Justia Drugs & Biotech Opinion Summaries

Lipitor, a pharmaceutical drug, is prescribed to lower patients’ “bad” cholesterol and triglycerides. Plaintiffs, more than 3,000 women, claim that they developed diabetes as a result of taking Lipitor. The Judicial Panel on Multidistrict Litigation consolidated the lawsuits for pretrial proceedings. The parties agreed on four bellwether cases. Plaintiffs enlisted general experts, to testify that there was a causal association between Lipitor and diabetes; specific experts, to testify that Lipitor proximately caused the onset of diabetes in the bellwether plaintiffs; and an expert biostatistician, who concluded that taking Lipitor led to a statistically significant increased risk of diabetes. Plaintiffs also sought to introduce internal Pfizer emails, information from Lipitor's labeling, a statement in Lipitor's FDA New Drug Application, and information from the Lipitor website. Citing Federal Rule of Evidence 702, the court excluded the opinions of the statistician; the general causation expert, except relating to a specific dosage; and the specific causation opinions. The rulings left the plaintiffs without their bellwether cases, limited to a subset of patients who had taken an 80 mg dose. The court issued show-cause orders asking whether any plaintiff could submit evidence that would enable her claim to survive summary judgment given prior rulings. Some plaintiffs submitted evidence showing only that they were not diabetic before taking Lipitor, that they were diagnosed with diabetes after taking Lipitor, and that they lacked certain risk factors that might make them especially likely to develop the disease. After the court rejected the evidence, the plaintiffs unsuccessfully argued that the cases ought to be returned to their transferor district courts for individual resolution on the issue of specific causation. The Fourth Circuit affirmed summary judgment for the defendants. View "Plaintiffs Appealing Case Management Order 100 v. Pfizer, Inc." on Justia Law

Dalton’s doctor implanted Teva’s Intrauterine Device (IUD) in her uterus for long-term birth control. Dalton became dissatisfied with the IUD and asked her doctor to remove it. The doctor did so by grasping its strings with a forceps and pulling the IUD down. A piece broke off either before or during the removal and lodged in her uterus. Dalton’s doctor advised that removing the remaining portion of the IUD would require a hysterectomy. Dalton sued Teva, asserting “strict liability,” “strict products liability failure to warn,” and “manufacturer’s defect.” Dalton failed to timely disclose any expert witness and serve the expert witness report required by FRCP 26(a)(2). The district court granted Teva summary judgment. The Seventh Circuit affirmed. Claims under the Indiana Products Liability Act, which governs all consumer actions against a manufacturer for physical harm caused by a product, require proof that the injury was proximately caused by whatever defect or breach of duty underlies the claim. The Act requires expert testimony when an issue “is not within the understanding of a lay person.” Dalton did not establish how a lay juror faced with a broken IUD could identify the cause of the break—maybe the IUD was damaged after coming into the possession of the physician, maybe human error resulted in damage during implantation or removal. This case is far removed from situations in which a causation issue is so obvious that a plaintiff may forgo expert testimony. View "Dalton v. Teva North America" on Justia Law

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