McGRAIN v. C. R. BARD, INC.
551 F.Supp.3d 529
E.D. Pa.2021Background
- In 2003 Plaintiff had a Bard G2 IVC filter implanted to treat pulmonary embolus and deep vein thrombosis; a 2020 CT scan showed two filter struts perforating the IVC wall up to 5 mm and Plaintiff alleged ongoing pain.
- Plaintiff sued C.R. Bard, Inc. and Bard Peripheral Vascular, Inc., asserting negligence; strict liability (design, manufacturing, warning); breach of express and implied warranties; fraudulent misrepresentation and concealment; negligent misrepresentation; and unjust enrichment.
- Defendants moved to dismiss under Fed. R. Civ. P. 12(b)(6), arguing many claims are barred under Pennsylvania law (including by Comment k and Pennsylvania decisions) or inadequately pleaded.
- The court dismissed all ten counts but granted leave to amend only four claims: negligence (Count I), breach of express warranty (Count V), fraudulent misrepresentation (Count VII), and negligent misrepresentation (Count IX).
- The court held strict liability claims (design, manufacturing, failure to warn) and implied warranty claims against medical device manufacturers are barred under Pennsylvania law (relying on Hahn and Lance and predicting the Pennsylvania Supreme Court would apply Comment k to medical devices).
- The court separately dismissed several negligence-based counts for pleading defects (no facts about the manufacturing process, no specific design defect or safer alternative, and no specific warning content), and dismissed fraudulent concealment and unjust enrichment with prejudice as legally unavailable or inconsistent with a products-liability context.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether strict liability (design/failure-to-warn) applies to medical devices | McGrain initially asserted these defects; concedes some decisions preclude such claims but sought to preserve manufacturing claim | Bard: Pennsylvania law bars strict liability for medical device defects under Comment k and Pennsylvania precedent | Court: design and failure-to-warn strict liability barred; Counts II & III dismissed with prejudice |
| Whether strict liability manufacturing-defect claim is cognizable | Plaintiff contended manufacturing defect survives Comment k exception | Bard: Comment k and Pennsylvania decisions bar strict liability generally for prescription/implantable devices | Court: predicts PA Supreme Court would bar manufacturing-defect strict liability for medical devices; Count IV dismissed with prejudice |
| Whether implied warranty of merchantability survives | Plaintiff urged viability | Bard: implied warranty is coextensive with strict liability and thus barred by Comment k | Court: implied warranty barred; Count VI dismissed with prejudice |
| Whether negligence claims (manufacturing, design, failure to warn) are plausibly pleaded | Plaintiff relied on general allegations that device was dangerous and caused injury | Bard: allegations are conclusory, lacking facts about manufacturing errors, specific design defects or safer alternatives, or specific missing/deficient warnings | Court: negligence claims dismissed for pleading deficiencies but Plaintiff granted leave to amend these claims |
| Whether express warranty was pleaded with sufficient specificity | Plaintiff alleged written literature/packaging warranted safety and fitness | Bard: complaint fails to identify warranty terms, source, or reliance | Court: express warranty dismissal for failure to plead specifics; leave to amend granted |
| Whether fraud-based claims (fraudulent/negligent misrepresentation; fraudulent concealment) are actionable | Plaintiff alleged affirmative misrepresentations and concealment regarding safety | Bard: these are disguised failure-to-warn claims barred by Hahn; fraudulent concealment is an equitable tolling doctrine, not an independent tort | Court: fraudulent misrepresentation and negligent misrepresentation dismissed with prejudice (treated as dressed-up failure-to-warn); fraudulent concealment dismissed with prejudice |
| Whether unjust enrichment claim is viable in products-liability case | Plaintiff asserted unjust enrichment for receiving an unsafe product | Bard: unjust enrichment not available where plaintiff received and used product and tort remedies exist | Court: unjust enrichment dismissed with prejudice |
| Whether leave to amend is appropriate | Plaintiff requested leave to amend if claims dismissed | Bard opposed in part | Court: granted leave to amend only for negligence, express warranty, fraudulent misrepresentation, and negligent misrepresentation; amendment futile as to strict liability, implied warranty, fraudulent concealment, and unjust enrichment |
Key Cases Cited
- Fowler v. UPMC Shadyside, 578 F.3d 203 (3d Cir. 2009) (pleading standard—accept well-pleaded facts)
- Ashcroft v. Iqbal, 556 U.S. 662 (2009) (legal conclusions insufficient to plead plausibly)
- Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007) (plausibility standard for complaints)
- Hahn v. Richter, 673 A.2d 888 (Pa. 1996) (Comment k bars strict liability for prescription drugs)
- Lance v. Wyeth, 85 A.3d 434 (Pa. 2014) (declined to extend strict liability in prescription drug context)
- Tincher v. Omega Flex, Inc., 104 A.3d 328 (Pa. 2014) (Pennsylvania product-liability framework)
- Phillips v. A-Best Prods. Co., 665 A.2d 1167 (Pa. 1995) (recognizes design, manufacturing, and warning defect categories)
- Makripodis v. Merrell-Dow Pharm., 523 A.2d 374 (Pa. Super. Ct. 1987) (implied warranty precluded for prescription drugs under Comment k)