Gourdine v. Crews

• Decision Date: 04 September 2008
• Docket Number: No. 134 September Term, 2007.,134 September Term, 2007.
• Citation: 405 Md. 722,955 A.2d 769
• Parties: Mary GOURDINE v. Ellen CREWS, et. al.
• Court: Court of Special Appeals of Maryland

955 A.2d 769

405 Md. 722

Mary GOURDINE v. Ellen CREWS, et. al.

No. 134 September Term, 2007.

Court of Appeals of Maryland.

September 4, 2008.

Albert D. Brault (Joan F. Brault of Brault graham, LLC, Rockville, MD; Allen T. Eaton, III and LaVern D. Wiley of The Eaton Law Firm, PLLC, Washington, DC), on brief, for Petitioner.

Brief of The Maryland Trial Lawyers Ass'n as Amicus Curiae: James MacAlister, Saiontz, Kirk & Miles, Baltimore, MD; Michael Wein, Law Offices of Michael Wein, Greenbelt, MD; Denis C. Mitchell, Stein, Mitchell & Mezines, Wassington, DC.

Jan M. Carroll (Terri L. Bruksch of Barnes & Thornburg, LLP, Indianapolis, IN; Phillip R. Zuber of Sasscer, Clagett & Bucher, Upper Marlboro, MD), on brief, for Respondents.

Brief of Amicus Curiae of the American Tort Reform Ass'n in Support of Appellee, Eli Lilly and Co.: H. Sherman Joyce,

American Tort Reform Ass'n, Washington, DC; Victor E. Schwartz, Cary Silverman, Shook, Hardy & Back, L.L.P., Washington, DC.

Brief Amicus Curiae of Public Legal Foundation in Support of Respondent Eli Lilly & Co.: Theodore Hadzi-Antich, The Law Offices of Theodore Hadzi-Antich, Buffalo, NY; Deborah J. La Fetra, Pacific Legal Foundation, Sacramento, CA.

ARGUED BEFORE BELL, C.J., HARRELL, BATTAGLIA, GREENE, JOHN C. ELDRIDGE, (Retired Specially Assigned), IRMA S. RAKER, (Retired Specially Assigned), and ALAN M. WILNER, (Retired Specially Assigned), JJ.

BATTAGLIA, Judge.

In this products liability case, premised on negligence, strict liability and fraud, Ellen Crews, a Type I diabetic¹ who was taking a combination of insulin medications manufactured by Respondent, Eli Lilly and Company ("Lilly"), while operating her car, suffered a debilitating episode and struck a vehicle driven by Isaac Gourdine, resulting in his death. We are asked to determine whether Lilly owed a duty to Mr. Gourdine, the third-party who did not ingest the drugs. Petitioner, Mary Gourdine, the wife of Mr. Gourdine, argues that it was foreseeable for Lilly that Ms. Crews, allegedly suffering an adverse reaction to the medications, would cause injury and death to third persons while she was operating a motor vehicle, when she had not been adequately warned about the dangers that allegedly were associated with the specified medications, and that such foreseeability, thus, created a duty owed to Mr. Gourdine.² The certiorari questions presented are:

1. Where the FDCA[³] imposes a duty on a drug manufacturer to refrain from selling a drug with false and misleading advertising and labeling, the violation of which gives rise to criminal liability for misbranding under 21 U.S.C. §§ 331(a), 333(a)(1), and 352, is there any public policy reason for relieving the drug company from liability for injuries to an innocent third-party bystander injured in an actionable motor vehicle accident caused by a drug-induced loss-of-consciousness, when the drug manufacturer sold the drugs consumed by the at-fault driver with inadequate warnings, false advertising and made conscious misrepresentations to the medical community as to the true risks associated with the drugs?

2. Did the intermediate appellate court err in a finding as matter of law that Mr. Gourdine's death was not a foreseeable consequence of Defendant Lilly's conduct when Lilly's managing agents admitted that such injuries were foreseeable?

3. Whether a claim for misbranding, false and misleading advertising, a claim for failure to warn, and a claim for negligent misrepresentation and fraud brought against a drug manufacturer is preempted by the FDCA, 21 U.S.C. § 321, et seq.?

We respond to the first question by affirming the judgment of the Court of Special Appeals, and thereby the trial court's grant of summary judgment to Lilly, because Lilly did not owe the requisite duty to Mr. Gourdine to sustain the negligence, strict liability and fraud claims asserted in the instant case.⁴

I. Introduction

On the morning of February 25, 2002, Ms. Crews took a combination of Humalog, a quick-acting form of insulin taken with meals, and Humulin N (or "Humulin NPH"),⁵ a medication designed to supply a constant source of insulin to the body, both of which were manufactured by Lilly, and prescribed by Ms. Crews' doctor.⁶ While driving from Baltimore to College Park, Ms. Crews hit an automobile driven by Isaac J. Gourdine; the force of the collision caused Mr. Gourdine's car to leave the highway and crash into a tractor-trailer, leaving him with a mortal head wound.

On January 7, 2005, Ms. Gourdine, individually, and as Personal Representative of the Estate of Mr. Gourdine, and as Next Friend of Monica J. Gourdine and Lamar T. Gourdine, their two children, filed a Complaint for Wrongful Death and Survival Action and for Compensatory and Punitive Damages for Sale of a Defective Product, Fraud, Conscious Misrepresentation, Negligence and Breach of Warranty, in the Circuit Court for Prince George's County against Lilly, as well as a number of other individuals and companies who are not implicated in the present appeal. In the Complaint, Ms. Gourdine contended that, at the time of the accident, Ms. Crews suffered a hypoglycemic⁷ reaction and experienced a "blackout" causing her to lose control of her vehicle.

Against Lilly, several theories of liability were posited, based upon Ms. Gourdine's contention that the combination of Humalog and Humulin N caused increased rates of hypoglycemia, neuroglycopenia and drowsiness between 6 a.m. and noon and that Lilly knowingly failed to include a warning of such possibilities in its labeling and advertising. In Count 1, "strict liability in tort for sale of a misbranded drug with false and misleading advertising and labeling," Ms. Gourdine alleged that the Humalog label at the time it was sold was "false and misleading" because "it boast[ed] on one hand that patients such as Defendant Crews, who had Type I diabetes, had fewer hypoglycemic episodes between midnight and 6 a.m. while on the other hand ignoring the fact that most episodes with both of the constituent insulins contained in the Humalog mixtures tested occurred during mid-day and that a substantial number of the hypoglycemic reactions experienced by type I diabetics occurred without warning at mid-day." Ms. Gourdine alleged that Lilly owed a duty to her husband, as follows:

77. At all times relevant hereto, Defendant Lilly had a duty imposed by statute and the common law to warn users of the drug Humalog of the risks to which the drug as compounded and its constituent drugs exposed persons who consumed them.

78. Decedent Isaac J. Gourdine, as a user of the highway, was in the class of persons the statute and regulations of the FDA that Lilly violated intended to protect.

79. Defendant Lilly, therefore, owed a duty to protect users of the highway from drivers suffering from hypoglycemia induced by Defendant Lilly's misbranded drug.

80. It was foreseeable that a Type I diabetic suffering from neuroglycopenia caused by hypoglycemia would cause injury and death to third persons while operating a motor vehicle on a highway if the diabetic was not warned of the period of greatest vulnerability for drowsy driving. Such information would enable Type I diabetics to take proper precautions before operating an automobile during this period of maximum vulnerability for drowsiness.

In Count 2, "negligent failure to warn of dangers associated with the use of the drug Humalog as directed," Ms. Gourdine alleged, similarly, that "Lilly breached its duty by failing to warn consumers that a high percentage of Type I diabetics were at greatly increased risk of drug-induced hypoglycemia, neuroglycopenia and drowsiness at mid-day"; with respect to the duty violated by Lilly, Ms. Gourdine repeated:

86. At all times relevant hereto, Defendant Lilly had a duty imposed by statute and the common law to warn users of the drug Humalog of the risks to which they were exposed by the drug as compounded and its constituent drugs.

87. Decedent Isaac J. Gourdine, as a user of the highway, was in the class of persons the statute and regulations of the FDA that defendant Lilly violated intended to protect.

In Count 3, "conscious misrepresentation and fraud," Ms. Gourdine alleged that "Lilly published, or caused to be published, ... statements that failed to disclose that Humalog and the Humalog mixtures containing Humulin NPH tested were most likely to be associated with hypoglycemia and drowsiness at mid-day while boasting that Humalog was associated with lower nighttime hypoglycemia," that Lilly knew the statements to be untrue or that Lilly did not have proof that they were true, and that Ms. Crews and her physician "relied on Defendant Lilly's misrepresentations and Defendant Crew's drove her automobile at mid-day without taking the proper precautions against undetected hypoglycemia and drowsiness, resulting in the accident which killed Isaac J. Gourdine."

Lilly subsequently filed a motion for summary judgment, arguing that it was entitled to judgment as a matter of law because "Lilly did not owe a duty to warn Mr. Gourdine, who did not use or consume Lilly's insulin products," "Lilly made no representations to Mr. Gourdine, a nonuser, and therefore essential elements of fraud are lacking," and that "without a basis to claim fraud, plaintiff's punitive damages claim fails." Lilly also contended that because the United States Food and Drug Administration ("FDA") approved the warnings for Lilly's insulin products the "failure to warn claim is preempted as a matter of federal law."

Ms. Gourdine responded and asserted that Lilly owed a duty to Mr. Gourdine to adequately warn Ms. Crews about the risks of the combination of Humalog and Humulin N because it was foreseeable for Lilly that Ms. Crews, allegedly suffering an adverse reaction to the medications, would cause injury and death to third persons while she was operating a motor vehicle, when she had not been adequately warned about the...