Litigation, Regulation, & Reform Track B: The Defense - PowerPoint PPT Presentation

Responding to the Opioid Crisis: Litigation, Regulation, & Reform Track B: The Defense Perspective George Talarico, Esq. Partner (973) 643-5566 | gtalarico@sillscummis.com One Riverfront Plaza Newark, NJ 07102 Giovanni Ciavarra, PhD Senior Consultant (973) 889-1600 x110 | ciavarra@innovativescience.net Morristown, NJ 0 | Track B: The Defense Perspective

Introduction • Civil litigation at forefront of opioid crisis • In the last several years, approximately 400 lawsuits have been filed • Plaintiffs include: individuals; federal government; states; counties; cities and, Native American tribes • Defendants include: drug manufacturers; distributors; pharmacy retailers; Joint Commission on Accreditation of Healthcare Organizations (JCAHCO); and, physicians 1 | Track B: The Defense Perspective

Introduction (cont’d) • Opioid litigation entering its second phase • First phase early 2000s • Second phase 2014 to present 2 | Track B: The Defense Perspective

First Phase Plaintiffs • Individuals • Class Actions • States Attorneys General 3 | Track B: The Defense Perspective

First Phase Defendants • Manufacturers • Physicians 4 | Track B: The Defense Perspective

First Phase – Theories of Liability • Negligence • Strict Products Liability • Warranty • Consumer Protection Laws (i.e. unlawful deceptive and unconscionable trade practices) • Negligent Marketing • Fraudulent Misrepresentation • Civil Conspiracy 5 | Track B: The Defense Perspective

Second Phase Plaintiffs • Federal Government • State Government • County Government • Municipal Government • Native American Tribes 6 | Track B: The Defense Perspective

Second Phase Defendants • Manufacturers • Physicians • Distributors • Pharmacy Retailers 7 | Track B: The Defense Perspective

Second Phase – Theories of Liability • Public nuisance • Negligent marketing • Controlled Substances Act (“CSA”) • Fraudulent misrepresentation • Unjust Enrichment • Consumer Protection Laws 8 | Track B: The Defense Perspective

Defenses • Lack of causation (i.e. misuse or wrongful conduct by the plaintiff) – A long chain of causation from manufacturer to the end user • Chain of causation from manufacturer to end user broken by “intervening conduct” of patients and physicians – Major obstacle for individual plaintiffs • Most opioid patients do not abuse the drug • According to the NIH, 78% of OxyContin abusers have a history of drug addiction • Most opioid abusers were never given a prescription • Overdoses involving solely a prescribed opioid seem rare as most involve a combination of drugs 9 | Track B: The Defense Perspective

Defenses (cont’d) • Statute of Limitations – Can be fact specific – Discovery rule can save some cases but the courts have dismissed cases on statute of limitations grounds 10 | Track B: The Defense Perspective

Defenses (cont’d) • Learned Intermediary Doctrine – A drug companies duty to warn “is fulfilled by giving adequate warning through the prescribing physician, not directly to the patient” Martin v. Hacker , 83 NY2d 1, 9 (NY 1993) – Does not relieve the drug company of its duty to warn – Has been succesful in at least one Opiod case Frantz v. Valuck , 2018 Okla. Civ. App. Lexis 5 (Ct. of App. of Okla., March 9, 2018) 11 | Track B: The Defense Perspective

Defenses (cont’d) • Fraud not plead with particularity – Complaint does not detail “the who, what, where, or how of their fraud claim” – In the Parens Patriae cases defendants argue that governmental entity (e.g. state, county, municipality) plaintiffs have not plead with specificity: 1. Who made or who received the allegedly false statements within the governmental entity; 2. What false statements were allegedly made to the relevant subscribing physician who wrote the opioid prescription for which the governmental entity paid; 3. Where within the governmental entity were the false statements made; and, 4. How any of the allegedly fraudulent statements affects any of the prescriptions paid for by the governmental entity 12 | Track B: The Defense Perspective

Defenses (cont’d) • Preemption – Defendants argue that the federal government has preempted claims involving drugs approved by the FDA • The plaintiffs cannot establish or explain how it can be fraudulent or misleading to market drugs for FDA approved indications • Statements that are consistent with a FDA approved label are “not misleading as a matter of law.” Prohias v. Pfizer, Inc. , 490 F.Supp.2d 1228, 1235 (S.D.Fla.2007) 13 | Track B: The Defense Perspective

Defenses (cont’d) • Preemption • Defendants argue that the CSA does not create a cause of action • The CSA requires that if a drug company handles ‘controlled substances’, it must monitor the movement of these substances • Plaintiffs have alleged that violation of the CSA is somehow a violation of state or local law • At least one federal court has held that CSA does not create a private cause of action McKesson Corp.v. Hembree , 2018 U.S. Dist. Lexis 3700, 2018 WL 340042 14 | Track B: The Defense Perspective

Defenses (cont’d) • Fraudulent Misrepresentation in inapplicable absent a direct sale – In the Parens Patriae cases defendants argue that governmental entity cannot establish justifiable reliance • The drug manufacturer who allegedly made the misrepresentation is four steps removed from the governmental entity plaintiff • The allegedly fraudulent misrepresentation was made to the physician, who then prescribed the opioid to the patient leading to an alleged injury to the governmental entity 15 | Track B: The Defense Perspective

Defenses (cont’d) • Nuisance – Governmental entity plaintiffs allege that a public nuisance exists from a misuse of opioids which has caused increased cost and strain on the health care system as well as increased criminal behavior – Defendants can rely upon the success of gun manufactures in defeating some public nuisance cases • Multiple jurisdictions dismissed nuisance claims brought against: Smith & Wesson; Ruger; Beretta; and others in part “because defendants are engaged in the lawful manufacture, marketing and sale of a defect-free product in a highly regulated activity far removed from the downstream, unlawful use of handguns that is out of their control and constitutes the nuisance alleged.” People v. Sturm, Ruger & Co., 309 A.D. 91, 93 (N.Y. App. Div. 2003) 16 | Track B: The Defense Perspective

Defenses (cont’d) • Unjust enrichment – Open to attack on at least two grounds: 1. There is no correlation between the injury and the remedy – governmental entities seek to recoup costs of prescription payment not the human costs of the epidemic; and 2. It is an equitable remedy which requires an underlying duty of care or that a risk of the alleged harm was created by defendant 17 | Track B: The Defense Perspective

Defenses – Scientific and Genetic • Can a better understanding of genetics help in the defense of opioid cases? • Genetic defenses are finding there way into toxic tort litigation • Giovanni Ciavarra of Innovative Science Solutions, LLC will talk about Medical and Genetic aspects of Opioids 18 | Track B: The Defense Perspective

Wha hat t does does Inno Innova vativ tive e Scien Science ce Solut Solutions ions Do? Do? 19 | Track B: The Defense Perspective

Scientific and Genetic Considerations What are the injuries? Causation is Difficult • Setting the Stage: – Dependence vs. addiction – Pain scale • Explosion of scientific information • Genetic variability - Effects on metabolism and dependence/addiction 20 | Track B: The Defense Perspective

Dependence vs. Addiction • DEPENDENCE: “Physical dependence is a state of adaptation that is manifested by a drug class specific withdrawal syndrome…” [characterized by the symptoms of tolerance and withdrawal] • ADDICTION: “a primary, chronic disease of brain reward, motivation, memory, and related circuitry,’’ with a ‘‘dysfunction in these circuits’’ being reflected in ‘‘an individual pathologically pursuing reward and/or relief of withdrawal symptoms by substance use and other behaviors.’’ [change in behavior caused by the biochemical changes in the brain] The National Practical Guideline for the Use of Medications in the Treatment of Addiction Involving Opioid Use. (2015). American Society of Addiction Medicine . 21 | Track B: The Defense Perspective

“The Fifth Vital Sign” • Dr. James Campbell’s view that pain should be treated as “ The Fifth Vital Sign ” 22 | Track B: The Defense Perspective

Increasing Scientific Interest in Opioid Abuse PubMed Indexed “Opioid Abuse” Opioid Abuse 1600 1400 1200 1000 800 600 400 200 0 1995 2017 23 | Track B: The Defense Perspective

Increasing Scientific Interest in Opioid Abuse (cont’d) PubMed Indexed “Opioid Abuse Genetics” Opioid Abuse Genetics 100 80 60 40 20 0 1995 2017 24 | Track B: The Defense Perspective

Tracking Scientific Developments Is Key 25 | Track B: The Defense Perspective