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The Bundesgerichtshof asked the Court of Justice whether the device may be classified as defective based solely on evidence that quality control checks on devices of the same model disclosed a potential defect.

Alan Kaplan and Robert Sanzillo published an article in Product Liability Law & Strategy on product liability issues for driverless cars. In it they explore some of the legal issues that may emerge as blame for driverless...

Suna Lee (Of Counsel-Madison, NJ) was granted a Motion to Dismiss this case in its entirety for lack of personal jurisdiction without the need for jurisdictional discovery following extensive...

A medtech startup typically focuses on two key legal needs: (1) ensuring that its technology has proper and thorough intellectual property protection...

Last week Bexis published a Legal Backgrounder for the Washington Legal Foundation, entitled "Recent Rulings Establish New Beachheads For Preemption In Drug And Device Product Liability Litigation."

Click here to listen to Rachel Raphael share her insights on the Modernization of Cosmetics Regulation Act (MoCRA) with Allison Stevenson, co-chair of the National Association

FDA determined that the following drugs were not withdrawn from sale for reasons of safety or effectiveness...

Last week, FDA announced the release of an enhanced version of a free web-based tool called FDA-iRISK 2.0 that helps users conduct their own quantitative risk assessments in support of food safety.

FDA recently issued a consumer alert advising readers not to be tricked by dietary supplement products that claim to treat concussions and other brain trauma injuries.

In the November 16, 2015, Federal Register, USDA's FSIS issued an updated version of the Agency's compliance guidelines for controlling hazards posed by allergens and other ingredients of public health concern.

President Obama has proposed additional funding resources that include an increase of $25.3M of new budget authority to implement FSMA.

Alan Lyons and Ronald Levine authored a bylined article for Food Manufacturing's October issue about how food companies can prepare proactively for a recall.

Since we last reported on enforcement actions in March 2015, FDA posted a notice from the N.C. Board of Pharmacy regarding the recall of certain lots of compounded pharmaceutical products.

PFAS litigation is expanding rapidly across federal and state courts, with new claims emerging and an increasingly diverse range of parties becoming involved. Updated data through the first quarter of 2026...

Legislation setting out new EU-wide rules on reparability, availability of spare parts and access to repair and maintenance information for certain appliances has been adopted and will apply from 2021.

EFSA has launched a public consultation on a draft guidance document on the risk assessment of genetically modified organisms ("GMOs") present at low levels in food and feed material.

A recently-published study reported that Celltrion's CT-P6 (HERZUMA, trastuzumab-pkrb) demonstrated equivalent safety and efficacy compared with...

Last week, my colleague Seth Goldberg and I published a client alert highlighting a series of cases filed in Oregon federal court against Curaleaf for allegedly mislabeling THC products...