Federal Appeals Court in Massachusetts Considers “Off Label” Product Injury Case Against Makers of Certain Antidepressants

Massachusetts product liability cases can cover a multitude of products – from the cars we drive to the toys that amuse our children to the medications that we take to try to be our healthiest selves.

Product injury lawsuits are not easy, and litigation can be lengthy. In many cases, there are a number of obstacles that must be overcome, if the plaintiff is to ultimately receive fair compensation for his or her injuries (or for a loved one’s death).

Facts of the Case

In a recent federal case, the plaintiffs had filed individual lawsuits against the defendant pharmaceutical companies, asserting that the defendants had engaged in “off label” prescription drug marketing and fraud intended to push their antidepressant drugs on minors for whom the Federal Drug Administration had not approved usage. The plaintiffs’ actions were aggregated for pretrial proceedings by order of a multi-district litigation panel.

The United States District Court for the District of Massachusetts entered summary judgment for one of the defendants as to two of the plaintiffs’ claims under the Racketeer Influenced and Corrupt Organizations Act (“RICO”), 18 U.S.C. § 1962(c)–(d), holding those plaintiffs could not demonstrate injury. The court also dismissed the plaintiffs’ state-based allegations as deriving from their noncognizable RICO claims.

The Court’s Holding

On appeal, the United States Court of Appeals for the First Circuit reversed the dismissal of the claims brought by two of the four plaintiffs, vacated the denial of plaintiffs’ motion to compel the production of additional documents, and otherwise affirmed the challenged district court rulings. In so holding, the court found that the FDA’s 2009 approval of one of the drugs at issue did not preclude the jury from concluding that the off-label uses of the drugs in question were ineffective in treating pediatric depression. Thus, the district court had erred in granting summary judgment on the RICO and state-law claims on this issue.

The court went to acknowledge that, in addition to demonstrating economic injury, a RICO plaintiff must prove that the defendant’s racketeering conduct caused his or her injury. The appellate court then agreed with the plaintiffs that the district court had erred in holding that the defendants were entitled to judgment as a matter of law on this issue.

The court also affirmed the lower tribunal’s denial of class certification.

Consult a Cape Cod Attorney

Consumers can be injured or killed by many different types of products, including prescription medications. If you or a loved one has suffered physical harm due to a defective or unreasonably dangerous drug, you need legal advice about how to file a claim against the makers and sellers of the medication. To schedule a free case evaluation with an experienced Cape Cod product liability lawyer, call the Law Offices of John C. Manoog, III at 888-262-6664 today. Please be mindful of the statute of limitations and other important deadlines for filing a personal injury or wrongful death claim in Massachusetts; untimely claims are usually dismissed without consideration of their merits.

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