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Juelsgaard Clinic Students Ask FDA to Protect Innovation and Patient Benefits in Pharmacogenomics

Juelsgaard Intellectual Property and Innovation Clinic students (pictured below) Yale Fu (JD ‘15), Hyosang (Mark) Kim (JD ‘16), and Marta Belcher (JD ‘15)  submitted comments to the Food and Drug Administration (FDA) on behalf of three Stanford pharmacogenomics researchers on February 2, 2015. LDT JIPIC TeamResponding to the FDA’s draft guidance on regulating Laboratory Developed Tests (LDTs), the comments urge FDA to avoid regulation that could stifle innovation in pioneering pharmacogenomics laboratories.

The comments were submitted on behalf of Pharmacogenomics Knowledgebase (PharmGKB) researchers Russ Altman (MD, PhD), Teri Klein (PhD), and Michelle Whirl-Carrillo (PhD). Pharmacogenomics focuses on using individual patients’ genetic data to predict the likely effectiveness and side effects of particular drugs on each patient. This growing field seeks to help physicians make prescription decisions. PharmGKB, managed by Stanford University and funded by the National Institutes of Health, is a publicly available resource that aggregates, curates, integrates, and disseminates knowledge regarding the impact of human genetic variation on drug response.

Historically, the FDA has not exercised regulatory authority over LDTs. Unlike direct-to-consumer genetic tests like 23andMe, LDTs are designed, manufactured, and used within a single laboratory. In June 2014, the FDA issued a draft guidance proposing to regulate LDTs, followed by a request for public comments on the guidance in October 2014. The proposal raised some concerns among pharmacogenomic laboratories and researchers because the proposed regulations could hinder clinical implementation of pharmacogenomic tests, which could be marketed as LDTs.

The comments urge the FDA to minimize regulation on pharmacogenomic tests and avoid overburdening a growing field that promises to improve patients’ health and well being. The FDA’s proposed regulation, with its broad definitions and unclear classification systems, could increase financial risk in the new technological frontier and push investors away from pharmacogenomics. Furthermore, the regulation would conflict with the White House’s recent Precision Medicine Initiative, which has made personalized medicine a national priority with $215 million in proposed research investments.

The comments submitted by the clinic emphasize that the potential burdens are neither justified nor necessary because pharmacogenomics inherently pose little risk to patient welfare. Pharmacogenomic tests differ from diagnostic genomic tests in that they do not diagnose disease risk. Pharmacogenomics-based decisions rely on extensive physician involvement and the field’s own rigorous, self-developed guidelines, which ensure effectiveness and reliability. The comments therefore warn FDA against regulating pharmacogenomics under the same framework as other LDTs.

Big Suppression Win for the Criminal Defense Clinic

CDC student Grace Kouba (JD ’16) and Emi Young (JD ’16 ) at the San Mateo County Superior Court

CDC students Grace Kouba (JD ’16) and Emi Young (JD ’16 ) at the San Mateo County Superior Court

On February 4, 2015, Criminal Defense Clinic students Grace Kouba (JD ‘16) and Emi Young (JD ‘16) argued a suppression motion in San Mateo County Superior Court on behalf of a client charged with petty theft. The motion was based on two separate constitutional violations; the unlawful search of the clients’ belongings and an unreasonable detention. After hearing testimony from two prosecution witnesses and argument from both sides, the judge granted the motion from the bench.

This ruling came despite a surprise development from the prosecution on the day of the hearing. The prosecution’s briefing relied on an account of the facts virtually identical to that in the defendant’s briefs—and these facts were very favorable to the defense arguments. However, on the day of the hearing, both prosecution witnesses suddenly remembered that the items recovered in the search were in “plain view.” Because these facts were not only missing in, but also inconsistent with, the witnesses’ prior reports, Grace and Emi successfully impeached their testimony. It was apparent from the subsequent ruling that the judge did not believe the testimony was credible.

This victory means that much of the evidence the prosecution could have relied on at trial is now excluded. The team and their client are confident they’ll be able to secure a favorable outcome as they move forward in the case.

SCOTUS Clinic Takes On Confrontation Clause in Ohio v. Clark

Professor Jeffrey Fisher and students from the Supreme Court Litigation Clinic took on the Constitution’s Confrontation Clause this week during oral arguments in the clinic’s case Ohio v. Clark. The Confrontation Clause guarantees all defendants in criminal prosecutions “the right . . . to be confronted with the witnesses against him.” At issue here is whether the prosecution in a child abuse case may introduce statements a child previously made to teachers alleging that the defendant abused him, without providing the defense any opportunity at trial to cross-examine the child.

SCOTUS Clinic students on the steps of the Supreme Court.

SCOTUS Clinic students on the steps of the Supreme Court. Photo by Bill Petros.

“All we are asking for is that a state not to be allowed to have it both ways,” argued Fisher. “Introducing such evidence while at the same time prohibiting the defense from any form of confrontation whatsoever.”

The clinic represented the respondent in the case, Darius Clark, who claimed that a trial court violated his right to confrontation by allowing teachers to testify about the statements a three-year-old child in their preschool class made to them. The child’s statements constituted the only direct evidence that Clark, and not someone else, committed the abuse. An Ohio appeals court ruled that the teachers shouldn’t have been allowed at the trial to convey the child’s allegations, finding a violation of the Confrontation Clause.  The case was then taken to the Ohio Supreme Court, which agreed with that ruling by a 4-3 vote.  The State then took the case on to the Supreme Court-where it was argued on Monday.

Clinic students Morgan Weiland, JD ’15, Stephany Reaves, JD ’15, Percy Lee, JD ’15, and Michael Skocpol, JD ’16, under the guidance of Fisher, who argued the case, outlined and drafted the response brief on the merits. The group also traveled to Cleveland to meet with Clark and the local co-counsel.

“Meeting Mr. Clark reminded us of his great personal liberty at stake, and we remembered this throughout the experience,” said Lee.

Morgan Weiland, JD '15, Professor Jeffrey Fisher, Stephany Reaves, JD '15, Percy Lee, JD '15, and Michael Skocpol, JD '16,  leave Court after oral arguments in Ohio v. Clark.

Morgan Weiland, JD ’15, Professor Jeffrey Fisher, Stephany Reaves, JD ’15, Percy Lee, JD ’15, and Michael Skocpol, JD ’16, leave Court after oral arguments in Ohio v. Clark. Photo by Bill Petros.

Reaves echoed Lee’s sentiments, “By now, as students, we’ve become emotionally invested in Mr. Clark’s case—and know the facts and legal issues so well,” said Reaves. “It was great to have the opportunity to see the case through to the oral argument.”

The clinic students worked full-time on the case during the fall quarter—even leading a workshop with other Supreme Court Clinic students to receive feedback at various phases. It was Fisher’s, they say, that was most impactful.

“Jeff is equal parts appellate advocate and teacher,” said Weiland. “After we mooted the case, we reviewed argument substance and strategy —and even then, just days before the argument, he focused on illuminating the craft and method of appellate advocacy to teach us how to use these tools for ourselves and our future clients.”

“The student team did an outstanding job working through a very difficult legal problem,” said Fisher. “And there’s nothing for them quite like seeing all of those hours of hard work come to life in thoughtful dialogue with the Justices.”

And it was that thoughtful dialogue that students say they won’t soon forget.

“It was thrilling to have Justices point out parts of our brief or highlight an argument and think, “Hey, I worked on that!” said Weiland.

“I was surprised by how nerve-racking it felt to watch the arguments,” said Skocpol.

SCOTUS Clinic Students debriefing after oral arguments Ohio v. Clark.

SCOTUS Clinic Students debriefing after oral arguments in Ohio v. Clark. Photo by Bill Petros.

“We were all remarking as a team afterward that even though all we did was sit in the audience, our adrenaline was still pumping several hours later. It’s one thing to go to the Court and hear interesting intellectual issues being debated, but it’s quite another when you’re there and you’ve got a client, and you care about him, you’ve been pouring your heart into his case, and he’s got thirty years of his life riding on the arguments. We all really felt the stakes for Mr. Clark in there.”

The Court’s opinion in Ohio v. Clark is expected to be issued later in the term. You can read the oral arguments from the case here. 

Organizations and Transactions Clinic Autumn 2014 Projects

The Organizations and Transactions Clinic was hard at work this past Autumn quarter, with eight full-time students involved in a number of contractual and advisory matters. At the local, county, and state levels, clinical students contributed to diverse legal fields, from health and agriculture, to education and corporate governance.

Advice and Contract Matters:

Photo APhillip Arredondo (JD ‘16) and Christopher Deetz (JD ‘16) advised a statewide agricultural organization about a substantial change in its corporate structure and drafted related documents for its board and members. The team also prepared a range of advice, contract, and employee communication materials for the nonprofit affiliate of one of the world’s leading design firms, and helped refine and document a new program for a Peninsula nonprofit that connects STEM professionals at large companies with K-12 students for weekly mentoring sessions.

 Photo BGordon Grafft (JD ‘16) and Tiffany Mason (JD ‘16) prepared medical clinic site agreements for a Santa Cruz County health center that is a principal provider of primary medical and dental care to low-income families in the Monterey Bay area. Gordon and Tiffany also designed and documented governance arrangements for a newly-formed statewide alliance of farmers’ markets, and drafted a contract for a group of Bay Area cycling organizations relating to Bike to Work Day planning and activities.

Photo CErin Cho (JD ‘15) and Yonatan Moskowitz (JD ‘15) provided advice to a large San Francisco social enterprise about joint venture and collaboration design, and also drafted a set of contracts for the client relating to facility use, job training programs, and other matters. Erin and Yoni also prepared transaction review tools and worked on several contract projects for a rapidly-growing national organization focused on K-12 teacher development, and for a San Mateo County organization that designs and delivers sex education programming in local schools.

Photo DHaley Horton (JD ‘16) and Blake Meyer (JD ‘16) drafted an option agreement and letter of intent for one of California’s most prominent agricultural land trusts. Haley and Blake also provided fiscal sponsorship advice and documents to a national organization committed to advancing the rights of lesbian, gay, bisexual, and transgender individuals, and they developed compliance program materials and employee communications for a large Silicon Valley health services and advocacy organization.

Corporate Governance:

Photo EIn addition, all O&T students executed comprehensive corporate governance reviews. These engagements involve reviewing the client’s existing governance documents and practices, preparing a detailed advice deliverable, drafting an extensive suite of bylaws, board committee charters, and other documents, and making a formal presentation to the board of directors and to the CEO. Phillip Arredondo and Blake Meyer represented a long-established San Mateo County affordable housing organization. Christopher Deetz and Gordon Grafft advised a prominent East Bay theatre company. Tiffany Mason and Yonatan Moskowitz worked with the board of a growing Santa Cruz provider of residential and outpatient substance abuse services. Erin Cho and Haley Horton worked with a North Bay organization that operates a major children’s museum and research center.   ◊

 

Religious Liberty Clinic Takes Homeless Ministry Case to Ninth Circuit

On February 2, 2015, members of the Religious Liberty Clinic appeared before the U.S. Court of Appeals for the Ninth Circuit (Pasadena) on behalf of its longstanding client, Harbor Missionary Church. Clinic students Alex Kasner (JD ‘15), Kimberly Larkin (JD ‘16), and Tom Wakefield (JD ‘15) prepared and assisted appellate co-counsel Lisa Freeman of Horvitz & Levy LLP, who presented argument for the church to the three-judge panel. The opening brief filed August 11, 2014 can be found here.

 Alex Kasner '15, Kimberly Larkin '16, and Tom Wakefield '15 with Religious Liberty Clinical Director James Sonne

Alex Kasner, Kimberly Larkin, and Tom Wakefield with Religious Liberty Clinical Director James Sonne

The case concerns Harbor Missionary Church’s right under the Religious Land Use and Institutionalized Persons Act (RLUIPA) to minister to the homeless at its church building in accordance with its faith. The church had operated the ministry from its sanctuary for years until city officials decided it could no longer do so. The district granted a TRO but then denied a preliminary injunction to allow the church ministry to remain open pending trial.

In advance of the Ninth Circuit argument, Alex, Kimberly, and Tom helped file a letter brief arguing the U.S. Supreme Court’s recent unanimous decision in Holt v. Hobbs – where the Court emphasized RLUIPA’s exacting standard on government in placing burdens on religious activity – supported their client’s position. (Note, the RLC also filed an amicus brief in the Holt case last spring.) The clinic and its client await the Ninth Circuit’s decision.

In Dialogue with Sherrilyn Ifill on Modern Day Civil Rights

We were thrilled to co-sponsor a fabulous event last Friday, February 6 with Sherrilyn Ifill, head of the NAACP Legal Defense Fund in conversation with our own David Mills as part of the #SLS for Justice series.

 

Once Ousted East Palo Alto Schools Superintendent Returns as Board Member to Find Vast Improvements in Special Education

For over thirteen years, the Youth & Education Law Project (YELP) has represented children with disabilities in East Palo Alto’s Ravenswood City School District in a federal class action lawsuit, Emma C. v. Delaine Eastin.  A recent article in the San Jose Mercury News summarizes some of the history and current status of YELP’s long-standing special education case against the Ravenswood District, and focuses on the return of one of the lawsuit’s principal defendants – formerly indicted Superintendent, Charlie Mae Knight.  Dr. Knight, who departed from East Palo Alto twelve years ago under a cloud of controversy surrounding her administration of Ravenswood’s special education services and her alleged malfeasance during the litigation, has returned to take up a seat on the Ravenswood City School Board – to find a strongly emerging and transformed special education program in place of the one she left behind.

Despite its early recalcitrance and the formidable challenges in reforming the schools in a high-poverty community, the District, prodded by the litigation and monitored by YELP, has made great strides in improving its services to children with disabilities. More.

 

Supervising Attorney Stephan Sonnenberg Joins an Interdisciplinary Teaching Team for Innovative Course on Human Trafficking

For the second year in a row, Stephan Sonnenberg, Clinical Supervising Attorney in the International Human Rights and Conflict Resolution Clinic has teamed up with Prof. Katherine Jolluck (History), and Prof. Suzanne Lippert and Rebecca Walker, (both from the Emergency Medicine Department at the Stanford Medical School), to teach a multidisciplinary course on human trafficking. The course is open to graduate and undergraduate students, and is cross-listed as a course open to Law Students as well. The course is designed to expose students to a range of professional approaches to the problem of human trafficking, emphasizing the need to look for new and better approaches to combat the estimated $32 billion global “market” for human trafficking. Each member of the team utilizes different teaching methods, such as inquiry-based learning and case studies, to encourage students to actively engage with the structure and content of their course material. The cases prompt students to co-define their own learning priorities as they develop a deeper understanding of the various forms of human trafficking.

The course also includes an optional service learning component for additional credit. Students enrolled in the service learning component translate their learning in the course into practice by means of project work with a local Bay Area service provider or trafficking activist. Service learners this year are helping drive preparations in the Bay Area for what some analysts predict will be a spike in sex- and labor trafficking to coincide with the 2016 Super Bowl, which will be held less than 14 miles from Stanford’s campus at Levi’s Stadium in Santa Clara, California.

For a more informational discussion of the course, please visit:

https://teachingcommons.stanford.edu/teaching-talk/studying-human-trafficking-through-medical-legal-and-historical-lenses

Updates from the Environmental Law Clinic

The Environmental Law Clinic had a fantastic fall quarter with seven full-time students and four advanced students.  The clinic kicked things off with a three-day field trip to Medicine Lake in northeastern California, the site of one of the clinic’s longest-running cases.  In this case, the clinic represents the Pit River Tribe, Tribal coalitions, and environmental organizations in their efforts to protect the Medicine Lake Highlands from geothermal fracking.  During the trip students met with the clients, presented at a Pit River Tribal Council meeting, and visited some of the sites that make the Highlands so special.  The trip served as the foundation for work by full-time students Philip Womble (JD ‘16/PhD ‘18) and Rose Stanley (JD ’16) on a variety of policy matters, which will contribute to continuing litigation against the decision by the Bureau of Land Management to continue to expose the Highlands to the specter of industrial development. More

Environmental Law clinical team pictured at Medicine Lake

 

Shortly after visiting Medicine Lake, students, faculty, and staff spent a day in the historic Presidio in San Francisco, a National Landmark, the long-term of which is the subject of a clinic case currently being litigated in the Ninth Circuit.  The Presidio Trust, the organization charged with overseeing the public Presidio, has proposed building a large commercial hotel in the Main Post, at the very center of the Presidio.  The clinic represents the Presidio Historical Association and the Sierra Club, agencies that believe the Trust’s plans are inconsistent with the Trust’s legal obligations and with the Presidio’s exceptional historic character and value.  Full-time students Abigail Barnes (JD ‘16) and Raza Rasheed (JD ‘15) wrote the Ninth Circuit reply brief  in the state court case against the regulatory agency, while advanced student Jason George (JD ‘15) presented oral argument at an all-day hearing in Monterey County Superior Court in the case against the water management agency.  Jason’s excellent representation spurred actions by the court and state regulators to bring the water management agency one step closer to addressing the problems caused by agricultural pollution.

Jason George MCWRA hearing

Jason George outside the Monterey County Superior Courtroom

The impacts of agriculture also formed the basis for work by advanced student Amanda Prasuhn (JD ‘15), who led research into how to limit antibiotics in factory animal farms in California.  Amanda also spearheaded research into the corporate governance and tax obligations of non-profit entities involved in the clinic’s ongoing projects.

A mix of full-time and advanced students worked on a new matter, challenging a desalination project in Cambria, on the central California coast.  Despite the need for long-term and deliberative planning about how to best manage Cambria’s spare water resources, the project was hastily built without the environmental review required by state law.  Full-time clinic students Abigail Barnes, Raza Rasheed, and Liz Jones (JD ‘16), along with advanced student Elizabeth Hook (JD ‘15), worked with clients Landwatch San Luis Obispo County, the Sierra Club, and Greenspace to write and file a petition for a writ of mandate and public record requests, as well as learn the matter’s unusually complicated factual and procedural history.  Abigail and Liz also visited the project site and represented the clients at a case management conference in San Luis Obispo Superior Court.

Students appeared at, and worked on, a number of other hearings and matters.  Advanced student Evan Stein (JD ‘15) presented oral argument in the California Court of Appeal in Sacramento.  The case concerns a challenge to the California Department of Fish & Wildlife’s annual fish-stocking program; every year, the Department stocks lakes throughout the State with non-native fish, with devastating impacts on native fish, amphibians, insects and other species.  On behalf of the Center for Biological Diversity, Evan argued before a panel of judges that the Department of Fish & Wildlife needed to conduct more thorough environmental review of the stocking program.  We expect a decision in Spring 2015.

2014-11-21 Fish stocking hearing

ELC students at the California Court of Appeal in Sacramento

Fish were also at the center of a court appearance by full-time students Rose Stanley and Philip Womble, who appeared in Marin County Superior Court to argue on behalf of clinic client Salmon Protection and Watershed Network.  In spring 2014, the clinic won a huge victory in the California Court of Appeal (briefed by former clinic students Will Cooper (JD ‘14) and Chris Jones (JD ‘14), and argued by Chris), which held that Marin County’s environmental review for a county general plan failed to adequately account for impacts of streamside development on the imperiled coho salmon.  During the fall quarter, Rose and Philip authored opening and reply briefs on the appropriate remedy and argued their cause in the trial court.

2014-12-05 Marin Coho hearing

Rose Stanley and Philip Womble at the Marin County Superior Court

Last but not least, the Environmental Law Clinic celebrated two fantastic victories in cases aimed at protecting California’s Mojave Desert.  The first case, which has been part of the clinic’s docket since its doors opened in 1997, involved a challenge to a landfill on the flanks of Joshua Tree National Park.  clinic students successfully challenged a decision by the Bureau of Land Management to convert public land into private land so the landfill could be built.  In December 2014, the parties agreed to a settlement under which the land will once again be public, and perhaps eventually become part of Joshua Tree National Park.

In the second case, the Bureau of Land Management denied an application to build a large-scale solar facility in the Silurian Valley, an unusually intact and beautiful expanse in the heart of the Mojave Desert.  Advanced student Elizabeth Hook prepared extensive comments during the decision-making process.

This winter, the clinic continues its work on many of these matters, as well as some new ones, with an unprecedented eight full-time students and ten advanced students.  We look forward to another great quarter.

MLC Co-Sponsoring Civil Rights Event with David Mills and Sherilyn Ifill

Open to the Stanford community!SLS Civil Rights Event