The Year That Was: 2017 Agenda Trends in Life Sciences Judicial - PowerPoint PPT Presentation

Sonia M. Valdes, Esq. Vice President, Medmarc Lisa M. Rice, Esq. Partner, Walsworth Laurie E. Sherwood, Esq. Partner, Walsworth December 13, 2017 The Year That Was: 2017

Agenda Trends in Life Sciences Judicial Hellholes Litigation Updates - Noteworthy Verdicts Regulatory Actions On the Horizon Expanding Litigation ProAssurance Investor Update March 6, 2017 1

Trends in Life Sciences

Updates from the Trump Administration and New FDA Gottlieb’s First Six Months Drug Prices and Regulations FDA Funding Bill Challenges Confronting the FDA Under the Trump Administration ProAssurance Investor Update March 6, 2017 3

SCOTUS Recent SCOTUS Decisions on Personal Jurisdiction  BNSF Railway Co. v. Tyrrell (May 30, 2017) •General jurisdiction – defendant must be at home in the forum •“At home” = place of incorporation and principal place of business  Bristol-Myers Squibb v. Superior Court of CA, San Francisco (June 19, 2017) •Specific jurisdiction – requires a connection between forum and specific claims at issue; defendant's unrelated contacts with forum are irrelevant ProAssurance Investor Update March 6, 2017 4

SCOTUS Cases Applying BMS  Motion to Dismiss Granted in MO (6/ 27/ 17)  Motion to Dismiss Granted in MO (9/ 18/ 17)  J&J Gets Reversal of St. Louis Talc Cancer Verdict (10/ 17/ 17)  MO State Court Upholds $110M Talc Verdict Against J&J (11/ 29/ 17)  PA State Court Affirms Jurisdiction in 70 Pelvic Mesh Cases (12/ 5/ 17) ProAssurance Investor Update March 6, 2017 5

The Opioid Addiction Crisis In the News  Endo Opana ER Withdrawal Request (July 2017)  DOJ Opioid Task Force (August 2017)  60 Minutes and Washington Post Investigation (Oct 15, 2017)  Administration’s response to the Opioid epidemic (Oct 26, 2017) ProAssurance Investor Update March 6, 2017 6

The Opioid Addiction Crisis Statistics  91 people a day have died in 2017 due to Opioid Addiction  In 2016, more than 60,000 people have died  In 2015, more than 52,000 people have died  In 2017, it is estimated that expenditures for Opioid Addiction will cost $78.5B •This includes costs for healthcare, substance abuse treatment, lost productivity and additional resources for the criminal justice system  Manufacturers of Opioids have created a $13B a year industry  Examples of abuse •Kenet, WV •Ohio ProAssurance Investor Update March 6, 2017 7

State Actions ProAssurance Investor Update March 6, 2017 8

Opioid Crisis – Actions Pending Actions brought by State Attorney Generals Actions brought by Counties and Cities Two Indian Tribes: Cherokee and St. Croix Chippewa Putative class action in Arkansas Two Florida hospitals Teamsters Health and Welfare Benefit Fund ProAssurance Investor Update March 6, 2017 9

Opioid Litigation Settlements Purdue Pharma reached a settlement to pay the federal government $634M in 2007 after three top executives pled guilty to criminal and civil charges involving its false marketing of Oxycontin. Early on, Purdue also reached settlements with the State of WV and Ohio. WV also filed suit against large distributors of Opioids in 2007. After coverage battles with their insurers, most of the distributors settled as well. Most settlements were $15-30M. Purdue also recently settled class actions brought by all 10 provinces in Canada for $20M. Controversy over the low amount paid. In January of 2017, McKesson (a distributor) settled with the DOJ for $150M. ProAssurance Investor Update March 6, 2017 10

Opioid Litigation – Allegations Allegations against manufacturers (Purdue, Endo, Allergan) focus on fraudulent and illegal marketing practices Allegations against the distributors include failure to maintain controls and put in procedures to prevent theft and diversion of the drugs, and a failure to report and investigate suspicious orders Claims against the pharmacies are based on their failure to report or stop suspicious orders of, and to prevent the theft or diversion of opioid drugs Against the physicians, the allegations are both civil and criminal ProAssurance Investor Update March 6, 2017 11

Opioid Litigation – State Actions and New MDL Allegations from Complaints  West Virginia  Ohio  Kentucky New MDL Created  Northern District of Ohio  Judge Polster ProAssurance Investor Update March 6, 2017 12

Opioid Crisis – The New Tobacco? Similarities  The Tobacco litigation was brought by State Attorney Generals and health advocates  The Tobacco litigation was filed to recover health expenditures and reform the marketing practices of the industry  The allegations against the tobacco manufacturers were consumer fraud, public nuisance, restitution and unjust enrichment •Most of the litigation was advanced on the State’s Consumer Protection Statutes ProAssurance Investor Update March 6, 2017 13

Opioid Crisis – Coverage Issues Is there a duty to defend claims for which no specific compensation has been sought for BI/ PD to specific individuals? Does the alleged violation of business practices (illegal and fraudulent marketing) constitute an occurrence? Do the knowledge-based exclusions bar coverage for the alleged actions of distributors? How many occurrences? ProAssurance Investor Update March 6, 2017 14

Judicial Hellholes

Judicial Hellholes 2017-2018 The list of shame  Florida  California  St. Louis, Missouri  NYC Asbestos Litigation  Philadelphia  New Jersey  Madison and Cook Counties  Louisiana ProAssurance Investor Update March 6, 2017 16

Judicial Hellholes Watch List Dishonorable Mention  Baltimore, Maryland  Georgia  Newport News, Virginia  Oregon Supreme Court  Pennsylvania Supreme Court  US Court of Appeal for the 9th Circuit  West Virginia ProAssurance Investor Update March 6, 2017 17

Litigation Updates: Noteworthy Verdicts

Devices – Pelvic Mesh Plaintiff Wins  $20M Verdict Against J&J – Phil. Court of Common Pleas (April 2017)  $2M Verdict Against J&J – Phil. Court of Common Pleas (May 2017)  J&J’s Defense Verdict Overturned – Phil. Court of Common Pleas (July 2017)  $57M Against J&J – Phil. Court of Common Pleas (September 2017)  $3M Verdict Against Ethicon Affirmed – U.S. Supreme Court (October 2017) ProAssurance Investor Update March 6, 2017 19

Devices – Hernia Mesh Defense Win  Motion for Summary Judgment Granted (C.R. Bard) – Southern District of Indiana (February 2017) ProAssurance Investor Update March 6, 2017 20

Devices – Da Vinci Surgical System Plaintiff Win Defense Win  Washington High Court Says  Motion to Dismiss Granted Over Intuitive Had Duty to Warn Alleged Metal Debris – District Hospital (February 2017) Court for Northern Georgia (January 2017)  Motion to Dismiss Granted – U.S. Court of Appeals for Eleventh Circuit (August 2017) ProAssurance Investor Update March 6, 2017 21

Devices – Knee Implants Defense Win  Defense Verdict (Zimmer) – Northern District of Illinois (January 2017)  Summary Judgment Granted in 137 Lawsuits (Zimmer) – Northern District of Illinois (March 2017) ProAssurance Investor Update March 6, 2017 22

Devices – Hip Implants Plaintiff Win Defense Win  $1B Verdict Against J&J –  Defense Verdict (Zimmer) – Northern District of Texas Eastern District of Texas (May (January 2017) 2017)  $2M Verdict Against Zimmer – Second Judicial District, New Mexico (March 2017)  $247M Verdict Against J&J – Northern District of Texas (November 2017) ProAssurance Investor Update March 6, 2017 23

Drugs – Risperdal Plaintiff Win Defense Win  Defense Verdict Reversed in  J&J Wins Summary Judgment – Philadelphia, PA (November Philadelphia, PA (March 2017) 2017)  Mississippi Supreme Court Overturns $2M Verdict Against J&J (October 2017)  PA Appeals Court bars Michigan residents’ claims in Philadelphia mass tort action (November 2017) ProAssurance Investor Update March 6, 2017 24

Drugs – Depakote Plaintiff Win Defense Win  $15M Jury Verdict - Southern  Defense Verdict – Northern District of Illinois (June 2017) District of Ohio (February 2017)  $38M Verdict Affirmed by  Summary Adjudication Granted Missouri Supreme Court On Causation – Southern District (September 2017) of Illinois (November 2017)  Abbott's Motion to Dismiss Denied - Southern District of Illinois (September 2017) ProAssurance Investor Update March 6, 2017 25

Drugs – Xarelto Plaintiff Win Defense Win  $28M Jury Verdict -  Bayer, Janssen Win The First Philadelphia, PA (December Three Federal MDL Bellwether 2017) Trials (U.S. District Court for the Eastern District of LA)  1,500 pending cases – next trial in January 2018 •May 3, 2017 •June 13, 2017 •August 21, 2017 ProAssurance Investor Update March 6, 2017 26

Drugs – Testosterone Replacement Plaintiff Win Defense Win  $150M Jury Verdict (AndroGel) –  Defense Verdict (Androgel) – Northern District of Illinois (July Illinois State Court (August 2017) 2017)  Defense Verdict (Auxilium) – No.  $140M Jury Verdict (AndroGel) – Dist. of Ill. (November 2017) No. District of Illinois (October 2017) ProAssurance Investor Update March 6, 2017 27