A global healthcare manufacturer, which I will refer to as “GHM,” acquired a foreign “boutique” company that made an innovative medical device. The deal went down without a hitch, and both parties to the transaction were very happy. The product fit perfectly within GHM’s long-term objectives, and the success of the product seemed assured. It was a device with the potential to save millions of lives.
By all accounts, GHM’s acquired product saved a significant number of lives. But the first report of a death signaled a possible problem. Reports of additional fatalities soon followed from other parts of the world.
GHM immediately sprung to action when it received the first hint of a potential safety issue. It assembled a top team of scientists to investigate each fatality, and it subsequently launched a voluntary worldwide recall of the product. It notified the U.S. Food and Drug Administration and other health authorities of the findings of its internal investigations and pulled the product off the market. GHM, however, didn’t stop there. It publicly acknowledged that a change in manufacturing practices may have contributed to the reported deaths.
In the interest of patient safety, GHM embarked on the most conservative course of action conceivable: permanent cessation of manufacturing the medical device. All GHM plants that manufactured the device and components for the device terminated operations. Employees were laid off. In the shadows of this very painful and public experience were trundles of lawyers signing up plaintiffs. A deluge of lawsuits and public investigations followed.
GHM, a valued and long-standing firm client, hired us to work with the company and an international team of lawyers to defend its interests at home and abroad. I was involved in the unique capacity as lawyer-filmmaker to find a solution to preserving evidence necessary for the defense of the global litigation.
With the impending shut down of all GHM facilities associated with manufacturing the device and components of the product, it would not be long before the manufacturing story — the crux of the defense — would be lost in the dust building up in the non-operational plants. Time was of the essence.
Working with in-house counsel, key GHM scientists and engineers, and key personnel at the manufacturing facilities, we delved into learning all aspects of the manufacturing process. It was a collaborative endeavor to sustain key evidence, and everyone worked long hours without complaint to get the best results. From interviews and group strategy sessions, we developed a script for filming each facility. Because we were part of the litigation team, the script fell into the important protections of the attorney-client privilege and the attorney work-product doctrine.
With a completed script and an experienced crew, we headed abroad to film the manufacturing process for the device at issue. The production phase of the filming project had challenges, such as lost equipment and luggage along the way and working with former employees who felt hurt, but the results were well worth the challenges. The final film, a labor of focused energy by a committed team from multiple disciplines, contributed to the overall success of the litigation.