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 the Restatement (Second) of Torts, Section 402A rather than adopt the Restatement (Third) of Torts. The majority opinion explained that the appropriate question in products liability litigation is whether either Restatement, Second or Third, articulates a standard of proof for strict liability claims consistent with Pennsylvania common law. ...
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Zoloft MDL Excludes on Daubert Grounds Plaintiffs’ Experts’ Opinions on General Causation

Last month the Pennsylvania federal judge presiding over the multi-district litigation in which the plaintiffs allege that the prescription anti-depressant Zoloft, taken during pregnancy, causes birth defects, issued another in an series of Daubert rulings on the plaintiffs’ proposed experts as to general causation. Although the defendant conceded the qualifications of the three research scientists whose expert evidence was being tested, the reliability of their general causation opinions was hotly contested and received a full evidentiary hearing. The Zoloft court’s rulings represent an important addition to the Daubert jurisprudence that has cut into the plaintiff’s bar’s ability to advance contrived mass, toxic tort litigation in the areas of prescription and over-the-counter medications. The court first addressed the scientists’ opinions as to whether there is a plausible biological mechanism by which ...
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Alabama Supreme Court Decision Lends Support to Plaintiffs’ Innovator Liability Theory

It is a bedrock principle of the American legal system that a product manufacturer is typically not held responsible for an injury to a plaintiff when that manufacturer’s product was not used.  In other words, if a plaintiff was injured while using Product A, the manufacturer of Product B cannot be responsible. This common-sense rule has been challenged over the years by various plaintiffs’ theories, and one of those efforts – the so-called “innovator liability” theory – recently gained a bit more traction in a case from the Alabama Supreme Court called Wyeth v. Weeks. For those who may not be as familiar with innovator liability, a little background. Under federal law, manufacturers of generic pharmaceuticals are required to provide the same FDA-approved warnings with their products that accompany the ...
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Eleventh Circuit Rejects Plaintiff’s Expert Evidence on Daubert Grounds

An important and interesting Daubert opinion was issued yesterday by the 11th Circuit which affirmed the trial court’s Daubert preclusion order against the plaintiff’s experts in litigation seeking to prove that the use of a denture adhesive causes neurological disease.  The decision sets forth the infirmities in the plaintiffs’ expert evidence under Daubert standards. This blog post will be short and reportorial, rather than analytic, because the authors have worked extensively for the defense in the denture cream litigation, and on the Chapman case itself, and we will leave it to others to analyze the import of this decision.  There is a similar opinion, decided on Frye grounds, dealing with many of the same experts from an intermediate appellate court in Pennsylvania with the same result, and well as a Pennsylvania ...
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Defendants in Mass Tort Pelvic Mesh Lawsuits May Now Succeed With Removal to Federal Court – Non-Diverse Defendant Wins Dismissal

In a significant win for Secant Medical LLC, (Secant), Judge Arnold L. New of the Court of Common Pleas of Philadelphia County granted its motion to dismiss mass tort pelvic mesh personal injury claims in a decision dated August 22, 2014.  The court held that under the Biomedical Access Assurance Act (BAAA), Secant is not a manufacturer or seller of the pelvic mesh. Secant, a Pennsylvania company, was undoubtedly named to defeat diversity jurisdiction in an effort by plaintiffs to stay in state court in Pennsylvania.  With its dismissal from the case, there is now diversity jurisdiction, which may enable the remaining defendants to successfully remove the case to federal court.  Judge New’s decision is available here. Secant is the manufacturer of polypropylene mesh that was used in many pelvic ...
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Drug Decision Discusses Learned Intermediary Doctrine and Failure to Warn Claims

On July 28, 2014, Judge Mark R. Hornak of the Western District of Pennsylvania granted Novartis partial summary judgment on product liability claims for Zometa in Rowland v. Novartis Pharmaceuticals Corp., 12-cv-1474.  These plaintiffs brought claims in strict liability, negligence and breach of warranty arising out of their use of Zometa, a prescription bisphosphonate medication for metastatic bone cancer. The plaintiffs claimed that the use of Zometa caused osteonecrosis of the jaw bone. Novartis moved for summary judgment arguing that the plaintiffs’ claims were not viable under Pennsylvania law. The FDA approved Zometa treatment for metastatic bone cancer in February 2002, and Novartis received the first adverse event for osteonecrosis in December of 2002. In September 2003, the first published case report linked osteonecrosis to Zometa.  From September of 2003 to ...
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City of Chicago Files Suit Against Prescription Painkiller Manufacturers

Earlier this week, the City of Chicago filed a lawsuit against five major producers of pharmaceutical products, alleging that the manufacturers concealed the risks associated with certain types of painkillers, such as Oxycontin and Percocet, as well as a host of generics. According to the city, the manufacturers launched a campaign in the 1990s to expand the market for prescription opioids by exaggerating the drugs’ effectiveness while downplaying their risk, even though the companies supposedly knew that the drugs were addictive and could cause long-term health problems from extended use. The suit further contends that the drugs have increased the rate of addiction, causing a major health problem in Chicago and other major American cities. Chicago’s lawsuit follows recent actions filed by two California counties alleging similar claims against prescription ...
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FDA Considers Regulatory Overhaul of Over-the-Counter Drugs

Earlier this year, the FDA announced a review of the system through which it ensures the safety and use of over-the-counter (OTC) drugs, opening the possibility to the most significant reform of OTCs in decades. OTCs are used daily by millions of Americans and generate billions of dollars in revenue each year.  Yet most OTCs are not formally approved by the FDA.  Instead, the FDA publishes regulations, called monographs, that set forth lists of permissible OTC ingredients and labeling claims for therapeutic categories of OTC drugs.  The FDA’s system of notice rulemaking has been in effect since 1972; however, many have criticized the system for its slow process and inability to respond to emerging safety issues.  For instance, last fall, an investigation on acetaminophen, the active ingredient in Tylenol, found ...
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FDA Track-and-Trace Rules Impose New Regulations on Pharmaceutical Industry

The Drug Quality and Security Act, signed into law in November 2013, includes a “track-and-trace” provision that will reform the manufacture and transport of prescription medications. The track-and-trace legislation is designed to curb counterfeit and contaminated drugs from entering the supply chain. As of January 1, 2015, manufacturers and wholesale distributors will be prohibited from shipping any medication unless it has a transaction history or documentation for each individual unit of a drug. Once the law takes effect, drug manufacturers and re-packagers will have to put a unique product identifier that can be scanned on prescription drug packages and groups throughout the supply chain will be required to set up systems to verify the product identifier for every package that comes through. Pharmacists will have to reject any products without ...
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FDA Cracks Down on Promotional Claims Made on Facebook

In this day and age nearly everyone has a Facebook page, including companies which often use Facebook pages to promote their products and services. Given that Facebook is quite an informal marketing medium, companies may not always scrutinize everything they post as highly as they would more organized or targeted media. But that doesn’t mean the Food and Drug Administration isn’t scrutinizing every wall post and status update. On March 12, 2014, the FDA posted an untitled letter to a Switzerland-based international drug maker, noting that it had made misleading and/or misbranding claims about a thyroid drug it manufactures on its Facebook page. Among other things, the FDA noted the drug maker had made promotional claims about the efficacy of the drug without including risk information regarding its use. In ...
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