Justia Drugs & Biotech Opinion Summaries

Bard manufactures a surgical patch, consisting of two pieces of mesh that surround a flexible plastic ring. During a hernia repair, the patch is folded to fit through a small incision, then the plastic ring springs back into its original shape and flattens the mesh against the abdominal wall. Bard recalled several versions of the patch in 2005-2006 following reports that the plastic ring was defective. Sometimes the ring broke, exposing a sharp edge that could perforate the patient’s intestines. Other times the ring caused the patch to bend and warp, exposing the patch’s adhesive to a patient’s viscera. Before the recall, Bowersock underwent hernia repair surgery, involving a Bard patch. Roughly one year later, she died of complications arising from an abdominal-wall abscess. Her estate sued. Unlike defective patches in other injured patients, Bowersock’s patch did not adhere to her bowel or perforate her organs. Plaintiff's expert tried to present a new theory of causation: the patch had “buckled,” forming a stiff edge that rubbed against and imperceptibly perforated her internal organs. The court excluded that testimony, finding the “buckling” theory not sufficiently reliable. The Seventh Circuit affirmed summary judgment for the defense. The novel theory of causation was not peer-reviewed, professionally presented, consistent with Bowersock’s medical records or autopsy, or substantiated by other cases. View "Robinson v. Davol, Inc." on Justia Law

In 2010, a doctor prescribed Paxil, the brand‐name version of paroxetine, to treat Stewart’s depression and anxiety. His prescription was filled with generic paroxetine manufactured by another company (not a defendant). Days later, Stewart committed suicide at age 57. He had paroxetine in his system. GSK manufactured brand‐name Paxil and was responsible under federal law for the content of the drug’s label. Labels for paroxetine and similar antidepressant drugs then warned that they were associated with suicide in patients under the age of 24 but did not warn about any association between the drugs and an increased risk of suicide in older adults. It is virtually impossible to sue generic drug manufacturers for failure to warn because they are required to use the FDA-approved label used by the brand-name (original) manufacturer. Only the brand-name manufacturer can seek FDA approval to change the label. Stewart’s wife sued GSK, alleging that it negligently failed to include warnings that paroxetine was associated with suicide in patients older than 24. The jury awarded her $3 million. The Seventh Circuit reversed, holding that federal law prevented GSK from adding a warning about the alleged association between paroxetine and suicides in adults. The FDA repeatedly told GSK not to add a paroxetine‐specific suicide risk warning. View "Dolin v. GlaxoSmithKline LLC" on Justia Law

Accutane was a prescription medication developed by defendants and approved by the FDA to treat recalcitrant nodular acne. Accutane’s alleged role as a cause of gastrointestinal disease ultimately resulted in a series of lawsuits against defendants. The case before the New Jersey Supreme Court here involved over two thousand plaintiffs who alleged they developed Crohn’s disease as a result of taking Accutane. In the years since many earlier Accutane cases were decided, epidemiological studies were published, all of which concluded that Accutane was not causally associated with the development of Crohn’s disease. Defendants filed a motion seeking a hearing on the association between Accutane and Crohn’s disease. The issue presented for the New Jersey Supreme Court’s consideration reduced to the admissibility of scientific evidence under the New Jersey Rules of Evidence. Plaintiffs claimed that a causal connection existed between Accutane and Crohn’s disease. The Supreme Court discerned little distinction between “Daubert’s” principles regarding expert testimony and New Jersey’s, and Daubert’s factors for assessing the reliability of expert testimony “will aid New Jersey trial courts in their role as the gatekeeper of scientific expert testimony in civil cases.” The Court reconciled the standard under N.J.R.E. 702, and relatedly N.J.R.E. 703, with the federal Daubert standard to incorporate its factors for civil cases. Here, the trial court properly excluded plaintiffs’ experts’ testimony. Moreover, the Court reaffirmed that the abuse of discretion standard must be applied by an appellate court assessing whether a trial court has properly admitted or excluded expert scientific testimony in a civil case. In this matter, the trial court did not abuse its discretion in its evidential ruling and, therefore, the Appellate Division erred in reversing the trial court’s exclusion of the testimony of plaintiffs’ experts. View "In re: Accutane Litigation" on Justia Law

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

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

Testosterone replacement drugs have been FDA-approved prescription drugs for more than 60 years. In recent years, manufacturers have found a new market: older men. Numerous lawsuits were filed against manufacturers alleging that the drugs increase health risks. Cases alleging that the manufacturers failed to warn doctors and patients adequately about the risks, citing state product-liability laws, were consolidated for pretrial proceedings. The district court granted a motion to dismiss brought by Depo-T’s manufacturer, finding the failure-to-warn claims preempted by federal law. The court stated that DepoT’s manufacturers could not change their drug labels to add warnings because FDA regulations prohibit them from “making a unilateral labeling change.” The Seventh Circuit affirmed. In Wyeth v. Levine, the Supreme Court held that claims against a manufacturer of a brand-name prescription drug for failure to warn adequately of the drug’s dangers were not preempted by federal law.; in PLIVA v. Mensing, the Court held that such failure-to-warn claims against manufacturers of generic drugs are preempted. The Court cited the different regulatory requirements and processes for approving and labeling prescription drugs. Depo-T “does not fit neatly into the colloquial dichotomy between brand-name and generic drugs” so the Seventh Circuit focused on whether the FDA approved public sale of its drugs through the “new drug application” or through the “abbreviated new drug application” (ANDA) and stated that the FDA-approved label defines an ANDA holder’s duty of sameness and the lines of federal preemption. View "Guilbeau v. Pfizer Inc." on Justia Law

To seek redress for an opioid epidemic, characterized by the Court of Appeal as having placed a financial strain on state and local governments dealing with the epidemic’s health and safety consequences, two California counties sued (the California Action) various pharmaceutical manufacturers and distributors, including the appellants in this matter, Actavis, Inc., Actavis LLC, Actavis Pharma, Inc., Watson Pharmaceuticals, Inc., Watson Laboratories, Inc., and Watson Pharma, Inc. (collectively, “Watson”). The California Action alleged Watson engaged in a “common, sophisticated, and highly deceptive marketing campaign” designed to expand the market and increase sales of opioid products by promoting them for treating long-term chronic, nonacute, and noncancer pain - a purpose for which Watson allegedly knew its opioid products were not suited. The City of Chicago brought a lawsuit in Illinois (the Chicago Action) making essentially the same allegations. The issue presented by this appeal was whether there was insurance coverage for Watson based on the allegations made in the California Action and the Chicago Action. Specifically, the issue was whether the Travelers Property Casualty Company of America (Travelers Insurance) and St. Paul Fire and Marine Insurance Company (St. Paul) owe Watson a duty to defend those lawsuits pursuant to commercial general liability (CGL) insurance policies issued to Watson. Travelers denied Watson’s demand for a defense and brought this lawsuit to obtain a declaration that Travelers had no duty to defend or indemnify. The trial court, following a bench trial based on stipulated facts, found that Travelers had no duty to defend because the injuries alleged were not the result of an accident within the meaning of the insurance policies and the claims alleged fell within a policy exclusion for the insured’s products and for warranties and representations made about those products. The California Court of Appeal concluded Travelers had no duty to defend Watson under the policies and affirmed. View "The Traveler's Property Casualty Company of America v. Actavis, 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