We have to admit that we’re scratching out heads about a recent decision out of Alabama that – contrary to everything else we’ve seen – concluded that the manufacturer of a branded drug could be liable in a case where it never sold the generic product that was all the plaintiff every took and thereby (allegedly) suffered injury.
It’s not like this issue hasn’t been litigated before in Alabama.
The first Alabama case we know of to consider the issue was Barnhill v. Teva Pharmaceuticals USA, Inc., 2007 WL 5787186 (S.D. Ala. April 24, 2007), a Stephens-Johnson case where the plaintiff took cephalexin, a generic form of Keflex, but nevertheless tried to sue the manufacturer of branded Keflex. The court held that no non-manufacturer product liability cause of action existed under Restatement (Second) of Torts §402B (a strict liability form of misrepresentation), for negligent failure to warn, for negligent failure to test (which shouldn’t exist at all), for negligent design, for negligent marketing and sale, for negligent manufacturing, for negligent failure to training physicians, and breach of express and implied warranty. The court found all of these theories “essentially nonexistent” against a non-manufacturer, and that there was no evidence that the branded defendant was somehow an licensee, agent, or co-conspirator with the generic manufacturer. Id. at *1-2
Next, in Green v. Wyeth Pharmaceuticals, Inc., 2007 WL 6428717 (Ala. Cir. May 14, 2007), an Alabama state court judge reached the same conclusion in a metoclopramide/Reglan case:
The majority of courts that have considered the issues presented in this case have found that only the manufacturer of the generic drug which was sold are liable. The cases cited by defendants are persuasive that [non-manufacturing] defendants . . . are not liable.
Id. at *1.
Fast forward a few years, and in Mosley v. Wyeth, Inc., 719 F. Supp.2d 1340 (S.D. Ala. 2010), another metoclopramide/Reglan case, the court threw out negligent misrepresentation, fraud, and warranty theories against manufacturers of both branded and generic products that the plaintiff admittedly never used. In Mosley the plaintiffs claimed: (1) that the FDCA made branded manufacturers “primarily responsible” for labeling even for drugs they didn’t sell, and (2) that the branded manufacturer “created a sense of security and safety” through dissemination of supposedly “false” information about its own drug. Id. at 1344.
Mosley accepted that plaintiffs, having fled from product liability, “did not argue that the defendants’ product caused them harm, but rather that their dissemination of false and misleading information, which they knew would be relied upon by the generic manufacturers in generating their own labels, was a direct and proximate cause of plaintiffs’ injuries.” Id. at 1344-45. That didn’t turn out to change the bottom line in Mosley – no liability.
Rather, Mosley dismissed the misrepresentation claim because the Alabama Supreme Court had never included product manufacturers within the category of persons who could be liable for “supply[ing] information” as “part of their business or profession” for “the guidance of others in their business transactions.” Id. at 1346 (construing Restatement (Second) of Torts §552). Product liability plaintiffs are not suing over “business transactions,” and the Alabama Supreme Court has only applied §552 in “limited circumstances” that did not include product warnings made to non-customers. Id.
There was also no viable fraud claim in Mosley under Alabama law where the defendant was not a manufacturer of the product that injured the plaintiff. Alabama has rejected market share liability and similar non-manufacturer theories in cases involving alleged product-related injuries. Id. (citing Franklin County School Board v. Lake Asbestos of Quebec, Ltd., 1986 WL 69060, at *6 (N.D. Ala. Feb. 13, 1986)). No fraud claim had ever been permitted in Alabama to hold a manufacturer liable for injuries caused by the products of a competing manufacturer:
The plaintiffs present no evidence or argument tending to establish that a relationship existed between [plaintiffs] and the [non-manufacturer defendants]. The plaintiffs cite no binding authority for the assertion that a manufacturer of brand-name drugs owes a duty to consumers of the generic version of their products. Nor do [they] cite any binding authority for the contention that an injury resulting from consumption of a generic version of the drug can be considered a “proximate consequence” of a manufacturer’s alleged misrepresentation regarding the brand-name version of the drug.
Mosley, 719 F. Supp.2d at 1347.
Nor did the FDA’s regulatory scheme mandate that brand name manufacturers be liable for competing generic products. Nothing in the FDCA revealed an intent to change common-law duties. Rather “generic manufacturers bear the same burden as brand manufacturers of providing a warning that adequately describes the risks associated with the particular drug they are manufacturing.” Id. at 1348.
Likewise express and implied UCC warranty claims fail where there isn’t any contact between the plaintiffs and the “goods” that were allegedly subject to the breached warranties:
[Plaintiff] cite no authority holding that [UCC] §7-2-318 . . ., as adopted in any other jurisdiction-provides a cause of action to plaintiffs who were neither purchases, users, or consumers of, nor in contact with, goods produced by the manufacturer against whom they claim breach of warranty resulting in personal injury.
719 F. Supp.2d at 1351. The court in Mosley refused plaintiffs’ “invitation” to be come the first court to do so. Id.
That’s three – and the third one was a whopper.
Next, in Simpson v. Wyeth, Inc., 2010 WL 5485812 (Mag. N.D. Ala. Dec. 9, 2010), adopted, 2011 WL 10607 (N.D. Ala. Jan. 4, 2011), yet another metoclopramide/Reglan case, the plaintiffs conceded negligence, strict liability, and warranty. Instead they argued that, by virtue of prior branded drug sales, the non-manufacturer “entered into a relationship with plaintiffs’ prescribing physicians that required them to notify those physicians of” allegedly suppressed information, even in the absence of prescription in a particular case. Id. at *2. They further claimed that if the prescribers had known of the “true” risks of the branded drug, they would not have prescribed the generic either. Id.
In Simpson plaintiffs claimed that a general fraud proposition – that fraud can pass through intermediate “third parties” – allowed a non-manufacturer claim, when tied to the learned intermediary rule. Id. No way, said the court. There was no duty. The learned intermediary rule was a product liability doctrine, and plaintiffs could not cloak themselves in a product liability doctrine while at the same time violating the fundamental tenet of product liability, which is that manufacturers are the liable parties:
“[U]nder the learned intermediary doctrine, a manufacturer’s duty to warn is limited to an obligation to advise the prescribing physician of any potential dangers that may result from the use of its product.” Thus, the duty to warn of risks related to the use of a drug is owed to the prescribing physician by the drug manufacturer, not some other manufacturer of the same or a similar product. As a matter of law, the manufacturers of [a drug] have no duty to communicate any information regarding the risks of taking this product to anyone other than their own customers.
2010 WL 5485812, at *5 (quoting Walls v. Alpharma USPD, Inc., 887 So.2d 881, 883 (Ala. 2004)) (emphasis added).
Finally, in Overton v. Wyeth, Inc., 2011 WL 1343392 (Mag. S.D. Ala. March 15, 2011), adopted, 2011 WL 1343391 (S.D. Ala. April 7, 2011), pretty much the same result ensued, after the plaintiff was forced to amend her complaint to identify who did and did not manufacture the metoclopramide she took. “[I]t is abundantly clear . . . that Plaintiff cannot state a claim against the Brand Name Defendants.” Id. at *5.
Misrepresentation under Ala. Code. §6-5-101 required that a duty to disclose be owed to the particular plaintiff. As in Mosley and Simpson, the non-product liability fraud claims foundered on lack of either duty or causation. There is “no binding authority for the assertion that a manufacturer of brand-name drugs owes a duty to consumers of the generic version of their products.” 2011 WL 1343392, at *7. Nor can “an injury resulting from consumption of a generic version of the drug can be considered a ‘proximate consequence’ of a manufacturer’s alleged misrepresentation regarding the brand-name version of the drug.” Id.
Overton also rejected the FDA-created duty theory. Id. at *7 n.9. UCC warranty claims also failed because the statute’s anti-privity language required the plaintiff to have been “affected” by “the goods” themselves, not merely by purported “negligent misrepresentations in the warning labels.” Id. at *7.
That’s five – including three – Mosley, Simpson, and Overton, that specifically addressed and just as specifically rejected the plaintiffs’ non-product liability theories that did not depend upon any “defect” in the generic product or its warnings.
So what just happened in Weeks v. Wyeth, Inc., 2011 WL 1216501 (M.D. Ala. March 31, 2011)?
For one thing, we’d have to say that that federalist concerns for the power of state courts to develop state tort law got mugged.
Weeks was essentially indistinguishable from, at least, Mosley, Simpson, and Overton, since plaintiffs suing over the same drug in the same situation asserted the same product liability and non-product liability theories of liability. First, the Weeks court conceded that “a brand name manufacturer has no duty to warn a consumer about a generic manufacturer’s drug.” 2011 WL 1216501, at *3, and dismissed all the product-related claims. However, the court interpreted the plaintiff’s allegations as asserting an independent duty to warn “prescribing physicians,” including the doctor who prescribed the drug to the plaintiff, irrespective of product use. In the words of the court:
[Plaintiffs’] claims center, however, on statements the brand name defendants made or failed to make to [the] prescribing physician. Specifically, [plaintiffs] argue that the brand name defendants had a duty to disclose information about Reglan, the product they did manufacture, to [the] physician. . . . They also claim that the brand name defendants’ failure to adequately warn prescribing physicians about Reglan’s side effects caused [the prescriber] to prescribe generic MCP for extended use.
When framed in this way, [plaintiffs] would not be required to demonstrate that the brand name manufacturers had a duty to warn about generic MCP. [Plaintiffs] would not even have to demonstrate that the brand name defendants owed a duty to [the patient] himself, only that the brand name defendants owed a duty to the prescribing physician to adequately disclose and warn about the risks associated with Reglan.
Weeks, 2011 WL 1216501, at *3 (emphasis added).
Whoa! Let’s think about that.
That analysis isn’t a restatement of the learned intermediary rule – at least not any learned intermediary rule we’re familiar with. Rather than a duty to warn the prescriber of the drug that injured the plaintiff, Weeks postulates that drug manufacturers have some broad, nebulous duty to warn the medical community as a whole, totally divorced from what drug any particular doctor actually prescribed to any particular patient, since this purported duty extends to situations where the defendant’s drug was not in fact prescribed to the patient.
Is that something that Alabama recognizes? We don’t think so.
Alabama has followed the learned intermediary rule since Stone v. Smith, Kline & French Laboratories, 447 So.2d 1301, 1305 (Ala. 1984). In Stone, the Court was explicit that the learned intermediary rule involved “the manufacturer’s” duty involving “the use” of its “drug”. “[T]he manufacturer’s duty to warn is limited to an obligation to advise the prescribing physician of any potential dangers that may result from the drug’s use.” 447 So.2d at 1304 (quoting Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1276 (5th Cir. 1974)) (emphasis added).
The learned intermediary rule next came up in Morguson v. 3M Co., 857 So.2d 796 (Ala. 2003), involving a device that included some tubing. Again, the duty to warn under the learned intermediary rule was limited to the physician actually using the defendant’s product. “[Defendant’s] duty was to warn the physicians and perfusionists at [the hospital] who used the vent tubing.” Id. at 802 (emphasis added).
In Walls v. Alpharma USPD, Inc., 887 So.2d 881, 883 (Ala. 2004), the Court decided that the learned intermediary rule precluded liability against a pharmacist for failing to warn the plaintiff. The Court once again stated the rule in terms of warnings about the uses of particular products:
Under the learned intermediary doctrine, a manufacturer’s duty to warn is limited to an obligation to advise the prescribing physician of any potential dangers that may result from the use of its product. This standard is an understandable exception to the Restatement’s general rule that one who markets goods must warn foreseeable ultimate users of dangers inherent in his products.
Id. at 883 (quoting Toole v. Baxter Healthcare Corp., 235 F.3d 1307, 1313-14 (11th Cir. 2000) (applying Alabama law)) (emphasis added).
Finally, in Springhill Hospitals, Inc. v. Larrimore, 5 So.3d 513 (Ala. 2008), the Court provided its most recent interpretation of Alabama’s learned intermediary rule in another pharmacist situation – where a pharmacist voluntarily provided information about the same drug that the plaintiff in fact took. The Court once again refused to expand warning duties under the learned intermediary rule beyond a manufacturer’s “customers”:
In those cases [Stone and Walls], the duty at issue was a drug manufacturer’s or a drug dispenser’s duty to warn customers. Here, the duty at issue is not a duty to warn a customer . . . of potential risks or side effects, but a duty of care, allegedly breached by [a pharmacist] when he gave [a prescriber] allegedly incomplete dosing information.
Id. at 518 (emphasis added). The alleged warning duty – going beyond “customers” – did not exist:
In light of the foregoing, we are unpersuaded by the estate’s argument that [the pharmacist] voluntarily assumed a duty of care when he answered [the prescriber’s] question. . . . Because we find the principles articulated in Walls and Stone applicable to this case, we hold that the learned-intermediary doctrine precludes [the pharmacist’s] liability for harm resulting from any mistakes on [the prescriber’s] part in prescribing [the drug].
Id. at 521 (emphasis added).
Thus, in all four cases in which the Alabama Supreme Court has interpreted the state’s learned intermediary rule, it has never once suggested that the scope of a manufacturer’s duty to warn extends beyond those persons actually using the drug that the manufacturer’s warnings accompanied. The quote from Toole, that the Alabama Supreme Court adopted in Walls, demonstrates that the Eleventh Circuit has likewise not expanded liability in the way envisioned in Weeks. No Alabama law case has applied the learned intermediary rule to allow liability where the doctor in question never treated the plaintiff with products that the defendant actually made. See also Toole v. McClintock, 999 F.2d 1430, 1433 (11th Cir. 1993) (breast implant maker owed duty to physician who implanted its product) (applying Alabama law); Southern v. Pfizer, Inc., 471 F.Supp.2d 1207, 1218 (N.D. Ala. 2006) (drug reps cannot be liable under learned intermediary rule, even where their employer’s drugs were prescribed); Bloodsworth v. Smith & Nephew, 2005 WL 3470337, at *7 (M.D. Ala. Dec. 19, 2005) (same with respect to device manufacturer’s representative); Emody v. Medtronic, Inc., 238 F. Supp.2d 1291, 1296 (N.D. Ala. 2003) (no liability under learned intermediary rule where doctor failed to follow manufacturer’s warnings about its own product). In Alabama, the learned intermediary rule has never previously been construed as creating duties to the “medical profession” in the abstract.
That’s not to say that plaintiffs haven’t argued before in favor of a broad duty owed to the medical profession as a whole. They used to, but to no avail. For instance, in Lindsay v. Ortho Pharmaceutical Corp., 637 F.2d 87, 91 (2d Cir. 1980), the court rejected such an argument under New York law:
It is somewhat misleading to say that defendant owed a duty to warn the “medical profession”. We are not concerned here with whether adequate warnings were given to chiropodists in California or orthopedists in Arizona. [Plaintiff] contends that [the defendant’s] drug was defective as to her because [defendant] did not adequately warn her doctors. So far as these plaintiffs are concerned, if [defendant] adequately warned [plaintiff’s] doctors, the drugs were not defective.
Id. at 91. Likewise, in Desmarais v. Dow Corning Corp., 712 F. Supp. 13 (D. Conn. 1989), the court, applying Connecticut law, held:
Warnings to the medical profession generally rather than to individual prescribing physicians would be illogical and contrary to the very policy and purpose underlying the learned intermediary doctrine and the duty to warn. Unless the individual prescribing physician receives specific, relevant warnings, she cannot make a careful, balanced assessment of the risks and benefits to her patient, nor can the patient herself be adequately informed. Thus, the learned intermediary doctrine does not alter the duty of a manufacturer to provide adequate warnings of risks with each product sold; rather, the doctrine simply substitutes the physician for the consumer as the person to receive those warnings.
Id. at 18.
There is thus no basis in Alabama law (or any other state’s law, save maybe the bizarre California Conte case) for expanding the learned intermediary rule to the medical profession generally, without regard to what doctor prescribed what drug to what patient. Indeed, the court in Weeks admits that there is no “case on point.” 2011 WL 1216501, at *6. The plaintiff’s claim in Weeks was allowed to proceed only after the court imposed a burden on the defendant to come up with precedent affirmatively debunking the existence of this novel cause of action:
[T]he Court finds that neither side has provided a case on point. The defendants’ cases do not establish that a relationship between [plaintiffs] and the brand name defendants is required when the plaintiff’s claims are based on fraud perpetrated against the prescribing physician. Therefore, the defendants have not demonstrated, based on this argument, that [plaintiffs] fail to state a claim for which relief can be granted.
Thus the root cause of this Alabama muddle is the same fundamental Erie doctrine principle upon which we have harped time and time again. The Weeks court failed to respect Alabama’s right, as a co-sovereign in our federal system, to decide when and if to expand its own tort liability. When in doubt – and even Weeks conceded that there is doubt – a federal court sitting in diversity should refrain from expansive interpretations of state-law tort liability:
A federal court in diversity is not free to engraft onto those state rules exceptions or modifications which may commend themselves to the federal court, but which have not commended themselves to the State in which the federal court sits.
Day & Zimmerman, Inc. v. Challoner, 423 U.S. 3, 4 (1975); see Seaboard Surety Co. v. Garrison, Webb & Stanaland, P.A., 823 F.2d 434, 438 (11th Cir. 1987) (in a “federal forum” a plaintiff “must abide by federal determination as to the present state of [state] law”); Lee v. Hunt, 631 F.2d 1171, 1175 (5th Cir. 1980) (quoting and following Day & Zimmerman).
We can only hope that appropriate appellate supervision – preferably by the Alabama Supreme Court – isn’t long in coming.