News & Analysis as of

Manufacturers Third-Party

BakerHostetler

FTC Alerts Advertisers and Digital Platforms About Misleading MUSA Claims

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There is nothing new about companies providing platforms for other companies to sell their wares. That is, after all, exactly what supermarkets do, and TV and radio networks have long run ads for other companies. The rise of...more

Foley & Lardner LLP

Episode 36: Let’s Talk Compliance: The Risks and Pitfalls of Health Care Supply Chain Compliance

Foley & Lardner LLP on

In this episode, Monica Chmielewski, vice chair of Foley’s Health Care Practice Group and Shannon Sumner, Chief Compliance Officer and Nashville’s Office Managing Principal of PYA explore how supply chain compliance is...more

Knobbe Martens

FDA Accuses Third Party Testing Labs of Falsifying Data

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The Food and Drug Administration (FDA) recently issued General Correspondence Letters to two third-party nonclinical testing laboratories. The FDA cited the laboratories “after discovering data that was falsified or otherwise...more

Alston & Bird

Addressing Data Integrity Challenges in Medical Device Submissions

Alston & Bird on

The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, valid data for medical device premarket submissions. Our FDA/Food, Drug & Device...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Contradicts Benzene Class Actions, Highlighting Risks of Third-Party Lab Testing

In March 2024, Valisure, an independent quality advocate, filed a citizen petition claiming to have detected elevated levels of benzene in benzoyl peroxide acne treatment products. Valisure’s petition included testing results...more

Jenner & Block

Client Alert: FTC Challenges Medical Device Coating Transaction

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On March 7, 2025, the FTC filed a complaint in federal court seeking to block GTCR BC Holdings, LLC, a Chicago private equity firm, from acquiring Surmodics, Inc. The FTC alleges that Surmodics is the leading provider of a...more

Foley & Lardner LLP

Controlling Entities to Dealer Contracts Subject to Puerto Rico’s Law 75 May Be Liable for Tortious Interference

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Plaintiffs asserting claims for tortious interference of contracts covered by Puerto Rico’s Dealer’s Contracts Act, commonly known as Law 75, may automatically satisfy one element of such a claim. Law 75 regulates...more

WilmerHale

Department of Labor Accuses Hyundai of Child Labor Violations for Supplier Conduct

WilmerHale on

On May 30, 2024, the US Department of Labor (DOL) filed a complaint in the Middle District of Alabama against a US subsidiary of Korean carmaker Hyundai seeking to hold Hyundai liable for child labor violations alleged to...more

Husch Blackwell LLP

Asbestos Defendants Beware: Iowa’s Tort Reform Was Apparently Weaker Than We Thought

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In a 4-3 decision, the Iowa Supreme Court issued an opinion that significantly narrowed Iowa’s new statutory asbestos defense – holding the defense only protects asbestos product defendants who did not manufacture or sell the...more

McDermott Will & Emery

The Tale of Two CE Programs: OIG Compares Healthcare Provider and Third-Party Continuing Education in Recent Advisory Opinion

The Office of Inspector General of the US Department of Health and Human Services (OIG) issued Advisory Opinion 22-14 (AO 22-14) on June 29, 2022, concerning continuing education (CE) programs to be offered by an...more

White and Williams LLP

Too Late for The Blame Game: Massachusetts Court Holds That the Statute of Repose Barred a Product Manufacturer from Seeking...

White and Williams LLP on

In State Farm Fire & Cas. Co. v. Wangs Alliance Corp., No. 21-cv-10389-AK, 2022 U.S. Dist. LEXIS 26712, the United States District Court for the District of Massachusetts (District Court) considered whether a product...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - April 2021

Wi-LAN Inc. v. Sharp Electronics Corporation, Appeal Nos. 2020-1041, -1043 (Fed. Cir. Apr. 6, 2021) - In this week’s Case of the Week, the Federal Circuit addressed issues of claim construction and various issues...more

American Conference Institute (ACI)

[Virtual Event] U.S. Export & Reexport Compliance For Canadian Operations - January 26th - 27th, 9:00 am - 5:00 pm EST

For a whole decade, ACI’s U.S. Export & Reexport Compliance for Canadian Operations conference continues to stand apart as the only practical, comprehensive event of its kind for the export compliance community in Canada. ...more

Husch Blackwell LLP

Manufacturers Liable For Third Party Replacement Parts Says NJ Supreme Court

Husch Blackwell LLP on

In June, the New Jersey Supreme Court affirmed a 2018 Appellate Division ruling holding that manufacturers and distributors can be held strictly liable for damages caused by third party replacement parts containing...more

Foley & Lardner LLP

The Missing Link: Keeping Sales Reps From Turning Into Franchisees

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Manufacturers and suppliers do not ordinarily think to check state franchise or product distribution statutes when terminating a third-party sales representative, and for good reason: sales reps are mostly regulated...more

Foley & Lardner LLP

Best Practices for Customers Structuring Directed-Buy Arrangements

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This article explores the following topics: (1) What is a directed-buy arrangement? (2) What significant issues exist for a customer in a directed-buy arrangement? and (3) What are the best practices for a customer entering...more

Robinson+Cole Manufacturing Law Blog

A Contract Provision Often Overlooked By Manufacturers

Most manufacturers scrutinize indemnification clauses in contracts to determine what liability they make be taking on if something goes wrong in a transaction or sale. A typical indemnification clause will also provide that...more

Thomas Fox - Compliance Evangelist

Four Things Compliance Practitioner Should Know About the Eurasian Economic Union

Four Things Compliance Practitioner Should Know About the Eurasian Economic Union - An effective Compliance risk management at emerging markets for any business significantly depends on timeous observation of changes in...more

Arnall Golden Gregory LLP

FDA Issues Draft Guidance on 510(k) Third Party Review Program

The Center for Devices and Radiological Health (CDRH) recently issued a draft guidance on the 510(k) Third Party (TP) Review Program. The TP Review Program (formerly known as the Accredited Persons Program) allows FDA to...more

Foley & Lardner LLP

Common FCPA Issues

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As our previous posts illustrate, violations of the Foreign Corrupt Practices Act (“FCPA”) can carry a hefty cost. Two issues are commonly the impetus for FCPA violations and, practically speaking, pose significant FCPA...more

Thomas Fox - Compliance Evangelist

Supply Chain as a Source of Compliance Innovation

On this day we celebrate the greatest upset in the history of the NCAA Basketball Tournament, when Villanova beat Georgetown for the 1985 national championship. Georgetown was the defending national champion and had beaten...more

Zelle  LLP

Testing Texas CGL Coverage For 3rd Party Products

Zelle LLP on

On Sept. 19, the Fifth Circuit certified four questions to the Texas Supreme Court regarding coverage under a commercial general liability policy in U.S. Metals Incorporated v. Liberty Mutual Group Incorporated, No. 13-20433,...more

Mintz

New Children’s Product Testing and Certification Rule Set to Impact Manufacturers and Importers on February 8

Mintz on

On February 8, 2013, manufacturers and importers of children’s products (a consumer product designed or intended primarily for children 12 years of age or younger) will be required to follow certain testing and certification...more

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