Is the decision to submit a 510(k) application versus a Premarket Application (PMA) at the sole discretion of a medical device manufacturer? The answer is not always clear to product liability lawyers, judges, and juries. FDA recently published revised guidance on its “Refuse to Accept Policy for 510(k)s” that reinforces and clarifies that the regulatory path may be analyzed multiple times by FDA before it clears a 510(k) device. This clarification underscores the reality that the type of application submitted is largely dictated by the agency, not the applicant. This post discusses some key takeaways from this new guidance before briefly discussing how this guidance may be implicated in medical device litigation.
How demanding is the causation standard in a California failure to warn claim when a learned intermediary testifies that he would have read and incorporated more stringent warnings if they had been available? Is the plaintiff required to show that the stronger warning would have altered the physician’s decision to prescribe the product? Or may the plaintiff establish causation by showing that the physician would have communicated the stronger warnings to the patient and that a prudent person in the patient’s position would have declined the treatment as a result?
The Ninth Circuit isolated this undefined causation standard in Himes v. Somatics, LLC, and certified the question to the California Supreme Court. After confirming that the learned intermediary doctrine is alive and well in California and that a failure to warn claim cannot survive when the learned intermediary does not read the warnings at all, the Ninth Circuit stopped short of defining the causation standard that applies when a learned intermediary does read the warnings.
On March 15, 2022, the Georgia Supreme Court revived a negligent design claim that had been brought against Snapchat, Inc. (n/k/a Snap, Inc.) involving Snap’s “Speed Filter.” As one of the few decisions across the country addressing products liability law in the context of platform “products” (more accurately categorized as services) such as Snapchat, the opinion provides a glimpse of the sort of issues that other courts may soon be required to address.
The Factual & Procedural Background:
Plaintiffs Wentworth and Karen Maynard alleged that Defendant Christal McGee was using Snapchat’s “Speed Filter” and driving over 100 miles per hour when she rear-ended them, causing severe injuries. The “Speed Filter” is a feature that allows the user to record their real-life speed on a photo or video and share it with other users. Plaintiffs sued Snap as well, alleging that Snap had negligently designed the “Speed Filter” because the filter promoted unsafe driving and encouraged dangerous behavior.
A frequent and vexing issue for corporate defendants, in products liability and other cases, is the demand for a deposition of the company’s CEO or depositions of other senior executives. Even when these executives were not involved in the relevant events and have no relevant personal knowledge, plaintiffs push for their depositions to gain leverage for settlement or for other illegitimate reasons.
Many federal courts provide protection from these demands by applying the “apex doctrine,” a rule that usually shields high level officers if they have no unique personal knowledge or involvement and the relevant information is available from other sources. These courts have recognized that corporations may be involved in many lawsuits and forcing busy executives to testify when they have no significant personal knowledge or involvement would impair their ability to manage the corporation’s business.
The Florida Supreme Court will abandon the state’s previous summary judgment standard in favor of the federal standard — a familiar, achievable standard to dispose of claims that are unsupported by evidence. For pending dispositive motion practice that may be decided during the gap period before the rule amendment takes effect, movants should consider requesting that any decision be made without prejudice to seek summary judgment under the new summary judgment standard once it takes effect.