General Business Products Liability Health

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Launch of openFDA Increases Accessibility to Adverse Drug Event Reports

On June 2, 2014, the Food and Drug Administration launched openFDA, a program designed to improve access to publicly available data beginning with adverse event reports. While greater accessibility to adverse event reports...more

China Amends Key Medical Device Regulations

The State Council of China passed amendments to the Regulations on Supervision and Administration of Medical Devices which came into effect on June 1, 2014. The amendments present significant regulatory changes that will...more

After Recalls, Pharmacies Wonder How Well They REALLY Know Their Subcontractors

Pharmacy compounding has been a very hot topic over the last 12 months. Whether it is news from Capitol Hill regarding possible legislation, regulation from the Food and Drug Administration (FDA) or action by a state board of...more

FDA Issues New Medical Device Reporting Guidance

Device manufacturers should be aware of new issues and policy changes, which include the removal of the "two-year rule" for malfunctions. On July 9, the U.S. Food and Drug Administration (FDA) issued a new draft...more

FDA’s Medical Device “Enhancement” Reporting Has Potential Product Liability Implications

The U.S. Food and Drug Administration (FDA) recently issued a draft guidance document that could potentially require medical device manufacturers to report a wide variety of device improvements, ranging from routine updates...more

Pro Te Solutio - Vol. 5 No. 3 August 2012

In This Issue: - Diversity In Clinical Trials: The Need For Diversity To Ensure Safety And Efficacy - Federal Removal Statutes: A Review Of The Federal Courts Jurisdiction And Venue Clarification Act Of 2011 -...more

Protecting Yourself from Class Action Lawsuits

Over the past few years, the food industry has become the darling of the plaintiffs’ class action bar. Food companies have everything that class action lawyers love: huge numbers of consumers; heavy advertising; products that...more

First Circuit Holds That Warranty Not Exclusive Remedy When Repeated Corrective Efforts Fail

According to the U.S. Court of Appeals for the First Circuit in Berkshire Medical Center, Inc. v. U.W. Marx, Inc., an owner is at some point legally entitled to run out of patience, at least where defective work is concerned....more

The Learned Intermediary And Implied Warranties

In a relatively recent case, Currier v. Stryker Corp., 2011 WL 4898501 (E.D. Cal. Oct. 13, 2011), the court stated, with respect to a claim for implied warranty: “Because this is a medical implant case, and the...more

10 Things You Need to Know: The New Canada Consumer Product Safety Act

The CCPSA substantially revises the existing legal scheme in Canada for "consumer products". There are important implications for those who import, manufacture and sell products in Canada. Do you have operations in...more

Advertising Law Newsletter - January 31, 2011

In this issue: U.S. Supreme Court to Decide Marketing Consent Law; NAD Weighs In on Toning Shoes; ‘Well-Known’ Robocaller Banned from Telemarketing; FTC Settles False Environmental Certification Claims; and Kellogg Settles...more

Information on the New Law on Food Safety

Please find below the recent Client Alert sent out regarding the New Law on Food Safety....more

Federal Government to Provide Its Position on Generic Preemption to the U.S. Supreme Court

Following the U.S. Supreme Court's March 2009 landmark decision in Wyeth v. Levine, state and federal courts have struggled with how to apply Levine to failure-to-warn products liability claims against generic pharmaceutical...more

FDA Deviations In Menaflex Knee Device Clearance

Law360, New York (October 05, 2009) -- In an unusual “preliminary report” released recently, the U.S. Food and Drug Administration admitted to “multiple departures from processes, procedures and practices” in the 510(k)...more

Massachusetts Supreme Judicial Court Recognizes Cause of Action for Projected Medical Monitoring Costs Based on Subclinical...

In a decision rendered in the context of a cigarette product liability case but with broad implications for product manufacturers and sellers, the Massachusetts Supreme Judicial Court (“SJC”) has recognized a cause of action...more

Greening of Consumer Products - May 7, 2008

IN THIS ISSUE: *FTC workshop focuses on retailers' environmental claims made on packaging *More US companies are investing in environmentally friendly business products in order to cut future costs *Survey indicates...more

New EPA Reporting Requirements for Lead in Children's Products (Ages 14 and Under)

In the wake of multiple recalls of children’s toys, jewelry and other household articles, and under pressure from environmental advocacy groups to exercise its regulatory authorities under the Toxic Substances Control Act...more

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