Blister pack of pills, but instead of bills dollar bills are rolled up in the packaging

Legal Challenges to California’s Pay-for-Delay Ban

By Phebe Hong

On October 7th, toward the end of his health care “bill-signing marathon,” Governor Gavin Newsom signed bill AB 824, making California the first state to ban pharmaceutical “pay-for-delay” deals. The new law prohibits pay-for-delay deals, which is the practice of pharmaceutical companies giving “anything of value” to generic manufacturers to keep lower-cost generic versions off the market. The measure allows civil suits to be brought against pharmaceutical companies using such payment agreements to maintain monopolies for their higher-cost brand-name drugs.

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Ohio state flags waving in front of the Ohio State House

Ohio’s Efforts to Centralize Control Over Opioid Claims

By Daniel Aaron

On October 21, two Ohio counties are slated to present their opioid claims in a federal trial. However, last week, 13 states and the District of Columbia signed onto a brief requesting that the 6th Circuit Court of Appeals stay the upcoming trials. Their reasoning? States should control lawsuits for harms within the state; cities and counties do not have authority to sue on their own. While it makes sense that Ohio’s attorney general, spearheading this effort, would want more power and control over opioid claims, the move has the potential to harm public health by disempowering local governments from addressing public health crises. Ohio’s three main arguments will be discussed in turn.

Argument 1: Violation of State Sovereignty

First, Ohio argues that the county lawsuits violate state sovereignty and disrupt the “federal dual-sovereign structure” of the United States:

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Illustration of a cartoon man jumping from one oversized blister pack of pills to another

Stopping the Pharmaceutical “Product Hop”

By Phebe Hong

It happens every year like clockwork: Apple releases a new iPhone, and then hordes of people rush to buy it, despite still owning perfectly functional older models. We’re willing to shell out hundreds of dollars for a few extra camera features and new colors. As a result, Apple profits. A similar phenomenon is occurring in the drug industry, but with less consumer choice and more dire consequences.

“Product hopping” in the drug industry occurs when a pharmaceutical manufacturer winds down production of an old drug formulation whose patent expiration date has passed or is approaching. The company then forces or persuades patients to switch prescriptions to the drug’s new – and newly patented – formulation. A successful “product hop” extends a pharmaceutical manufacturer’s monopoly and therefore its ability to charge high prices.

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Photograph of Purdue Pharma headquarters

The Role of Attorneys General in the Opioid Litigation

By Daniel Aaron

People following the opioid lawsuits might have noticed some strange headlines as of late. Virtually every state’s attorney general (AG) is suing Purdue Pharmaceuticals, maker of the blockbuster drug OxyContin. Purdue filed for bankruptcy and is hoping to settle for “$10 billion.” However, the deal only includes $4.4 billion in cash, which is less than the Sackler family, owners of Purdue, transferred to personal accounts over the past decade. In other words, the amount of money the Sacklers made from the opioid epidemic is more than what they will pay more than forty states to help abate the crisis. Is anyone supporting this deal?

Yes, in fact, and this is where the plot thickens. With several exceptions, support for the deal falls along party lines: Republican AGs support the deal, and Democratic AGs oppose it. Why does a decision about settling with an opioid company appear to be political? What is the role of an attorney general? And are they supposed to defend public health?

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Photograph of a gavel and three open books

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Charlie Lee, Frazer Tessema, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

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Photograph of a stack of magazines on a chair

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Charlie Lee, Frazer Tessema, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of July. The selections feature topics ranging from the price increases of protected-class drugs in Medicare Part D, to the impact of price regulation on the availability of new drugs in Germany, to the association between FDA advisory committee recommendations and agency actions. A full posting of abstracts/summaries of these articles may be found on our website.

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New Podcast Tackles Drug Pricing, Market Power, and More

About 24 percent of adults report difficulty in affording prescription drugs, including 9 percent who report it is “very difficult” to afford them and 15 percent who report it is “somewhat difficult.” Approximately 11 percent of adults reported rationing high-priced drugs in 2017.

Recently, @Arnold_Ventures launched a new podcast, “Deep Dive with Laura Arnold,” that tackles the issue of drug prices. In its debut episode, podcast host Laura Arnold sits down with David Mitchell, founder of Patients for Affordable Drugs, who began his fight for drug pricing reform after a devastating diagnosis of an incurable blood cancer. The cost of his medicine each year: $325,000. They discuss a broken system built to serve those who make money — not those who depend on it for their health.

“Our mission is to improve people’s lives by fixing broken systems,” Arnold says. “We view drug pricing as a broken system, and not just from a theoretical perspective, but from a human perspective. We see this as a crisis in our nation. People can’t afford their drugs, and the consequences for all of us, both personally and from a societal perspective, are dire.”

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American Opioid Litigation: A Conversation with Professor Elizabeth Chamblee Burch

Professor Elizabeth Chamblee Burch

In my last post about recent developments in American aggregate opioid litigation, I teased about a future segment documenting a fantastic conversation with Professor Elizabeth Chamblee Burch. This post delivers that promise. Professor Burch is Fuller E. Callaway Chair of Law at the University of Georgia School of Law and an expert in complex litigation, mass torts, multidistrict litigation, and civil procedure.

Readers can access her impressive scholarly contributions on these topics here.

As Professor Burch elucidates in her research, the United States civil justice system has witnessed the waning of class certification cases and, concomitantly, the rise of multidistrict litigation (MDL) to resolve high-stakes, aggregate civil disputes.

This trend includes the massive national multidistrict litigation currently pending in the United States District Court for the Northern District of Ohio (Opioid MDL). Unlike class certification litigation, which is governed by Federal Rule of Civil Procedure 23, the MDL process is subject to the 1968 Multidistrict Litigation ActRead More

The Funding Effect: How Drug Manufacturers Design Clinical Trials to Produce Favorable Results

By Ryan J. Duplechin

Many consumers are unaware that the U.S. Food and Drug Administration (“FDA”) does not test drugs in the approval process. Instead, drug manufacturers test their drugs and submit their own results to the FDA for review. Hoping to convince the FDA and investors of the safety and effectiveness of their new drug, manufacturers go to great lengths to report positive results in clinical trials. Read More

Recent Developments in Opioid Litigation: A Re-Cap, Visual Aid, and Summary of Outstanding Inquiries

Media reports suffered no shortage of hot takes concerning opioid “arch-villain” Purdue Pharma’s agreement to pay $270 million to settle its OxyContin lawsuit in Oklahoma. The highlights of that settlement include Purdue’s payment of $102.5 million to fund a new Center for Addiction Studies and Treatment at Oklahoma State University, $60 million for attorney’s fees and litigation expenses, $20 million worth of drugs to treat opioid use disorder, and $12.5 million to cover the opioid-related costs incurred by Oklahoma’s local governments. Members of the Sackler family, who were not named as defendants in the litigation, also agreed to contribute an additional $75 million to Oklahoma over a five-year period.

A noteworthy concentration of the media coverage dedicated to Purdue’s Oklahoma settlement has involved speculation regarding its potential impact on the numerous outstanding opioid cases in other states as well as the myriad federal cases aggregated in the opioid multidistrict litigation (Opioid MDL) before the United States District Court for the Northern District of Ohio. The New York Times, for example, was quick to claim that the Oklahoma resolution “could jolt other settlement talks with [Purdue], including those in a consolidated collection of 1600 cases overseen” in the Opioid MDL. The Wall Street Journal similarly reported that “Purdue Pharma LP has forged the first deal to resolve more than 1,600 lawsuits blaming the OxyContin maker for fueling the opioid crisis, a move that could lay the groundwork for the resolution of the rest of the litigation.”

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