Grinage v. Mylan Pharmaceuticals, Inc.
840 F. Supp. 2d 862
D. Maryland2011Background
- Grinage, as personal representative, sues Mylan for compensatory and punitive damages under Maryland-law theories (negligence, strict products liability, fraud, and implied warranty) after her husband died from Allopurinol-induced Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis.
- Allopurinol is a generic version of Zyloprim; labeling for both warns of skin reactions and relation to SJS/TEN.
- Labeling for generics must remain “substantively identical” to brand labeling under Hatch-Waxman and FDA regulations.
- Grinage alleges Mylan knew or should have known of higher-risk incidence than the label indicates and failed to report evidence to FDA and Prometheus Labs; claims include negligence, strict liability, fraud, and implied warranties.
- Mylan moved to dismiss under Fed. R. Civ. P. 12(b)(6) on pre-emption grounds, arguing federal law and FDA regulations bar the state-law claims.
- Court grants Mylan’s motion, dismisses all claims as pre-empted or inadequately pled, and cases closes.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether state-law claims are pre-empted by federal law under Mensing. | Grinage argues Mensing allows non-labeling warnings/communication duties. | Mensing bars state-law failure-to-warn and related claims for generics. | Pre-emption; claims precluded. |
| Whether failure-to-warn claims survive under a design-defect theory. | Grinage seeks design-defect and warning-based theories not pre-empted. | Mensing pre-empts failure-to-warn and design theories based on labeling. | Pre-empted or inadequately pled; design claim dismissed. |
| Whether breach of implied warranty claims survive. | Grinage asserts merchantability and fitness-for-a-particular-purpose warranties. | Without viable design/warn claims, warranty claims fail. | Dismissed due to lack of viable underlying defect. |
| Whether fraud claims survive given labeling-based representations. | Fraud alleged in label and FDA communications; some claims excluded by Buckman/FDA pre-emption. | Fraud claims pre-empted or inadequately pled under Rule 9(b). | Fraud claims dismissed. |
| Whether wrongful-death claim survives. | Wrongful death rests on underlying tort liability. | No viable underlying claim; death claim fails. | Wrongful-death claim dismissed. |
Key Cases Cited
- PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (U.S. 2011) (impossibility pre-emption prevents state-law claims against generics.)
- Buckman Co. v. Plaintiff's Legal Comm., 531 U.S. 341 (U.S. 2001) (fraud-on-the-FDA claims pre-empted.)
- Holliday v. Sturm, Ruger & Co., Inc., 368 Md. 186, 792 A.2d 1145 (Md. 2001) (consumer expectation vs. risk-utility design testing; preemption discussed.)
- Miles Lab., Inc. Cutter Lab. Div. v. Doe, 315 Md. 704, 556 A.2d 1107 (Md. 1989) (unavoidably unsafe drug doctrine and design defect standards.)
- Pease v. American Cyanamid Co., 795 F. Supp. 755 (D. Md. 1992) (seven-factor design defect analysis in some Maryland contexts.)
- Jensen v. American Motors Corp., Inc., 50 Md. App. 226, 437 A.2d 242 (Md. App. 1981) (risk-utility considerations in design cases.)