Keenan Quoted in Law360 on Off-Label Marketing Claims
Shook, Hardy & Bacon Partner Matt Keenan discusses rejecting off-label marketing claims over medical devices after the recent Medtronic win in the Tenth Circuit for an April 22 Law360 article.
The Tenth Circuit decision cemented the idea that medical devices are usually immune to injury claims if they have completed the FDA’s pre-market approval (PMA) process, which will help future defendants get suits dismissed earlier in the process, saving costly and drawn-out discovery battles.
Keenan explains the impact of the case, saying, “This body of law that we have now with PMA-approved devices provides a rare opportunity for defendants to get cases dismissed at the motion to dismiss stage, and avert any additional discovery for PMA-approved devices."
In the Patricia Caplinger v. Medtronic Inc. decision, the plaintiff brought claims including failure-to-warn, but Medtronic argued that the FDA-approved label for the device does warn that the agency has not established the safety of using the device in the way the plaintiff’s doctor used it.
Talking about the case, Keenan says, "The off-label use claim used to be an opportunity for plaintiffs to carve out some life for these suits, to say that manufacturers affirmatively took on some additional duty because they did something beyond what the regulatory framework required them to do, by marketing an off-label use.”
Keenan adds that “This opinion really goes a long way to say that those types of attempts to create exemptions will not be allowed.”
The Tenth Circuit decision cemented the idea that medical devices are usually immune to injury claims if they have completed the FDA’s pre-market approval (PMA) process, which will help future defendants get suits dismissed earlier in the process, saving costly and drawn-out discovery battles.
Keenan explains the impact of the case, saying, “This body of law that we have now with PMA-approved devices provides a rare opportunity for defendants to get cases dismissed at the motion to dismiss stage, and avert any additional discovery for PMA-approved devices."
In the Patricia Caplinger v. Medtronic Inc. decision, the plaintiff brought claims including failure-to-warn, but Medtronic argued that the FDA-approved label for the device does warn that the agency has not established the safety of using the device in the way the plaintiff’s doctor used it.
Talking about the case, Keenan says, "The off-label use claim used to be an opportunity for plaintiffs to carve out some life for these suits, to say that manufacturers affirmatively took on some additional duty because they did something beyond what the regulatory framework required them to do, by marketing an off-label use.”
Keenan adds that “This opinion really goes a long way to say that those types of attempts to create exemptions will not be allowed.”