The Mensing Conundrum: Litigating Generic Drug Injuries in California

The Mensing Conundrum: Litigating Generic Drug Injuries in California It is an elementary maxim of equity jurisprudence that there is no wrong without a remedy. 1 I. Introduction As long as there have been prescription drugs, people have suffered injuries caused by those drugs. While a perfect level of safety is just not possible, state tort laws have long provided protection to injured drug consumers and incentive to drug manufacturers to improve and maintain the safety of their products. However, the United States Supreme Court has recently revealed an alarming gap in this consumer protection and safety incentive scheme. A series of cases now reveals that state law claims of injury resulting from a prescription drug are not preempted by federal law if the drug is a brand name, but are preempted if the drug is a generic. This incongruity in federal law may leave a consumer injured by a generic drug without a viable civil remedy. Consumers are likely to be completely unaware of the protections they are giving up when they accept a cheaper, generic prescription, leaving them at a significant legal disadvantage. Generic drugs continue to capture an increased market share of prescriptions, so the number of consumers affected by federal preemption will grow. This article will provide a brief history of generic drugs, outline the recent United States Supreme Court cases that have revealed the consumer protection problem related to generics, and address potential solutions for litigating generic prescription drug injury claims in California. II. A Brief History of Generic Drugs The generic drug industry effectively began under the 1984 Hatch-Waxman Amendments, which became a part of the Federal Food, Drug and Cosmetic Act (FDCA). 2 The goal was to balance the need for innovative new pharmaceuticals and the availability of less expensive generic drugs. 3 Hatch-Waxman streamlined the FDA approval of generic drugs, creating the Abbreviated New Drug Application (ANDA) to reduce the time and cost required to obtain FDA approval for generic versions of approved drugs. A generic manufacturer need only certify that the generic product is the bioequivalent of the name-brand drug and that the labeling and warnings for the generic drug are identical to those for the approved name-brand drug. 4 This requirement has become known as a duty of sameness. The Hatch-Waxman Act has certainly achieved the goal of cost savings: IMS Health estimates that the availability of cheaper generic alternatives saved the U.S. health care system more than $800 billion in the last decade. 5 At the same time, as of 2010, total generic market 1 Feist v. Young, 138 F. 2d 972, 974 (7th Cir. 1943). 2 Federal Food, Drug and Cosmetic Act, 21 USC 355(j) (2010). 3 The Hatch-Waxman Act: Selected Patent-Related Issues, United States Congressional Research Service, April 1, 2002. 4 Conte v. Wyeth, 168 Cal. App. 4th 89, 98 (2008). 5 IMS Health, Generic Medicines saved U.S. Healthcare System $139.6 Billion in 2009; $824 Billion Saved Over The Last Decade, (July 2010). 1

share has risen to 78% of all retail prescriptions. 6 Many insurers now only reimburse the cost of the generic version of the drug, with some even mandating the use of the generic version. With a number of popular name brand drugs (e.g. Lipitor, Plavix, Nexium) scheduled to lose their patent protection between now and 2015, generics will continue to be an increasing share of the total prescription drug market in the U.S. 7 making the lack of legal protections for consumers of generic drugs all the more alarming. A brief review of the cases that supplied the recent legal revelation and ensuing conundrum helps explain why. III. Current Law: A Trilogy of Pharmaceutical Tort Preemption Cases The Supreme Court s recent federal preemption jurisprudence has invalidated state causes of action used to remedy harms caused by generic drugs. Over the last five years, the Supreme Court has heard three cases on the question of federal preemption of state torts related to pharmaceutical labels: Wyeth v. Levine, 8 Pliva v. Mensing, 9 and Mutual Pharmaceutical Co. v. Bartlett. 10 All three deal with implied preemption in the category of conflict preemption. 11 The holdings from these cases reveal an alarming gap in consumer protection law: namely, brand drug manufacturers must comply with state product liability laws while generic manufacturers, in many cases, need not. These state product liability laws are commonly broken into three theories of liability for defective products: negligence, strict liability, and breach of warranty. In order to recover under any of these theories, a plaintiff must generally show that the product is defective and the defect existed when the product left the defendant s control. There are three types of defects common to product liability cases: manufacturing, design, and warnings/labeling. A manufacturing defect occurs when an individual product has a defect that makes it more dangerous than other identical products. A design defect occurs when all products of a particular design are defective 6 Medical News Today, New Study: Generics Account For 78% Of All Retail Prescriptions (19 Apr 2011) (http://www.medicalnewstoday.com/articles/222874.php). Generics now account for 78% of all retail prescriptions dispensed, a result of the greater availability of molecules in generic form as patents expire, along with patients choosing lower-cost options. On average, more than 80% of a brand's prescription volume is replaced by generics within six months of patent loss. For the full study, see http://www.imshealth.com/deployedfiles/imshealth/global/content/ims%20institute/static%20file/ihii_useofme d_report.pdf, relevant information at p. 22. 7 Ron Rajecki, Generic drug market strong through 2015, Drug Topics: Voice of the Pharmacist, http://drugtopics.modernmedicine.com/drugtopics/modern+medicine+now/generic-drug-market-strong-through- 2015/ArticleStandard/Article/detail/682076. 8 Wyeth v. Levine, 555 U.S. 555 (2009). 9 Pliva v. Mensing, 131 S.Ct. 2567 (2012). 10 Mutual Pharmaceutical Co. v. Bartlett, No. 12-142, 2013 BL 166063 (U.S. June 24, 2013). 11 For a general overview of preemption doctrine, see Stephen Wermiel, SCOTUS for law students (sponsored by Bloomberg Law): Preemption again, SCOTUSblog (Mar. 11, 2013), http://www.scotusblog.com/2013/03/soctusfor-law-students-sponsored-by-bloomberg-law-preemption-again/. Wermiel explains that there are two types of preemption: express and implied. Preemption is express when Congress states clearly in a federal law that it intends to supersede related state laws. Implied preemption, on the other hand, tends to bring out more disagreement among the Justices and is the focus of the trilogy of prescription drug cases we discuss in this article. There are two types of implied preemption: field preemption and conflict preemption. Field preemption occurs when Congress, without expressly declaring that state laws are preempted, nevertheless legislates in a way that is so comprehensive as to occupy the entire field of an issue. Conflict preemption has two subcategories and occurs when it is impossible to comply with both state and federal laws (impossibility preemption), or when the purposes and objectives of federal law would be thwarted by state law (purposes and objectives preemption). 2

and dangerous. Finally, a warning/labeling defect occurs when a manufacturer fails to provide adequate warnings about potential dangers associated with the product. 12 The cases below address claims of negligent warnings/labeling and strict liability design-defect. A. Wyeth v. Levine: Failure to Warn Claims and Brand Prescription Drugs In 2009 the United States Supreme Court in Wyeth v. Levine recognized that a state failure to warn claim of injury against a brand name manufacturer was not preempted by federal law. 13 Plaintiff Levine s injury resulted from an incorrectly administered IV-push injection of the brand drug Phenergan. As a result, Levine, a professional musician, developed gangrene and eventually had her arm amputated. 14 After settling claims against the health center and clinician, Levine brought an action for damages against Wyeth, relying on state law negligence and strictliability theories for Phenergan s failed warning label. Although Phenergan's labeling warned of the danger of gangrene and amputation following inadvertent intra-arterial injection, Levine alleged that the labeling was defective because it failed to instruct clinicians to use the IV-drip method of intravenous administration instead of the higher risk IV-push method. She alleged that Phenergan was not reasonably safe for intravenous administration because the foreseeable risks of gangrene and loss of limb are great in relation to the drug's therapeutic benefits. 15 The drug manufacturer argued that Levine s claims were preempted by federal law. 16 The Court was not persuaded that failure-to-warn claims like Levine s fell within express or impossibility preemption or obstructed the federal purposes and objectives of drug labeling because federal regulation [under the FDCA] left room for Wyeth to alter its warning labels and because Congress did not specify any intent to preempt state failure-to-warn claims. 17 The bottom line: State law claims brought by consumers injured by brand drugs are not preempted by federal law. 18 B. Pliva v. Mensing: Failure to Warn Claims and Generic Drugs In contrast to Levine, in 2011 a divided United States Supreme Court held that federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus preempt, these same state law claims. 19 After taking the generic drug Metoclopramide as prescribed for several years, Plaintiff Mensing developed the neurological disorder tardive dyskinesia and sued the generic drug manufacturer. Mensing alleged that long-term Metoclopramide use caused her disorder and that 12 Kubasek et al., Dynamic Business Law 234-255 (2d ed. 2012). 13 Wyeth v. Levine, 555 U.S. 555 (2009) (hereinafter Levine ). 14 Id. at 559. 15 Id. at 560. 16 Id. at 555. 17 Stephen Wermiel, SCOTUS for law students (sponsored by Bloomberg Law): Preemption again, SCOTUSblog (Mar. 11, 2013, 11:05 AM), http://www.scotusblog.com/2013/03/scotus-for-law-students-sponsored-by-bloomberglaw-preemption-again/. See also Wyeth v. Levine, at 581. 18 For an extensive analysis and annotation of federal pre-emption of state common law products liability claims pertaining to drugs, medical devices, and other health-related items see: 23 A.L.R.6 th 223, 98 A.L.R. Fed. 124. 19 Pliva v. Mensing,131 S.Ct. 2567 (2012). 3

the generic manufacturers were liable under state tort law for failing to provide adequate warning labels. 20 Justice Thomas, writing for the majority, conceded that state law places a duty directly on all drug manufacturers to adequately and safely label their products. 21 However, federal drug regulations prevent generic manufacturers from independently changing their drugs safety labels. 22 The Court distinguished this case from Levine because federal law does allow brand manufacturers to change their drugs safety labels; therefore, it was possible for a brand-name drug manufacturer to comply with both state and federal law. In contrast, Mensing s facts show the state law duty on the generic manufacturers to maintain and update their drug safety labels conflicts with federal law barring them from taking that action. Because compliance with both federal law and state law was impossible, Mensing s tort claims were preempted. 23 The bottom line: Failure to warn claims and possibly other state law claims by consumers injured by generic prescriptions are preempted by federal law. C. Mutual Pharmaceutical Co. v. Bartlett: Design-Defect Claims and Generic Drugs After Mensing, failure to warn claims against generic manufacturers are preempted. But what about other state law claims? The latest in the trilogy of federal preemption cases related to pharmaceutical labels is Mutual Pharmaceutical v. Bartlett (hereinafter Bartlett). 24 However, unlike the failure to warn claims of Levine and Mensing, Bartlett concerns a design-defect claim. The Supreme Court heard oral arguments in Bartlett on March 19, 2013, as to whether the FDCA (and in particular the Hatch-Waxman Act) preempts a state strict liability designdefect claim against a generic manufacturer. The lower court verdict against the generic manufacturer was premised on finding the generic drug unreasonably dangerous to consumers (and therefore defectively designed), in part, because of the label s failings. 25 The generic drug Sulindac is an anti-inflammatory medication that plaintiff Bartlett s doctor prescribed to help treat her shoulder pain. The plaintiff suffered burns over most of her body associated with Stevens-Johnson Syndrome and toxic epidermal necrolysis caused by a recognized, but rare, side effect of Sulindac. The generic product and label conformed to FDA standards requiring that it be substantially similar to the brand drug and its label. 26 The generic manufacturer argued that the federal sameness rule that denies generics discretion to use a different label than the brand drug should preempt a state defective-design claim. Interestingly, the First Circuit held, in part, that state law design-defect claims against generics survive a federal impossibility preemption challenge because the conflict can be avoided if the generic stops making the product. 27 But that solution, the generic manufacturer 20 Id. at 2569. 21 Id. at 2573. 22 Id. at 2581. 23 Id. at 2581. 24 See generally, Ronald Mann, Argument preview: Court to write yet another chapter on tort protections for generic pharmaceutical manufacturers, SCOTUSblog (Mar. 14, 2013, 11:33 AM), http://www.scotusblog.com/2013/03/argument-preview-court-to-write-yet-another-chapter-on-tort-protections-forgeneric-pharmaceutical-manufacturers/. 25 Bartlett v. Mutual Pharmaceutical Co., 678 F.3d 30 (1st Cir. 2012). 26 Ronald Mann, Argument preview: Court to write yet another chapter on tort protections for generic pharmaceutical manufacturers, SCOTUSblog (Mar. 14, 2013), http://www.scotusblog.com/2013/03/argumentpreview-court-to-write-yet-another-chapter-on-tort-protections-for-generic-pharmaceutical-manufacturers/ 27 See generally, MUTUAL PHARMACEUTICAL CO. v. BARTLETT, The Oyez Project at IIT Chicago-Kent College of Law, http://www.oyez.org/cases/2010-2019/2012/2012_12_142 (last visited March 25, 2013). However, see also, 4

argued, would thwart the alternate federal purposes and objectives preemption after all, the purpose and objective of the Hatch-Waxman Act is to promote the availability of generic drugs. 28 The manufacturer also argued that even if sulindac was unreasonably dangerous for reasons other than its label, the federal sameness rule still applies: it denies generics discretion to alter not only the drug s label, but also the drug s recipe, to make it safer than the brand drug. Therefore, a generic has no ability to deal with the design defect and Mensing s impossibility preemption reasoning again applies. 29 On June 24, 2013, the U.S. Supreme Court agreed with the generic manufacturer, extending its Mensing logic: The Court of Appeals' solution that Mutual should simply have pulled sulindac from the market in order to comply with both state and federal law is no solution. Rather, adopting the Court of Appeals' stop-selling rationale would render impossibility pre-emption a dead letter and work a revolution in this Court's pre-emption case law. 30 The bottom line: [S]tate-law design-defect claims that turn on the adequacy of a [generic] drug's warnings are preempted by federal law. 31 IV. Federal Legislative Response and Failure The pharmaceutical tort preemption trilogy has created quite a conundrum for plaintiffs injured by generic drugs. Congressional action has not been wholly absent, just unsuccessful. Senate Bill 2295, sponsored by Senator Patrick Leahy (D-VT), sought to permit manufacturers of generic drugs to provide additional warnings with respect to such drugs in the same manner that the Food and Drug Administration allows brand names to do so. 32 The bill, also known as the Patient Safety and Generic Labeling Improvement Act, would have amended the FDCA by adding provisions to allow generic drug manufacturers to change the labeling of those approved generic drugs in the same manner authorized for brand name drug manufacturers. This proposed change in law would be significant because it would place generic drugs in the same position as brand drugs for purposes of state law labeling tort preemption. Introduced on April 18, 2012, the bill was immediately referred to the Senate Committee on Health, Education, Labor, and Pensions, where it thereafter languished, only to die a slow death. 33 The corresponding House bill, H.R. 4384, sought nearly identical additions to the Stephen Wermiel, SCOTUS for law students (sponsored by Bloomberg Law): Preemption again, SCOTUSblog (Mar. 11, 2013, 11:05 AM), http://www.scotusblog.com/2013/03/scotus-for-law-students-sponsored-by-bloomberglaw-preemption-again/, pointing out that requiring generics to stop selling their product in order to avoid a federal and state law conflict would thwart the purposes and objectives of Congress, which made clear in the 1984 law that it wanted to promote the availability of generic drugs. 28 Stephen Wermiel, SCOTUS for law students (sponsored by Bloomberg Law): Preemption again, SCOTUSblog (Mar. 11, 2013, 11:05 AM), http://www.scotusblog.com/2013/03/scotus-for-law-students-sponsored-by-bloomberglaw-preemption-again/ 29 Id. 30 Bartlett, No. 12-142, 2013 BL at *3. 31 Id. But also see id. at *6 and fn 1 for the Court s discussion of the possibility that a true absolute-liability statelaw system could avoid impossibility preemption and see id. at *12 for a discussion of why the Texas state-law design-defect claim in question in Bates v. Dow Agrosciences LLC, 544 U. S. 431 (2005) was not preempted by federal law. 32 http://www.govtrack.us/congress/bills/112/s2295. 33 Id. 5

FDCA. Like S. 2295, the bill was introduced and immediately referred to the House Committee on Energy and Commerce where it lay dormant until its ultimate demise. 34 It is unfortunate that, to date, no legislator has taken the opportunity to reintroduce these bills, even as the Supreme Court is practically begging for Congressional action: Suffice to say, the Court would welcome Congress explicit resolution of the difficult pre-emption questions that arise in the prescription drug context. That issue has repeatedly vexed the Court and produced widely divergent views in recent years. 35 The Court goes on to lament that Congress' decision to regulate the manufacture and sale of generic drugs in a way that reduces their cost to patients but leaves generic drug manufacturers incapable of modifying either the drugs' compositions or their warnings is a contributing factor to producing rare and devastating injuries in generic drug consumers. 36 Instead of waiting for the pressure point that will force Congress into action, the time has come to explore what options are left that can provide appropriate remedies. V. Practical Solutions for Litigating in California Under the trilogy of product liability cases above, the Supreme Court has effectively eliminated state tort claims against generic drug manufacturers for both negligent and strict liability drug warnings and design defects. What is left of state product liability laws may not be terribly helpful to injured plaintiffs. Manufacturing defects remain a viable avenue of tort recovery, but such defects are comparatively rare. 37 So what is left for plaintiffs after Levine, Mensing and Bartlett? In seeking to provide some practical solutions for plaintiffs who are injured by generic drugs in California, we will explore alternative avenues (and defendants) presented by learned intermediary doctrine and innovator liability theory. A. On the Offensive with Learned Intermediary Doctrine: Resuscitating Defective Warning Claims Learned intermediary doctrine has been adopted by at least 28 states, including California. 38 The California Supreme Court describes the doctrine as follows: 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. 39 The reasoning here is that the doctor (or learned intermediary) has the access to and relationship with the patient that the manufacturer lacks, and 34 http://www.govtrack.us/congress/bills/112/hr4384. 35 Bartlett, No. 12-142, 2013 BL at *12. 36 Id. 37 A manufacturing defect occurs when an individual product has a defect that makes it more dangerous than other identical products. 38 See In re Norplant Contraceptive Prods. Liab. Litig., 215 F. Supp. 2d 795, 806 (E.D. Tex. 2002), for the proposition that all but two states have adopted it (New Jersey and Vermont). However, see State ex rel. Johnson & Johnson Corp. v. Karl, 220 W.Va. 463, 904 (2007), for the competing conclusion that only 22 states officially recognize the doctrine with six others referring to it favorably in dicta and 22 not adopting it. 39 Stevens v. Parke, Davis & Co. (1973) 9 Cal. 3d 51, 65 (internal citation omitted). 6

has the training to communicate highly technical information in an understandable way. 40 Thus, warning the patient becomes the duty of the doctor the learned intermediary between the drug manufacturer and the patient. Although learned intermediary doctrine has typically been used as a defense by both generic and brand-name drug manufacturers, it could be used by a plaintiff to reach an alternative defendant the prescribing physician. The effect of a successful learned intermediary defense by a drug manufacturer is to shift the focus, and ultimate responsibility, for any failure to warn about the medication's risks from the manufacturer to the prescribing physician. This may move the prescribing physician from being a low-profile, minor defendant in these claims to being a primary target and possibly the sole target. 41 After all, as the intermediary between the drug manufacturer and the patient, the doctor becomes responsible for any harm caused by the drug if he or she was aware of the possible risks involved in the use of the product but decided to use it anyway. 42 Since the generic manufacturer is already protected by federal preemption of state tort claims for failure to warn, plaintiffs may find more success in directing claims against prescribing physicians. As the learned intermediary between the generic drug manufacturer and the patient injured by that drug, the physician may be one of the only viable defendants left. The most likely objection that a defendant physician will raise when an injured patient tries to hold a doctor liable as the learned intermediary is that he or she never qualified as learned. In pursuing this defense, the defendant will try to show that the drug manufacturer did not provide him or her with adequate warning hence, the doctor never actually became learned. However, if the physician received warnings from the drug manufacturer, but did not transmit those warnings to the patient, the learned intermediary doctrine may resuscitate an inadequate warning tort, or at very least, preserve a good medical malpractice claim. B. Conte v. Wyeth: Innovator Liability Another alternative available to plaintiffs in California who are injured by a generic drug is to pursue the brand drug manufacturer, or innovator. This defendant is not affected by the Levine/Mensing/Bartlett trilogy. In fact, pursuing this defendant requires an entirely unique cause of action no longer strict or negligent product liability, but instead, intentional and/or negligent misrepresentation. 40 See Carmichael v. Reitz, 17 Cal. App. 3d 958, 989 (1971) ( The rationale of the foregoing rule is: (1) The doctor is intended to be an intervening party in the full sense of the word. Medical ethics as well as medical practice dictate independent judgment, unaffected by the manufacturer's control, on the part of the doctor. (2) Were the patient to be given the complete and highly technical information on the adverse possibility associated with the use of the drug, he would have no way to evaluate it, and in his limited understanding he might actually object to the use of the drug, thereby jeopardizing his life. (3) It would be virtually impossible for a manufacturer to comply with the duty of direct warning, as there is no sure way to reach the patient. (internal citations and footnote omitted)). See also In re: Levaquin Products Liability Litigation, 700 F.3d 1161, at fn. 5 (8th Cir. 2012) (Explaining that a physician has more information than the drug manufacturer about individual patients susceptibility to various potential adverse drug effects and is in the best position to give a highly individualized warning to a patient based on the physician s knowledge of the patient and the inherent risks of the drug. ). 41 Russell G. Thornton, The learned intermediary doctrine and its effects on prescribing physicians, Baylor University Medical Center Proceedings, http://www.ncbi.nlm.nih.gov/pmc/articles/pmc1200796/. 42 Pustejovsky v. Pliva, 623 F.3d 271, 276 (5th Cir. 2010). (internal citation omitted). 7

In 2008 a California appellate court held in Conte v. Wyeth 43 that the common law duty to use due care owed by a name-brand prescription drug manufacturer when providing product warnings extends not only to consumers of its own product, but also to those whose doctors foreseeably rely on the name-brand manufacturer's product information when prescribing a medication, even if the prescription is filled with the generic version of the prescribed drug. 44 Plaintiff Conte was prescribed the drug metoclopramide to treat her gastroesophageal reflux disease. As a result of taking only the generic version of the drug not the name brand she developed a debilitating and incurable neurological disorder. Nonetheless, Conte brought claims against the brand manufacturer premised on intentional and/or negligent misrepresentations in the drug labeling and in information the manufacturer provided about the drug for the Physician's Desk Reference (PDR), an annual publication about pharmaceuticals and sent free of charge to licensed physicians. The court found it persuasive that pharmacists are authorized to fill name brand prescriptions with generic equivalents, making it highly likely that a brand prescription written in reliance on the brand product information will be filled with a generic. 45 Further, since generics and brands are biologically equivalent, it is eminently foreseeable that a physician might prescribe a generic in reliance on the brand s representations. 46 This is the crux of socalled innovator liability. The theory has been controversial, from both a public policy perspective and a legal perspective. Since much of the public policy rationale for a period of brand name exclusivity is to provide a strong enough incentive for firms to undertake the long and risky process of researching new drugs, imposing an additional potential liability for harms done by generic versions could potentially reduce this incentive and choke off the development of new drugs. 47 From a legal perspective, some commentators have argued that by holding the name brand manufacturer liable for a drug that they did not sell, the Conte decision effectively stands product liability law on its head. 48 A Florida Circuit court opinion called Conte the lone outlier against the overwhelming weight of authority on this point. 49 While many jurisdictions 43 Conte v. Wyeth, 168 Cal. App. 4th 89 (2008). The California Supreme Court refused to review the decision. Conte v. Wyeth, Inc., No. S169116, 2009 Cal. LEXIS 233, at *1 (Cal. Jan. 21, 2009). 44 Id., at 94-95. 45 Id., at 105. 46 Id. 47 Interestingly, the general objection that the Conte decision holds a brand name manufacturer liable for harms caused by a generic drug it had no role in making or selling may in some cases actually not be true. In some cases, the brand name firm is directly involved in manufacturing the generic: Pfizer has a wholly-owned subsidiary called Greenstone, LLC. that makes and sells a variety of generic versions of well-known Pfizer products whose patents have expired (e.g. Zoloft, Zithramax, Xanax). Teva Pharmaceuticals and Novartis Sandoz also have divisions or subsidiaries devoted to manufacturing generics. If the brand name/pioneer firm is still deriving some revenue from sales of a generic version of its brand name drug, the objection that Conte imposes liability on a party that had nothing to do with the product that caused the harm becomes much less tenable. 48 James M. Beck & Mark Herrmann, Generic Drug Pioneer Liability, DRUG & DEVICE L. (Nov. 7, 2008, 4:10 PM), http://druganddevicelaw.blogspot.com/2008/11/generic-drug-pioneerliabilty.html. Some commentators may also attempt to use the California Supreme Court s decision in O Neil v. Crane Co. to cast doubt on Conte s continued application since O Neil held that the foreseeability of harm, standing alone, is not a sufficient basis for imposing strict liability on a manufacturer for another company s product. 53 Cal. 4th 335, 362 (2012). It is important to note the fundamental misunderstanding inherent in that criticism: Conte does not seek to impose strict product liability; rather, it opens the door to a misrepresentation claim. 49 Dietrich v. Wyeth, Inc., No. 50-2009-CA-021586 XXX MB, 2009 WL 4924722 (Fla. Cir. Ct. 15th Jud. Cir. 2009). 8

have rejected Conte s reasoning, it is by no means the lone outlier. Courts in Alabama 50 and Vermont 51 have become supporters of the innovator liability concept. In Kellogg v. Wyeth 52 a United States District Court in Vermont held that a plaintiff could maintain a fraud (or intentional misrepresentation) action against a brand drug manufacturer even though the plaintiff was injured by ingesting the generic version. The Court opined that it is reasonably foreseeable that a physician will rely upon a brand name manufacturer's representations or the absence of representations about the risk of side effects of its drug, when deciding to prescribe the drug for a patient, regardless of whether the pharmacist fills the prescription with a generic form of the drug. 53 Under similar facts, the Alabama Supreme Court held that name brand manufacturers may be liable under misrepresentation theories. 54 The Ninth Circuit has also recently recognized Conte as the law of the state. 55 Successful application of innovator liability requires several steps. First, make sure your cause of action is for intentional and/or negligent misrepresentation, not negligent or strict product liability. Product liability causes of action will not win an innovator liability case. However, intentional and negligent misrepresentations are both actionable forms of fraud in California. 56 Next, it must be established that the prescribing physician relied on inadequate warnings about the brand drug when the physician planned the plaintiff s treatment. This might include evidence that the doctor read the product information (possibly in the PDR) about the name brand drug, believed it to be accurate, and relied on the PDR when he/she considered prescribing the drug to patients. This evidence could support a reasonable inference that the brand drug s product information was a causal factor in the physician s decision to treat the plaintiff patient with the generic drug. 57 While the Conte decision is certainly controversial, for now it remains in force, offering California plaintiffs injured by generic drugs a way out of Mensing s Catch-22. VI. Conclusion 50 Wyeth, Inc. v. Weeks, No. 1101397, 2013 WL 135753 (Ala. 2013) (held that name brand manufacturers may be liable under misrepresentation theories). 51 Kellogg v. Wyeth, Inc., 762 F.Supp.2d 694 (D. Vt. 2010). 52 Id. 53 Id. at 708-709. 54 Wyeth, Inc. v. Weeks, No. 1101397, 2013 WL 135753 (Ala. 2013) (held that name brand manufacturers may be liable under misrepresentation theories). 55 Rosa v. TASER Int l Inc., 684 F.3d 941, 949 (9th Cir. 2012) ( California s negligence law may impose on a manufacturer a duty to warn individuals who, while not users of its products, could foreseeably rely on its warnings. For example, when the user of a generic pharmaceutical sues the manufacturer of the brand name medication for the warning included in the Physician's Desk Reference, the user cannot recover under strict liability because he or she was not injured by the manufacturer's own products. However, because the brand name manufacturers are responsible for disseminating the information in the Physician's Desk Reference, which others would foreseeably rely upon, they may be held liable under negligence. ). 56 Conroy v. Regents of University of California, 45 Cal. 4th 1244, 1255 (2009) ( The elements of fraud, which give rise to the tort action for deceit, are (1) a misrepresentation, (2) with knowledge of its falsity, (3) with the intent to induce another's reliance on the misrepresentation, (4) justifiable reliance, and (5) resulting damage. The tort of negligent misrepresentation, a species of the tort of deceit, does not require intent to defraud but only the assertion, as a fact, of that which is not true, by one who has no reasonable ground for believing it to be true. ). 57 See Conte, 168 Cal. App. 4th at 100. 9

With various influences requiring, encouraging, or merely allowing pharmacists and doctors to substitute generics when available, generics account for over 78% of all prescriptions.58 Since product liability claims by injured plaintiffs against generic drug manufacturers will, absent Congressional action, continue to be stymied in a post-mensing world, those plaintiffs must look elsewhere for viable defendants. Consumers who reach for prescribing physicians by way of learned intermediary doctrine, or for brand manufacturers by way of innovator liability, may have some success. Whatever the theory of recovery, it is imperative that injured patients not be left without a remedy. Authors: Richard E. Custin, J.D. LL.M. Attorney, Visiting Professor of Business Law & Ethics University of San Diego School of Business Administration Contact Information: School of Business Administration Alcala Park West- Coronado, Room 216 San Diego, CA 92110-2492 Phone: (619) 260-4854 Email: rcustin@sandiego.edu Michelle O Connor- Ratcliff, J.D. Attorney, Adjunct Professor of Business Law & Ethics University of San Diego School of Business Administration 58 See infra, footnote 6. 10

Contact Information: School of Business Administration Olin Hall, Room 211 San Diego, CA 92110-2492 Email: moconnorratcliff@sandiego.edu Ryan Ratcliff, Ph.D. Assistant Professor of Economics University of San Diego School of Business Administration Contact Information: School of Business Administration Olin Hall, Room 211 San Diego, CA 92110-2492 (619)260-7560 ratcliff@sandiego.edu Contributor: Sean Proehl Juris Doctorate Candidate, 2015 University of San Diego, School of Law 11

Contact Information: (858) 208-6766 sproehl@sandiego.edu 12