Policy and Medicine March 2022 Issue Features FDA Exclusivity, Baby Powder, and FCA Case Dismissal
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March 2022 issue focus is on the financials. We begin by analyzing the DOJ’s FY 2022 False Claim Act (“FCA”) Statistics. Although the money recovered declined when compared to FY 2021, that only tells part of the story.
Next, we shift gears to explore the latest developments with J&J’s baby powder. Recently the Third Circuit rejected J&J’s attempt to place its litigation liability in a single entity and put it into bankruptcy (the so-called Texas Two-Step). Although the case involves consumer products, it has significant implications for pharmaceutical companies attempting to contain their product liability exposure.
We also explore Sandoz’s attempts to overturn an FDA decision granting new chemical entity (“NCE”) exclusivity. According to the complaint, Sandoz estimated that FDA’s decision would cost the company well over $100 million.
In our final article, we return to the FCA. In this article, we explore the government’s recent opposition to attempts to dismiss a whistleblower’s lawsuit utilizing the public disclosure bar. The case is unusual because the government is typically pushing for dismissal.
FALSE CLAIM ACT STATISTICS FOR FISCAL YEAR 2022
SIGNIFICANT RECOVERIES FROM A LARGER NUMBER OF SMALLER CASES
By Gwendolyn A. Ball, Staff Writer
FCA recoveries across the most important program areas declined in FY 2022. However, there is some indication that the decline may be part of a more significant trend, especially if the DOJ increasingly declines to intervene in whistleblower cases.
THE THIRD CIRCUIT LIMITS BANKRUPTCY AS A PRODUCT LIABILITY SAFE HARBOR
By Robert N. Wilkey, Esq., Senior Staff Writer
Summary: On January 30, 2023, the Third Circuit Court of Appeals issued a highly anticipated decision regarding J&J’s controversial plan to limit the company’s talc product liability exposure by redirecting plaintiffs’ suits from trial courts into the bankruptcy process. For the moment, the Court’s rejection of J&J’s approach signals that bankruptcy is not an ironclad safe harbor against massive product liability exposure, as was previously thought.
SANDOZ CHALLENGE RAISES INTERESTING QUESTIONS
By Kirt Kraeuter
After losing a recent appeal, Sandoz has likely reached the end of its challenge that the FDA had erred in approving Aubagio (teriflunomide) in September 2012 as a new drug. Sandoz claimed that teriflunomide was already approved in 1998, but the courts disagreed, finding that the FDA does not approve impurities. Nevertheless, the case highlights essential questions about determining exclusivity periods and the stakes involved.
FLORIDA FEDERAL CASE HIGHLIGHTS LIMITS TO FCA PUBLIC DISCLOSURE BAR
By Dr. Seth B. Whitelaw, Editor
In a rare development, the government filed a motion opposing dismissing a whistleblower’s FCA lawsuit, even though it chose not to intervene. The case provides helpful insights into the use of the public disclosure bar.
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