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Administrative Agency Conflict of Laws Products Liability

Read need-to-know updates, commentary, and analysis on Administrative Agency issues written by leading professionals.

Generic Drug Preemption Scorecard

by Dechert LLP on

We’ve decided that, since PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), product liability preemption in the context of generic drugs has come into its own and should no longer be lumped in with the overall topic of...more

Preemption Notes

by Dechert LLP on

A couple of recent preemption developments warrant mention. Horned In; Horned Out In Horn v. Boston Scientific Neuromodulation Corp., 2011 U.S. Dist. Lexis 102164 (S.D. Ga. Aug. 26, 2011), the defendant, a...more

Another PMA Preemption Win

by Dechert LLP on

For those of you who come here for wit, sarcasm, or pop-culture references, you may be disappointed today. This is a straight-forward post about a straight-forward PMA preemption summary judgment victory. So, we are going...more

Product Development Protocol? Preempted.

by Dechert LLP on

Just a note about Malbroux v. Jancuska, 2011 U.S. Dist. Lexis 96590 (W.D. La. Aug. 29, 2011), an otherwise forgettable opinion throwing out medical device claims on the basis of preemption under Riegel v. Medtronic, Inc., 552...more

One Shoe Drops

by Dechert LLP on

Wyeth v. Levine, 555 U.S. 555 (2009), was decided more than two years ago, now. Even though its anti-preemption rationale hinged on an the Court’s interpretation of an exception in an FDA regulation that was in no way...more

Implications of I.O.M.

by Dechert LLP on

The other day, the Institute of Medicine came out with its long-awaited – and it seems to us, rather short on specifics – report, “Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years,” on the...more

No Preemption for the Common Cold Remedy

by Dechert LLP on

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

by Dechert LLP on

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

Implied Preemption And Medical Devices

by Dechert LLP on

Was anyone else out there struck, like we were, that the Court described the preemptive FDA action it recognized in Pliva, Inc. v. Mensing, ___ U.S. ___, 2011 WL 2472790 (U.S. June 23, 2011), in terms of “equivalence”? ...more

Generic Drug Makers Protected from Failure to Warn Claims

by Morrison & Foerster LLP on

In a surprising decision that could affect thousands of pending lawsuits, the Supreme Court held today that federal law preempts failure to warn claims against generic pharmaceutical companies. Justice Thomas delivered the...more

Some Good News On SSRI Preemption

by Dechert LLP on

Finally, a judge with some common sense.... We've always thought (and the FDA did too) that the adult suicide/SSRI warning claims were the strongest possible claims for implied preemption in the prescription drug context....more

Utah Preemption Split Deepens

by Dechert LLP on

We've blogged before about the split among Utah courts about whether Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), preempts the fraud on the FDA exception to Utah's statutory bar (Utah Code Ann. §78B-8-203)...more

New Sharkey Preemption Article

by Dechert LLP on

Catherine Sharkey, one of the leading academic commentators on preemption in the administrative context, has released a new article on the subject, entitled "Inside Agency Preemption." Here's a link to an online copy of the...more

How Is Generic Preemption Like Fraud On The FDA?

by Dechert LLP on

A couple of months ago, we provided our stream-of-consciousness impressions of the Mensing/Demahy generic preemption argument to the Supreme Court. As we mentioned then, we were all set to write an obituary on generic...more

Fasten Your Seatbelt: U.S. Supreme Court Rules Federal Seatbelt Regulation Does Not Preempt State Law Tort Suit

by Morrison & Foerster LLP on

Yesterday the U.S. Supreme Court held in Williamson v. Mazda Motor of America, Inc., 562 U.S. __ (2011), that federal regulations do not preempt a claim for design defect based on the failure to provide lap-and-shoulder belts...more

Weekly Law Resume - December 30, 2010: Federal Preemption Expanded as to State Law Product Liability Claims Involving Medical...

by Low, Ball & Lynch on

This case considered the scope of federal preemption of state law product liability claims involving a medical device. The court held that for a medical device that has been approved for clinical testing pursuant to an...more

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

by Butler Snow LLP on

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

Wyeth v. Levine: No Federal Preemption for Drug Labeling

by Foley Hoag LLP on

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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