What's Happening

After nearly a decade of litigation and roughly $50 billion in opioid settlements, the massive U.S. opioid litigation is moving into another important legal fight.

A federal judge in Ohio, U.S. District Judge Dan Aaron Polster, allowed hundreds of plaintiffs to add two major pharmacy benefit managers, Optum Rx and Express Scripts, as defendants to their cases, even though the deadline for amending most lawsuits had passed years earlier.

The two companies are now appealing that decision to the 6th U.S. Circuit Court of Appeals in Cincinnati. They argue that Judge Polster improperly handled hundreds of cases together instead of determining whether each individual plaintiff had met the requirements for amending its lawsuit. (Reuters)

The appeal could have consequences beyond the opioid litigation. At issue is how much flexibility federal judges should have when managing enormous multidistrict litigation (MDL) proceedings involving hundreds or thousands of plaintiffs.

The Opioid Litigation Has Been Going On for Nearly a Decade

The nationwide case began in 2017

The opioid litigation began in 2017, when local and state governments and other plaintiffs began bringing lawsuits against companies they accused of contributing to the opioid crisis.

Over time, the litigation expanded dramatically and became one of the largest collections of coordinated mass-tort cases in U.S. history.

Many of the industry's largest participants, including drugmakers, opioid distributors and pharmacy chains, have already reached settlements over allegations concerning their roles in the crisis. (Reuters)

The litigation has now generated approximately $50 billion in settlements.

More than 800,000 People Have Died From the Crisis

The scale of the public-health emergency

The scale of the underlying public-health crisis remains enormous.

The CDC has reported that the opioid crisis has been associated with more than 800,000 deaths in the United States since 1999. (Reuters)

That is why the litigation has involved not only enormous financial claims but also questions about responsibility for how addictive medications were manufactured, distributed, prescribed and managed.

Optum Rx and Express Scripts Are Now Major Targets

The companies are pharmacy benefit managers

The two companies at the center of the appeal are Optum Rx and Express Scripts, both major pharmacy benefit managers, or PBMs.

PBMs manage prescription-drug benefits for health plans and perform functions such as processing claims for prescription medicines.

The plaintiffs now accuse the companies of contributing to the opioid crisis by allegedly colluding with drugmakers and helping promote opioids, which plaintiffs say contributed to oversupply of addictive medications in communities. (Reuters)

Both companies deny wrongdoing.

Optum Is Owned by UnitedHealth Group

Scale within the healthcare ecosystem

Optum Rx is part of UnitedHealth Group.

UnitedHealth generated $154.7 billion in revenue in 2025, giving Optum significant scale within the U.S. healthcare system. (Reuters)

Express Scripts was acquired by Cigna for $54 billion in 2018.

The involvement of two companies of this size means the outcome could have major financial and strategic implications.

About 800 Plaintiffs Were Allowed to Add the PBMs

Municipalities and government entities join the suit

Judge Polster allowed approximately 800 plaintiffs to amend their complaints to add Optum and Express Scripts.

Those plaintiffs include municipalities and other government entities ranging from small communities such as Cherokee, Alabama, to large cities including Detroit and Cleveland. (Reuters)

The defendants argue that the judge should have assessed each plaintiff separately rather than allowing the amendments through a coordinated process.

That procedural distinction is the central issue in the appeal.

The Original Deadline Had Passed Years Earlier

A five-year gap between deadlines and amendments

Judge Polster had established March 16, 2019 as the deadline for most litigants to make changes to their lawsuits.

The plaintiffs did not seek permission to add Optum and Express Scripts until 2024, roughly five years after that deadline. (Reuters)

Plaintiffs' lawyers argued that information discovered later in litigation justified the delay.

They specifically pointed to information produced during litigation involving Jefferson County, Missouri, which they said provided new insight into the role of the PBMs in the opioid crisis. (Reuters)

The defense disputes that explanation.

Federal Rules Generally Require Good Cause for Late Changes

Rule 15 and Rule 16 are at the center of the dispute

Two Federal Rules of Civil Procedure are especially important here.

Rule 15 generally allows courts to permit amendments to lawsuits when justice requires.

Rule 16 requires a party seeking to change a case after an established scheduling deadline to demonstrate good cause for failing to comply with that deadline. (Reuters)

Defense lawyers from Sullivan & Cromwell, Alston & Bird, and Quinn Emanuel argue that Judge Polster should have applied those standards to each of the approximately 800 cases independently.

Their position is that many of the plaintiffs may not meet the legal requirements for adding the PBMs so late in the litigation.

Judge Polster Said Individual Review Would Require “Colossal Resources”

The scale of the MDL drove his approach

Judge Polster acknowledged the enormous administrative burden of reviewing every request separately.

He said conducting a case-by-case analysis would require “colossal resources” and would undermine the efficiency goals of the multidistrict litigation process. (Reuters)

Instead, he issued a series of rulings addressing issues common to the plaintiffs and ultimately allowed the 800 amended complaints.

This is precisely what the PBMs are challenging.

They argue that efficiency cannot justify bypassing procedural rules that apply to federal civil cases.

The Appeal Raises a Larger Question About MDL Courts

Balancing judicial efficiency and individualized legal rights

Multidistrict litigation allows related cases to be coordinated before one federal judge.

The goal is to prevent repetitive discovery and resolve common issues more efficiently.

But MDLs can become enormous, creating tension between judicial efficiency and individualized legal rights.

The current appeal asks where the line should be drawn.

If judges have broad discretion to modify ordinary procedures whenever a case becomes sufficiently large, mass litigation could potentially move faster.

But if the rules must be applied strictly on an individual basis, large MDLs could become considerably more difficult and expensive to manage.

The Sixth Circuit Has Already Warned Judge Polster About This

A similar dispute happened in 2020

This is not the first time the 6th Circuit has criticized Judge Polster's procedural approach in the opioid litigation.

In 2020, the appeals court reversed him after he allowed two Ohio counties to add untimely claims. (Reuters)

In that ruling, the court emphasized that MDL proceedings do not operate outside the normal Federal Rules of Civil Procedure.

The defense is now asking the same appeals court to reinforce that principle.

That history makes the latest appeal particularly significant.

The Defense Says the Plaintiffs Had Relevant Information Earlier

Disputing the justification for delay

Lawyers representing Optum and Express Scripts say plaintiffs and their attorneys had access to relevant documents about the PBMs as early as July 2018. (Reuters)

If true, that could weaken plaintiffs' argument that newly discovered information justified waiting until 2024 to seek amendments.

The defense position is therefore not simply that the plaintiffs were late, but that they were late without sufficient justification.

The Plaintiffs Say Later Evidence Changed the Picture

New information is their main justification

Plaintiffs' lawyers argue that litigation over the opioid crisis continued producing important evidence after the original deadline.

They say documents uncovered through other lawsuits changed their understanding of the PBMs' potential role.

That argument goes to the heart of Rule 16's good-cause standard.

If later-discovered evidence materially changes what plaintiffs know about a potential defendant, a judge can have more reason to permit an otherwise late amendment.

The appeals court will have to determine how that principle applies to hundreds of cases simultaneously.

The PBMs Argue They Could Still Face the Lawsuits

Winning the appeal would not necessarily end the litigation

An important point is that Optum and Express Scripts are not necessarily seeking to escape all litigation permanently.

Even if the 6th Circuit rules that Judge Polster improperly allowed the mass amendments, the plaintiffs could potentially seek permission individually and attempt to satisfy the applicable procedural requirements.

The immediate effect would likely be to create additional hurdles and delay the process. (Reuters)

That could nevertheless be highly significant because delaying the cases could reduce settlement pressure on the defendants.

Settlement Pressure Is an Important Part of the Fight

Timing can influence negotiations

The opioid litigation has already produced enormous settlements.

If the PBMs are allowed to remain as defendants in hundreds of cases simultaneously, they could face substantial litigation costs and potentially greater pressure to negotiate settlements.

If the appeals court makes plaintiffs start over or prove their claims individually before adding the PBMs, that pressure could ease.

The procedural ruling could therefore have a meaningful impact on the economics of the cases even without deciding whether the underlying allegations against the PBMs are true.

Business Groups Are Watching the Case Closely

The U.S. Chamber of Commerce supports the PBMs

The U.S. Chamber of Commerce filed an amicus brief supporting Optum and Express Scripts.

The Chamber warned that allowing MDL judges to depart from ordinary procedural rules could have “devastating” effects on American businesses and the national economy. (Reuters)

The Chamber also noted that MDLs now account for nearly two-thirds of all private civil litigation in federal court.

That statistic explains why a procedural decision in one opioid case could have consequences for companies involved in mass litigation across many industries.

Mass-Tort Cases Are Becoming Increasingly Important

MDLs now dominate federal private litigation

The opioid proceeding is an example of a broader legal trend. MDLs bring together large numbers of cases involving similar allegations and common factual or legal questions. They are particularly common in areas such as:

  • Pharmaceuticals
  • Medical devices
  • Consumer products
  • Environmental exposure
  • Mass personal injury claims

Because these cases can involve thousands of plaintiffs, decisions about how judges manage them can significantly affect companies facing mass claims.

The Case Also Shows How Healthcare Responsibility Can Be Distributed

The complex network of the opioid crisis

The opioid crisis involved a complex network of participants:

  • Drugmakers manufactured medications.
  • Distributors moved them through the supply chain.
  • Pharmacies dispensed them.
  • PBMs processed prescription-benefit claims.
  • Doctors prescribed them.
  • Insurers and healthcare systems paid for or managed treatment.

The litigation increasingly asks where responsibility should fall within that system. The claims against Optum and Express Scripts represent an effort by plaintiffs to extend accountability beyond the companies traditionally associated with opioid manufacturing and distribution.

The Underlying Allegations Are Still Unresolved

The appeal is procedural, not a ruling on fault

It is important to distinguish the current legal fight from the underlying claims.

Optum and Express Scripts deny that they contributed to the opioid crisis.

Optum has said it did not contribute to the crisis and instead has been a leader in fighting opioid abuse. Express Scripts has declined to comment on the Reuters article. (Reuters)

The current appeal therefore does not determine whether those allegations are true.

It asks whether Judge Polster had the authority to allow plaintiffs to add the companies in the manner he did.

The Sixth Circuit Has Asked for Responses

The appeals court is taking the challenge seriously

Mandamus petitions, which ask an appeals court to intervene before a case reaches final judgment, are rarely granted.

But the Sixth Circuit has ordered the plaintiffs' lawyers to respond and has also invited Judge Polster to respond by September 15. (Reuters)

That does not mean the PBMs have won.

It does, however, show that the court is giving the procedural challenge substantial consideration.

Why This Matters

The significance of the appeal goes far beyond Optum and Express Scripts.

At the most basic level, it asks how federal courts should balance efficiency against procedural fairness when handling enormous healthcare-related mass-tort cases.

A ruling that gives MDL judges broad flexibility could make it easier to manage thousands of cases collectively.

A ruling requiring stricter case-by-case compliance could make mass litigation slower and more expensive, but could also strengthen the role of ordinary procedural safeguards.

Because MDLs represent such a large share of federal civil litigation, the precedent could affect businesses well beyond the opioid industry. (Reuters)

Looking Ahead

September 15 deadline and next steps

The immediate deadline is September 15, when the plaintiffs' lawyers and Judge Polster are expected to respond to the Sixth Circuit.

The appeals court will then determine whether to intervene in the proceedings.

If the court sides with Optum and Express Scripts, plaintiffs could face additional procedural hurdles before the PBMs can remain defendants in the hundreds of cases.

If the court allows Judge Polster's approach to stand, the opioid litigation could proceed more efficiently toward the merits of the allegations against the PBMs.

Either outcome could influence how future federal judges manage enormous multidistrict proceedings involving healthcare companies.

Key Takeaways

  • The U.S. opioid litigation has produced roughly $50 billion in settlements after nearly a decade of lawsuits. (Reuters)
  • A federal judge allowed about 800 plaintiffs to add Optum Rx and Express Scripts as defendants.
  • The plaintiffs allege the PBMs helped promote opioids and contributed to oversupply, allegations both companies deny. (Reuters)
  • The plaintiffs' amendments came roughly five years after the March 2019 deadline for most case changes.
  • Optum and Express Scripts argue that the judge should have reviewed each plaintiff's request individually.
  • Judge Polster said individual review would require “colossal resources” and would undermine MDL efficiency. (Reuters)
  • The defense says relevant information about PBMs was available as early as July 2018.
  • Plaintiffs say later evidence, including documents from other litigation, gave them new insight into the PBMs' role.
  • The 6th Circuit previously reversed Judge Polster in 2020 over another procedural decision in the opioid MDL. (Reuters)
  • The U.S. Chamber of Commerce warned that excessive judicial flexibility in MDLs could have broad economic consequences.
  • MDLs now account for nearly two-thirds of private civil litigation in federal court, according to the Chamber. (Reuters)
  • The 6th Circuit has asked the plaintiffs' lawyers and Judge Polster to respond by September 15.
  • The immediate dispute is procedural, not a ruling on whether Optum or Express Scripts are actually responsible for the opioid crisis.

What This Means for Healthcare Marketers

The most relevant signal here is the way major litigation can reshape healthcare organizations, markets and decision-making even before a final judgment.

The opioid cases involve PBMs, insurers, drugmakers, distributors, pharmacies and healthcare providers, showing how interconnected the U.S. healthcare system is. A major court decision involving one part of that network can eventually affect contracts, risk management, compliance spending and business strategy across the ecosystem.

For healthcare marketers, this reinforces the importance of tracking legal exposure, regulatory developments and organizational changes alongside conventional market signals. A company facing significant litigation may change its priorities, budgets, partnerships or purchasing behavior well before the case is finally resolved.