Products Liability Conflict of Laws Health

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$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

The Gap Between Express and Implied Preemption Narrows In The Ninth Circuit

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

There They Go Again

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

Successful Class II Medical Device Preemption Decision

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

No Preemption for the Common Cold Remedy

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

IOM Releases Controversial 510K Device Report

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

Supreme Court’s Finding of Preemption for Generic Manufacturers Will Have Significant Implications for Brand-Name Companies

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

Two More From The Supreme Court

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

Pro Te: Solutio - Vol. 3, No. 4 - October 2010

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

Federal Government to Provide Its Position on Generic Preemption to the U.S. Supreme Court

Following the U.S. Supreme Court's March 2009 landmark decision in Wyeth v. Levine, state and federal courts have struggled with how to apply Levine to failure-to-warn products liability claims against generic pharmaceutical...more

Generic Drug Manufacturers Post-ANDA Approval Duties With Reference To Labeling Changes: Viability of Federal Preemption Defense...

The U.S. Supreme Court's decision in Wyeth v. Levine, 129 S.Ct. 1187 (2009), found that plaintiffs' state-law based failure-to-warn claims were not preempted in the context of drugs manufactured by innovator manufacturers....more

Federal Pre-Emption in Medical Device and Pharmaceutical Litigation

Over the past two years, the United States Supreme Court has had two opportunities to address and add to the jurisprudence in the area of federal pre-emption of state law claims regarding allegedly defective medical devices...more

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