‘Call’ing All Pharmaceutical Manufacturers: An Update On The Legal Implications Of Sales Representative Call Notes

Consistent messaging with physician customers can often lead to an increase in sales performance for pharmaceutical sales representatives. To achieve the desired consistency, pharmaceutical manufacturers provide various means by which sales representatives can track their interactions with their customer physicians and document important information specific to each customer. One of the most widely used methods for tracking physician/customer interactions is creating “call notes.” Call notes record important information from sales calls with physicians and are typically stored in company-created databases. Reviewing prior call notes before making the next sales call theoretically allows the representatives to build on their previous conversations and focus on a specific customer’s hot buttons in hopes of increasing sales. Call notes also allow the manufacturer to track the productivity of their sales representatives.

BUT BEWARE! In today’s pharmaceutical industry that is so often subject to litigation, it can be easy for call notes to be taken out of context and used by plaintiffs’ attorneys—who are often able to obtain these call notes through written discovery—as a means to inflame the jury. As such, defense attorneys should know how to effectively argue for limiting the scope of discovery and the admissibility of call notes.

In addition, recent advances in technology provide sales representatives with independent electronic means by which they can track office visits with customer physicians. Instead of ignoring these new technologies, creating and implementing comprehensive policies on how to address them will now more than ever be important to pharmaceutical manufacturers who find themselves subject to litigation.

Call Notes As Evidence And The Consequences Of Improper Preservation

The typical scenario in products liability litigation is this: a plaintiff claims to have been injured by a prescription pharmaceutical product and brings suit against the manufacturer. During written discovery, the plaintiff requests information from the sales representatives responsible for promoting the product, including call notes describing interactions between sales representatives and healthcare providers. An initial consideration is whether this information is discoverable. Overwhelmingly, the answer is yes, but with certain limitations.

In Baker v. Bayer Healthcare Pharmaceuticals Inc.,, 2014 BL 308969 (N.D. Cal. Oct. 31, 2014), the court addressed the admissibility of call notes in the context of an intrauterine device. The plaintiff sought call notes without any geographical or time limitations, arguing that all of the notes, including those unrelated to the physician who had prescribed and inserted her device, were relevant to her claims. The defendant objected on the grounds that producing the requested call notes would be unduly burdensome and disproportionate to what would be relevant. The court ruled in favor of the plaintiff, but with certain limitations. The court first determined that the notes the plaintiff sought were relevant, reasoning that call notes to other physicians could demonstrate the defendant’s aggressive marketing efforts, which could arguably lead a physician to ignore the product’s FDA-approved warnings. The court, however, also agreed with the defendant’s undue burden argument. Granting the plaintiff’s request in its entirety would have required the defendant to produce millions of call notes from sales representatives across the country for a 14-year period. The court thus ordered production of call notes already produced in a corresponding multidistrict litigation (MDL), which it determined to be an adequate sampling.

In In re Zyprexa Products Liability Litigation, 2009 BL 382385 (E.D.N.Y. Mar. 23, 2009), the defendant produced approximately 132,000 call notes under seal pursuant to a confidentiality order. After the call notes were reviewed by the special master and the parties, the court was tasked with determining what information should remain protected. Although the parties agreed that information related to the plaintiffs should remain redacted, the extent to which information related to the plaintiffs’ physicians should be kept confidential was heavily contested. The plaintiffs opposed redaction of physician information contained in the call notes—including the physicians’ names and personal details about the physicians recorded by the sales representatives—because they believed that the information demonstrated the close relationships the sales representatives formed with their physician customers. The plaintiffs admitted that they intended to post the call notes on the internet in the broadest sense possible, allowing anyone who wanted to review the information the ability to do so by using keyword searches tied to the doctors’ names. The defendants argued that the release of such information would cause unnecessary embarrassment and damage to both the physicians and the sales representatives. The court agreed with the defendants and ordered all information related to the physicians and their staff to be redacted.

Thus, while most courts are likely to rule that call notes are discoverable, defense attorneys may be able to limit the scope of discovery with appropriate objections.

Once produced, call notes can be used to support a variety of claims that plaintiffs typically assert in pharmaceutical products liability actions. For instance, in Murthy v. Abbott Laboratories, 2012 BL 314495 (S.D. Tex. Dec. 3, 2012), the plaintiff brought claims for breach of contract, breach of warranty, strict products liability, and negligence stemming from her participation in a clinical trial of a drug indicated for moderate to severe rheumatoid arthritis. After the plaintiff’s claims for breach of warranty, strict liability, and negligence were dismissed, she filed a motion to vacate on the grounds that newly produced call notes supported the dismissed claims. Specifically, one of the call notes described a conversation where the sales representative informed a physician that the drug was also indicated for early-stage rheumatoid arthritis—the type for which the plaintiff was being treated—even though it was not. The court granted the plaintiff’s motion and allowed her to file an amended complaint based on the information from the call notes.

In addition, because call notes are discoverable, a manufacturer’s failure to properly preserve call notes could be used to support a spoliation claim or lead to a possible adverse inference instruction under Federal Rule of Civil Procedure 37(e). In Alexander v. Abbott Laboratories, Inc., 2014 BL 493684 (S.D. Ill. Aug. 8, 2014), the plaintiffs sought an adverse inference instruction based on the defendant’s failure to timely place litigation holds on call notes from the sales force. The defendant ultimately was able to avoid the requested sanction, but only after informing the court that all call notes were stored in an internal database and would be produced as requested. See also In re Ethicon, Inc. Pelvic Repair Sys. Prod. Liab. Litig.,
299 F.R.D. 502, 507 n.1 (S.D. W. Va. 2014) (recognizing that an adverse instruction may be appropriate to support spoliation claim where the plaintiff has made a prima facie showing of failure to warn and introduces evidence that call notes were destroyed). These examples thus emphasize the importance of instructing sales representatives and all appropriate internal personnel on how to properly preserve call notes.

Taking Control Of Internal Call Notes And The Use Of External Project Management Tools

Recognizing the implications inherent in having to produce call notes that are left solely to the devices of sales representatives, many forward-thinking manufacturers long ago implemented policies designed to significantly curb, if not completely eliminate, the use of individualized call notes. Today, many manufacturers have replaced their sales representatives’ narrative format for recording call notes with company-provided tablets that contain internally created drop-down menu options that have been reviewed and approved by the manufacturers’ legal teams. No longer do these companies have to worry about a representative recording a note that might improperly document a conversation with a physician customer. Instead, those options are now generally vetted to include only the information that is key to understanding physician customer needs. Drop-down menu options might include: “provided x number of samples,” “discussed package inserts,” “provided in-service to office staff,” “discussed managed care benefits,” or “described safety and efficacy advantages.” Drop-down menus on call notes also provide the manufacturer with the information it needs to track the sales representatives’ productivity.

But there is a sense among some sales representatives that their business will be less effective without a way to record and organize all of the information obtained during sales calls.

While some representatives still use handwritten notes or monthly planners to supplement their call notes, a relatively new technology has made its way into the industry and warrants attention. Project management systems such as Trello and JIRA are being used by sales representatives as a means of supplementing their company-provided recording capabilities, only now the information is in an external app that can be downloaded to any tablet or mobile device. Although the format is somewhat different from internal databases—different “boards,” “lists,” and “cards” containing customer information are created and stored in the app—the end result is the same. One representative can create a “project” containing any information related to a customer that the representative chooses to enter. He or she can then invite other teammates to view that information and use it in subsequent interactions with physician customers so long as the teammate also has downloaded the app, thus recreating the very same legal risks that manufacturers sought to avoid when implementing drop-down menus.

Because this new technology presents the potential to raise the same legal issues previously presented by individualized call notes, manufacturers would be well-served to adopt a proactive approach of acknowledging this new technology and creating formal policies addressing its use.

Conclusion

Recording sales call information is a traditional and effective means for pharmaceutical sales representatives to increase sales performance and productivity. But because of the discoverability of call notes, particularly in products liability litigation, manufacturers should be aware of the most effective means for managing how call notes are recorded. Moving away from individualized call notes and using drop-down menus with concise, company-approved messages is an effective tool in most instances.

Today’s technology, however, also requires the pharmaceutical industry to go one step further. Detail-orientated sales representatives will always find a way to supplement call notes. Today’s JIRA and Trello are the equivalent of yesterday’s monthly planner. These new technologies and other app-centered databases allow sales representatives to record call information outside the internal constraints imposed by their employers. Manufacturers hoping to avoid the same legal issues of the past should thus familiarize themselves with these new technologies, create policies governing their use, and appropriately counsel and train their sales representatives on proper recording methods.