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Agree to disagree: FDA and customs origin and drug labeling requirements

Drinker Biddle & Reath LLP
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USA
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March 7 2013

When merchandise is imported into the United States, there is a slew of information required to be reported to United States Customs and Border

Sequestration: the ripple effect on the life sciences industry

Drinker Biddle & Reath LLP
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USA
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March 1 2013

With sequestration scheduled to take effect today, the looming cuts to the U.S. Food and Drug Administration are concerning for the whole of the life

Update: Second Circuit rejects government’s off-label enforcement approach

Drinker Biddle & Reath LLP
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USA
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January 24 2013

On Wednesday, January 23, Food and Drug Administration officials said the government will not appeal the decision in the United States v. Caronia, No

Second Circuit throws out conviction for off-label marketing as violating the First Amendment

Drinker Biddle & Reath LLP
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USA
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December 17 2012

The recent decision in United States v. Caronia, No. 09-5006-cr (2d Cir. Dec. 3, 2012) dealt a blow to the government's efforts to prosecute off-label

Whistleblower lawsuit against drug maker fails because “off-guideline” marketing does not constitute “off-label” marketing

Drinker Biddle & Reath LLP
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USA
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November 27 2012

In welcome news for the pharmaceutical industry, the U.S. District Court for the Eastern District of New York, in United States ex rel. Polansky v. Pfizer, Inc., 2012 U.S. Dist. LEXIS 163557 (E.D.N.Y. Nov. 15, 2012), issued a decision distinguishing between unlawful “off-label” marketing and lawfully marketing a drug for use outside of recommended guidelines

The FDA proposes new rule on unique medical device identification and marking requirements

Drinker Biddle & Reath LLP
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USA
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August 2 2012

The United States Food and Drug Administration (FDA) has proposed a rule establishing a unique device identification system for medical devices and requiring a unique device identifier (UDI) to be placed on medical devices and device packages

Plaintiffs’ attempts to hold brand manufacturers liable for harm caused by generic products thwarted again despite Mensing’s glimmer of hope

Drinker Biddle & Reath LLP
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USA
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May 2 2012

The Conte decision is well known by brand and generic manufacturers alike

Illinois Supreme Court applies risk-utility analysis in negligent design case and refuses to expand a manufacturer’s postsale duty to warn in reversal of $43 million jury verdict in exploding gas tank accident case

Drinker Biddle & Reath LLP
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USA
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May 2 2012

In a significant victory for product manufacturers, the Illinois Supreme Court reversed a $43 million jury verdict against defendant Ford Motor Company in a case involving a fatal accident in which the fuel tank of a 1993 Lincoln Town Car exploded

Update on California Civil Jury Instructions concerning products liability litigation

Drinker Biddle & Reath LLP
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USA
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May 2 2012

As reported in our June 2011 Newsletter, the Judicial Council of California in 2011 proposed revisions to California Civil Jury Instructions related to the element of the foreseeability and effect of product misuse

A tried and true summary judgment option in pharmaceutical and medical device failure to warn cases

Drinker Biddle & Reath LLP
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USA
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May 2 2012

Summary judgment is a manufacturer’s goal in almost every case

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Search results

Agree to disagree: FDA and customs origin and drug labeling requirements

Sequestration: the ripple effect on the life sciences industry

Update: Second Circuit rejects government’s off-label enforcement approach

Second Circuit throws out conviction for off-label marketing as violating the First Amendment

Whistleblower lawsuit against drug maker fails because “off-guideline” marketing does not constitute “off-label” marketing

The FDA proposes new rule on unique medical device identification and marking requirements

Plaintiffs’ attempts to hold brand manufacturers liable for harm caused by generic products thwarted again despite Mensing’s glimmer of hope

Illinois Supreme Court applies risk-utility analysis in negligent design case and refuses to expand a manufacturer’s postsale duty to warn in reversal of $43 million jury verdict in exploding gas tank accident case

Update on California Civil Jury Instructions concerning products liability litigation

A tried and true summary judgment option in pharmaceutical and medical device failure to warn cases

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