Justia Drugs & Biotech Opinion Summaries

In this appeal arising from a demurrer, Plaintiffs could allege a cause of action against Novartis Pharmaceuticals Corporation for warning label liability.The Supreme Court affirmed the Court of Appeal, which directed the trial court to enter an order sustaining Novartis’s demurrer with leave to amend Plaintiffs’ negligence and negligent misrepresentation causes of action. Plaintiffs claimed, inter alia, that Novartis knew or should have known that its warning label failed to alert pregnant women or their doctors to the risk Brethine posed to fetal brain development. Novartis filed a demurrer, arguing that it had no duty to Plaintiffs. The trial court sustained the demurrer without leave to amend. The Court of Appeal reversed and directed that the order sustaining the demurrer be modified to grant Plaintiffs leave to amend their causes of action for negligence and negligent misrepresentation. The Supreme Court affirmed, holding (1) brand-name drug manufacturers have a duty to use ordinary care in warning about the safety risks of their drugs, regardless of whether the injured party was dispensed the brand-name or generic version of the drug; and (2) a brand-name manufacturer’s sale of the rights to a drug does not terminate its liability for injuries foreseeably and proximately caused by deficiencies present in the warning label prior to the sale. View "T.H. v. Novartis Pharmaceuticals Corp." on Justia Law

Petitioner, by and through her mother and next friend, was one of nineteen minor plaintiffs who alleged that they sustained birth defects as a result of their mothers’ use of the prescription medication Zoloft. The Mass Litigation Panel granted summary judgment to Respondents - Pfizer, Inc., Roerig, a division of Pfizer, Inc., and Greenstone, LLC - upon concluding that there existed no genuine issue of material fact and that Pfizer was entitled to judgment as a matter of law. The Supreme Court affirmed, holding that the Panel correctly concluded that (1) Michigan law governed Petitioner’s claims; (2) federal law operated to preempt the exception to Michigan’s failure to warn immunity where Zoloft has received FDA approval; (3) no genuine issues of material fact remained in the case; and (4) Respondents were entitled to judgment as a matter of law. View "M.M. v. Pfizer, Inc." on Justia Law

This products liability lawsuit centered on Risperdal. Louise Taylor began suffering psychotic episodes when she was seventy-one years old, in early 1998. From March 1998 to January 2001, Psychiatrist Richard Rhoden prescribed Risperdal to Taylor for the treatment of her recurrent psychotic manifestations. In February 2001, Taylor developed tardive dyskinesia, a syndrome of potentially irreversible, involuntary, dyskinetic movements in patients treated with antipsychotic drugs. In 2002, Taylor filed a complaint against Ortho-McNeil Janssen Pharmaceuticals, the manufacturer, seller, and distributer of Risperdal, and its parent company Johnson & Johnson (collectively “Janssen”), claiming that Risperdal caused her to develop tardive dyskinesia. Taylor also named her treating physician, Dr. Richard Rhoden, as a defendant in her complaint. Taylor settled her claims against Dr. Rhoden prior to trial. The case went to trial oin 2014. The jury, in a nine to three decision, found that Taylor was harmed by Risperdal due to: (1) Janssen’s “failure to provide adequate warnings/instructions” and (2) Janssen’s “negligent marketing/misrepresentation.” The jury awarded Taylor $650,000 in actual economic damages and $1.3 million in noneconomic damages, for a total damages award of $1,950,000. On review, the Mississippi Supreme Court held that, as a matter of law, the Risperdal in question contained an adequate warning; the Court reversed and rendered the statutory inadequate warning judgment. Furthermore, the Court held that various errors in the jury instructions required reversal of the plaintiff’s verdict that sounded in negligent misrepresentation, and the Court reversed and remanded the negligent misrepresentation claim. View "Johnson & Johnson, Inc. v. Fortenberry" on Justia Law

After plaintiff's son died of Hepatosplenic T-cell lymphoma (HSTCL), an exceedingly rare and aggressive form of cancer, they filed suit alleging negligence and strict liability concerning the manufacture and distribution of drugs used to treat inflammatory bowel disease (IBD). The Ninth Circuit reversed the grant of summary judgment to Teva, holding that the district court erred by excluding plaintiffs' causation experts' testimony. In this case, the district court looked too narrowly at each individual consideration under Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 589 (1993), without taking into account the broader picture of the experts' overall methodology. The district court improperly ignored the experts' experience, reliance on a variety of literature and studies, and review of the son's medical records and history, as well as the fundamental importance of differential diagnosis by experienced doctors treating troubled outpatients. Furthermore, the district court overemphasized the fact that the experts did not develop their opinions based on independent research and the experts did not cite epidemiological studies. The panel reversed the district court's grant of summary judgment to Teva in regard to the duty to warn claim because there was a genuine dispute of material fact as to whether the prescribing physician's conduct would have changed with warnings from Teva and GSK. The panel declined to affirm the district court on four alternative grounds and reversed the district court's denial of plaintiffs' motion for reconsideration. View "Wendell v. GlaxoSmithKline" on Justia Law

In multi-district litigation involving 315 product liability claims, plaintiffs alleged that Pfizer’s drug, Zoloft, a selective serotonin reuptake inhibitor (SSRI), caused cardiac birth defects. The Plaintiffs’ Steering Committee introduced several experts to establish causation. The testimony of each of these experts was excluded in whole or in part. In particular, Nicholas Jewell, Ph.D., a statistician, used the “Bradford Hill” criteria to analyze existing literature on the causal connection between Zoloft and birth defects. The district court conducted a Daubert hearing, excluded Jewell's testimony, and granted summary judgment to defendants, stating that Jewell: “failed to consistently apply the scientific methods he articulates, has deviated from or downplayed certain well-established principles of his field, and has inconsistently applied methods and standards to the data so as to support his a priori opinion.” The Third Circuit affirmed, holding that the district court did not require replication of significant results to establish reliability, but merely made a factual finding that teratologists generally require replication of significant results, and this factual finding did not prevent it from considering other evidence of reliability. View "In Re: Zoloft t (Sertraline Hydrochloride) Products Liability Litigation" on Justia Law

Hundreds of plaintiffs sued the drug manufacturer Merck, alleging that the osteoporosis drug Fosamax caused them to suffer serious thigh bone fractures. Each brought a state-law tort claim alleging that Merck failed to add an adequate warning of the risk to Fosamax’s FDA-approved drug label. Many also brought claims including defective design, negligence, and breach of warranty. Plaintiffs’ suits were consolidated in multi-district litigation in the District of New Jersey. Following discovery and a bellwether trial, the court granted Merck summary judgment, based on the Supreme Court’s holding in Wyeth v. Levine, that state-law failure-to-warn claims are preempted when there is “clear evidence” that the FDA would not have approved the warning that plaintiffs claim was necessary. The Third Circuit vacated. Preemption is an affirmative defense; Merck did not carry its burden to prove that it is entitled to that defense. The Wyeth “clear evidence” standard is demanding and fact-sensitive. It requires a court sitting in summary judgment to anticipate the range of conclusions that a reasonable juror might reach and the certainty with which the juror would reach them. Here, plaintiffs produced sufficient evidence for a reasonable jury to conclude that the FDA would have approved a properly-worded warning about the risk of thigh fractures—or to conclude that the odds of FDA rejection were less than highly probable. View "In Re: Fosamax Products Liability Litigation" on Justia Law

After Plaintiff gave birth to a son, she filed a complaint against Merck & Co., Inc. and the United States, alleging that a community health center physician negligently failed to insert into her arm an implant manufactured by Merck that was designed to prevent pregnancy as a result of Merck’s defective applicator. The federal court certified questions of state law to the Maine Supreme Judicial Court. The Court answered (1) the protection of Maine’s Wrongful Birth statute extends to Merck as a drug manufacturer and distributor; and (2) pursuant to the Wrongful Birth statute, Plaintiff may not recover any damages on her claims against either defendant because of the nature of the procedure she underwent. View "Doherty v. Merck & Co., Inc." on Justia Law

Wagner, a licensed attorney proceeding pro se, took both brand‐name and generic hormone therapy drugs as prescribed by her gynecologist to treat her post‐menopausal endometrial hyperplasia. After taking the drugs, Wagner developed breast cancer. Wagner sued multiple pharmaceutical companies that designed, manufactured, promoted and distributed the drugs she took, asserting Wisconsin state law tort claims, all based upon allegations that the defendants sold dangerous products and failed to adequately warn of their risks. Defendants moved for Rule 12(c) judgment on the pleadings, arguing that federal law preempted Wagner’s claims. In response, Wagner asserted, for the first time, that the defendants delayed updating their generic brand labels to match the updated, stricter labels on the brand‐name drug. The district judge granted the motion, finding that the Food, Drug, and Cosmetics Act, 21 U.S.C. 301, preempted the state law claims. The Seventh Circuit affirmed: Wagner’s complaint lacked the requisite factual allegations to support a failure to update theory and federal law preempts her Wisconsin state‐law claims. View "Wagner v. Teva Pharmaceuticals USA, Inc." on Justia Law