881 F. Supp. 2d 992
S.D. Ill.2012Background
- Diversity action pending against Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) over Pradaxa injuries; plaintiff Vera Lee Sellers alleges severe gastrointestinal bleeding after Pradaxa use.
- The court denied BIPI’s Rule 12(b)(6) motion, allowing most claims to proceed.
- There are multiple Pradaxa product liability cases (MDL No. 2385); this court has 17 Pradaxa cases in this district.
- Procedural posture involves evaluating the complaint under Twombly/Iqbal pleading standards and exceptions to evidence outside the complaint.
- The court considers Pradaxa labeling/warnings as pleaded and as publicly available material, with March 2011 and other label changes at issue.
- The decision discusses the learned intermediary doctrine, Restatement (Second) of Torts comment K, and preemption arguments related to the FDCA.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether strict liability claims survive under Illinois law post-Twombly/Iqbal. | Seller claims Pradaxa was unreasonably dangerous and inadequately warned. | BIPI asserts warnings/design defects insufficient to state a claim. | Plaintiff’s claims survive at this stage. |
| Whether fraud-based claims meet Rule 9(b) particularity and are preempted. | Fraud claims alleged with who/when/where/how; not preempted. | Claims are preempted as fraud-on-the-FDA. | Fraud-based claims plausibly pled and not preempted at this stage. |
| Whether the learned intermediary doctrine bars claims or leaves duty of care intact. | Duty to design reasonably safe product exists despite intermediary warnings. | Learned intermediary shields manufacturer from direct consumer warnings. | Doctrine does not bar all claims; duty to design safely remains viable. |
| Whether negligence per se claims are viable given lack of private FDCA action. | FDCA defines standard of care; no private action forecloses per se claim. | No private right of action under FDCA. | Negligence per se viable under Illinois common law. |
Key Cases Cited
- Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (U.S. 2001) (FDCA preemption of fraud-on-the-FDA claims)
- Bell Atl. Corp. v. Twombly, 550 U.S. 544 (U.S. 2007) (establishes plausibility standard for Rule 12(b)(6))
- Ashcroft v. Iqbal, 556 U.S. 662 (U.S. 2009) (clarifies plausibility standard post-Twombly)
- Pugh v. Tribune Co., 521 F.3d 686 (7th Cir. 2008) (plausibility beyond mere labels or conclusions)
- Calles v. Scripto-Tokai Corp., 224 Ill.2d 247 (Ill. 2007) (Illinois duty to design reasonably safe products; learned intermediary context)
- Wigod v. Wells Fargo Bank, N.A., 673 F.3d 547 (7th Cir. 2012) (nevertheless supports applying applicable duty standards)
- Walton v. Bayer Corp., 643 F.3d 994 (7th Cir. 2011) (learned intermediary doctrine principles)