Justia Drugs & Biotech Opinion Summaries

In this product liability action, the district court did not abuse its discretion in excluding the claimant’s expert’s testimony regarding causation.Plaintiff brought this product liability action against Hoffman-La Roche, Inc. and Roche Laboratories, Inc. (collectively, Roche) alleging that she developed health issues as a result of ingesting Accutane, a pharmaceutical drug manufactured and distributed by Roche. After conducting a Daubert/Schafersman hearing, the district court entered an order precluding Plaintiff’s expert witness from rendering opinions on the general and specific causation of Plaintiff’s Crohn’s disease. Thereafter, the Court entered summary judgment in favor of Roche. The Supreme Court affirmed, holding that the district court did not abuse its discretion in excluding the expert testimony after finding that the expert’s methodology was unreliable and conclusion-driven; and (2) with the exclusion of this testimony, there remained no issue of material fact, and therefore, summary judgment was properly granted in favor of Roche. View "Freeman v. Hoffman-La Roche, Inc." on Justia Law

The Supreme Court affirmed the order of the Mass Litigation Panel through which summary judgment was granted in favor of Defendants, Pfizer, Inc., Roerig, a division of Pfizer, Inc., and Greenstone, LLC (collectively, Pfizer) on Plaintiffs’ claims that Pfizer negligently failed adequately to warn them of the risk of birth defects through the ingestion of Zoloft, a prescription medication, during pregnancy.The Court held (1) this was a case where expert testimony was necessary, and therefore, the Panel did not erroneously based its decision on the absence of expert testimony to support Plaintiffs’ claims that Pfizer failed adequately to warn women of childbearing age of the risks of Zoloft; (2) Petitioners could not sustain their evidentiary burden with Pfizer’s witnesses; and (3) there was no unfairness in requiring Plaintiffs to meet their burden of proof with expert testimony under the circumstances of this case. View "J.C. v. Pfizer, Inc." on Justia Law

There is no cause of action in West Virginia for failure to warn and negligent misrepresentation against a branded drug manufacturer when the drug ingested was produced by a generic manufacturer.Petitioners, Kimmy and Larry McNair, filed an action against Respondent, Janssen Pharmaceuticals, alleging that Kimmy developed acute respiratory distress after ingestion the generic drug levofloxacin that was manufactured by Dr. Reddy’s Laboraties Limited. Janssen originally trademarked and sold levofloxacin under the brand Levaquin and produced the warnings on the label that accompanied the distribution of the drug, which were subsequently used by generic manufacturers of levofloxacin. The McNairs alleged that Janssen had exclusive control of the content of the warning for both the brand-name and generic forms of the drug and was therefore liable for their alleged injuries. The federal district court granted summary judgment to Janssen, finding that because Janssen did not manufacture the product ingested by Kimmy, there was no basis on which to hold Janssen liable. On appeal, the Fourth Circuit Court of Appeals certified to the Supreme Court a question of law. In answering as set forth above, the Supreme Court declined to expand its products liability law. View "McNair v. Johnson & Johnson" on Justia Law

A plaintiff who alleges that he was injured from his use of a generic drug because of a failure to warn of the drug’s side effects cannot bring a common-law general negligence claim against the brand-name manufacturer that created the warning label. The plaintiff, however, may bring a common-law recklessness claim against the brand-name manufacturer if it intentionally failed to update the label on its drug, knowing or having reason to know of an unreasonable risk of death or grave bodily injury associated with its use. Further, a plaintiff who is injured by a generic drug due to a failure to warn cannot bring a claim under Mass. Gen. Laws ch. 93A, 9 against a brand-name manufacturer that did not advertise, offer to sell, or sell that drug because such failure did not occur in the conduct of “trade or commerce” as defined in section 1(b).In the instant case, the trial judge dismissed Plaintiff’s claims against Merck & Co, Inc. asserting negligence for failure to warn and a violation of Mass. Gen. Laws ch. 93A, 9. The Supreme Judicial Court vacated the order dismissing Plaintiff’s common-law claim and remanded with instructions that Plaintiff be granted leave to amend his complaint and affirmed the order dismissing Plaintiff’s chapter 93A claim. View "Rafferty v. Merck & Co., Inc." on Justia Law

A plaintiff who alleges that he was injured from his use of a generic drug because of a failure to warn of the drug’s side effects cannot bring a common-law general negligence claim against the brand-name manufacturer that created the warning label. The plaintiff, however, may bring a common-law recklessness claim against the brand-name manufacturer if it intentionally failed to update the label on its drug, knowing or having reason to know of an unreasonable risk of death or grave bodily injury associated with its use. Further, a plaintiff who is injured by a generic drug due to a failure to warn cannot bring a claim under Mass. Gen. Laws ch. 93A, 9 against a brand-name manufacturer that did not advertise, offer to sell, or sell that drug because such failure did not occur in the conduct of “trade or commerce” as defined in section 1(b).In the instant case, the trial judge dismissed Plaintiff’s claims against Merck & Co, Inc. asserting negligence for failure to warn and a violation of Mass. Gen. Laws ch. 93A, 9. The Supreme Judicial Court vacated the order dismissing Plaintiff’s common-law claim and remanded with instructions that Plaintiff be granted leave to amend his complaint and affirmed the order dismissing Plaintiff’s chapter 93A claim. View "Rafferty v. Merck & Co., Inc." on Justia Law

Joas underwent knee replacement at a Wisconsin hospital and received a Zimmer NexGen Flex implant. Within a few years, he began experiencing pain in his new knee. X-rays confirmed that the implant had loosened and required a surgical fix. Joas brought multiple claims against Zimmer. His case was transferred to a multidistrict litigation, where it was treated as a bellwether case. Applying Wisconsin law, the presiding judge granted Zimmer summary judgment. The Seventh Circuit affirmed, declining to reinstate a single claim based on a theory of inadequate warning. The court predicted that the Wisconsin Supreme Court would follow the majority of states and adopt the “learned intermediary” doctrine, which holds that the manufacturer of a medical device has no duty to warn the patient as long as it provides adequate warnings to the physician. In addition, Joas has not identified any danger that Zimmer should have warned him about. Joas has no evidence to support causation. Joas did not select the NexGen Flex implant, so the information would not have caused him to change his behavior. His doctor selected the product, making his decision based on his own past experience, not on any marketing materials or information provided by Zimmer. View "Joas v. Zimmer, Inc." on Justia Law

Joas underwent knee replacement at a Wisconsin hospital and received a Zimmer NexGen Flex implant. Within a few years, he began experiencing pain in his new knee. X-rays confirmed that the implant had loosened and required a surgical fix. Joas brought multiple claims against Zimmer. His case was transferred to a multidistrict litigation, where it was treated as a bellwether case. Applying Wisconsin law, the presiding judge granted Zimmer summary judgment. The Seventh Circuit affirmed, declining to reinstate a single claim based on a theory of inadequate warning. The court predicted that the Wisconsin Supreme Court would follow the majority of states and adopt the “learned intermediary” doctrine, which holds that the manufacturer of a medical device has no duty to warn the patient as long as it provides adequate warnings to the physician. In addition, Joas has not identified any danger that Zimmer should have warned him about. Joas has no evidence to support causation. Joas did not select the NexGen Flex implant, so the information would not have caused him to change his behavior. His doctor selected the product, making his decision based on his own past experience, not on any marketing materials or information provided by Zimmer. View "Joas v. Zimmer, Inc." on Justia Law

Shuker underwent a hip replacement surgery that resulted in unexpected complications and brought tort claims against Smith & Nephew, the manufacturer of his hip replacement system. The Medical Device Amendments of 1976, added comprehensive medical device approval processes to the Federal Food, Drug, and Cosmetic Act, prescribing tiers of federal requirements for certain devices corresponding to the device’s inherent risk level. In exchange for compliance with the strictest federal mandates, Congress afforded manufacturers express preemption from state laws imposing different or additional “safety or effectiveness” requirements for those devices, 21 U.S.C. 360k(a)(2). Shuker’s medical device was comprised of multiple components, some of which are from “Class III” medical devices subject to federal requirements and some of which are from medical devices that carry a different class designation and are not subject to those requirements. The Third Circuit affirmed a determination that Shuker’s negligence, strict liability, and breach of implied warranty claims are expressly preempted. The court reversed the dismissal of other claims. Shuker adequately pleaded non-preempted claims based on Smith & Nephew’s alleged off-label promotion in violation of federal law and loss of consortium, and jurisdictional discovery is warranted with respect to personal jurisdiction over one of the defendants. View "Shuker v. Smith & Nephew PLC" on Justia Law

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