Category Archives: Preemption

Banana Boat High SPF Sunscreen Class Action Survives Challenge

A California plaintiff survived a challenge to her consumer fraud complaint against Playtex Products and other makers of Banana Boat sunscreens with SPF [sun protection factor] of 85 to 110.  The critical allegation is the claim that that scientific studies show that sunscreen with SPF over 50 provides no clinically-significant benefit over the use of SPF 50 products.  Plaintiff claims the marketing of the Banana Boat products is misleading because the advertising campaign combined extreme SPF values with unproven claims of greater sun protection than…

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Litigation Concerns Rise as FDA Proposes Reclassification of Tanning Beds

The Food and Drug Administration (FDA) issued a press release regarding its proposed order to reclassify sunlamp products from a Class I medical device (low risk) to a Class II medical device (moderate risk).  Additionally, the FDA is now recommending that persons under the age of 18 be warned to not use these products at all. The FDA press release notes that “[a]ccording to the American Academy of Dermatology, there is a 75 percent increase in the risk of melanoma, the deadliest type of skin…

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More Class III Medical Device Decisions

Two more preemption cases involving Class III medical devices were recently decided.  One was a 12(b)(6) motion to dismiss, and the other was decided in the context of a motion to amend a complaint to add a failure to warn and a breach of warranty claim.  The standard of review for the two motions is the same. The first case we discuss (Gavin v Medtronic) involved a variety of legal theories based on alleged off label promotion by the manufacturer.  The court rejected…

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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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Preemption Wars Over Class III Medical Devices Continue

Preemption wars over Class III medical devices continue unabated.  The plaintiff’s bar is vigilant, creative and undeterred in their efforts to limit the effects of the Buckman case.  In some cases, their efforts are rewarded.  An example is a case decided just this week.  The issue was addressed in a device manufacturer’s 12(b)(6) motion to dismiss a lawsuit against a Class III device on federal preemption grounds.  According to the court’s opinion, a previous preemption motion to dismiss was granted with leave to re-plead.  The…

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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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Changing the Law on Federal Preemption of Medical Devices?

St. Jude Medical Inc. is at the center of a number of lawsuits about an allegedly defective implanted defibrillator.  The lawsuits allege that the Riata defibrillator had faulty leads which caused the devices to fail or deliver excess electricity.  The plaintiffs allege that 30 people died as a result. Plaintiffs see this lawsuit as a way to reach the Supreme Court and reverse its decision in Riegel v. Medtronic.  The governing precedent generally holds that state court product liability claims are preempted by federal…

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