Practice Tip: Failure-to-Warn Causation and The Learned Intermediary

The different standard of proof is partially the result of the nature of the claim itself and the need to prove some causal link between the absence (or inadequacy) of a particular warning and the alleged harm. More significantly, the different standard of proof is the result of the learned intermediary doctrine. For prescription drugs and medical devices, the manufacturer's duty to warn runs to the physician, the learned intermediary, rather than to the consumer. Accordingly, to establish causation in failure-to-warn claims involving a learned intermediary, the plaintiff must offer evidence that the physician would not have prescribed the drug or device had adequate warnings been given.

With respect to the causation standard described above, practitioners must be aware of a number of specific issues. Chief among them is the importance of the testimony of the learned intermediary. Several recent cases decided on such testimony are addressed below. Other issues, while purely legal in nature, arise early while developing case strategy and understanding them will be vital to developing certain themes and defenses.

Failure-to-Warn Causation and the Testimony of the Learned Intermediary

The testimony of the prescribing physician(s) is absolutely crucial to the ability of the defense to prevail at summary judgment on the issue of causation. Unless prohibited by the laws of the jurisdiction, every effort should be made to contact the prescribing physician. An early understanding of the nature of his or her testimony ' particularly whether it is favorable to your client ' will assist you in developing the themes of the case. Your relationship with the physician will likely be more complicated if the physician is (or was at some point) your co-defendant. In such cases, it is still advisable to reach out to the physician's counsel; if nothing else, perhaps you will be able to gauge the physician's level of support for and consistency with your client. The cases described below demonstrate the impact of physician testimony.

In Ebel v. Eli Lilly & Co., 321 Fed. Appx. 350, 2009 WL 837325 (5th Cir. 2009) and Clark v. Eli Lilly & Co. (In re Zyprexa Prod. Liability Litig.), Nos. 04-MD-1596, 06-CV-1600, 2009 WL 1514427 (E.D.N.Y. May 29, 2009), the respective courts affirmed (or granted) summary judgment due, in substantial part, to the favorable testimony of the prescribing physician. In contrast, the court denied summary judgment in Earl v. Eli Lilly & Company (In re Zyprexa Prod. Liability Litig.), Nos. 04-MD-1596, 07-CV-3912, 2009 WL 2762170 (E.D.N.Y. Aug. 28, 2009), finding that the physician's testimony was not favorable to the defendant. The Hurley case (Hurley v. The Heart Physicians P.C. et al., No. X05-CV-00-0177475 S, Connecticut Superior Court, 2006), a medical device trial in which the authors were involved, presents a hybrid example of how causation issues come into play at trial. (Lori Cohen was lead trial counsel for defendant Medtronic, Inc. Daniel Smulian was one of Medtronic's trial counsel.)

Recent Failure-to-Warn Decisions Affirming (or Granting) Summary
Judgment on Causation

In Ebel, the plaintiff claimed that the defendant's failure-to-warn that Zyprexa could result in feelings of severe restlessness and suicide caused her husband to commit suicide in November 2002. Id. at *1. The defendant moved for summary judgment, in part, on the grounds that the allegedly inadequate warning was not the producing cause of the decedent's death. The district court agreed and the plaintiff appealed. Id. The Fifth Circuit Court of Appeals, applying Texas law, affirmed the lowers cour't ruling. As the court explained:

the failure-to-warn is a producing cause of the injury if the alleged inadequacy caused the doctor to prescribe the drug for the patient. If, however, the physician was aware of the possible risks involved in the use of the product but decided to use it anyway, the adequacy of the warning is not a producing cause of the injury and the plaintiff's recovery must be denied. Even if the plaintiff is not aware of a risk, the plaintiff must show that proper warning would have changed the decision of the treating physician, i.e., that but for the inadequate warning, the treating physician would have not used or prescribed the product. Id. at *5.

Applying this standard, the court found that the plaintiff had presented no evidence that the decedent's physician was unaware of the risks when he prescribed the drug. Indeed, deposition testimony established that the doctor was aware of the specific risks about which the plaintiff complained and, moreover, that he communicated those risks to the decedent. The records also reflected that Zyprexa was perceived to be the last available treatment option for the decedent, who had tried upwards of 45 other medications. Thus, the court found no evidence that an alternate warning would have changed the physician's decision to prescribe Zyprexa.

In another recent case, Clark, the plaintiff alleged that the defendant's drug, Zyprexa, caused the plaintiff's diabetes. The plaintiff alleged that the defendant failed to warn about the dangers associated with the drug, and that the plaintiff would not have developed diabetes had proper warnings been given. The defendant moved for summary judgment, in part, on the grounds that the drug would have been prescribed for the plaintiff even if the defendant had given the warnings sought by the plaintiff. The testimony of the plaintiff's prescribing physicians supported the defendant's position. The physician who first prescribed Zyprexa for the plaintiff testified that he routinely analyzed the possible risks and benefits associated with any drug that he prescribed to his patients. He also testified that he knew that significant weight gain was associated with Zyprexa for some patients. His decision to prescribe Zyprexa was based, in part, on the ineffectiveness or side effects of previous medications. Perhaps most importantly, the prescribing physician testified that had he been aware of the increased risk of diabetes, he would have continued to prescribe Zyprexa for his patients. The plaintiff's other physician offered similar testimony.

The court found a clear record both that: 1) the prescribing physician had knowledge of potential weight gain in other patients when he prescribed Zyprexa for plaintiff; and 2) the plaintiff's physicians did not prescribe other medication for the plaintiff for several reasons. The court further found “no evidence that a different warning regarding Zyprexa would have changed [the prescribing physician's] decision to prescribe Zyprexa to [plaintiff], a troubled adolescent suffering from severe mental health and behavior problems.” Accordingly, the court ruled that “[f]ailure to warn was not a cause of plaintiff's diabetes” and granted summary judgment in favor of the defendant.

Recent Failure-to-Warn Cases Denying Summary Judgment on Causation

A recent New York decision, Earl, demonstrates that unfavorable physician testimony significantly decreases the likelihood of a successful dispositive motion. In this case, the plaintiff alleged that the defendant's drug, Zyprexa, caused the decedent's diabetes, that the defendant failed to warn of the drug's dangers, and that Zyprexa would not have been prescribed, or a different treatment would have been undertaken, if the defendant's warnings had been adequate. The defendant moved for summary judgment, in part, on the grounds that the actions of the learned intermediary precluded proof of any causal connection between the alleged inadequacy of defendant's warnings and the decision to prescribe Zyprexa to the decedent.

The court found that an issue of fact existed as to whether the decedent's treating physician was aware of the risks of the drug when he treated the decedent. Although the physician admitted a general awareness that weight gain was a possible side effect of psychiatric drugs, the physician indicated some uncertainty about whether he was “completely aware of [Zyprexa's] benefits versus the risks ' ” Id. at *19 (internal quotation marks omitted). The court found that the decedent's medical records, which documented when the physician first became aware of Zyprexa's potential side effects and when he began to monitor the decedent and consider other treatment options, confirmed this testimony. The court found it significant that the physician's “critical understanding” was first recorded shortly after the defendant began sending letters to physicians, notifying them of Zyprexa's potential side effects. Perhaps most importantly, the physician testified in a post-deposition affidavit:

[H]ad I known that Zyprexa had a significantly greater risk of weight gain, insulin resistance, and diabetes, than had been revealed by Eli Lilly, I would have pursued other options for the treatment of Mr. Earl's psychotic symptoms. Id.

The court found that a reasonable juror could find that the physician would have made different treatment decisions for plaintiff, including prescribing a different medication or monitoring plaintiff more closely, if the physician had been fully aware of the drug's side effects. Thus, “[t]he alleged inadequacy of the Zyprexa warning related to metabolic risks, a jury might conclude, may have led to the treatment decisions that contributed to [plaintiff's] subsequent injuries, including diabetes and death.” Id.

An Example of Failure-to-Warn Causation at Trial

As demonstrated above, the prescribing physician's testimony is of great importance. How you develop that testimony will depend on your relationship with the physician's attorneys, the claims against the physician, if any, and your strategic preparation for (and the outcome of) the physician's deposition. Hurley v. The Heart Physicians P.C. et al., No. X05-CV-00-0177475 S, Connecticut Superior Court, 2006, demonstrates the significance of at least two of these factors.

The Hurley case centered around injuries sustained by Nicole Hurley, who was 12 years old at the time of the incident at issue. Ms. Hurley was diagnosed in utero with complete congenital heart block, a serious cardiac condition that impairs the electrical functioning of the heart. She received her first pacemaker within a week of her birth. This device (or, later, its battery) was routinely changed every three to five years. In the summer of 1998, Ms. Hurley's pacemaker exhibited indications that it needed to be replaced. Ms. Hurley's treating cardiologist scheduled an appointment for Sept. 14, 1998, and asked a Medtronic sales representative to attend the visit to interrogate the device. At the office visit, Ms. Hurley's mother refused to consent to battery replacement. As a result, Ms. Hurley's physician decided to reduce the rate of the pacemaker to assess Ms. Hurley's condition without pacing support. At the direction of the physician, the Medtronic sales representative reduced the rate of the device. Ms. Hurley returned to the physician's office over four weeks later, on Oct. 19, 1998. Again, Ms. Hurley's parents refused to consent to battery replacement. One week later, on Oct. 26, 1998, Ms. Hurley suffered a cardiac arrest. According to Ms. Hurley and her parents (collectively, “plaintiffs”), the reduction of the rate of her pacemaker caused Ms. Hurley's cardiac arrest. Plaintiffs initially asserted a medical malpractice claim against Nicole Hurley's treating physician. At the physician's deposition, plaintiffs learned that a sales representative from Medtronic, Inc. (“Medtronic”) ' the pacemaker manufacturer ' was present during the office visit at which the physician ordered the reduction of the pacemaker's rate. The plaintiffs subsequently amended their complaint to add Medtronic as a defendant. Shortly thereafter, the plaintiffs settled their claims against Ms. Hurley's physician.

In essence, the plaintiffs' claim sounded in an alleged failure-to-warn. The plaintiffs alleged that the statements and conduct of Medtronic's sales representative were inconsistent with the technical manual for Ms. Hurley's pacemaker, thereby rendering ineffective the warnings set forth in the manual. Defendant initially prevailed at summary judgment on the grounds that the learned intermediary doctrine barred the plaintiff's claims as a matter of law. The Connecticut Supreme Court reversed, holding that an issue of fact precluded summary judgment, and remanded the case for trial. See Hurley v. Heart Physicians, P.C., 278 Conn. 305, 326 (2006).

At trial, the plaintiffs did not call the prescribing physician to testify as a live witness. Instead, the plaintiffs read portions of the physician's deposition testimony into the record. The physician was deposed before the plaintiffs amended their complaint, and the plaintiffs never sought leave to re-depose the physician about their new claims against the newly-added defendant. Consequently, the plaintiffs presented no evidence at trial about what the prescribing physician would have done differently if, according to the plaintiff's theory, the sales representative's statements and conduct had been consistent with the applicable technical manual. To the contrary, the physician's deposition testimony established that he decided to reduce the rate of the pacemaker based on his own medical judgment. Similarly, the plaintiffs adduced no testimony from their own expert about what a reasonable physician would have done in the same situation.

At the close of the plaintiffs' case, the defendant moved for directed verdict on the grounds that the plaintiffs had failed to establish causation. In response to the defendant's argument, the court stated that the defendant had raised “serious issues” about the plaintiff's case. Out of concern for judicial economy, however, the court reserved its ruling on the defendant's motion pending the jury's verdict. As the jury ultimately returned a verdict for the defendant, the court never ruled on the motion for directed verdict.

Other Legal Issues

While favorable physician testimony is perhaps the most important ' and uniform ' factual predicate for a successful failure-to-warn causation defense, certain legal standards vary between jurisdictions. In preparing a failure-to-warn causation defense, the practitioner should keep in mind the following issues.

Causation Standards: Statutory v. Common Law

Not all causation standards are the same and even the same standard might have different implications across jurisdictions, depending on its source. In Connecticut, for example, a statute provides the causation standard in a failure-to-warn product liability case. See C.G.S.A. ' 52-572q(c) (in a failure-to-warn case, the “claimant shall prove by a fair preponderance of the evidence that if adequate warnings had been provided, the claimant would not have suffered the harm”). Other states, in contrast, look to common law to determine the applicable causation standard. For example, in Eck v. Parke, Davis & Co., the court explained that:

To recover in a failure-to-warn case, a plaintiff must establish both cause-in-fact (that the product in question caused the injury) and proximate cause (that the manufacturer of the product breached a duty to warn of possible detrimental reactions. To qualify as a proximate cause of the injury, the breach of a duty or the failure-to-warn must be a substantial contributing factor in bringing about the harm in question. 256 F.3d 1013, 1017 (10th Cir. 2001) (citations and internal quotation marks omitted).

See also Thomas v. Hoffman-LaRoche, Inc., 949 F.2d 806, 812 (5th Cir. 1992) (citing Wyeth Labs, Inc. v. Fortenberry, 530 So.2d 688, 691-92 (Miss. 1988)). The source of a jurisdiction's causation standard is particularly important where the standard has not been affirmatively addressed in pharmaceutical or medical device cases or in the context of other doctrines or presumptions. In Hurley, the plaintiffs asked for a charge on failure-to-warn causation that incorporated a heeding presumption not previously addressed under Connecticut law. In declining to give the requested instruction, the court emphasized that the standard had been affirmatively proscribed by the state's legislature. As such, the court reasoned, there was little room to deviate. Had the standard for causation been a creature of common law, the judge might have felt more at liberty to engraft additional requirements.

Know Your Permissible Proof: Subjective v. Objective Testimony

In the majority of cases, proving causation requires subjective testimony about the particular plaintiff and warnings at issue. In other words, establishing what the prescribing physician would or would not have done if presented with different warnings requires the prescribing physician's own testimony. Indeed, with the exception of Hurley, all of the cases discussed above were decided on the basis of subjective physician testimony. Nevertheless, subjective physician testimony is not the only means to prove causation; the Fifth Circuit Court of Appeals has ruled that objective testimony can also prove or refute causation:

To satisfy the burden of establishing warning causation, a plaintiff may introduce either objective testimony evidence of how a reasonable physician would have responded to an adequate warning or subjective evidence of how the treating physician would have responded. Thomas, 949 F.2d at 812.

Even if objective evidence may not be admissible in your jurisdiction, you should know your expert's opinion on this issue and prepare him or her to respond to questions. At worst, your expert will be prepared to respond to questions from your adversary. At best, your expert can provide direct evidence to rebut causation. Similarly, the practitioner should consider whether to address this issue with the plaintiff's expert witnesses. Use caution, however, as the expert may provide testimony that is harmful to the defense.

Is There a Heeding Presumption?

Some states have adopted the so-called “heeding presumption” in failure-to-warn cases involving learned intermediaries. See, e.g., In re Prempro Prod. Liab. Litig., 586 F.3d 547, 569-70 (8th Cir. 2009) (predicting that Arkansas would likely apply the heeding presumption to cases involving pharmaceutical products). In such cases, it is assumed that the treating physician would have read and heeded an adequate warning had it been given. This presumption effectively shifts the burden of causation to the defendant, who must affirmatively prove that additional information would not have changed the physician's actions with respect to the drug or device at issue. Needless to say, defendants face a higher burden in jurisdictions that employ the heeding presumption.

Conclusion

In light of the critical importance of the prescribing physician's testimony, it is imperative to develop a strategic plan early in the litigation. Knowing the law in your jurisdiction, particularly the cases involving issues of proof, will allow you to understand and develop the specific evidence you will need to make a causation argument based on the learned intermediary doctrine. Then, use this roadmap at the deposition of the prescribing physician to elicit the requisite testimony. Likewise, ensure that your witnesses, particularly the experts, are prepared to address these issues affirmatively should the need arise. With the appropriate planning and development, using the learned intermediary doctrine to challenge causation can be a powerful (and cost-effective) weapon against the ubiquitous failure-to-warn claim.

Lori G. Cohen, a member of this newsletter's Board of Editors, is a shareholder in Greenberg Traurig, LLP's Atlanta office and is the Chair of Greenberg Traurig's Pharmaceutical and Medical Device Litigation Group. Daniel I.A. Smulian is an associate in the firm's New York office. He has expertise in product liability litigation, and he is admitted to practice in New York and Georgia.

In pharmaceutical and medical device litigation, the failure-to-warn claim continues to be among the most common causes of action. With respect to pharmaceutical products, the relative ease of asserting this claim stands in stark contrast to the difficulty of proving either a manufacturing or design defect. With respect to medical devices, the failure-to-warn claim remains prevalent despite the preemption afforded by Riegel v. Medtronic , 552 U.S. 312 (2008), particularly when the claim is premised on or combined with allegations involving the actions or statements of sales representatives. While not conceptually complex, failure-to-warn claims involving pharmaceutical and medical devices raise specific issues that can be challenging. One of the most critical issues relates to causation and its intersection with the learned intermediary doctrine. This article examines some of the key factors involved in proving causation in a failure-to-warn case and discusses recent case law in this area.

Background

In a typical product liability action (i.e., not a failure-to-warn), the element of causation is fairly straightforward. While terminology may vary, the basic question is: Did the pharmaceutical product or medical device cause the alleged injury or outcome at issue? This question is also present in failure-to-warn claims, though it is only half of the causation issue. The more complex causation question, and the subject of this article, is whether the alleged failure-to-warn, in contrast to the underlying drug or device, caused the plaintiff's injury or outcome. This question requires different proof.

The different standard of proof is partially the result of the nature of the claim itself and the need to prove some causal link between the absence (or inadequacy) of a particular warning and the alleged harm. More significantly, the different standard of proof is the result of the learned intermediary doctrine. For prescription drugs and medical devices, the manufacturer's duty to warn runs to the physician, the learned intermediary, rather than to the consumer. Accordingly, to establish causation in failure-to-warn claims involving a learned intermediary, the plaintiff must offer evidence that the physician would not have prescribed the drug or device had adequate warnings been given.

With respect to the causation standard described above, practitioners must be aware of a number of specific issues. Chief among them is the importance of the testimony of the learned intermediary. Several recent cases decided on such testimony are addressed below. Other issues, while purely legal in nature, arise early while developing case strategy and understanding them will be vital to developing certain themes and defenses.

Failure-to-Warn Causation and the Testimony of the Learned Intermediary

The testimony of the prescribing physician(s) is absolutely crucial to the ability of the defense to prevail at summary judgment on the issue of causation. Unless prohibited by the laws of the jurisdiction, every effort should be made to contact the prescribing physician. An early understanding of the nature of his or her testimony ' particularly whether it is favorable to your client ' will assist you in developing the themes of the case. Your relationship with the physician will likely be more complicated if the physician is (or was at some point) your co-defendant. In such cases, it is still advisable to reach out to the physician's counsel; if nothing else, perhaps you will be able to gauge the physician's level of support for and consistency with your client. The cases described below demonstrate the impact of physician testimony.

In Ebel v. Eli Lilly & Co. , 321 Fed. Appx. 350, 2009 WL 837325 (5th Cir. 2009) and Clark v. Eli Lilly & Co. (In re Zyprexa Prod. Liability Litig.), Nos. 04-MD-1596, 06-CV-1600, 2009 WL 1514427 (E.D.N.Y. May 29, 2009), the respective courts affirmed (or granted) summary judgment due, in substantial part, to the favorable testimony of the prescribing physician. In contrast, the court denied summary judgment in Earl v. Eli Lilly & Company (In re Zyprexa Prod. Liability Litig.), Nos. 04-MD-1596, 07-CV-3912, 2009 WL 2762170 (E.D.N.Y. Aug. 28, 2009), finding that the physician's testimony was not favorable to the defendant. The Hurley case (Hurley v. The Heart Physicians P.C. et al., No. X05-CV-00-0177475 S, Connecticut Superior Court, 2006), a medical device trial in which the authors were involved, presents a hybrid example of how causation issues come into play at trial. (Lori Cohen was lead trial counsel for defendant Medtronic, Inc. Daniel Smulian was one of Medtronic's trial counsel.)

Recent Failure-to-Warn Decisions Affirming (or Granting) Summary
Judgment on Causation

In Ebel, the plaintiff claimed that the defendant's failure-to-warn that Zyprexa could result in feelings of severe restlessness and suicide caused her husband to commit suicide in November 2002. Id. at *1. The defendant moved for summary judgment, in part, on the grounds that the allegedly inadequate warning was not the producing cause of the decedent's death. The district court agreed and the plaintiff appealed. Id. The Fifth Circuit Court of Appeals, applying Texas law, affirmed the lowers cour't ruling. As the court explained:

the failure-to-warn is a producing cause of the injury if the alleged inadequacy caused the doctor to prescribe the drug for the patient. If, however, the physician was aware of the possible risks involved in the use of the product but decided to use it anyway, the adequacy of the warning is not a producing cause of the injury and the plaintiff's recovery must be denied. Even if the plaintiff is not aware of a risk, the plaintiff must show that proper warning would have changed the decision of the treating physician, i.e., that but for the inadequate warning, the treating physician would have not used or prescribed the product. Id. at *5.

Applying this standard, the court found that the plaintiff had presented no evidence that the decedent's physician was unaware of the risks when he prescribed the drug. Indeed, deposition testimony established that the doctor was aware of the specific risks about which the plaintiff complained and, moreover, that he communicated those risks to the decedent. The records also reflected that Zyprexa was perceived to be the last available treatment option for the decedent, who had tried upwards of 45 other medications. Thus, the court found no evidence that an alternate warning would have changed the physician's decision to prescribe Zyprexa.

In another recent case, Clark, the plaintiff alleged that the defendant's drug, Zyprexa, caused the plaintiff's diabetes. The plaintiff alleged that the defendant failed to warn about the dangers associated with the drug, and that the plaintiff would not have developed diabetes had proper warnings been given. The defendant moved for summary judgment, in part, on the grounds that the drug would have been prescribed for the plaintiff even if the defendant had given the warnings sought by the plaintiff. The testimony of the plaintiff's prescribing physicians supported the defendant's position. The physician who first prescribed Zyprexa for the plaintiff testified that he routinely analyzed the possible risks and benefits associated with any drug that he prescribed to his patients. He also testified that he knew that significant weight gain was associated with Zyprexa for some patients. His decision to prescribe Zyprexa was based, in part, on the ineffectiveness or side effects of previous medications. Perhaps most importantly, the prescribing physician testified that had he been aware of the increased risk of diabetes, he would have continued to prescribe Zyprexa for his patients. The plaintiff's other physician offered similar testimony.

The court found a clear record both that: 1) the prescribing physician had knowledge of potential weight gain in other patients when he prescribed Zyprexa for plaintiff; and 2) the plaintiff's physicians did not prescribe other medication for the plaintiff for several reasons. The court further found “no evidence that a different warning regarding Zyprexa would have changed [the prescribing physician's] decision to prescribe Zyprexa to [plaintiff], a troubled adolescent suffering from severe mental health and behavior problems.” Accordingly, the court ruled that “[f]ailure to warn was not a cause of plaintiff's diabetes” and granted summary judgment in favor of the defendant.

Recent Failure-to-Warn Cases Denying Summary Judgment on Causation

A recent New York decision, Earl, demonstrates that unfavorable physician testimony significantly decreases the likelihood of a successful dispositive motion. In this case, the plaintiff alleged that the defendant's drug, Zyprexa, caused the decedent's diabetes, that the defendant failed to warn of the drug's dangers, and that Zyprexa would not have been prescribed, or a different treatment would have been undertaken, if the defendant's warnings had been adequate. The defendant moved for summary judgment, in part, on the grounds that the actions of the learned intermediary precluded proof of any causal connection between the alleged inadequacy of defendant's warnings and the decision to prescribe Zyprexa to the decedent.

The court found that an issue of fact existed as to whether the decedent's treating physician was aware of the risks of the drug when he treated the decedent. Although the physician admitted a general awareness that weight gain was a possible side effect of psychiatric drugs, the physician indicated some uncertainty about whether he was “completely aware of [Zyprexa's] benefits versus the risks ' ” Id. at *19 (internal quotation marks omitted). The court found that the decedent's medical records, which documented when the physician first became aware of Zyprexa's potential side effects and when he began to monitor the decedent and consider other treatment options, confirmed this testimony. The court found it significant that the physician's “critical understanding” was first recorded shortly after the defendant began sending letters to physicians, notifying them of Zyprexa's potential side effects. Perhaps most importantly, the physician testified in a post-deposition affidavit:

[H]ad I known that Zyprexa had a significantly greater risk of weight gain, insulin resistance, and diabetes, than had been revealed by Eli Lilly, I would have pursued other options for the treatment of Mr. Earl's psychotic symptoms. Id.

The court found that a reasonable juror could find that the physician would have made different treatment decisions for plaintiff, including prescribing a different medication or monitoring plaintiff more closely, if the physician had been fully aware of the drug's side effects. Thus, “[t]he alleged inadequacy of the Zyprexa warning related to metabolic risks, a jury might conclude, may have led to the treatment decisions that contributed to [plaintiff's] subsequent injuries, including diabetes and death.” Id.

An Example of Failure-to-Warn Causation at Trial

As demonstrated above, the prescribing physician's testimony is of great importance. How you develop that testimony will depend on your relationship with the physician's attorneys, the claims against the physician, if any, and your strategic preparation for (and the outcome of) the physician's deposition. Hurley v. The Heart Physicians P.C. et al., No. X05-CV-00-0177475 S, Connecticut Superior Court, 2006, demonstrates the significance of at least two of these factors.

The Hurley case centered around injuries sustained by Nicole Hurley, who was 12 years old at the time of the incident at issue. Ms. Hurley was diagnosed in utero with complete congenital heart block, a serious cardiac condition that impairs the electrical functioning of the heart. She received her first pacemaker within a week of her birth. This device (or, later, its battery) was routinely changed every three to five years. In the summer of 1998, Ms. Hurley's pacemaker exhibited indications that it needed to be replaced. Ms. Hurley's treating cardiologist scheduled an appointment for Sept. 14, 1998, and asked a Medtronic sales representative to attend the visit to interrogate the device. At the office visit, Ms. Hurley's mother refused to consent to battery replacement. As a result, Ms. Hurley's physician decided to reduce the rate of the pacemaker to assess Ms. Hurley's condition without pacing support. At the direction of the physician, the Medtronic sales representative reduced the rate of the device. Ms. Hurley returned to the physician's office over four weeks later, on Oct. 19, 1998. Again, Ms. Hurley's parents refused to consent to battery replacement. One week later, on Oct. 26, 1998, Ms. Hurley suffered a cardiac arrest. According to Ms. Hurley and her parents (collectively, “plaintiffs”), the reduction of the rate of her pacemaker caused Ms. Hurley's cardiac arrest. Plaintiffs initially asserted a medical malpractice claim against Nicole Hurley's treating physician. At the physician's deposition, plaintiffs learned that a sales representative from Medtronic, Inc. (“Medtronic”) ' the pacemaker manufacturer ' was present during the office visit at which the physician ordered the reduction of the pacemaker's rate. The plaintiffs subsequently amended their complaint to add Medtronic as a defendant. Shortly thereafter, the plaintiffs settled their claims against Ms. Hurley's physician.

In essence, the plaintiffs' claim sounded in an alleged failure-to-warn. The plaintiffs alleged that the statements and conduct of Medtronic's sales representative were inconsistent with the technical manual for Ms. Hurley's pacemaker, thereby rendering ineffective the warnings set forth in the manual. Defendant initially prevailed at summary judgment on the grounds that the learned intermediary doctrine barred the plaintiff's claims as a matter of law. The Connecticut Supreme Court reversed, holding that an issue of fact precluded summary judgment, and remanded the case for trial. See Hurley v. Heart Physicians, P.C. , 278 Conn. 305, 326 (2006).

At trial, the plaintiffs did not call the prescribing physician to testify as a live witness. Instead, the plaintiffs read portions of the physician's deposition testimony into the record. The physician was deposed before the plaintiffs amended their complaint, and the plaintiffs never sought leave to re-depose the physician about their new claims against the newly-added defendant. Consequently, the plaintiffs presented no evidence at trial about what the prescribing physician would have done differently if, according to the plaintiff's theory, the sales representative's statements and conduct had been consistent with the applicable technical manual. To the contrary, the physician's deposition testimony established that he decided to reduce the rate of the pacemaker based on his own medical judgment. Similarly, the plaintiffs adduced no testimony from their own expert about what a reasonable physician would have done in the same situation.

At the close of the plaintiffs' case, the defendant moved for directed verdict on the grounds that the plaintiffs had failed to establish causation. In response to the defendant's argument, the court stated that the defendant had raised “serious issues” about the plaintiff's case. Out of concern for judicial economy, however, the court reserved its ruling on the defendant's motion pending the jury's verdict. As the jury ultimately returned a verdict for the defendant, the court never ruled on the motion for directed verdict.

Other Legal Issues

While favorable physician testimony is perhaps the most important ' and uniform ' factual predicate for a successful failure-to-warn causation defense, certain legal standards vary between jurisdictions. In preparing a failure-to-warn causation defense, the practitioner should keep in mind the following issues.

Causation Standards: Statutory v. Common Law

Not all causation standards are the same and even the same standard might have different implications across jurisdictions, depending on its source. In Connecticut, for example, a statute provides the causation standard in a failure-to-warn product liability case. See C.G.S.A. ' 52-572q(c) (in a failure-to-warn case, the “claimant shall prove by a fair preponderance of the evidence that if adequate warnings had been provided, the claimant would not have suffered the harm”). Other states, in contrast, look to common law to determine the applicable causation standard. For example, in Eck v. Parke, Davis & Co., the court explained that:

To recover in a failure-to-warn case, a plaintiff must establish both cause-in-fact (that the product in question caused the injury) and proximate cause (that the manufacturer of the product breached a duty to warn of possible detrimental reactions. To qualify as a proximate cause of the injury, the breach of a duty or the failure-to-warn must be a substantial contributing factor in bringing about the harm in question. 256 F.3d 1013, 1017 (10th Cir. 2001) (citations and internal quotation marks omitted).

See also Thomas v. Hoffman-LaRoche, Inc. , 949 F.2d 806, 812 (5th Cir. 1992) (citing Wyeth Labs, Inc. v. Fortenberry , 530 So.2d 688, 691-92 (Miss. 1988)). The source of a jurisdiction's causation standard is particularly important where the standard has not been affirmatively addressed in pharmaceutical or medical device cases or in the context of other doctrines or presumptions. In Hurley, the plaintiffs asked for a charge on failure-to-warn causation that incorporated a heeding presumption not previously addressed under Connecticut law. In declining to give the requested instruction, the court emphasized that the standard had been affirmatively proscribed by the state's legislature. As such, the court reasoned, there was little room to deviate. Had the standard for causation been a creature of common law, the judge might have felt more at liberty to engraft additional requirements.

Know Your Permissible Proof: Subjective v. Objective Testimony

In the majority of cases, proving causation requires subjective testimony about the particular plaintiff and warnings at issue. In other words, establishing what the prescribing physician would or would not have done if presented with different warnings requires the prescribing physician's own testimony. Indeed, with the exception of Hurley, all of the cases discussed above were decided on the basis of subjective physician testimony. Nevertheless, subjective physician testimony is not the only means to prove causation; the Fifth Circuit Court of Appeals has ruled that objective testimony can also prove or refute causation:

To satisfy the burden of establishing warning causation, a plaintiff may introduce either objective testimony evidence of how a reasonable physician would have responded to an adequate warning or subjective evidence of how the treating physician would have responded. Thomas, 949 F.2d at 812.

Even if objective evidence may not be admissible in your jurisdiction, you should know your expert's opinion on this issue and prepare him or her to respond to questions. At worst, your expert will be prepared to respond to questions from your adversary. At best, your expert can provide direct evidence to rebut causation. Similarly, the practitioner should consider whether to address this issue with the plaintiff's expert witnesses. Use caution, however, as the expert may provide testimony that is harmful to the defense.

Is There a Heeding Presumption?

Some states have adopted the so-called “heeding presumption” in failure-to-warn cases involving learned intermediaries. See, e.g., In re Prempro Prod. Liab. Litig., 586 F.3d 547, 569-70 (8th Cir. 2009) (predicting that Arkansas would likely apply the heeding presumption to cases involving pharmaceutical products). In such cases, it is assumed that the treating physician would have read and heeded an adequate warning had it been given. This presumption effectively shifts the burden of causation to the defendant, who must affirmatively prove that additional information would not have changed the physician's actions with respect to the drug or device at issue. Needless to say, defendants face a higher burden in jurisdictions that employ the heeding presumption.

Conclusion

In light of the critical importance of the prescribing physician's testimony, it is imperative to develop a strategic plan early in the litigation. Knowing the law in your jurisdiction, particularly the cases involving issues of proof, will allow you to understand and develop the specific evidence you will need to make a causation argument based on the learned intermediary doctrine. Then, use this roadmap at the deposition of the prescribing physician to elicit the requisite testimony. Likewise, ensure that your witnesses, particularly the experts, are prepared to address these issues affirmatively should the need arise. With the appropriate planning and development, using the learned intermediary doctrine to challenge causation can be a powerful (and cost-effective) weapon against the ubiquitous failure-to-warn claim.

Lori G. Cohen, a member of this newsletter's Board of Editors, is a shareholder in Greenberg Traurig, LLP's Atlanta office and is the Chair of Greenberg Traurig's Pharmaceutical and Medical Device Litigation Group. Daniel I.A. Smulian is an associate in the firm's New York office. He has expertise in product liability litigation, and he is admitted to practice in New York and Georgia.