BACKGROUND

Over the past few years, three courts have overturned the fundamentals of tort law, holding that a manufacturer of a brand-name prescription drug can be subject to liability even when a plaintiff alleges that he or she was harmed by a generic drug made by the brand manufacturer’s competitor. Most courts, including four federal courts of appeal and dozens of federal district and state trial courts, have rejected this expansion of tort law. This tension intensified after two U.S. Supreme Court rulings on the viability of state failure-to-warn claims against manufacturers of prescription drugs created different liability rules for generic manufacturers than for makers of brand-name drugs.

In the first case, the U.S. Supreme Court held that federal drug law does not preempt state failure-to-warn claims with respect to brand-name drugs;¹ in the second case, it ruled that federal law does preempt failure-to-warn claims stemming from the use of generic products.² As a result, the U.S. Supreme Court allowed users of brand-name drugs to potentially have an avenue for recovery not available to users of generic drugs.

The brand-name ruling came from the 2009 case Wyeth, Inc. v. Levine. The Court considered whether a plaintiff who had been administered brand-name Phenergan, an antihistamine used to treat nausea, could claim that its manufacturer, Wyeth, inadequately warned of the risk of developing gangrene when the drug is injected into a patient’s vein rather than administered through an IV drip.³ At the time of the suit, the drug had long been available in generic form.⁴ In allowing the claim against Wyeth to go forward, the majority of the Court reasoned it was not impossible for Wyeth to comply with both federal labeling law and any state law warning requirements that would be derived if the litigation deemed its warnings inadequate.⁵ The majority opinion explained that Wyeth could have used the “changes being effected” (CBE) process to add the safety information required by the jury’s determination and then seek FDA approval for that change.⁶ In order to demonstrate that FDA labeling law preempts a state failure-to-warn claim against a brand-name manufacturer, the manufacturer must show “clear evidence that the FDA would not have approved a change to [the drug’s] label.”⁷ While Wyeth showed that the FDA had approved Phenergan’s label and worked with the company to update the label several times, the Court said it did not show that the FDA would have prohibited the change required if the warning was deemed inadequate under a state’s tort law.⁸ As a result, plaintiffs who take brand-name drugs can generally move forward with state failure-to-warn claims against the drug’s manufacturer.

Two years later, in PLIVA, Inc. v. Mensing, the Supreme Court faced the preemption issue, but this time with respect to generic drugs. In Mensing, two individuals who developed tardive dyskinesia claimed that the drug’s manufacturer failed to adequately warn of this risk.⁹ Here, plaintiffs’ doctors wrote the prescription for the brand-name version of the drug, Reglan.¹⁰ Pursuant to state substitution laws, the pharmacists filled the prescriptions with generic metoclopramide, manufactured by PLIVA.¹¹ As in Levine, the Court applied the forward-looking “impossibility preemption” test. Here, though, the majority found that it would be impossible for PLIVA to adhere to both its federal labeling requirements to use the “same” warning approved for the brand-name drug and to change those warnings to cure any defect a jury in a state failure-to-warn suit determines to exist.¹² Unlike the manufacturer of the branded drug, a generic drug maker cannot use the CBE process to change its labels; it can only request the FDA to make such a change.¹³

Thus, the primary distinction between the Levine and Mensing preemption rulings seems to hinge on the old adage about asking for forgiveness or permission. Brand manufacturers can change the label first and ask for permission second, while generics must ask for permission first and can only make a change once the FDA has agreed with the request. The sole issue related to the preemption analysis is whether the manufacturer had the ability to implement new labeling requirements. The Court held that brand manufacturers could do so, while generic manufacturers could not.¹⁴

NO POST-MENSING “INNOVATOR LIABILITY” FOR BRAND MANUFACTURERS

After the Court decided Mensing in 2011, generic drug users were left searching for possible avenues of legal recovery after incurring injury. This controversial decision made the ability to bring a successful lawsuit against generic drug manufacturers near impossible. The theory of innovator liability, which holds the brand manufacturer responsible for injury resulting from the generic drug, has been tested as a work-around to the Mensing decision. Innovator liability has repeatedly been defeated in courts on many occasions, with the argument made that one company does not owe a duty to those taking a drug manufactured by an entirely different company. Since Mensing was decided, courts have declared that traditional product liability law remains unchanged under the laws of Arizona, Arkansas, Connecticut, Florida, Georgia, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Mississippi, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Washington, and West Virginia.¹⁵

In a recent innovator liability ruling, the Eleventh Circuit in Guarino v. Wyeth rejected the theory of liability where the plaintiff admitted she was harmed by generic metoclopramide manufactured and distributed by a company other than the brand defendants.¹⁶ The brand defendants moved for summary judgment arguing that, as a matter of Florida law, they were not liable for plaintiff’s injuries because plaintiff did not ingest a product manufactured by them. Specifically, the brand defendants contended that Florida law prevents consumers from suing brand-name manufacturers for injuries arising from use of a generic equivalent. The district court granted summary judgment on behalf of the brand defendants.¹⁷ On appeal, the panel of judges affirmed the district court’s grant of summary judgment.¹⁸ The court relied heavily on well-settled state law that recognized that no cause of action existed against the brand manufacturer of a drug when a plaintiff admits to having only taken the generic equivalent.¹⁹ Specifically, the court noted:

Every court in Florida to consider the question has concluded that the brand manufacturer of a prescription drug cannot be held liable for injuries suffered by consumers who ingested only the generic form of a drug[…]. As one court explained, ‘[i]t is well-settled under Florida law that a plaintiff may only recover from the defendant who manufactured or sold the product that caused the injuries in question.’ We see no reason to doubt this interpretation of the law.²⁰

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In further justification of its holding, the Eleventh Circuit noted that a “mountain of authority” from across the country “steels us in our determination” that a brand-name manufacturer cannot be liable for injuries caused by the ingestion of a generic form of a product.²¹

ATTEMPTS TO CIRCUMVENT MENSING AND HOLD GENERIC MANUFACTURERS LIABLE HAVE FAILED

Despite the clear and unmistakable holding in Mensing, plaintiffs have continued to challenge the adequacy of generic labels. Some have done so by making the same claims and arguments squarely rejected in Mensing. Others have tried to challenge the label by arguing that their claims, such as strict liability, design defect, negligence, breach of express and implied warranties, fraud, misrepresentation, unfair trade practices, etc., are not failure-to-warn claims; rather, they are distinct causes of action not addressed in Mensing. The generics manufacturers have maintained that Mensing preempts any claim that relates to the generic drug label regardless of the name given the claim. Courts across the country have routinely ruled that claims related to the generic drug label are preempted under Mensing.²² As one judge has explained in dismissing such claims, “Mensing means what it says: all failure-to-warn claims against generic drug manufacturers are preempted if generic manufacturers cannot independently alter their warning labels.”²³

The First Circuit, however, created a stir when it allowed a case to proceed against a generic manufacturer on a design defect theory for simply selling the drug. The First Circuit stated that “while the generic maker has no choice as to label[,] the decision to make the drug and market it […] is wholly its own.”²⁴ The court suggested that a jury should be able to “second-guess the FDA”²⁵ and determine that the drug’s “risks outweighed its benefits making it unreasonably dangerous to consumers, despite [the FDA] having never withdrawn its statutory ‘safe and effective’ designation.”²⁶ The court stated it was willing to redefine the relationship between state liability law and federal drug laws because it did not believe a plaintiff should lose the right to recover “by the mere chance of her drugstore’s selection of a generic.”²⁷ The First Circuit then urged the Supreme Court to take the case and review its novel design defect theory, noting that “the Supreme Court has yet to decide” it, but that it “needs a decisive answer from the only court that can supply it.”²⁸

On June 24, 2013, the U.S. Supreme Court rejected the First Circuit’s ruling that design defect claims against generic drug companies are not preempted by Mensing on the grounds that the defendant could simultaneously comply with both state and federal law by choosing not to sell the medication altogether. As Justice Alito explained for the majority, the Court’s “pre-emption cases presume that an actor seeking to satisfy both his federal- and state-law obligations is not required to cease acting altogether in order to avoid liability,” for “if the option of ceasing to act defeated a claim of impossibility, impossibility pre-emption would be ‘all but meaningless.’”²⁹

It was this understanding that the Bartlett decision was predicated on, with five of the nine justices finding that the same preemption standard under Mensing held for design defects as well. The Supreme Court held that the plaintiff’s “stop selling” theory is “incompatible” with its preemption jurisprudence, which “presume[s] that an actor seeking to satisfy both his federal- and state-law obligations is not required to cease acting altogether” in order to avoid liability.³⁰

The Court’s opinion in Bartlett marks a decisive victory for generic pharmaceutical manufacturers who, despite Mensing, have continued to face personal injury lawsuits on the grounds that they could have stopped selling the medications at issue. Following this ruling, it would appear that attorneys representing individuals who claim to be injured by generic drugs may be forced to turn to legislative and regulatory avenues to address the broad reach of federal preemption of warning and design defect claims. At the close of the majority opinion, the Court stated that it “would welcome Congress’ ‘explicit’ resolution of the difficult pre-emption questions that arise in the prescription drug context.”³¹

DEFENDING AGAINST INNOVATOR LIABILITY

Despite the “mountain of authority” from across the country rejecting innovator liability, the issue still persists. With courts faithfully applying Mensing and dismissing claims against generic manufacturers, brand manufacturers must be prepared to defend against claimed innovator liability. In defending such claims, the procedural history of Mensing could be useful to counsel in showing that the Supreme Court’s decision does not justify a departure from the overwhelming majority of authority rejecting innovator liability. Additionally, the recent Supreme Court opinion in Bartlett is another arrow in the quiver of pharmaceutical companies defending suits on preemption gr

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[i] See Wyeth, Inc. v. Levine, 555 U.S. 555, 558-59 (2009).

[ii] See PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2572 (2011).

[iii] Levine, 555 U.S. at 558.

[iv] Id. at 561.

[v] Id. at 573.

[vi] Id.

[vii] Id. at 571.

[viii] id. at 568-73.

[ix] Mensing, 131 S. Ct. at 2572-73.

[x] Id. at 2573.

[xi] Id.

[xii] Mensing, 131 S. Ct. at 2579.

[xiii] Id.

[xiv] Id. at 2581.

[xv] See Demahy v. Schwarz Pharm., Inc., 702 F.3d 177 (5th Cir. 2012) (applying Louisiana law); Smith v. Wyeth, Inc., 657 F.3d. 420, 423-24 (6th Cir. 2011) (applying Kentucky law); Hogue v. Pfizer, Inc., 893 F.Supp.2d 914 (S.D. Ohio 2012); Baymiller v. Ranbaxy Pharmaceuticals, Inc., 894 F.Supp.2d 1302 (D. Nev. 2012); Phares v. Actavis-Elizabeth, LLC, 892 F.Supp.2d 835 (S.D. Tex. 2012); Strayhorn v. Wyeth Pharmaceuticals, Inc., 882 F.Supp.2d 1020 (W.D. Tenn. 2012); Lashley v. Pfizer, Inc., 877 F.Supp.2d 466, 471-73 (S.D. Miss. 2012); Guarino v. Wyeth, LLC, 2012 U.S. Dist. LEXIS 55665 at *1-2 (M.D. Fla. April 3, 2012); In re Darvocet, Darvon and Propoxyphene Products Liability Litigation, 856 F.Supp.2d 904, 910-13 (E.D. Ky. 2012) (applying Georgia, Indiana, Louisiana, Minnesota, Mississippi, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, and Texas law); Moore v. Mylan, Inc., 840 F.Supp.2d 1337, 1344 (N.D. Ga. Jan. 5, 2012); In re Darvocet, Darvon and Propoxyphene Products Liability Litigation, 2012 WL 4831632, at *2-3 (E.D. Ky. Oct. 10, 2012) (applying Arizona, Florida, Kentucky, Louisiana, Massachusetts, Michigan, Mississippi, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, and West Virginia law); Del Valle v. PLIVA, Inc., 2012 WL 4747259, at *5-8 (S.D. Tex. Sept. 12, 2012); Metz v. Wyeth, Inc., 830 F. Supp.2d 1291, 1294 (M.D. Fla. Nov. 18, 2011); Madden v. Teva Pharmaceuticals, USA, Inc., 2012 Phila. Ct. Com. Pl. LEXIS 293 (Pa. C.P. 2012) (applying Washington law); Condouris v. Wyeth, 2012 WL 2401776 (N.J. Super. Law Div. June 26, 2012).

[xvi] Guarino v. Wyeth, LLC, 2013 U.S. App. LEXIS 12966, at *2-*3 (11th Cir. June 25, 2013).

[xvii] Id.

[xviii] Id. at *18.

[xix] Id. at *14-*15.

[xx] Id. at *14-*15 (citations omitted).

[xxi] Id. at *21.

[xxii] Demahy v. Schwarz Pharma, Inc., No. 11-31073, 2012 WL 5261492, at *6 (5th Cir. Oct. 25, 2012); Gaeta ex rel. A.G. v. Perrigo Pharm. Co., 469 Fed.Appx. 556, 557 (9th Cir. 2012); Smith v. Wyeth, Inc., 657 F.3d 420, 423 (6th Cir. 2011), cert. denied, 132 S.Ct. 2103 (2012); Bell v. PLIVA, Inc., 845 F.Supp.2d 967, 970-71 (E.D. Ark. 2012); Moretti v. Mutual Pharm. Co., 852 F.Supp.2d 1114, 1118 (D. Minn. 2012); In re Pamidronate Prod. Liab. Litig., 842 F.Supp.2d 479, 484 (E.D.N.Y. 2012).

[xxiii] Strayhorn, 11-2058-STA-cgc, 2012 WL 3261377, at *10 (W.D. Tenn. Aug. 8, 2012) (Order Granting Generic Defendants’ Motion to Dismiss).

[xxiv] Bartlett v. Mut. Pharm. Co., 678 F. 3d 30, 38 (1st Cir. 2012), cert. granted, 133 S. Ct. 694 (2012).

[xxv] Id. at 38. The trial would presumably consider whether all versions of sulindac, including the innovator drug, are defective in design, even though the FDA approved the branded-drug-specific design and warning.

[xxvi] Id. at 34.

[xxvii] Id. at 38.

[xxviii] Id. at 36, 38.

[xxix] Mutual Pharm. Co. v. Bartlett, 2013 U.S. LEXIS 4702, at *27 (U.S. June 24, 2013) (quoting Mensing, 131 S. Ct. 2567 (slip op., at 14)).

[xxx] Id. at *28.

[xxxi] Id. at *36.

Finis