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From Products Liability Law Daily, November 16, 2015

Design defect claims against makers of Tylenol survive in bellwether MDL case

By Pamela C. Maloney, J.D.

Whether Jonson & Johnson and McNeil failed to design Extra Strength Tylenol so as to reduce or eliminate the risk of liver damage raised a question of fact for the jury, a federal district court in Pennsylvania ruled in a bellwether case that is part of Multidistrict Litigation (MDL) involving claims that use of over-the-counter pain reliever at or just above the recommended dosage can cause acute liver failure. Finding that the U.S. Supreme Court’s decision in Wyeth v. Levin, 555 U.S. 555 (2009) applied to the companies preemption defense, the district court also determined that the estate’s design defect claim was not impliedly preempted (In re: Tylenol (Acetaminophen) Marketing, Sales Practices and Products Liability Litigation (Terry v. McNeil-PPC, Inc.), November 13, 2015, Stengel, L.).

Background. A consumer had taken Extra Strength Tylenol for many years to treat various conditions without experiencing any adverse effects. After undergoing lumbar laminectomy surgery in mid-August 2010, she was instructed by her doctor to take Regular Strength Tylenol in conjunction with Lorcet, a prescription drug containing acetaminophen, but not to exceed 4 grams of acetaminophen in a 24-hour period. She used the Regular Strength Tylenol for about two weeks until the bottle ran out, after which she began using Extra Strength Tylenol. At some point, she stopped taking the Lorcet due to its side effects. During this time, she was in and out of the hospital, and on August 29, she was diagnosed with acute liver failure and died two days later. Her sister brought a products liability law suit—including claims for defective design and negligent failure to warn—against McNeil, which manufactures the drug, and Johnson & Johnson, McNeil’s parent company. The sister asserted that the defendants knew that Tylenol could cause liver damage at or just above the recommended dose, especially when a consumer is fasting or malnourished, and that the defendants were liable for the consumer’s death because they had failed to warn her of the risks of injury and/or death. The defendants moved for summary judgment on the ground that the sister had not offered sufficient evidence to support her failure to warn claim and that the claim also was impliedly preempted. Alabama law governed her claims. The court dealt with the estate’s failure-to-warn claim in a separate order (see the companion story entitled “Failure-to-warn claim also cleared for trial in bellwether case in Tylenol-liver failure MDL” in today’s issue of Products Liability Law Daily).

The court distinguished the claims in this case from those previously asserted about the safety of Tylenol, explaining that while the previous cases had questioned whether Tylenol could cause liver damage, the cases in this MDL question the extent of the damage and the quickness with which it could occur.

Design defect claim. Under the Alabama Extended Manufacturer’s Liability Doctrine, the scope of a manufacturer’s legal duty depended on two factors: (1) the foreseeability of the danger and (2) the feasibility of an alternative design that averted that danger. The estate offered sufficient evidence to show that the manufacturers knew or should have known that Extra Strength Tylenol could cause liver damage either because consumers took the OTC drug at or just above the recommended dose or that consumers unintentionally took too much. The facts also showed that the manufacturers were working to find a substitute that could provide the same benefits without the hepatotoxicity risks posed by acetaminophen and that the FDA was considering whether to remove Extra Strength Tylenol from OTC status because of the risks posed to uninformed consumers. Finally, the evidence also showed that the decedent died of acetaminophen-induced liver failure after taking Extra Strength Tylenol as directed.

Alternative designs/dosing instructions. The district court went on to find that the estate offered evidence of several alternative designs in support of the design defect claim. First, the estate offered evidence that the drug companies had researched and developed acetaminophen/antidote combination drugs in the 1990s. Whether these alternative combination drugs, which are sold in other countries, were safer or more practical than Extra Strength Tylenol in its current form was a question of fact that could not be resolved without a trial.

The estate also claimed that Extra Strength Tylenol could have been re-designed to be safer by changing the dosing instructions for the drug as the drug makers did following the decedent’s death. The court rejected the drug companies’ claim that this argument was not appropriate for a design defect claim but, instead, related to the estate’s failure-to-warn claim. According to the court, dosing instructions and warnings were two different parts of a label and a change in the dosing instruction could have reduced the potential danger inherent in Extra Strength Tylenol. As such, the dosing instructions were an element of the design for an OTC monograph product like Extra Strength Tylenol. This suggested design alternative also raised a question for a jury that defeated the manufacturers’ summary judgment motion.

As a final alternative design, the estate contended that the drug makers could have offered instructions with “dose titration,” which would have encouraged consumers to take the least amount of Tylenol to treat their condition thereby building in a wider margin of safety. Whether the drug companies should have used this method and/or should have used it sooner to build more of a safety margin into the design of this OTC drug was also a question for the jury to answer, the court concluded.

Implied preemption. In response to the manufacturers’ preemption defense, the court rejected the argument that the U.S. Supreme Court’s decision in Mutual Pharmaceuticals, Inc. v. Bartlett, 133 S.Ct. 2466 (2013) required a finding that the estate’s design defect claim was impliedly preempted. The Bartlett case was distinguishable from the case at bar in that it did involve a generic drug manufacturer, not a brand-name manufacturer. Furthermore, the Supreme Court had not addressed whether a design defect claim brought against a brand-name OTC drug maker is preempted. However, the dictates of the High Court’s decision in Wyeth, which involved failure-to-warn claims against brand-name drug manufacturers, led the district court to conclude that preemption was not warranted in this case because brand-name drug makers could petition the FDA to change a drug’s dosing, strength, etc., if the design posed a risk to consumers. This was especially true in the context of acetaminophen which operates under a tentative final monograph rather than a final monograph.

The district court also concluded that there was no reason why the manufacturers of Tylenol could not comply with both federal and state obligations. In terms of changing the dose of Extra Strength Tylenol, the manufacturers could and did lower the dose after the decedent’s death and the new dosage directions were more in line with FDA guidance. In addition, the manufacturers could have changed the dosing instructions and had been advised to do so by the FDA in the 1990s but had determined that this was not necessary. Finally, with regard to the alternative designs relating to acetaminophen/antidote combinations, the manufacturers put forth no evidence that the FDA would not have allowed these alternatives on the market in the United States. Explaining that impossibility preemption is a defense, the court concluded that the manufacturers failed to demonstrate that it was impossible for them to comply with both federal and state requirements. Thus, the manufacturers were not entitled to summary judgment on their preemption defense.

The case is MDL No. 2436; 2:13-md-02436.

Attorneys: Laurence S. Berman (Levin Fishbein Sedran & Berman) for Rana Terry. Alyson B. Jones (Butler Snow LLP) and David F. Abernethy (Drinker Biddle & Reath LLP) for McNeil-PPC, Inc. Alyson B. Jones (Butler Snow LLP) for McNeil Consumer Healthcare Division of McNeil-PPC, Inc. and Johnson & Johnson.

Companies: McNeil-PPC, Inc.; McNeil Consumer Healthcare Division of McNeil-PPC, Inc.; Johnson & Johnson

MainStory: TopStory DesignManufacturingNews PreemptionNews ClassActLitigationNews EvidentiaryNews DrugsNews PennsylvaniaNews

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