Illinois Federal Court Considers Whether Plaintiff Expert’s Methodologies Were Sufficiently Reliable under Daubert in a Pharmaceutical Case

GlaxoSmithKline has attempted to knock out the plaintiff’s experts in Dolin v. GlaxoSmithKline, in its latest round of Daubert motions. Wendy Dolin is suing GSK after the suicide death of her prominent lawyer husband, who had been taking the generic form of Paxil, paroxetine, an antidepressant.  This case made national news just a year ago when Judge Zagel of the Northern District of Illinois held that GSK could be liable for Dolin’s death under a negligence theory, not a product liability theory, even though he only consumed the generic equivalent manufactured by Mylan and did not consume a GSK product. That decision was in stark contrast to 90 other court decisions that have all rejected brand-name manufacturer liability for generic products. In light of that decision, GSK’s defense of the case ...
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Drug Promotion on Social Media By Consumers: Can It Be Regulated?

Kim Kardashian recently used social media to promote the use of a prescription drug. In her Instagram post, Ms. Kardashian told her followers that a physician recommended use of the drug Diclegis to alleviate her symptoms of morning sickness. Ms. Kardashian is not the only public figure to recently deal with morning sickness as the Duchess of Cambridge also dealt with this issue, reported here. Having experienced positive results following the use of this drug, Ms. Kardashian posted her intent to pair with the maker of Diclegic to “raise awareness about treating morning sickness.” Other than noting that studies have shown no increased risk to the baby due to the use of this drug, Ms. Kardashian did not reference any potential complications or known side-effects of the drug in her ...
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Preemption Ruling: Federal Appeals Court Strikes Strict Liability and Warranty Claims As to “Off-Label” Use of Bone Graft Device

Last week, the U.S. Court of Appeals for the 10th Circuit in Denver, in a 2-1 decision, upheld a trial court ruling dismissing a complaint on the grounds that federal law preempted a plaintiff’s state law breach of warranty and design defect claims. The claims stem from complications following the alleged “off-label” manner of implantation of a spinal bone graft system. Click here for the opinion in Caplinger. Background As the majority explained, under the Food, Drug, and Cosmetics Act, and the Medical Device Amendments thereto, a medical device manufacturer’s products and labeling must receive prior approval. Once approved, changes are not usually permitted without FDA consent. Although Congress expressly provided for the supremacy of federal law regarding medical devices, 21 U.S.C. §360k(a), legal challenges frequently arise when plaintiffs seek to ...
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Texas Court Holds that Compounding Pharmacies are Subject to Requirements of the Texas Medical Liability Act

On April 24, 2015, in a significant win for pharmacies in the State of Texas, the Texas Supreme Court dismissed a plaintiff’s product liability action that alleged that the lipoic acid treatment she received caused her to go blind. The court held that the defendant compounding pharmacy that provided the supplement was entitled to protection under the Texas Medical Liability Act (TMLA) and dismissed the case. The decision is available here. In 2011, Ms. Miller was undergoing weekly injections of lipoic acid with her physician to treat a medical condition. She had no reaction to the first 9 weeks of treatment, but while receiving the tenth treatment she had a severe adverse reaction and was hospitalized. She is now permanently blind in both eyes. A licensed compounding pharmacy in Arlington, Texas ...
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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 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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