Michael Walsh

United States

  • 214.651.4459

5th Circuit Delivers Knockout Punch to Drug Claims

In 2003 the Texas Legislature provided a presumption that a manufacturer is not liable for a claim that it failed to provide adequate warnings for a pharmaceutical product if the product was approved by the Food and Drug…more
| Products Liability

Par Pharmaceutical vs USA - Off-Label Promotion and the First Amendment

Par filed suit seeking a judgment declaring FDA’s regulations unconstitutional and preventing FDA from deeming lawful First Amendment protected speech as evidence of criminal intent. In response, FDA is seeking early dismissal,…more
| Administrative Law, Constitutional Law, Health, Products Liability

Off-Label Communications about Drugs and Devices for Responding to Unsolicited Requests: Charting a Path to the Holy Grail of Truthful Information?

On December 27, 2011, FDA issued its Draft “Guidance for Industry Responding to Unsolicited Requests for Off-Label Information about Prescription Drugs and Medical Devices.” This long sought Draft Guidance breaks little new…more
| Consumer Protection, Health, Products Liability
Areas of Practice
  • Health
  • Products Liability
This profile may constitute attorney advertising. Prior results do not guarantee a similar outcome. Any correspondence with this profile holder does not constitute a client/attorney relationship. Neither the content on this profile nor transmissions between you and the profile holder through this profile are intended to provide legal or other advice or to create an attorney-client relationship.