JURIST

NOVEMBER 7, 2023

This is not the first suit the government has filed related to pharmaceutical distributors’, manufacturers’ and pharmacies’ role in the opioid epidemic. Cencora has denied the allegations. Johnson & Johnson and Mallinckrodt.

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Statute Manufacturing Government Court 221

Day on Torts

MARCH 24, 2022

Where plaintiff filed a products liability claim based on a hip replacement device she had received, but her hip replacement occurred more than ten years before her suit was filed, dismissal based on the statute of repose was affirmed. The statute of repose for products liability cases is a hard line with very limited exceptions.

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Statute Tort Manufacturing Court 59

Day on Torts

JANUARY 25, 2021

Plaintiff brought this products liability claim against numerous defendants, including several industrial equipment manufacturers who made and sold equipment used by the deceased husband at his job. The husband died after being diagnosed with mesothelioma due to asbestos exposure at work. Code Ann. § 29-28-102(6).

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Manufacturing Court Statute Laws 59

FDA Law Blog

NOVEMBER 7, 2021

We reported that HRSA was proceeding with enforcement actions against drug manufacturers that have declined to sell to 340B covered entities that use multiple contract pharmacies to dispense 340B drugs to their patients, despite the pendency of several lawsuits challenging such enforcement.

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Statute Contract Manufacturing Court 52

SCOTUSBlog

MARCH 20, 2023

The case involves a dispute between Jack Daniel’s (the largest American whiskey manufacturer) and VIP Products (the second-largest American dog toy manufacturer). 7 Tennessee Sour Mash Whiskey” manufactured by “Jack Daniel’s,” the toy refers to a “Bad Spaniel” that makes “Old No. 2 on your Tennessee carpet.”

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Statute Manufacturing Court Decisions Court 107

JonathanTurley

JULY 12, 2021

The centerpiece of Cuomo’s plan is a new law to allow victims of gun violence to sue gun manufacturers under a nuisance theory. Indeed, its main component — a law allowing citizens to sue gun manufacturers — will be as productive as trying to win the New York Marathon by running furiously in place. Andrew Cuomo. Of the $138.7

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Manufacturing Laws Litigation Litigating 43

FDA Law Blog

JUNE 15, 2022

Writing for a unanimous court, Justice Kavanaugh explained that the Medicare statute provides CMS a choice between two options on how to set reimbursement rates for drugs provided in the hospital outpatient setting. The statute sets this “average price” as ASP plus 6%. Becerra, No. 20-1114, 596 U. S. _ (2022). See 42 U.S.C.

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Statute Court Court Decisions Healthcare 52

Patently O

DECEMBER 7, 2023

The Federal Circuit recently affirmed a district court judgment finding that Abbreviated New Drug Applications (“ANDAs”) submitted by generic drug manufacturers did not infringe patents rights held by H. The statute’s patent specific.” But, as relevant for this case, 35 U.S.C. §

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Manufacturing Statute Court Construction 126

Conflict of Laws

DECEMBER 19, 2023

The Court held that local consumer legislation – in the form of the Consumer Guarantees Act 1993 (CGA) – applies to foreign manufacturers. The decision is of particular interest to New Zealand consumers and manufacturers of goods that are supplied in New Zealand, as well as traders advertising their products to New Zealanders.

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Manufacturing Court Statute Laws 67

At the Lectern

MARCH 4, 2024

FCA US LLC , the Supreme Court today holds that restitution a manufacturer owes under the Song-Beverly Act (Civ. That rule applies “at least where, as here, a consumer has been forced to trade in or sell a defective vehicle due to the manufacturer’s failure to comply with the Act.” In Niedermeier v. Code, § 1790 et seq.)

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Manufacturing Laws Statute Court 45

JURIST

FEBRUARY 20, 2021

House Bill 1272 , which passed with a 69-23 vote, provides that any “personal firearm, firearm accessory, or ammunition manufactured commercially or privately in the state and which remains within the state is not subject to federal law or federal regulation, including registration.”

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Manufacturing Statute Legal Legal 146

Mondaq

AUGUST 16, 2021

Sale of goods statutes afford consumers a set of protections, which are fairly uniform across jurisdictions. Product liability claims are often rooted in provincial sale of goods legislation.

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Manufacturing Statute 40

SCOTUSBlog

FEBRUARY 16, 2024

brings the justices yet another case under a statute with which they are all too familiar – the Federal Arbitration Act. The workers in this particular case (including Neil Bissonnette) are commercial truck drivers, who transport packaged goods manufactured by Flowers Foods, best known for its production of Wonder Bread.

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Statute Manufacturing Contract Court 105

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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Manufacturing Statute Contract Court 40

JURIST

JUNE 15, 2022

AHS argued that, under 42 USC § 1395l(t)(14)(A)(iii)(II) , HHS was required to set reimbursement rates at the average price hospitals at which bought each drug from the manufacturer for all hospitals. HHS did not conduct a survey that would have allowed them to vary rates between hospitals.

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Court Rules Court Manufacturing Statute 195

FDA Law Blog

JANUARY 4, 2022

Many of the updates relate to drug manufacturer practices with regard to speaker events, including meals, choice of venue, and attendance. Although the PhRMA Code is a voluntary code of conduct, drug manufacturers should consider updating their marketing policies and practices to align with the new Code. (We

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Manufacturing Statute Litigation Litigating 98

Mondaq

SEPTEMBER 28, 2022

The Federal Food, Drug, and Cosmetic Act (FDCA) and the Public Health Service Act (PHSA) are the two key statutes governing the development, manufacturing, distribution, registration, licensing, clearance.

Manufacturing 40

Manufacturing Statute Government 40

FDA Law Blog

FEBRUARY 5, 2023

Both courts found the statute to be ambiguous, but only the Delaware court vacated HRSA’s penalties; the New Jersey court remanded the issue to HRSA. Last week, a panel of three judges at the Third Circuit who reviewed these three cases decided in favor of the drug manufacturers.

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Contract Statute Manufacturing Court 52

FDA Law Blog

JANUARY 4, 2022

Many of the updates relate to drug manufacturer practices with regard to speaker events, including meals, choice of venue, and attendance. Although the PhRMA Code is a voluntary code of conduct, drug manufacturers should consider updating their marketing policies and practices to align with the new Code. (We

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Manufacturing Statute Litigation Litigating 75

JURIST

NOVEMBER 8, 2021

involves a complicated copyright dispute between two clothing manufactures. The statute requires that district courts ask the Register of Copyrights to assess whether the copyright would have been granted if the Register was aware the information was inaccurate. H&M Hennese & Mauritz, L.P

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Court Manufacturing Statute Litigation 197

Patently O

NOVEMBER 21, 2023

In it, the USPTO reaffirmed its prior interpretation of the phrase “design for an article of manufacture” and did not—as many had hoped—expand its interpretation of that phrase. In late December 2020, the USPTO published a request for information on “The Article of Manufacture Requirement.” 11380, 11381 (footnotes omitted).

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Manufacturing Technology Law School Statute 59

The IP Law Blog

JANUARY 18, 2024

For example, a trade secret can be a manufacturing process, recipe, distribution method for products, research and development information, software algorithm, list of ingredients, list of suppliers, list of customers, pricing strategy, business plan, or advertising strategy. then it is no longer a trade secret. Under 35 U.S.C. §

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Manufacturing Laws Statute Technology 113

SCOTUSBlog

JUNE 9, 2023

VIP Products firmly rejected the use of the Jack Daniel’s trademarks by a manufacturer selling a line of dog toys that mock various beverage manufacturers. That statute has an exception that protects competing uses if their use of the mark is “noncommercial.” Share Thursday’s decision in Jack Daniel’s Properties v.

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Manufacturing Statute Cause of Action Court 112

Patently O

JANUARY 17, 2022

This was a very technical decision and we can manufacture the entire machine without any complication in the United States, with the exception that there are two parts that must not be assembled in the United States, but assembled after the machine arrives in Brazil. .” manufacturing capability. Deepsouth Packing Co.

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Manufacturing Litigation Litigating Statute 122

SCOTUSBlog

MARCH 15, 2024

In this case, Truck Insurance Exchange wants to object to the plan proposed by the bankrupt asbestos company Kaiser Gypsum because the plan does not require the disclosure of parallel claims to other asbestos manufacturers that would allow the insurer to make sure the claims it must pay are not fraudulent.

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Court Contract Statute Manufacturing 111

FDA Law Blog

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028.

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Manufacturing Calendaring Statute Administrative Law 105

Patently O

AUGUST 8, 2022

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. process that the machine or manufacture perform. ‘(B) B) HUMAN GENES AND NATURAL MATERIALS.

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Manufacturing Technology Statute Court Decisions 97

FDA Law Blog

JUNE 16, 2023

Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers. We address each below. Best price?

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Manufacturing Calendaring Healthcare Statute 45

Patently O

MARCH 27, 2024

A forceful dissent by Judge Lourie argues that the majority’s approach, while following precedent, improperly reads the word “solely” out of the statute and unduly expands the safe harbor exemption. In dissent, Judge Lourie criticized the court for reading the word “solely” out of the safe harbor statute.

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Statute Manufacturing Court Technology 45

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.,

Manufacturing 72

Manufacturing Healthcare Contract Government 72

FDA Law Blog

MAY 8, 2023

Once FDA has cleared or approved a PCCP, that statute states that a supplemental application “shall not be required” to make a change consistent with such PCCP. Manufacturers should be able to verify and validate the proposed modifications within their existing quality system.

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Drafting Manufacturing Data Management Technology 98

Patently O

JUNE 15, 2021

Although it required invention in name, it was really just becoming a replacement to monopolies barred by the Statute of Monopolies (1624). . Van Ness argues that the U.S. patent system at the time was being overrun by large numbers of trivial inventions. The patent in question is dated on the 12th day of August, 1820.

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Statute Manufacturing Construction Laws 92

SCOTUSBlog

JUNE 15, 2023

Jackson’s opinion starts by restating the long-standing rule that a congressional statute “abrogates” sovereign immunity only if Congress uses language that is “unmistakably clear.” Therefore, [the statute] unmistakably abrogates their sovereign immunity too.” Tribes are indisputably governments.

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Statute Government Manufacturing Court 109

Patently O

FEBRUARY 10, 2022

2015) in finding that manufacture and delivery of a product in a foreign country can infringe a US patent if sufficient sales-activity occurred within the US. The Federal Circuit rejected this appeal — holding that the presumption is applied when courts interpret the law or construe a statute. Broadcom Ltd. and Apple Inc.,

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Manufacturing Contract Statute Technology 126

JURIST

FEBRUARY 22, 2021

The law, 13 VSA § 4021(a) , bans people from manufacturing, possessing, transferring, selling, purchasing, receiving or importing large-capacity magazines in the state of Vermont. The law also sets limits for magazine sizes at 15 rounds for handguns and 10 rounds for long guns. The trial court denied his motion.

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Laws Court Statute Manufacturing 151

SCOTUSBlog

MARCH 23, 2023

Specifically, the 9th Circuit reasoned that Rogers requires an exception to the trademark statute for expressive speech and that the “Bad Spaniels” dog toy fell within the exception. Kagan’s questioning of Bennett Cooper, representing the toy manufacturer, shows just how settled she was in her position by the end of the morning.

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Statute Manufacturing Court Lawyer 96

FDA Law Blog

MAY 31, 2021

One of these amendments was a poorly thought-out rule that, if implemented, will render virtually unusable the current best price exclusion for manufacturer patient savings programs in the form of coupons, patient rebates/refunds, copay assistance, vouchers, and free drug programs. The effective date of this amendment is January 1, 2023.

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Manufacturing Statute 52