Gourdine v. Crews
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HEADNOTE Gourdine, et al v. Crews, et al No. 1190, September Term, 2006 Appellee Crews suffered an insulin induced seizure while driving, thus causing a collision in which Gourdine was killed. Suit was filed against numerous parties, including Eli L illy, Inc. manufacturer of the insulin medications. The Circuit Court granted summary judgmen t in favor of Lilly on two g rounds: (1) Lilly owed no duty to Gourdine; and (2) federal preemption. The learned intermediary rule imposes a duty on a drug manufacturer to warn physicians of the potential danger of particular medications. Since a manufacturer owes no duty to the patient, it follows that there is no duty to a non-user of the drug. Moreover, it was not reasonably foreseeable to Lilly that Crew s use of the medications would result in ultimate injury to Gourdine. REPORTED IN THE COURT OF SPECIAL APPEALS OF MARYLAND No. 1190 September Term, 2006 MARY GOURDINE, INDIVIDUALLY, etc. v. ELLEN CRE WS, et al Salmon, Adkins, Sharer, JJ. Opinion by Sharer, J. Filed: November 29, 2007 This appeal stems from a tort action filed by appellants, Mary S. Gourdine, the widow and personal representative of the estate of Issac J. Gourdine ( Gourdine ), and their two children, Monica J. and Lamar T., against appellee, Eli Lilly and Company ( Lilly ), and others. The Circ uit Court fo r Prince G eorge s C ounty (Hon . Steven I. Pla tt) granted Lilly s motion for summ ary judgmen t, the other def endants h aving bee n dismissed from the s uit. Appellan ts pose four questions for our review, which we have condensed and rephrased as:1 1 In their brief, appellants ask: 1. Did the circuit court err in granting summary judgment to Lilly on Cou nt I of [app ellants ] Com plaint on the basis that Lilly owed no legal duty to protect Gourdine, an innocent bystander, from harm cau sed by Lilly s sale of the drugs Humulin NPH and Humalog in a defective and unreasonably dangerous condition? 2. Did the circuit court err in entering summary judgment against [appellants] holding that tortfeaso rs are liable only to the persons to whom their misrepresentations are made or upon whom they commit fraud - not innocent bystanders such as Gourdine? 3. Did the circuit court err in granting summary judgment to Lilly and denying [appellants] discovery based on the FDA s opinion that common law tort claims involving prescription drug injuries are preempted? 4. Did the circuit court err in granting summary judgment to Lilly with respe ct to [appe llants ] punitive damages count (Count X II of the Co mplaint), in ruling that Lilly owed no legal duty to the [appellants], that [appellants ] claims were preemp ted and that, therefore, [appe llants ] request fo r punitive da mages w as withou t merit? 1. Whether the circuit court erred in granting Lilly s motion for summ ary judgmen t. 2. Whether the circuit court erred in determining that federal law preempte d state law failure to warn claims involving prescription drugs. For the reasons that follow, we shall hold that the circuit court correctly granted summary judgment on the basis that Lilly did not owe a duty to Mr. Gourdine. In light of our ho lding, w e need not add ress app ellants f ederal p reemp tion arg umen t. FACTUAL and PROCEDURAL BACKGROUND At the time of the motor vehicle accident giving rise to this litigation, Ellen Crews was a type 1 diabetic.2 On the morning of February 25, 2002, Crews took a combination therapy of Humalog, a rapid-acting insulin, and Humulin N, a long-acting neutral protamine hagedorn ( NPH ) insulin, both of which are manufactured and distributed by Lilly. Later that morning, just before 11:00 a.m., while driving south on the Capital Beltway, Crews experienced hypoglycemia or low blood sugar. Near Indian Head Highway, Crews, whom eyewitnesses described a s driving erra tically, struck the rear of a vehic le driven by Isaac J. Gourdine, pushing G ourdine s v ehicle into th e back of a tracto r-trailer rig parke d illegally on the shoulder of the Beltway. Gourdine suffered a fatal head injury as a result of the collision. 2 Type 1 diabetes results from the b ody s failure to pro duce insu lin. Diabetes patients may be susceptible to hyperglycemia (high blood sugar) or hypoglycemia (low blood sugar). -2- On January 7, 20 05, appellan ts filed a com plaint, 3 in the Circu it Court for Prince George s County, against Crews, Lilly, Joseph Scott, the driver of the tractor-trailer, F&S Contract Carrier, Inc., the owner of the truck tractor, and ESF Trailer Systems, LLC, the owner of the trailer.4 The com plain t alleged the f ollowing against Lilly: (1) Strict Lia bility in Tort for Sale of a Misbra nded D rug with F alse and M isleading A dvertising an d Labelin g; (2) Negligent Failure to Warn of Dangers Associated with the Use of the Drug Humalog as Directed; (3) Conscious Misrepresentation and Fraud; (4) Wrongful Death; (5) Damages ... Resulting from the Survival Act; and (6) Punitive Damages. All of appellants claims against Lilly were based on their contention that Humalog and Humulin N combination therapy caused increased rates of hypoglycemia between 6 a.m. and 12 p.m., and that Lilly knowingly failed to include a warning to that effect in its labeling and advertising. Lilly mov ed fo r sum mary judg men t on a ll cou nts o n M ay 19, 2006, to which appellants filed their opposition on June 2, 2006. The circuit cou rt heard oral arguments on June 8, 2006, and, after holding the matter sub curia , issued an order granting Lilly s motion for summary judgment on June 12, 2006. The court s memorandum opinion, stating the 3 Appellan ts complain t was cap tioned as a Comp laint for W rongful D eath and Survival Action and for Compensatory and Punitive Damages for Sale of a Defective Produ ct, Frau d, Con scious M isrepres entation , Neglig ence a nd Bre ach of Warra nty. 4 By order of court on May 9, 2006, the claims against Joseph Scott, F&S Contract Carrier, Inc., and ESF Trailer Systems, LLC, were dismissed with prejudice. Crews was likewise dismissed from this case. -3- reasons for [the] order, was filed on July 5, 2006. In his memorandum opinion, Judge Platt reasoned. The existence of a legal duty is a question of law, to be decided by the co urt. Doe v. P harma cia & Upjo hn Co ., Inc. 338 Md. 407, 414 , 879 A.2d 108 8, 1092 (2005). In this case the issue is what duty is owed the public by a drug ma nufactu rer in a failure to w arn case. W ith respect to prescription drugs, Maryland courts have adopted the Learned Intermediary Rule, which states that a prescription drug manufacturer has a duty to warn physicians of potential risks associated with taking a drug, but does n ot have a d uty to warn patients. Hunt v. Hoffmann-LaRoche, Inc. 785 F. Supp. 547, 550 (D. Md. 1992). It follows that if a pharmaceutical manufacturer does not have a duty to giv e patients usin g their prod ucts warnings, they do not have a duty to warn the people with whom those patien ts interact. In this case , Ellen C rews w as takin g Hum alog, a prescription drug, and Humulin N, a drug that Ms. Crews was taking by prescription, but which was also available over-thecounter. With over-the-counter medications, pharmaceutical manufacturers do owe a duty to wa rn the pat ient d irect ly. Howeve r, even if this d uty were app licable in this ca se, this duty does not extend to Mr. Gourdine. [Appellants] concede in their Memorandum of Points and Authorities in Opposition to [Appellee s] Motion for Summa ry Judgment that Eli Lilly had no duty to warn Mr. Gourdine directly. Instead they argue that it was foreseeable that not warning patients of an increased risk of hypoglycemia between 6 a.m. and 12 p.m. could cause people to suffer from hypoglycemia or neuroglycopenia, and if that occurred while the patient was driving a veh icle, that they could seriously injure other users of the road. [Appellants] argue tha t this foreseeab ility extends a du ty to users of the road and so to Mr. Gou rdine. Th is Co urt declin es to exte nd th at du ty to E li Lilly. -4- Instead this trial court echoes what the Maryland Cou rt of Appeals said in Doe v. Pharma cia & U pjohn C o., Inc., 388 Md. 407, 879 A.2d 1088 (2005), the imposition of duty of care in this case would create an indeterminate class of potential plaintiffs. Id. at 421, 1096. In Pharmacia & Upjohn, the plaintiff was the wife o f a laboratory technician who had contracted HIV from his employme nt in a lab oratory. The Court held that the employer did not owe a duty to the wife, because that would create an indeterminate class of potential plaintiffs, including spouses, sexual partners, and then anyone the employee could pos sibly pass the disease onto [sic]. Ce rtain ly, if this were an indeterminate class of people, then expanding duty to users of the highway, as [appellants] strenuously urge this Court to do in the instant case, would create an equally large and amorphous indeterminate class of Plaintiffs. [Appellants] would h ave us interp ret Valk Mfg. Co. v. Rangaswamy as authority to im pose a liability on E li Lilly on this case. Id., 74 M d. App . 304, 537 A.2d 622 (1988). In Rangaswamy, the Court held that bystanders... are protected under the d octrine o f strict liability in tort. Id. at 323, 632. However, in the sentence immediately preceding, the Rangaswamy Court c ited W . Keeto n, Prosser and Keeton on Torts 704 (5 th ed. 1984), to explain that the effect of an expanded duty to bystanders was to put strict liability on the same footing as negl igence , as to all f oresee able inju ries. Rangaswamy, 74 Md. App. at 323, 537 A.2d 632. It is this Court s opinion in this case, that E li Lilly did not ow e a duty to [appellants] even in the negligence claim, and so Rangaswamy does not aid [appellants] in their strict liability claim. (Emphasis in original) (foo tnote omitted). This timely appeal followed. STANDARD of REVIEW Our review o f a circuit cou rt s grant of summary judgment is de novo. Aventis Pasteur, Inc. v. Skevofilax, 396 Md. 405, 440 (2007). W e determin e whethe r the circuit -5- court properly conc luded that th ere was n o dispute o f material fa ct, and, if so, whether the circuit court s decision that the moving party was entitled to summary judgment was lega lly correct . Cruickshank-Wallace v. County Banking & Trust Co., 165 Md. App. 300, 310 (2005), cert. denied, 391 M d. 114 (20 06); see Md. Rule 2-501(f). On appeal from an order entering summa ry judgment, we review only the legal ground s relied upon by the trial court in granting summary judgment. Cochran v. Norkunas, 398 M d. 1, 12 ( 2007) . Our review is likewise premised on the basis that, in the case sub judice, the parties concede the lack of dispute of a material fac t. DISCUSSION In granting su mmary judg ment, the circuit court found that Eli Lilly did not owe a duty to Mr. Gourdine[.] The existence of a legal duty is a question of law, to be decided by the court. Doe v. Pharm acia & U pjohn C o., 388 Md. 407, 414 (2005). Our analysis of whether a duty is owed to a plaintiff in a failure to warn case is the same whether recove ry is sought under a negligence or a strict l iability in tor t theory. See Mayor & City Council of Baltimore v. Utica Mut. Ins. Co., 145 Md. App. 256, 287-88 (2002)(describing negligence and stric t liability failu re to wa rn theo ries as n early iden tical. ). With respect to prescription drugs,5 Maryland law reco gnizes the learned inter med iary doctrine, which provides that manufacturers need only warn the prescribing 5 Although Humulin N was available over-the-counter, Crews was taking the drug by prescription. Thus, for purposes of our analysis, Humulin N and Humalog are prescription drugs. -6- physician and not the patient directly. Ames v. Apothecon, Inc., 431 F.Supp. 2d 566, 572 (D.Md. 2006); see also Nolan v. Dillon, 261 Md. 516, 523 (1971). Stated alternatively, under the learned intermediary doctrine, the manufactu rer of a pres cription drug has no du ty to directly warn patients. Diane S. K ane, A nnotatio n, C ONSTRUCTION AND A PPLICATION OF L EARNED-INTERMEDIARY D OCTRINE, 57 A.L .R. 5 th 1 (1998). It follows, therefore, that since there is no duty on the part of prescription drug m anufacturers to directly warn users of the drug of possible adverse effects, the manufacturer has no duty to warn a nonuser such as Gourdine. See Kirk v. Michael Reese Hosp. & Med. Ctr., 513 N.E.2d 387, 393 (Ill. 1987)(applying the learned intermediary doctrine and holding that drug manufacturers owed no duty to warn a third party wh o was injured by a patient using their products). Appellants nonetheless maintain tha t it was fores eeable that f ailing to wa rn patients of an increased risk of hypoglycemia between 6 a.m. and 12 p.m. could cause them to suffer from hypoglycemia , and if that oc curred w hile a patient was driving a vehicle, that the patient could seriously injure other users of the road. According to appellants, the foreseeability of the injuries here at issue extended a duty to warn all users of the road and, thus, Gourdine. Appellants correctly state that liability for injuries which are foreseeable resulting from a defective product ex tends to bystanders who are put in peril by the defect. See e.g. Valk Mfg. Co. v. Rangaswamy, 74 Md. A pp. 304 , 322-2 3 (198 8), rev d on other grounds sub nom. Montgomery County v. Valk Mfg. Co., 317 Md. 185 (1989). Even assuming, arguendo, that the warnings rendered about the drugs were defective, the injuries sustained by Gourdine -7- were not reason ably foreseeable. It cannot be said that Lilly should have reasonably foreseen that Crews, with her history of hypoglycem ia, would ig nore her d octor s orde rs to discontinue her morning insulin, drive a car, suffer a hypoglycemic episode, lose control of her car, strike Go urdine s ca r, push it into the back of an illegally parked tractor-trailer, and fatally injure Gourdin e. Indeed, to im pose a du ty on Lilly in these circ umstance s would create an indetermin ate class of potential plaintiffs. Pharmacia & Upjohn C o., supra, 388 Md. a t 421. JUDGMENT OF TH E CIRCU IT COURT FOR P RINC E GEO RGE S COUNTY AFFIRMED; COSTS ASSESSED TO APPELLANT. -8-
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