MEDICAL AND LIFE SCIENCES

Last Year’s Lessons Shape This Year’s Outlook To prepare the best product liability defense for pharmaceuticals and medical devices as well as anticipate and strategically plan for future challenges in the medical and life sciences legal world, it is often helpful to step back and review the major decisions that have impacted the industry which may shape the year ahead. Following are several key judicial holdings in New York from 2018 pertaining to: • Failure to Warn - Prescription Drugs • NY Counties Claims Against Manufacturers • Design and Warning Claims - Endovascular Medical Device • Opioid from Pill-Mills • Product Liability Claims - Biologic • Contraceptives - No Causation Under Daubert

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This may be considered Attorney Advertising according to the Rules of Professional Conduct. Pharmaceutical Product Liability Claim Dismissed; Plaintiff Failed to Show Specific Causation Plaintiff claimed labeling of anti-psychotic label listed the precise malady that Plaintiff Risperdal failed to incurred. On the issue of causation, adequately warn of risk of gynecomastia, general causation was established both by providing only general warnings, in by expert testimony and the listing of the passing, of possibility of enlarged breasts. side effect on the label; Plaintiff could not Without the support of expert witness establish specific causation, as there was opinion evidence, Plaintiff cherry-picked no evidence that a different more accurate two of 18 studies on the drug to advance warning would have made any difference. the theory that the product label listed The two prescribing physicians knew about an inaccurate, lower incidence rate of the the risk and made their own risk-benefit side effect. Without an expert, the New assessments; one of the prescribers had York federal court held, Plaintiff could not not read the label and chose not to warn opine on the statistical or methodological Plaintiff of the specific risk—an intervening differences between the studies or why the cause severing the causal connection two studies cited were correct. Moreover, between the alleged failure to warn and the court was not in a position to second- the injury. Chandler v. Janssen, Case guess the FDA approved label. The 1:15-cv-03106 (E.D.N.Y. June 29, 2018). undisputed evidence showed the Risperdal

Potential implication for future cases: In asserting a failure to warn claim for a prescription medical product, a plaintiff must prove both general and specific causation. When a case rests on complex medical issues, plaintiff must introduce evidence, including expert medical testimony, establishing causation. Even where general causation is established, through expert witness opinion or the product labeling itself, specific causation must be independently shown. If the treating physician/prescriber is aware of the risks of the drug, independent of any warning by the manufacturer, or the treating physician/prescriber did not read the warning on the drug’s label, but was aware of the risks and benefits from independent sources, specific causation cannot be shown in the failure to warn context. It is essential to obtain thorough testimony from the learned intermediary about both his/her understanding of the package insert warnings and independently acquired knowledge about the drug’s risks.

2 New York State Court Allows Multi-County Action Against Opioid Sellers to Proceed Multiple pharmaceutical Defendants’ show that the FDA had approved their motions for an order pursuant to means, methods, and/or the content of CPLR 3211, dismissing the master form their drug promotion to warrant a finding long complaint filed in consolidated opioid that the Plaintiffs’ claims were preempted action brought by counties within the State by virtue of the FDA’s approval of their of New York for harm allegedly caused by drugs. The Defendants’ arguments that false and misleading marketing campaigns the complaints did not allege a cognizable promoting semi-synthetic, opium-like injury, or that the Plaintiffs were barred pharmaceutical pain relievers, including under the municipal cost recovery rule , hydrocodone, oxymorphone, from recovering the costs of governmental and tapentadol, as well as the synthetic services incurred in connection with the opioid prescription pain opioid crisis, were also rejected. The court , as safe and effective for long- rejected dismissal arguments based on term treatment of chronic pain, were inadequate pleading of public nuisance, denied. The Defendants collectively moved fraud, negligence, state statutes, and on preemption grounds, asserting that defenses based on causation and the their marketing of was consistent economic loss doctrine. The court also with FDA-approved labeling; therefore, rejected the manufacturer Defendants’ any state law that would require them to argument that, as only physicians and make statements that are inconsistent other medical providers can prescribe with existing labeling, would directly prescription drugs, misrepresentations conflict with the FDA regulations. The court concerning the risks and benefits of considered whether New York’s consumer opioids made in connection with their protection laws and traditional tort marketing campaigns cannot constitute principals posed an obstacle to the FDA’s “consumer-oriented” conduct under the regulation of prescription drug promotion informed or knowledgeable intermediary and advertising or made it impossible for doctrine, a defense against a failure to the manufacturer Defendants to comply warn claim. In Re Opioid Litigation, 2018 with those regulations as a matter of law. WL 3115102 (N.Y.Sup.) (Sup. Ct. Suffolk The court held the Defendants failed to County 2018).

Potential implication for future cases: This litigation, being closely watched by courts and litigants from around the country, highlights the marketing efforts of opioid manufacturers and distributors who disseminated allegedly deceptive messages about the dangers and benefits of prescription opioid use. Traditional failure to warn defenses such as the learned intermediary doctrine, an adequate product label and FDA approval are not defenses to claims which center upon deceptive marketing practices upon a pre-answer dismissal motion.

3 Endovascular Medical Device Not Defective; Expert Proof Conclusory and Speculative In a medical device product liability device favored Defendant, as the retriever case brought in New York state court was the only device on the market at the on behalf of a severely brain-damaged time that could mechanically remove Plaintiff, arising from the fracture of clots, it was one of only three FDA–cleared two endovascular retrieval devices used devices to remove foreign bodies, and the to capture a foreign body (a migrated retriever had a low fracture rate of less coil) during an interventional radiology than one-quarter of 1%. While Plaintiff’s procedure under fluoroscopic guidance, experts alluded to their own fracture Appellate Division First Department tests and experiments, for which the affirmed New York Supreme Court grant of methodology was provided only in general summary judgment on all claims, including terms, unsupported by analysis or data, design defect, failure to warn and breach the expert witness opinion evidence was of warranty. Manufacturer had established properly rejected by the motion court as entitlement to dismissal of the duty to lacking probative value. Plaintiff’s experts’ warn claim as its Instructions for Use opinions contained conclusory and specifically warned of the risk of fracture speculative assertions as to the existence and how to reduce such risk. Further, the and nature of defect and failed to explain learned intermediary acknowledged being how the proposed design changes, even if aware of the risk of fracture through, inter feasible, would have altered the outcome. alia, case reports, published literature, and Ford v. Riina, 160 A.D.3d 588 (N.Y.A.D. 1st the Instructions for Use. The design defect Dept.) motion for reargument of, or in claim was properly dismissed on the basis the alternative, for leave to appeal to the that the endovascular retrieval device was Court of Appeals, denied 2018 WL 3911272 state- of-the-art at the time of its design (N.Y.A.D. 1st Dept. 2018). Case litigated by and complied with all applicable industry Harris Beach attorney Judi Abbott Curry. standards. The risk-utility analysis of the

Potential implication for future cases: This decision underscores the importance of expert witness opinion that is grounded in the scientific method. Not only must parties support scientific theories with empirical data, but when subjecting a product to litigation-driven tests, the experts must disclose and describe the testing performed and attest that those tests are “generally accepted” in the scientific community, under the Frye rule. Where plaintiffs submit expert witness opinion evidence on the design of the medical device, they must refute proof that the design was a state-of-the-art and posit an alternate feasible design which would have actually altered the outcome.

4 Opioid Manufacturer – No Duty to Patient Under Controlled Substances Act Oxycodone manufacturer alleged to have moved to dismiss the complaint for turned a “blind eye” to co-defendant negligence against it, arguing that it medical providers prescribing practices was an attempt to privately enforce the that caused Plaintiff to become addicted. Controlled Substances Act. Manufacturer The health care provider prescribing was dismissed on the basis that it did not practices resulted in seven government breach any duty owed to Plaintiff, since the agencies serving indictments on 13 intervening criminal acts of Defendants individuals in connection with a massive broke any causal nexus between any scheme to defraud Medicaid and reporting requirement on manufacturer’s Medicare of millions of dollars, illegally part and Plaintiff’s addiction to oxycodone. sell prescriptions for opioid painkillers Floyd v. Feygin, No. 507458/17, ( Sup. Ct. and money laundering. Manufacturer Kings County 2018).

Potential implication for future cases: An individual plaintiff claiming opioid addiction may be relegated to seeking recovery from his health care provider in traditional claims of medical malpractice rather than the opioid manufacturer, especially where the health care provider is operating a criminal “pill-mill.” Under both the federal Controlled Substances Act and the New York State regulations, the opioid manufacturer’s sole duty was to collect and record data and make reports to federal and state agencies. The regulations did not require a manufacturer to stop or restrict its distribution of opioids. Since the opioids were being distributed pursuant to valid prescriptions by licensed physicians, the manufacturer had no duty to control the prescribing, dispensing and use of its oxycodone by individual health care providers.

5 Sponsors of Clinical Trial Owed No Duty to Plaintiff While Enrolled Clinical trial participant alleged that she the clinical trial, Defendant owed no duty developed tongue cancer (squamous cell to the Plaintiff, during the time she was carcinoma) as the result of her use of enrolled in the clinical trial. Thus her claims the prescription biologic Enbrel for the concerning the drug Enbrel must be limited treatment of her rheumatoid arthritis. to those that allegedly arose after she Wyeth moved pre-answer to dismiss stopped participating in the clinical trial and the Amended Complaint’s allegations of was prescribed the drug as a patient. The products liability, negligence, fraud, breach appellate court also dismissed the claims of of warranty, and unfair and deceptive violation of New York General Business Law trade practices causes of action based sections 349 and 350 because the generally upon failure to state a cause of action. alleged deceptive practice of failing to CPLR 3211(a)(7). Additionally, Defendants provide adequate warnings by concealing argued that Plaintiff’s design defect claim information is, as a matter of law, not a failed because there were insufficient practice directed at consumers. Additionally facts to support the claim, no alternative the fraud claim was dismissed as it did not design is possible for a biologic drug such plead the requisite particularity. The court as Enbrel and any design defect claim rejected Wyeth’s argument that the learned would be preempted under Mutual Pharm intermediary doctrine compelled dismissal Co. v. Bartlett, 133 S. Ct. 2466, 2475 (2013). of the labeling claims, since the warning The New York state trial court held that claims were premised not on the failure to issues such as whether Enbrel is incapable warn Plaintiff directly but on their failure to of redesign or whether Enbrel could have provide proper warnings to her prescribing been designed differently before FDA medical professionals. Nor did Defendant approval are matters for post-discovery show that the warnings were sufficient dispositive-motion practice, not a motion as a matter of law. While Defendant was for judgment on the pleadings. With the correct that there is no independent exception of the manufacturing defect cause of action for punitive damages, claim, the trial court permitted Plaintiff’s their argument that plaintiffs cannot seek causes of action to stand. 2017 WL 931326 punitive damages in connection with their (N.Y.Sup.) On appeal, the Appellate other claims was incorrect. Wholey v. Amgen, Division First Department modified the 165 A.D.3d 458 (N.Y.A.D. 1st Dept. 2018). holding, finding that as the sponsors of

Potential implication for future cases: A clinical trial participant may not bring a product liability action for alleged warning defects, for the time frame during which plaintiff was a clinical trial participant. Plaintiff may bring suit for product liability failure to warn for the period of time that she received the drug as a prescription medical product. Moreover, a pre-answer dismissal motion under CPLR 3211(a)(7) is not the vehicle for dismissal of failure to warn defenses such as the learned intermediary doctrine and an adequate product label.

6 Mirena Mass Tort Plaintiffs Fail to Establish General Causation Mass Torts Plaintiffs in a multidistrict study, which did not definitively conclude litigation pending in the Southern District that Mirena causes IIH. The methodology of New York claimed a levonorgestrel- of the study came under attack, as did based contraceptive device caused Dr. Etminan’s failure to disclose his idiopathic intracranial hypertension relationship to the litigation. After being (IIH). All parties moved under Daubert served with a notice of deposition, this v. Merrell Dow Pharmaceuticals, Inc. 509 expert repudiated much of his study’s U.S. 579 (1993) to exclude the other’s analysis. No peer-reviewed scientific expert testimony on the issue of general literature found that Mirena or any causation. Plaintiffs had put forward seven contraceptive product using levonorgestrel expert witnesses and Defendants’ 12 is a cause of IIH. Applying Daubert’s expert witnesses, all of whom submitted a reliability factors and consideration of the report and were deposed. After a Science Bradford Hill criteria, the court granted Day and Daubert hearing, the federal the Defendants’ motions to preclude all court precluded each of Plaintiffs’ general seven of the Plaintiffs’ general causation causation experts. At the center of this experts. In re Mirena IUS Levonorgestrel- controversy was a study conducted by Related Prods. Liab. Litig., 2018 WL 5276431 one of Plaintiffs’ experts, the Etminan (S.D.N.Y. Oct. 24, 2018).

Potential implication for future cases: Litigating general causation in the MDL as a threshold issue facilitated prompt resolution of this pharmaceutical mass tort. Significant efforts to understand and set out causation theories on the front-end of such litigation ferreted out litigation-driven expert theories which could not meet the federal standards for admissibility, and which underlied the entirety of Plaintiffs’ claims.

7 The developments of 2018 indicate that it is critical to remain informed about changes in the law in order to develop the strongest product liability defense of pharmaceuticals and medical devices. We know it takes an enormous investment to develop innovative pharmaceuticals and medical devices to improve life experiences. That’s why our attorneys, with a national reputation for aggressively defending some of the largest entities in the regulated pharmaceutical, medical device and nutritional supplement industries, leverage their credentials and experience as former pharmacists and nurses to protect your critical life sciences products.

To learn more about our Medical and Life Sciences Industry Team please visit our website at: www.harrisbeach.com/industry/medical-life-sciences/

For more information, contact: JUDI ABBOTT CURRY Medical and Life Sciences Co-Leader [email protected] 212-313-5404 or 800-685-1429

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February 5, 2019 9:15 AM Prior results do not guarantee a similar outcome. Images used are stock photography.