal and obstetric courses had been uncomplicated. Many of these patients experiencing seizures during therapy with Parlodel ... were also preceded by visual disturbances (blurred vision and transient cortical blindness). Four cases of acute myocardial infarction have been reported, including 3 cases receiving Parlodel... for the prevention of physiologic lactation. The relationship of these adverse reactions to Parlodel ... administration is not certain. The use of Parlodel... is not recommended for patients with uncontrolled hypertension or toxemia of pregnancy. Although there is no conclusive evidence which demonstrates the interaction between Parlodel ... and other ergot alkaloids, the concomitant use of these medications is not recommended. Particular attention should be paid to patients who have recently received other drugs that can alter the blood pressure. The above warning was approved by the FDA in 1987. In conjunction with the new warning, the FDA required Sandoz to send a Dear Doctor letter to obstetricians noting the changes in the package insert and specifically calling attention to the adverse reactions. At trial, the Gundersons presented evidence that Sandoz failed to send the Dear Doctor letter to more than a small fraction of the doctors registered in the college of obstetricians and gynecologists. Because of the FDA's concern that so few doctors had received the letter, in 1988, the FDA required Sandoz to send the letter again to a wider audience and decided to reconsider Parlodel's indication for use as a lactation suppressant at a 1988 FDA advisory committee meeting. Upon reviewing the available data on Parlodel's use for PPLS during that meeting, including the results of the ERI study and ADRs, the advisory committee recommended that Parlodel's indication for PPLS should be withdrawn. The committee concluded that risks of potentially serious side effects from Parlodel use outweighed the relatively minor discomfort of postpartum lactation. The committee recommended that the condition be treated conservatively as it had traditionally been, with breast binding and analgesics. The FDA adopted the committee's recommendation in 1989 and asked manufacturers of bromocriptine to voluntarily withdraw their drug's lactation suppression indications. With the exception of Sandoz, all manufacturers complied with the FDA's request. Sandoz, however, continued to market Parlodel for PPLS. In fact, in the second Dear Doctor letter sent by Sandoz dated May 3, 1990, Sandoz wrote: The results of the epidemiologic study, conducted by Epidemiology Resources, Incorporated, were presented [to the FDA Fertility and Maternal Health Advisory Committee] showing no causal relationship between reported seizures and the use of Parlodel. ... Subsequently, the FDA requested Sandoz to voluntarily withdraw this [PPLS] indication for Parlodel. Sandoz considers this request inappropriate for the following reasons: The question of need is one that should be determined between an informed patient and her physician and not by a governmental agency. There is strong disagreement with the conclusion that there is no need for a drug to prevent lactation in the postpartum period. Although not all women who elect not to breast feed may require therapy to prevent lactation, a significant number will benefit from such therapy. As demonstrated in controlled trials, the use of Parlodel therapy to prevent the engorgement and pain that occur in many women who elect not to breast feed is a more effective approach than treating the engorgement and pain once they occur with analgesics and ice packs. Prior to the above-mentioned change in the package insert, Sandoz had placed an ad for Parlodel in the March 1984 issue of Obstetrics and Gynecology (commonly referred to in the obstetric community as the green journal) claiming that Parlodel had a low order side effects, was natural, and left patients completely free of engorgement. The Gundersons offered into evidence a letter to Sandoz from the FDA maintaining that said ad was misleading as to those three claims, and further that the ad failed to inform doctors of the high rate of rebound with Parlodel therapy. There was also evidence that Sandoz instructed its sales force not to mention the risks or the FDA's concerns about Parlodel unless questioned by the doctor. Instead, the sales representatives were to continue to encourage doctors to include Parlodel on standing orders as a routine therapy for PPLS. Further, the Gundersons presented evidence that before Mrs. Gunderson's death in 1993, Sandoz knew of additional adverse reactions to Parlodel and misrepresented them or failed to report them to the FDA as required by law. In particular, there was evidence that prior to 1993, Sandoz knew of at least ninety-eight cases of hypertension, eighty-six cases of seizure, and thirty-three cases of stroke associated with Parlodel, but made no effort to provide doctors with these updated figures after the 1987 package insert. It was not until 1994, after the FDA had initiated procedures to withdraw its approval for the PPLS indication for Parlodel, that Sandoz voluntarily withdrew that indication. In his deposition read at trial, [2] Dr. Armstrong admitted that he had not read the 1987 updated package insert for Parlodel. Dr. Armstrong testified that he did not receive either Dear Doctor letter sent by Sandoz regarding Parlodel, and that if he had, he would not have prescribed Parlodel for Mrs. Gunderson. From our review of the record, we conclude that Sandoz failed to present sufficient evidence of an adequate warning to Dr. Armstrong of the risks of Parlodel, thus it was not error for the trial court to fail to give the jury instruction on the learned intermediary doctrine. While the package insert and PDR entry for Parlodel contained warnings of the risks of seizure and hypertension for postpartum patients, other evidence undermined the effectiveness of these warnings. The evidence that Sandoz did not send the Dear Doctor letters to Dr. Armstrong, the language in the second letter that Parlodel was a reasonable and effective treatment for PPLS, the evidence that Sandoz misrepresented or failed to report known additional ADRs (for seizures, strokes and hypertension), the misleading ad in the journal of Obstetrics and Gynecology, and Sandoz's instructions to its sales representatives to encourage the continued use of standing orders for Parlodel for PPLS and not to mention the risks of the drug, was such strong evidence of its efforts to minimize or conceal the risks of Parlodel (much of which was undisputed). This evidence showed that Sandoz repeatedly attempted to downplay or conceal the risks of Parlodel and intentionally undermined any existing warnings. This systematic approach to minimizing the risk posed by Parlodel rendered the various warnings that were available inadequate under the learned-intermediary doctrine. Thus, we conclude that the trial court did not err in failing to instruct the jury as to the learned-intermediary defense.