Manufacturers

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Your daily dose of financial news - The Brief – 8.23.16

The 2d Circuit has refused the DOJ’s motion for reconsideration of the panel’s May decision overturning a jury verdict and accompanying $1.27 billion fine against Bank of America over its “Hustle” mortgage generation program....more

HRSA Proposes Administrative Process to Resolve Disputes Between 340B Program Covered Entities and Drug Manufacturers

Taking a step toward completing a requirement imposed by the Affordable Care Act, the federal government has proposed regulations that would create an administrative dispute resolution (“ADR”) process to resolve disputes...more

HRSA Releases Proposed Rule Governing the Administrative Dispute Resolution Process for 340B-Related Claims

On August 12, 2016, the Health Resources and Services Administration (“HRSA”) released a notice of proposed rulemaking (the “Proposed Rule”) to formally regulate the administrative dispute resolution (“ADR”) process for...more

New FDA Draft Guidance Helps Define the Scope of §510(k) Medical Device Preemption

Earlier this month the FDA issued a draft guidance entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device.” It’s long, and anyone interested in reviewing the whole thing can download it from the FDA’s...more

FTC Scrutinizes Dual Distributor Communications

A dual distribution relationship does not protect against Section 5 liability for an invitation to collude. For the first time, the Federal Trade Commission (FTC) has charged a company with violating Section 5 of the FTC...more

$3 Million Spoliation Sanction Despite Company’s Litigation Hold

Manufacturers involved in litigation must properly preserve electronically-stored information (“ESI”) or potentially face daunting sanctions. A recent antitrust case, however, demonstrates that lessons—multi-million dollar...more

Seventh Circuit Reverses Package Size Promotional Service Decision Under the Robinson-Patman Act

On August 12, 2016, the Seventh Circuit reversed the district court decision allowing Woodman’s Food Market, Inc.’s (Woodman’s) price discrimination lawsuit against The Clorox Company and The Clorox Sales Company (Clorox) to...more

When Is a Software Change Really a Change that Requires FDA Review?: When to Submit a 510(k) for a Software Change to an Existing...

On the same day the Food and Drug Administration issued its revised draft guidance document on when to submit a new 510(k) premarket notification for an existing medical device, it released a similar document specific to...more

Next Steps on New EPA Toxics Rule Implementation Reinforce the Need to Engage

The passage of the Lautenberg Chemical Safety Act ("2016 TSCA Amendments") was a rare bipartisan success story. However, the August 9-10th Environmental Protection Agency ("EPA") stakeholder public comment meetings on the...more

Seventh Circuit Decrees That Package Size Alone Is Not Enough for a Robinson-Patman Claim

On August 12, 2016, the U.S. Court of Appeals for the Seventh Circuit issued an opinion in Woodman's Farm Market, Inc. v. The Clorox Co., No. 15-3001 (7th Cir. August 12, 2016), in which it held that a plaintiff cannot state...more

HHS Proposes Administrative Dispute Resolution Process for 340B-Related Claims

On August 12, 2016, the US Department of Health and Human Services (HHS) Health Resources and Services Administration issued a notice of proposed rulemaking that establishes an administrative dispute resolution process for...more

FDA Releases Revised Guidance on Device Modification Policy

FDA released two new draft guidances on Monday, August 8 in an attempt to help device manufacturers determine when a modification triggers the obligation to file a new 510(k) under 21 C.F.R. § 807.81(a)(3). The first draft...more

How Far Is Too Far? New York Clarifies Potential Warnings Liability for Third-Party Products

It’s probably common knowledge to even a novice product liability practitioner that a manufacturer can be held liable for a defect in a component part supplied by another company that is integrated into the manufacturer’s end...more

Structured Thoughts: News for the financial services community, Volume 7, Issue 8

Brexit and Structured Products: A Framework for Considering Disclosures - The U.K.’s recent referendum to withdraw from the European Union has affected virtually all segments of the financial industry. The structured...more

New York Decision Not Good For Asbestos, But Not Bad For Drug/Device

The recent decision of the New York Court of Appeals in In re New York City Asbestos Litigation, ___ N.E.3d ___, 2016 WL 3495191 (N.Y. June 28, 2016) (“NYCAL”), was not too good for asbestos defendants – as it permitted,...more

DEA Expands Marijuana Manufacturing But Refuses to Reclassify Schedule I Drug

On Thursday, the DEA announced a policy change expanding the number of DEA-registered marijuana manufacturers producing marijuana for research. This move is expected to expand and diversify the supply of marijuana for...more

Many Big Announcements for the UAS Industry and its Safety and Privacy Initiatives

The commercial drone industry is projected to generate over $82 billion for the U.S. economy and over 100,000 new jobs by 2025. Last week, at the White House Office of Science and Technology Policy’s (OSTP) “Workshop on...more

Overlapping Labels Can Lead to Liability

Multiple regulatory agencies worldwide exercise jurisdiction over how hazards associated with chemicals in the workplace are communicated to employees and others. This creates a complex web of requirements and...more

Environmental Notes - August 2016

Time to Pay More: EPA Increases Maximum Civil Penalties - Remember the days when the maximum civil penalty EPA could assess for a violation of environmental law was $25,000 per day? Those days disappeared 26 years ago...more

New FDA Draft Guidance on Benefit-Risk Factors Affecting Medical Device Compliance and Enforcement

In June, the U.S. Food and Drug Administration released draft guidance to clarify the benefit and risk factors it may consider in compliance and enforcement actions involving medical devices. Medical device manufacturers...more

U.S. Manufacturers Need Immigration Certainty to Grow Economy

When President Barack Obama unveiled his Immigration Accountability Executive Actions in 2014, a measure supported by the National Association of Manufacturers, the media was focused on how the current administration’s...more

How These Contract Provisions Can Reduce A Manufacturer’s Margins

One of the key aspects of any supply chain contract is the section regarding pricing.  Nothing is more important in a business deal than determining how much one manufacturer might pay another in a B2B transaction....more

Penalties for OSHA Non-Compliance Just Got Stiffer

On November 2, 2015, President Obama signed into law the Federal Civil Penalties Inflation Adjustment Improvements Act of 2015. The Act requires numerous federal enforcement agencies, including OSHA, to substantially...more

Guest Post – Benicar MDL Court: An Unconventional, but Relatively Simple, Remand Decision

This is a guest post, by Jaimee Farrer, an associate at Reed Smith. We’re always looking for new twists that can help in efforts to remove cases to federal court, and the case Jaimee describes does that, relying on an MDL...more

FAA Regulations Clear Way for Delivery Drones

The Federal Aviation Administration (FAA) has finalized its regulations concerning operational drones, allowing retailers to start using drone delivery systems. In making drones available for retail delivery use, the...more

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