FDA and CDC Face Flood of Litigation After Supreme Court Ruling

By Stephanie Armour, KFF Health News

A landmark Supreme Court decision that reins in federal agencies’ authority is expected to hold dramatic consequences for the nation’s health care system, calling into question government rules on anything from consumer protections for patients to drug safety to nursing home care.

The June 28 decision overturns a 1984 precedent that said courts should give deference to federal agencies in legal challenges over their regulatory or scientific decisions. Instead of giving priority to agencies, courts will now exercise their own independent judgment about what Congress intended when drafting a particular law.

The ruling will likely have seismic ramifications for health policy. A flood of litigation — with plaintiffs like small businesses, drugmakers, and hospitals challenging regulations they say aren’t specified in the law — could leave the country with a patchwork of disparate health regulations varying by location.

Agencies such as the FDA are likely to be far more cautious in drafting regulations, Congress is expected to take more time fleshing out legislation to avoid legal challenges, and judges will be more apt to overrule current and future regulations.

Health policy leaders say patients, providers, and health systems should brace for more uncertainty and less stability in the health care system. Even routine government functions such as deciding the rate to pay doctors for treating Medicare beneficiaries could become embroiled in long legal battles that disrupt patient care or strain providers to adapt.

Groups that oppose a regulation could search for and secure partisan judges to roll back agency decision-making, said Andrew Twinamatsiko, director of the Health Policy and the Law Initiative at Georgetown University’s O’Neill Institute. One example could be challenges to the FDA’s approval of a medication used in abortions, which survived a Supreme Court challenge this term on a technicality.

“Judges will be more emboldened to second-guess agencies,” he said. “It’s going to open agencies up to attacks.”

Regulations are effectively the technical instructions for laws written by Congress. Federal agency staffers with knowledge related to a law — say, in drugs that treat rare diseases or health care for seniors — decide how to translate Congress’ words into action with input from industry, advocates, and the public.

Fragmented Health Policy

Up until now, when agencies issued a regulation, a single rule typically applied nationwide. Following the high court ruling, however, lawsuits filed in more than one jurisdiction could result in contradictory rulings and regulatory requirements — meaning health care policies for patients, providers, or insurers could differ greatly from one area to another.

One circuit may uphold a regulation from the Centers for Disease Control and Prevention, for example, while other circuits may take different views.

“You could have eight or nine of 11 different views of the courts,” said William Buzbee, a professor at Georgetown Law.

A court in one circuit could issue a nationwide injunction to enforce its interpretation while another circuit disagrees, said Maura Monaghan, a partner at Debevoise & Plimpton. Few cases are taken up by the U.S. Supreme Court, which could leave clashing directives in place for many years.

In the immediate future, health policy leaders say agencies should brace for more litigation over controversial initiatives. A requirement that most Affordable Care Act health plans cover preventive services, for example, is already being litigated. Multiple challenges to the mandate could mean different coverage requirements for preventive care depending on where a consumer lives.

Drugmakers have sued to try to stop the Biden administration from implementing a federal law that forces makers of the most expensive drugs to negotiate prices with Medicare — a key cog in President Joe Biden’s effort to lower drug prices and control health care costs.

Parts of the health care industry may take on reimbursement rates for doctors that are set by the Centers for Medicare & Medicaid Services because those specific rates aren’t written into law. The agency issues rules updating payment rates in Medicare, a health insurance program for people 65 or older and younger people with disabilities. Groups representing doctors and hospitals regularly flock to Washington, D.C., to lobby against trims to their payment rates.

And providers, including those backed by deep-pocketed investors, have sued to block federal surprise-billing legislation. The No Surprises Act, which passed in 2020 and took effect for most people in 2022, aims to protect patients from unexpected, out-of-network medical bills, especially in emergencies. The high court’s ruling is expected to spur more litigation over its implementation.

“This really is going to create a tectonic change in the administrative regulatory landscape,” Twinamatsiko said. “The approach since 1984 has created stability. When the FDA or CDC adopt regulations, they know those regulations will be respected. That has been taken back.”

Industry groups, including the American Hospital Association and AHIP, an insurers’ trade group, declined to comment.

Agencies such as the FDA that take advantage of their regulatory authority to make specific decisions, such as the granting of exclusive marketing rights upon approval of a drug, will be vulnerable. The reason: Many of their decisions require discretion as opposed to being explicitly defined by federal law, said Joseph Ross, a professor of medicine and public health at Yale School of Medicine.

“The legislation that guides much of the work in the health space, such as FDA and CMS, is not prescriptive,” he said.

In fact, FDA Commissioner Robert Califf said in an episode of the “Healthcare Unfiltered” podcast last year that he was “very worried” about the disruption from judges overruling his agency’s scientific decisions.

The high court’s ruling will be especially significant for the nation’s federal health agencies because their regulations are often complex, creating the opportunity for more pitched legal battles.

Challenges that may not have succeeded in courts because of the deference to agencies could now find more favorable outcomes.

“A whole host of existing regulations could be vulnerable,” said Larry Levitt, executive vice president for health policy at KFF.

Other consequences are possible. Congress may attempt to flesh out more details when drafting legislation to avoid challenges — an approach that may increase partisan standoffs and slow down an already glacial pace in passing legislation, Levitt said.

Agencies are expected to be far more cautious in writing regulations to be sure they don’t go beyond the contours of the law.

The Supreme Court’s 6-3 decision overturned Chevron U.S.A. v. Natural Resources Defense Council, which held that courts should generally back a federal agency’s statutory interpretation as long as it was reasonable. Republicans have largely praised the new ruling as necessary for ensuring agencies don’t overstep their authority, while Democrats said in the aftermath of the decision that it amounts to a judicial power grab.

KFF Health News is a national newsroom that produces in-depth journalism about health issues. 

Cities Sued to Make Sidewalks Accessible for Disabled People

By Maureen O’Hagan, Kaiser Health News

From her Baltimore dining room, Susan Goodlaxson can see her neighbor gardening across the street. But while other neighbors stop to chat, Goodlaxson just watches from the window. She uses a wheelchair, and there isn’t a single curb ramp on her block.

If the 66-year-old wanted to join, she’d have to jump her wheelchair down the 7½-inch curb and risk a fall. Ditto if she wanted to wheel over to the library, a trip that would require riding in the street to avoid rampless curbs and broken sidewalks.

“I don’t feel like it’s asking too much to be able to move your wheelchair around the city,” she said.

Federal law backs her up. Since 1990, the Americans With Disabilities Act has required governmental entities to provide people with disabilities access to programs and services enjoyed by their nondisabled peers. That includes sidewalks and curb ramps that make it possible to safely cross the street.

In Baltimore and many other communities across the U.S., there has been widespread noncompliance with this part of the law.

“An awful lot of [communities] have either disregarded their obligations under the ADA or made it the last priority,” noted Tom Stenson, a lawyer with Disability Rights Oregon, a nonprofit advocacy group. “There’s a culture throughout America of not taking the needs of people with disabilities seriously.”

SUSAN GOODLAXSON

In Baltimore, just 1.3% of curb ramps meet federal standards, according to the city’s own figures. In Oregon, about 9% of corners maintained by the state transportation department are compliant. San Jose, California, counted 27,621 corners with faulty or nonexistent curb ramps. Boston estimates fewer than half of its curb ramps are compliant.

Class-Action Lawsuits

In recent years, there’s been a flurry of class-action lawsuits, including one filed against Baltimore in June, with Goodlaxson among the plaintiffs.

Philadelphia was sued in 2019 over the condition of its sidewalks. Chicago was sued the same year for failure to install audible pedestrian signals, more than a decade after settling a suit over curb ramps.

In 2018, Atlanta was sued. A survey there determined that only 20% of sidewalks were in sufficient condition to be used by people in wheelchairs or motorized scooters and about 30% had curb ramps. Seattle settled a class-action suit in 2017. San Francisco and Long Beach, California, were sued in 2014 to make their sidewalks more accessible to wheelchairs.

The city of New York and its transit authority have faced repeated major ADA lawsuits, some alleging the same lack of access for people with disabilities that was supposed to be addressed in a lawsuit that was filed in the 1990s and later settled.

Los Angeles settled what is believed to be the largest of these suits in 2015. Its problems with sidewalks and curb ramps were so widespread that the city estimated it would cost $1.4 billion and take 30 years to get into compliance. In the years leading up to the suit, the city wasn’t allocating money for sidewalk repairs, for the ADA or otherwise, even while paying out millions in injury claims.

In all, hundreds of jurisdictions have faced lawsuits or entered settlement agreements after failing to meet ADA requirements for pedestrians and mass transit users.

The sheer number of noncompliant sidewalks, curb ramps, pedestrian signals and subway stations illustrates the challenges for people with disabilities.

It also leaves cities in a legal and financial squeeze, with the average curb ramp costing between $9,000 and$19,000. When the court requires a jurisdiction to build thousands of them to catch up, it can strain budgets.

Rosem Morton / for KHN

The ADA and the 1973 Rehabilitation Act resulted in significant changes that improved access and accommodations for people with disabilities. The ADA is clear that people with disabilities have the same right to pedestrian infrastructure as anyone else.

There are requirements covering a curb ramp’s width, slope and other specifications. Even a 1-inch lip can be too high for a wheelchair user to navigate. A slope that is a few degrees too steep can tip someone to the ground. Sidewalks that are crumbling, pothole-filled or otherwise obstructed — with utility poles, for example — force wheelchair users into the street for a dangerous ride.

No one expected the ADA to fix all these problems immediately. Under the law, new sidewalks must be built for accessibility. As for existing sidewalks, a federal appeals court in 1993 ruled that curb ramps must be installed or regraded when the road is altered — say, when it’s repaved.

Compliance Lags

Yet by 1999 it was clear many jurisdictions were ignoring the law. The U.S. Department of Justice began enforcement efforts, entering into settlement agreements with more than 200 non-compliant jurisdictions representing every state since 2000.

Still, compliance still lags.

Officials in Baltimore, New York and Los Angeles declined to comment for this article. Tony Snyder, manager of the Oregon Department of Transportation’s ADA program, said siloed funding sources, strict regulations and costs have been among the hurdles over the years.

“It wasn’t that ODOT doesn’t value accessibility,” he said. While fewer than 10% of the state’s ramps meet standards, he said, a lot of noncompliant ramps are nonetheless “usable.”

Kelly Lynch, deputy director and general counsel for the Montana League of Cities and Towns, an association that represents 127 municipal governments, agreed that costs can add up. She’s been working to help fellow Montanans —and, she hopes, officials in other jurisdictions across the country through the National League of Cities — find a path toward full accessibility, even if the steps are incremental.

Some changes, including educating road crews on the rules, are relatively simple. But a bigger problem is a widespread lack of spending on the nation’s infrastructure. “Our streets are falling apart, and so are our sidewalks,” Lynch said.

In August, the Senate defeated an amendment by Sen. Tammy Duckworth (D-Ill.) to a $1 trillion infrastructure bill that would have required state and local entities to describe how they would use federal dollars to improve accessibility for people with disabilities and for underserved communities. Sen. Pat Toomey (R-Pa.) called Duckworth’s amendment “politically correct virtue signaling” and argued that transit agencies don’t need that kind of federal oversight.

On top of the broader infrastructure issues, many officials don’t fully understand the ADA or its requirements, Lynch believes. And as the mother of a disabled son, she also said there’s another big factor at play: “People still discriminate against people with disabilities.”

As for Baltimore, Goodlaxson said she repeatedly called the city asking for curb cuts and sidewalk repairs. She remembers a crew coming to look at the sidewalks — and then nothing happening.

Advocacy organizations tried to negotiate with city officials, hoping to get Baltimore’s infrastructure brought into compliance on a timetable. When that didn’t work, they filed suit.

Most of these kinds of ADA cases begin similarly, with negotiations long before lawsuits. Some jurisdictions settled quickly and worked hard at improvements. Other cases go less smoothly. Oregon’s transportation department, which was also sued, is in danger of missing its construction deadlines under the settlement. Some repairs had to be redone because they still fell short of ADA requirements.

Sometimes cities try to get cases thrown out of court by pointing to the 1993 appeals court decision and arguing there’s no evidence the road has been altered since then, so ADA requirements haven’t kicked in. In New York, the transit authority argues in an ongoing lawsuit that while wheelchair users can’t ride, say, three-quarters of the city’s subways because there are no elevators, they can instead take the bus.

Some jurisdictions fight bitterly. Los Angeles spent five years in court before agreeing to settle. Linda Dardarian, one of the plaintiff’s attorneys, said cities don’t fully recognize sidewalk and curb ramp accessibility as a civil right. “They have viewed it as just another maintenance obligation, [like] grooming street trees.”

When the case was settled, the judge ordered Los Angeles to pay nearly $12 million to cover the other side’s legal fees and costs, on top of the estimated $1.4 billion it will cost to come into compliance.

Under these settlements, repairs often stretch a decade or more, and the city or town typically must pay for surveys, measurements and disability consultants to ensure compliance.

From the plaintiffs’ point of view, the challenge of these lawsuits is that there isn’t a huge hammer to hold governments accountable.

“If you don’t build the ramps, the penalty is you have to build the ramps,” said Stenson of Disability Rights Oregon, which provided legal representation to a plaintiff in the Oregon transportation department suit.

For those who can easily get around town, the issue can be invisible.

Goodlaxson didn’t see the problem until she began using a wheelchair five years ago, after surgery for a brain tumor. She remembers seeing people riding their wheelchairs in the street, thinking, “that doesn’t look safe. But I didn’t give it any more thought.”

Now, she realizes “people are terrified, but they can’t do it any other way.”

Kaiser Health News is a national newsroom that produces in-depth journalism about health issues.

The 2019 Event With Major Impact for Millions of Pain Patients

By Dr. Lynn Webster, PNN Columnist

The demise of the American Pain Society (APS) in June of 2019 was a major blow to pain patients, their providers and pain research. For 42 years, APS enjoyed an unimpeachable reputation as an academic, scholarly organization and an icon of scientific integrity.

However, with an opportunity to make billions of dollars, opioid plaintiffs' attorneys targeted professional medical organizations like APS as complicit in creating the opioid crisis. They labeled them as front organizations for deceptive opioid manufacturers and distributors.

As implausible as the claims were, it was a real problem for APS and other professional organizations and individuals who care for patients with pain. There were more than a thousand lawsuits filed against myriad defendants. I don't know the exact number of claims filed against APS, but I was named in several hundred of them.  

The plaintiffs required records about, and responses to, each claim. Complying with that many demands proved to be such a financial burden that APS could not survive. I, too, have struggled to deal with these baseless attacks on my integrity and resources.

Law firms representing over 2,000 states, counties and municipalities, along with national media, have judged and found blameworthy those who have devoted their careers to helping people in pain.

Even deep-pocketed companies such as Purdue Pharma are not always able to weather the financial and administrative burden of responding to thousands of legal claims. The manufacturer of OxyContin, Purdue Pharma filed for bankruptcy in September 2019.

It strikes me as an injustice when small organizations like APS cannot defend themselves in court due to the overpowering financial and political forces alleging spurious conspiracies and dubious claims of wrongdoing. 

In the past decade, the number of doctors and other providers who have been criminally charged for prescribing controlled substances without a legitimate medical purpose has increased dramatically. Some were appropriately charged, but others were caught up in a social fever to cast blame for the destruction that substance abuse can cause.

Providers are easy targets. It is much simpler to accuse doctors and pharmacists of wrongdoing than it would be to try to correct social disparities that drive the demand for drugs of abuse. I have attempted to defend many such providers, who eventually decided to plea bargain because of the enormous legal costs they would incur if they continued their defense.

Justice for Some

Attorney Bryan Stevenson shines a light on the naked injustices that treat the rich and guilty better than the poor and innocent in his memoir, Just Mercy. Stevenson shows that racial prejudice fuels injustice, but the lack of resources to secure adequate defense makes the process painfully unfair and the outcome predestined. 

Another injustice was in the national news some years ago. You may remember that Richard Jewell was unfairly accused of a bombing at the 1996 Atlanta Olympics. The media essentially convicted Jewell before he was charged with anything. After several months of cruel media persecution and harassment, the truth emerged and Jewell was exonerated. A movie about what happened to Jewell is currently playing in theaters. 

Veteran newscaster Tom Brokaw recently apologized for suggesting to viewers that Jewell was guilty. NBC reportedly paid Jewell $500,000 for contributing to his suffering, but this is a rare consequence when such injustices occur. APS is not likely to receive either vindication or reparations.  

Groundless accusations, media hysteria and the enormous financial backing of a false narrative exploit the weaknesses of our civil and criminal justice systems. 

Two of the most powerful forces in America are the media and the government. When they join together to fight evil, they can strengthen a democracy and serve the people well. But if they combine forces to propagate a false narrative, it is nearly impossible for the innocent to survive the damage on a personal or professional level. The catastrophic results can undermine the integrity of our legal system and free press. 

The media's framing of an issue, whether factual or not, changes attitudes and even public policies if it is repeated often enough. The media has certainly carried the water for the plaintiffs against organizations like APS. 

Most disheartening is that, in the case of APS, the harm goes far beyond the organization and its members. One hundred million Americans with pain and their families are the ultimate victims of APS's collapse. The harm will not be confined to 2019 but will extend for decades into the future.  

Lynn R. Webster, MD, is a vice president of scientific affairs for PRA Health Sciences and consults with the pharmaceutical industry. He is the author of the award-winning book, “The Painful Truth,” and co-producer of the documentary, “It Hurts Until You Die.” You can find Lynn on Twitter: @LynnRWebsterMD.

Opinions expressed are those of the author alone and do not reflect the views or policy of PRA Health Sciences.