The sophisticated user defense, also known as the learned intermediary doctrine, has been widely used by drug manufacturers in defending against failure to warn claims in products liability lawsuits. Although less well known, the sophisticated user defense has also been applied outside the pharmaceutical drug context and just recently, in Parker v. Schmiede Machine & Tool Corp.,1 the U.S. Court of Appeals for the Eleventh Circuit relied on the sophisticated user defense in affirming a district court’s grant of summary judgment to the defendants in a case in which employees at Lockheed Martin’s Marietta, Georgia facility alleged that they developed illnesses as a result of exposure to beryllium.
The Use of the Sophisticated User Defense in Toxic Tort Cases
A plaintiff asserting a failure to warn claim must show that the defendant had a duty to warn, that the defendant breached that duty, and that the breach proximately caused the plaintiff’s injury.2 The “sophisticated user” or “learned intermediary” defense relieves a product supplier of the duty to warn an ultimate consumer or user of a known hazard where there is an intermediary with knowledge of the hazard.3
In Stuckey v. Northern Propane Gas Co., the Eleventh Circuit issued its first decision addressing the scope of the sophisticated user/learned intermediary defense outside the pharmaceutical drug context.4 In Stuckey, a plaintiff filed suit against a propane gas supplier after the plaintiff was burned in an explosion. The plaintiff alleged that the supplier failed to warn him about the tendency of the odorant added to propane gas to fade over time. However, the defendant supplier distributed propane to another company which then sold and delivered the propane at the location of the explosion. Although the Eleventh Circuit affirmed the trial court’s denial of the supplier’s directed verdict motion because the propane supplier was unable to establish that the seller of the propane had actual knowledge of odor fade, the court in Stuckey explained the scope of the learned intermediary defense. Relying on comment n to the Restatement (Second) of Torts § 388, the Eleventh Circuit held that “a supplier’s duty to warn a consumer does not turn on whether a warning was actually given to the intermediary, but on whether the intermediary’s knowledge was sufficient to protect the ultimate consumer.”5
As explained by subsequent courts, where a learned intermediary “has actual knowledge of the substance of the alleged warning and would have taken the same course of action even with the information the plaintiff contends should have been provided, courts typically conclude that the learned intermediary doctrine applies or that the causal link has been broken and the plaintiff cannot recover.”6
The Lengthy Saga of the Parker Beryllium Case
In 2004, a number of current and former employees of Lockheed Martin’s Marietta, Georgia facility7 filed a putative class action alleging that the plaintiffs and members of the putative class had developed beryllium sensitization and/or “sub-clinical, cellular, and sub-cellular damage” from exposure to beryllium-containing products utilized at the Lockheed facility. Early in the case, the federal district court dismissed the plaintiffs’ claims for alleged sub-clinical, cellular, and sub-cellular damage, and dismissed plaintiffs’ claims for emotional distress and for medical monitoring costs. The Court also concluded that the plaintiffs’ claims for beryllium sensitization did not constitute an actionable injury under Georgia law.8 On appeal, the Eleventh Circuit affirmed the district court’s dismissal of the plaintiffs’ claims for “sub-clinical, cellular, and sub-cellular damage” and for emotional distress and medical monitoring costs. However, the Court reversed the district court’s grant of summary judgment on the claims of the plaintiffs who alleged beryllium sensitization.9
Following remand of the case, and after extensive additional discovery, the district court granted summary judgment to the defendants after finding that the plaintiffs’ employer, Lockheed Martin, was a sophisticated user of beryllium, and thus, the plaintiffs’ failure to warn claims were barred.10
On October 21, 2011, the Eleventh Circuit affirmed the dismissal based on “the ‘sophisticated user’ or ‘learned intermediary’ doctrine, and found that Lockheed Martin was an intermediary with knowledge of the hazard.”11 In concluding that “the Defendants have established that Lockheed is a sophisticated user of beryllium and a learned intermediary between its employees and the manufacturers of beryllium products,” the court explained that, among other things, the Lockheed facility had produced aircraft containing beryllium parts for almost sixty years and employed a team of industrial hygienists and toxicologists who had studied beryllium health effects and developed Lockheed’s own internal warnings regarding the hazards of beryllium.12
In addition, the Eleventh Circuit expressly declined the plaintiffs’ invitation to rely on the decision in Genereux v. American Beryllia Corp.,13 in which the First Circuit relied on Massachusetts law in concluding that a court considering a sophisticated user defense “must analyze ‘the particular dangers to be guarded against'” and engage in a detailed fact-specific analysis of whether the intermediary had sufficient knowledge of each and every particular danger of the allegedly hazardous substance.14 In contrast, Georgia law regarding the sophisticated user defense only requires that an intermediary possess general knowledge of the dangers associated with a product’s use.15 In addition, the decision in Genereux was readily distinguishable from the facts of Parker because the record evidence in Genereux established that the lead defendant had greater sophistication regarding beryllium than the plaintiffs’ employer and that the employer adjusted its industrial hygiene practices based upon input from that defendant.16
In another important aspect of its decision in Parker, the Eleventh Circuit concluded that a plaintiff cannot avoid the application of the sophisticated user defense simply by showing that the intermediary failed to take measures to adequately protect against a certain hazard–rather, plaintiffs must show that the intermediary lacked actual knowledge of the hazard.17 Thus, the relevant inquiry is focused on the intermediary’s knowledge; not on the adequacy of the intermediary’s implementation of its knowledge or the intermediary’s failure to act on its knowledge.
The Future of the Sophisticated User Defense in Toxic Tort Cases
The decisions in Parker demonstrate the continuing viability of the sophisticated user defense in toxic tort cases in which plaintiffs allege that the supplier or manufacturer of a product failed to sufficiently warn the end user of the hazards of the product. Although the applicability of the defense tends to be fact-specific, numerous courts have made it clear that this issue can be resolved at the summary judgment stage.18
Although not expressly addressed by the courts in the Parker decisions, the case also demonstrates how the timing of when an intermediary obtained its knowledge can impact the application of the sophisticated user defense in a case involving a lengthy alleged exposure period. In Parker, the plaintiffs alleged that they were exposed to beryllium for over a forty-year period and the knowledge of beryllium health risks had evolved over that time, but the record evidence was clear that Lockheed was always at the forefront of knowledge regarding beryllium health risks. However, it is not difficult to imagine a scenario where a plaintiff could attempt to create a fact issue by arguing that a particular intermediary was not a sophisticated user of a hazardous product during the early portion of the plaintiff’s alleged period of exposure to the product, and thus, the intermediary’s subsequent sophistication should not bar the plaintiff’s failure to warn claim against suppliers. In such a scenario, it will be important for courts to compare the respective knowledge of the industry and the intermediary at comparable time periods and not fall into an “apples to oranges” comparison of the current state of the art regarding a product’s hazards to what was known about the product during earlier time periods.
In light of the fact that employees allegedly exposed to toxic substances or hazardous products in the workplace are typically barred by workers’ compensation laws from recovering damages from their employers, it is commonplace for such employees to name manufacturers, suppliers, and distributors of allegedly hazardous products as defendants in toxic tort and product liability lawsuits. However, summary judgment may be available to manufacturers and suppliers based upon the sophisticated user defense when the plaintiffs’ employer possessed sufficient knowledge of the hazards associated with the substance or product at issue. It is reasonable to expect that the use of the sophisticated user defense will increase as society becomes more regulated, which imputes knowledge to the regulated community and creates more “learned intermediaries,” and information regarding hazardous substances and products becomes more readily available leading to more sophisticated users of hazardous products.
- Parker v. Schmiede Machine & Tool Corp., 445 Fed. Appx. 231 (11th Cir. 2011). ↩
- Wheat v. Sofamor, S.N.C., 46 F.Supp.2d 1351, 1362 (N.D.Ga. 1999). ↩
- Morgan v. Brush Wellman, Inc., 165 F. Supp. 2d 704, 718 (E.D. Tenn. 2001). ↩
- 874 F.2d 1563 (11th Cir. 1989). ↩
- Id. at 1568. ↩
- Wheat, 46 F. Supp. 2d at 1363. ↩
- Beryllium is a light metal with extreme hardness and a high melting point that makes it very desirable for use in a number of industries, particularly the aerospace industry and in the production of nuclear energy and weapons. In certain individuals, exposure to beryllium can result in beryllium sensitization, which is similar to an allergy and can be a precursor to the development of chronic beryllium disease–a respiratory illness. ↩
- See Parker v. Brush Wellman, Inc., et al., 377 F. Supp. 2d 1290 (N.D. Ga. 2005); and Parker v. Brush Wellman, Inc., et al., 420 F. Supp. 2d 1355 (N.D. Ga. 2006). ↩
- See Parker v. Brush Wellman, Inc., et al., 230 Fed. Appx. 878 (11th Cir. 2007) (concluding that an issue of fact existed regarding whether beryllium sensitization constituted a current physical impairment). ↩
- See Parker v. Brush Wellman, Inc., et al., 2010 WL 3730924 (N.D. Ga. Sept. 17, 2010). ↩
- Parke v. Schmiede Machine & Tool Corp., et al., 2011 WL 5025135 at *2 (11th Cir. October 21, 2011). ↩
- Id.at *3. ↩
- 577 F.3d 350 (1st Cir. 2009). ↩
- Id. at 366. ↩
- See Whirlpool Corp. v. Hurlbut, 166 Ga. App. 95, 101, 303 S.E.2d 284, 288 (1983). ↩
- Genereux, 577 F.3d at 373. ↩
- Parker, 2011 WL 5025135 at *5 n.8 (“Even if the Plaintiffs could prove that Lockheed did not employ the proper [beryllium] control devices, that proof would not be enough to rebut the evidence that Lockheed had actual knowledge of the need for such controls”). ↩
- See Parker, 2011 WL 5025135 at 5; *Morgan, 165 F. Supp. 2d at 718; Byrd v. Brush Wellman, Inc., 753 F. Supp. 1403, 1413 (E.D. Tenn. 1990). ↩