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

December 13, 2017

Sonia M. Valdes, Esq. Vice President, Medmarc Lisa M. Rice, Esq. Partner, Walsworth Laurie E. Sherwood, Esq. Partner, Walsworth

The Year That Was: 2017

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ProAssurance Investor Update March 6, 2017

Agenda

Trends in Life Sciences Judicial Hellholes Litigation Updates - Noteworthy Verdicts Regulatory Actions On the Horizon Expanding Litigation

Trends in Life Sciences

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ProAssurance Investor Update March 6, 2017

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

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ProAssurance Investor Update March 6, 2017

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

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ProAssurance Investor Update March 6, 2017

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)

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ProAssurance Investor Update March 6, 2017

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)

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ProAssurance Investor Update March 6, 2017

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

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ProAssurance Investor Update March 6, 2017

State Actions

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ProAssurance Investor Update March 6, 2017

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

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ProAssurance Investor Update March 6, 2017

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.

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ProAssurance Investor Update March 6, 2017

Opioid Litigation – Allegations

Allegations against manufacturers (Purdue, Endo, Allergan) focus

• n 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

• rders

Claims against the pharmacies are based on their failure to report

• r stop suspicious orders of, and to prevent the theft or diversion
• f opioid drugs

Against the physicians, the allegations are both civil and criminal

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ProAssurance Investor Update March 6, 2017

Opioid Litigation – State Actions and New MDL

Allegations from Complaints

West Virginia Ohio Kentucky

New MDL Created

Northern District of Ohio Judge Polster

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ProAssurance Investor Update March 6, 2017

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

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ProAssurance Investor Update March 6, 2017

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?

Judicial Hellholes

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ProAssurance Investor Update March 6, 2017

Judicial Hellholes 2017-2018

The list of shame

Florida California St. Louis, Missouri NYC Asbestos Litigation Philadelphia New Jersey Madison and Cook Counties Louisiana

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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

Litigation Updates: Noteworthy Verdicts

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ProAssurance Investor Update March 6, 2017

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)

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ProAssurance Investor Update March 6, 2017

Devices – Hernia Mesh

Defense Win

Motion for Summary Judgment Granted (C.R. Bard) – Southern District

• f Indiana (February 2017)

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ProAssurance Investor Update March 6, 2017

Devices – Da Vinci Surgical System

Plaintiff Win

Washington High Court Says Intuitive Had Duty to Warn Hospital (February 2017)

Defense Win

Motion to Dismiss Granted Over Alleged Metal Debris – District Court for Northern Georgia (January 2017) Motion to Dismiss Granted – U.S. Court of Appeals for Eleventh Circuit (August 2017)

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ProAssurance Investor Update March 6, 2017

Devices – Knee Implants

Defense Win

Defense Verdict (Zimmer) – Northern District of Illinois (January 2017) Summary Judgment Granted in 137 Lawsuits (Zimmer) – Northern District

• f Illinois (March 2017)

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ProAssurance Investor Update March 6, 2017

Devices – Hip Implants

Plaintiff Win

$1B Verdict Against J&J – Northern District of Texas (January 2017) $2M Verdict Against Zimmer – Second Judicial District, New Mexico (March 2017) $247M Verdict Against J&J – Northern District of Texas (November 2017)

Defense Win

Defense Verdict (Zimmer) – Eastern District of Texas (May 2017)

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ProAssurance Investor Update March 6, 2017

Drugs – Risperdal

Plaintiff Win

Defense Verdict Reversed in Philadelphia, PA (November 2017)

Defense Win

J&J Wins Summary Judgment – Philadelphia, PA (March 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)

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ProAssurance Investor Update March 6, 2017

Drugs – Depakote

Plaintiff Win

$15M Jury Verdict - Southern District of Illinois (June 2017) $38M Verdict Affirmed by Missouri Supreme Court (September 2017) Abbott's Motion to Dismiss Denied - Southern District of Illinois (September 2017)

Defense Win

Defense Verdict – Northern District of Ohio (February 2017) Summary Adjudication Granted On Causation – Southern District

• f Illinois (November 2017)

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ProAssurance Investor Update March 6, 2017

Drugs – Xarelto

Plaintiff Win

$28M Jury Verdict - Philadelphia, PA (December 2017) 1,500 pending cases – next trial in January 2018

Defense Win

Bayer, Janssen Win The First Three Federal MDL Bellwether Trials (U.S. District Court for the Eastern District of LA)

• May 3, 2017
• June 13, 2017
• August 21, 2017

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ProAssurance Investor Update March 6, 2017

Drugs – Testosterone Replacement

Plaintiff Win

$150M Jury Verdict (AndroGel) – Northern District of Illinois (July 2017) $140M Jury Verdict (AndroGel) –

• No. District of Illinois (October

2017)

Defense Win

Defense Verdict (Androgel) – Illinois State Court (August 2017) Defense Verdict (Auxilium) – No.

• Dist. of Ill. (November 2017)

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ProAssurance Investor Update March 6, 2017

Drugs – Zoloft

Defense Win

Summary Judgment Granted in Two WV Birth Defect Lawsuits (Feb 2017) Summary Judgment in Favor of Pfizer Upheld – Third Circuit Court of Appeals (June 2017)

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ProAssurance Investor Update March 6, 2017

Drugs – Motrin

Defense Win

McNeil Gets New Trial After $48M Verdict - CA Court of Appeal (July 2017)

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ProAssurance Investor Update March 6, 2017

Talc Powder

Plaintiff Win

$110M Jury Verdict for Ovarian Cancer – Missouri (May 2017)

Defense Win

Defense Verdict in Ovarian Cancer Case – MO (March 2017) JNOV/ New Trial for $417M Ovarian Cancer Verdict – Los Angeles (October 2017) $72M Verdict Reversed on Appeal in MO (October 2017) Defense Verdict in Mesothelioma Case - Los Angeles Superior Court (November 2017)

Regulatory Actions

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Final Guidance Issued in 2017

Assessment of Abuse Potential of Drugs

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ProAssurance Investor Update March 6, 2017

Final Guidance Issued in 2017

Deciding When to Submit a 510(k) for a Software Change to an Existing Device

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ProAssurance Investor Update March 6, 2017

Final Guidance Issued in 2017

Use of Real-World Evidence to Support Regulatory Decision- Making for Medical Devices

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ProAssurance Investor Update March 6, 2017

Final Guidance Issued in 2017

De Novo Classification Process (Evaluation of Automatic Class III Designation) - Draft Guidance for Industry and Food and Drug Administration Staff

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ProAssurance Investor Update March 6, 2017

Final Guidance Issued in 2017

Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices

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ProAssurance Investor Update March 6, 2017

Final Guidance Issued in 2017

Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request

On the Horizon

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ProAssurance Investor Update March 6, 2017

On the Horizon

Expedited Pathway for Approval of Biosimilars

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ProAssurance Investor Update March 6, 2017

On the Horizon

FDA approves first gene therapy treatment for cancer (August 2017)

Kymriah is a CAR T-cell therapy approved to treat certain children and young adults with B-cell acute lymphoblastic leukemia (ALL) ALL is cancer of the bone marrow and blood – most common childhood cancer. Dr. Scott Gottlieb lauded new technologies such as gene and cell therapies, which hold out the potential to transform medicine. First of its kind treatment that reprograms a patient’s own cells to attack deadly cancer growth.

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ProAssurance Investor Update March 6, 2017

On the Horizon

QC of Products Combined by Compounding Pharmacies

Expanding Litigation

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ProAssurance Investor Update March 6, 2017

Expanding Litigation

Expansion of the Hernia Mesh Litigation New Plaintiff and Defendants in the Opioid Litigation Third Party Litigation Funding

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ProAssurance Investor Update March 6, 2017

Questions?

For More Information:

Lisa R. Rice Partner, Walsworth lrice@wfbm.com (714) 634-2522 Laurie E. Sherw ood Partner, Walsworth lsherwood@wfbm.com (415) 781-7072 Sonia M. Valdes Vice President, Medmarc svaldes@medmarc.com (703) 652-1300