FDA Gets Aggressive With Companies Over Marketing of Alleged Diabetes Treatments

The U.S. Food and Drug Administration (FDA) has started its campaign to stop sales of multiple products advertised and labeled as diabetes treatments. According to data from 2011, over 25 million people in the U.S. have diabetes and perhaps more alarming is that 79 million people have prediabetes. Clearly there is a market for diabetes remedies. To read the rest of this blog post, please visit Risky Business: Avoiding Product Liability, Commercial, and Other Litigation
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Preemption Defense Not Completely Dead for Branded Drugs

As all who follow drug and device law know full-well, the 2009 decision from the United States Supreme Court in Wyeth v. Levine represented a significant setback for brand-name drug manufacturers seeking to defend failure-to-warn claims on preemption grounds.  In Levine, the court held that state law failure-to-warn claims involving brand-name drugs are not preempted, unless there is “clear evidence” that the Food and Drug Administration (FDA)  would not have approved whatever labeling change forms the basis for the failure-to-warn claim.  Such a standard…
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Trio of Favorable Preemption Decisions for New Jersey Pharmaceutical Companies

A trio of recent preemption decisions – from the United States Supreme Court, the United States District Court for the District of New Jersey, and the Superior Court of New Jersey – are good news for pharmaceutical companies facing product liability suits in New Jersey. First, in Mutual Pharmaceutical Co. v. Barlett, the United States Supreme Court issued an important ruling (copy available here) on several critical issues affecting product liability suits against generic pharmaceutical manufacturers.  Bartlett involved claims by a woman that…
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HHS Proposes to Undo the Supreme Court Rulings in Pliva and Bartlett by Regulation Changes

In 2011, the Supreme Court decided PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011), which affected “75 percent of all prescription drugs dispensed in this country.”  The court held that because the FDA requires generic drug manufacturers to use the same labels and warnings as those of the name-brand manufacturer, state law claims against generic companies regarding labeling and warnings are pre-empted. Put another way, because generic drug manufacturers cannot change their labels or warnings, even if they later learn of additional risks associated…
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Supreme Court Holds that State Law Tort Claims Regarding Labeling of Generic Drugs are Preempted

In Mutual Pharmaceutical Co. v. Barlett, plaintiff Karen Bartlett alleged that she took Mutual’s generical non-steroidal anti-inflammatory drug, sulindac, in 2004 after her doctor prescribed it for shoulder pain.  She suffered a rare hypersensitivity reaction three weeks after she started taking and she was left severely disfigured with burn-like lesions over two-thirds of her body.  The plaintiff’s action was based upon a design defect theory after her failure-to-warn claims were dismissed prior to trial and the district court rejected the defendant’s preemption defense. A…
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Cephalon’s Billion Dollar Patent Struck Down

On April 8, 2013, the Federal Court upheld the trial court’s judgment of invalidity and unenforceability for Cephalon’s RE’516 patent.  Cephalon’s RE’516 patent used to protect their mainstay drug – Provigil®.  Provigil® is the brand name for modafinil which is used to treat sleep disorders.  In 2007, Cephalon, now owned by Teva Pharmaceuticals, had over $800 million in sales from Provigil®. Apotex, a generic drug manufacturer, challenged the validity and enforceability of Cephalon’s RE’516 patent, in Apotex, Inc. v. Cephalon Inc.  The trial court found…
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Compounding Pharmacies – Good or Bad?

Compounding pharmacies are no longer serving their original purpose and can potentially be causing more harm than good.  Compounding pharmacies originally converted pills into a liquid form of medicine for individuals who could not swallow pills.  Now, some compounding pharmacies manufacturer prescription drugs in mass quantities and have been tied to outbreaks such as the fungal meningitis outbreak in 2012. There are thirty compounding pharmacies in eighteen states in the United States.  A House subcommittee is holding a hearing on April 16, 2013, to determine…
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A Potential Godsend to Mothers-to-Be

After a 30-year hiatus, the Food and Drug Administration (FDA) has once again approved a drug to specifically treat morning sickness.  Diclegis, made by Canadian Duchesnay Inc., is scheduled to be available in June 2013.  Diclegis combines Vitamin B6 and antihistamine doxylamine in a time released formula to prevent nausea before it sets in. The same drug combination was marketed as Benedectin from the 1950’s to 1980’s.  Despite no conclusive medical evidence that it caused birth defects and court rulings in its favor, Merrell Dow…
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