Judge Orders USC to Restore Control of Alzheimer’s Study to UCSD

[Updated, 8:25 am PT, with court document] A San Diego judge yesterday ordered the University of Southern California and a prominent Alzheimer’s disease researcher to restore control over a nationwide Alzheimer’s research program to UC San Diego “with all deliberate speed.”

The five-page preliminary injunction (posted below), signed by Superior Court Judge Judith Hayes, is intended to preserve the “status quo” until civil lawsuits filed by the warring research universities can be resolved. The term refers to what Hayes describes as “the last actual peaceable, uncontested status which preceded the pending controversy” between UC San Diego and USC.

That means returning control of the data and computer systems that former UC San Diego neuroscientist Paul Aisen and his team have been using to manage the Alzheimer’s Disease Cooperative Study (ADCS). UC San Diego has argued that Aisen and his team took root control of the ADCS computer system and database, and precluded UC San Diego from maintaining its authority over the network.

USC hired Aisen away from UC San Diego in mid-June with a job offer that made him the founding director of USC’s new San Diego-based Alzheimer’s Therapeutic Research Institute, reportedly with an annual salary of $500,000.

In a lawsuit filed July 2, UC San Diego alleged that USC and Aisen conspired to “misappropriate” the Alzheimer’s study by moving the ADCS program to USC.

UC San Diego founded the study in 1991 as a kind of joint venture with the National Institute on Aging, with funding provided by federal research grants, the pharmaceutical industry, and private foundations. UC San Diego hired Aisen to oversee the study in 2007.

The order came as no surprise. Following arguments by lawyers for both sides during a July 24 hearing, Hayes said she would grant UC San Diego’s request for an injunction against USC. In issuing the order, Hayes wrote that UC San Diego “demonstrated a likelihood of succeeding on the merits of one or more claims” made in its lawsuit. A USC spokesman said last week that the university was planning to appeal the injunction.

USC, however, could also claim a partial victory yesterday, after Eli Lilly (NYSE: [[ticker:LLY]]) notified UC San Diego it was ending its contract with UCSD to manage Lilly’s Anti-amyloid treatment in Asymptomatic Alzheimer’s disease (A4) study. The A4 study is a trial testing Lilly’s Alzheimer’s antibody drug, solanezumab, in older patients showing evidence of amyloid buildup—the telltale protein clumps that are a hallmark of Alzheimer’s—in their brains, yet don’t have any symptoms of disease.

In its statement, Lilly says, “From the outset of this unfortunate dispute, Lilly has publicly stated that the company’s objectives are to maintain the safety of the A4 participants, ensure scientific and data integrity for the study and maintain our obligations as the regulatory sponsor…Lilly has determined that it is in the best interest of the A4 study and its participants to end UCSD’s management of the study.”

The Indianapolis-based company said it has begun meeting with USC to discuss moving the A4 study to the private university in Los Angeles.

Judge Hayes also named attorney David Garrett as a special master to ensure that USC and others comply with her order. Garrett is the managing director of the San Francisco office of Stroz Frieberg, a firm that provides specialized computer-related services in legal disputes.

The judge also named Karl Kieburtz, a neurobiologist at the University of Rochester Medical Center, to serve as Garrett’s consultant and act as the primary decision-maker in any issues or disputes that might arise in the contentious case.

The two sides will equally share the cost of Garrett’s legal bills in the case, which pencil out at a billing rate of $770 an hour, and for Kieburtz, who bills at $500 per hour.

Preliminary Injunction in UCSD v. USC

Author: Bruce V. Bigelow

In Memoriam: Our dear friend Bruce V. Bigelow passed away on June 29, 2018. He was the editor of Xconomy San Diego from 2008 to 2018. Read more about his life and work here. Bruce Bigelow joined Xconomy from the business desk of the San Diego Union-Tribune. He was a member of the team of reporters who were awarded the 2006 Pulitzer Prize in National Reporting for uncovering bribes paid to San Diego Republican Rep. Randy “Duke” Cunningham in exchange for special legislation earmarks. He also shared a 2006 award for enterprise reporting from the Society of Business Editors and Writers for “In Harm’s Way,” an article about the extraordinary casualty rate among employees working in Iraq for San Diego’s Titan Corp. He has written extensively about the 2002 corporate accounting scandal at software goliath Peregrine Systems. He also was a Gerald Loeb Award finalist and National Headline Award winner for “The Toymaker,” a 14-part chronicle of a San Diego start-up company. He takes special satisfaction, though, that the series was included in the library for nonfiction narrative journalism at the Nieman Foundation for Journalism at Harvard University. Bigelow graduated from U.C. Berkeley in 1977 with a degree in English Literature and from the Columbia University Graduate School of Journalism in 1979. Before joining the Union-Tribune in 1990, he worked for the Associated Press in Los Angeles and The Kansas City Times.