Prescription Drug Overpromotion
Posted in on January 30, 2014
By Mark P. Robinson, Jr. and Kevin F. Calcagnie
Introduction
The core issues in the vast majority of products liability cases involving prescription pharmaceuticals concern the adequacy of warnings. A plaintiff is required to prove not only that the warnings accompanying the drug were inadequate, but that the inadequacy was a legal cause of the doctor’s decision to prescribe the drug. In other words, the plaintiff must prove that the physician would not have prescribed the drug if an adequate warning had been provided. This is sometimes referred to as “warning causation.” See e.g. Thomas v. Hoffman-LaRoche, Inc., 949 F.2d 806, 812 (5th Cir.1992).
If the warnings were adequate, and a prescribing physician testifies the he or she was fully aware of the risks involved and would have prescribed the drug regardless of a better warning, the plaintiff may be out of luck. Under such circumstances, courts in some jurisdictions are not reluctant to grant summary judgment. Even if the plaintiff survives summary judgment juries may to render a defense verdict where the doctor testifies that a better warning would not have changed his mind about prescribing the drug.
One method of addressing this hurdle to demonstrate that the warnings accompanying the drug have been rendered ineffective by the manufacturer’s overpromotion, whether by direct communication from sales representatives, or indirectly through representations to the medical community. Courts in several jurisdictions have recognized that overpromotion of a drug through a vigorous sales program can have the effect of eroding or nullifying warnings, causing physicians to disregard them.
Overpromotion was an issue in Barnett v. Merck, the first federal court jury verdict for a plaintiff in a case involving the prescription drug Vioxx. On August 17, 2006 a New Orleans jury awarded $51,000,000 in a personal injury action against Merck, the maker of Vioxx. Prior to deliberations, the court instructed the jury as follows:
In order to prove his failure to warn claim, the Plaintiff must not only show that Merck’s warnings regarding Vioxx were inadequate, but also that such inadequacy affected the decision of his prescribing physicians to prescribe or not to prescribe Vioxx. In other words, the Plaintiff must show that his doctors would not have prescribed Vioxx to him if Merck had provided an adequate warning. An adequate warning to the profession may be eroded or even nullified by overpromotion of the drug through a vigorous sales program which may have the effect of persuading the prescribing physicians to disregard the warnings given.
This article will discuss the overpromotion theory, how it relates to the fundamental issues in pharmaceutical litigation, and how it opens the door for the admissibility of evidence relating to sales, marketing, and profits on the issues of adequacy of warnings and warning causation.
Failure to Warn and the Learned Intermediary Doctrine
Because most jurisdictions follow comment k to the Restatement Second of Torts, which has been interpreted to proscribe prohibits liability for design defects where the product is a prescription drug, (see e.g. Brown v. Superior Court (1988) 44 Cal.3d 1049, 1069, 245 Cal.Rptr. 412, 751 P.2d 470) the vast majority of claims in pharmaceutical products liability litigation are based upon some form of failure to warn regarding the risks associated with the use of the product. These are typically asserted through causes of action for strict liability as well as negligence. Additionally, causes of action are sometimes asserted for fraud, deceit and negligent misrepresentation in connection with a manufacturer’s public disclosures or non-disclosures about the dangers of the drug in question. Also, because most jurisdictions follow the learned intermediary doctrine, the question of the adequacy of warnings is usually limited to their adequacy for the physician, and not for the consumer.
The learned intermediary doctrine is a common law rule adopted in almost every jurisdiction which provides that “a prescription-drug manufacturer fulfills its duty to warn of a drug’s potentially harmful effects by informing the prescribing physician, rather than the end user, of those effects.” Stated another way, a drug manufacturer is excused from warning each patient who receives the product when the manufacturer properly warns the prescribing physician of the product’s dangers. (Porterfield v. Ethicon, Inc., 183 F.3d 464, 467-68 (5th Cir.1999)) The doctrine operates as an exception to the manufacturer’s duty to warn the ultimate consumer and shields manufacturers from liability where the warning to the prescribing physician is adequate. (Tracy v. Merrell Dow Pharmaceuticals, Inc., 58 Ohio St.3d 147, 569 N.E.2d 875 (1991)) See Carlin v. Superior Court (1996) 13 Cal.4th 1104, 1116, 56 Cal.Rptr.2d 162, 920 P.2d 1347, (“Moreover, in the case of prescription drugs, the duty to warn runs to the physician, not to the patient.”) citing Stevens v. Parke, Davis & Co. (1973) 9 Cal.3d 51, 65, 107 Cal.Rptr. 45, 507 P.2d 653 (“In the case of medical prescriptions, ‘if adequate warning of potential dangers of a drug has been given to doctors, there is no duty by the drug manufacturer to insure that the warning reaches the doctor’s patient for whom the drug is prescribed.”)
The underlying premise of the doctrine is that patients rely on their doctors’ expert judgment-not any materials included on the label or in the drug packaging-when deciding which drugs to use and how to use them. ( In re Meridia Products Liability Litigation, 328 F.Supp.2d 791, 810 (N.D.Ohio 2004)) “[M]anufacturers of prescription drugs have a duty to warn prescribing physicians of the drugs’ known dangerous propensities, and the physicians, in turn, using their medical judgment, have a duty to convey the warnings to their patients.” (Kirk v. Michael Reese Hosp. and Medical Center, 117 Ill.2d 507, 513 N.E.2d 387(Ill. 1987))
While drug manufacturers must warn the ultimate purchasers about the dangers inherent in drugs sold over the counter, where the doctrine applies the manufacturer need not warn the individual consumer about the dangers of prescription drugs. The manufacturer is required to warn only the prescribing physician, who then acts as a ‘learned intermediary’ between the manufacturer and the consumer. (Happel v. Wal-Mart Stores, Inc., 199 Ill.2d 179, 766 N.E.2d 1118, 1126(Ill. 2002)) Unlike warnings related claims in most products liability actions, the adequacy of the warning is judged according to its adequacy for the physician, and not the user of the product. Also, the issue of causation insofar as it concerns the effect of the inadequacy upon the use of the product, centers upon the physician’s knowledge and decision making process, and not the consumer’s.
Warning Causation and the Burden of Proof
In order to recover for a failure to warn, a plaintiff must typically prove: (1) that the product warnings given by the drug manufacturer to healthcare providers are inadequate; and (2) that those inadequate warnings were a producing cause of and/or proximately caused the plaintiff’s subsequent injuries. (Porterfield v. Ethicon, Inc., 183 F.3d 464, 468 (5th Cir.1999)). If the physician would have prescribed the product regardless of an adequate warning, the inadequacy of the warning is not a legal cause of the injury. (Stewart v. Janssen Pharmaceutica, Inc., 780 S.W.2d 910, 912 (Tex. Ct.App. 1989)) Therefore, in products liability litigation involving prescription pharmaceuticals, defendants will usually contend that the warnings provided were adequate for the physician, and that even if a different or better warning had contained the information allegedly absent from the warnings already with the product, the physician’s decision to prescribe the drug would have been the same regardless.
An adequate warning to physicians has been defined as one “sufficient to apprise the general practitioner as well as the ‘unusually sophisticated medical man’ of the dangerous propensities of the drug.” (Parke-Davis & Co. v. Stromsodt, 411 F.2d 1390, 1400 (8th Cir.1969)). Defendants will usually argue that warnings for physicians need not contain detailed information regarding risks. (In re Meridia Products Liability Litigation, 328 F.Supp.2d 791 (N.D.Ohio 2004)(summary judgment granted even though warning did not ‘detail the scope of the danger’)(‘Physicians are well aware of the scope of the risks associated with increased blood pressure and do not need specifics regarding the possible consequences of blood pressure increases.’ Id at 812.)) However, a manufacturer’s duty is to warn of all potential dangers in its prescription drugs that it knew or should have known to exist, and a warning must be correct, complete, and fully descriptive, and it must convey updated information as to all of the drug’s known side effects. ((Martin v. Hacker, 83 N.Y.2d 1, 11, 607 N.Y.S.2d 598, 628 N.E.2d 1308 (1993); Krasnopolsky v. Warner-Lambert Co., 799 F.Supp. 1342, 1345-46 (E.D.N.Y.1992) (manufacturer’s duty to warn of all potential dangers “is a continuous one, and requires that the manufacturer be aware of the current information concerning the safety of its product.”)) A warning must also have clarity so that the language of the warning is “direct, unequivocal and sufficiently forceful to convey the risk.” (Martin supra, 83 N.Y.2d, at 11)
Merely mentioning a possible injury or adverse effect is not necessarily adequate. (Stahl v. Novartis Pharms. Corp., 283 F.3d 254, 267 (5th Cir.2002)) Just because the manufacturer discloses a particular risk of injury will not absolve the defendant from liability if the degree of risk is not sufficiently conveyed. (McDonnell v. Chelsea Mfrs., Inc., 259 A.D.2d 674, 676, 687 N.Y.S.2d 172, 1999 N.Y. Slip Op. 02491 (N.Y.A.D. 2 Dept. 1999)(Summary judgment denied where competing affidavits raised issues of fact as to whether the warnings were “accurate, clear, [and] consistent on [their] face, and whether [they] portray[ed] with sufficient intensity the risk involved in taking the drug.”))
What the Prescribing Physician Would Have Done
In addition to establishing that the warnings were inadequate, many jurisdictions require that the plaintiff demonstrate that the physician would not have prescribed the drug if an adequate warning had been provided. To meet the burden of proof on warning causation, a plaintiff may introduce either objective evidence of how a reasonable physician would have responded to an adequate warning, (Hermes v. Pfizer, Inc., 848 F.2d 66, 69-70 (5th Cir.1988)), or subjective evidence of how the treating physician would have responded. (Stanback v. Parke, Davis & Co., 657 F.2d 642, 645 (4th Cir.1981)) Accordingly, a jury can consider both the physician’s testimony as well as expert testimony regarding the adequacy and effect of the warnings. The physician’s testimony is not in and of itself dispositive on the issues of adequacy of warnings and warnings causation. Even where a doctor testifies he or she appreciated the risks, this does not preclude a finding that the warnings were inadequate, nor does it preclude a finding of causation. In Anderson v. Sandoz Pharmaceuticals Corp., 77 F.Supp.2d 804 (S.D.Tex. 1999) 808-809, the court denied summary judgment, even though the prescribing physician testified that he was aware of the risks and continued to prescribe the drug:
“Despite the wealth of evidence provided by Defendants on this issue, the fact remains that Dr. Holt may not have been fully apprised of all the attendant risks associated with reactive hyperprolactimia patients who take Parlodel. And while Defendants urge the Court to rely exclusively upon that portion of Dr. Holt’s deposition testimony in which he states that at the time he prescribed Parlodel to Ms. Anderson he had ample knowledge from alternative sources about the risks associated with the drug, the Court nevertheless notes other portions of his deposition testimony in which Dr. Holt admits having no knowledge of a variety of studies concerning Parlodel and stroke and myocardial infarction. And, because some of these studies may have been sponsored by Defendant, the Court finds it possible to conclude that Dr. Holt was not in a position to fully appreciate Parlodel’s risks – even through independent knowledge – at the time he prescribed the drug to Ms. Anderson.”
Moreover, even where a risk is disclosed, and even where the prescribing physician testifies he would have still prescribed the drug in light of the risk, liability is not foreclosed. See also McNeil v. Wyeth, 464 F.3d 364, 372-373 (5th Cir. 2006). holding that inadequate labeling could be a producing cause of the injury even if the prescribing physician did not testify he would not have prescribed the drug had a contraindication been given:
“Wilkinson gave conflicting testimony. On the one hand, he stated that he still would have prescribed the drug had he known that the risk was “significant,” but would have alerted the plaintiff to that risk. On the other hand, he testified that he would not have prescribed the drug had its label stated that use for longer than twelve weeks is contraindicated because the risks are significant and the benefits have not been proven. Therefore, McNeil has raised a genuine issue of fact as to whether Wilkinson would have prescribed the drug had the label’s warning been adequate.
Moreover, because Wilkinson testified that he was never informed of the significant risk of tardive dyskinesia associated with long-term Reglan use and that such information certainly would have changed the “risk/benefit analysis” and the conversation he would have had with McNeil about the risks, the inadequate labeling could be a producing cause of the injury even if Wilkinson had never testified that he would not have prescribed Reglan had a contraindication been inserted. Sworn testimony from McNeil establishes that she was never told of the significantly increased risk of tardive dyskinesia with use of Reglan for greater than twelve weeks and that, if she had known of such a risk, she would not have taken Reglan for longer than that.
*8 The doctrine of the “learned intermediary” presupposes that the physician will act as an intermediary. This function includes discussing the cost-benefit ratio with the patient if necessary. Where the physician would have adequately informed a plaintiff of the risks of a disease, had the label been sufficient, but fails to do so on that account, and where the plaintiff would have rejected the drug if informed, the inadequate labeling could be a “producing” cause of the injury, because it effectively sabotages the function of the intermediary.FN6…Reasonable minds can differ on whether not mentioning that the increase in risk for long-term use was significant would be misleading. But this is precisely why that question should go to the jury.”Id at *7-8.
Nevertheless, the physician’s testimony is significant, and may sometimes determine the fate of the case. In re Norplant Contraceptive Products Liability Litigation, 215 F.Supp.2d 795,825 (E.D.Tex. 2002))(partial summary judgment granted where evidence failed to show that any of the healthcare providers cited by plaintiffs were unaware of the 26 side effects listed as ‘adverse reactions.’)(“None of the healthcare providers cited by Plaintiffs state that any additional information regarding the 26 side effects would have altered their decisions to prescribe Norplant.”; Lawson v. Smith and Nephew Richards, Inc., 1999 WL 1129677*7 (N.D.Ga. 1999)(summary judgment granted) (“Here, Plaintiff’s treating physician testified that he was aware of the risks associated with spinal implant surgery, that such risks were well known in the medical community, and, most significantly, that he would have taken the same course of action in spite of the information Plaintiff contends should have been provided.”);Eck v. Parke, Davis & Co., 256 F.3d 1013, (10th Cir. 2001)(Presumption that a proper warning would have been heeded was rebutted where prescribing physician testified that she would have not changed her course of treatment, and would still have prescribed anti-convulsant drug, had warning been provided.)
The Overpromotion Theory and Adequacy of Warnings
Courts around the country have recognized that overpromotion of a drug by the manufacturer may have the effect of watering down and nullifying the warnings accompanying a drug, thereby rendering them inadequate. See Tinnerholm v. Parke, Davis & Co., 285 F.Supp. 432, 451 (S.D.N.Y.1968), mod. 411 F.2d 48 (2 Cir. 1969) (“‘Watering down’ the substance of a warning so as to give false assurance to the medical profession that a drug or biological can be safely administered, thereby minimizing the danger which exists in the use of a product, amounts to an inadequate warning.”), citing Love v. Wolf, 226 Cal.App.2d 378, 38 Cal.Rptr., 183, 197 (1964)) (“[I]f the over-promotion can reasonably be said to have induced the doctor to disregard the warnings previously given, the warning given is thereby withdrawn or canceled.” Id at 398-400.); See also Hill v. Searle Laboratories, a Div. of Searle Pharmaceuticals, Inc., 884 F.2d 1064, 1071 (8th Cir.1989), wherein the court, in noting that “physicians are inundated with information about various prescription drug products,” stated that “the overpromotion by a drug manufacturer may cause the prescribing physician not to rely on the warnings and package inserts associated with a particular drug product.” Id at FN13, citing Holley v. Burroughs Wellcome Co., 318 N.C. 352, 348 S.E.2d 772 (1986) (Expert testimony that failure of the health personnel responsible for decedent’s care failed to recognize malignant hyperthermia syndrome due in part to drug manufacturer’s “over-promotion of these drugs without giving fair balance to the dangers of the drugs,” raised triable issue of fact.) Id at 358-361. According to the court in Caraker v. Sandoz Pharmaceuticals Corp., 172 F.Supp.2d 1018, 1030 ( S.D.Ill. 2001):
“[T]he overpromotion theory is simply that, by over-promoting a product, the over-promoter has de-emphasized or diluted the full effect of the warnings. See Hill v. Searle Laboratories, a Div. of Searle Pharmaceuticals, Inc., 884 F.2d 1064, 1071 n. 3 (8th Cir.1989) (noting that overpromotion by a drug manufacturer may cause the prescribing physician not to rely on the warnings and package inserts associated with a particular drug product); Plummer v. Lederle Laboratories, Div. of American Cyanamid Co., 819 F.2d 349, 358 (2d Cir.1987) (distinguishing Stevens v. Parke, Davis & Co., 9 Cal.3d 51, 107 Cal.Rptr. 45, 507 P.2d 653 (1973), which imposed liability on a drug manufacturer because its overpromotion of a dangerous drug to the medical profession was coupled with a gross minimization of the risk of prescribing the drug in the product warnings); Salmon v. Parke Davis & Co., 520 F.2d 1359, 1363 (4th Cir.1975) (noting that overpromotion nullifies effect of valid warnings); Baldino v. Castagna, 505 Pa. 239, 478 A.2d 807, 810 (1984); Mahr v. G.D. Searle & Co., 72 Ill.App.3d 540, 28 Ill.Dec. 624, 390 N.E.2d 1214, 1238 (1979) (noting that overpromotion evidence is evidence showing that, in marketing the drug in question, the drug manufacturer tried to “play down” the warnings making them ineffective).”
In Salmon v. Parke Davis & Co., 520 F.2d 1359, 1363 (4th Cir.1975), an action against the manufacturer of an antibiotic administered to a child who thereafter developed aplastic anemia, the court reversed summary judgment in favor of the defendant. Although the trial court found the warnings issued by the manufacturer to be adequate as a matter of law, the appellate court found that a jury could infer that the absence of a warning on an advertisement for the drug was a form of overpromotion which nullified the effect of even a valid warning on the package:
“Timothy’s physician had received a calendar advertising chloromycetin, together with a sample package containing a warning about the drug. The district court held that as a matter of law this evidence was insufficient to show overpromotion. Though the evidence is slight, we cannot say that its probative value is wholly lacking. It is 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. A jury could infer, therefore, that the absence of a warning on an advertisement for the use of a drug as potentially dangerous as chloromycetin was a form of overpromotion which nullified the effect of even a valid warning on the package.” Id at 1363-1364.
The court in Salmon cited Stevens v. Parke, Davis & Company, 9 Cal.3d 51, 65, 107 Cal.Rptr. 45, 53, 507 P.2d 653, 661 (1973) (“Although the manufacturer or supplier of a prescription drug has a duty to adequately warn the medical profession of its dangerous properties or of facts which make it likely to be dangerous, an adequate warning to the profession may be eroded or even nullified by overpromotion of the drug through a vigorous sales program which may have the effect of persuading the prescribing doctor to disregard the warnings given.”), and Incollingo v. Ewing, 444 Pa. 263, 282 A.2d 206 (1971) (“We think that whether or not the warnings on the cartons, labels and literature of Parke, Davis in use in the relevant years were adequate, and whether or not the printed words of warning were in effect cancelled out and rendered meaningless in the light of the sales effort made by the detail men, were questions properly for the jury. Action designed to stimulate the use of a potentially dangerous product must be considered in testing the adequacy of a warning as to when and how the product should not be used; if detail men are an effective means of selling a product and explaining its nature, a jury could find that they also afforded an effective medium of conveying a warning.”) Id at 288-289.
One court has even referred to overpromotion as an exception to the learned intermediary doctrine. Nobles v. Astrazeneca Pharmaceuticals, 48 Conn.Supp. 134, 832 A.2d 1241, 1242-1243 (Conn.Super. 2003), an action against the manufacturer of a prescription nasal spray, the defendant moved for summary judgment asserting that the action was barred by the learned intermediary doctrine. In denying the motion, the court found, inter alia, that triable issues existed as to whether the manufacturer had overpromoted the drug:
“Courts have recognized several exceptions to the learned intermediary doctrine that include incidences where the drug is advertised directly to the consumer or where the drug is overpromoted. (citation)…Upon close review of the insert, the court finds that there are disputed issues of fact as to whether proper warning regarding the drug and its proper usage were provided to the treating physician. There are also disputed issues of fact as to whether Astrazeneca overpromoted the drug or directly advertised to the consumer.”
Proof of Warnings Causation Despite Prescriber’s Contrary Testimony
Overpromotion may have a critical impact on the question of warnings causation, particularly where the prescriber’s testimony appears to be in conflict with the failure to warn claims. This is true because even where the prescribing physician’s testimony indicates an awareness of the risks, and an intention to prescribe the drug notwithstanding a better warning, evidence of overpromotion may establish that the conduct of the manufacturer rendered the warnings ineffective. Despite a physicians awareness of a drug’s risks, where overpromotion has affected the prescribing decision, resulting in a lack of awareness of the extent of the risks, or inducing the physician to fail to heed the warnings or ignore risks where sound practice dictates otherwise, the manufacturer may still be liable. In Whitley v. Cubberly, 24 N.C.App. 204, 210 S.E.2d 289 (1974), a wrongful death action involving a prescription drug, the appellate court reversed summary judgment for the manufacturer. Although the prescribing physician testified that he was familiar with the manufacturer’s warnings, the court held that the manufacturer would not be relieved of liability if overpromotion of the drug though a ‘vigorous sales campaign’ should induce a physician to fail to adequately heed the warnings given:
“[W]e find the material insufficient to establish that there is no genuine issue of fact in connection with plaintiff’s allegations that Parke, Davis was negligent in improperly marketing and over-promoting Chloromycetin, in failing to heed warnings given to it about the dangerous properties of Chloromycetin, and in failing to make adequate warnings about the dangerous properties of the drug to the medical profession. That Parke, Davis may have fully complied with all applicable Federal laws in its marketing and labeling of Chloromycetin would not in itself free it of liability for harm caused by use of the drug if it were shown that such use and resulting harm was caused by the Company’s negligent acts in overpromoting the drug, the dangerous properties of which it was aware or in the exercise of due care should have been aware. For example, even though all warnings required by Federal authorities may have been given, such warnings would be insufficient to exonerate Parke, Davis from all liability if over-promotion through a vigorous sales campaign should induce the medical profession in general, and in this case Dr. Cubberly in particular, to fail adequately to heed the warnings given. In the present case, Dr. Cubberly’s deposition discloses that, despite his statement that he was familiar with the manufacturer’s warnings, he was not ‘completely aware’ that there should be periodic blood studies during treatment with the drug nor was he aware of the manufacturer’s warning that ‘to facilitate appropriate studies and observation during therapy, it is desirable that patients be hospitalized.’ Whether the doctor’s lack of awareness was due to negligent over-promotion of the drug by Parke, Davis is not answered by the present record.” Id at 207-208.
In Stevens v. Parke-Davis & Co., (1973) 9 Cal.3d 51, 507 P.2d 653, a wrongful death action, the heirs of a woman who died of aplastic anemia resulting from chloromycetin use, obtained a jury verdict against Parke-Davis. The California Supreme Court affirmed the judgment for plaintiff, even though the prescribing physician testified that he was aware of the dangers:
“Parke, Davis contends, however, that even if it did overpromote the drug, this overpromotion was not the proximate cause of Mrs. Stevens’ death. In support of this contention, it points to testimony of Dr. Beland that he was cognizant of the dangers involved in continuously prescribing Chloromycetin for a patient.FN15 Parke, Davis argues that this testimony establishes as a matter of law that the negligence of Dr. Beland was an intervening cause which exonerated Parke, Davis from liability. (See Magee v. Wyeth Laboratories, Supra, 214 Cal.App.2d at pp. 351-352, 29 Cal.Rptr. 322.)
FN15. Dr. Beland first began prescribing Chloromycetin in 1950. He testified that, at the time the present cause of action arose, he was aware that Chloromycetin had been linked to aplastic anemia in certain cases and that its prolonged administration carried some danger of fatality. Id at 54-55.
…There is adequate circumstantial evidence in the record before us to support a reasonable inference by the jury that Dr. Beland was induced to prescribe the drug for Mrs. Stevens because of Parke, Davis’ overpromotion. Like many others of the profession, he had been exposed to the promotional tactics employed by Parke, Davis. It is reasonable to assume that the company’s efforts consciously or subconsciously influenced him. In addition, plaintiff introduced expert testimony by a physician that the advertising and promotion of the drug ‘played a role’ in inducing physicians to prescribe it when it was not sound practice to do so. The jury could reasonably infer from the above circumstantial evidence that Dr. Beland was induced by the manufacturer’s activities to prescribe the drug and were entitled to reject Dr. Beland’s testimony to the contrary.” Id at 55-56.
In Incollingo v. Ewing, 444 Pa. 263, 282 A.2d 206 (1971), (cited by the court in Salmon v. Parke Davis & Co., 520 F.2d 1359, 1363 (4th Cir.1975)), there were two prescribing physicians. One of them, the initial prescriber, testified that he had received adequate warnings. He also testified ‘that he received no impression, when visited by the Parke, Davis detail men, that Chloromycetin could be used with impunity, was not influenced by salesmanship of the manufacturer in his use of the drug, and was aware that it should be used only in serious cases.’ Id at 213. Nevertheless, the court upheld a jury verdict in favor of the plaintiffs:
“Dr. Cucinotta stated, in effect, that he was adequately warned and understood the dangers and proper use of the drug, while Dr. Levin for his part indicated the contrary. Plaintiffs were allowed over objection to introduce, by expert witnesses, evidence directed to showing a failure to warn the Medical profession. This consisted of the custom and practice of the manufacturer, Parke, Davis, in ‘overpromoting’ its product, primarily through the use of detail men who minimized the dangers of the drug while emphasizing its effectiveness, wide acceptance and use, and lack of certain objectionable side effects associated with other drugs. The question is whether this evidence was properly admitted.
While the question is close, we think the answer is in the affirmative in the setting of this case. The jury *292 was not obliged to believe the oral, uncorroborated testimony of either doctor. The evidence of Parke, Davis’ efforts in promoting the drug would tend to refute Dr. Cucinotta’s testimony in the sense that he may have been influenced by the efforts, perhaps even unconsciously, to prescribe the drug (his memory was vague as to what transpired at visits of detail men to his office); and conversely, it would tend to corroborate and lend credence to Dr. Levin’s testimony that he was so influenced.” Id at 221-222.
Overpromotion Evidence – Marketing, Sales & Profits
In addition to assisting plaintiffs in meeting their burden of proof on the critical issues relating to failure to warn and warning causation, the theory of overpromotion provides a means of obtaining admission of a wide range of evidence, including the defendant’s marketing practices, its sales revenues, and the profit motive behind the defendant’s wrongful conduct. Typically pharmaceutical manufacturing defendants will seek to severely limit or exclude altogether any evidence relating to marketing, sales and profits, arguing that the physicians never heard, read or relied upon such information in making the decision to prescribe the drug. Such evidence should be germane to liability issues such as breach of duty, intentional misrepresentation and punitive damages issues such as willful and reckless disregard for safety. However, this type of evidence takes on additional relevance to the primary elements of proof on failure to warn claims when overpromotion is in issue.
Courts have recognized that in prescription drug products liability cases, evidence demonstrating a profit motive is relevant evidence on issues relating to overpromotion, and ultimately adequacy of warnings. In Mahr v. G.D. Searle & Co., 72 Ill.App.3d 540, 574, 28 Ill.Dec. 624, 390 N.E.2d 1214, 1238 (1979) the plaintiff alleged that the defendant had failed to give adequate warnings of possible side effects in connection with an oral contraceptive. Affirming a jury verdict against the manufacturer, the court rejected the defendant’s arguments regarding the admissibility of various letters, directives and memoranda addressed by Searle to its detailmen were irrelevant and highly prejudicial. The court found that the jury was entitled to consider marketing efforts in its decision on the adequacy of warnings, and noted the ‘motives for profit’ behind the manufacturer’s promotional efforts through its sales force, which were designed to place the drug in the most positive light while downplaying its side effects:
“The plaintiff maintains the exhibits were properly admitted as evidence of Searle’s “overpromotion” of Enovid, and, therefore, relevant to the issue of adequate warning.”…
“The questioned exhibits indicate an aggressive promotional campaign aimed at increased exposure and prescription of Enovid for birth control purposes. The exhibits placed into the hands and minds of the sales force suggestions for marketing the drug only in a most positive light and without much attention to the possible side effects. Given the motives for profit, both for Searle and its commissioned sales representatives, it cannot be said that the information contained in the exhibits did not, to a degree, affect the marketing of Enovid in such manner as to play down or ignore those warnings of dangers available only in writing. That such a manner of marketing was intended and encouraged by Searle is manifested by the exhibits, and it is our opinion that the jury was entitled to consider them in arriving at a decision as to the adequacy of the warnings.”
Likewise, in Love v. Wolf (1964) 226 Cal.App.2d 378, 38 Cal.Rptr. 183, supra, the plaintiff sued a drug manufacturer, alleging that the she had been injured as a result of the overpromotion of a prescription drug. Although the court reversed a judgment entered on a verdict for plaintiff due to the misconduct of plaintiff’s counsel, the court found that proof of sales was relevant to show a motive or reason for the overpromotion:
“Here it cannot be said that the wealth of Parke-Davis was relevant to any issue. Proof of its sales, however, expressed either in grams or dollars, was relevant to show a motive or reason for the alleged over-promotion of the drug, a definite issue in the case.” Id at 389
The court in Stevens v. Parke, Davis & Co., (1973) 9 Cal.3d 51, 107 Cal.Rptr. 45, affirmed a jury verdict against a pharmaceutical manufacturer based upon similar allegations, noting that sales dollar amounts “were admissible to prove a motive of overpromotion.” Id at 72.
In an action based upon fraud, evidence of the defendant’s profits is relevant to demonstrate motive and intent to commit fraud. U.S. v. Amr, 132 Fed.Appx. 632, 2005 WL 1285700 (6th Cir.(Mich.)), 2005 Fed.App. 0434N, 6th Cir.(Mich.), May 25, 2005. (In prosecution for, inter alia, health care fraud and mail fraud evidence establishing the high profit margin defendant earned when he sold power wheelchairs and then billed Medicare was relevant to establish defendant’s motive for committing fraud. “The evidence of the high profit margin that the Defendant earned on selling power wheelchairs was highly relevant to showing why the Defendant, in violation of Medicare rules, steered patients who expressed interest only in lift or manual chairs to purchase power wheelchairs and did not inform the patients that they had a right to lease the chairs…Thus, since the evidence was relevant to establishing the Defendant’s motive, the district court properly admitted the evidence pursuant to Rule 401.”)
Profit motive is also relevant to demonstrate reckless disregard. In re Diet Drugs, 2000 WL 876900 (E.D.Pa., Jun 20, 2000) (“[T]he court specifically notes that its ruling does not preclude Plaintiffs from introducing evidence of the intent of AHP leadership or personnel. In fact, the court recognizes that such evidence could be relevant and, indeed, could be admissible. For example, in a particular civil action, punitive damage claims may bring into play the right of plaintiffs to show what conduct of AHP was in reckless indifference to the health and well being of persons that were targeted for diet drug consumption by reason of a dominating or overriding policy to maximize profits at any cost.” Id at *9.); CSX Transp., Inc. v. Palank, 743 So.2d 556, 560 (Fla. App. 1999) (Evidence presented during punitive damage liability phase of trial that railroad engaged in cutbacks of maintenance employees resulting in savings of $2.4 billion was relevant to wrongful death claim arising out of train derailment. “[D]uring the punitive damage liability phase of the trial, appellee presented evidence showing that CSX and its predecessors engaged in cutbacks of maintenance of way employees from 1981 through 1993, and that these cutbacks resulted in savings of approximately $2.4 billion for the company. CSX contends that the trial court erred in admitting this evidence because it brought information regarding CSX’s wealth before the jury during the liability phase…Evidence of corporate downsizing for profits was relevant to show a motive for CSX continuing such conduct. The evidence of downsizing and the testimony that the limited number of CSX inspectors could not conduct proper inspections of the lengths of track and switches to which they were assigned supports a jury finding of a conscious disregard for the safety of the public.”) (See also Palmer v. A.H. Robins Co., Inc., 684 P.2d 187, 204 (Colo. 1984) (In action involving IUD, evidence that manufacturer hired advertising agency to encourage media publicity favorable to all of its products was relevant to claim for exemplary damages. “This evidence demonstrated a motive on the part of Robins to profit by making exaggerated statements regarding the safety and efficacy of its product.”; Grimshaw v. Ford Motor Co., 119 Cal.App.3d 757, 813,174 Cal.Rptr. 348 (1981) (Affirming award of punitive damages award in product liability action. “There was evidence that Ford could have corrected the hazardous design defects at minimal cost but decided to defer correction of the shortcomings by engaging in a cost benefit analysis balancing human lives and limbs against corporate profits. Ford’s institutional mentality was shown to be one of callous indifference to public safety.”); Bic Pen Corp. v. Carter, 171 S.W.3d 657, 675 (Tex.App. 2005) (Affirming jury verdict including punitive damages in action by burn victim against manufacturer of disposable lighter. “The jury could have listened to such evidence and concluded that Bic had a profit motive for producing lighters with the least child resistance allowable under the federal standards.”)
Manufacturers may argue that such evidence is prohibited under State Farm Mut. Auto. Ins. Co. v. Campbell, 538 U.S. 408, 123 S. Ct. 1513 (2003), which holds that a jury must be instructed “that it may not use evidence of out-of-state conduct to punish a defendant for action that was lawful in the jurisdiction where it occurred.” Id. at 1522-1523, quoting from BMW of North America v. Gore, 517 U.S. 559, 572-573 (1996) (noting that a State “does not have the power ··· to punish [a defendant] for conduct that was lawful where it occurred and that had no impact on [the State] or its residents”.) However, State Farm did not proscribe the introduction of evidence of a party’s wealth. It merely held that the wealth of a defendant cannot justify an otherwise unconstitutional award. “[Wealth] provides an open-ended basis for inflating awards when the defendant is wealthy…That does not make its use unlawful or inappropriate; it simply means that this factor cannot make up for the failure of other factors, such as ‘reprehensibility,’ to constrain significantly an award that purports to punish a defendant’s conduct.” Id. at 427-428, quoting BMW, supra, at 591, 116 S.Ct. 1589. In fact, the Court in BMW of North America, Inc. v. Gore 517 U.S. 559, 116 S.Ct. 1589, 134 L.Ed.2d 809 (1996) stated just the opposite:
“Of course, the fact that the Alabama Supreme Court correctly concluded that it was error for the jury to use the number of sales in other States as a multiplier in computing the amount of its punitive sanction does not mean that evidence describing out-of-state transactions is irrelevant in a case of this kind. To the contrary, as we stated in TXO Production Corp. v. Alliance Resources Corp., 509 U.S. 443, 462, n. 28, 113 S.Ct. 2711, 2722, n. 28, 125 L.Ed.2d 366 (1993), such evidence may be relevant to the determination of the degree of reprehensibility of the defendant’s conduct.” Id. at FN21. See State Farm, supra, at 409-410. (“Lawful out-of-state conduct may be probative when it demonstrates the deliberateness and culpability of the defendant’s action in the State where it is tortious, but that conduct must have a nexus to the specific harm suffered by the plaintiff.”); White v. Ford, 312 F.3d 998, 1014 (9th Cir. 2002)(” Evidence of extraterritorial conduct, such as sales in other states, “may be relevant to the determination of the degree of reprehensibility of the defendant’s conduct…”)
Conclusion
In prescription drug litigation plaintiffs’ counsel should determine if overpromotion of the product potentially affected the decision to prescribe the drug. Regardless of prescribing physician testimony that the risks were known or that the warnings were adequate, overpromotion by the manufacturer and its sales force can result in watering down and nullifying warnings, rendering them inadequate. Where overpromotion of a prescription drug is in issue, evidence relating to sales, marketing and profit motive will often provide essential proof on causes of action based upon failure to warn, as well as misrepresentation, fraud and liability for punitive damages.
Mark P. Robinson Jr. and Kevin F. Calcagnie are partners in the firm of Robinson Calcagnie, Inc. in Newport Beach, California, specializing in products liability litigation. Mr. Robinson was lead trial counsel in Barnett v. Merck, the first successful federal court Vioxx trial, which resulted in a $51 million verdict for the plaintiff.