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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
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
Recent public discussion about the federal role in regulating compounding pharmacies has focused on compounded drugs for human use. Compounded drugs are also vital to companion animal health (like pets). In the world of...more
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
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
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
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
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
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
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
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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