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Saturday, October 19, 2019

PHARMACEUTICAL INDUSTRY


Oklahoma Lands in Historic Settlement with OxyContin Maker
Oklahoma notched a historic win on March 26, 2019 by forcing an out-of-court settlement with OxyContin maker, Purdue Pharma, resulting in $270 million in disbursement to the state to fight against the alarming opioid crisis. The Oklahoma Attorney-General Mike Hunter filed suits against three opioid makers in June 2017. The other two are Johnson and Johnson and Teva Pharmaceutical. Under the $270 million settlement, Purdue will immediately give $102.5 million to establish a foundation at the Oklahoma State University for addiction treatment and research. Sackler family, owner of the company, but not defendant in this case, will provide too $75 million over five years. However, separate lawsuits, numbering about 1,600, filed by the states, municipalities and individuals are still pending against the Purdue Pharma.

Teva Reaches Settlement with Oklahoma
Days before trial begins related to unethical marketing of painkillers by some of the well-known drug manufacturers, including Johnson and Johnson, and almost two months after extracting a similar, but larger, deal from OxyContin maker, Purdue PharmaOklahoma Attorney-General Mike Hunter on May 26, 2019 secured another high-profile settlement, this time with Teva Pharmaceuticals, maker of many of the generics. The price tag of the Teva deal is $85 million.

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Purdue Pharma Reaches a Tentative Deal
Purdue Pharma is reported on September 11, 2019 to have reached a multi-billion deal with 22 states and more than 2,000 cities that would force the OxyContin maker to file for bankruptcy and resurrect as a trust focused on fighting against opioid crisis. The Stamford, Connecticut-based company announced a $270 million settlement in March with Oklahoma and won a victory against North Dakota. In 2007, Purdue pleaded guilty along with three of its executives on misleading doctors about OxyContin and paid $635 million. The deal is estimated to be between $10 billion and $12 billion in price tag, including $3 billion from its founder Sackler family. The settlement is separate from a behemoth federal case, known as multidistrict litigation, or MDL, against the pain killer makers that will begin in October 2019 in Cleveland.

Purdue Files for Bankruptcy
The OxyContin maker Purdue Pharma on September 15, 2019 filed for Chapter 11 bankruptcy as part of a highly publicized settlement plan. Under the potential settlement, the founding Sackler family will give up the control over company and the company will be resuscitated as "public benefit trust". Local governments and 24 states have agreed to the settlement, but 24 other states have rejected the settlement too.

Purdue to Settle Opioid Lawsuit for $8 billion 
The OxyContin maker is to plead guilty to three federal criminal charges, including kickback and defrauding deferral government, as part of an $8 billion settlement announced on October 21, 2020 by the U.S. Department of Justice. The settlement plan will be introduced to the bankruptcy court where Purdue Pharma has filed its Chapter 11 reorganization plan. The settlement does not preclude future criminal prosecution against any former Purdue executive or founding Sackler family. However, some Democratic-ruled states and jurisdictions took strong exception to how this settlement was being rushed into. Their frustration was reflected during the day by Massachusetts Attorney-General Maura Healy, who vowed to expose the truth.

Settlement with OxyContin Maker Conditionally Approved by the Bankruptcy Judge
A federal bankruptcy court judge on September 1, 2021 said that he would give approval for a $10 billion settlement that Purdue Pharma had reached with the state and local governments, Native American tribes, unions and others. There are two minor changes that need to be made in the settlement, and U.S. Bankruptcy Judge Robert Drain is going to approve the deal after those changes are made, most likely on September 2, 2021. Under the deal:
* Sackler family has to get out of the opioid business altogether and contribute $4.5 billion in exchange for immunity from future opioid overdose-related lawsuits
* Purdue Pharma will transform itself into a non-profit company, with all the profits going to treatment and remediation
* Purdue's board will be appointed by public officials
* Settlement funds will be created for compensations to individual victims and their families, with amount ranging from $3,500 to $48,000
* Close to 3,000 lawsuits will be dissolved as part of the settlement

New Settlement Reached after Sackler Family ups Their Monetary Contribution
After eights states--California, Maryland, Connecticut, Delaware, Oregon, Rhode Island, Vermont and Washington--and the District of Columbia rejected the previous settlement, Purdue Pharma on March 3, 2022 reached a new nationwide settlement with state, city and local authorities. Under the more than $10 billion settlement deal, Sackler family will chip in $6 billion, marked increase from the previous deal, in exchange for immunity from future civil, not criminal, lawsuit. Sacklers will also give up stakes in Purdue Pharma

Supreme Court Voids OxyContin Settlement
The U.S. Supreme Court on June 27, 2024 tossed out the opioid settlement that committed Sackler Family to $6 billion in payment in exchange for legal immunity. The 5-4 verdict injects uncertainty into the overall picture of how this deal will be enforced, or even changed. The U.S. Justice Department filed an amicus curiae, or friend of the court, brief, opposing the settlement that had a provision involving nonconsensual third-party release. The provision forces non-consenting victims to accept the settlement if majority of the victims do support the deal. 
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Pharma Companies to Recoup Billions over Drug Overdose Settlement
A February 12, 2021, report on Washington Post analysis of four pharmaceutical giants that had agreed to pay a combined $26 billion in opioid overdose settlement fund found that all four were taking advantage of a corporate loophole embedded in the Coronavirus aid package passed last year. Congress allowed corporations as part of last year's Coronavirus aid package to seek tax break by taking advantage of so called "net operating loss carryback". On the average, according to the Washington Post analysis, four biggies--Johnson & Johnson, McKesson, AmerisourceBergen and Cardinal Health--will reap about $1 billion in tax relief. 

J&J Agrees to Pay $230 million to Avoid Trial by NY AG 
Johnson and Johnson on June 26, 2021 agreed to settle the case with New York Attorney-General Letitia James for $230 million in charges related to opioid deaths. As part of the deal, in addition to paying $230 million, the pharmaceutical giant agreed to stop manufacturing and distributing opioids in New York state and beyond.

********************************** $26 billion Opioid Settlement
Potential Multibillion Dollar Settlement Reached in Opioid Overdose Cases
Long a dream of lawyers representing the states and local authorities, the lawyers' group representing the local authorities, Plaintiffs' Executive Committee, on July 20, 2021 announced that a $26 billion deal had been arrived at between the lawyers representing the local authorities and three largest drug distributors--AmerisourceBergen, Cardinal Health and McKesson--and Johnson & Johnson. Under the deal, J&J will not produce opioids for at least a decade. The final amount may go down if states do not opt in this deal. J&J will contribute about $5 billion to this deal. According to the draft of the deal, the money will be paid over 18 annual installments, with first few years accounting for bulk of the pot. Billions of dollars are to be reaped in by the attorneys, but tens of billions of dollars will still be used for mitigation and treatment purpose in an epidemic that has touched almost all the parts of the U.S. and cost, according to the Society of Actuaries, $630 billion between 2015 and 2018. The White House Council of Economic Advisors has estimated the broader toll of the opioid--which includes both prescribed pain-killers as well as illicit drugs such as heroin and fentanyl--on families and communities at around $500 billion per year. According to a tally published by The Associated Press, at least $40 billion in settlements, fines and penalties have either been concluded or proposed since 2007. 

Four Drug Giants to Go Forward with $26 billion Settlement
Three largest drug distributors--AmerisourceBergen, Cardinal Health and McKesson--and Johnson & Johnson confirmed on September 4, 2021 that they would go forward with the settlement after they had received notification of buy-ins from at least 42 states. September 4, 2021 was the last date to obtain the buy-in. 

$26 billion Settlement Finalized
After a critical number of plaintiff states, cities and local jurisdictions joined the settlement by the cutoff date of February 25, 2022, the $26 billion settlement seemed finalized at last. 
********************************** $26 billion Opioid Settlement


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Washington Takes the Drug Distributors to Trial over Opioid Overdose Crisis
Spurning a $500 million settlement offer, Washington State Attorney-General Bob Ferguson on November 15, 2021 argued before King County Superior Court Judge Michael Ramsey Scott that "these companies knew what would happen if they failed to meet their duties". The case, a very high-stake gamble, will be observed by legal scholars as it is the first case against the three largest drug distributors--AmerisourceBergen, Cardinal Health and McKesson--to go to trial. Going to trial does not always yield the best outcome for the plaintiffs as a court in California has ruled against three California counties this month. In the California trial, Orange County Superior Court Judge Peter Wilson issued a tentative ruling on November 1, 2021, saying that the counties and the city of Oakland could not show that the pharmaceutical companies had used deceptive marketing practices to increase Opioid use and cause "public nuisance". Recently, Oklahoma Supreme Court ruled against a lower court verdict of $465 million penalty against drug giant Johnson & Johnson. The "public nuisance" rationale can be an achilles heel for the state of Washington.

Washington State Strikes a $150 million Deal with J&J
Washington State's attorney general on January 24, 2024 said that the state had finally a deal on hand with drugmaker Johnson & Johnson. The deal is worth $149.5 million
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More than 100K Drug Overdose Deaths in a 1-year Period
A treacherous mix of Coronavirus pandemic, social isolation, lack of enough mitigation availability and flooding of the market by fentanyl all contributed to more 100,000 deaths between May 2020 and April 2021, according to a Centers for Disease Control and Prevention report made public on November 17, 2021. In the calendar year of 2020, more than 93,000 people have died of overdose. 

Jury Verdicts against Three Big Retail Pharmacies
A Cleveland jury on November 23, 2021 issued a verdict against three of the country's large pharmacy chains. The jury held Walmart, CVS and Walgreen responsible for what plaintiffs--in this case, Lake and Trumbull Counties--had said as their failure to be :diligent in dealing drugs". The two other retail pharmacy chains, Rite Aid and Giant Eagle, had settled with the counties before the trial. A judge will decide the financial penalty in the Spring of 2022. 

Indian Tribes Reach $590 million Settlement in Opioid Overdose Case
Native American tribes have reached a $590 million settlement with three largest drug distributors--McKesson, AmerisourceBergen and Cardinal Health--and Johnson & Johnson as part of a broader $26 billion deal, according to a court filing on February 1, 2022. The filing in the U.S. District Court in Cleveland is yet to be approved. The settlement will cover most of the Native American tribes. 

More than 107K Overdose Deaths in 2021
Centers for Disease Control and Prevention said on May 11, 2022 that at least 107,000 people had died of overdoses in 2021, setting a new record. According to the CDC, overdose deaths from fentanyl and other synthetic opioids jumped by 23% to at least 71,000. There were increases in deaths from other categories: 23% and 34% increases in cocaine and meth-plus-other stimulants-caused deaths, respectively. 

At-home Methadone Usage Does not Increase Overdose Death
The Associated Press reported on July 13, 2022 that the overdose death from Methadone did not increase after the authorities had changed the rules at the height of the Coronavirus pandemic from administering it in-person at clinic to at-home administration of this [reversal] liquid medication. The rule change can be made permanent in the coming days. Methadone reverses the effect of drug overdose, but Methadone itself can be an addictive drug. The Methadone overdose deaths decreased from 4.5% in January 2019 to 3.2% in August 2021

********************************** INSULIN DRUGS **************************************
Eli Lily Caps Out-of-Pocket Cost of Insulin at $35
Pharma giant Eli Lily on March 1, 2023 announced that it would cap out-of-pocket costs to patients for insulin drugs at $35, heeding to a call by President Joe Biden during this year's State of the Union address to lower the insulin drug costs. Democrats are trying to expand the insulin drug cost relief beyond Medicare patients. Medicare recipients have been provided the insulin drug cost relief thanks to the landmark Inflation Reduction Act. In addition to capping the out-of-pocket costs, Lily took additional actions on March 1, 2023, including:
* Reducing the list price of non-branded Lispro insulin injection to $25 a vial in May 2023
* Cutting the prices of some Humalog and Humulin doses by 75% in the fourth quarter of 2023
* Offering 78% discount to the newly launched insulin drug Rezvoglar in parity with a biosimilar version, Sanofi's Lantus, beginning in April 2023
Eli Lily is also seeking coverage of its obesity drugs by Medicare. However, Eli Lily CEO David Ricks ruled out any connection between the insulin drug costs reduction and its push for obesity drugs to be covered by Medicare. 
Eli Lily's March 1, 2023, action will increase pressure on other insulin makers, namely Danish pharmaceutical company Novo Nordisk AS and French firm Sanofi.

A Second Pharma Firm Cuts Insulin Prices
Novo Nordisk AS announced on March 14, 2023 that it would cut some insulin prices as deep as 75%.
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FDA Approves OTC Sales of Narcan
Food and Drug Administration on March 29, 2023 approved over-the-counter sales of Narcan, the best form of Naloxone, a drug used for the reversal of Opioid. 

DEA Strips Fourth-largest Pharma Distributor's Opioid Distribution License
Almost four years of a DEA administrative judge's ruling against Shreveport, La-based Morris and Dickson, DEA on May 26, 2023 revoked license for the nation's fourth-largest medical distributor's license for opioid and pain-killers. The DEA's stripping of license order becomes effective in 90 days, giving the company a 90-day reprieve to curate the situation. 

RITE AID

Pharmacy Chain Files Voluntary Chapter 11
Rite Aid, which has a nationwide 2,000 pharmacy retail stores, mostly on the East and West Coasts, on late October 15, 2023 filed for voluntary bankruptcy protection. The Chapter 11 filing portends potential closure of 400 to 500 poor performing retail stores, mostly in Latino and Black communities. That may, in turn, crate what many analysts call pharmacy deserts. In recent years, Rite Aid is facing sagging sales and opioid-related lawsuits, creating unsustainable financial pressure concomitant with falling foot traffic at many of its locations.