Company Delays Product Launch to Avoid Payouts to Securities Holders

Joseph O'Neill

Written by
— Updated on January 5, 2018

Marketing Expert WitnessThis case involves a defendant medical device company that allegedly breached its contract with securities holders. The company intentionally delayed the process of FDA approval and did not sufficiently market a new surgical device in order to avoid performance based payouts to securities holders. As a result of doing so, the medical device company is thought to have made several hundred million dollars. It was claimed that the company’s behavior in this incident represented a significant departure from the industry norms involved in marketing a novel medical device, in that they did not aggressively pursue FDA approval or market the device despite forecasts of the device’s probable success in the market.

Question(s) For Expert Witness

  • 1. Please briefly describe your work marketing medical devices
  • 2. Could you review the facts of the case to determine whether or not the defendants marketing efforts were sufficient?

Expert Witness Response E-075178

I have held leadership positions within most all functions of commercial operations of pharmaceutical and biotechnology firms. I have led brand teams to launch products as a marketing director, owned product, portfolio, and enterprise profit and loss statements as  the head of primary care and specialty marketing business unit, managed the brand planning and budgeting process, led strategic global business unit level planning sessions, and overseen commercial operations. Currently, I run a consultancy that advises on organizational design, as well as corporate and brand strategic planning for the launch of new assets. I have also worked on in-licensing and out-licensing deals, co-promotions, and joint ventures. I can opine on the process of launching products in this space, and can determine realistic parameters for promotional spending as a percent of expected net sales. I also can speak to what it takes to be successful in the surgical device marketplace. I also have the capability to conduct competitive intelligence into the marketplace and give an assessment of this marketing plan compared to that of the competition. I have reviewed, critiqued, adjusted and relaunched marketing plans for other products, and I would be applying those skills to this particular case. There are usually huge marketing efforts undertaken for surgical devices, and I think I could determine fairly quickly if the defendant’s efforts were insufficient.

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