Early last year, the In re: Incretin-Based Therapies MDL court held that the plaintiffs’ warnings claims were preempted, excluded plaintiffs’ general causation experts, and granted summary judgment to all defendants on dual preemption and causation grounds. In re: Incretin-Based Therapies Prods. Liab. Litig., 524 F. Supp. 3d 1007 (S.D. Cal. 2021). For context, that was the second time the defendants won summary judgment; the Ninth Circuit had reversed an earlier preemption victory in an opinion that predated the Supreme Court’s decision in Albrecht. In re Incretin-Based Therapies Prods. Liab. Litig., 721 F. App’x. 580 (9th Cir. 2017). Now, however, the Ninth Circuit has affirmed summary judgment as to one defendant (Novo Nordisk A/S (“Novo”)). In re: Incretin-Based Therapies Prod. Liab. Litig., 2022 WL 898595 (9th Cir. Mar. 28, 2022).
Category: Failure to Warn
Another Brick in the Wall: The District Court Finds Preemption in Fosamax Case After Remand From the Supreme Court
We have written before about the Supreme Court’s impossibility preemption decision, Merck Sharpe & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019) (Albrecht) (here, here, here, and here), highlighting some open questions and uncertainties that might come into play on remand. Albrecht held that impossibility preemption is a question of law for the court, not for the jury, “elaborated” on the “clear evidence” standard arising from Wyeth v. Levine, 555 U.S. 555 (2009) (Wyeth), and remanded to the Third Circuit for determination of the preemption issue. That court in turn remanded to the District of New Jersey and further directed the district court “to determine the effect of the FDA’s Complete Response Letter and other communications with Merck on the issue of whether the agency actions are sufficient” to find preemption.
We predicted that the decision on remand would be “interesting” and opined that the case for preemption was “strong.” We now have that decision, In re Fosamax (Alendronate Sodium) Prod. Liab. Litig., 2022 WL 855853 (D. N.J. Mar. 23, 2022) (Fosamax), and we were right on both counts.
Northern District of Illinois Excludes Engineering Expert’s Testimony and Grants Partial Summary Judgment, Fulfilling its Responsibility as Gatekeeper
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.
Going Paperless: What Manufacturers Need to Know Before Digitizing Warnings
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.
Continue reading “Going Paperless: What Manufacturers Need to Know Before Digitizing Warnings”
Treating Physician’s Informed Consent Process and Decision-Making in Device Selection Lead to Partial Summary Judgment for Device Manufacturer
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.
Southern District of Texas Holds Learned Intermediary Doctrine Applies to Clinical Trials
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.