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Coveting Characters: Navigating FDA's Draft Guidance on Social Media

Last week the U.S. Food and Drug Administration (FDA) issued two long-awaited draft guidances on social media: Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and...more

Supreme Court Reinforces Need for Robust Adverse Event Reporting Process

On June 23, 2014, the United States Supreme Court denied certiorari in Medtronic, Inc. v. Stengel, leaving in place the Ninth Circuit's en banc decision permitting a failure-to-warn claim against a pre-market approval (PMA)...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

Federal Judge Trims Diet Supplement Maker’s Earnings by $40M and Orders Recall of Banned Labeling

On May 14, a Georgia federal court dished out severe contempt sanctions against Hi-Tech Pharmaceuticals, its president and two others for violating a 2008 court order relating to the advertising and labeling of Hi-Tech’s...more

3D Printing Products at Home: Manufacturer, Consumer, or Both?

Soon, instead of clicking buy now and entering your shipping information, you may be able to download a file, click “Start,” and watch a 3D printer at work. Thus, the manufacturer-consumer will be born. ...more

Should Have Stayed on The Farm(ville): Class Action Plaintiffs' ECPA Claims Put Out to Pasture

Ah, to be a class action plaintiff these days. One day you’re up, plowing through the Northern District of California on expansive theories of injury, the next you’re down, upended like a top-heavy apple cart by a failure to...more

Who Is at Fault When a Driverless Car Is in an Accident?

One author's view on how to determine the answer that may surprise you....more

Florida Appellate Court Embraces Daubert Standard And Provides First In-Depth Analysis Under New Law

Last week, the Third District Court of Appeal resolved any questions concerning the applicability of the Daubert standard in Florida following the legislative changes to Florida's evidence code in July 2013. ...more

Your smartphone is NOT a medical device

Wearable technology issues relating to the potential qualification of such products as a medical devices have become popular on the press following the presentation of the first smartphone with a heart rate sensor, quickly...more

Unauthorized Children’s In-App Purchases Round Two: Google Faces Class Action

Just two months after Apple’s settlement with the FTC over lax parental controls over children’s in-app purchases, Google takes the spotlight with claims of unauthorized children’s in-app purchases in the Google Play Store!...more

“Brand” New Law: Illinois Court Holds Brand Manufacturers Owe Duty of Care to Generic Users

Last week, a federal district court in Illinois held that GlaxoSmithKline (GSK), a branded drug manufacturer, owed a duty of care to a patient who took the generic version of its drug. Dolin v. SmithKline Beecham Corp., No....more

FDA Report to Congress: 1997 Guidance Provides Solid Foundation for 510(k) Modification Decisions

Interested stakeholders have until June 4, 2014, to comment on the FDA's long-anticipated report to Congress that includes its Proposed Policy on the Premarket Notification Requirements for Modified Medical Devices. The FDA...more

Food Litigation Newsletter - March 2014

In This Issue: - Recent Significant Developments and Rulings ..Class Certification Denied in Ben & Jerry’s “All Natural” Ice Cream Case ..FDA Responds to Court Referrals Regarding “Natural” and...more

$4 Billion Price Tag for Pleasing Plaintiffs' Bar? New Study Estimates Costs of FDA's Proposed Rule on Generic Drug Labeling

An economic consulting group recently published findings that a Food and Drug Administration (FDA) proposed rule will increase annual healthcare costs by $4 billion. The FDA's proposal, announced in November 2013, would allow...more

Judicial Notice of FDA Website Documents Can Be a Powerful Lever in a Medical Device Manufacturer’s Motion to Dismiss

A motion to dismiss can be a powerful tool in the hands of medical device companies to eliminate cases that should be dismissed from the outset on preemption grounds, before engaging in costly discovery. Oftentimes, however,...more

Liability for Pharmaceutical Manufacturers Expands for the First Time to Include Design Defect Claims

Product liability law in Pennsylvania has been fundamentally altered as it relates to the manufacturing and selling of prescription drugs. Manufacturers are now subject to design defect claims following a recent state Supreme...more

New Jersey punitive damages analysis ignores established precedent

Since 2008 New Jersey law has effectively granted pharmaceutical manufacturers immunity from punitive damages claims. While New Jersey state courts continue to recognise and enforce that immunity, some recent federal court...more

Plaintiffs May Assert Negligent Design Claims for Prescription Drugs, Pa. Supreme Court Holds

In a stunning decision with broad implications for pharmaceutical companies in Pennsylvania and elsewhere, the Supreme Court of Pennsylvania has held that plaintiffs may assert negligence claims against pharmaceutical...more

A Short-Lived Victory for Generic Manufacturers? – Part 2

In our prior blog post of the same title on July 5, 2013, we predicted that the protection from product liability/failure to warn litigation for generic manufacturers as a result of the Supreme Court decision in Mutual...more

Recent Trends in Class Action and Aggregate Litigation in the Life Sciences Industry

Introduction - For the last several years, the life sciences industry has been fertile ground for class action and aggregate litigation. Developments in this area have driven several trends, including state consumer...more

Consumer Protection Laws And Prescription Meds: A Poor Fit

Purchasers of prescription medications often file class actions in large, multidistrict litigation alleging that they were defrauded by manufacturers. In these actions, patients, many of whom disclaim any physical injury,...more

Careful What You Say – No Preemption for Statements Made in Operating Room

Makers of medical devices marketed pursuant to the Food and Drug Administration’s (FDA) premarket approval process are generally relieved from defending state law failure to warn claims by operation of express preemption, a...more

New FDA Rule on Drug Labeling May Mean Increased Exposure and an Uncertain Path for Generic Pharmaceutical Manufacturers

Litigation over the labeling of pharmaceuticals dates back to the mid-1800s. In only the last five years, however, two watershed decisions by the United States Supreme Court have established clear, albeit controversial,...more

Goodbye to Generic Preemption? FDA Publishes Proposed Rule

Today, the U.S. Food and Drug Administration (FDA) published a long-awaited proposed rule in the Federal Register in an effort to “create parity” between brand-name and generic manufacturers for their labeling obligations. 78...more

FDA Proposed Rule Would Require Generics to Update Label Warnings Even Before Branded Pharmaceuticals Do

On Wednesday, November 13, 2013, the U.S. Food and Drug Administration (FDA) will publish a proposed rule in the Federal Register that will mandate that generic drug firms update their labels for drugs under approved...more

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