The Cost to Society of Pharmaceutical Mass Tort Litigation
In this lecture, lawyer Mary Bartkus shares her firsthand experience of the international litigation of multibillion dollar claims against Big Pharma when a medication taken by millions of users worldwide is withdrawn.
She will address the impact of the withdrawal and United States litigation on regulators, legislators, and on cross-border litigation in common law and civil law jurisdictions across six continents.
When Merck & Co., Inc. withdrew the innovative painkiller Vioxx (Rofecoxib) from more than eighty countries following evidence that high-dosage use could cause an increased risk of heart attack and stroke, thousands of US citizens brought personal injury claims.
A Texas jury awarded more than $250 million to one individual claimant. Although that verdict was reduced and later overturned on appeal, and most US juries found for the company, with more than 26,000 US court claims yet to be tried and another 14,100 waiting to be filed, the company agreed to resolve the US personal injury claims for $4.85 billion, a deal said to be “favourable” to the company and “clearly at the low end of general expectations”.
Internationally, claims were brought in waves following developments in the US. These international cases would be heard and decided in jurisdictions with different traditions and conditions for litigants.
In Australia, a justice of the Federal Court dismissed all claims against Merck & Co., Inc. in class litigation, finding “Merck had done everything that might reasonably be expected of it in the discharge of its duty of care”. The Full Court overturned an award of damages to the individual representative claimant for failure to establish causation, and awarded full costs to the company; the High Court denied claimants leave to appeal. Claims of remaining group members then were resolved.
In England, claimants abandoned multi-party actions filed in the High Court. In Scotland, the parties litigated and resolved individual actions. In Canada, the parties litigated and resolved overlapping class and individual actions in ten provinces. Courts regularly dismissed cases in civil law jurisdictions.
The lecture considers this landmark international litigation alongside the challenges companies face when investing billions of dollars to develop innovative medications, and asks: Who won and who lost?
Mary E. Bartkus is Special Counsel at Hughes Hubbard & Reed LLP, a member of the Bars of New York and New Jersey; previously Executive Director & Senior Counsel, Merck & Co., Inc.