A patient who sued the manufacturer of the generic version of Reglan® (metoclopramide) after suffering from a neurological movement disorder allegedly caused by her long-term exposure to the product, could not establish that the manufacturer’s inadequate warning caused her injuries, and, thus, the manufacturer was entitled to summary judgment in its favor, a federal district court in Ohio ruled. The patient’s prescribing physicians had not read the drug’s packaging insert and had not seen the allegedly inadequate warnings prior to prescribing the medication. Therefore, the patient could not establish that the manufacturer’s lack of warning caused her physicians to prescribe the drug to her for lengthy periods of time resulting in her injury (Fulgenzi v. PLIVA, Inc., October 23, 2015, Lioi, S.).

Background. Reglan was approved in 1980 to treat a variety of digestive illnesses, including, gastroesophageal reflux and acute diabetic gastric stasis. During post-market studies, it was discovered that patients who used the drug had a risk of developing tardive dyskinesia (TD), a neurological movement disorder. Patients with TD suffer from involuntary and uncontrollable head, neck, and facial movements, and “grotesque facial grimacing and tongue thrusting.”

Early warnings. In 1985, Reglan’s package insert was changed to include a warning about TD, which stated that it was likely to occur in one in 500 patients taking the medication. In 1987, the warning label again was revised to state that the drug was indicated for short-term use in adults with gastroesophageal reflux who did not respond to other drugs. It also stated that using the drug for longer than 12 weeks was not recommended.

2004 warning. Another change to the label took place in 2004 at the request of the manufacturer to state, “The use of Reglan® tablets is recommended for adults only. Therapy should not exceed 12 weeks in duration.” The approved revision also included a sentence written in bold font found directly under the Dosage and Administration section, which stated: “Therapy with Reglan® tablets should not exceed 12 weeks in duration.” PLIVA, Inc., which manufactured a generic version of Reglan, failed to revise its generic label for metoclopramide to include the updated sentences.

Black-box warning. In 2009, the FDA announced that it approved additional changes to the warning label to include a black-box warning that stated, “Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. … Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases.”

Prescriptions. The patient was prescribed Reglan by three different physicians for varying lengths of time between July 2004 and August 2007. The patient obtained the generic version of the drug for each of the prescriptions. Her physicians testified that they did not review the packaging insert prior to prescribing the drug to the patient. She was subsequently diagnosed with TD caused by her long-term exposure to the drug.

Lawsuit. The patient’s suit was originally filed against PLIVA and other manufacturers alleging multiple causes of action that were dismissed on various grounds. On appeal, the U.S. Court of Appeals for the Sixth Circuit found that, under principles of preemption, the patient could bring suit only under the theory that PLIVA’s warning was inadequate because it did not update its Reglan labeling in 2004, and that this was the proximate cause of her injuries (see Products Liability Law Daily, March 18, 2013, analysis). The patient then filed an amended complaint against PLIVA alleging a cause of action for the manufacturer’s failure to warn under Ohio’s products liability statute. PLIVA moved for summary judgment.

Causation. The patient could not establish that PLIVA’s failure to update its label in 2004 to include the bolded warning that, “Therapy should not exceed 12 weeks in duration,” was the cause of her injuries. She also could not establish that her prescribing physicians relied upon PLIVA’s inadequate 2004 warning because the physicians all testified that they did not read or rely on the 2004 warning. An inadequate warning in a prescription package cannot be the proximate cause of an injury if the physician did not read the insert prior to prescribing the drug, the court said. Therefore, the court determined that the evidence demonstrated that an adequate warning would not have made a difference in the patient’s injuries.

The case is No. 5:09-cv-1767.

Attorneys: Daniel J. McGlynn (McGlynn Glisson & Mouton) and William B. Curtis (Curtis Law Group) for Eleanor Fulgenzi. Jeffrey F. Peck (Ulmer & Berne) for Pliva, Inc.

Companies: PLIVA, Inc.