SCHEDIN v. ORTHO-McNEIL-JANSSEN PHARMACEUTICALS, INC., 776 F. Supp. 2d 907

Schedin was prescribed Levaquin in Feb 2008 and suffered bilateral Achilles tendon ruptures after eight days of use.
At prescribing, Levaquin's label warned of tendon rupture risk, mentioning possible increase when using corticosteroids, especially in the elderly.
Schedin argues the warning was inadequate due to placement, noticeability, and lack of a higher toxicity warning for Levaquin vs. other fluoroquinolones.
Ortho-McNeil contends the FDA-approved label could not be unilaterally strengthened and that the FDCA would preclude stronger warnings unless FDA approved.
The FDA later ordered a black box warning in 2008; the court analyzes whether manufacturers can warn through methods other than label changes via the CBE process or other means.
This motion involves whether state failure-to-warn claims are preempted and whether punitive damages rely on a fraud-on-the-FDA theory under Buckman.

Issue	Plaintiff's Argument	Defendant's Argument	Held
Whether state failure-to-warn claims are preempted by the FDCA	Schedin asserts state-law warnings are permissible and not precluded by federal labeling rules.	Ortho-McNeil contends FDCA labeling requirements and impossibility preclude state-law warnings.	Not preempted; state-law warnings feasible via non-label means and label changes where possible.
Whether Ortho-McNeil could adequately warn without violating federal law (CBE, black box, comparative data)	Ortho-McNeil could have used CBE, Dear Doctor letters, and other steps to strengthen warnings.	Label changes were restricted and not feasible without FDA action; black box not unilateral.	Ortho-McNeil could have warned through alternatives (CBE, letters, proposals); not legally impossible.
Whether the black box warning issue bars state claims or is immaterial	A stronger warning could have been pursued; black box not the sole path.	Unilateral black box warnings may be prohibited.	Not dispositive; failure-to-warn claims survive; black box issue does not preempt state claims.
Whether punitive damages rely on fraud-on-the-FDA and are preempted under Buckman	Punitive damages rely on misrepresentation to FDA but are grounded in state tort law.	Buckman preempts fraud-on-FDA claims.	Buckman inapplicable; punitive-damages claims rest on state tort theories, not solely FDA fraud.

Wyeth v. Levine, 555 U.S. 555 (Supreme Court 2009) (manufacturer bears label content responsibility; preemption analysis per Wyeth framework)
Mensing v. Wyeth, 588 F.3d 603 (8th Cir. 2009) (conflict preemption when compliance with federal and state law is impossible; label-change possibilities via FDA processes)
Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (Supreme Court 2001) (implied preemption where claim hinges on fraud on the FDA)
Automated Med. Labs., Inc., 471 U.S. 707 (Supreme Court 1985) (conflict preemption analysis; impossibility standard in preemption)
Cipollone v. Liggett Grp., Inc., 505 U.S. 504 (Supreme Court 1992) (Supremacy Clause; express/implied preemption framework)
Robinson v. McNeil Consumer Healthcare, 615 F.3d 861 (7th Cir. 2010) (FDA failure to act evidence; context for black box and labeling)
In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200 (8th Cir. 2010) (Buckman-like analysis in product-liability context)