Manufacturers

News & Analysis as of

Major Win for Products Manufacturers on Safer, Alternative Design Requirement

In a unanimous decision released last week, the Alabama Supreme Court delivered a significant victory for manufacturers defending products liability claims in Hosford v. BRK Brands, Inc. As in most jurisdictions, a plaintiff...more

Refusal to Sell Bulk-Size Packs, Without More, Is Not Price Discrimination – “Size is Not a Service”

Woodman’s Food Market, Inc. v. Clorox Co., No. 15-3001 (7th Cir. August 12, 2016). Clorox Sales Company and Clorox Company produce a range of consumer goods. Clorox sold goods to Plaintiff Woodman’s Food Market, a...more

The Brexit and Patent Law: What You Need to Know

Now that some time has passed since the Brexit vote, some of the ways in which the vote is likely to impact British patent law are becoming clearer. Here is a quick summary of some of the primary concerns....more

Cybersecurity Risks to the Manufacturing Sector

The 2016 Manufacturing Report by Sikich finds that there has been a progressive growth in cyber-attacks in the manufacturing sector. This is consistent with the most recent IBM /X-Force Research 2016 Cyber Security...more

Modern slavery reporting rises five-fold

Recent reports have suggested that there has been a steep rise in modern slavery reporting. This indicates that efforts to highlight the issue have been somewhat successful. The Salvation Army has confirmed that it supported...more

New Zealand Issues Guidance for Major Hazard Facilities

The Health and Safety at Work (Major Hazard Facilities) Regulations 2016 came into force on April 4, 2016. It provides specific requirements for specified major hazard facilities. In order to help facilities maintain...more

Court Strikes FDA Preapproval for Tobacco Product Labeling Changes

Court holds that FDA guidance cannot require preapproval for label modifications to existing tobacco products, but can require preapproval for quantity modifications....more

Alberta Government Favours Local Breweries in New Mark Up Regime

Earlier this month, the Alberta government implemented a new subsidy for Alberta-based craft breweries and increased the provincial mark-up on all beer imported into the province. The introduction of the subsidy is part of an...more

Litigation Alert: The Sixth Circuit Expands Potential Federal Wiretap Act Liability for Developers and Sellers of Cloud-Based...

Last week, the Sixth Circuit expanded potential liability for violations of the Federal Wiretap Act for manufacturers of devices that can be used for wiretapping, like monitoring software, in reversing the dismissal of a...more

OSHA Responds to Manufacturers’ Lawsuit on New Workplace Injury and Illness Reporting Rule

Seyfarth Synopsis: OSHA asserts that its new injury illness reporting rule is fully within OSHA’s mandate. This is in follow-up to our earlier blog on OSHA’s new rule, Improve Tracking of Workplace Injuries and Illnesses...more

New Guidance on ITAR Registration in the Firearms Industry

The State Department has issued new policy guidance regarding the requirement for gunsmiths and others involved in the firearms industry to register with the State Department under Part 122 of the International Traffic In...more

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

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