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 worked diligently since the Mensing decision to craft theories of liability that would not fall under the preemption ambit of Mensing. In the Iowa case, the state court allowed claims against the generic manufacturer to proceed where they were not brought under the sameness requirement ...
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First Circuit Affirms Preemption of State-Law Claim for Consumer Fraud

In a key preemption ruling late last month, the United States Court of Appeals for the First Circuit affirmed the dismissal of a putative class action. The First Circuit affirmed dismissal where the plaintiffs alleged consumer fraud, holding that state-law claims for false or misleading labeling are preempted by federal law. Read the full decision here. The First Circuit’s ruling built upon recent United States Supreme Court decisions holding that state-law claims aimed at generic drug labeling are preempted by applying this important defense to makers of brand named drugs. Background In May 2012, the plaintiffs, Randy and Bonnie Marcus, filed their class claims in California federal district court, seeking to represent a class of consumers who purchased the antidepressant Lexapro for use by an adolescent after early 2009. The ...
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Judge Precludes Plaintiffs’ Experts that “Cherry Picked” Evidence

A recent win for the defense in New Jersey highlights how challenging an expert’s use of unreliable data and methods can be an effective way to prevail. The carefully drafted February 20, 2015 opinion by Judge Nelson Johnson of the Superior Court of New Jersey was a major win for the pharmaceutical manufacturer of Accutane, an acne medication, which the plaintiffs’ said caused them to develop Crohn’s disease. The decision is available here through Law360. Judge Johnson issued his decision after a hearing that took several weeks, in order for the court to determine if the plaintiffs’ expert witnesses met the requisite New Jersey standard set forth in Kemp v. State of New Jersey, 174 N.J. 412 (2002). Under that inquiry, an expert witness must “be able to identify the factual ...
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Recent Philadelphia Verdict Highlights Need to Combat Punitive Damages

In the Philadelphia Court of Common Pleas, a jury recently awarded the plaintiff $2.3 million in compensatory damages for injuries he alleged arose from his use of a diabetes treatment drug.  The plaintiff claimed that the drug company failed to properly warn that its use was linked to a higher incidence of bladder cancer, a condition he subsequently developed.  In addition to awarding a compensatory sum, the jury awarded $1.3 million in punitive damages, apparently based upon evidence that the company’s pharmaceutical reps were instructed not to bring up the link to bladder cancer when marketing the drug to physicians. If the evidence supports that a party acted in a wanton, willful, oppressive or malicious way, or that the party exhibited a reckless indifference to the rights of others, an ...
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Judicial Call for More Guidance on Punitive Damages Awards

Earlier this year, in a bellwether trial in the Actos multidistrict litigation, a Louisiana federal court jury awarded $9 billion  in punitive damages to plaintiffs who claimed that the use of the diabetes drug Actos caused bladder cancer. Not surprisingly, post-trial challenges followed. In particular, while the defendants did not challenge the amount of compensatory damages ($1,475,000), they argued that the award of punitive damages had to be reduced in order to comply with previous United States Supreme Court rulings that established limits on punitive damages pursuant to the Due Process Clause of the United States Constitution. Recently, Judge Rebecca Doherty, the federal judge who presided over the trial, issued her decision regarding the post-trial motions that were filed by the defense. To view Judge Doherty’s order, click here; and her ...
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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 found here. (subscription required) SCOTUS is being asked to rule that the Iowa Supreme Court erred when it held that “federal law does not bar state tort claims predicated on allegations that a generic drug manufacturer violated the FDCA by failing to immediately implement or ...
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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 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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