Relearning the Learned Intermediary Doctrine

Failure to Use 'Adequate' Means to Communicate a Warning

Late last year, the Eighth Circuit examined the application of the learned intermediary doctrine in In re: Levaquin, 2012 U.S. App. LEXIS 24640 (8th Cir. Nov. 30, 2012). In Levaquin, the court focused on whether the manufacturer had properly warned the prescribing doctor that Levaquin carried a potential risk of Achilles tendon rupture. The package insert ' that is, the label ' did contain a warning of this risk. But the doctor had not read it. He testified that he nonetheless knew of a risk, although the decision does not explain how he obtained that knowledge. Id. at *1165.

He also testified that if he had read the label he would not have prescribed the drug, evidence that the warning was in fact adequate and maybe would have given the doctor an even better understanding of the risk. Id. at *1168. The doctor testified that he did not generally take the time to read package inserts and he relied on sales representatives “only minimally.” Id. at *1164. While the court noted that the company did not send a “Dear Doctor” letter that warned of the risk, there was no evidence that the doctor read or relied on such letters. Id. These facts present strong support for summary judgment or judgment as a matter of law for defendants, either because the warning in the label was adequate or because the doctor was aware of the risk.

But ultimately, the case was presented to a jury, which ruled in favor of the plaintiff. On appeal, the Eight Circuit affirmed the award, finding that the jury was entitled to believe that “some piece of information” may have “altered [the doctor's] prescribing decision.” Id. at *1168. Although the doctor did not testify that he relies upon “Dear Doctor” letters, the court found persuasive a study showing that “properly worded and highly publicized “Dear Doctor” letters may reduce risky prescribing practices.” Id. at *1169. The Eighth Circuit recognized that the reasoning was a “stretch.” Nonetheless, it found that the jury could have reasonably inferred the doctor would have altered his decision to prescribe Levaquin if some greater effort to provide a warning was made, such as sending Dear Doctor letters, and the jury could have reasonably concluded that the failure to take these additional precautions actually caused the plaintiff's injury. Id at *1168.

In reaching this conclusion, the Eighth Circuit relied on its own prior ruling in Sterling Drug, Inc. v. Yarrow, 408 F. 2d 978 (1969), in which the court created a requirement that a drug manufacturer provide warnings of known risks through all usual means. In the court's own words:

Under the circumstances of this case, when the dangers of the prolonged use of this drug, mass produced and sold in large quantities, became reasonably apparent, it was not unreasonable to find that the appellant should have employed all its usual means of communication ' to warn the prescribing physicians of these dangers. In this connection it is noted that no extraordinary means of giving a warning of high intensity was employed.

Id. at 992. This reasoning does not appear to have been applied outside of the Eighth Circuit.”

'Overpromotion' Negates the Warning

Even when there is no question that an adequate warning was provided to, and received by, the prescribing doctor, certain courts have found judgment as a matter of law to be inappropriate under the theory that “overpromotion” of a product can negate an otherwise adequate warning.

Stevens v. Parke, Davis & Co., 9 Cal. 3d 51 (1973), is remarkable for its holding that overpromotion could trump a doctor's testimony that, despite the promotion, he was aware of the risk. The prescribing doctor testified that at the time he prescribed the drug, he was aware that it had been linked to bone marrow failure and that prolonged use of the drug could potentially have fatal consequences. Id. at 67 n. 15. He learned about these risks from medical journals and discussions with other physicians. Id. at 68 n. 16. Despite this, he prescribed the drug anyway. Based on this testimony, the manufacturer argued that the plaintiff could not prove proximate causation.

However, a jury eventually found the manufacturer to be liable and the California Supreme Court affirmed the award on the grounds that the jury was entitled to disbelieve the doctor's testimony. The court cited “circumstantial evidence” that the doctor was “induced to prescribe the drug” by the manufacturer's “overpromotion” of the product. Id. at *68. Because the company gave away merchandise (such as calendars) that promoted the benefits of the drug without mentioning the risks and had not instructed personal salespersons to describe the risks during sales calls, the court found that the jury could have believed that the doctor, despite his actual testimony, had been “consciously or subconsciously” influenced by the drug's “overpromotion.” Id.

The Fourth Circuit followed suit two years later when it addressed the same situation in Salmon v. Parke, Davis & Co., 520 F. 2d 1359, 1361 (4th Cir. 1975). Here, the court found that the prescribing doctor had either seen the original warning in a package insert, or a revised warning provided with a sample of the drug. The court also found that the doctor could have seen the warning in the Physicians' Desk Reference (PDR). Id. at 1361. Despite this evidence that the doctor had actually been warned, the court affirmed a jury's verdict against the manufacturer, finding the jury was entitled to believe that the doctor's knowledge did not prevent the plaintiff from proving proximate causation on two grounds. First, with fairly conventional reasoning, the court held that the jury was entitled to believe that warnings on the package inserts and included in the PDR were not strong enough. Id. at 1363. Second, the court endorsed the same “overpromotion” theory applied by the California Supreme Court. In particular, the court took issue with the existence of a desk calendar provided to the physician that promoted the drug but did not contain a warning of the drug's risks. Although the court acknowledged that this evidence was “slight,” it found that a jury could reasonably believe that providing the calendar was “overpromotion which nullified the effect of even a valid warning on the package.” Id. The court found it “foreseeable that a calendar might remain on a physician's desk as a constant reminder to prescribe a drug long after the sample and its warning had been removed.” Id.

Other Courts Disagree

Other courts, however, have not applied the “overpromotion” theory so liberally. In Patteson v. Astrazeneca, LP 2012 U.S. Dist. LEXIS 97052, at **22-23 (D.D.C. July 9, 2012), the court held that even if it were to recognize the overpromotion theory, it would not apply: “With no evidence regarding [the prescribing doctor's] exposure to the alleged overpromotion of Seroquel and no evidence that such efforts influenced his treatment of [the patient], Plaintiffs cannot avail themselves of the overpromotion exception ' even if the exception were to be recognized in this jurisdiction.” Thus, Patteson requires a plaintiff to show more than the mere possibility that the prescribing doctor may have been consciously or subconsciously influenced by the marketing. The plaintiff must show evidence that the marketing actually influenced the prescribing decision. The plaintiff failed to make this showing and the court granted summary judgment to the manufacturer. See also Dean v. Eli Lilly & Co., 2009 U.S. Dist LEXIS 60074, *60 (E.D.N.Y. July 1, 2009) (“A plaintiff arguing in favor or application of the overpromotion exception with respect to a prescription drug must establish with individualized proof that such overpromotion was 'an inducing, or proximate, cause of the resulting injuries' to that plaintiff. General claims of overpromotion are not sufficient.”) (quoting Beale v. Biomet, Inc., 492 F. Supp 1360, 1377 (S.D. Fla. June 15, 2007)).

Conclusion

Although the learned intermediary doctrine dictates that a drug manufacturer's duty to warn is owed to the doctor, rather than the patient, informing the doctor of the risks may not always be sufficient to guard against liability. As courts continue to reinterpret the learned intermediary doctrine, litigators should pay particular attention to the prescribing doctor's testimony. Of particular importance, litigators should be careful to develop the extent to which the doctor did or did not rely upon warnings and other representations that may have been made by sales representatives or included in drug labels, “Dear Doctor” letters, and promotional materials.

Brian Raphel is an associate in the San Francisco office of Dechert LLP. He may be reached at [email protected].

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In typical product liability cases, the manufacturer owes a duty to the eventual consumer to warn of any risks associated with the product. However, in the context of prescription drug cases, courts have recognized that the prescribing doctors, and not their patients, are in the best position to weigh the risks and benefits of a given drug for a particular patient. Accordingly, courts in nearly every state have embraced some form of the “learned intermediary doctrine,” which provides that a prescription drug manufacturer satisfies its duty to warn so long as it provides an adequate warning of the drug's potential risks to the plaintiff's prescribing doctor. If the warning is adequate, or even if the doctor was somehow otherwise aware of the risk, then the manufacturer will not be liable, either because it satisfied its duty to warn or because there can be no proximate causation of the plaintiff's injury if the doctor already knew of the risk but prescribed the drug anyway.

This has made the deposition of the prescribing doctor a key event in these litigations. Many courts have granted motions for summary judgment in favor of prescription drug manufacturers when the record established that the prescribing doctor was aware of the risk associated with the drug. See, e.g., McClamrock v. Eli Lilly & Co., 2012 U.S. App. Lexis 24539, at *2 (2nd Cir. Nov. 29, 2012) (“Because [the plaintiff] would have the burden of establishing proximate cause at trial, his failure to offer any evidence that [his prescriber] was unaware that diabetes was a risk associated with [the drug] when he prescribed it warranted granting summary judgment in favor of [the defendant]“); Ebel v. Eli Lilly & Co., 2009 U.S. App. LEXIS 6710, *21 (5th Cir. March 30, 2009) (affirming ruling granting summary judgment where “[the plaintiff] presented no evidence to suggest that [the doctor] would have changed either his decision to prescribe [the drug] or his risk ' benefit analysis had he received some alternative warning.”).

This article, however, considers instances where courts have allowed the case to be presented to a jury or upheld a jury verdict even though the prescribing doctor testified he knew of the risk. The reasons have varied, but here we address two of the more common ways in which courts have done this: 1) where some additional means to communicate the warning could have changed the prescribing doctor's mind; or 2) where the manufacturer “overpromoted” the benefits of the drug to the point that the warning could have been negated. The rationale that some courts have applied to avoid the application of the learned intermediary doctrine warrants review by those who depose prescribing physicians in product liability cases.

Failure to Use 'Adequate' Means to Communicate a Warning

Late last year, the Eighth Circuit examined the application of the learned intermediary doctrine in In re: Levaquin, 2012 U.S. App. LEXIS 24640 (8th Cir. Nov. 30, 2012). In Levaquin, the court focused on whether the manufacturer had properly warned the prescribing doctor that Levaquin carried a potential risk of Achilles tendon rupture. The package insert ' that is, the label ' did contain a warning of this risk. But the doctor had not read it. He testified that he nonetheless knew of a risk, although the decision does not explain how he obtained that knowledge. Id. at *1165.

He also testified that if he had read the label he would not have prescribed the drug, evidence that the warning was in fact adequate and maybe would have given the doctor an even better understanding of the risk. Id. at *1168. The doctor testified that he did not generally take the time to read package inserts and he relied on sales representatives “only minimally.” Id. at *1164. While the court noted that the company did not send a “Dear Doctor” letter that warned of the risk, there was no evidence that the doctor read or relied on such letters. Id. These facts present strong support for summary judgment or judgment as a matter of law for defendants, either because the warning in the label was adequate or because the doctor was aware of the risk.

But ultimately, the case was presented to a jury, which ruled in favor of the plaintiff. On appeal, the Eight Circuit affirmed the award, finding that the jury was entitled to believe that “some piece of information” may have “altered [the doctor's] prescribing decision.” Id. at *1168. Although the doctor did not testify that he relies upon “Dear Doctor” letters, the court found persuasive a study showing that “properly worded and highly publicized “Dear Doctor” letters may reduce risky prescribing practices.” Id. at *1169. The Eighth Circuit recognized that the reasoning was a “stretch.” Nonetheless, it found that the jury could have reasonably inferred the doctor would have altered his decision to prescribe Levaquin if some greater effort to provide a warning was made, such as sending Dear Doctor letters, and the jury could have reasonably concluded that the failure to take these additional precautions actually caused the plaintiff's injury. Id at *1168.

In reaching this conclusion, the Eighth Circuit relied on its own prior ruling in Sterling Drug, Inc. v. Yarrow , 408 F. 2d 978 (1969), in which the court created a requirement that a drug manufacturer provide warnings of known risks through all usual means. In the court's own words:

Under the circumstances of this case, when the dangers of the prolonged use of this drug, mass produced and sold in large quantities, became reasonably apparent, it was not unreasonable to find that the appellant should have employed all its usual means of communication ' to warn the prescribing physicians of these dangers. In this connection it is noted that no extraordinary means of giving a warning of high intensity was employed.

Id. at 992. This reasoning does not appear to have been applied outside of the Eighth Circuit.”

'Overpromotion' Negates the Warning

Even when there is no question that an adequate warning was provided to, and received by, the prescribing doctor, certain courts have found judgment as a matter of law to be inappropriate under the theory that “overpromotion” of a product can negate an otherwise adequate warning.

Stevens v. Parke, Davis & Co. , 9 Cal. 3d 51 (1973), is remarkable for its holding that overpromotion could trump a doctor's testimony that, despite the promotion, he was aware of the risk. The prescribing doctor testified that at the time he prescribed the drug, he was aware that it had been linked to bone marrow failure and that prolonged use of the drug could potentially have fatal consequences. Id. at 67 n. 15. He learned about these risks from medical journals and discussions with other physicians. Id. at 68 n. 16. Despite this, he prescribed the drug anyway. Based on this testimony, the manufacturer argued that the plaintiff could not prove proximate causation.

However, a jury eventually found the manufacturer to be liable and the California Supreme Court affirmed the award on the grounds that the jury was entitled to disbelieve the doctor's testimony. The court cited “circumstantial evidence” that the doctor was “induced to prescribe the drug” by the manufacturer's “overpromotion” of the product. Id. at *68. Because the company gave away merchandise (such as calendars) that promoted the benefits of the drug without mentioning the risks and had not instructed personal salespersons to describe the risks during sales calls, the court found that the jury could have believed that the doctor, despite his actual testimony, had been “consciously or subconsciously” influenced by the drug's “overpromotion.” Id.

The Fourth Circuit followed suit two years later when it addressed the same situation in Salmon v. Parke, Davis & Co. , 520 F. 2d 1359, 1361 (4th Cir. 1975). Here, the court found that the prescribing doctor had either seen the original warning in a package insert, or a revised warning provided with a sample of the drug. The court also found that the doctor could have seen the warning in the Physicians' Desk Reference (PDR). Id. at 1361. Despite this evidence that the doctor had actually been warned, the court affirmed a jury's verdict against the manufacturer, finding the jury was entitled to believe that the doctor's knowledge did not prevent the plaintiff from proving proximate causation on two grounds. First, with fairly conventional reasoning, the court held that the jury was entitled to believe that warnings on the package inserts and included in the PDR were not strong enough. Id. at 1363. Second, the court endorsed the same “overpromotion” theory applied by the California Supreme Court. In particular, the court took issue with the existence of a desk calendar provided to the physician that promoted the drug but did not contain a warning of the drug's risks. Although the court acknowledged that this evidence was “slight,” it found that a jury could reasonably believe that providing the calendar was “overpromotion which nullified the effect of even a valid warning on the package.” Id. The court found it “foreseeable that a calendar might remain on a physician's desk as a constant reminder to prescribe a drug long after the sample and its warning had been removed.” Id.

Other Courts Disagree

Other courts, however, have not applied the “overpromotion” theory so liberally. In Patteson v. Astrazeneca, LP 2012 U.S. Dist. LEXIS 97052, at **22-23 (D.D.C. July 9, 2012), the court held that even if it were to recognize the overpromotion theory, it would not apply: “With no evidence regarding [the prescribing doctor's] exposure to the alleged overpromotion of Seroquel and no evidence that such efforts influenced his treatment of [the patient], Plaintiffs cannot avail themselves of the overpromotion exception ' even if the exception were to be recognized in this jurisdiction.” Thus, Patteson requires a plaintiff to show more than the mere possibility that the prescribing doctor may have been consciously or subconsciously influenced by the marketing. The plaintiff must show evidence that the marketing actually influenced the prescribing decision. The plaintiff failed to make this showing and the court granted summary judgment to the manufacturer. See also Dean v. Eli Lilly & Co., 2009 U.S. Dist LEXIS 60074, *60 (E.D.N.Y. July 1, 2009) (“A plaintiff arguing in favor or application of the overpromotion exception with respect to a prescription drug must establish with individualized proof that such overpromotion was 'an inducing, or proximate, cause of the resulting injuries' to that plaintiff. General claims of overpromotion are not sufficient.”) (quoting Beale v. Biomet, Inc. , 492 F. Supp 1360, 1377 (S.D. Fla. June 15, 2007)).

Conclusion

Although the learned intermediary doctrine dictates that a drug manufacturer's duty to warn is owed to the doctor, rather than the patient, informing the doctor of the risks may not always be sufficient to guard against liability. As courts continue to reinterpret the learned intermediary doctrine, litigators should pay particular attention to the prescribing doctor's testimony. Of particular importance, litigators should be careful to develop the extent to which the doctor did or did not rely upon warnings and other representations that may have been made by sales representatives or included in drug labels, “Dear Doctor” letters, and promotional materials.

Brian Raphel is an associate in the San Francisco office of Dechert LLP. He may be reached at [email protected].

”