Author Archives: Sean T. Stadelman

Blacklist of “Scientific” Journals to Return

For any television fans that may have stumbled upon this post, it has nothing to do with Raymond Reddington and it will not be as clever as this author’s favorite James Spader character, Alan Shore (from Boston Legal). Nonetheless, as readers of scientific journals we were excited at the announcement this week that the “blacklist” of “scientific” journals is returning, albeit from a new publisher and with a little help from the original. For those that may not have followed Jeffrey Beall’s blog that…

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Seventh Circuit: Insurer Has Duty to Defend Drug Distributor in “Pill Mill” Lawsuit

This week, a unanimous Seventh Circuit panel found that a major insurance company has a duty to defend H.D. Smith, L.L.C. against a lawsuit brought by the State of West Virginia. The lawsuit claims that the drug distributor helped cause the state’s prescription drug abuse epidemic by knowingly oversupplying painkillers to certain pharmacies and clinics, pejoratively known as “pill mills.” The decision reversed an earlier ruling by the U.S. District Court for the Central District of Illinois. By way of background, in June 2012, the…

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“Symptom Threshold Methodology” Rejected by Court of Appeals of New York Pursuant to Frye

In an opinion decided February 11, 2016, the Court of Appeals of New York precluded two causation experts put forth by a plaintiff in a toxic tort case. The case involved allegations that a minor was born with severe mental and physical disabilities caused by in utero exposure to unleaded gasoline vapor. The vapor was allegedly emitted into the car from a defective fuel hose. The automobile manufacturer subsequently recalled the vehicle at issue due to defects in the feed fuel hoses. In support of…

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District Court Judge Denies Manufacturer of OTC Pain Reliever Summary Judgment Based on Preemption

Judge Lawrence Stengel of the United States District Court for the Eastern District of Pennsylvania denied summary judgment to the manufacturer of an over-the-counter pain reliever. The manufacturer had sought to dismiss the plaintiff’s fraud and fraudulent misrepresentation claims as preempted by federal law. The Food and Drug Administration (FDA) regulates how OTC drugs should be labeled and sold. The Federal Trade Commission regulates whether an OTC drugs advertising is misleading. In the case before Judge Stengel, the OTC manufacturer argued that the fraud claims…

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Ninth Circuit Outlines for Plaintiff How to Meet the Twombly/Iqbal Standard in a Third Amended Complaint

In this case, the plaintiff, Nicole Weber, appealed the United States District Court for the District of Arizona’s dismissal of her second amended complaint pursuant to Federal Rule of Civil Procedure 12(b)(6). The issue on appeal before the Ninth Circuit panel was whether Weber’s allegations were sufficient to survive a 12(b)(6) motion under the Twombly/Iqbal standard requiring a complaint to set out a plausible claim. Since the Supreme Court’s rulings in Bell Atlantic v. Twombly and Ashcroft v. Iqbal, federal district courts have seen…

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U.S. Supreme Court Denies Certiorari in Generic Pharmaceutical Preemption Case

The United States Supreme Court today issued an order declining a generic pharmaceutical manufacturer’s petition for a writ of certiorari. The drug manufacturer had sought to challenge a ruling from the Iowa Supreme Court. In that state court ruling, the Iowa Supreme Court found that the U.S. Supreme Court’s preemption decision in Mensing did not necessarily prohibit failure to update claims. The U.S. Supreme Court’s decision in Mensing held that failure to warn claims brought against generic drug manufactures were preempted. The plaintiffs’ attorneys have…

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Will Supreme Court End Split Over Whether Generic Drug Companies Can Face “Failure to Timely Update” Claims?

The U.S. Supreme Court (SCOTUS) has (again) been asked to determine the question of whether claims can be made against generic drug manufacturers for failing to timely update and/or disseminate their labels following U.S. Food and Drug Administration (FDA) approvals. Essentially, the issue is whether the time taken by a generic company to effect a labeling change can be tortious and subject to a private cause of action.  A Law360 article with the Petition for Writ of Certiorari in Pliva Inc., v. Huck can be…

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Pennsylvania Supreme Court Overrules Azzarello But Declines Opportunity To Adopt Restatement Third of Torts

On November 19, 2014, the Pennsylvania Supreme Court issued its much-anticipated decision in  Tincher v. Omega Flex, Inc.Having originally granted allowance of appeal to decide whether to replace the strict liability analysis of Section 402A of the Restatement Second, Pennsylvania’s highest court declined the opportunity and instead overruled  its 1978 ruling in Azzarello vs. Black Brothers, 391 A.2d 1020 (Pa. 1978). The four justice majority opinion (available here), written by Chief Justice Ronald D. Castille, held that Pennsylvania will continue to apply…

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Direct Mailers for Aranesp Targeted by FDA

The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) recently criticized the makers of Aranesp for a direct mailer that was allegedly in violation of the Federal Food, Drug and Cosmetic Act (FD&C Act). Specifically, the mailer was found to be false or misleading because it omitted important risk information, suggested use beyond that which was substantiated, made unsubstantiated efficacy claims, and omitted material facts. OPDP also found that the mailer evidenced that Aranesp was intended for a new…

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FDA Using Authority Under Food Safety Modernization Act To Control Dietary Supplements

On Wednesday, November 20, 2013, the Food and Drug Administration (FDA) issued a notice advising consumers that the product Slim Max should not be purchased or used. Slim Max, a weight loss product, was found to contain Sibutramine and Phenolphthalein, according to FDA laboratory analysis. Due to safety concerns, Sibutramine was removed from the market in October 2010. Sibutramine can substantially increase blood pressure and/or pulse rate in some users which may present a significant risk for patients with some medical conditions. Phenolphthalein is classified…

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