Mass Tort Defense : Mass Tort Defense Lawyer & Attorney : Sean P. Wajert : Dechert Law Firm : Products Liability, Class Actions, Pharmaceutical Litigation

The maker of  a drink containing alcohol and caffeine was not liable to a woman allegedly injured when the driver of the motorcycle on which she was a passenger crashed, after the driver consumed the beverage.  See Cook v. MillerCoors LLC, No. 11-1488 (M.D. Fla., 10/28/11).

The operator of the motorcycle in the accident was killed, and plaintiff Cook, who was a passenger, was injured.  Prior to the crash, the driver allegedly had consumed several “Sparks”
alcoholic beverages containing caffeine and other stimulants, manufactured by defendant.

Cook argued that alcoholic beverages such as Sparks containing stimulants are “uniquely dangerous” because they appeal to younger drinkers and because the addition of caffeine enables one to drink more alcohol without feeling as intoxicated as one normally would. Thus, she alleged, consumers of these beverages are more likely to “engage in dangerous behavior such as driving.”  She asserted the driver did not appear impaired, even though toxicology reports from his autopsy revealed that his blood alcohol level was 0.10 at the time of the crash.

Defendant responded that the risks associated with operating a motor vehicle while under the influence of alcohol are well known; therefore, it could not be held responsible for the operator's choice to consume Sparks then illegally operate his motorcycle. The addition of other ingredients to the beverage did not lessen his responsibility to refrain from operating his motorcycle after having consumed the alcohol, and his actions, not the manufacture of Sparks,
proximately caused Cook’s injuries.  The crux of the defense motion to dismiss thus was that there is no cause of action against a manufacturer of alcoholic beverages for injuries resulting from their consumption because the effects of alcohol consumption are well known. With a response from plaintiff that the legion of such holdings in courts everywhere apply to “conventional” alcoholic beverages, not to an alcoholic beverage mixed with stimulants which allegedly suppress the consumer’s subjective awareness of alcohol’s well-known effects.

Regarding the failure to warn theory, a plaintiff must establish the existence of a duty. A manufacturer’s duty to warn arises when there is a need to inform consumers of dangers of which they are unaware.  The effects of alcohol and the need to not drink and drive are universally known.  While plaintiff argued about the unconventionality of this product, plaintiff did not and could not allege that the driver was unaware that he was drinking alcohol. His alleged subjective awareness of the speed or impact of those effects did not alter the legal reasoning of precedent that holds that there is no duty to warn because of the universal recognition of all potential dangers associated with alcohol. 

Plaintiff also failed to adequately allege how the product was unreasonably dangerous for the design defect claim. The effects of alcohol are universally and objectively well known, irrespective of the operator's alleged subjective awareness of them. The defectiveness of a design is determined based on an objective standard, not from the viewpoint of any specific user, said the court.

Moreover, plaintiff's theories failed as to proximate cause. Plaintiff alleged that the manufacturer's negligence caused the driver to become intoxicated to the point of impairment,
causing the crash and Cook’s injuries. In Florida, however, voluntary drinking of alcohol is the proximate cause of an injury from an intoxicated driver, rather than the manufacture or sale of those intoxicating beverages to that person.  This doomed the negligence claim.

Readers can readily see why the court was reluctant to make an exception to the rule for the "unconventional" beverage.  There are hundreds of alcohol-containing products that are not "conventional" in one way or another, by taste, ingredients, color, manufacturing process, advertising... To shift responsibility from the person who over-consumes one of these and then drives impaired is to send the absolutely wrong policy message.

Courts have typically recognized no duty on the maker, regardless of plaintiff's attempt to differentiate either themselves or the product. See, e.g., Malek v. Miller Brewing Co., 749 S.W.2d 521 (Tex. App. 1988) (finding no duty to warn despite claim that advertising led plaintiff to believe that “Lite” beer was less intoxicating than other beer); Pemberton v. Am. Distilled Spirits Co., 664 S.W.2d 690 (Tenn. 1984); Greif v. Anheuser-Busch Cos., Inc., 114 F. Supp. 2d 100 (D. Conn. 2000)(particular, alleged tolerance of an individual consumer); MaGuire v. Pabst Brewing Co., 387 N.W.2d 565 (Iowa 1986).

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Delaware's supreme court held last month that an employer owes no duty of care to an employee's spouse, who allegedly contracted asbestos-related disease from exposure to her spouse's work clothes. Price v. E.I. du Pont de Nemours & Co., No. 719, 2009 (Del. 7/11/11).

Bobby Price worked as a maintenance technician in defendant's facility from 1957 until 1991. During his employment, Mr. Price allegedly worked with and around products containing asbestos. Allegedly, Mr. Price transported asbestos fibers home on his clothing, vehicle, and skin. Patricia Price, his wife, alleged that years of living with her husband, and handling and washing his work clothes, exposed her to the fibers. Mrs. Price claimed to suffer from bilateral interstitial fibrosis and bilateral pleural thickening of the lungs. These maladies, she claimed, stemmed directly from her exposure to the asbestos dust and fibers her husband brought home from work.

Plaintiff sued, alleging that the company wrongfully released asbestos from its plant and that she was a reasonably foreseeable victim of its asserted misconduct. 

To prevail on a negligence claim under Delaware law, a plaintiff must prove that a defendant owed her a duty of care, the respondent breached that duty, and the breach proximately caused an injury. Whether a duty exists is a question of law, typically. To determine whether one party owed another a duty of care, Delaware courts look to the Restatement (Second) of Torts for guidance.  Negligent conduct involves either (1) an act which the actor as a reasonable person should recognize as involving an unreasonable risk of causing an invasion of an interest of another (described in some cases as misfeasance), or (2) a failure to do an act which is necessary for the protection or assistance of another and which the actor is under a duty to do (sometimes described as nonfeasance).

Plaintiffs moved to amend the complaint to state a claim based on an asserted theory of misfeasance—that the release of asbestos was carried into a worker's home — rather than a claim of nonfeasance based on a failure to warn. The Delaware court noted that in the case of misfeasance, the party who does an affirmative act owes a general duty to others to exercise reasonable care, but, in the case of nonfeasance, the party who merely omits to act owes no general duty to others unless there is a "special relationship" between the actor and the other which gives rise to the duty.

DuPont contended that as a matter of substance the amended complaint really alleged  nonfeasance—not misfeasance. Again, in order to recover for nonfeasance, a plaintiff must specifically allege a “special relationship” between herself and the defendant. Having not alleged any “special relationship” in this case, DuPont argued, Price’s amendments were futile because they failed to state a claim as a matter of law.

The court noted that Price’s allegations, stripped of all reformatory re-characterization, were that: (1) Mr. Price, an employee of defendant, worked with and around products containing asbestos for 34 years, (2) asbestos fibers settled on his skin, clothing, and vehicle, (3) defendant allegedly did not provide locker rooms, uniforms, or warnings to the Prices regarding the dangers of asbestos, (4) defendant did not prevent Mr. Price from transporting the asbestos fibers home on his skin, clothing, and vehicle, and (5) Mrs. Price, because she lived with Mr. Price and washed his clothes, developed disease. These alleged acts were pure nonfeasance—nothing more. Dupont’s alleged failures to prevent Mr. Price from taking asbestos fibers home or to warn the Prices about the dangers of asbestos did not rise to the level of affirmative misconduct required to allege a claim of misfeasance. No amount of semantics can turn nonfeasance into misfeasance or
vice versa.

Having alleged only nonfeasance, Price needed to allege that a “special relationship” existed between her and DuPont in order for DuPont to owe her a duty of care. But the relationship between Mrs. Price and DuPont did not fit any of the recognized “special relationships”
giving rise to a duty to aid or protect. Just because her husband worked for DuPont for over thirty years, or DuPont provided health insurance to her as Mr. Price’s spouse, or DuPont sponsored company picnics and participated in programs promoting a "family friendly" workplace, a special relationship did not exist. 

The plaintiff's bar has been aggressive in efforts to create new methods of recovery from asbestos exposures -- new defendants, new legal theories, new injuries, new plaintiffs. For once, a court has put the brakes on this seemingly endless expansion. 

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A court of appeals has affirmed the dismissal of multiple claims alleging that negligent dredging operations before Hurricane Katrina led to the failure of levee systems in Louisiana.  See In Re: In the Matter of the Complaint of Great Lakes Dredge & Dock Co. LLC, No. 08-30738 (5th Cir. Oct. 14, 2010). Claimants were Hurricane Katrina flood victims who filed claims alleging negligence on the part of operators of dredging vessels along the Mississippi River Gulf Outlet. Plaintiffs argued that they suffered damages from the flooding of Orleans and St. Bernard Parishes when several levee systems failed as a result of the erosion of protective wetlands allegedly caused by the defendants’ negligent dredging operations.

The Mississippi River Gulf Outlet  (“MRGO”) is a 76-mile navigational channel that connects the Gulf of Mexico with the Industrial Canal in New Orleans, bisecting the marshy wetlands of St. Bernard Parish and Chandeleur Sound. It was built between 1958 and 1965 by the United States Army Corps of Engineers.  Beginning in 1993, the Corps of Engineers contracted with numerous private dredging companies, including the defendants, to assist the Corps of Engineers in maintenance dredging along the MRGO. From 1999 to 2004, the Corps of Engineers awarded more than 150
contracts to private dredging companies to dredge the length of the MRGO channel.

Plaintiffs, who numbered in the tens of thousands, were individuals, businesses, and other entities who owned property that was damaged due to flooding after Hurricane Katrina made landfall on August 29, 2005. (BTW, for readers, there is a fascinating new exhibit at the Newseum in Washington, DC, on the media coverage of Katrina.)  Plaintiffs contend that the defendants'  maintenance dredging operations caused severe damage to the Louisiana wetlands, which had been providing a natural barrier against tidal surge from storms and hurricanes. This damage to the wetlands allegedly caused an amplification of the storm surge in the New Orleans region
during Hurricane Katrina, which increased the pressure on the levees and flood walls along the MRGO, leading eventually, they alleged, to levee breaches and the subsequent flooding of St. Bernard Parish and Orleans Parish.

These allegations were different from some earlier Katrina claims, adding that their injuries resulted from the erosion to the wetlands caused by the negligent dredging, performed in breach of the standards set out in their Corps of Engineers contracts and various rules and regulations
alleged to apply to their operations, to try to defeat the dredgers’ government contractor immunity defenses, as well as the dredgers’ entitlement to exoneration from or limitation of liability under the Limitation of Liability Act.

Defendants moved to dismiss.  The district court dismissed the claims, and plaintiffs appealed. The 5th Circuit noted that to avoid dismissal, a complaint must contain sufficient factual matter,
accepted as true, to state a claim to relief that is plausible on its face.  Ashcroft v. Iqbal, 129 S.Ct. 1937, 1949 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 554, 570 (2007)). To be plausible, the complaint’s factual allegations must be enough to raise a right to relief above the speculative level. In deciding whether the complaint states a valid claim for relief, we accept all well-pleaded facts as true and construe the complaint in the light most favorable to the plaintiff.

Defendants argued that they could not have foreseen that discrete acts of negligent dredging could have resulted in the absolutely devastating and cataclysmic damages that occurred to St.
Bernard and Orleans Parishes.  Plaintiffs asserted that it is well known, as a matter of general knowledge, that the wetlands provide storm surge mitigation; that the levees protecting cities and towns in the coastal areas were designed with the assumption that the buffering action provided by the wetlands would remain intact; and that dredging activities cause damage to the wetlands.

Duty and forseeability were the key concepts here, and maritime law on this issue mirrored general negligence law.  Determination of the tortfeasor’s duty is a question of law.  A duty may be owed only with respect to the interest that is forseeably jeopardized by the negligent conduct. Thus, if the injuries suffered allegedly as a result of the negligent dredging were not foreseeable, the defendants owed no duty; to show a duty, plaintiffs had to show that each dredger reasonably should have foreseen that the sequence of events leading to their damages—the amplification of the storm surge during Hurricane Katrina, the failure of the levee systems, and the subsequent flooding of Orleans and St. Bernard Parishes—would be a probable result of its negligent acts and the marginal erosion to the wetlands caused thereby.

The 5th Circuit agreed with the trial court that the defendants in this case had no knowledge of an immediate and pending natural disaster that would affect how they conducted their dredging operations. Furthermore, it cannot be said that any dredger could have foreseen that performing its dredging activities negligently—as opposed to in conformity with the Corps of Engineers’ specifications— would probably result in the series of events culminating in the catastrophic damages that occurred during Hurricane Katrina. No reasonable dredger could have anticipated that its negligence would make the difference between the levee systems holding or failing in the event of a hurricane. The damages alleged here were beyond the pale of general harm which reasonably might have been anticipated by negligent dredgers.

The court cautioned that that was not to say that it could never be foreseen that dredging could create conditions that would result in flooding after a hurricane. Rather, it was not foreseeable that the marginal erosion caused by any act of negligence by a defendant here would substantially affect the impact of the hurricane such that the failure of the levee systems and subsequent flooding would be the probable result. The causal sequence alleged in the present case was just far too attenuated.

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The Third Circuit has affirmed the dismissal of two putative class actions that sought medical monitoring for workers and neighbors of factories using beryllium. Sheridan, et al.  v. NGK Metals Corp., et al., 2010 WL 2246392 (3d Cir. June 7, 2010). 

Readers may recall that previously we posted on the district court's dismissal of the claims against one of the defendants, an engineering firm that, according to the plaintiffs’ Amended Complaint, was involved with testing, sampling, analyzing, and monitoring the air quality and levels of beryllium at one plant involved in the cases. The Third Circuit affirmed.  Boiled down to its core, plaintiffs’ Amended Complaint contended that the engineering firm breached its duty of reasonable care by failing to warn members of the community surrounding one of the plants at issue about the alleged beryllium emissions from the facility. But there was no legal duty to warn.  In order for the engineers to have negligently failed to warn plaintiffs of harmful beryllium exposures, they must have undertaken the responsibility of making that warning. Plaintiffs never alleged that the firm negligently performed the tasks it actually undertook—that is, testing, analyzing, and monitoring the levels of beryllium, and reporting those tests to the owner and operator of the facility. 

Also of note for readers is the remainder of the court's analysis regarding other defendants, which focused on one of the elements of medical monitoring.

Some background.  Plaintiffs in each case filed a putative class action lawsuit against multiple defendants, alleging negligence in connection with beryllium exposure, and seeking a medical monitoring trust fund based on their alleged increased risk of developing chronic beryllium disease int he future. In the first action, (the “Anthony action”), the District Court granted defendants’ joint motion for summary judgment. In the second (the “Zimmerman action”), the District Court addressed three separate legal issues— medical monitoring under Pennsylvania law, claim preclusion of the claims of one named plaintiff, Sheridan, and third-party liability—and issued final orders in favor of defendants. Although the cases presented similar legal issues, they arose out of different locations and distinct facts. However, plaintiffs’ lawyers, many of the expert witnesses, and one defendant, were the same in each case. The Third Circuit did not consolidate the two separate appeals, but resolved them in one opinion.

Inhaling beryllium particles can lead to scarring of the lungs, a condition known as chronic beryllium disease.  CBD occurs when the immune system mounts an attack against beryllium particles that have entered the body. The lung sacs become inflamed and fill with large numbers of white blood cells that accumulate wherever the beryllium particles are found. The cells form balls around the particles called granulomas. Eventually, the lungs become scarred and lose their ability to transfer oxygen to the blood stream.

The dose-response picture is a bit unusual. Mere exposure itself appears to be insufficient because only persons who have a particular genetic “marker”—the Human Leukocyte Antigen (HLA)-DPB1 allele—can potentially recognize beryllium in the lungs as an antigen. This reaction is called beryllium sensitization (“BeS”). The parties did not dispute that BeS is a necessary precursor to CBD. BeS by itself causes no abnormal lung function and requires no treatment (i.e., it is asymptomatic).  The experts debated how many people have the marker with estimates ranging from below 10% to 40% of the population. The most common test for sensitization is the beryllium lymphocyte proliferation test (“BeLPT”), which is not a test for the genetic marker, but a reasonably accurate test for sensitization according to the experts.

Readers know that one of the typical elements of a medical monitoring claim is proof of a significantly increased risk (of contracting the latent disease for which plaintiff seeks medical monitoring). Plaintiffs' expert testimony was that all individuals exposed to beryllium at above background levels are at a significantly increased risk and require medical monitoring. They  declared that there is a direct relationship between the level of exposure and risk, and that CBD is not qualitatively different from any other environmental exposure disease.  Defendants' expert opined that given class rep Anthony’s negative result in the test to show whether he had become sensitized, and the fact that only a small percentage of the population can become sensitized, Anthony was not at a significantly increased risk of developing CBD.

In the other class action, the parties stipulated that class rep Zimmerman was not beryllium sensitized. Plaintiff experts argued, however, that anyone who has lived in the area surrounding the plant in question was at a significantly increased risk given the levels of beryllium in the
ambient air and documented cases of CBD in the community. They made a quantitative risk assessment based on collected exposure data, concluding that the risk of contracting CBD to the members of the proposed class represented by Zimmerman was 3 per 10,000, and for those
individuals who have lived near the plant for at least ten years, the risk allegedly increased to 1 per 500.

The Third Circuit noted that the intermediate appellate court in Pennsylvania had addressed analogous medical monitoring claims in Pohl v. NGK Metals Corp., 936 A.2d 43 (Pa. Super. Ct. 2007). The Pennsylvania Superior Court concluded there that the record provided no support for plaintiffs’ contention that they were sensitized to beryllium and thus that they faced a significantly increased risk of contracting CBD. Plaintiffs in federal court contended that Pohl was neither controlling nor persuasive, because it was a fact-specific decision in which the state court dismissed the three plaintiffs’ claims based on their individual failure of proof.

The court of appeals, however, concluded that the state court drew a line along the exposure-to-disease continuum -- at sensitization. The Third Circuit held that unlike its role in interpreting federal law, it may not "act like a judicial pioneer" in a diversity case. Contrary to both Anthony’s and Zimmerman’s contentions, Pohl was not based only on a simple lack of proof; it was based on plaintiffs’ failure to meet the requisite threshold for establishing significantly increased risk due to (1) the undisputed facts about beryllium exposure, BeS, and CBD, and (2) plaintiffs’ inability to demonstrate a significant increase in risk of disease before sensitization. Although the disparate data on how many people have the marker shows the gaping holes in the current state of scientific research, as well as the substantial factual disagreements between scientists, it was not material to this appeal. The parties stipulated that Anthony had not developed BeS, and there was no proof that he has the genetic marker associated with CBD. This background data did not prove his individual significantly increased risk.

As to the Zimmerman class (all persons who resided within a one-mile radius of the Reading Plant for at least six months during the time period between 1950 and 2000), the court noted that plaintiffs tried to make a different showing, including by presenting data on specific exposure levels around the Reading Plant and the number of documented cases of CBD in the community there. From Zimmerman’s perspective, exposure to beryllium is analogous to exposure to other toxins, such as asbestos and PCBs. Defendants contended CBD’s immunological nature distinguishes beryllium from other toxins, which do not invoke an allergic response in only a subset of susceptible persons and instead have a more linear exposure-to-disease relationship.

The state of the art is that only a small subset of an exposed population (those who carry the genetic marker) is at risk of developing CBD; the relationship between beryllium exposure and CBD is relatively non-linear, making generalized risk assessments inappropriate. Thus, there was a failure of proof on the risk element, given the current state of scientific knowledge on the
relationship between beryllium exposure and disease. Plaintiff failed to present sufficient evidence that as a proximate result of the exposure, he had a significantly increased risk of contracting
CBD.

The failure of the class reps to show they could meet a necessary element of the claim meant that the class actions could not proceed. (Sheridan's claim was barred.)

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A federal court has granted defendant summary judgment in a case which alleged that cartilage damage sustained by the plaintiff, a former high school athlete, was caused by the post-surgery use of the drug company’s pain medication in an automated pump device. Jensen Meharg, et al. v. I-Flow Corp., et al., No. 1:08-cv-00184 (S.D. Ind. 3/1/10).

The former high school athlete underwent shoulder surgery, after which a pain pump was utilized. The pain pump in question was manufactured and sold by I-Flow Corporation; the local anesthetic–bupivacaine Hcl – was manufactured and sold by defendant AstraZeneca.  AstraZeneca did not in any way promote the use of bupivacaine with pain pumps, and that use was not mentioned in the instructions and warnings provided with the drug -- an off-label use. Several months later, plaintiff began to experience shoulder pain again. An MRI allegedly revealed that plaintiff had developed chondrolysis in her shoulder, which she alleged was caused by the post-surgery administration of the bupivacaine with the pain pump.

The strict liability claim was for alleged failure to warn; a warning defect claim requires that defendant had a duty to warn.  Duty is generally a legal issue.  In the context of a prescription drug manufacturer, the duty to warn does not arise until the manufacturer knows or should know of the risk.  In cases that involve an off-label use of a prescription drug that is not promoted by the manufacturer, the requisite knowledge of the risk, at a minimum, includes that the manufacturer must know (or be charged with knowledge of) both that the off-label use is occurring and that the off-label use carries with it the risk of the harm at issue – in this case, damage to cartilage.

The court found as a matter of law that the information allegedly possessed by defendant was insufficient to trigger AstraZeneca’s duty to warn of the risk of cartilage damage from continuous infusion of bupivacaine into a patient’s joint. Simply put, the plaintiff failed to point to sufficient evidence that demonstrated that at the time of plaintiff’s surgery AstraZeneca knew of that risk or that it should have known of the risk because experts in the relevant field had such knowledge.

More interesting was plaintiff's other theory. Plaintiff's expert also opined that prior to plaintiff’s surgery the defendant supposedly knew that bupivacaine was being used in pain pumps, and that this knowledge triggered an alleged duty to “investigate the nature of that use, determine whether the drug was being promoted in accordance with approved indications, conduct or sponsor those studies necessary to ensure that the promoted use was safe, and to warn physicians that long-term risks to the joint had not been scientifically established but that the risks should be weighed seriously, given that the anticipated use was for elective post-operative pain therapy for which multiple alternatives existed.”  The court noted that such a  “duty” does not exist under relevant (Indiana) law.  The duty to warn does not arise until the manufacturer knows or should know of the risk.  The alleged far broader duty  – a  duty, in essence, to warn physicians that there might be a risk, although we don’t know yet because neither we or the scientific community at large has studied it yet -- doesn't exist.

Such a duty would cause physicians to be inundated with such pseudo-warnings and quasi-risk information distracting them from heeding real warnings of actual risk; and it would add very little to the fact that physicians already know, i.e., that if a use is omitted from a prescription drug’s label, that use has not been tested sufficiently to demonstrate to the FDA that it is safe and effective.

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Maryland's top court recently affirmed summary judgment for defendant Eli Lilly & Co., in a case brought by a widow whose husband was killed in an auto accident. His car was allegedly hit by a diabetic who blacked out while under treatment with two insulin medications. Gourdine v. Crews, No. 134 (Md. Ct. App. 9/4/08).

Background
Ellen Crews, a Type I diabetic who was taking a combination of insulin medications from Lilly, while operating her car, allegedly suffered some kind of debilitating episode and struck a vehicle driven by Isaac Gourdine, resulting in his death. The issue for the Court was whether Lilly owed a duty to Mr. Gourdine, the third-party who did not ingest the drugs. Plaintiff, the wife of Mr. Gourdine, argued that it was somehow foreseeable to Lilly that Ms. Crews, might allegedly suffer an adverse reaction to the medications, which in turn would cause injury and death to third persons while she was operating a motor vehicle. If she had not been adequately warned about the dangers that allegedly were associated with the specified medications, that would supposedly impact a duty owed to Mr. Gourdine.

Specifically, Ms. Crews took a combination of Humalog, a quick-acting form of insulin taken with meals, and Humulin N, a medication designed to supply a constant source of insulin to the body. Ms. Gourdine contended that, at the time of the accident, Ms. Crews suffered a hypoglycemic reaction and experienced a “blackout” causing her to lose control of her vehicle. Defendant Lilly, plaintiff alleged, owed a duty to protect users of the highway from drivers suffering from hypoglycemia induced by the allegedly misbranded drug.

Lilly sought and obtained summary judgment below on the basis it owed no duty to decedent Gourdine, a nonuser of the drug, to warn about alleged risks associated with the medications. Plaintiff appealed, and the Maryland Court of Special Appeals affirmed; the case then went up again.

Reasoning
The Court began with a discussion of the elements of plaintiff’s causes of action, noting that duty is an essential element of both negligence and strict liability causes of action for failure to warn. In contrast to the reasoning of the lower courts, however, the Court stated that the duty issue should not be analyzed in the context of the learned intermediary rule – which holds that the manufacturer’s duty to warn is to the prescriber – but as an issue of the common law of torts.

At its core, the determination of whether a duty exists represents a policy question whether the specific plaintiff is entitled to protection from the acts of the defendant; ultimately, the determination of whether a duty should be imposed is made by weighing the various policy considerations and reaching a conclusion that the plaintiff's interests are, or are not, entitled to legal protection against the conduct of the defendant. The foreseeability test relied on by plaintiff  “is simply intended to reflect current societal standards with respect to an acceptable nexus between the negligent act and the ensuing harm.”  While foreseeability is often considered among the most important of the relevant factors, its existence alone does not suffice to establish a duty under Maryland law.

In this case, there was no direct connection between Lilly’s warnings, or the alleged lack thereof, and Mr. Gourdine’s in jury. In fact, there was no contact between Lilly and Mr. Gourdine whatsoever. To impose the requested duty from Lilly to Mr. Gourdine would expand traditional tort concepts beyond manageable bounds, because such duty could apply to all individuals who could have been affected by Mr. Crews after her ingestion of the drugs. Essentially, Lilly would owe a duty to the world, an indeterminate class of people, for which the Court has “resisted the establishment of duties of care.”

Gourdine attempted to draw support from cases in other jurisdictions, in which she asserted that a doctor's duty to warn his or her patient of the risks associated with medication extends to nonpatients who are foreseeably at risk. The Court responded that it has not historically embraced the belief that duty should be defined mainly with regard to foreseeability, without regard to the size of the group to which the duty would be owed, which the courts in Alabama, Hawaii, and Washington, according to plaintiff, have.

On the other hand, numerous jurisdiction had rejected this kind of universal duty, the Court noted. See Kirk v. Michael Reese Hospital & Medical Center, 513 N.E.2d 387 (Ill. 1987); Gilhuly v. Dockery, 615 S.E.2d 237, 239 (Ga. Ct. App. 2005) (patient who was involved in a car accident in which sons were injured filed suit on their behalf based on physician’s alleged failure to warn patient not to drive after taking certain medications; the Court of Appeals of Georgia rejected the claims on behalf of the sons because “[t]o expand a doctor’s duty to his patient to generally include members of the public at large in a case such as this one would be contrary to Georgia public policy”); Lester ex rel. Mavrogenis v . Hall, 970 P.2d 590, 597 (N.M. 1998) (holding that physician owed no duty non-patient injured in automobile accident with patient because the “consequences of placing a legal duty on physicians to warn may subject them to substantial liability even though their warnings may not be effective to eliminate the risk in many cases”); Rebollal v. Payne, 145 A.D.2d 617, 618 (N.Y. App. Div. 1988) (“There is no duty on the part of the operator of a methadone clinic to control the travel activities of a methadone patient giving rise to liability for accidents to a third party such as plaintiff’s decedent.”); Praesel v. Johnson, 967 S.W.2d 391, 398 (Tex. 1998) (stating that treating physicians do not owe a duty to third parties to warn epileptic patients not to drive, for purposes of negligence claims against physicians for failure to warn if patient has accident and injures third party during seizure; “Balancing both the need for and the effectiveness of a warning to a patient who already knows that he or she suffers from seizures against the burden of liability to third parties, we conclude that the benefit of warning an epileptic not to drive is incremental but that the consequences of imposing a duty are great.”).

Gourdine also argued that the Federal Food, Drug, and Cosmetic Act, which prohibits drug manufacturers from placing a misbranded product into interstate commerce, conferred a duty on Lilly. This statute and its regulations, however, are framed to protect the public in general, and, a statutory obligation which “runs to everyone in general and no one in particular” cannot impose a duty between two parties.
 

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