Appellate Court Holds Pharmaceutical Company Need Only Warn Physician of Side Effects; No Duty to Warn Patients

Earlier this month, the Sixth Circuit Court of Appeals decided a case reinforcing the laws surrounding whom the manufacturer of a medication must warn about the potentially dangerous side effects of the medication. In the case, Yates v. Ortho-McNeil-Janssen Pharma., Inc., the Court ultimately determined that the duty to warn extends only to the physician, and not to the patient. Thus, the patient’s case against the drug manufacturer was properly dismissed by a lower court.

Yates v. Ortho-McNeil-Janssen Pharma., Inc.

The plaintiff was a sexually active woman who was suffering from extreme menstrual cramps and consulted her doctor about potential medications that may help her. The doctor told her of two choices, ORTHO-EVRA and Depo-Provera. The doctor warned the plaintiff that there was some risk of blood clotting and stroke with ORTHO-EVRA, and the plaintiff decided to first try Depo-Provera.

After a few months, the plaintiff noticed she had gained weight, which was a side effect of Depo-Provera. She consulted her doctor, who again advised her of the risks associated with ORTHO-EVRA, and this time she decided to give it a try. The plaintiff suffered a stroke during the application of her first weekly patch. The woman filed a lawsuit against ORTHA-EVRA’s manufacturer, alleging that the company did not adequately warn her of the risks involved with taking the medication.

The Duty to Warn Extends Only to the Prescribing Physician

The plaintiff made two claims against the manufacturer. First, she alleged that it did not adequately warn her of the level of risk involved. Second, she argued that the manufacturer failed to warn her directly. The Sixth Circuit Court of Appeals rejected both arguments in turn.

Regarding the first issue, the court noted that the paper inserts that came with the medication explicitly mentioned that there was an “increased risk of several serious conditions including … stroke.” The court also pointed to the plaintiff’s testimony, in which she admitted that her physician advised her of the risks, and she chose to take the medication nonetheless. The court found that the plaintiff was properly warned as to the level of risk.

Next, the court considered the manufacturer’s failure to warn the plaintiff directly. The court considered the previous case law on the topic and noted that the default rule was to allow a manufacturer to warn the prescribing physician only. The court did explain that there was an exception to this general rule, but after a discussion of the relevant case law on the topic, it determined that the plaintiff’s situation did not fit within it. The cases meeting the exception dealt with medications delivered in a mass-immunization type setting, with little to no face-to-face time with a physician who may warn the patient of the risks involved. Here, it was uncontroverted that the plaintiff was involved in detailed discussions with her physician, so the manufacturer was not required to warn the plaintiff directly.

Have You Been Harmed by a Dangerous Drug?

If you or a loved one has recently been made ill or suffered some other serious adverse health condition after taking a medication, you may be entitled to monetary compensation from one of several potentially responsible parties. As this case illustrates, recovering financially after taking a dangerous drug can be difficult. By contacting the dedicated personal injury attorneys at the Maryland-based law firm of Lebowitz & Mzhen Personal Injury Lawyers, you will be sure that you understand what is expected of you and be advised on how to proceed to maximize your chances of recovery. Call 410-654-3600 today to set up a free consultation with a dedicated personal injury attorney.

More Blog Posts:

New Study Shows Post-Op Medication Errors More Common than Previously Thought, Pharmacy Error Injury Lawyer Blog, November 2, 2015.

Statutes of Limitations in Pharmacy Error Cases, Pharmacy Error Injury Lawyer Blog, December 9, 2015.

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