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Timestamp: 2019-04-18 23:01:27+00:00

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There is no Generic Product Phamaceutical warnings to consumers. Here's why!
WYETH, INC., et al., Defendants and Respondents.
Court of Appeals of California, First District, Division Three.
*94 Law Office of Laurence O. Masson, Laurence O. Masson; Medical Legal Consultants of Washington, Ralph D. Pittle; Public Citizen Litigation Group, Brian S. Wolfman; Center for Constitutional Litigation and Valerie M. Nannery for Plaintiff and Appellant.
Gordon & Rees, Stuart M. Gordon, James R. Reilly, Fletcher C. Alford; Davis Graham & Stubbs and Jeffrey R. Pilkington for Defendant and Respondent Wyeth, Inc.
Hanson Bridgett Marcus Vlahos & Rudy, Merton A. Howard and Jill N. Cartwright for Defendant and Respondent Pliva, Inc.
Tucker Ellis & West, Michael C. Zellers, Peter E. Schnaitman, Richard A. Dean, Kristen L. Mayer and Jade T. Chao for Defendant and Respondent Purepac Pharmaceutical Co.
Goodwin Procter, Elizabeth F. Stone and Jonathan I. Price for Defendant and Respondent Teva Pharmaceuticals, Inc.
Plaintiff Elizabeth Ann Conte developed a serious and irreversible neurological condition. She alleges her condition is due to her long-term consumption of a generic prescription drug, and that the warnings provided by the manufacturers of the drug failed to adequately warn of known dangers resulting from its long-term use. The trial court granted summary judgment in favor of all the manufacturers. Judgment was entered in favor of Wyeth, Inc. (Wyeth), the name-brand manufacturer of the drug, on two grounds: (1) Conte could not show that she or her physician relied upon warnings or product labeling disseminated by Wyeth; and (2) a name-brand pharmaceutical manufacturer owes no duty to individuals who take only generic versions of its product. The court granted summary judgment in favor of three generic manufacturers on grounds of federal preemption and Conte's lack of reliance on their warnings or product labeling.
defendants in these consolidated appeals manufacture and market metoclopramide, which Conte's physician prescribed in its generic and name-brand form, Reglan, to treat her gastroesophageal reflux disease. Wyeth manufactures and markets Reglan. Defendants Purepac Pharmaceutical Company (Purepac), Teva Pharmaceutical USA, Inc. (Teva), and Pliva, Inc. (Pliva), manufacture generic versions of metoclopramide.
Conte developed tardive dyskinesia, a debilitating and incurable neurological disorder. She alleges she developed her condition as a result of taking metoclopramide for almost four years between August 2000 and April 2004. It is undisputed that Conte took only the generic version of the medication, not Reglan. She claims that defendants knew or should have known of a widespread tendency among physicians to misprescribe Reglan and generic metoclopramide for periods of 12 months or longer, even though the medication is only approved for 12 weeks of use, because the drug's labeling substantially understates the risks of serious side effects from extended use.
Her complaint, after various pretrial amendments, asserts claims for fraud, fraud by concealment and negligent misrepresentation against Wyeth; negligence, strict products liability, negligence per se, and breach of express and implied warranties against the generic manufacturers; and medical negligence against her doctor, Robert Elsen, M.D. The crux of Conte's claims against all of the drug company defendants is that she was injuriously overexposed to metoclopramide due to their dissemination of false, misleading and/or incomplete warnings about the drug's side effects.
*96 Purepac successfully moved for summary judgment on the ground that Conte's claims against it are preempted by the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. § 301 et seq.) and its implementing regulations. Pliva and Teva subsequently filed a joint motion for summary judgment on the same basis. While the Pliva/Teva motion was pending, Wyeth moved separately for summary judgment arguing its product information had no causal relationship to Conte's injuries and it owed her no duty of care. Unlike the generic manufacturers, it did not assert that Conte's claims were preempted by federal law. Pliva (but not Purepac or Teva) joined in Wyeth's motion asserting a lack of causation, and argued Conte could not prove any alleged inadequacies in its own labeling caused her injuries because neither she nor her doctor relied on it.
The court granted Wyeth's motion on both grounds. The court found that neither Conte nor her doctor relied on drug information provided by Wyeth, and that as a name-brand manufacturer, Wyeth owes no duty of care to the users of generic versions of its name-brand drug. The court subsequently granted the Pliva/Teva summary judgment motion on the ground that Conte's state tort claims were preempted by federal law.
(1) Wyeth and the generic manufacturers market their respective metoclopramide products under the FDCA. Section 505 of the FDCA, title 21 United States Code section 355, forbids the distribution of any new drug unless an application has been approved by the federal Food and Drug Administration (FDA).
Conte's claims against Wyeth are premised on misrepresentations in Wyeth's labeling of Reglan and in a monograph on Reglan it provided for the Physician's Desk Reference (PDR). It is undisputed that Wyeth (or its predecessor in interest) prepared the PDR monograph on Reglan/metoclopramide, which is identical to the FDA-approved package insert. Wyeth contends the trial court correctly ruled that Conte cannot establish causation because she cannot show that her prescribing physician, Dr. Elsen, relied on its allegedly inadequate warnings about Reglan when he planned her treatment. The record, reviewed in accord with the standards required for summary judgment, reveals a factual dispute that refutes Wyeth's contention.
But, there is more. Dr. Elsen's deposition testimony submitted by Conte in opposition to Wyeth's motion raises significant questions about the import of his declaration. Dr. Elsen testified in his deposition that he "probably" read Wyeth's monograph on Reglan in the PDR during his residency training; that the PDR was one of the sources he generally refers to in his clinical practice when he considers prescribing Reglan for his patients; and that he believed the information it contained was accurate. Dr. Elsen also had no recollection of having prescribed Reglan for Ms. Conte, but his lack of recollection testimony is contradicted by pharmacy records and his secretary's testimony. Accordingly, there are disputed factual issues as to both the accuracy of Dr. Elsen's recollection and, even if he did not specifically refer to the PDR when he formulated Conte's treatment, whether information he had previously garnered from the PDR was a substantial factor in his decision to prescribe Reglan for her.
Wyeth relies on Motus v. Pfizer Inc. (C.D.Cal. 2001) 196 F.Supp.2d 984, to demonstrate that Conte cannot show causation. But that case is very different. Victor Motus committed suicide six days after his physician prescribed the *100 antidepressant Zoloft. His widow sued the drug manufacturer for failing to provide adequate warnings in its package insert and marketing materials that use of Zoloft could lead to an increased risk of suicidal behavior. On summary judgment, Pfizer argued that Motus's widow could not prove that inadequate warnings caused her husband's death because his physician testifiedunequivocally that he read neither the package insert nor the PDR entry for Zoloft until after Mr. Motus died. Critically, the plaintiff presented no evidence to dispute Pfizer's showing. (Id. at pp. 989, 996; see also Motus v. Pfizer Inc. (Roerig Div.), supra, 358 F.3d at pp. 660-661 [affirming summary judgment because it was undisputed that the prescribing doctor did not read the manufacturer's information before prescribing the drug].) Here, the evidence is much more equivocal. Conte produced evidence tending to show that Dr. Elsen had probably read the PDR entry for Reglan, believed it to be accurate, and generally would rely on the PDR when he considered prescribing Reglan to his patients. This evidence supports a reasonable inference that Wyeth's PDR product information was a causal factor in Dr. Elsen's decision to treat Conte with metoclopramide and raises a sufficient question of fact to defeat summary judgment on that ground.
Conte readily admits that she took only generic metoclopramide, and not the name-brand Reglan that was made and distributed by Wyeth. She argues that Wyeth can be liable for her injuries because a name-brand manufacturer that disseminates information about its product owes a duty of care to ensure the information's accuracy to any doctor who prescribes the drug in reasonable reliance on that information, even if the patient ends up taking the name-brand product's generic equivalent. Wyeth argues, and the trial court agreed, that it cannot be held liable to Conte for her injuries caused by generic metoclopramide because Wyeth has no duty to users of the generic *101 version of its products, which are produced by other manufacturers. The issue is apparently one of first impression in California.
As a preliminary matter, we reject Wyeth's syllogism premised upon products liability doctrine that (1) this is merely a products liability lawsuit disguised as an action for fraud and misrepresentation; and (2) Conte cannot prevail on a strict products liability claim because Wyeth did not manufacture or sell the product that allegedly caused her injury; so (3) Conte loses. The conclusion would be sound were Conte in fact pursuing a cause of action against Wyeth for strict products liability. But she is not. The complaint alleges that Wyeth made intentional and/or negligent misrepresentations about the safety of metoclopramide, the risks of its long-term use, and the likelihood of its serious side effects. She does not allege that Wyeth is strictly liable because inadequate warnings rendered its product unreasonably dangerous. (See, e.g., Carlin v. Superior Court, supra, 13 Cal.4th at p. 1113.) Rather, she charges that Wyeth failed to use due care when disseminating its product information.
Our decision today is rooted in common sense and California common law. We are not marking out new territory by recognizing that a defendant who authors and disseminates information about a product manufactured and sold by another may be liable for negligent misrepresentation where the defendant should reasonably expect others to rely on that information and the product causes injury, even though the defendant would not be liable in strict products liability because it did not manufacture or sell the product. (See Hanberry v. Hearst Corp. (1969) 276 Cal.App.2d 680 [81 Cal.Rptr. 519] [misrepresentation claim permitted against magazine publisher that endorsed manufacturer's product].) We perceive no logical or legal inconsistency between allowing the suit for negligence and disallowing the suit for strict products liability.
We will analyze Wyeth's duty in context and consider whether a name-brand prescription drug manufacturer in disseminating product warnings owes a duty of care to patients who take a generic version of the drug pursuant to a prescription written in reliance on the name-brand maker's information. The parties cite no California authority directly on point, and our research has disclosed none. However, we do not write on a completely blank slate.
(6) As in Garcia and Randi W., in this case our duty analysis must look primarily to the foreseeability of physical harm. "Although foreseeability is most often a question of fact for the jury, when there is no room for a *105 reasonable difference of opinion it may be decided as a question of law." (Hedlund v. Superior Court (1983) 34 Cal.3d 695, 705 [194 Cal.Rptr. 805, 669 P.2d 41].) This is such a case. (7) In California, as in most states, pharmacists have long been authorized by statute to fill prescriptions for name-brand drugs with their generic equivalents unless the prescribing physician expressly forbids such a substitution. (Bus. & Prof. Code, § 4073;Inwood Laboratories v. Ives Laboratories (1982) 456 U.S. 844, 847-848, fn. 4 [72 L.Ed.2d 606, 102 S.Ct. 2182].) It is therefore highly likely that a prescription for Reglan written in reliance on Wyeth's product information will be filled with generic metoclopramide. And, because by law the generic and name-brand versions of drugs are biologically equivalent (21 U.S.C. § 355(j)(2)(A), (B); see Foster, supra, 29 F.3d at p. 169), it is also eminently foreseeable that a physician might prescribe generic metoclopramide in reliance on Wyeth's representations about Reglan. In this context, we have no difficulty concluding that Wyeth should reasonably perceive that there could be injurious reliance on its product information by a patient taking generic metoclopramide.
We are not persuaded that the application of these factors supports a departure in this case from the general rule that all persons have a duty to use ordinary care to prevent harming others. (See Randi W., supra, 14 Cal.4th at p. 1077.) We have already addressed the issue of foreseeability in the first part of this duty analysis, so we will not belabor the point here. Suffice that a generic metoclopramide user is within Wyeth's range of apprehension of those affected by its Reglan product warning. There is no dispute that Conte suffers from tardive dyskinesia. If it is established that Dr. Elsen relied on Wyeth's product warnings when he prescribed metoclopramide and Conte's long-term use of the medication led to her condition, a close link between Wyeth's nondisclosure of its long-term effects and Conte's condition is readily apparent.
Turning to the next Rowland factor, we cannot assess the moral culpability of Wyeth's conduct on this record. If Wyeth intentionally, or even negligently, excluded a warning from its product information, it may be morally culpable for the resulting harm. On the other hand, it is possible that the information available to Wyeth was so scientifically unsubstantiated that it was not below the standard of care to omit any warning for the product information. While full assessment of this factor must await the outcome of trial, we think one thing is clear: that if Wyeth misrepresented the risks of taking its medication, any moral culpability it might bear for that misrepresentation is not lessened if the person who is harmed by his or her reliance on it happened to ingest the generic version as a result, rather than Wyeth's Reglan brand.
We are unpersuaded by Wyeth's assertion that imposing liability would undermine the goal of preventing future harm because it would chill innovation in the pharmaceutical industry. No evidence was introduced on summary judgment to support this supposition, much less to permit an informed balancing of such a risk against the harm to patients that might be prevented by recognizing a duty of care.
*107 We are also in no position to assess whether holding that Wyeth owed a duty to Conte will subject Wyeth to "permanent and uncontrolled liability" "in perpetuity." Although Wyeth makes the argument, it appears Wyeth no longer has primary responsibility for Reglan-related claims arising after March 31, 2002.
While there is much that could and will be said in various fora about the burdens, societal consequences, cost, and insurance implications of Wyeth's potential liability, the limited record on summary judgment does not provide the information necessary to inform such a debate. These broader consequences of the duty we identify today cannot be considered on the limited facts in the record.
On the record that is before us, we find the conclusion inescapable that Wyeth knows or should know that a significant number of patients whose doctors rely on its product information for Reglan are likely to have generic metoclopramide prescribed or dispensed to them. "In the absence of `overriding policy considerations ... foreseeability of risk [is] of ... primary importance in establishing the element of duty.' [Citations.] As a classic opinion states: `The risk reasonably to be perceived defines the duty to be obeyed.'" (Dillon v. Legg, supra, 68 Cal.2d at p. 739, quoting Palsgraf v. Long Island R. R. Co., supra, 162 N.E. at p. 100.) As the foreseeable risk of physical harm runs to users of both name-brand and generic drugs, so too runs the duty of care, and Wyeth has not persuaded us that consideration of other factors requires a different conclusion. We hold that Wyeth's duty of care in disseminating product information extends to those patients who are injured by generic metoclopramide as a result of prescriptions written in reliance on Wyeth's product information for Reglan.
3. Foster v. American Home Products Corp.
In the absence of California authority directly on point, Wyeth urges us to follow law from other jurisdictions that have rejected the proposition that name-brand drug manufacturers may be liable under theories of misrepresentation for injuries resulting from the use of a generic equivalent. The seminal case principally relied upon by the trial court is Foster, supra, 29 F.3d 165 (see Colacicco v. Apotex, Inc., supra, 432 F.Supp.2d at pp. 540-541).
In Foster, the parents of an infant who died after ingesting generic promethazine sued Wyeth, the name-brand manufacturer of Phenergan. The *108complaint alleged negligence, strict liability, breach of warranty and negligent misrepresentation. (Foster, supra, 29 F.3d at p. 167.) As here, Wyeth moved for summary judgment on all counts on the ground that it did not manufacture the drug given to the plaintiffs' child.
The federal District Court for the District of Maryland granted summary judgment in Wyeth's favor on the negligence, strict liability and breach of warranty counts. As to the plaintiffs' negligent misrepresentation theory, however, the court found it was immaterial that Wyeth did not manufacture the drug the child ingested. The trial court reasoned that Wyeth could be liable for the injury, without reference to any products liability-based theory, if (1) it made false representations about the drug's safety for treating infants; and (2) the prescribing doctor relied on those representations in prescribing generic promethazine. (Foster, supra, 29 F.3d at pp. 167-168.) The Fourth Circuit Court of Appeals reversed. Applying Maryland law, it held the manufacturer of a name-brand prescription drug cannot be held liable under a theory of negligent misrepresentation for an injury arising from the use of a generic version of the drug. Because Foster appears to be the leading case on this issue, we examine its analysis in detail.
As the trial court did in this case, the Foster court first criticized the plaintiffs' negligent misrepresentation claim as an attempted end run around the requirements of products liability law and, specifically, the requirement that the plaintiff must prove the defendant made the injurious product. (Foster, supra,29 F.3d at p. 168.) Echoing this theme, Wyeth maintains that Conte's action is an attempt to "evade ... black-letter California law" by labeling products liability claims as causes of action for negligent and intentional misrepresentation. As we have already explained (see pt. III.B., ante), we do not agree that a suit based on a theory of negligent or intentional misrepresentation is governed by rules developed under the distinct doctrine of strict products liability law. Just because a products liability claim arising from an injury might lie against other parties (Conte concedes that no such claim lies against Wyeth) does not mean that Wyeth has no potential liability for a negligent or intentional tort.
Foster goes on to consider and reject the plaintiffs' argument that they can pursue a negligence claim against Wyeth based on its product labeling *109because, as a name-brand manufacturer, it knows that (1) generic manufacturers simply rely on and duplicate their labeling; and (2) prescriptions for the name-brand drug may be filled with the generic version. Although the court did not dispute these basic factual premises, it concluded that to impose a duty under these circumstances would "stretch the concept of foreseeability too far." (Foster, supra, 29 F.3d at pp. 170-171.) The Fourth Circuit's reasoning for this determination seems circular, and we will not employ it here.
Foster starts its analysis of duty by stating the basic principle that, as in California, foreseeability is the principal determinant of duty where the risk created is one of personal injury. (Foster, supra, 29 F.3d at p. 171; see Dillon v. Legg, supra, 68 Cal.2d at p. 739.) From there, the Foster court observes that the duty required for negligent misrepresentation arises when there is "`such a relation that one party has the right to rely for information upon the other, and the other giving the information owes a duty to give it with care.'" (Foster, supra, at p. 171.) We agree with this formulation of the question as to whether the party who gives the information owes a duty of care to the recipient. But the Foster court's analysis falters in the next step. As foreseeability is the principal determinant of duty, the foreseeability of harm to consumers of the generic drug in reliance on information disseminated about the name-brand version should have some significance in considering whether a duty of care arises in these circumstances. But Foster does not address that point. Instead, it concludes?without further discussion?that no duty lies because "Brandy Foster was injured by a product that Wyeth did not manufacture." (Ibid., italics added.) But that is the very question posed?not the answer.
Foster also supports its holding with various policy reasons that we consider unpersuasive. It reasons it would be unfair to allow misrepresentation actions against name-brand manufacturers for injuries caused by generic drugs because name-brand makers bear the expense of developing, testing, and formulating labeling information for new medications, while generic manufacturers merely "rid[e their] coattails" by duplicating the innovator's successful drugs and labels. (Foster, supra, 29 F.3d at p. 170.) The trial court here agreed: "[i]t also seems unfair to hold the pioneer manufacturer liable as insurer for not only its own production but also its generic competitors, especially when the latter enjoys the full financial benefits but no risk regarding the product." But we do not.
(9) We find the reasoning problematic. As Conte asks, what is unfair about requiring a defendant to shoulder its share of responsibility for injuries caused, at least in part, by its negligent or intentional dissemination of inaccurate information? California law is well established that concurrent *110 tortfeasors whose separate acts contribute to an injury are each liable (5 Witkin, Summary of Cal. Law (9th ed. 1988) Torts, § 49, pp. 116-117), and we see nothing novel or unjust in recognizing application of the rule in the present circumstances. The circumstances certainly do not warrant creating an exception to the general rule of concurrent liability.
We are also reluctant to create an exception to the general rule of duty based on the very limited "fairness" analysis permitted on the summary judgment record before us. While we have no reason to doubt that generic manufacturers do not invest the same time and expense in research and development of their products as innovators (see Foster, supra, 29 F.3d at p. 170), there are countervailing factors that may warrant an outcome on policy analysis that is different than Foster's. For example, the innovator who brings a new drug to market enjoys unique advantages, such as the initial period of patent protection from competition, the fiscal rewards of name brand recognition and the commensurate ability to charge a higher price for its product, even after its exclusive marketing position expires. While Wyeth predicts that holding it subject to the duty to avoid injurious misrepresentations would impose "permanent and uncontrolled liability" "in perpetuity, for all injuries allegedly caused by generic equivalents," these dire consequences are neither self-evident nor substantiated by the record. We also question the trial court's assumption in this case that a generic manufacturer has "no risk" regarding the product, a premise that Foster itself undermines with its holding that generic manufacturers adopt a name-brand manufacturer's warnings and representations at their own risk and are equally responsible for their accuracy. (Foster, supra, 29 F.3d at pp. 170-171.) In sum, we think the policy factors identified and considered in Foster's analysis of the duty question tell less than the full story, and we depart from Foster in declining to find on the limited record before us that they warrant relieving an innovator of responsibility for injuries foreseeably caused by its negligent or intentional misrepresentations.
We are aware that in declining to follow Foster we depart from the majority of courts to have wrestled with this particular issue. (See Colacicco v. Apotex, Inc., supra, 432 F.Supp.2d at p. 540 [compilation of federal district *111 court rulings following Foster]; Goldych v. Eli Lilly & Co. (N.D.N.Y., July 19, 2006, No. 5:04-CV-1477) 2006 U.S.Dist. Lexis 49616 [following Foster and Colacicco].) Here, as in Foster, the trial court misapplied to Ms. Conte's fraud and negligent misrepresentation claims the rule that no products liability exists unless the defendant manufactured or sold the injurious product that causes injury. This, in our view, was erroneous. The fact that Wyeth did not manufacture or sell the metoclopramide Conte ingested does not relieve Wyeth from its general duty to use due care in disseminating product information to those it knows or should know are likely to be harmed as a result of their physician's reliance on that information. (See Randi W., supra, 14 Cal.4th 1066; Garcia, supra, 50 Cal.3d 728; Hanberry v. Hearst Corp., supra, 276 Cal.App.2d at p. 683.) We believe California law supports Conte's position that Wyeth owes a duty of due care to those people it should reasonably foresee are likely to ingest metoclopramide in either the name-brand or generic version when it is prescribed by their physicians in reliance on Wyeth's representations. We are also satisfied that Conte's evidence in opposition to summary judgment establishes a triable issue of material fact as to whether Dr. Elsen in fact relied on Wyeth's representations in the PDR. Accordingly, we conclude the court erred in granting summary judgment in favor of Wyeth.
Pliva joined Wyeth's motion on the ground that Conte could not prove any alleged inadequacy in its own labeling caused her injury, and asserted as an additional undisputed material.

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