Author Archives: Matthew R. Shindell

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 Holds Plaintiffs May Assert Negligent Design Claims Against Drug Companies

The Pennsylvania Supreme Court in Lance v. Wyeth (2014 Pa.LEXIS 205) recently ruled that pharmaceutical companies can be held liable for negligent design, testing, marketing, and distribution of drugs regulated by the FDA. This decision alters the landscape of Pennsylvania law because pharmaceutical companies previously succeeded in having similar claims dismissed based upon the learned intermediary doctrine. Under this doctrine, the manufacturer of prescription medications discharges its duty to warn users of the risks associated with its products by warning the prescribing physician of…

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Drug Quality and Security Act

In October of 2012, a meningitis outbreak that caused the death of sixty-four people was traced to tainted steroids purchased from a Compounding Center in New England.  In response to this outbreak, last November President Barack Obama signed the Drug Quality and Security Act into law, which overhauls the FDA’s regulation of Compounding Pharmacies by establishing a system to trace the supply chain of prescription drugs. (See the bill here). Furthermore, under this bill, the FDA is given more authority to regulate and monitor…

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Drug Quality and Security Act

In October of 2012, a meningitis outbreak that caused the death of sixty-four people was traced to tainted steroids purchased from a Compounding Center in New England.  In response to this outbreak, last November President Barack Obama signed the Drug Quality and Security Act into law, which overhauls the FDA’s regulation of Compounding Pharmacies by establishing a system to trace the supply chain of prescription drugs. (See the bill here). Furthermore, under this bill, the FDA is given more authority to regulate and monitor…

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Pennsylvania Superior Court Upholds Dismissal of Suit Claiming Paxil Caused Birth Defects

The Pennsylvania Superior Court recently upheld the trial court’s ruling in Thomas v. SmithKline Beecham Corp., 27 Pa.D.&C. 5th 279 (Pa.Commw. Ct. 2012).  Thomas dismissed plaintiff’s wrongful death and survival claims based on her use of the antidepressant drug Paxil during pregnancy as time barred.  She ingested Paxil during her pregnancy and she was subsequently informed in 2001 that a fetal echocardiogram revealed that her fetus had congenital heart defects.  Three days later she chose to undergo a therapeutic abortion at less than…

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United States Supreme Court to Determine Whether It Should Hear Lupron Labeling Suit

The United States Supreme Court has been asked to determine whether a drug manufacturer’s older labeling is admissible to establish its failure to warn consumers of a product’s dangerous side effects.  See the Petition for Writ of Certiorari here.   In Klein v. TAP Pharmaceutical, 518 Fed.Appx. 583 (9th Cir. May 14, 2013), the plaintiff alleged a drug manufactured and marketed by TAP Pharmaceuticals, in a joint venture with Abbott Laboratories, did not contain adequate warnings regarding the dangerous side effects associated with Lupron…

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D.C. Circuit to Determine if FDA can Regulate Stem Cell Treatments

The intersection of what is the practice of medicine and what is a regulated drug or biologic is an interesting place with constitutional and regulatory implications. These issues have come to the forefront in a significant case involving an autologous stem cell procedure used by an orthopedic group in Colorado.  In United States of America v. Regenerative Sciences, LLC, 878 F. Supp. 2d. 248 (D.D.C. 2012), available here,  a D.C. district court judge issued an opinion addressing many of these constitutional and regulatory issues, which…

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FDA Requires Drug Company to Address Quality Control Issues

Earlier this month, the United States Food and Drug Administration (FDA) sent a warning letter to Posh Chemicals Pvt. Ltd. (Posh), an Indian drug manufacturing company, to improve its documentation regarding its quality control and testing systems. The drug company was warned that its failure to correct these issues would result in the FDA refusing admission of its products into the United States. Last March, the FDA inspected Posh and found it lacked the ability to protect data concerning its products from becoming altered or…

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Congress’ Concern with Heparin Supply

The United States Food and Drug Administration has determined more than 90 deaths were caused by contaminated Heparin imported from China in 2008.  Heparin is widely used as an injectable anticoagulant during heart surgery and kidney dialysis.  Last week, concern was raised in the United States House of Representatives regarding Shanghui International Holdings Ltd’s pending $4.7 acquisition of Smithfield Food Inc., which is a supplier of raw heparin.  House Republicans believe this business transaction could threaten the safety and availability of the drug.  Apparently, concerns…

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New Jersey Appellate Court Takes Bite Out Of Zometa Cases

The drug Zometa, which is manufactured by Novartis Pharmaceuticals Corporation, is used to prevent skeletal fractures in patients with various cancers.  Novartis has been hit with some plaintiff’s verdicts recently where it was alleged that it failed to disclose dead jaw bone risks associated with Zometa.  However, two recent appellate rulings in New Jersey have clarified any ambiguity associated with the application of that state’s statute of limitations for similar cases.  Under New Jersey law, the statute of limitations in product liability actions…

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