Manufacturers

News & Analysis as of

Court Finds FDA Explanation of Knee Implant Reversal Lame

The FDA had approved the mesh—called the Collagen Scaffold—in December 2008. But after the change in administrations the following month, the agency decided that the approval process had been flawed and had been the focus of...more

EEOC Sues Oran Safety Glass for Pregnancy Discrimination

Manufacturer Fired Female Employee Because She Was Pregnant, Federal Agency Charges - RICHMOND, Va. - Oran Safety Glass, Inc., a manufacturer of armored safety glass, such as bulletproof glass for use by the military...more

U.S. Steel Subsidiary Sued By EEOC for Religious Discrimination and Retaliation

Manufacturing Company Revoked Job Offer and Refused to Accommodate Applicant Whose Religious Beliefs Prohibited Hair from Being Cut From His Scalp, Agency Says - HOUSTON -- U.S. Steel Tubular Products, Inc., a...more

Court Rules That Settlement Term Sheet Is Not Worth The Paper It’s Written On

Judge Amy J. St. Eve of the Northern District of Illinois recently held that a purported settlement agreement in a putative class action filed by Craftwood Lumber Co. against Interline Brands, Inc. was not enforceable. See...more

The Revitalize American Manufacturing And Innovation Act Passes House Of Representatives

On September 15, 2014, the U.S. House of Representatives passed H.R. 2996, the Revitalize American Manufacturing and Innovation (RAMI) Act. The Act "earmarks up to $300 million in federal funding -- $30 million annually for...more

FDA Allowing Additional Comment Period for Draft Social Media Guidances

The Food and Drug Administration (FDA) is reopening the comment period for two draft social media guidances in response to requests for additional time to allow interested persons to submit comments. Beginning September 29,...more

Pennsylvania Supreme Court Denies Review of Faulty Workmanship Decision

Last week, the Pennsylvania Supreme Court let stand the appellate decision in Indalex, Inc. v. National Union Fire Insurance Co. of Pittsburgh, Pa., which held that mold related health problems and property damage allegedly...more

Denial Of Arbitration Reversed Where Trial Court Failed To Hold Trial To Resolve Disputed Questions Of Fact

The Eighth Circuit reversed a trial court’s decision to deny arbitration, based on the fact that the lower court failed to hold a trial (as required by the FAA) when disputed questions of fact surrounding the parties’...more

China’s Pollution Woes Trigger a New Environment for Manufacturers in China

The most modern of manufacturing operations can exist nearby the most backward. Thousands of quality assurance, hygiene, energy conservation and other regulatory standards are in place, but access to, enforcement and...more

Steeda Autosports Seeks to Put the Brakes on Alleged Patent Infringement

Steeda Autosports, Inc. ("Steeda"), a Valdosta, Georgia-based company specializing in the design and manufacture of after-market parts for Ford vehicles, particularly Ford Mustangs, filed suit on August 22, 2014, in the...more

"Federal Circuit Decision Underscores the Importance of Customs Compliance for All Parties to an Import Transaction"

A decision issued last week by the U.S. Court of Appeals for the Federal Circuit in United States v. Trek Leather, Inc. has shaken fundamental assumptions held by many U.S. importers and their business partners (including...more

Breach of Contract and Section 75-1.1: The Beginning

A breach of contract alone does not violate N.C. Gen. Stat. § 75-1.1. If a breach is accompanied by “substantial aggravating circumstances,” however, the breach does violate section 75-1.1—and the plaintiff’s contract damages...more

Indalex: The Pennsylvania Supreme Court Rejects Insurer’s Request for Review

On September 18, 2014, the Pennsylvania Supreme Court rejected the insurer’s attempt to reverse last year’s favorable ruling in Indalex Inc. v. National Union Fire Insurance Co. of Pittsburgh PA, 83 A.3d 418, 421 (Pa. Super....more

EPA Requests Comments on Nanomaterials Manufacturing and Formulating for Effluent Guidelines Program Plan

On September 16, 2014, the U.S. Environmental Protection Agency (EPA) published a Federal Register notice announcing the availability of the combined Final 2012 and Preliminary 2014 Effluent Guidelines Program Plans and EPA’s...more

GAF Materials Corporation Sued by EEOC for Disability Discrimination

Company Refused to Permit Disabled Worker to 'Bump' in a Layoff, Federal Agency Charges - ATLANTA - GAF Materials Corporation, a roofing materials manufacturer headquartered in Wayne, N.J., unlawfully terminated a...more

California Appellate Court Rules That California’s Prevailing Wage Laws Do Not Apply to Off-Site Fabrication

On August 27, 2014, the California Court of Appeal issued its decision in the long-anticipated Russ-Will case, Sheet Metal Workers’ International Association, Local 104 v. Duncan; Russ Will Mechanical, Inc., Court of Appeal...more

‘Chemical (Over)reaction’?: States Push for Tighter Regulation of Consumer Products

The chemical wars are in full swing. And for consumer products and chemicals manufacturers, victory on the regulatory front is by no means a foregone conclusion. Progressive legislators in states such as California,...more

Does Pennsylvania Permit Manufacturing Defect Claims Involving Medical Devices?

I am writing to report about a recent dismissal of a manufacturing defect claim made against a medical device manufacturer in the USDC for the Eastern District of Pennsylvania. This decision is favorable to our clients that...more

Factoryless Goods Producers May Be as Hypothetical as Their Domestic Factories

Recently, the Office of Management and Budget (“OMB”) has considered a controversial new federal classification: “Factoryless Goods Producers” (“FGP”). FGP recognizes that a significant portion of the American workforce is...more

Spray Drift and Volatilization: Issues to Navigate Carefully as EPA Develops Registration Review Decisions

Spray drift and volatilization issues increasingly are significant issues in pesticide product risk assessments. Earlier this year, the U.S. Environmental Protection Agency (EPA) issued drafts of key guidance documents, which...more

Products Liability Cases Often Involve Complicated Issues, Such as When Competing Experts Disagree Over Cause of Car Accident

Because many automotive manufacturers or parts suppliers reside in or do business in Michigan, products liability cases arising from car accidents are frequently litigated in Michigan. These cases can be extremely...more

Seller Beware: California Announces Draft Plan for New Consumer Product Categories Under Its Green Chemistry Initiative

California’s toxics agency, the Department of Toxic Substances Control (DTSC), has released a draft three-year work plan identifying seven consumer product categories that may be the focus of the state’s Green Chemistry...more

Do Not Pass Go: Federal Judge Orders Execs Jailed for Contempt of Recall Order

A recent federal decision has made clear that court-ordered recalls can have real teeth, not just for manufacturers but also their officers—especially when the court has reason to suspect a company’s execs are deliberately...more

FDA Regulatory and Compliance Monthly Recap

Mobile health industry could get a boost as FDA draft guidance exempts certain medical devices, including digital health devices - The FDA’s decision to not require a number of mobile health devices to go through the...more

California Issues Draft Three-Year Green Chemistry Priority Product Work Plan

On September 12, 2014, the California Department of Toxic Substances Control (DTSC) issued a draft Priority Product Work Plan (Work Plan) pursuant to the California Safer Consumer Product (SCP) regulations. The Work Plan...more

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