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Will Purdue Bankruptcy Filing Resolve 'Unrelenting Chaos' Of Opioid Litigation?

 
• By Brenda Sandburg

Filing stays litigation but state attorneys general will be battling company's settlement proposal in US bankruptcy court. Details emerge on Purdue finances, rebate expenditures and litigation costs.

Purdue headquarters in Stamford
Purdue Pharma files for Chapter 11 bankruptcy to end opioid litigation

Purdue Pharma LP's filing for bankruptcy to end more than 2,000 lawsuits alleging it bears significant responsibility for the US opioid epidemic will spur a new battle with state attorneys general over whether the company can use this maneuver to implement its proposed settlement plan.

In its 15 September Chapter 11 bankruptcy filing, Purdue said it would be seeking a preliminary injunction to halt all pending actions against it by government plaintiffs

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Life After Loper: Vaping Case Shows US FDA Retains Considerable Deference

 
• By Craig Bleifer, Royce DuBiner, Max Bogost, Michael Brody, and Allyson Maur

A US Supreme Court ruling in favor of the agency in an e-cigarette case has implications for drugs and other medical products as the justices decided not to disturb the FDA’s ‘change in position’ authority, while also creating a complex new landscape.

HHS Secretary Kennedy Says Trump Will Make Final Decision On Mifepristone Policy

 
• By Derrick Gingery

With an FDA review ongoing, Kennedy’s admission, made during a Senate hearing on the Health and Human Services Department’s budget request, suggests political officials could supersede scientific decisions.

Medicare Negotiation Does Not Violate Due Process, Appeals Court Rules, Other Suits At Risk

 
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Decision in AstraZeneca’s lawsuit against the Health and Human Services Department is a precedent-setting victory for the government and a blow to manufacturer efforts to block the price negotiation program.

UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 
• By Anabel Costa-Ferreira

Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.

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US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems

 
• By Michael McCaughan

US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.

EU Moment Of Truth For Obe-Cel And 10 Other New Medicines

 
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Autolus’s CAR T therapy obe-cel is among the medicines that are this week due for an opinion by the European Medicines Agency on whether they should be marketed in the EU.

Blenrep’s Revival Gains Steam: EMA Decision Imminent As Japan Approves New Regimen

 
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The European Medicines Agency is due to decide whether GSK’s previously approved multiple myeloma drug that was withdrawn from the market in 2022 should be approved again for use in combination with BorDex or PomDex. Meanwhile, Japan today became the second major regulator to approve the Blenrep combinations.