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

0 | Track B: The Defense Perspective

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

1 | Track B: The Defense Perspective

• 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

Introduction

2 | Track B: The Defense Perspective

• Opioid litigation entering its second phase
• First phase early 2000s
• Second phase 2014 to present

Introduction (cont’d)

3 | Track B: The Defense Perspective

• Individuals
• Class Actions
• States Attorneys General

First Phase Plaintiffs

4 | Track B: The Defense Perspective

• Manufacturers
• Physicians

First Phase Defendants

5 | 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

6 | Track B: The Defense Perspective

• Federal Government
• State Government
• County Government
• Municipal Government
• Native American Tribes

Second Phase Plaintiffs

7 | Track B: The Defense Perspective

• Manufacturers
• Physicians
• Distributors
• Pharmacy Retailers

Second Phase Defendants

8 | Track B: The Defense Perspective

• Public nuisance
• Negligent marketing
• Controlled Substances Act (“CSA”)
• Fraudulent misrepresentation
• Unjust Enrichment
• Consumer Protection Laws

Second Phase – Theories of Liability

9 | Track B: The Defense Perspective

• 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

Defenses

10 | Track B: The Defense Perspective

• Statute of Limitations

– Can be fact specific – Discovery rule can save some cases but the courts have dismissed cases on statute of limitations grounds

Defenses (cont’d)

11 | Track B: The Defense Perspective

• 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.

• f App. of Okla., March 9, 2018)

Defenses (cont’d)

12 | Track B: The Defense Perspective

• 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

Defenses (cont’d)

13 | 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

• f law.” Prohias v. Pfizer, Inc., 490 F.Supp.2d

1228, 1235 (S.D.Fla.2007)

14 | Track B: The Defense Perspective

Defenses (cont’d)

• Preemption
• Defendants argue that the CSA does not create a cause
• f action
• The CSA requires that if a drug company handles

‘controlled substances’, it must monitor the movement

• f 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

15 | 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

• pioid to the patient leading to an alleged injury

to the governmental entity

16 | 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)

17 | 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

18 | 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

19 | Track B: The Defense Perspective

Wha hat t does does Inno Innova vativ tive e Scien Science ce Solut Solutions ions Do? Do?

20 | 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

21 | 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.

22 | Track B: The Defense Perspective

• Dr. James Campbell’s view that pain should be

treated as “The Fifth Vital Sign”

“The Fifth Vital Sign”

23 | Track B: The Defense Perspective

PubMed Indexed “Opioid Abuse”

200 400 600 800 1000 1200 1400 1600

Opioid Abuse

1995 2017

Increasing Scientific Interest in Opioid Abuse

24 | Track B: The Defense Perspective

PubMed Indexed “Opioid Abuse Genetics”

20 40 60 80 100

Opioid Abuse Genetics

1995 2017

Increasing Scientific Interest in Opioid Abuse (cont’d)

25 | Track B: The Defense Perspective

Tracking Scientific Developments Is Key

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• Genetic differences contribute to the variability in

patient response to opioids (efficacy and safety)

• Pharmacogenomics - how genetics influence a

person's response to medications. Research is largely focused on drug targets, disease genes or drug metabolizing enzymes (among others)

Role for Genetics in Opioid Defense?

27 | Track B: The Defense Perspective

• Metabolism

– Phase I (Cytochrome P450s) & Phase II enzymes (Glutathione, N-acetyltransferase, etc.); drug transporters

• Dependence/Addiction

– Is there an opioid dependence/addiction gene? [estimated that only 1-2% develop a pain reliever use disorder]

Relevance of Pharmacogenomics

28 | Track B: The Defense Perspective

Scientific Information is Constantly Emerging

• Ongoing research is uncovering new genomic

markers that are associated with FDA approved therapies but not included in the label (e.g., eMERGE Network)

• eMERGE has screened 500+ therapeutic products for

identification of pharmacogenomic markers. Information is publicly available on Sequence and Phenotype Integration Exchange (SPHINX)

29 | Track B: The Defense Perspective

New research findings may increase the risk of pharmacogenomics-inspired litigation

Oxycodone Results from SPHINX

30 | Track B: The Defense Perspective

Opioid Addiction Gene? Stay Tuned…

31 | Track B: The Defense Perspective

Opioid Addiction Gene? Stay Tuned…

32 | Track B: The Defense Perspective

• Genetic
• Epigenetic
• Epidemiology
• Clinical specialists
• Toxicology
• Risk Assessment/Regulatory
• Biostatistics

Strong Expert Teams Can Help Build Bullet Proof Defenses

33 | Track B: The Defense Perspective

MDL – Does It Change The Landscape?

• Do the defenses even matter?

– Judge Polster has made it clear that “we don’t need a lot of briefs and we don’t need trials” – His approach which is geared to negotiated settlement may not give much weight to defenses

• A global settlement in the MDL may help defendants

resolve all their liability in one proceeding

34 | Track B: The Defense Perspective

MDL – Developments

• Discovery Proceedings

– Plaintiff’s looking for smoking gun

• US DEA database

‒ Nine years of data on opioid sales ‒ State by state breakdown ‒ Will show “aggregate amount of pills sold and the market shares of each manufacturer and distribution.”

35 | Track B: The Defense Perspective

MDL – Developments (cont’d)

• US DOJ requested permission to participate as a

“friend of the court” – Seeks to provide the Federal Government’s knowledge and perspective – The DOJ wants to be involved in the settlement discussions.

36 | Track B: The Defense Perspective

• Inevitably the Opioid litigation has been compared to

tobacco – Similarities

• Opioid crisis defined as a major health care

issue by politicians of all ilk

• Same cast of characters involved in both

litigations

• Most state and local governments represented

by contingency fee private lawyers

Comparison to Tobacco

37 | Track B: The Defense Perspective

Comparison to Tobacco (cont’d)

– Differences

• Far more complex
• Not direct sale to consumer
• More parties involved
• Opioids are approved as safe and effective by

the FDA

38 | Track B: The Defense Perspective

Comparison to Tobacco (cont’d)

• The Tobacco settlement could be harbinger of what

may happen with any opioid settlement funds – The tobacco settlement funds have not ended tobacco use – Much of the money went to lawyers and to state general funds not necessarily earmarked for addressing health concerns caused by tobacco use

39 | Track B: The Defense Perspective

Summary and Conclusion

• Plaintiffs’ cases have evolved

– Moved away from individual and class action to state and municipal government plaintiffs – Broader causes of actions to avoid defenses that blame prescriber or user – Wider array of defendants

40 | Track B: The Defense Perspective

Summary and Conclusion (cont’d)

• Plaintiffs’ strategy has also evolved and uses public opinion

by creating several narratives: 1. The public scourge created by the opioid epidemic which was fueled by the opioids companies saturating the market with opioids; 2. The opioid companies have engaged in a pattern of deception making false claims about their products’ addictiveness and efficacy; 3. The opioid companies have failed to monitor the flow of their drugs as required by the CSA and have been inattentive to suspicious or unusual orders; and, 4. The opioid companies have made enormous profits

41 | Track B: The Defense Perspective

Summary and Conclusion (cont’d)

• Defendants have some strong legal and factual

defenses

• 1. Lack of causation remains an issue
• 2. FDA preemption
• 3. CSA creates neither a duty nor a private cause of

action

• 4. Genetics?

42 | Track B: The Defense Perspective

Summary and Conclusion (cont’d)

• Defendants should articulate a counter narrative such

as:

• 1. Explaining that opioids are an approved class of

drugs and are safe and effective when properly used;

• 2. Most opioid abusers who overdose obtained the

drugs without a prescription;

• 3. Studies in NYC indicate that 94% of overdoses

involving prescription opioids were due to a combination of drugs.

43 | Track B: The Defense Perspective

Questions? Get in Touch

George Talarico, Esq.

Partner Sills Cummis & Gross P.C.

(973) 643-5566 | gtalarico@sillscummis.com

Giovanni Ciavarra, PhD

Senior Consultant Innovative Science Solutions, LLC

(973) 889-1600 x110 | ciavarra@innovativescience.net