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Parties seek dismissal in case questioning FDA authority to regulate animal-drug compounding

Shook Hardy & Bacon LLP
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USA
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October 25 2012

A Florida pharmacist, whom the Food and Drug Administration (FDA) sought to enjoin from filling veterinarians’ prescriptions for non-food producing animals by compounding from bulk substances without FDA approval, has joined with the U.S. government in seeking the dismissal of its appeal from a district court decision finding that FDA had no authority to do so

No SCOTUS review for ear candlers’ challenge to FDA warning letters

Shook Hardy & Bacon LLP
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USA
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October 25 2012

The U.S. Supreme Court has denied the petition for review filed by the Holistic Candlers and Consumers Association and others claiming that the D.C. Circuit Court of Appeals erred when it determined that Food and Drug Administration (FDA) warning letters are not subject to judicial review

Italy’s Supreme Court links mobile phones to brain tumors in landmark ruling

Shook Hardy & Bacon LLP
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Italy
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October 25 2012

Italy’s Supreme Court of Cassation has reportedly affirmed a lower court ruling allowing businessman Innocente Marcolini to recover compensation for developing a brain tumor after using a mobile phone for up to six hours each day for 12 years

FDA seeks dismissal of whistleblower retaliation claims

Shook Hardy & Bacon LLP
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USA
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October 11 2012

In an ongoing dispute between scientists critical of the Food and Drug Administration’s (FDA’s) medical-device review process, FDA has sought to dismiss claims of adverse employment action allegedly taken in retaliation for whistleblowing

FDA urges SCOTUS to reject review in ear candles case, says warning letters are not reviewable in court

Shook Hardy & Bacon LLP
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USA
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September 27 2012

The Food and Drug Administration (FDA) has urged the U.S. Supreme Court to reject the petition for review filed by the Holistic Candlers and Consumers Association and companies making ear candle products from a D.C. Circuit Court of Appeals ruling dismissing their challenge to FDA’s warning letters about their products

Federal Circuit rules claim for injury benefits under Vaccine Act filed too late

Shook Hardy & Bacon LLP
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USA
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August 23 2012

Finding the Vaccine Act unambiguous, the Federal Circuit Court of Appeals has affirmed a Federal Claims Court ruling that did not allow the estate of a woman whose death was allegedly caused by an influenza vaccination to recover for injury benefits

Class claims dietary supplements with DMAA are dangerous, alleges consumer fraud

Shook Hardy & Bacon LLP
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USA
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June 28 2012

Seeking to certify a nationwide class and statewide subclass of consumers, an Illinois resident has filed a lawsuit against the companies that make and sell dietary supplements intended for weight loss, alleging that they contain dangerous stimulants, including an illegal synthetic compound referred to as DMAA, as well as “large amounts of caffeine, synephrine, and yohimbine.”

Disbarred fen-phen attorneys ordered to forfeit assets

Shook Hardy & Bacon LLP
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USA
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June 28 2012

A federal judge in Kentucky has issued an order allowing the U.S. Marshal to seize property owned by two plaintiffs’ attorneys who were disbarred and ordered to pay former clients $127 million from a class action settlement involving the diet pill fen-phen

FDA warning letters bring round of class actions against dietary supplement makers

Shook Hardy & Bacon LLP
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USA
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May 10 2012

According to a news source, seven of the 10 dietary supplement companies that recently received Food and Drug Administration (FDA) warnings have been sued for consumer fraud in a federal court in California

First Circuit finds design defect claims against generic drug maker not preempted

Shook Hardy & Bacon LLP
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USA
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May 10 2012

The First Circuit Court of Appeals has upheld a jury verdict of $21.06 million in compensatory damages awarded to a women allegedly injured by a generic drug she took for shoulder pain, finding, among other matters, that her state law-based design-defect claims were not preempted by federal law