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Generic drug manufacturers and failure to warn: what duty is there after Pliva v. Mensing?

Sheppard Mullin Richter & Hampton LLP
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USA
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June 27 2011

The Supreme Court ruled on June 23, 2011, that generic drug manufacturers cannot be sued for a failure to warn under state tort law, as long as their labeling complies with the FDA mandated labeling for the innovator drug product

Generic drug preemption scorecard

Dechert LLP
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USA
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September 20 2011

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 drugvaccine preemption

Gunvalson revisited

Dechert LLP
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USA
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April 6 2011

We've been vigilant opponents of plaintiffs who would impose new duties upon drug and device companies with respect to products still in the development pipeline

Expanded liability for generic, brand manufacturers ahead?

Pepper Hamilton LLP
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USA
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May 18 2011

Consider the following scenario: A research-based pharma companycall it "X Pharma"discovers and patents a compound that holds great promise as a treatment for a widespread, chronic condition

Safe-harbor provision of Hatch-Waxman Act does not protect post-approval research activities

Sheppard Mullin Richter & Hampton LLP
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USA
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October 24 2011

The Federal Circuit issued its opinion in Classen Immunotherapies, Inc. v. Biogen Idec, 2011 U.S. App. Lexis 18126, on August 31, 2011

Post-Mensing sands still shifting on generic design defect claims

Baker Donelson Bearman Caldwell & Berkowitz PC
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USA
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February 14 2013

Pharmaceutical companies anticipate that the next several months will provide needed clarity and consistency regarding the pre-emption landscape for

FDA User Fee Act full of surprises for pharma and biotech

Morgan Lewis & Bockius LLP
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USA
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July 25 2012

FDA user fee reauthorization law expands fees to include generic and biosimilar applications, and includes a new emphasis on drug supply chain safety and incentives for development of new therapies

DRI seeks to protect against "innovator liability"

Epstein Becker Green
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USA
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January 12 2012

In the case of Wyeth v. Weeks, the Alabama Supreme Court consented to answer the following question from the Middle District of Alabama: “Under Alabama law, may a drug company be held liable for fraud or misrepresentation (by misstatement or omission), based on statements it made in connection with the manufacture or distribution of a brand-name drug, by plaintiffs claiming physical injury from a generic drug manufactured and distributed by a different company?"

Another court throws generic plaintiffs a lifeline

Dechert LLP
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USA
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January 18 2012

As evidenced by our generic preemption scorecard the post-Mensing scales have been heavily tipped in favor of the generic manufacturers who have racked up dismissals across the country

Developments in federal pre-emption after Pliva v Mensing

Arnold & Porter LLP
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USA
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August 30 2012

In recent months a number of courts have been called upon to interpret and apply the US Supreme Court's holding in that federal pre-emption bars failure-to-warn claims against a generic drug manufacturer whose labelling mirrors the Food and Drug Administration approved labelling for the brand-name counterpart of the generic product

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