FDA Law Blog

FEBRUARY 5, 2023

By Faraz Siddiqui — In the Spring of 2021, the Health Resources and Services Administration (HRSA) threatened six drug companies with billions of dollars in penalties for not providing 340B discounts to covered entities that sell drugs through vast networks of contract pharmacies (more background on earlier posts ). A lot is at stake here.

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FDA Law Blog

SEPTEMBER 29, 2021

The 340B program, authorized under Section 340B of the Public Health Services Act and administered by HRSA, imposes a ceiling price on pharmaceutical manufacturer sales to “covered entities,” which are certain health clinics that receive federal funding and certain types of safety net hospitals to provide them drugs at lower prices.

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FDA Law Blog

NOVEMBER 30, 2022

According to the allegations in the complaint, approval of the new Los Angeles manufacturing facility required a Prior Approval Supplement (PAS) and a Pre-Approval Inspection (PAI) of the facility. 3729) quit tam suit, alleging that Grifols USA, Grifols Biologicals, Grifols, S.A.,

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Manufacturing Healthcare Contract Government 72

Mondaq

AUGUST 2, 2022

District Court for the District of Puerto Rico has recently ruled on a case dealing with Puerto Rico's Dealer's Contracts Act, also known as Law 75.

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FDA Law Blog

OCTOBER 6, 2021

By Faraz Siddiqui — Last week, we blogged about a growing list of drug manufacturers that have refused to follow a 2010 guidance issued by the Health Resources and Services Administration (“HRSA”), which permits 340B covered entities to contract with multiple pharmacies to dispense drugs to covered entity patients. Code Ann. §

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Manufacturing Contract Statute Court 52

Patently O

FEBRUARY 10, 2022

The collaborative idea was that Eddings would manufacture the sheaths because Junker did not have that capability. The Federal Circuit relies upon traditional contract law principles to determine whether a particular communication constitutes such an offer. Remember the contract foundational trio: Offer, Acceptance, Consideration.

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FDA Law Blog

NOVEMBER 27, 2023

the “Gree Companies”), an appliance manufacturer and two of its subsidiaries that were involved in the manufacturing, marketing, and sale of dehumidifiers. of Zhuhai, Hong Kong, Gree Electric Appliances Sales Co. and Gree USA Inc. DOJ’s enforcement against the Gree Companies and its executives occurred in stages.

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SCOTUSBlog

SEPTEMBER 29, 2023

The question comes to the court in the case of George Sheetz , who in 2016 applied for a permit to build a 1,854-square-foot manufactured home on land that he owns in Placerville, California. To receive the permit, Sheetz was required to pay El Dorado County $23,420 in traffic-mitigation fees. In Corner Post v. Warner Chappell Music v.

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SCOTUSBlog

JUNE 11, 2021

The employee alleges that the union contracted with his employer, United Airlines, to compel employees to pay fees in an amount equal to union dues. New York passed a law imposing an annual surcharge on opioid manufacturers and distributors. The state uses the money to pay for remedial programs related to opioid abuse.

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Conflict of Laws

OCTOBER 23, 2023

The contracts contain an exclusive foreign jurisdiction clause nominating a non-Australian jurisdiction. Many passengers contracted COVID-19; some died. Statute has left little of the common law untouched. Background The Ruby Princess’ passengers contracted on different sets of terms and conditions (US, UK and AU).

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Laws Contract Statute Construction 59

Constitutional Law Reporter

MARCH 4, 2025

.” The Fifth Circuit Court of Appeals has determined that a manufacturer may seek judicial review in that circuit even if it neither resides nor has its principal place of business there, so long as its petition is joined by a seller of its products, such as a gas station or convenience store, based in the circuit. Cunningham v.

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Manufacturing Court Constitutional Law Statute 52

FDA Law Blog

JUNE 12, 2022

Under the False Claims Act (FCA), if a company’s fraudulent conduct induces a governmental entity to enter into a contract with the company, then any claims for payments under that contract are false. established by statute and case law. This fraudulent inducement theory is well?established

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Manufacturing Contract Data Management Statute 52

The Process Street

NOVEMBER 28, 2023

Applications of AI manufacturing AI has various applications in manufacturing that are revolutionizing the traditional methods and streamlining the processes. Enhanced safety AI-powered systems can identify and prevent potential hazards in the manufacturing environment.

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At the Lectern

SEPTEMBER 21, 2023

” The officials (but not the State) moved under the anti-SLAPP statute for an early dismissal of the action against them. ” Vehicle sales arbitration grant-and-hold.

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FDA Law Blog

OCTOBER 4, 2023

As such, that statute was unjust, confiscatory and violated their constitutional due process rights. The court did not make much of Plaintiff’s argument that a manufacturer cannot terminate its participation in Medicare for close to two years, see Motion at 8; Complaint at 27-28, potentially dismissing it as a mere administrative matter.

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At the Lectern

DECEMBER 19, 2024

The Second District, Division Six, published opinion , held that the car manufacturer in the case “is not a third party beneficiary of the sale contract and petitioners are not estopped from objecting to arbitration.” Section 11362.3 ” Another f orum selection grant-and-hold. In People v.

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Manufacturing Contract Court Statute 45

At the Lectern

NOVEMBER 16, 2023

The court wants a Court of Appeal opinion on the constitutionality of a state statute barring public employers from discouraging union membership. He argued that the statute criminalizing his conduct violates the Second Amendment. Clark about the legislation’s application. Lopez already has its own grant-and-hold.

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At the Lectern

DECEMBER 12, 2024

The appellate court answered “no” to these questions: “is a consumer entitled to recover as ‘restitution’ amounts paid to a third party for a service contract on the vehicle? The First District, Division Four, unpublished opinion rejects the constitutional challenge to the statute.

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Statute Court Manufacturing Contract 45

At the Lectern

JULY 28, 2022

.” The appellate court concluded that, because common law claims cannot be brought against public entities, the county could not be sued for breach of an implied-in-fact or implied-in-law contract. ” Horvitz & Levy filed the successful petition for review. ” Here are the petition for review , answer , and reply.

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At the Lectern

MAY 30, 2024

” Division Two brushed off the statement as “an uncodified declaration in a subsequent law amending a different statute” (cf. to reconsider past decisions to impose prior strikes” and that “[c]ourts should consider Section 1385.” ” (See also here.)

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Conflict of Laws

SEPTEMBER 15, 2024

For instance, in a case involving a request for evidence from French airplane manufacturing companies by victims of an airplane crash, instead of a first resort to the Hague Evidence Convention, the U.S. On the basis of case law in England and the U.S. 3] Collins argued that in practice, U.S. 3] Collins argued that in practice, U.S.

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Laws Court Contract Litigation 59

Conflict of Laws

MAY 17, 2022

Hau: Interim relief against contracting authorities: classification as a civil and commercial matter, coordination of parallel proceedings and procedural autonomy of the Member States. an assignee as a third party is bound by a jurisdiction clause agreed by the original contracting parties.

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FDA Law Blog

OCTOBER 1, 2024

Murphy, Director of the Office of Generic Drugs’] ratification cured any Appointments Clause deficiency because it is unclear whether any statute properly authorized her appointment. In that case, the DDC recently said : [T]he Court has lingering concerns about whether [Dr.

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Litigation Litigating Government Court 59

Foley Hoag LLP

MARCH 11, 2022

Securities and Exchange Commission, that: (1) has annual, worldwide gross receipts exceeding $500 million; and (2) is involved in the mining, production, or manufacture of goods for sale. The post New U.S Legislation Would Require Forced Labor Audits first appeared on Global Business and Human Rights.

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The IP Law Blog

MARCH 2, 2021

es the threat posed to companies that rely on third-party manufacturers. Considering the importance of Chinese manufacturing to global trade, the Chinese legal system and its evolving trademark enforcement system will likely cause companies to get creative. 7 While the statute makes willfulness a prerequisite to a pro?ts

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Manufacturing Mens Rea Contract Tort 52

ClimateChange-ClimateLaw

JUNE 14, 2023

There are several statutes that form the basis of our antitrust laws. They also required any financial company entering (or renewing) contracts with state entities to affirm they do not, and will not, boycott those companies. And what are the permissible boundaries of that behavior? What is a Boycott, according to antitrust law?

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ClimateChange-ClimateLaw

OCTOBER 20, 2020

1442, or the civil-rights removal statute, 28 U.S.C. The district court rejected eight grounds for removal, but the Fourth Circuit concluded its appellate jurisdiction was limited to determining whether the companies properly removed the case under the federal-officer removal statute. Truck Trailer Manufacturers Association, Inc.

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ClimateChange-ClimateLaw

SEPTEMBER 10, 2021

The New Jersey court also found no basis for Grable jurisdiction, rejecting the companies’ arguments that the City’s claims necessarily raised substantial and actually disputed issues of federal law such as First Amendment issues or issues addressed by federal environmental statutes. Mayor & City Council of Baltimore v. BP p.l.c. ,

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ClimateChange-ClimateLaw

MARCH 13, 2023

In 2022, Texas, along with several other states and industry groups representing fuel manufacturers (together, Petitioners), challenged EPA’s new emissions standards in court. These standards required each automobile manufacturer to reduce the average emissions from its vehicle fleet by approximately 5% per year between 2012 and 2025.

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Manufacturing Government Court Administrative Law 59

SCOTUSBlog

APRIL 14, 2023

It is used in conjunction with the drug misoprostol, which causes the uterus to contract, expelling the pregnancy. The post Biden administration and drug manufacturer ask court to block suspension of mifepristone approval appeared first on SCOTUSblog. This article was originally published at Howe on the Court.

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Customs & International Trade Law

JANUARY 10, 2025

If genuine, the merchandisewould have an estimated total Manufacturer Suggested Retail Price (MSRP) value of approximately $29,989. Industry News The International Longshoremens Association (ILA) and United States Maritime Alliance (USMX) have reached a tentative agreement on all items for a new six-year Master Contract.

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eFiling Statute Manufacturing Finance 52

ClimateChange-ClimateLaw

MARCH 6, 2018

The plaintiffs had challenged the CEQA “baseline” for “fail[ing] to account for ongoing increases in global temperatures,” but the court found that the plaintiffs did not develop the argument “in any serious way” and said it would not “manufacture an argument where none is made and where none exists.”

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Court Government Laws Litigation 40

ClimateChange-ClimateLaw

NOVEMBER 7, 2017

Circuit Court of Appeals granted a motion by a truck trailer manufacturers trade group to stay the final rule adopted by the U.S. Truck Trailer Manufacturers Association, Inc. The court also granted motions to strike the state law claims pursuant to California’s anti-SLAPP (Strategic Lawsuits Against Public Participation) statute.

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ClimateChange-ClimateLaw

OCTOBER 25, 2024

The Republican-led “anti-ESG” (environmental, social, governance) movement over the last two years has largely been a legislative effort, comprised primarily of state-level bills that attempt to halt the consideration of climate risk and other commonplace factors in investment decisions connected with government funds, contracts, and pensions.

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