Improperly Attempting to Circumvent the Learned Intermediary Doctrine: Challenging the Adequacy of Warnings to Physicians

The learned intermediary doctrine is one of the most important doctrines for medical device and pharmaceutical drug defendants in product liability cases because under the doctrine, they are often able to obtain summary judgment on failure to warn claims. (The learned intermediary doctrine has been adopted and recognized in at least 45 states. See Larkin v. Pfizer, Inc., 153 S.W.3d 758, 767 (Ky. 2005).) The learned intermediary doctrine provides that a manufacturer, designer or distributor of a medical device or pharmaceutical drug does not have a duty to directly warn patients of possible dangers associated with the use of the device or drug. See Presto v. Sandoz Pharm. Corp., 487 S.E.2d 70 (Ga. Ct. App. 1997). Rather, “'a warning as to possible danger in its use to the prescribing physician is sufficient.'” Id. at 73. As noted in Restatement (Third) of Torts:

The rationale supporting this 'learned intermediary' rule is that only health-care professionals are in a position to understand the significance of the risks involved and to assess the relative advantages and disadvantages of a given form of prescription-based therapy. The duty then devolves on the health-care provider to supply to the patient such information as is deemed appropriate under the circumstances so that the patient can make an informed choice as to therapy. Restatement (Third) of Torts: Prods. Liab. '6 cmt. b.

In addition, courts throughout the country have noted that the learned intermediary doctrine is a sound and rational doctrine because: 1) “manufacturers lack effective means to communicate directly with each patient” and 2) “imposing a duty to warn upon the manufacturer would unduly interfere with the physician-patient relationship.” Larkin v. Pfizer, Inc., 153 S.W.3d 758, 764 (Ky. 2005). Consistent with these policies, courts have found that the learned intermediary doctrine applies not only to pharmaceutical drugs, but to medical devices as well, because medical devices are available only upon “prescription, application (insertion) and supervision of a physician.” Lance v. Am. Edwards Labs., 452 S.E.2d 185, 186 (Ga. Ct. App. 1994). See also Cather v. Catheter Tech. Corp., 753 F. Supp. 634, 640 (S.D. Miss. 1991).

Plaintiffs often attempt to circumvent the learned intermediary doctrine and defeat summary judgment on failure to warn claims by arguing that there is an issue of fact as to whether the warning the pharmaceutical or medical device defendant provided physicians was “adequate.” Courts, however, have consistently rejected such attempts and have held that defendants' warnings to physicians may be declared adequate as a matter of law.

Warnings Mentioning the Risk Complained of Are Adequate As a Matter of Law

Courts throughout the nation have found that where the warning provided by the pharmaceutical drug defendant to the physician specifically mentions the circumstances complained of, the warning is adequate as a matter of law. In Percival v. Am. Cyanamid Co., 689 F. Supp. 1060 (W.D. Okla. 1987), plaintiffs sued the manufacturer of a DTP vaccine for various causes of action, including failure to warn, after their son developed severe and permanent neurological damage as a result of an adverse reaction to the DTP vaccine. Id. at 1061. In granting summary judgment for defendant on the failure to warn claim, the court initially found that under the learned intermediary doctrine, the manufacturer was only required to warn the physician, and not the patient, of the dangers associated with the vaccine. Id. at 1063. The court then reviewed the contents of the warning to determine whether the warning provided to the physician was adequate. Although the court stated that the question of the adequacy of a warning is ordinarily a question of fact for the jury, it found that under the facts of the case, the warning was adequate as a matter of law because it warned that use of the vaccine could result in neurological disorders and permanent brain damage, the very injuries suffered by plaintiffs' son. Because the warning was adequate as a matter of law, the court granted summary judgment to the vaccine manufacturer on plaintiffs' failure to warn claim. See also Rolen v. Burroughs Wellcome Co., 856 S.W.2d 607 (Tex. App. 1993) (affirming summary judgment on failure to warn claim because warning provided to learned intermediaries that mentioned risk of Stevens-Johnson syndrome, the allergic reaction plaintiff developed following use of defendant's pharmaceutical drug, was adequate as a matter of law); Dunkin v. Syntex Labs., Inc., 443 F. Supp. 121 (W.D. Tenn. 1977) (granting summary judgment on failure to warn claim brought by plaintiff who suffered a stroke as a result of her use of defendant's birth control pills because warning provided to physician that specifically warned of the risk of stroke was adequate as a matter of law); Weinberger v. Bristol-Myers Co., 652 F. Supp. 187 (D. Md. 1986) (warning provided to learned intermediary is legally adequate if it explains the risk which allegedly caused the plaintiff's injury).

Consistent with the principles outlined above, courts have similarly found that the warnings accompanying a medical device may be adequate as a matter of law. The plaintiff in Adams v. Synthes Spine Co., LP, 298 F.3d 1114 (9th Cir. 2002) sued Synthes for various causes of action, including failure to warn, after the Synthes plate that had been implanted in her cervical spine broke. It was undisputed that the warning Synthes provided in its package insert specifically warned of the possibility of plate breakage. Nevertheless, plaintiff alleged that the warning was inadequate because: 1) it failed to warn the plaintiff of the risk of breakage, and 2) although the warning recommended that the plate be removed if it breaks, the warning with respect to removal was inadequate because most physicians did not remove the plates after they broke. The court rejected plaintiff's argument and found that the warning was adequate as a matter of law. In support of its ruling, the court noted that “[t]here isn't any evidence in the record from which reasonable jurors could conclude that the warning was inadequate. It plainly said that the plate could break and that the manufacturer recommended removal.” Id. at 1118. After so finding, the court affirmed the trial court's grant of summary judgment to Synthes on plaintiffs' failure to warn claim. See also Cather, 753 F. Supp. at 640 (applying the learned intermediary doctrine to a medical device case and finding “[a] warning may be held adequate as a matter of law where the adverse effect that was ultimately visited upon the patient was one that the manufacturer specifically warned against”).

Similarly, in Ellis v. C.R. Bard, Inc., 311 F.3d 1272 (11th Cir. 2002), the Eleventh Circuit held that where the device defendant's warning to the learned intermediary specifically warns of the adverse effect allegedly sustained by the patient, the defendant's warning is adequate as a matter of law. In Ellis, plaintiff's mother died from an alleged overdose of morphine that was administered following surgery when the decedent's family members, rather than the decedent, activated the Patient Controlled Analgesia Infusion Pump (“PCA”) that administered morphine to the decedent. Id. Although neither the PCA pump itself nor its user's manual warned about the dangers of third-party activation, the pump manufacturer's sales force and its distributor educated the hospital staff “about the risk of third-party activation and provided patient brochures to the [hospital] staff advising that only the patient should press the PCA button.” Id. at 1277. In addition, the health care providers caring for decedent testified that they were aware that only the patient should activate the pump. Id. Under these facts, the court affirmed summary judgment for the defendant on the failure to warn claim and rejected plaintiff's claim that there was a jury issue regarding the sufficiency of the warnings because the manufacturer warned of the danger complained of ' namely third-party pump activation. Id. at 1281. In support of its ruling, the court noted that: 1) the manufacturer provided warnings related to third-party activation of the pump, 2) the risks associated with third-party activation were well known to the medical community, and 3) at the time of decedent's injuries, her doctors and nurses had actual knowledge of the dangers of those risks. Id. at 1283 n.8.

Adequate Warning Need Not Indicate the Incidence or Frequency of a Side Effect Or Complication

Where the defendants' warning specifically warns of the complication or risk sustained by the plaintiff, plaintiffs attempt to defeat summary judgment by arguing that the warning is inadequate because it fails to warn of the incidence or frequency of the complication. Such attempts, however, fail, because there is no legal requirement that a warning provided to a learned intermediary contain information on the incidence or frequency of the complication or side effect. In the previously cited cases, including Percival, Ellis, Adams, Rolen, Dunkin, Weinberger, and Cather, none of the warnings provided information on the incidence or frequency of the condition of which plaintiff complained. Nevertheless, all of those courts found that the warnings provided were adequate as a matter of law. Furthermore, in Calabrese v. Trenton State College, 392 A.2d 600, 604 (N.J. Super. Ct. App. Div. 1978), the court addressed this exact position and found that       “[p]laintiff's central argument that a drug manufacturer's warnings must, as a matter of law, include not only information concerning undesirable side effects of the drug it is marketing but, as well, statistical information concerning the incidence of the condition for which the drug can be used, is without merit.” Thus, the failure to include the incidence of the risk does not create a jury issue about the adequacy of the drug or medical device defendant's warning that precludes summary judgment.

Defendants Are Entitled to Summary Judgment If the Prescribing Doctor Knows of the Risk

Even if the warning does not warn of the risk complained of, defendants are still entitled to summary judgment on plaintiff's failure to warn claim if they can show that the treating physician knew of the risks complained of at the time he or she prescribed the drug or device. In order to state a claim for failure to warn, the plaintiff must not only show that the warning was inadequate, but must also show that the inadequate warning proximately caused his or her injuries. In order to satisfy this burden of proof in a case involving the application of the learned intermediary doctrine, the plaintiff must prove:

that the manufacturer's failure to warn the physician was the proximate cause of the injuries to the plaintiff. In other words, the plaintiff must show that the physician would not have used the device in question if he or she had been warned by the manufacturer of its risks. A physician's independent awareness of those risks thus disrupts probable cause and obviates any liability for a manufacturer's failure to warn. Edgar v. Danek Med., Inc., No. 96-2451-CIV-T-24A, 1999 WL 1054864, at *6 (M.D. Fla. Mar. 31, 1999) (emphasis added).

See also Minisan v. Danek Med., Inc., 79 F. Supp. 2d 970, 978-79 (N.D. Ind. 1999) (In a case involving application of the learned intermediary doctrine, “a plaintiff must not only show that a manufacturer's warning was inadequate, but that such inadequacy affected the prescribing physician's use of the product and thereby injured the plaintiff.”); In re Norplant Contraceptive Prods. Liab. Litig., 215 F. Supp. 2d 795, 823 (E.D. Tex. 2002) (“[E]ven assuming the warnings are inadequate, Plaintiffs 'must show that a proper warning would have changed the decision of the treating physician, ie, that but for the inadequate warning, the treating physician would not have used or prescribed the product'”); Hall v. Merck, Sharp & Dohme, 774 F. Supp. 604, 607 (D. Kansas 1991) (“[w]here it is uncontroverted that the prescribing physician is aware of the risks associated with a drug, courts have consistently held that a drug manufacturer is entitled to summary judgment”).

Consistent with the above principles, courts have routinely granted summary judgment on plaintiffs' failure to warn claims where the treating physician had knowledge of the risk or side effect plaintiff sustained because such knowledge breaks the causal chain between the allegedly inadequate warning and the physician's decision to use the drug or device. In Felix v. Hoffmann-LaRoche, Inc., 540 So. 2d 102 (Fla. 1989), plaintiff alleged that defendant failed to provide adequate warnings related to the potential of Accutane to cause birth defects in the children of women who used the drug while pregnant. In affirming summary judgment on plaintiff's failure to warn claim, the Florida Supreme Court noted:

even if it could be said that there was a factual dispute concerning the adequacy of the warning, any breach of the duty to warn in this case could not have been the proximate cause of the damage. The court [of appeal] reached this conclusion because the prescribing physician testified that he fully understood the warnings and also had prior knowledge of the teratogenic propensity of Accutane. Therefore, we agree that any inadequacy in the Accutane warning could not have been the proximate cause of the birth defects in this case. Id. at 105.

Similarly, in Muller v. Synthes Corp., No. 99 C 1492, 2002 WL 460827 (N.D. Ill. Mar. 26, 2002), the court granted summary judgment for defendant on plaintiff's failure to warn claim in a case involving a medical device because plaintiff's physician knew of the risk of plate breakage independent of the Synthes warning. See also Wheat v. Sofamor, S.N.C., 46 F. Supp. 2d 1351, 1364 (N.D. Ga. 1999) (granting summary judgment on failure to warn claim in a case involving medical device and application of the learned intermediary doctrine where “[e]ach of the plaintiffs' treating physicians testified that he was aware of the risks associated with spinal implant surgery, that such risks were well known in the medical community, and that he would have taken the same course of action in spite of the information Plaintiffs contend should have been provided”).

Obtaining Summary Judgment under the Learned Intermediary Doctrine

As the cases cited above show, the learned intermediary doctrine is alive and well and is an important vehicle for obtaining summary judgment on failure to warn claims. Attorneys representing medical device and pharmaceutical defendants in products liability actions involving failure to warn claims should seek summary judgment on such claims early in the case. Even before discovery is complete, counsel may be able to obtain summary judgment with deposition testimony or an affidavit from the treating physician showing that the condition or complication complained of was specifically warned against in the package insert or other warnings provided by the defendant. Even if the plaintiff's specific injury or complication is not specifically warned against, a defendant may still obtain summary judgment with an affidavit or deposition testimony from the treating physician showing: 1) the risks complained of were well known in the medical community, and 2) the risks complained of were known to the treating physician before he or she prescribed the drug or utilized the device. Overall, it is important to keep the learned intermediary defense in mind when conducting discovery of treating physicians and experts in order to establish the facts and evidence needed for obtaining summary judgment on failure to warn claims.

The learned intermediary doctrine is one of the most important doctrines for medical device and pharmaceutical drug defendants in product liability cases because under the doctrine, they are often able to obtain summary judgment on failure to warn claims. (The learned intermediary doctrine has been adopted and recognized in at least 45 states. See Larkin v. Pfizer, Inc ., 153 S.W.3d 758, 767 (Ky. 2005).) The learned intermediary doctrine provides that a manufacturer, designer or distributor of a medical device or pharmaceutical drug does not have a duty to directly warn patients of possible dangers associated with the use of the device or drug. See Presto v. Sandoz Pharm. Corp ., 487 S.E.2d 70 (Ga. Ct. App. 1997). Rather, “'a warning as to possible danger in its use to the prescribing physician is sufficient.'” Id. at 73. As noted in Restatement (Third) of Torts:

The rationale supporting this 'learned intermediary' rule is that only health-care professionals are in a position to understand the significance of the risks involved and to assess the relative advantages and disadvantages of a given form of prescription-based therapy. The duty then devolves on the health-care provider to supply to the patient such information as is deemed appropriate under the circumstances so that the patient can make an informed choice as to therapy. Restatement (Third) of Torts: Prods. Liab. '6 cmt. b.

In addition, courts throughout the country have noted that the learned intermediary doctrine is a sound and rational doctrine because: 1) “manufacturers lack effective means to communicate directly with each patient” and 2) “imposing a duty to warn upon the manufacturer would unduly interfere with the physician-patient relationship.” Larkin v. Pfizer, Inc., 153 S.W.3d 758, 764 (Ky. 2005). Consistent with these policies, courts have found that the learned intermediary doctrine applies not only to pharmaceutical drugs, but to medical devices as well, because medical devices are available only upon “prescription, application (insertion) and supervision of a physician.” Lance v. Am. Edwards Labs ., 452 S.E.2d 185, 186 (Ga. Ct. App. 1994). See also Cather v. Catheter Tech. Corp., 753 F. Supp. 634, 640 (S.D. Miss. 1991).

Plaintiffs often attempt to circumvent the learned intermediary doctrine and defeat summary judgment on failure to warn claims by arguing that there is an issue of fact as to whether the warning the pharmaceutical or medical device defendant provided physicians was “adequate.” Courts, however, have consistently rejected such attempts and have held that defendants' warnings to physicians may be declared adequate as a matter of law.

Warnings Mentioning the Risk Complained of Are Adequate As a Matter of Law

Courts throughout the nation have found that where the warning provided by the pharmaceutical drug defendant to the physician specifically mentions the circumstances complained of, the warning is adequate as a matter of law. In Percival v. Am. Cyanamid Co., 689 F. Supp. 1060 (W.D. Okla. 1987), plaintiffs sued the manufacturer of a DTP vaccine for various causes of action, including failure to warn, after their son developed severe and permanent neurological damage as a result of an adverse reaction to the DTP vaccine. Id. at 1061. In granting summary judgment for defendant on the failure to warn claim, the court initially found that under the learned intermediary doctrine, the manufacturer was only required to warn the physician, and not the patient, of the dangers associated with the vaccine. Id. at 1063. The court then reviewed the contents of the warning to determine whether the warning provided to the physician was adequate. Although the court stated that the question of the adequacy of a warning is ordinarily a question of fact for the jury, it found that under the facts of the case, the warning was adequate as a matter of law because it warned that use of the vaccine could result in neurological disorders and permanent brain damage, the very injuries suffered by plaintiffs' son. Because the warning was adequate as a matter of law, the court granted summary judgment to the vaccine manufacturer on plaintiffs' failure to warn claim. See also Rolen v. Burroughs Wellcome Co ., 856 S.W.2d 607 (Tex. App. 1993) (affirming summary judgment on failure to warn claim because warning provided to learned intermediaries that mentioned risk of Stevens-Johnson syndrome, the allergic reaction plaintiff developed following use of defendant's pharmaceutical drug, was adequate as a matter of law); Dunkin v. Syntex Labs., Inc., 443 F. Supp. 121 (W.D. Tenn. 1977) (granting summary judgment on failure to warn claim brought by plaintiff who suffered a stroke as a result of her use of defendant's birth control pills because warning provided to physician that specifically warned of the risk of stroke was adequate as a matter of law); Weinberger v. Bristol-Myers Co., 652 F. Supp. 187 (D. Md. 1986) (warning provided to learned intermediary is legally adequate if it explains the risk which allegedly caused the plaintiff's injury).

Consistent with the principles outlined above, courts have similarly found that the warnings accompanying a medical device may be adequate as a matter of law. The plaintiff in Adams v. Synthes Spine Co., LP , 298 F.3d 1114 (9th Cir. 2002) sued Synthes for various causes of action, including failure to warn, after the Synthes plate that had been implanted in her cervical spine broke. It was undisputed that the warning Synthes provided in its package insert specifically warned of the possibility of plate breakage. Nevertheless, plaintiff alleged that the warning was inadequate because: 1) it failed to warn the plaintiff of the risk of breakage, and 2) although the warning recommended that the plate be removed if it breaks, the warning with respect to removal was inadequate because most physicians did not remove the plates after they broke. The court rejected plaintiff's argument and found that the warning was adequate as a matter of law. In support of its ruling, the court noted that “[t]here isn't any evidence in the record from which reasonable jurors could conclude that the warning was inadequate. It plainly said that the plate could break and that the manufacturer recommended removal.” Id. at 1118. After so finding, the court affirmed the trial court's grant of summary judgment to Synthes on plaintiffs' failure to warn claim. See also Cather, 753 F. Supp. at 640 (applying the learned intermediary doctrine to a medical device case and finding “[a] warning may be held adequate as a matter of law where the adverse effect that was ultimately visited upon the patient was one that the manufacturer specifically warned against”).

Similarly, in Ellis v. C.R. Bard, Inc., 311 F.3d 1272 (11th Cir. 2002), the Eleventh Circuit held that where the device defendant's warning to the learned intermediary specifically warns of the adverse effect allegedly sustained by the patient, the defendant's warning is adequate as a matter of law. In Ellis, plaintiff's mother died from an alleged overdose of morphine that was administered following surgery when the decedent's family members, rather than the decedent, activated the Patient Controlled Analgesia Infusion Pump (“PCA”) that administered morphine to the decedent. Id. Although neither the PCA pump itself nor its user's manual warned about the dangers of third-party activation, the pump manufacturer's sales force and its distributor educated the hospital staff “about the risk of third-party activation and provided patient brochures to the [hospital] staff advising that only the patient should press the PCA button.” Id. at 1277. In addition, the health care providers caring for decedent testified that they were aware that only the patient should activate the pump. Id. Under these facts, the court affirmed summary judgment for the defendant on the failure to warn claim and rejected plaintiff's claim that there was a jury issue regarding the sufficiency of the warnings because the manufacturer warned of the danger complained of ' namely third-party pump activation. Id. at 1281. In support of its ruling, the court noted that: 1) the manufacturer provided warnings related to third-party activation of the pump, 2) the risks associated with third-party activation were well known to the medical community, and 3) at the time of decedent's injuries, her doctors and nurses had actual knowledge of the dangers of those risks. Id. at 1283 n.8.

Adequate Warning Need Not Indicate the Incidence or Frequency of a Side Effect Or Complication

Where the defendants' warning specifically warns of the complication or risk sustained by the plaintiff, plaintiffs attempt to defeat summary judgment by arguing that the warning is inadequate because it fails to warn of the incidence or frequency of the complication. Such attempts, however, fail, because there is no legal requirement that a warning provided to a learned intermediary contain information on the incidence or frequency of the complication or side effect. In the previously cited cases, including Percival, Ellis, Adams, Rolen, Dunkin, Weinberger, and Cather, none of the warnings provided information on the incidence or frequency of the condition of which plaintiff complained. Nevertheless, all of those courts found that the warnings provided were adequate as a matter of law. Furthermore, in Calabrese v. Trenton State College , 392 A.2d 600, 604 (N.J. Super. Ct. App. Div. 1978), the court addressed this exact position and found that       “[p]laintiff's central argument that a drug manufacturer's warnings must, as a matter of law, include not only information concerning undesirable side effects of the drug it is marketing but, as well, statistical information concerning the incidence of the condition for which the drug can be used, is without merit.” Thus, the failure to include the incidence of the risk does not create a jury issue about the adequacy of the drug or medical device defendant's warning that precludes summary judgment.

Defendants Are Entitled to Summary Judgment If the Prescribing Doctor Knows of the Risk

Even if the warning does not warn of the risk complained of, defendants are still entitled to summary judgment on plaintiff's failure to warn claim if they can show that the treating physician knew of the risks complained of at the time he or she prescribed the drug or device. In order to state a claim for failure to warn, the plaintiff must not only show that the warning was inadequate, but must also show that the inadequate warning proximately caused his or her injuries. In order to satisfy this burden of proof in a case involving the application of the learned intermediary doctrine, the plaintiff must prove:

that the manufacturer's failure to warn the physician was the proximate cause of the injuries to the plaintiff. In other words, the plaintiff must show that the physician would not have used the device in question if he or she had been warned by the manufacturer of its risks. A physician's independent awareness of those risks thus disrupts probable cause and obviates any liability for a manufacturer's failure to warn. Edgar v. Danek Med., Inc., No. 96-2451-CIV-T-24A, 1999 WL 1054864, at *6 (M.D. Fla. Mar. 31, 1999) (emphasis added).

See also Minisan v. Danek Med., Inc., 79 F. Supp. 2d 970, 978-79 (N.D. Ind. 1999) (In a case involving application of the learned intermediary doctrine, “a plaintiff must not only show that a manufacturer's warning was inadequate, but that such inadequacy affected the prescribing physician's use of the product and thereby injured the plaintiff.”); In re Norplant Contraceptive Prods. Liab. Litig., 215 F. Supp. 2d 795, 823 (E.D. Tex. 2002) (“[E]ven assuming the warnings are inadequate, Plaintiffs 'must show that a proper warning would have changed the decision of the treating physician, ie, that but for the inadequate warning, the treating physician would not have used or prescribed the product'”); Hall v. Merck, Sharp & Dohme , 774 F. Supp. 604, 607 (D. Kansas 1991) (“[w]here it is uncontroverted that the prescribing physician is aware of the risks associated with a drug, courts have consistently held that a drug manufacturer is entitled to summary judgment”).

Consistent with the above principles, courts have routinely granted summary judgment on plaintiffs' failure to warn claims where the treating physician had knowledge of the risk or side effect plaintiff sustained because such knowledge breaks the causal chain between the allegedly inadequate warning and the physician's decision to use the drug or device. In Felix v. Hoffmann-LaRoche, Inc., 540 So. 2d 102 (Fla. 1989), plaintiff alleged that defendant failed to provide adequate warnings related to the potential of Accutane to cause birth defects in the children of women who used the drug while pregnant. In affirming summary judgment on plaintiff's failure to warn claim, the Florida Supreme Court noted:

even if it could be said that there was a factual dispute concerning the adequacy of the warning, any breach of the duty to warn in this case could not have been the proximate cause of the damage. The court [of appeal] reached this conclusion because the prescribing physician testified that he fully understood the warnings and also had prior knowledge of the teratogenic propensity of Accutane. Therefore, we agree that any inadequacy in the Accutane warning could not have been the proximate cause of the birth defects in this case. Id. at 105.

Similarly, in Muller v. Synthes Corp. , No. 99 C 1492, 2002 WL 460827 (N.D. Ill. Mar. 26, 2002), the court granted summary judgment for defendant on plaintiff's failure to warn claim in a case involving a medical device because plaintiff's physician knew of the risk of plate breakage independent of the Synthes warning. See also Wheat v. Sofamor, S.N.C. , 46 F. Supp. 2d 1351, 1364 (N.D. Ga. 1999) (granting summary judgment on failure to warn claim in a case involving medical device and application of the learned intermediary doctrine where “[e]ach of the plaintiffs' treating physicians testified that he was aware of the risks associated with spinal implant surgery, that such risks were well known in the medical community, and that he would have taken the same course of action in spite of the information Plaintiffs contend should have been provided”).

Obtaining Summary Judgment under the Learned Intermediary Doctrine

As the cases cited above show, the learned intermediary doctrine is alive and well and is an important vehicle for obtaining summary judgment on failure to warn claims. Attorneys representing medical device and pharmaceutical defendants in products liability actions involving failure to warn claims should seek summary judgment on such claims early in the case. Even before discovery is complete, counsel may be able to obtain summary judgment with deposition testimony or an affidavit from the treating physician showing that the condition or complication complained of was specifically warned against in the package insert or other warnings provided by the defendant. Even if the plaintiff's specific injury or complication is not specifically warned against, a defendant may still obtain summary judgment with an affidavit or deposition testimony from the treating physician showing: 1) the risks complained of were well known in the medical community, and 2) the risks complained of were known to the treating physician before he or she prescribed the drug or utilized the device. Overall, it is important to keep the learned intermediary defense in mind when conducting discovery of treating physicians and experts in order to establish the facts and evidence needed for obtaining summary judgment on failure to warn claims.