Failure to Warn Standards Archives - Page 2 of 5

Subject: Failure to Warn Standards

Another Brick in the Wall: The District Court Finds Preemption in Fosamax Case After Remand From the Supreme Court

We have written before about the Supreme Court’s impossibility preemption decision, Merck Sharpe & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019) (Albrecht) (here, here, here, and here), highlighting some open questions and uncertainties that might come into play on remand. Albrecht held that impossibility preemption is a question of law for the court, not for the jury, “elaborated” on the “clear evidence” standard arising from Wyeth v. Levine, 555 U.S. 555 (2009) (Wyeth), and remanded to the Third Circuit for determination of the preemption issue. That court in turn remanded to the District of New Jersey and further directed the district court “to determine the effect of the FDA’s Complete Response Letter and other communications with Merck on the issue of whether the agency actions are sufficient” to find preemption.

We predicted that the decision on remand would be “interesting” and opined that the case for preemption was “strong.” We now have that decision, In re Fosamax (Alendronate Sodium) Prod. Liab. Litig., 2022 WL 855853 (D. N.J. Mar. 23, 2022) (Fosamax), and we were right on both counts.

Continue reading “Another Brick in the Wall: The District Court Finds Preemption in Fosamax Case After Remand From the Supreme Court”

Southern District of Texas Holds Learned Intermediary Doctrine Applies to Clinical Trials

Does the learned intermediary doctrine apply in the context of a clinical trial? According to the Southern District of Texas, it does. The case in question is Butler et al. v. Juno Therapeutics, Inc., a tragic case involving the death of a 19-year-old woman with terminal leukemia who died within days of receiving an experimental cancer drug as a participant in a clinical trial.

In 2015, Juno Therapeutics (Juno) was developing a treatment for advanced blood cancers involving Chimeric Antigen Receptor T-cell (CAR-T) therapy. CAR-T therapy is designed to modify a patient’s white blood cells to target cancer cells with the goal of improving the patient’s condition so a bone marrow or stem cell transplant can be tolerated. In October 2015, Juno entered into a Clinical Study Agreement with MD Anderson (and other hospitals) as part of a Phase 2 clinical trial (the “Rocket Study”) of a drug identified as JCAR015, a CAR-T therapy. Drs. William Wierda and Michael Rytting were the principal investigators of the Rocket Study at MD Anderson.

Continue reading “Southern District of Texas Holds Learned Intermediary Doctrine Applies to Clinical Trials”

A Component Part Supplier’s Duty to Warn Following the U.S. Supreme Court’s Maritime Asbestos Decision

Under the Restatement (Third) of Torts: Products Liability § 5, Comment b (1998), the supplier of a product generally must warn about only those risks associated with the product itself, not those associated with the “products and systems into which [it is] integrated.”

However, in Air and Liquid Sys. Corp. v. DeVries, 139 S. Ct. 986 (2019), the Supreme Court created a different rule in the context of maritime asbestos claims. In that case, the defendants produced “bare-metal” equipment, such as pumps, blowers, and turbines, for Navy ships that required asbestos insulation or asbestos parts to function as intended. The manufacturers delivered the equipment to the Navy without asbestos, and the Navy later added asbestos to the equipment. Two Navy veterans were exposed to asbestos on the ships and developed cancer. The district court granted summary judgment for the manufacturers, finding no duty to warn. In reversing, the Third Circuit Court of Appeals adopted a “more plaintiff-friendly” foreseeability rule, rejecting the “more defendant-friendly” bare-metal defense.

Continue reading “A Component Part Supplier’s Duty to Warn Following the U.S. Supreme Court’s Maritime Asbestos Decision”

Ninth Circuit Affirms Dismissal of Breast Implant Cases on Preemption Grounds

The Ninth Circuit has confirmed in quadrophonic sound that plaintiffs cannot avoid preemption by relying on vague and speculative allegations to establish a parallel claim. The court affirmed the dismissal of four lawsuits by plaintiffs claiming they were injured by breast implants on the grounds that their claims are barred by the 1976 Medical Device Amendment to the Food, Drug and Cosmetic Act (MDA). Sewell v. Mentor Worldwide, LLC, et al., no. 19-56393; Vieira v. Mentor Worldwide, LLC, et al., no. 19-56394; Billetts v. Mentor Worldwide, LLC, et al., no. 19-56398; Nunn v. Mentor Worldwide, LLC, et al., no. 19-56391.

In each case, California plaintiffs alleged their breast implants were defective and caused them to experience fatigue, muscle pain, and migraines. The district courts dismissed the complaints for failure to state a claim on grounds of preemption, and plaintiffs appealed.

Continue reading “Ninth Circuit Affirms Dismissal of Breast Implant Cases on Preemption Grounds”

California’s Parallel State Law Duty to Report Adverse Events to U.S. Food and Drug Administration Cannot Be Reconciled with Legal Precedent

Earlier this year, the California Court of Appeals in Mize v. Mentor Worldwide LLC, 51 Cal.App.5th 850 (2020), reversed a trial court’s dismissal of failure to warn and other claims against a medical device manufacturer, holding that “California law recognizes a manufacturer’s duty to warn the [U.S. Food and Drug Administration] of adverse events.” Mize concluded that California’s duty to warn FDA was “parallel” to the requirements of federal law, and therefore not expressly preempted.

Cases like Mize involving medical devices approved for sale through the FDA’s Premarket Approval (PMA) process are generally subject to the U.S. Supreme Court’s decision in Riegel v. Medtronic, 552 U.S. 312 (2008). Riegel held that the federal Medical Device Amendments preempt state tort laws if they are “different from, or in addition to” the requirements imposed by federal law. Riegel bars state tort law claims because PMA devices are subject to specific requirements adopted by FDA through the rigorous PMA approval process. However, Riegel left open the possibility, based on an articulated judicially imposed policy, that a state might “[provide] a damages remedy for claims premised on a violation of FDA regulations” because “the state duties in such a case ‘parallel’ federal law.” 552 U.S. at 329.

Continue reading “California’s Parallel State Law Duty to Report Adverse Events to U.S. Food and Drug Administration Cannot Be Reconciled with Legal Precedent”

California [Again] Confronts the High Cost of Litigation Uncertainty

The first appellate shoe has dropped in the litigation involving the herbicide Roundup, Johnson v. Monsanto Co., decided July 20, 2020, by California’s 1st District Court of Appeal, Division One. We discussed the verdict and the trial court’s post-trial rulings here, and we now follow through with an update.

Initially, the price tag for allowing questionable science into the courtroom, as measured by this verdict, has been reduced. The court of appeal lowered the compensatory damages award from $39 million to about $10.25 million, concluding the jury had improperly awarded noneconomic damages that plaintiff would likely never suffer. Because plaintiff’s counsel had argued to the jury that plaintiff’s Non-Hodgkins Lymphoma had reduced his future life expectancy to two years, the jury could not award pain and suffering damages beyond that two-year span. And, agreeing with the trial court that constitutional limits required a 1:1 ratio between compensatory and punitive damages, the court slashed the $78 million punitive award to about $10.5 million.

Continue reading “California [Again] Confronts the High Cost of Litigation Uncertainty”