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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CHICAGO, ILLINOIS, USA - JUNE 8, 2019: First ever Medicare for All rally led by Bernie Sanders held in The Loop of Chicago. Crowd holds up a sign that says "Medicare for All Saves Lives".

Sustaining the Promise of Universal Access

By David Orentlicher

Should the United States achieve universal access to health care by adopting a single-payer, Medicare-for-All kind of system? Or should we build on the Affordable Care Act (ACA) and not disrupt the health care coverage of the 160 million Americans who have private health insurance?

Both reforms rely on important arguments about affordability, feasibility, and consumer choice. But there is one key reason to favor a single-payer system over an expansion of our current system. Experience with public benefit programs in the United States tells us that such programs thrive only when they serve all Americans.

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Hand placing wood toy block on top of a tower. The blocks all have images of medical-related items on them, like pills, stethoscope, syringe

Lost in the Jungle of Patient Safety Reports, Publications and Initiatives?

By John Tingle

In terms of the progress of developing a patient safety culture in the National Health Service (NHS) in England, the Daily Telegraph reports comments made by Professor Ted Baker, the Chief Inspector of Hospitals at the Care Quality Commission (CQC) at a recent conference in London. He held the view that “little progress” has been made improving patient safety in the NHS in 20 years, and that never events such as wrong site surgery were still happening because the overall culture is one of defensiveness. The Telegraph reported, “He told The Patient Safety Learning conference that hospital managers routinely hide evidence from the CQC, because they regard the organisation as out to blame them.”

The Telegraph also mentions an NHS estimate in July that 11,000 patients a year may be dying as a result of blunders, partly as a result of a “blame game” culture between staff.

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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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Black and white photograph of the front of the Supreme Court. Pro-abortion protestors stand holding signs, one of which reads "I stand with Whole Woman's Health"

Challenging the Contours of the “Undue Burden” Standard in June Medical Services v. Gee: A Slippery Slope?

By Beatrice Brown

On October 4, the Supreme Court announced that it would hear June Medical Services v. Gee, in which a 2014 Louisiana law that requires abortion providers to have admitting privileges at a nearby hospital will be examined. The case is nearly identical to Whole Woman’s Health v. Hellerstedt, in which the Supreme Court held that a Texas law with a similar requirement for admitting privileges was unconstitutional according to the “undue burden” standard asserted in the landmark 1992 case Planned Parenthood v. Casey. According to the 5-3 ruling, such requirements for admitting privileges posed an undue burden on a woman’s constitutional right to abortion without also providing a significant health benefit to the woman.

As noted by many experts, the two cases are remarkably similar, with the key difference being the composition of the Supreme Court. In 2016, Justice Anthony Kennedy joined the four liberal judges in the majority opinion, whereas now, Justice Brett Kavanaugh will likely join the four other conservative justices. The uncertain factor, however, is that in February, Chief Justice John Roberts voted with the majority opinion to delay the Louisiana law from going into effect in light of ongoing litigation, despite voting against the majority in Whole Woman’s Health v. Hellerstedt about the constitutionality of this similar Texas law. As such, it is unclear if the Court will hold that the Louisiana law is constitutional – given that Justice Kavanaugh will likely vote for its constitutionality, the direction of the ruling hinges on whether Justice Roberts votes as he did in Whole Woman’s Health v. Hellerstedt or as he did in February. Read More

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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Pipette and test tubes in a rack

Novartis, Dana Farber, Oregon Health & Science University Wait 18 Years to Disclose NIH Funding in Key Gleevec Patent

By James Love

This is a story about U.S. patent number 6,958,335, and how it took more than 18 years for Novartis to acknowledge National Institutes of Health (NIH) funding in a key patent for Gleevec, allowing Novartis to shape the narrative regarding its role in the development of Gleevec, and also to avoid demands that Novartis make the invention “available to the public on reasonable terms,” which is an obligation under the Bayh-Dole Act.

On May 10, 2001, the United States FDA approved a new drug, imatinib, initially for the treatment of a rare indication: chronic myeloid leukemia (CML). The drug was registered by Novartis, which sold the drug under the brand name Gleevec in the United States and several other markets, and as Glivec in others.

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Couple sitting on a couch, leaning forward to have a serious conversation with a doctor or counselor

Genetic Testing: Is There a “Duty to Warn” At-Risk Family Members?

By Shelly Simana

Genetic information is quite distinguishable from much medical information due its familial nature and its unique ability to predict future health. The fact that genetic testing supplies comprehensive information about the genetic make-up of patients and their family members underlies the ethical and legal challenges faced by physicians and patients when deciding whether to disclose genetic information to family members. Failure to disclose information may “lead to harm, particularly when knowledge could result in avoidance, treatment, or prevention of a genetic condition or in significant changes to reproductive choices or lifestyle.” Due to the potential harm, one may ask herself if there is a legal “duty to warn” family members about the presence of defective genes, and if so, upon whom should it be imposed.

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Female gynecologist talking to female patient while holding a tablet

How to understand the Mexican Supreme Court Decision Regarding Abortion Based on Health Risks

Friday, October 4, the Petrie-Flom Center will host “Abortion Battles in Mexico and Beyond: The Role of Law and the Courts,” from 8:30 AM to 12:30 PM. This event is free and open to the public, but registration is required. 

By Adriana Ortega Ortiz

In Mexico, abortion is a state-law matter. It is considered a crime in most of the Mexican states except for Mexico City and Oaxaca where abortion is permitted within the first trimester of the pregnancy.

In the rest of the states abortion is allowed under limited legal indications: rape, health risks, danger of death, fetal impairment, and distressing economic situations. The legal indications are similar but not identical in the Mexican territory. The only legal indication for abortion that applies in every state is rape.

In this context, what makes the recent abortion ruling of the Mexican Supreme Court important?

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Black and white photograph of a gavel in front of scales of justice

Big Ruling in Philadelphia: The Controlled Substances Act does not forbid a safe drug consumption room

By Scott Burris

Federal District Judge Gerald McHugh of the Eastern District of Pennsylvania ruled today that the operation of a safe injection site to prevent overdose, HIV, and other harms associated with drug injection would not violate the federal Controlled Substances Act.  The ruling came in an action for declaratory and injunctive relief brought by the local U.S. Attorney, seeking to prevent the opening of “Safehouse” by a private group led by former Pennsylvania Governor and Philadelphia Mayor Edward G. Rendell. The judge denied the requested relief.

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