Michael Walsh

United States
Phone: 214.651.4459
Areas of Practice
  • Health
  • Products Liability

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 This long sought Draft Guidance breaks little new…more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
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