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Current & Critical

Panel Discussion: What Companies Need to Know about Litigation Issues

During the NASS meeting in October, The Oswald Companies co-hosted a panel of experts to discuss litigation and regulatory issues faced by spine companies. Clearly, such matters affect all industry segments.

Participants included Jill Wadlund, President of Berkley Life Sciences, an insurance company serving the life sciences industry; Kim Schmid, Executive Managing Partner at Bowman and Brooke, a product liability firm; and Mark DuVal, President of DuVal and Associates, a boutique regulatory law firm. Michael Cremeans of Oswald Companies moderated.

We’ve summarized only the briefest of salient points from the event, and urge readers to visit the series on YouTube. Links are found at the end of this article.

Begin with the end in mind when assembling your regulatory strategy, and factor in all of your teams that need to weigh in on the strategy decision, including reimbursement, clinical and marketing.

By asking, “How would you like to sell this device in an ideal world?,” your team can work backwards to craft the best course of action. In fact, your legal team may be able to help develop the regulatory strategy, if you involve them early on.

Anticipate litigation. (Experts note an uptick involving medical device manufacturers, from start-ups to the modestly-sized.) Do a product risk assessment. Have regulatory, legal and your insurance carrier look at your product, your testing practices and your marketing materials. Look at how your reps and distributors are trained, and understand how they interact with surgeons.

Document everything. When (not if) you are brought to court, your defense team will be most helped if you’ve dotted your Is and crossed your Ts.

Compliance to regulatory standards is your bare minimum of protection during litigation. Also, pay close attention to all feedback received on your device—from surgeons, from reps and distributors.

Monitor your product in use. Train your surgeons—they’re your first line of defense in reducing your risk profile.

Other points addressed included:

  • What about social media and matters of promotion?
  • What happens if my independent rep observes practices in the O.R. that he believes may yield suboptimal clinical outcomes?
  • Help! I’ve been sued. What should I do immediately?
  • What should I know when classifying a recall?


View the panel at these YouTube links:

Part 1: http://youtu.be/FVgaL6jKauI

Part 2: http://youtu.be/Z4QkqS2o0wM

Part 3: http://youtu.be/gFggocu3K8s

Part 4: http://youtu.be/LDYCaEDxtgM

Expect more coverage of these critical issues throughout 2014!