Life Sciences

     
       

Publications

  • The Wide-Ranging Effects of the Federal Circuit’s Assault on Skinny Labels

    Federal Circuit’s Assault on Skinny Labels

    December 4, 2020

    A recent decision by the U.S. Federal Circuit Court of Appeals dramatically changes the risk exposure for generic manufacturers that have a drug on the market with a skinny label. The Federal Circuit has paved the way for a finding of induced infringement against every skinny-label drug, many of which have been on the market for years, and therefore have years of potential exposure.
  • HHS Secretary’s Fourth Amendment to PREP Act Declaration Clarifies Its Intent for Federal Jurisdiction and Broad Application to COVID-19-Related Claims

    Fourth Amendment to PREP Act Declaration Issued

    December 4, 2020

    The fourth amendment to HHS Secretary Azar’s PREP Act Declaration assertively addresses current disputes involving federal jurisdiction for courts hearing disputes about the Act’s application to claims for injury, and further suggests an intention for a broad application of the Act.
  • What If Your Automaker-Manufactured Ventilator Is a Lemon?

    What If Your Automaker-Manufactured Ventilator Is a Lemon?

    May 6, 2020

    Ventilators are being manufactured pursuant to U.S. Food and Drug Administration emergency use authorizations by companies that don’t normally make such devices, and the FDA has effectively waived most federal regulations relative to the manufacture of these devices in response to the current health emergency. The Public Readiness and Emergency Preparedness (PREP) Act typically would provide immunity for liability arising from the use of these devices in response to the health emergency, but only for a limited period of time. What happens when the PREP Act authorization expires in October 2024 and one of these ventilators allegedly injures a patient, and what can these companies do to protect themselves from liability claims?
  • FDA’s Role in Battling the COVID-19 Pandemic: Part I What Manufacturers, Diagnostic Laboratories and Their Insurers Need to Know

    FDA’s Role in Battling COVID-19 Pandemic: Part I

    March 23, 2020

    Manufacturers and diagnostic laboratories need to remain aware of decisions and actions taken by the FDA and take corresponding measures to comply. Insurance carriers also should be alert to impacts on the manufacture and shipment of their covered products as well as the FDA’s reaction to these impacts, as both could precipitate the need for changes in their policies.

  • Liability Immunity Relating to Implementation of Countermeasures to COVID-19

    Liability Immunity for Drug and Medical Device Manufacturers, Distributors and Users

    March 19, 2020

    The focus of an HHS Declaration is to permit the special use of drugs and other medical products during the COVID-19 pandemic that either have not yet been approved or cleared by the FDA or that may be used off-label without the risk of liability in the event of an injury or other claimed loss. In the event of injury, relief can be found via the Countermeasures Injury Compensation Program (CICP).
  • Learned Intermediary Doctrine Protects Pharmacy from Liability for Failure to Warn of Prescription Drug Side Effects

    Pharmacy Failure to Warn of Prescription Drug Side Effects

    March 28, 2019

    The Illinois First District Appellate Court recently held that pursuant to the learned intermediary doctrine a pharmacy has no duty to warn customers of prescription drug side effects that may occur in “anyone” who takes the drug.