996 N.E.2d 412
Ind. Ct. App.2013Background
- Medtronic designed and supplied a Transvene Model 6936 defibrillator lead implanted in David Malander in 1997; lead later tested during 2006 surgery with inconclusive results.
- Dr. Klein, the implanting physician, consulted Medtronic staff during the 2006 surgery about short V-V intervals; Medtronic technicians advised that the intervals did not indicate a problem and to proceed.
- David Malander died in January 2007 after ventricular tachycardia; testing showed 361 short V-V intervals in late December 2006.
- Malanders filed suit against Medtronic and Dr. Klein; Count 7 alleged design flaws, failure to recall, and a duty related to the 2006 surgery.
- Medtronic moved for summary judgment asserting federal preemption under the Medical Device Amendments (MDA); Malanders conceded preemption for some counts but argued 7(c) was not preempted and that Medtronic assumed a duty.
- Trial court denied summary judgment; interlocutory appeal was accepted by this court and Medtronic challenged both preemption and assumed-duty theories.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Preemption of Count 7(c) | Malanders argue 7(c) is not preempted as it concerns negligent oral representations during surgery. | Medtronic contends preemption applies because it concerns warnings/assistance tied to device labeling or federal requirements. | Not preempted; claim involves on-site technical advice, not labeling or design. |
| Assumed duty by Medtronic | Medtronic voluntarily assumed a duty by providing technical support in a reasonable and prudent manner. | Medtronic did not assume a duty to make medical recommendations or influence the surgical decision. | Genuine issues of material fact exist; summary judgment improper on assumed-duty theory. |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (two-pronged preemption test for FDA-imposed requirements and parallel claims)
- McGookin v. Guidant Corp., 942 N.E.2d 831 (Ind. Ct. App. 2011) (FDA labeling preemption; labeling claims challenged as add-on duties)
- Plan-Tec, Inc. v. Wiggins, 443 N.E.2d 1212 (Ind. Ct. App. 1983) (assumed duty doctrine under Restatement §324A)
- Merrill v. Knauf Fiber Glass GmbH, 771 N.E.2d 1258 (Ind. Ct. App. 2002) (assumed duty questions ordinarily for trier of fact)
- Ward v. First Indiana Plaza Joint Venture, 725 N.E.2d 134 (Ind. Ct. App. 2000) (discussion of Restatement §324A and assumed duty)