Understanding the Daubert Standard with Respect to the Tylenol Lawsuit

In June 2022, Tiffany Rutledge, mother to two minor daughters, filed a lawsuit against Wal-Mart on their behalf. Tiffany had consumed Tylenol, a ubiquitous drug for headaches found in almost every US drug store, during both pregnancies and complained that her daughters suffered from its side effects – one was affected with autism, whereas the other developed Attention Deficit Hyperactivity Disorder (ADHD).

Since then, 118 such lawsuits have been filed across US courts for six different causes of action, including:

• Breach of express warranty
• Breach of implied warranty
• General negligence
• Failure to warn of the possible side effects of the drug
• Negligent misrepresentation
• Violation of consumer protection laws

The National Institutes of Health (NIH) published a report in 2022, clearly stating that there was a direct link between Tylenol (Acetaminophen) and autism or ADHD disorders. However, the lawsuit is proceeding slowly through the US courts as the defendant raised a Daubert motion to exclude the presentation of the plaintiff’s expert testimony during the upcoming trial. To understand the significance of the Daubert motion, we need to know the Daubert standard.

What is the Daubert Standard in Federal Law?

The Federal Rules of Evidence No. 702 governs all expert testimonies presented in the US court. According to the Daubert Standard (created after the famous Daubert vs. Merrell Dow Pharmaceuticals litigation), the court judges hold a ‘gatekeeping’ role in determining the relevance and reliability of an expert’s scientific testimony during trials.

The following factors help determine whether an expert’s scientific testimony is admissible for the case in question:

• Has the technique or theory been tested?
• Whether the technique or theory has undergone peer-review studies
• Whether the particular scientific technique has the potential for error
• Is the technique or theory generally accepted?
• Whether the expert’s opinion is based on research conducted independent of the litigation, or it is exclusively done for testifying purposes
• Whether the expert has sufficiently accounted for alternative explanations
• Whether the expert is just as careful in their litigation consulting as they are in their professional role
• Whether an expert’s area of expertise can be trusted to produce reliable results

The ultimate aim of the Daubert standard is to eliminate scientific junk from the courtroom and to allow the court to reach a fair conclusion based on valid facts.

The Daubert Challenge and What It Means for Plaintiffs

More often than not, plaintiff-side experts are challenged based on Daubert standards than defendant-side experts. Every seasoned attorney has good reason to be terrified of a Daubert challenge because it presents the frightening possibility of their expert witness’ testimony being altogether excluded from the trial.

At its core, the Daubert challenge is a direct attack on the expert witness’ methodology behind forming their opinion. In the case of the Tylenol lawsuit, this would mean that the expert’s testimony that Tylenol is linked to autism is under attack.

What are the possible reasons for the expert’s testimony being challenged?

1. Lack of Reliability

A Daubert challenge may be raised in court against an expert if their testimony is considered unreliable. A reliability assessment is often made based on verifying the source of the evidence, its intrinsic qualities, and the manner in which it was procured.

If the evidence does not enhance the case’s fact-finding process, thereby helping the Court in its pursuit of justice, it may be deemed unreliable.

2. Questionable Data

Another reason why an expert’s testimony may be challenged in court is the presence of questionable data. An expert may have failed to Daubert-proof their witness if they collect insufficient data supporting their views, use available data selectively, or fail to evaluate data accuracy (especially if the data is provided by third parties).

3. Lack of Qualification

What some plaintiffs fail to realize is that an expert (witness) is not a generic term referring to any expert within an industry. They should qualify as an ‘expert’ in the context of the testimony required. For instance – It is not just important to be a researcher but also to be one from the pharmaceutical or medical industry to qualify as an expert for the Tylenol class-action MDL.

4. Legal Conclusions

Another reason why an expert’s testimony may be Daubert-challenged in court is if they’re found giving opinions about legal issues or drawing legal conclusions. An expert is required to stick to their area of expertise and avoid testifying about issues beyond their expert purview.

This does not mean that the evidence can be legally irrelevant. The US Supreme Court requires legal relevance in the sense that the evidence should be permissible, and not subject to privileges or exclusionary rules.

Holding Science Days

In some cases, the Judge may ask for ‘Science Days’ in court as a pre-trial to the Daubert hearing. Science Day allows the challenged litigation party to make educational presentations before the court regarding the case’s scientific issues.

In the case of the Tylenol MDL lawsuits, a Science Day would involve presenting the clinical use, epidemiological data, and specific causation theories surrounding the connection between Tylenol and autism or ADHD.

Science Days are crucial because they offer the court an opportunity to understand the scientific evidence surrounding the lawsuit. A court that clearly understands the case’s science is better equipped to handle discovery and causation issues as well as remove unmeritorious cases at the earliest.

As per the 2018 Federal Judicial Center, the court must consider the following questions before holding a Science Day –

• Does the complaint, response, or filing involve scientific concepts and terms that may be unfamiliar to those not belonging to the field in question?
• Are there recent scientific findings or new technologies involved in the litigation?
• Will scientific assertions play an important role when it comes to determining settlements and defenses?
• Is there expert testimony involved regarding complex data analyses?
• Will scientific methodologies, technologies, and principles come into play to determine future dispositive motions?

How the Daubert Hearing Will Impact the Tylenol Lawsuit

Once a Daubert challenge is raised, the court will schedule a Daubert hearing in which the challenged expert will be examined in open court to test the admissibility of their opinion. According to TorHoerman Law, only issues raised in the Daubert motion are examined in a Daubert hearing.

It is strictly forbidden to raise inquiries into issues that are not a part of the hearing. The Daubert hearing is one reason why hardly any new Tylenol lawsuits are being filed in the US courts. The plaintiffs wish to know whether or not the expert’s testimony will be completely excluded from the trial. If the Daubert hearing favors the plaintiffs, new Tylenol lawsuits will be filed.

If not, the next step would entirely depend upon the Court’s verdict. Sometimes, Judges do not exclude an expert testimony completely, but only partially. Other times, they may be willing to offer the challenged litigation party another chance to address issues with their expert evidence or present another expert (other than the one in question).

Since the crux of the case depends upon proving the direct link between Tylenol and autism, the Daubert hearing is a crucial event in Tylenol class-action MDL.

The Path Forward

As of now, it appears that the rest of 2023 will be spent preparing and submitting expert reports associated with the Tylenol litigation. While the plaintiffs have submitted their reports, the defendants are underway.

There may be a few rebuttal experts from the plaintiff’s side. It is expected that a hearing will be held by the end of this year where Judge Cote will examine the validity of the link between Tylenol and autism/ADHD.

If the Judge considers the expert evidence to be admissible, Tylenol lawsuits will race to the Federal Court. However, if the plaintiff’s side falls out of favor with the Judge, the litigation will move to the State Court.