Prophylactics Do Not Protect Pharmaceutical Companies From Data and Document Discovery Laws!

Prophylactics Do Not Protect Pharmaceutical Companies From Data and Document Discovery Laws!

In this case, the plaintiff Nicole Baker sued Bayer Healthcare Pharmaceutical Inc., complaining that the Bayer product Mirena was not adequately accompanied by warnings of its side effects. Baker asked Bayer to produce databases that contains sales calls made by the marketing and sales department to physician’s offices. The sales calls notes also contained conversations between sales representatives and healthcare providers. Bayer argued that only the sales calls notes concerning Baker’s treating physician are relevant. Bayer also argued that producing all the sales calls notes are unduly burdensome and excessive in light of the needs of the case. Ultimately, the court found in favor of the plaintiff, and finds that the databases containing all sales calls must be produced due to their relevance to the current case.

Federal Rule of Civil Procedure 26(b)(1) permits “discovery regarding any nonprivileged matter that is relevant to any party’s claim or defense.” The information sought “need not be admissible at the trial” so long as it “appears reasonably calculated to lead to the discovery of admissible evidence.”

The crux of the plaintiff’s argument is that all the sales call notes, not just limited to those related to her physician, are relevant to her case because they would ascertain whether the pharmaceutical company is overpromoting the product Mirena. Overproduction would mean that there could be dilution or nullification of any warnings, thereby rendering the warnings inadequate. The plaintiff argued that the volume and substance of the sales calls notes establish whether there was a vigorous, aggressive sales campaign to the medical profession, leading to failure to heed written warnings. While this argument appears to be attenuated, it does fall under the standard of being reasonably calculated to lead to the discovery of admissible evidence.

The court thought although it was a burden to the defendant, all of the sales calls notes are relevant to establishing if Bayer’s Mirena campaign was so pervasive that any doctor, including the plaintiff’s, would fail to pay attention to warnings about the product’s side effects.  

Rebecca Hsu, a Seton Hall University School of Law student (Class of 2015), focuses her studies in the area of patent law, with a concentration in Intellectual Property. She is also certified in Healthcare Compliance, and has worked in Compliance at Otsuka America Pharmaceuticals, Inc.  Prior to law school, she graduated cum laude from UCLA and completed graduate work in biomedical science. She has co-authored two medical science research articles, as well as completed fellowships through UCLA Medicine and the Medical College of Wisconsin. In addition to awards for her academic achievements, Rebecca has been honored by awards for her community service with disadvantaged communities. In her spare time, Rebecca regularly practices outdoor rock climbing, and can be found camping in the Adirondacks.

Want to read more articles like this?  Sign up for our post notification newsletter, here

Leave a Reply

  • Find an eLesson

  • Register for Post Notifications

    Subscribe to receive updates whenever a new eLesson is published.

    Manage Subscriptions
  • Let Us Blog Your Event!

    eLessons Learned is fast becoming the site of choice for employers, employees, judges, lawyers, and journalists who are interested in learning more about these areas without being intimidated by the complexity of the topic. In fact, organizations and event coordinators often feature eLessons Learned as their official eDiscovery blog. Fill out our simple registration form to have eLessons Learned be the official blog of your organization or event.

    Register Now
  • Recent Praise

    The blog takes a clever approach to [e-discovery]. Each post discusses an e-discovery case that involves an e-discovery mishap, generally by a company employee. It discusses the conduct that constituted the mishap and then offers its ‘e-lesson’ — a suggestion on how to learn from the mistake and avoid it happening to you.

    Robert Ambrogi

    Legal Tech Blogger and creator of LawSites




    Although I may have missed some, yours is the first article that I have seen addressing Zubulake II. It is often the lost opinion amongst the others.

    Laura A. Zubulake

    Plaintiff, Zubulake v. UBS Warburg


    Click here to see more.
zzzz