Author Archives: Michael D. Brophy

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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Pennsylvania Supreme Court Opens Door for Negligent Design Claims Against Pharmaceutical Manufacturers

In a decision with significant potential ramifications, the Pennsylvania Supreme Court has issued a ruling that pharmaceutical companies can be held liable for negligence in the design and marketing of drugs, regardless of claims that the drugs had been properly labeled and tested, as well as approved by the U.S. Food and Drug Administration. The ruling, announced January 22nd, upholds an intermediate appellate court decision against a Pfizer, Inc. subsidiary in a wrongful death action involving the diet drug Redux. In its 4-2 decision, the…

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Newly Released Study Links Glaucoma to Long-Term Use of Oral Contraceptives

Building upon data secured from the Centers for Disease Control and Prevention, an international team of researchers has concluded that women who have used birth control pills on a long-term basis are twice as likely to have glaucoma, a leading cause of blindness in the United States. Glaucoma is caused by increased fluid pressure on the eye, resulting in irreversible damage to the optic nerve. Glaucoma usually affects patients who are middle-aged and older, and has no known cure. Scientists from the University of California,…

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Philadelphia Jury Returns $4 Million Verdict in Topamax Lawsuit, But Will it Stand?

A Philadelphia County jury returned a verdict in excess of $4 Million on behalf of plaintiffs who alleged that their child suffered birth defects related to his mother’s use of Topamax during pregnancy, but the complex procedural battle which occurred before the October 30th verdict suggests that the final chapter has yet to be written in this case. Plaintiffs, April and Blake Czimmer, filed suit in 2011 alleging that April took the anti-seizure medication Topamax (Topiramate) for six months during her pregnancy, and their child…

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Indiana Appellate Court Holds Negligence Action Involving Medtronic Defibrillator Not Preempted by Federal Law

An Indiana appellate court decided that oral representations by a medical device manufacturer during a surgery about the function of device are not preempted by federal law.  Could this be a significant exception to the U.S. Supreme Court’s seminal decision in Riegel vs. Medtronic? In 1997, David Malander received an implanted Medtronic defibrillator and right ventricular lead (“Lead”), which remained in place until he began experiencing problems several years later.  The Lead was a Class III medical device subject to premarket approval by the…

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European Union’s Proposed Regulations Governing Medical Devices Raise Multiple Concerns for US Manufacturers

On September 25, 2013, the European Parliament Committee on the Environment, Public Health and Food Safety (“ENVI”) voted on draft Regulations including a proposal concerning high risk medical devices, raising concerns among US manufacturers. Expectations that a more restricted process in Europe could undermine the development of domestic medical devices appear increasingly well-founded, but the entire story has yet to be played out overseas. At issue is an attempt by the European Union (“EU”) to close loopholes that allowed breast implants made with industrial-grade silicone…

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Florida Federal Court Allows Claim that Novartis Should Have Issued “Black Box” Warning on Zometa

A United States District Court Judge, sitting in the Middle District of Florida, has rejected arguments by Novartis Pharmaceutical Corporation (“Novartis”) that federal law would prohibit claims that the company should have added “Black Box” warnings regarding potential side effects of Zometa, including potential bone loss.  As a result, plaintiffs will be allowed to proceed with their claims notwithstanding the company’s arguments (1) that all of the failure-to-warn claims were controlled by the Supreme Court’s 2009 decision in Wyeth vs. Levine; and (2) that…

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New Jersey Supreme Court Rejects Federal Approach, Refuses to Consolidate Tylenol Liver Cases in New Jersey

On August 16, 2013 the New Jersey Supreme Court denied a request to consolidate all pending Tylenol liver injury lawsuits in the state court system before a single judge, finding that the cases were inappropriate for centralized management as “Multicounty Litigation”.  Earlier this year, the U.S. Judicial Panel on Multidistrict Litigation established coordinated proceedings for Tylenol litigation, assigning Judge Lawrence Stengel of the United States District Court, Eastern District of Pennsylvania, to supervise all pretrial proceedings. Approximately 14 lawsuits have been filed in New Jersey…

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European Medicines Agency Issues New Restrictions on Reglan

On July 26, the European Medicines Agency (EMA) announced new restrictions on medications containing metoclopramide, known generally by the brand name Reglan, in the most recent development based upon potential neurological side effects related to use of this medication. Use of metoclopramide increased significantly in the 1990s after its predecessor, Cisapride, was found to cause serious side effects. By 2004, however, research began to suggest that use of metoclopramide was potentially related to a movement disorder known as tardive dyskinesia. Symptoms of tardive dyskinesia may…

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GlaxoSmithKline Announces $229 Million Settlement of Avandia Lawsuits

British drugmaker GlaxoSmithKline (GSK) announced on July 25th that it would pay $229 million to resolve lawsuits brought by eight U.S. states related to improper marketing of its diabetes drug Avandia (rosiglitazone).  In a regulatory filing, GSK said the settlement was within provisions it had previously set aside for litigation, and also resolved claims brought by the Attorney General of Louisiana involving other GSK products. The announcement by GSK explained that the settlements had been undertaken in order to avoid lengthy trials, and did…

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