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On Jan. 20, 2015, the U.S. Supreme Court declined to hear an appeal involving failure-to-warn claims against generic pharmaceutical manufacturers. Teva Pharms. USA Inc. v. Super. Ct., No. 13-956 (U.S. Jan. 20, 2015). This...more
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
The Ninth Circuit Court of Appeals recently shrank universe of state law claims pertaining to Class III medical devices that remain untouched by Riegel express preemption or Buckman implied preemption. In Stengel v....more
A lot of people think that Ronald Reagan won the presidency in 1980 in his first debate when he replied jokingly “there you go again” to then-President Carter’s attempt to portray him as some sort of rightwing nut intent upon...more
We don't see many successful applications of preemption with respect to 510k, Class II medical devices since Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), so when we do, it's a big deal. Here's one. Today, in Degelmann v....more
Since the first sneeze, people have been trying to cure the common cold. While the cure remains elusive, everyone has a remedy for its symptoms – chicken soup, salt water gargle, fresh chopped garlic on crackers and, our...more
Earlier this week, an Institute of Medicine’s Committee released its report on the Public Health Effectiveness of the FDA 510(k) Clearance Process. The report offers a variety of recommendations and suggested reforms for...more
On June 23, 2011, in a 5-4 decision, the Supreme Court held that federal law preempts state law failure-to-warn claims against generic pharmaceutical manufacturers. Pliva, Inc. v. Mensing, No. 09-993 (June 23, 2011). The...more
Generic Manufacturers Win Preemption In Mensing
The Court decided 5-4 in favor of generic preemption today in Pliva, Inc. v. Mensing, No. 09–993, slip op. (U.S. June 23, 2011). We’d like to talk about Mensing, but it’s a...more
In this issue: FDA Warning And Untitled Letters - Using Historical Reference To Avoid Receiving Them In The Future; Healthcare Reform - Actions That Can Be Implemented Today To Prepare For Changes; Generic Preemption After...more
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