A law firm is looking for plaintiffs to join a class-action lawsuit against Seattle-based Juno Therapeutics after the deaths of patients in an experimental trial testing a new cancer therapy. The clinical trial was suspended after three participants died from cerebral edema, or swelling of the brain, but was allowed to continue within a week.

The firm has filed suit in the U.S. District Court in Western Washington – but not for medical malpractice, as one might expect. The suit alleges that the company violated federal securities law because it didn’t publicize material information about two of the deaths, and should have announced the first death earlier. The class action addresses the injuries of investors, rather than the families of the patients – the company’s stock price took a 30% hit after the suspension was announced.

So, would the families of those who died have a viable claim? Without more details, it’s hard to know, but there are important differences between classic medical malpractice and suits involving clinical trials, sometimes referred to as research litigation. This is largely due to the fact that the aims of medical treatment and research are actually quite different.

Patients who seek treatment for a specific ailment are treated individually; for example, medications are adjusted based on the patient’s reaction. Although clinical studies can provide a benefit for an individual patient, they are not specifically designed to do so. Rather, the information gleaned from these trials is intended to add to a greater body of scientific knowledge, and perhaps advance individualized therapies in the future. In this context, failure to change the dosage of a drug to maximize the benefit to a patient is not a sign of a bad doctor, it is the sign of a good scientist – provided, of course, that the subject gave informed consent.

Even if research litigation is removed from the realm of medical malpractice, it doesn’t quite fit under ordinary negligence, either. A standard negligence model fails to account for the intuitively higher duty of care owed by a researcher to a subject than between two strangers. This duty is defined by the protocol put forth by the researchers themselves and approved by the proper reviewing body. In this sense, the standard of care is specific to each clinical trial – perhaps allowing research litigation to extricate itself from the malpractice vs. ordinary negligence debate altogether and carve out a niche of its own.

Sources:

[Firm targets Juno with class-action securities lawsuit related to drug trial death](http://www.bizjournals.com/seattle/blog/techflash/2016/07/firm-targets-juno-with-class-action-securities.html?ana=e_ptl_hc&u=fpT%2B17SDX2EeXojs4CyKTw02d6d55b&t=1469483331&j=75151442)

[Juno Therapeutics Stops Trial Of Cancer-Killing Cells After 3 Patient Deaths](http://www.forbes.com/sites/matthewherper/2016/07/07/juno-therapeutics-stops-trial-of-cancer-killing-cells-after-3-patient-deaths/#31d670ae5d89)

[Juno Therapeutics Re-Starts Cancer Trial After Deaths Put Study On Hold](http://www.forbes.com/sites/luketimmerman/2016/07/12/juno-therapeutics-re-starts-cancer-trial-after-deaths-put-study-on-hold/#689651a33889)

[Liability in Clinical Trials Research](http://www.ablminc.org/Model_Curriculum_LMME_2010/BOOK_MedMal%20Survival%20Handbook_2007/Ch09-A04438.pdf)

[Medical Research Litigation And Malpractice Tort Doctrines: Courts on a Learning Curve](https://www.law.uh.edu/hjhlp/volumes/Vol_4_1/Morreim.pdf)