For over two decades, dating back to Daubert and the ensuing amendments to Rule 702, federal district courts have been charged to act “as gatekeepers to exclude unreliable expert testimony.” Fed. R. Evid. 702 advisory committee’s note to 2000 amendments. However, some courts have not embraced that role, letting jurors weigh questions about an expert’s qualifications or methodology as though they go to credibility rather than admissibility. Indeed, the Advisory Committee on Evidence Rules proposed an amendment to Rule 702 to address the “pervasive problem” of courts holding that issues of admissibility are questions “of weight for the jury.” See, Sardis v. Overhead Door Corp., 10 F.4th 268, 282-84 (4th Cir. 2021). (quoting Advisory Comm. on Evidence Rules, Agenda for Committee Meeting (Apr. 30, 2021)).
A recent decision out of the Northern District of Illinois, however, provides an excellent example of a court discharging its duty to preclude inadmissible expert opinions. The Plaintiff in Pessman v. Trek Bicycle Corporation, 2021 WL 5769530 (N.D. Ill. Dec. 6, 2021) was injured in a bicycle accident. Plaintiff’s engineering expert opined that the cause of the accident was a crack in the carbon fiber frame of Plaintiff’s Trek bicycle attributable to a design defect. The engineer claimed that carbon fiber frames are prone to cracking and that the crack was mistaken for simple paint chipping by a dealer who had inspected the bicycle several days before the accident, allegedly due to Trek’s failure to train the dealer properly.
By the time the COVID-19 pandemic began, society was well into the so-called “Digital Age,” relying heavily on electronic communications, apps, websites, and the like to go about daily activities. Everything from ordering food to taking the bus to work could be achieved and tracked through a simple app. During the pandemic, the reliance on electronic mediums went from preferable to necessary, as many businesses shut down and transitioned to a remote or online-only presence.
The escalation of the digital age has led some manufacturers to consider electronic warnings for their products, through the manufacturer’s website, by providing a QR code, or by recommending (or requiring) the consumer to download an app. Even the American National Standards Institute (ANSI) has bought into digital warnings. ANSI’s Z535 standards provide guidance for product manufacturers related to the size, content, and location of warnings. Recently, ANSI created a subcommittee on warnings in electronic media and is in the process of developing a new standard, ANSI Z535.7, for safety information in electronic media. This new standard is expected to be published by December 2022. The FDA has also recently utilized electronic means to communicate information regarding the COVID-19 vaccines. In October 2021, the FDA published three Consumer Fact Sheets for the three currently authorized vaccines on its website and included a QR Code linked to the “most recent” COVID-19 Vaccine Fact Sheets.
A series of recent rulings out of the Southern District of Texas in an inferior vena cava (IVC) filter case reflect how well-planned discovery can lead to a successful multipronged summary judgment motion and can effectively prune a plaintiff’s ambitious product defect claims. Conn v. C.R. Bard, Inc., No. 4:14-CV-298.
In 2006, plaintiff’s physicians discovered a blood clot in his inferior vena cava. An IVC filter was inserted to prevent the blood clot from causing potentially fatal further injury. Because of plaintiff’s young age, the physician chose a removable filter. Plaintiff reported abdominal pain just four days after the IVC filter was placed. The blood clot was found to have moved and extended through and above the recently placed filter, and the physicians initiated anticoagulant therapy.
Does the learned intermediary doctrine apply in the context of a clinical trial? According to the Southern District of Texas, it does. The case in question is Butler et al. v. Juno Therapeutics, Inc., a tragic case involving the death of a 19-year-old woman with terminal leukemia who died within days of receiving an experimental cancer drug as a participant in a clinical trial.
In 2015, Juno Therapeutics (Juno) was developing a treatment for advanced blood cancers involving Chimeric Antigen Receptor T-cell (CAR-T) therapy. CAR-T therapy is designed to modify a patient’s white blood cells to target cancer cells with the goal of improving the patient’s condition so a bone marrow or stem cell transplant can be tolerated. In October 2015, Juno entered into a Clinical Study Agreement with MD Anderson (and other hospitals) as part of a Phase 2 clinical trial (the “Rocket Study”) of a drug identified as JCAR015, a CAR-T therapy. Drs. William Wierda and Michael Rytting were the principal investigators of the Rocket Study at MD Anderson.
Under the Restatement (Third) of Torts: Products Liability § 5, Comment b (1998), the supplier of a product generally must warn about only those risks associated with the product itself, not those associated with the “products and systems into which [it is] integrated.”
However, in Air and Liquid Sys. Corp. v. DeVries, 139 S. Ct. 986 (2019), the Supreme Court created a different rule in the context of maritime asbestos claims. In that case, the defendants produced “bare-metal” equipment, such as pumps, blowers, and turbines, for Navy ships that required asbestos insulation or asbestos parts to function as intended. The manufacturers delivered the equipment to the Navy without asbestos, and the Navy later added asbestos to the equipment. Two Navy veterans were exposed to asbestos on the ships and developed cancer. The district court granted summary judgment for the manufacturers, finding no duty to warn. In reversing, the Third Circuit Court of Appeals adopted a “more plaintiff-friendly” foreseeability rule, rejecting the “more defendant-friendly” bare-metal defense.
The nature of advocacy makes it hard sometimes for lawyers to focus solely on the outcome and the bottom line result. How a court gets there may not matter much to the prevailing party in the dispute as they celebrate the win, but it may have an impact on later cases. A recent example is the opinion in Burton et al. v. E.I. DuPont de Nemours and Co., Inc., 2021 WL 1422814 (7th Cir. Apr. 15, 2021). The court found the winner’s circle, but it dented the car a bit along the way.
[Disclosure/disclaimer: The author filed an amicus brief in support of defendants in the case.]
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