Vicki Marsh v. Genentech Inc.
2012 U.S. App. LEXIS 18703
| 6th Cir. | 2012Background
- Marsh and others sued Genentech for injuries from Raptiva under Michigan products liability law in a diversity action.
- Raptiva was FDA-approved in 2003 and marketed 2003–2009; Marsh used it starting in 2004 and alleged severe health effects.
- Michigan law provides immunity to drug manufacturers if the drug and labeling were in FDA-approved compliance when left the manufacturer’s control.
- Marsh alleged Genentech failed to update safety information post-approval and failed to comply with FDA reporting requirements.
- The district court granted immunity based on preemption under Garcia, and Marsh appealed arguing non-compliance is not preempted.
- Court examines whether non-compliance allegations fall within the Act’s immunity exceptions and whether such claims are preempted by federal law.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Garcia preempts immunity-exceptions under the Michigan Act | Marsh argues non-compliance claims are not preempted and can defeat immunity. | Genentech argues Garcia preempts such claims as fraud-on-the-FDA type defenses. | Preemption applies; Garcia controls immunity-exceptions. |
| Whether Marsh’s non-compliance allegations fit the Act’s 'compliance with FDA approval' | Non-compliance post-approval can defeat immunity. | Allegations concern post-market reporting, not substantive labeling compliance. | Allegations do not establish substantive non-compliance; immunity remains. |
| Whether immunity is an affirmative defense and burden-shifting applies | If affirmative, Genentech must prove FDA-approved compliance. | Immunity may be invoked by physician complaint; burden may shift if properly pled. | Marsh’s pleadings show inability to defeat immunity; Genentech’s burden not met by complaint. |
Key Cases Cited
- Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (U.S. 2001) (fraud-on-the-FDA claims preempted; federal scheme exclusive enforcement)
- Garcia v. Wyeth-Ayerst Laboratories, 385 F.3d 961 (6th Cir. 2004) (FDA fraud-on-the-FDA preemption of Act's exceptions)
- Wyeth v. Levine, 555 U.S. 555 (U.S. 2009) (state-law failure-to-warn claims not per se preempted by FDA; post-market information can matter)
- In re Aredia & Zometa Prods. Liab. Litig., 352 F. App’x 994 (6th Cir. 2009) (unpublished; preemption context relating to fraud-on-FDA claims)