My liability training is related to medical devices (and really fuckin' out of date) so my understanding is likely to be off-base, but the way you go after a medical device manufacturer is you make them cough up every document they've ever had on anything they've ever done on any continent in any year for any reason ever and then you go through and ding them for shit you don't see. Then you hassle them about the documents that are missing and pursue summary judgement. Then you go through and depose everybody who kept the notebooks to determine what's accurate and what isn't. And you aren't even to litigating yet but you're already neck-deep in compliance issues and settling starts to look pretty good, particularly as your insurance has kicked in and they've got an entirely different idea about how this should go than you do. And you don't even need to get to guilt or innocence because for some reason there's a lab notebook from 1994 that hasn't been found and yeah, the jury might not assume it's full of condemning evidence but Zurich Re doesn't want to take that risk so they're going to pay the plaintiff ten million and liquidate your company to cover the costs, bitch.

And that's why there are no medical device startups anymore.