How do you keep your life sciences business and innovations out of court?

Benjamin Franklin famously said there’s nothing certain but death and taxes. Many business owners would probably add litigation to Franklin’s list. However, there are steps your company can take—beyond having good liability coverage—to reduce the chances you’ll end up in court.

Here are 6 steps:

1. Benchmark your competitors. Kate Klaus, Senior Risk Management Attorney at Medmarc, recommends studying how the competition addresses safety. “Are you meeting or bettering what they’re doing?” she asks. “Are they using safeguards that you’ve decided not to employ? If so, is there a good reason?”
2. Rely on your insurance carrier. “We can provide guidance on regulatory strategy and look at risk shifting in contracts,” Klaus says. “I spend a lot of time doing site visits with our policyholders to evaluate their risk-management practices and give them suggestions based on the 45 years of data Medmarc has on companies that are operating in this space.”
3. Carefully craft informed consent documents. “The informed consent document should be written in a really clear manner that’s easily understood by a layperson,” Klaus says. “Are they doing the informed consent on video so they have proof of exactly what questions were asked and how they were answered?”
4. Police your partners. Ensure that your additional insureds aren’t putting you at risk. “With clinical trials, we want to ensure that the sites and the investigators are assuming responsibility for the actions of their own people,” Klaus says.
5. Go overboard on safety and documentation. “If you do those things, if you’re creating a safe product, you may not be able to avoid a lawsuit, but we’re going to be in a much better situation than if you don’t,” Andy Hall, Executive Claims Specialist at Medmarc, says.
6. Heighten your focus on product safety. Previously, juries were more inclined to trust companies that adhered to FDA regulations and obtained their approval. Nowadays, many jurors view FDA approval as merely a basic safety benchmark.