News & Analysis as of

Manufacturers Pharmaceutical Industry Warranties

McDermott Will & Emery

[Webinar] Contracting in Biotech and Pharmaceutical Manufacturing - March 31st, 2:30 pm - 3:30 pm CET

McDermott Will & Emery on

Companies frequently encounter challenges in the manufacture and supply of their innovative products, in particular with respect to process development and production capacity. In our latest webinar, we review how key...more

Morgan Lewis

OIG Embraces Broader Anti-Kickback Statute Safe Harbor Protection for Warranties

Morgan Lewis on

The US Department of Health and Human Services’ Office of Inspector General updated the warranty safe harbor to account for bundled product and service warranties to reflect realities of healthcare product sales, but rejects...more

Polsinelli

OIG Approves Warranty Program for Bundled Products Used in Joint Replacement Surgery

Polsinelli on

The U.S. Department of Health and Human Services, Office of Inspector General (“OIG”) recently released Advisory Opinion 18-10, which approved a proposed arrangement involving a manufacturer of medical devices and wound care...more

Robinson+Cole Health Law Diagnosis

OIG Advisory Opinion Approves Surgical Device Warranty Program Intended to Reduce Readmissions

On September 17, 2018, the Office of Inspector General (OIG) of the Department of Health and Human Services published a favorable Advisory Opinion allowing a manufacturer of surgical devices and wound care products to offer a...more

Nutter McClennen & Fish LLP

Product Liability: 2017 Year in Review

Massachusetts state and federal courts issued a number of important product liability decisions in 2017. The Product Liability and Toxic Tort Litigation Group at Nutter recently reviewed these cases. Highlighted below are...more

Baker Donelson

OIG Advisory Opinion 17-03 Approves Pharmaceutical Manufacturer's Product Spoilage/Replacement Program

Baker Donelson on

A pharmaceutical manufacturer proposing to offer customers – at no additional cost – replacements for certain spoiled products that can no longer be administered to patients (Replacement Program) has been granted approval by...more

Benesch

Benesch’s 2nd Annual 3D Printing Seminar (A Summary Repeat)

Benesch on

Several hundred business leaders, engineers, attorneys and academics gathered last week for an annual symposium on 3D Printing hosted by Benesch, Friedlander, Coplan & Aronoff. The ability to form physical objects from...more

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