Healthy liver and donation.

Here's a sobering thought as I'm mid-way through Dry January: There are more than 13,000 people on the waitlist for a liver transplant—and until now, if you happened to live in New York or California, it could take several years for your turn to come up (assuming you don't die first).

But other people—less sick people—who live in parts of the Midwest or the South have been able to get liver transplants in a few weeks or months.

Litigators from Boies Schiller Flexner have been at the forefront of challenging this system, pushing to remove arbitrary geographic distribution criteria so that donated livers go to the sickest candidates first. 

Last week, Boies Schiller partner Motty Shulman, counsel Evelyn Fruchter and associate Reed Forbush won an important victory in Atlanta federal court alongside lawyers from the Department of Justice, Winston & Strawn and Gordon Rees Scully Mansukhani. 

Their mission: to defend a new liver allocation policy by the U.S. Department of Health and Human Services and the United Network for Organ Sharing against a challenge by lawyers from Jones Day, who represent major hospitals and transplant centers in the South and Midwest, as well as individual transplant patients who fared better under the old system of allocation.

In a 100-page opinion rejecting the plaintiffs' request to enjoin the new policy, U.S. District Judge Amy Totenberg on Jan. 16 called the case "difficult and wrenching" and described the litigation as "deeply contentious."

"The court is mindful that this is just one clash in an ongoing struggle to shape national organ transplant policy and that all parties involved view the issues as involving life and death consequences," she wrote.

Boies Schiller got involved on the frontlines of organ donor litigation in 2017, when the firm working pro bono sued the government on behalf of 21-year-old Miriam Holman, who desperately needed a lung transplant.

The system for allocating lungs was similar to the one for livers—that is, the organs were offered first to people who lived in the same geographic "donation service area" as the deceased donor, even if those people weren't as sick as others who lived outside the area.

The Boies Schiller lawyers led by Shulman argued these geographic boundaries were arbitrarily drawn—some areas are enormous, while others are tiny—and contravene the National Organ Transplant Act of 1984, which mandates equitable distribution of donated organs on a nationwide basis.

Miriam Holman, for example, was registered to get a lung transplant at New York City's Columbia University Medical Center. If lungs became available across the Hudson River in Fort Lee, New Jersey—a three-mile drive from the hospital, but in a different donation service area—all suitable candidates in Northern and Central New Jersey would get first dibs, even if they weren't nearly as sick as Holman and lived hours away from Fort Lee.

The lung suit was successful. After Homan made an emergency appeal to the U.S. Court of Appeals for the Second Circuit, the government in late 2017 immediately scrapped the donation service area policy for lungs. In its place, it adopted an interim rule giving priority to candidates who live within a radius of 250 nautical miles from the donor hospital.

On the heels of the win, Shulman and the Boies Schiller team promptly turned their attention to donated livers. No longer working pro bono, they were retained by the Greater New York Hospital Association, which represents over 160 hospitals and numerous liver transplant centers in New York.

Liver transplants are bigger business than lungs, with about 8,000 procedures (versus 2,000 for lungs) performed each year, according to the American Liver Foundation. 

Indeed, the Boies Schiller lawyers assert that transplant centers in donation service areas with shorter wait times—including the plaintiffs in the Atlanta suit—exploit the current policy, encouraging "those with financial resources to engage in domestic transplant tourism. Unfortunately, for liver waitlist candidates around the country, the current policy is often fatally flawed because they do not have the financial means to move to areas of the country with shorter wait times." (Apple CEO Steve Jobs, for example, lived in California but got a liver transplant in 2009 in Tennessee—the same year he bought an $850,000 house in Memphis.)

In 2018, the Boies Schiller team filed suit in the Southern District of New York on behalf of Wilnelia Cruz, (who subsequently died of liver failure) and five other people in New York, California and Massachusetts who were waitlisted for livers.

"Plaintiffs are not looking for any special treatment. They only ask that available livers be allocated by medical priority as required by [Organ Procurement and Transplantation Network] policy and legislative mandate," Shulman wrote. 

Donated livers remain viable for 12 hours after being harvested—they're portable, and have been successfully transported across the county. "Neither a transplant center's financial gain nor 'local first' allocation is an appropriate or legally supportable basis for organ distribution," the Boies Schiller lawyers argue.

In response, the government moved to adopt a new policy that did away with donation service areas for livers. Instead, they propose a system of "acuity circles," which use circular boundaries of 150, 250 and 500 nautical miles from the donor hospital to prioritize liver allocations.

The Jones Day plaintiffs—hospitals in the Midwest in South and four patients awaiting transplants—sued to challenge the new acuity circle policy, arguing it was arbitrary and capricious, in violation of the Administrative Procedure Act, and that it also ran afoul of the due process clause.

They claim that the new policy will result in "at least 20% fewer liver transplants being performed in the most socioeconomically disadvantaged regions in the country," as well as livers being "misdirected and tossed away … rather than being used for the life-saving purpose intended by their generous donors," wrote Peter Canfield of Jones Day.

The Boies Schiller team counters that the new policy will save at least 140 more lives in the first year alone.

In a detailed opinion, Totenberg sided with the Boies Schiller team, allowing the new policy to go into effect.

"The court's role in this case is not to determine which policy is best, but whether the policymakers in question acted at very least within legal requirements—that their adoption of the new liver allocation policy was not arbitrary or capricious or in violation of plaintiffs' procedural due process rights," she wrote. "The court holds today that defendants met this basic threshold legal standard. The court also recognizes, however, the profound issues and institutional disruption created by defendants' handling of this policy change."

Shulman in an emailed comment applauded the ruling. "The new liver allocation policy will benefit all liver waitlist candidates and we are pleased to be a driving force in bringing equitable organ allocation to patients across the country," he said. "The court once again refused to enjoin the new policy and we look forward to the improved policy going into effect as soon as possible."