152 So. 3d 944
La. Ct. App.2014Background
- Decedent Harvey McCorkle saw family physician Dr. Wayne Gravois for insomnia/stress; Gravois gave him Lunesta samples and told him to call the clinic for any problems.
- McCorkle took Lunesta for several nights and was found dead from a self-inflicted gunshot; plaintiffs allege Lunesta caused hallucinations or deepened depression leading to suicide.
- A medical review panel concluded Dr. Gravois met the standard of care; plaintiffs sued for wrongful death/ survival and relied on the Lunesta package insert / PDR to prove the standard of care and breach.
- Dr. Gravois moved for summary judgment, arguing plaintiffs lacked an expert to establish breach and causation; plaintiffs argued package insert warnings and Medication Guide alone can establish the standard of care.
- Trial court granted summary judgment for Dr. Gravois; the court of appeal affirmed, holding package insert/PDR alone were insufficient to establish the medical standard of care absent expert testimony given the insert’s generalized warnings.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether manufacturer package insert or PDR alone can establish the applicable medical standard of care in malpractice claims | Package insert/PDR warnings and Medication Guide set prescribing instructions and therefore establish the standard of care or at least create a prima facie case of negligence | Package insert/PDR are not dispositive; complex medical issues normally require expert testimony to define standard and breach | The court held package insert/PDR alone are insufficient to establish the prevailing medical standard of care where warnings are general; expert testimony was required |
| Whether deviation from manufacturer warnings ipso facto establishes negligence | Plaintiffs: deviation from manufacturer instructions (failure to give Medication Guide/read warnings) is prima facie evidence of negligence | Gravois: physician discretion and common practice matter; deviation does not automatically equal breach | The court distinguished cases with specific contraindications/warnings and held generalized precautions here did not permit a lay inference of negligence without experts |
| Whether summary judgment was improper given experts’ conflicting views on causation | Plaintiffs claimed three experts concluded Lunesta likely caused suicide, so causation is established | Gravois argued plaintiffs had no expert opining he breached standard of care; causation contested and intertwined with breach | Court pretermitted detailed causation analysis because plaintiffs failed to establish standard/breach without expert support; affirmed summary judgment |
| Whether prior decisions permit reliance on PDR/package insert without expert testimony | Plaintiffs relied on Terrebonne, Fournet, Christiana and similar precedents to argue inserts can create prima facie proof | Defendant relied on cases (e.g., Deroche, Morlino) limiting PDR weight and requiring expert testimony | Court applied distinctions: where inserts contain specific contraindications or explicit directions, a lay jury may infer negligence; here warnings were general, so plaintiff needed expert proof |
Key Cases Cited
- Pfiffner v. Correa, 643 So.2d 1228 (La. 1994) (expert testimony generally required to prove standard of care unless negligence is obvious)
- Terrebonne v. Floyd, 767 So.2d 758 (La. App. 1st Cir. 2000) (discussing manufacturer warnings as possible prima facie evidence of negligence where specific directions/contraindications exist)
- Fournet v. Roule-Graham, 783 So.2d 439 (La. App. 5th Cir. 2001) (PDR contraindication treated as authoritative evidence against common practice)
- Christiana v. Sudderth, 841 So.2d 911 (La. App. 5th Cir. 2003) (deviation from manufacturer instructions may be negligence when insert contains specific, controlling directions)
- Deroche v. Tanenbaum, 131 So.3d 400 (La. App. 4th Cir. 2013) (labeling/package insert alone insufficient to establish standard of care)
- Mulder v. Parke Davis & Co., 181 N.W.2d 882 (Minn. 1970) (manufacturer’s dosage/warnings can create prima facie evidence requiring physician explanation)
- Morlino v. Medical Ctr. of Ocean Cnty., 706 A.2d 721 (N.J. 1998) (package inserts and PDR references alone do not establish the standard of care; expert support required)
- Ekendahl v. La. Med. Mut. Ins. Co., 124 So.3d 461 (La. App. 2d Cir. 2013) (manufacturer warning is evidence but not conclusive; trial court may credit expert testimony over insert)