A Pennsylvania judge has issued a number of evidentiary findings in favor of the plaintiff in a bellwether Tylenol liver damage case, ruling in part that the plaintiff may present evidence of adverse event reports, fraud on the FDA, employee compensation, and other lawsuits.
In an April 19 order, Judge Lawrence Stengel of the U.S. District Court for the Eastern District of Pennsylvania also said the plaintiff may proffer evidence of labeling changes that post-date the decedent’s acute liver failure and evidence of foreign labeling.
This case, which is part of the multidistrict litigation involving claims of liver damage caused by Tylenol, has been chosen for the first bellwether trial. Alabama resident Rayna Terry claims that her sister, Denice Hayes, died of acute liver failure after taking Tylenol “as directed.”
Hayes was diagnosed with acute liver failure “most likely from accidental Tylenol overuse” on Aug. 29, 2010, and was treated with an acetaminophen antidote. She died two days later and her cause of death was listed as cause of death is listed as “liver failure” caused by “acetaminophen intoxication.”
First, defendants moved to exclude evidence of, or reference to, adverse event reports, arguing that they are “irrelevant, unreliable and unsubstantiated anecdotes.” Judge Stengel, however, held that AERs are relevant to showing notice and therefore should be admitted for that purpose. If plaintiff plans to introduce specific AERs for any reason other than notice, i.e., causation or to show design defect, defendants may object at trial, the judge held.
“The purpose of recording AERs is to serve as a warning system or signaling system for drug manufacturers,” the judge explained. “AERs are often reviewed by the FDA and its subcommittees to determine if changes to a drug composition or its label need to be made. Drug manufacturers are expected to take certain steps to ensure their products are safe for consumers. Whether the defendants undertook the appropriate steps to carry out their duty of pharmacovigilance is important to the plaintiff’s failure-to-warn and design defect claims. With all this in mind, AERs would be admissible to show notice.”
Judge Stengel clarified that the AERs presented for the purpose of notice should be ones that would be similar to the circumstances of the instant case.
Next, Judge Stengel ruled that plaintiffs may present evidence of fraud on the FDA, noting that he has previously held that plaintiff’s fraud and fraudulent concealment claims were not impliedly preempted by Buckman Co. v. Plaintiffs’ Legal Committee.
“Evidence that the defendants attempted to manipulate the regulatory process, failed to comply with regulatory duties, or adhere to guidance provided by the FDA can be used to show other elements of the plaintiff’s claims,” the judge reasoned. “For example, how the defendants responded to FDA requests for information, what they did to comply with FDA regulations, and what information they presented to the FDA is all relevant to plaintiff’s failure-to-warn and design defect claims.”
In addition, Judge Stengel said plaintiff may present evidence concerning the September 2002 and June 2009 Advisory Committee Meetings of the FDA discussing acetaminophen-related liver issues. During the September 2002 meeting, the FDA presented findings from medical literature that liver damage may occur “at recommended doses” of acetaminophen,” that such cases were linked to risk factors such as alcohol use and/or fasting, and that some cases of unintentional overdose led to death. The Committee noted findings of liver damage in persons who have ingested less than 4 grams/day of acetaminophen and/or had risk factors like “poor nutritional status.”
In June 2009, several advisory committees within the FDA held a joint meeting to discuss the issue of liver injury related to acetaminophen use. McNeil representatives offered presentations to the committee members. The committee members voted to recommend that the current maximum single dose of OTC acetaminophen (i.e., 2 x 500 mg) be made available only by prescription. The majority of committee members recommended that the maximum single dose of acetaminophen be lowered to 650 mg (i.e., two tablets of Regular Strength Tylenol).
Judge Stengel concluded that this information is relevant to the question of whether defendants had notice or knowledge of the potential link between Extra Strength Tylenol and acute liver failure at or just above recommended doses.
“What was discussed at these meetings may show defendants’ state of mind. There is evidence that the defendants took specific actions in preparation for the meetings and as a result of what happened at them,” the judge explained. “The jury is entitled to hear this evidence and draw appropriate inferences about why the defendants acted as they did before and after these meetings.”
Judge Stengel then held that plaintiff may present evidence of employee compensation, holding that it is relevant to show bias or conflict of interest, and may present draft company documents and internal reports, finding they are relevant to show defendants’ knowledge, state of mind, motive, and/or intent.
In addition, the judge denied without prejudice defendants’ motion to exclude evidence of other lawsuits, noting that such evidence may be probative of notice/knowledge of a possible defect and/or of the motive of the defendants. Information related to past lawsuits also may be relevant for impeachment purposes, Judge Stengel added.
The judge also denied without prejudice defendants’ motion to exclude evidence regarding the documents, events, and/or labeling changes that post-date Hayes’ August 2010 acute liver failure. Because one of the key issues in the instant case is whether the defendants should have recommended different dosing or warnings for Extra Strength Tylenol, there may be instances when changes to a prescription acetaminophen label may be relevant, Judge Stengel held.
Next, the judge refused to exclude evidence regarding defendants’ lobbying efforts toward Congress or the FDA, ruling that it is not barred by the Noerr-Pennington doctrine. Plaintiff is not seeking to restrain defendants’ speech or enjoin their conduct towards the government, Judge Stengel explained; rather, she seeks to offer evidence about how the defendants attempted to influence, petition, or communicate with Congress and/or the FDA to show their knowledge, state of mind, or intent.
Judge Stengel also denied without prejudice defendants’ motion to exclude evidence concerning foreign labeling and foreign regulatory evidence. He recognized that the admission of foreign labels may require context of a foreign country’s regulatory system in order to present them accurately, leading to a trial within a trial and undue delay. However, he said it is possible for plaintiff to offer evidence that foreign regulatory agencies raised concerns about acetaminophen dosing years before the decedent’s death, to show notice and/or knowledge.
Plaintiff may also present evidence concerning marketing, public relations, and/or promotional materials for Tylenol products, Judge Stengel ruled, finding the evidence would be relevant to whether consumers were aware of the risk of acute liver failure. Moreover, the marketing evidence would be relevant to showing “the reasonable expectations of the ordinary consumer,” the judge held.
“The evidence may also help the plaintiff make out her fraud claims, by showing that the information communicated to the public through marketing, advertising, public relations, and the products’ label did not fully inform the decedent of Extra Strength Tylenol’s risks,” Judge Stengel added.
Moreover, plaintiff may present certain financial evidence, such as defendants’ substantially higher spending on marketing as compared to spending on research and development, the judge held, explaining that it is relevant to defendants’ state of mind. However, explicit or implicit references to defendants’ net worth is barred under Alabama law as highly prejudicial, the judge held.
Finally, the judge excluded evidence of a 2011 consent decree and a 2015 plea agreement concerning manufacturing, quality control, and production issues at McNeil’s facilities, Judge Stengel ruled.
“The plaintiff asserts a design defect claim, not a manufacturing defect claim. Her claims do not involve injury from a contaminated Tylenol product. For this reason, I see little to no relevance in admitting evidence regarding manufacturing defects,” the judge explained. “Any probative value this evidence might have would be substantially outweighed by the risk of unfair prejudice or confusion by the jury.”