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Clark Hill Wins Pharmaceutical Products Liability Case

March 8, 2023

Clark Hill Member Matthew Marshall and Senior Attorney Seta Sarabekian successfully secured a summary judgment ruling on Feb. 9 for a pharmaceutical company that sponsored a clinical trial involving its novel combination drug product.

The client faced a lawsuit from the family of a deceased subject in a clinical trial for claims of wrongful death, negligence, medical malpractice, and products liability. The case first began in Los Angeles Superior Court in late 2017 and was set to begin trial this upcoming April.

Case Background

The client’s product consisted of a combination of genetically modified T cells and a synthetic molecule that was used in support of stem cell transplantation in pediatric patients with inherited blood disorders. The purpose of the product is to facilitate the reconstitution of a subject’s immune system and act as a failsafe to help prevent injected stem cells from attacking host cells.

The 17-year-old subject in this case suffered from a genetic disorder in which his white blood cells were unable to kill certain types of bacteria and fungi. As a result, the subject suffered from frequent and potentially life-threatening bacterial and fungal infections throughout his life.

The patient was enrolled in a clinical study that was sponsored by the pharmaceutical client.  The study investigated the safety and efficacy of the use of the product in association with hematopoietic stem cell transplants from partially matched family donors.

Over a period of three months, the patient received three separate stem cell transplants from his parents, all of which were unsuccessful. The client’s product was only used in conjunction with the first transplant, and not the second or third.  Soon after the third transplant, the patient passed away from a widespread fungal infection, which is a common risk of stem cell transplants.

Legal Process

A successful demurrer in May 2022 resulted in the dismissal of negligence claims pertaining to the deceased subject’s enrollment in the clinical trial and the role that the client played as the clinical trial sponsor. The negligence claims that were dismissed included the allegation that the client had a duty to ensure that the subject was a clinically appropriate subject for the trial. This prior ruling played a significant role in limiting the issues that were the subject of the motion for summary judgment.

In November 2022, the motion for summary judgment was filed, seeking an adjudication of the remaining product liability claims of design and manufacturing defect and breach of warranty.

Marshall said that the lack of evidence demonstrating that the client’s product was a substantial cause of the subject’s infection and eventual death proved to be key to the case.

“If you can take out one element of the case due to a lack of admissible evidence, and in this situation, it was a lack of evidence of causation, and demonstrate that the drug didn’t cause the infection that killed the patient, the case is over,” Marshall said.

“Our medical expert, one of the most prominent stem cell transplant physicians in the world, testified that there was nothing about this product that increased the risk of infection that is generally associated with hematopoietic stem cell transplants, or any evidence that the product contributed to what the autopsy report described as a massive fungal infection.”

Marshall and Sarabekian also had to counter an argument from the plaintiffs that the protocol for selecting and enrolling subjects in the clinical study should also be considered a product in this case.

To counter that claim, Marshall and Sarabekian argued that federal guidelines define a protocol for a clinical study not as a product, but rather as a document that describes how the clinical trial is to be conducted and not as the investigational product itself.

“The protocol is a written document, while the combination drug that was investigated in this study was the actual product. As elemental as this sounds, it was the dispositive issue on the liability issue in this case, which, as framed by the pleadings, alleged a defective product and not a negligently designed clinical study and/or its associated protocol. A product is an actual product, while the protocol is a written document, and those are two very different things,” Marshall said.

Pointing out that distinction and demonstrating that the product did not play a role in the patient’s infection were critical to defeating the liability aspect of the claim, Marshall added.

“The plaintiffs argued that if he wasn’t in the study, he wouldn’t have died. But the case wasn’t about whether he should’ve been in the study, it was about whether the product was defective and if it caused his death, and the evidence demonstrated that there was no defect and that the product did not cause any harm to the subject,” Marshall said.

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