249 F. Supp. 3d 1321
N.D. Ga.2016Background
- Plaintiff (Georgia resident) sued multiple Janssen/Johnson & Johnson entities and Mitsubishi after being hospitalized for diabetic ketoacidosis following prescribed use of Invokana (an SGLT2 inhibitor). Plaintiff alleges Invokana caused ketoacidosis and other serious harms and that defendants failed to warn and marketed the drug despite known risks.
- Complaint asserts a broad set of claims: strict liability, design defect, failure to warn, negligence, warranty claims, several fraud-based claims, Georgia Fair Business Practices Act claim, and punitive damages.
- Defendants moved to dismiss for lack of personal jurisdiction (as to Johnson & Johnson) and for failure to state claims; Janssen subsidiaries and J&J argued separate corporate identities and limited forum contacts for J&J.
- Court found Plaintiff’s pleading to be a shotgun complaint that lumps defendants together and fails to allege specific facts linking particular defendants to alleged acts (jurisdictional contacts, manufacturing role, specific misrepresentations, or particularized defects).
- Court dismissed claims against Johnson & Johnson for lack of personal jurisdiction without prejudice, and dismissed the Complaint generally without prejudice for failure to state a claim, ordering Plaintiff to file an amended complaint within 21 days. Court rejected defendant preemption argument as to design-defect claims against a brand-name manufacturer.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Personal jurisdiction over J&J under Ga. long-arm §9-10-91(3) | Defendants transacted persistent business in Georgia by selling/marketing Invokana; J&J derived substantial revenue from product sales | J&J is a holding company with no direct manufacturing/sales in Georgia; subsidiary contacts cannot be imputed without showing alter-ego/sham | Dismissed J&J for lack of personal jurisdiction (no prima facie specific or general contacts shown) |
| Pleading sufficiency (Rule 8/Twombly-Iqbal) | Facts allege Invokana caused ketoacidosis and defendants concealed risks; discovery needed to identify specifics | Allegations are conclusory, lump defendants, and fail to identify who did what; Rule 12(b)(6) dismissal appropriate | Complaint is a shotgun pleading; dismissed without prejudice and plaintiff ordered to replead with greater specificity |
| Fraud-based claims (Rule 9(b)) | Need discovery to identify fraudulent statements; general allegations suffice to proceed | Fraud allegations lack particularity—do not state who, what, when, where, how for each defendant | Fraud, fraudulent misrepresentation, and fraudulent concealment claims dismissed for failure to plead with particularity under Rule 9(b) |
| Preemption of design-defect claims by federal law | Bartlett/Mensing preempt similar state claims; but plaintiff says those cases govern generics, not brand-name drugs | Preemption argued because FDA regulates drug composition/labeling and prevents unilateral remedial changes | Court held design-defect claims against brand-name manufacturer are not preempted here, distinguishing Mensing/Bartlett and relying on Wyeth/Levine because brand manufacturers can use the CBE process to strengthen warnings |
Key Cases Cited
- Diamond Crystal Brands, Inc. v. Food Movers Int'l, Inc., 593 F.3d 1249 (11th Cir.) (plaintiff bears prima facie burden to allege jurisdictional facts; burden shifts when defendant submits affidavits)
- Meier ex rel. Meier v. Sun Int’l Hotels, Ltd., 288 F.3d 1264 (11th Cir.) (when defendant submits affidavits, plaintiff must produce evidence supporting jurisdiction)
- Posner v. Essex Ins. Co., 178 F.3d 1209 (11th Cir.) (court accepts complaint allegations as true unless contradicted by defendant affidavits)
- Goodyear Dunlop Tires Operations, S.A. v. Brown, 564 U.S. 915 (U.S.) (distinguishes general and specific jurisdiction; general jurisdiction requires contacts so continuous and systematic as to be at home)
- Daimler AG v. Bauman, 134 S. Ct. 746 (U.S.) (standard for general jurisdiction: ‘at home’ in forum)
- Burger King Corp. v. Rudzewicz, 471 U.S. 462 (U.S.) (specific jurisdiction requires purposeful availment and nexus between contacts and litigation)
- J. McIntyre Machinery, Ltd. v. Nicastro, 564 U.S. 873 (U.S.) (plurality decision on stream-of-commerce and purposeful direction)
- Wyeth v. Levine, 555 U.S. 555 (U.S.) (brand-name manufacturers may unilaterally strengthen warnings under the CBE regulation; state failure-to-warn claims not necessarily preempted)
- PLIVA, Inc. v. Mensing, 564 U.S. 604 (U.S.) (generic manufacturers subject to a federal ‘sameness’ duty; state-law duties that require independent label changes are preempted)
- Mutual Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (U.S.) (design-defect claims against generic manufacturers preempted where state law would require changes federal law forbids)