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Patient in Unsuccessful Clinical Trial Stated a Claim under Massachusetts Law for Negligence as to Trial Sponsor’s Drafting of Consent Form – Zeman v. Williams

IVThe process of bringing new medicines and treatment options to patients can be long and tedious. The Food and Drug Administration (FDA), the federal agency that governs the procedure by which new drugs and treatments are approved for use on patients, is supposed to protect consumers, but dangerous drugs  do still make their way into the marketplace.

Remember Fen-Phen? Hailed as a miracle diet drug back in the 1990s, it was later discovered that fenfluramine/phentermine had dangerous side effects, including potentially fatal heart valve problems and pulmonary hypertension. Billions of dollars were awarded to people who were hurt by the bad drug.

In the recent case of Zeman v. Williams, the United States District Court for the District of Massachusetts took a look at the drug and medical treatment industry from a different perspective, namely from the point of view of a patient who participated in an unsuccessful clinical trial to test a possible therapy option for young-onset Parkinson’s disease.

Parkinson’s Patient Files Product Liability Lawsuit Against Clinical Trial Sponsor

The patient went to Massachusetts General Hospital in late 2008 with the intent of participating in a single blind placebo study of a new treatment for young-onset Parkinson’s disease. The patient was in the one-half of study participants who underwent the actual procedure. The procedure was called a “bilateral gene transfer.” The clinical trial was conducted under the Investigational Device Exemption (“IDE”) to the normal FDA pre-market approval requirements, and the patient was required to sign an informed consent form prior to enrolling in the trial.

The plan was for healthy genes to be injected into both sides of the brain in the sub-thalamic nucleus using a viral vector. The expectation was that the injected healthy genes would produce an enzyme called glutanic acid decarboxylase, which in turn would produce a neurotransmitter, gamma-aminobutyric acid, a deficiency of which is common in Parkinson’s patients. Two catheters were supposed to introduce the study agent into the patient’s brain, one on the left side of the brain and one in the right side. Unfortunately, the operating surgeon mistakenly placed both catheters in the left side of the patient’s brain, resulting in serious harm.

The Issues: Inadequacy in the Consent Form and Negligence in the Design/Manufacture of the Equipment

The patient and his wife sued the clinical trial sponsor, asserting claims for negligence, breach of warranty, and loss of consortium. According to the plaintiffs, the sponsor negligently drafted and approved the informed consent form used in the clinical trial. The plaintiffs further alleged that the sponsor was negligence in its design and manufacture of the medical equipment used in the procedure. The sponsor sought dismissal of the suit under Federal Rule of Civil Procedure 12(b)6), arguing that the plaintiffs had failed to state a claim for relief.

What the Court Held

The federal district court granted the sponsor’s motion in part and denied it in part. The court found that the plaintiffs had failed to plead sufficient allegations for their negligent design and manufacture claims to survive but found that the plaintiffs had made out a claim regarding the sponsor’s alleged negligence in drafting the informed consent form. According to the court, the plaintiffs’ claim that the sponsor knew or should have known that the form “did not adequately and reasonably present the alternatives to and risks and potential consequences of the trial” stated a claim under Massachusetts law. The court noted that whether the claim could actually be proven was a matter for another day.

 If You Have Been the Victim of a Dangerous Prescription Drug

Cape Cod injury attorney John C. Manoog III is here to help if you have suffered damages or lost a loved one due to an unreasonably dangerous drug or medical product or have been the victim of an improperly filled prescription. Call 888-262-6664 or fill out the contact form on this website to schedule an appointment to discuss your case. There is no charge for the initial consultation.

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