Innovation is a word that carries real weight in product safety. Is there an emerging “duty to innovate” — a duty to proactively adopt feasible, safer technologies — or is innovation simply a good practice that may also reduce risk? That is exactly what a panel of industry and legal professionals tackled at this year’s ICPHSO Annual Meeting & Training Symposium, with the goal of surfacing a practical toolkit for product safety professionals on when to push innovation, how to document feasibility and tradeoffs, and how to navigate regulatory momentum without stalling products that should go to market.
The panel brought together four voices with rare depth across law, engineering, and corporate governance: Kyran Hoff of GE Appliances, Meghan McMeel of Crowell & Moring, John McNulty of Google LLC, and moderator George Wray of Borden Ladner Gervais LLP.
Here are the four key themes that shaped the conversation.
The Emerging Legal Duty to Innovate
Innovation for safety is intentional, evidence-based improvement that makes a product inherently safer than existing solutions — meaningfully better at preventing harm, not just technically adequate. Courts and regulators are beginning to grapple with whether a legal “duty to innovate” may be emerging — one that could expose manufacturers to liability for failing to adopt foreseeable safety-enhancing technologies.
Meghan made clear that she does not believe a duty to innovate legally exists, yet — but any theory of recovery would be rooted in negligence. That means the basics matter: keeping compliance documentation and technical drawings up to date and being thoughtful about what is said and how. Innovation for safety requires a systems-level view. Risk travels with the product across its entire lifecycle, and supply chain decisions and packaging can introduce variability that directly affects whether a product reaches consumers safely.
The Gilead Warning ― A Case That Every Manufacturer Should Know
One of the panel’s most notable discussions centered on the Gilead Tenofovir case — a California state court matter quietly reshaping how lawyers and product safety professionals think about the boundary between “could have” and “should have.”
The key point to the case: plaintiffs were not alleging the product was defective — they were alleging the manufacturer’s conduct was negligent due to deliberately delayed development and release of a safer alternative drug and that this “delayed innovation” caused preventable injuries. The court affirmed a manufacturer that knows it has developed a safer, equally effective alternative owes a duty of reasonable care to current users when deciding whether to commercialize it.
As Meghan emphasized, the question is not simply whether a safer option existed, but whether the manufacturer should have acted on it. The legal matters are ongoing, but the architecture is being built. What is deemed safe today may not be enough tomorrow if a safer path is available and not taken.
Build Your Defense Before You Need It ― Documentation, Governance, and a Safety-First Culture
The good news from the panel? There are concrete, practical steps manufacturers can take right now.
As Meghan put it: data is your friend. A cross-functional team needs to identify potential problems and empower those gathering data — usually customer service — to seek guidance early and often. Companies must also expect the unexpected — consumers will ultimately shape what constitutes “foreseeable misuse.”
Benchmarking evaluations can help demonstrate that safety decisions were consistent with the market at the time of sale. Tools like Design Failure Mode and Effects Analysis (DFMEA) and hazard risk assessments are valuable, and compliance functions work best when they offer solutions rather than simply raise obstacles. The single documentation practice that wins in both court and regulator reviews: defensible, well-developed standard operating procedures (SOP) paired with objective checklists that speak for themselves.
Meghan’s perspective on execution was direct: create, execute, and audit your SOPs. Document deviations and decisions with major business impact. You cannot prevent someone from suing you, so at a certain point, you have to face forward and keep doing good work with the knowledge that you may need to defend it later.
Innovation vs. Regulation: Friend or Foe?
Compliance requirements may slow product development, but clear regulatory frameworks can provide clarity and encourage investment in safer technologies — but only when they prescribe the “what” and not the “how.” Overly prescriptive rules risk locking in outdated technologies. The right approach sets a test method and acceptance criteria, not a construction requirement.
Meghan highlighted the EU Product Liability Directive as a significant development — covering AI and software products, introducing additional presumptions of liability, and carrying disclosure obligations that plaintiffs’ lawyers in the U.S. will use to bolster cases here. When laws and regulators fail to align, standards-setting bodies can fill the gap. The EU AI Act at least provides clarity. The current U.S. patchwork may harbor worse outcomes: without clear compliance obligations, it is challenging for companies to defend themselves or seek to comply.
The Takeaway
The conversation around the duty to innovate is still evolving — but the direction of travel is clear. As this panel made clear, manufacturers can no longer treat innovation as a purely optional business decision. The legal landscape, consumer expectations, and ethical pressures are all converging to raise the stakes — and that gray area demands action, not paralysis. Smart, actionable innovation should never be stifled by lawsuits brought with the benefit of hindsight.
As the panel closed, the message was clear: innovating is messy. But manufacturers who treat safety as a living commitment, document their decisions rigorously, build cultures of continuous improvement, and stay ahead of regulatory signals will be far better positioned — in court and in the marketplace — when the legal landscape fully catches up.
Stay tuned for more from our ICPHSO Annual Meeting & Training Symposium recap series.