Regular readers of this blog may recall that, each year at this time, we report on our cherished annual trip to the Westminster Kennel Club dog show. This year, the trip was modified at the outset by a work conflict (an argument in Kentucky that we knew we would keep us from attending any part of the first day of the two-day event). We hoped to make it to Madison Square Garden for the Tuesday evening group judging and Best in Show, but that plan was affected (read, "doomed") Tuesday afternoon by a weather-related flight cancellation. Disappointed, we arranged for our ticket to be re-printed and held at Will Call for a friend who was delighted by the unexpected treat. But then we re-grouped. We figured out that we could make it to the Garden for the last hour, if everything went just right, by taking a still-on-time flight to Philadelphia and a train to New York. We got on the flight as they were closing the boarding door, and ended up standing at the door to the Garden at 9:35 pm. BUT WE NO LONGER HAD A TICKET. And the box office was closed, and Security was unimpressed by our near-tears offer to "pay anything" if we could just get into the building for the last hour. So we hovered outside for a while looking pathetic, and eventually hung our head and headed toward our hotel. Whereupon we encountered a scalper with a ticket for sale. And you can figure out the (very, very happy) ending.
So sometimes it pays to grasp at an unlikely straw when all logical avenues have been exhausted. Not so in today's case. In Mitchell v. Wyeth Pharms., Inc., 2018 U.S. Dist. LEXIS 220946 (W.D. Tex. Dec. 17, 2018), the plaintiff alleged that her decedent died from complications of taking the generic drug amiodarone for non-life-threatening atrial fibrillation. But amiodarone is a generic drug, and all ordinary product liability claims against generic drugs are preempted. Thus, plaintiff was forced to be creative. Under federal law, pharmacies must provide Medication Guides to patients filling amiodarone prescriptions. The plaintiff's original complaint, naming both the innovator drug manufacturer and the manufacturer of the generic version, included a claim that the generic manufacturer failed to supply the pharmacy with a Medication Guide that could be provided to the plaintiff. It also included warnings claims and the usual litany of product liability claims. All of the product liability claims were dismissed on the defendants' predictable preemption motion. The plaintiff filed an amended complaint against the generic manufacturer, asserting only a single substantive claim for failure to provide the required Medication Guide. The defendant moved for summary judgment again, arguing that the uncontroverted testimony established that the pharmacy had been provided with an adequate quantity of FDA-approved Medication Guides along with its amiodarone supply. In response, the plaintiff argued that, beyond sending the Medication Guides to the pharmacy, the manufacturer was required play nanny to pharmacies − to take reasonable steps to ensure that each and every pharmacy actually distributed the Medication Guides to patients − and that the manufacturer had not taken such steps.
The court disagreed, quoting federal regulations that required only that the manufacturer provide enough Medication Guides to the pharmacy (or provide the pharmacy with the ability to print additional copies). The court held, "The text, contrary to Plaintiff’s contention, does not place a duty upon [the manufacturer] to take steps to ensure that the Medication Guides are distributed to patients beyond providing them in “sufficient numbers" to the pharmacy. Mitchell, 2018 U.S. Dist. LEXIS 220946 at *9-10. Nor did FDA regulations require the manufacturer to monitor pharmacies practices to ensure that they were providing Medication Guides when required. In the absence of any evidence that the manufacturer had failed to supply the pharmacy with the required Medication Guides, the court granted summary judgment for the manufacturer. Id.
This is not the first time plaintiffs have tried to force the pharmaceutical industry to superintend the professional practice of pharmacy, and we doubt it will be the last. Bottom line: regardless of the difficulty of imposing liability for injuries allegedly caused by a generic drug, a plaintiff can't plead around the generic preemption/innovator liability framework by asserting a duty that doesn't exist. At least under a judge, like the Mitchell judge, who is committed to applying the law correctly. What more can a defendant ask?
This article is presented for informational purposes only and is not intended to constitute legal advice.
