Solely Updating Package Insert is Insufficient to Warn Prescriber

More plaintiffs’ attorneys have adopted the recent trend of alleging that pharmaceutical companies must distribute “Dear Doctor” letters or otherwise affirmatively call attention to label changes to satisfy their duty to warn prescribers besides merely updating the package insert with new warnings. The Eighth Circuit recently gave Plaintiffs’ argument support by upholding a Minnesota jury verdict finding that a drug manufacturer failed to warn a doctor despite the warning appearing in the package insert. Schedin v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., No. 11-317, 2012 WL 5971181 (Nov. 30, 2012).

In 2005, Dr. John Beecher prescribed John Schedin, who was 76 at the time, the drug Levaquin and a concomitant corticosteroid. The package insert warned that Levaquin could cause ruptures of the Achilles tendon and was amended in 2001 to also warn that the risk could be increased in patients receiving corticosteroids, especially in elderly patients. Schedin suffered an Achilles tendon rupture and sued Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJP), the company that marketed the drug.

The package insert and the Physician Desk Reference both included the warning regarding corticosteroids and the elderly. The risk of tendon rupture was listed in the Warnings section of the label but was not required to appear in a boxed warning until 2008, after Schedin’s injury. The sales representative testified that her common practice was to discuss labeling changes with prescribers but her notes from meetings with Dr. Beecher did not reference discussion of the warning and the sales aids she used at the time did not mention the risk of tendon rupture. Dr. Beecher testified that he was not aware of the risk associated with corticosteroids and the elderly and would not have prescribed Levaquin had he known of the risk.

Schedin argued that OMJP’s duty to warn obligated it to call prescriber’s attention to changes in the labeling through “Dear Doctor” letters or efforts by sales representatives. The jury returned a verdict for the Plaintiff despite the appearance of the warning in the package insert, the amendment of the PDR to reflect the warning, and the testimony regarding the sales representatives’ common practice to discuss labeling changes.

The Eighth Circuit acknowledged that many other jurisdictions held that pharmaceutical manufacturers satisfied their duty to warn as a matter of law if the warning appeared in the package insert and the PDR. However, as Minnesota courts had not addressed the issue, the Eighth Circuit held that there was sufficient evidence for a jury to find that OMJP had not adequately communicated the increased risk to prescribers.

The procedural posture limits the dangers this opinion poses to pharmaceutical companies. However, the Eighth Circuit highlighted that OMJP should have known that its warnings were inadequate due to the continued receipt of adverse events of tendon rupture in elderly patients prescribed concomitant corticosteroids after the label was amended in 2001. Further, the Court repeatedly described the warning as buried in a 15 page document of small type. These emphasized facts and the lack of weight given to the sales representative’s testimony confirm that pharmaceutical companies must carefully mange label changes, both in active litigation and to prevent future litigation.