Justia Products Liability Opinion Summaries

M.L. was born in 2003. At his 15-month well-child visit, his pediatrician noted that M.L. was walking and generally developing normally but did not “want to talk.” In 2005, M.L. received several immunizations, including the DTaP vaccination. Hours later, M.L. allegedly began experiencing an abnormally high fever and swelling. He was admitted to the hospital with a diagnosis of “vaccine adverse reaction with secondary fever, angiodema, and anaphylactoid reaction.” The morning after his discharge, M.L.’s mother called an ambulance because M.L. was exhibiting signs of hypothermia and seizure-like episodes. In the months that followed, M.L.’s vocabulary allegedly decreased. An MRI of M.L.’s brain with and without contrast was normal. After observing M.L.’s developmental delays and repetitive behaviors, a pediatric neurologist placed M.L. in the autism spectrum disorder category. A special master rejected claims under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. 300aa-1 to -34, and the Claims Court affirmed. The Federal Circuit affirmed. While the DTaP vaccination likely caused the initial anaphylactic reaction, there was no reliable medical theory that the M.L.’s anaphylaxis caused a focal brain injury. View "LaLonde v. Sec'y of Health & Human Servs." on Justia Law

From 1981 to 1989, Schultz worked painting equipment, floors, walls, ceilings, and pipes at AMC company plants. In 2005 he was diagnosed with acute myeloid leukemia (AML). He died 2006. His wife sued paint companies, alleging that the companies produced or distributed the paint Schultz used at work and that benzene from the paints caused his disease. She offered reports from two experts: Stewart, an industrial hygienist, who reconstructed Schultz’s work with the paints to quantify his benzene exposure, and Gore, an oncologist, who testified that benzene is generally known to cause AML and specifically was a substantial factor in the development of Schultz’s disease. The district court granted the companies summary judgment on the ground that Gore’s testimony was scientifically unreliable; without that evidence, Schultz had no way of linking his disease to the paints. The Seventh Circuit reversed in part, holding that the district court erred in excluding Gore’s testimony. View "Schultz v. Glidden Co." on Justia Law

Fulgenzi was prescribed the generic drug metoclopramide (FDA approved in 1980), sold originally under the brand name Reglan, a drug approved for short-term treatment of patients suffering from gastroesophageal reflux disease. In her suit, claiming failure to adequately warn of risks, she alleged that taking the drug caused her to develop tardive dyskinesia, an often-irreversible neurological disorder that causes involuntary movements, especially of the lower face. In 2009, the Supreme Court held that with respect to branded drug manufacturers, state failure-to-warn suits were not preempted by the federal Food Drug and Cosmetic Act , 21 U.S.C. 301. In 2011 the Court held that such suits could not go forward against generic drug manufacturers, as it is impossible to comply simultaneously with their state duty to adequately warn and their federal duty of sameness (federal law requires generic drug labels to be the same as their branded counterpart). The district court dismissed. The Sixth Circuit reversed, noting that after the branded-drug manufacturer of metoclopramide strengthened warnings on its label, the generic manufacturer failed to update its label as required by federal law, rendering compliance with both federal and state duties no longer impossible. View "Fulgenzi v. PLIVA, Inc." on Justia Law

Between 1994 and 1997 Wyeth’s predecessor sold fenfluramine and dexfenfluramine, prescription weight loss drugs. After the drugs were linked to valvular heart disease and an FDA public health advisory, Wyeth withdrew the drugs from the market in 1997. Thousands of individuals filed suit; the cases were consolidated. In 1999, Wyeth entered into a Settlement Agreement; in 2000, the court certified the class, approved the Agreement, and retained jurisdiction. The Agreement enjoins class members from suing Wyeth for diet drug-related injuries, but allows class members to sue Wyeth if they can demonstrate that they developed PPH (a condition that deprives the lungs of oxygen) at a specified level through the use of the diet drugs. In 2011, Cauthen sued, alleging that she developed PPH. She produced a pulmonary consultation prepared by Fortin, a cardiologist. Because Cauthen’s report showed that lung capacity of less than 60 percent of predicted at rest, Wyeth sought to enjoin the state court lawsuit for failing to satisfy the precondition provided by the Agreement. Dr. Fortin asserted that comparing individual lung capacity with average capacity of persons having a similar demographic profile is not determinative in diagnosing PPH. The district court enjoined the suit. The Third Circuit affirmed. View "In Re: Diet Drugs Prod. Liab. Litig." on Justia Law

Genentech manufactured and sold the psoriasis medication Raptiva, approved by the FDA in 2003. Raptiva works by suppressing T-cells ; because T-cells help fight infections, suppression has the potential to cause potentially life-threatening side effects. Following reports of adverse health effects, including a rare brain infection, Genentech voluntarily removed Raptiva from the market in 2009. Marsh began using Raptiva in 2004 and subsequently suffered viral meningitis and a collapsed lung. She sued in 2011, alleging strict products liability under design-defect and failure-to-warn theories, negligence, breach of warranty, and fraud. She claimed that, before and after FDA approval, Genentech knew of dangerous side effects that it concealed and did not include in the drug’s label. The district court dismissed, holding that Genentech was immune from suit because neither statutory exception to immunity for drug manufacturers applied. Marsh argued that immunity does not apply because failure to submit updated information rendered Raptiva noncompliant with FDA approval when it left Genentech’s control and that her claim was not preempted because it was premised on non-compliance rather than fraud or bribery. The Sixth Circuit affirmed. Allegations underlying Marsh’s argument that immunity does not apply are essentially the type of claim that is preempted.View "Marsh v. Genetech Inc." on Justia Law

Approximately one month after Dr. Richard Briggs prescribed sixteen-year-old Peter Schilf Cymbalta for his depression, Peter committed suicide. The Cymbalta literature did not include an FDA-approved black box warning stating that Cymbalta could induce suicidality in children diagnosed with depression. Peter's parents (Appellants) sued Eli Lilly & Company and Quintiles Transnational Corporation ("Lilly"), alleging that Lilly's failure to warn and deceit caused the death of Peter. The district court granted summary judgment in favor of Lilly. The Eighth Circuit Court of Appeals reversed, holding (1) there were genuine issues of material fact whether Dr. Briggs knew the suicide-related information that an adequate warning would have contained; and (2) there were genuine issues of material fact whether an adequate warning would have changed Dr. Briggs' decision to prescribe Cymbalta to Peter. View "Schilf v. Eli Lilly & Co." on Justia Law

Plaintiffs sought compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. 300aa, for injuries to their children allegedly caused by the Diptheria-Tetanus-acellular Pertussis vaccine. The children suffer a seizure disorder, known as Severe Myoclonic Epilepsy of Infancy. The same special master presided over both cases and determined that plaintiffs failed to show entitlement to compensation because evidence showed that a gene mutation present in both children was the sole cause of their injuries. The Court of Federal Claims affirmed. The Federal Circuit affirmed, noting considerable evidentiary support for the conclusion. View "Stone v. Sec'y of Health & Human Servs." on Justia Law

Plaintiff, a pipefitter, worked with asbestos-containing gaskets made by defendant from 1962 until 1970. From 1962 until 1975, he also sustained significant exposure to asbestos insulation. He died in 2008, of mesothelioma, a cancer of the lining of the lung. Before his death, plaintiff sued under theories including strict liability and negligence. Defendant does not dispute that asbestos-containing products likely caused the mesothelioma, but argues that the mesothelioma was caused by exposure to asbestos insulation, and that its own gaskets were not a substantial factor. A jury awarded plaintiff $516,094. The Sixth Circuit reversed. Given that plaintiff failed to quantify the exposure to asbestos from defendant's gaskets and concedes that plaintiff sustained massive exposure to asbestos from non-defendant sources, there was insufficient evidence to infer that defendant's gaskets probably, as opposed to possibly, were a substantial cause of plaintiff's mesothelioma. View "Moeller v. Garlock Sealing Techs., LLC" on Justia Law

Plaintiff had no adverse reaction to receiving the hepatitis B vaccine in 1997 until after her third dose. At that time, her chest pain was not attributed to the vaccine. Plaintiff saw other doctors for various symptoms and, in 1998, doctors identified "post vaccine syndrome." Plaintiff has had unrelated medical problems, suffered the loss of a child, and has had jobs that involved working with chemicals and bodily fluids. Her 1999 claim for compensation under the Vaccine Act (42 U.S.C. 300aa-1) was denied. The Federal Circuit affirmed, stating that if was an "unfortunate case," in which plaintiff suffered a multitude of symptoms but could not prove they were caused by the vaccine. View "Lombard v. Sec'y of Health & Human Servs." on Justia Law