The challenges facing today's biotechnology and medical device companies are greater than ever. Companies striving to take promising therapies from the laboratory to the market must protect those therapies from IP, regulatory and reputational risks. Meanwhile, they face steadily increasing pressure on numerous fronts. What new developments are affecting business strategies and bottom lines? Here is a look at eight big topics that life sciences businesses have been thinking about, and how DLA Piper has been covering those stories.
What starts the avalanche? Earlier triggers for life sciences mass torts in the era of big data and social media: The bar for safety issues to lead to claims that ultimately result in mass tort litigation has never been lower.
The CBD problem: searching for a legal pathway for CBD in foods and supplements: The state of the laws and regulations in the US, and potential pathways to a resolution.
The cybersecurity of digital medical devices: higher technological capabilities, higher likelihood of liability: Medical device manufacturers are assessing their compliance with HIPAA and FDA's Draft Guidance and completing a Risk Management Plan.
In Albrecht, US Supreme Court narrows implied preemption of failure-to-warn claims, finds preemption is legal issue for judge, not jury: The decision clarifies and substantially narrows the scope of preemption under the Wyeth v. Levine "clear evidence" standard.
Effective strategies for challenging master complaints in multidistrict litigation: There are a number of creative ways for defendants to challenge master complaints in MDLs.
Explainability: where AI and liability meet: Makers and users of AI face a new and interesting problem: what is the acceptable tradeoff between explanation and accuracy?
Local strategies in global class actions for product manufacturers and distributors: What global class actions are, how they may affect businesses operating in the global marketplace, and what to consider when a company is the target of such actions.
Supreme Court hears oral argument in Fosamax: key takeaways: None of the justices indicated a desire to upset the Wyeth v. Levine framework.
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