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TSCA Reform: Detailed Review of Representative Shimkus' Second Discussion Draft of TSCA Reform Legislation

On May 12, 2015, Representative John Shimkus (R-IL), Chair of the House Energy and Commerce Subcommittee on Environment and the Economy, released a new (second) draft of the TSCA Modernization Act of 2015 (TMA2 DD). In April,...more

Tomorrow is Another One-A-Day: FDA Guidelines Preempt Vitamin Claims, but Consumer Class Still Has Opportunity to Supplement

Although consumer class actions in California are dime-a-dozen, a recent Northern District of California case involving One A Day vitamins stands out because it demonstrates how federal regulations can preempt certain state...more

Product Liability Update - April 2015

In This Issue: - First Circuit Holds State Law Claims Against Drug Manufacturer for Allegedly Misleading Efficacy Representations in FDA-Approved Label Preempted by Food, Drug & Cosmetic Act Because Plaintiffs’...more

Can The FDA Do That?

A little like one of those peanut-shaped asteroids, today’s post cobbles together a couple of recent developments that, other than having relevance to the FDA, do not have all that much in common....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

Industry Group To Weigh In On GMO Labeling Debate

With the rise in state legislative efforts to require labeling for foods produced using genetic engineering or “GMOs,” the Grocery Manufacturers Association (GMA) is poised to enter the labeling debate by working with federal...more

Circuit Split: How Does the CFAA Apply to Employment Cases?

Imagine a disgruntled employee rummaging through your company’s confidential files and covertly stealing trade secrets to use as he builds a competing business. What recourse would you have against the rogue employee?...more

4th Circuit Issues Employee Friendly CFAA Opinion

As readers of this blog know, we have been following the diverse and seemingly irreconciliable decisions from federal courts regarding the scope of the federal Computer Fraud and Abuse Act ("CFAA"), 18 U.S.C. § 1030. Last...more

Fourth Circuit Decision Deepens Split of Authority on Federal Computer Fraud and Abuse Act's Prohibition on Conduct that "Exceeds...

The U.S. Court of Appeals for the 4th Circuit has issued a ruling in WEC Carolina Energy Solutions v. Miller, holding that the federal Computer Fraud and Abuse Act (“CFAA”) prohibition on exceeding “authorized access” to a...more

Federal Trade Commission v. Watson Pharmaceuticals, Inc. (11th Cir. 2012)

The practice of "reverse payments" in ANDA litigation (where, typically, the branded drug manufacturer settles litigation brought under 35 U.S.C. § 271(e)(2) with a generic challenger) have been a thorn in the side of the...more

Classen v. Biogen Idec et al. – The Latest Installment in the Patent-Eligibility Arena

On August 31, 2011, the Federal Circuit issued its long-awaited decision in Classen Immunotherapies, Inc. v. Biogen Idec et al. The case was remanded by the Supreme Court back to the Federal Circuit with instructions to...more

Health Law Alert 2010 Volume 2: Physician Payment Sunshine Act

The Patient Protection and Affordable Health Care Act (H.R. 3590) signed into law in March 2010 includes the Physician Payment Sunshine Act (section 6002) (PPSA), which requires pharmaceutical, medical device, biological, and...more

Electronic records mandates may clash with privacy laws: Patchwork of state laws adds complexity By Eric A. Klein and Christine C....

President Obama has declared that electronic medical records will “reduce error rates, reduce our long-term cost of health care and create jobs.” “Obama’s Prime Time Press Briefing,” N.Y. Times, Feb. 9, 2009. Congress has...more

Wyeth v. Levine: No Federal Preemption for Drug Labeling

The Supreme Court yesterday decided Wyeth v. Levine, the long-awaited decision on preemption of state court product liability claims against the pharmaceutical manufacturers. In a 6 to 3 decision, the Supreme Court determined...more

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