Justia Drugs & Biotech Opinion Summaries

Donaldson sought treatment for stress urinary incontinence and anterior pelvic organ prolapse. In 2010, to remedy these conditions, Dr. Schultheis surgically implanted in Donaldson two transvaginal polypropylene mesh medical devices. Both were manufactured by a subsidiary of Johnson & Johnson. In 2014, Donaldson sought treatment for injuries resulting from erosion of the mesh into her bladder, vagina, and adjacent tissues, causing scarring, bladder stones, and abdominal pain, among other problems. Information sheets packaged with the devices warned of the risks of erosion but Donaldson never saw the warnings and contends that Dr. Schultheis did not inform her of these risks. Dr. Schultheis testified that he was aware of the possible complications and that he believed that the benefits of the devices outweighed the risks. He also testified that, in implanting the devices, he followed all of the manufacturer’s instructions.The Seventh Circuit affirmed summary judgment in favor of the manufacturers. Although there is no doubt that Donaldson suffered severe and painful complications after the devices were implanted, she failed to produce sufficient evidence to avoid summary judgment in her case for non-specific defects under Illinois product liability law. There was no evidence eliminating abnormal use or secondary causes, or that the device failed to perform as expected. View "Donaldson v. Johnson & Johnson" on Justia Law

The United States District Court for the Western District of Washington certified a question to the Washington Supreme Court, asking whether Washington law recognized an exception to the "learned intermediary doctrine" when a prescription drug manufacturer advertises its product directly to consumers. Under the learned intermediary doctrine, a prescription drug manufacturer satisfies its duty to warn patients of a drug’s risks when it adequately warns the prescribing physician. The Supreme Court answered the question in the negative: there was no direct-to-consumer advertising exception. "The policies underlying the learned intermediary doctrine remain intact even in the direct-to-consumer advertising context. Further, existing state law sufficiently regulates product warnings and prescription drug advertising. Accordingly, we hold regardless of whether a prescription drug manufacturer advertises its products directly to consumers, the manufacturer satisfies its duty to warn a patient when it adequately warns the prescribing physician of the drug’s risks and side effects." View "Dearinger v. Eli Lilly & Co." on Justia Law

Blackburn, who has Crohn’s disease, was prescribed LIALDA, an anti-inflammatory drug specifically aimed at the gut. LIALDA is not FDA-approved to treat Crohn’s, but it is approved to treat ulcerative colitis, Crohn’s “sister” disease. Blackburn was subsequently diagnosed with advanced-stage kidney disease. Blackburn does not claim that Shire, LIALDA’s manufacturer failed to warn of the risk of kidney disease; he and his doctor knew that the drug might impair his kidney function. Blackburn contends that Shire should have more explicitly warned his doctor about how regularly to monitor his kidney function after prescribing LIALDA. He contends that, if LIALDA’s warning label had been better, his physician would have discovered the effect on his kidneys sooner and prevented his injury.The Eleventh Circuit identified two unsettled, dispositive questions of Alabama law, which it certified to the state’s highest court. May a pharmaceutical company’s duty to warn include a duty to provide instructions about how to mitigate warned-of risks? May a plaintiff establish that an improper warning caused his injuries by showing that his doctor would have adopted a different course of testing or mitigation, even though he would have prescribed the same drug? View "Blackburn v. Shire US Inc." on Justia Law

Smith’s hip resurfacing implant consists of a metal ball that covers the top of the femur and a cup that fits inside the hip socket. When a surgeon puts these ball-and-cup surfaces in the joint, the polished metal surfaces are supposed to allow smoother movement than the damaged bone or cartilage they replace. Gall, who had hip resurfacing surgery for his left hip, recovered and became physically active. Years later, convinced his implant was unsatisfactory, Gall sued Smith.Gall argued that Smith failed to properly warn Gall’s surgeon, Dr. Hernandez, about the risks of using Smith’s product. The trial court granted Smith summary judgment because Hernandez independently knew these risks and whether Smith gave Hernandez redundant warnings did not matter. Gall also argued that Smith’s product was defective. The trial court granted summary judgment because Gall did not show anything was wrong with his implant. Gall did show Smith’s quality control procedures once failed to satisfy regulatory authorities, but the court concluded this fact did not imply the parts Gall received were defective. The court of appeal affirmed. Gall’s claims share the same causation element and Gall did not establish causation. View "Gall v. Smith & Nephew, Inc." on Justia Law

The Fifth Circuit affirmed the district court's grant of summary judgment on plaintiff's failure-to-warn claim asserted against the manufacturers of Taxotere, a chemotherapy medication. Plaintiff argues that Taxotere's manufacturers failed to provide an adequate warning of potentially permanent hair loss, which caused her injuries.The court concluded that, under Louisiana law, plaintiff cannot establish causation where, on this record, it is beyond any genuine dispute that a warning of the risk of permanent hair loss—as opposed to temporary hair loss—would not have affected the prescribing physician's decision to prescribe Taxotere. Therefore, plaintiff's claim fails as a matter of law. View "Phillips v. Sanofi U.S. Services, Inc." on Justia Law

In this case involving claims of personal injury and product liability against the manufacturer of a medical device the Supreme Judicial Court reversed the decision of the superior court judge denying the manufacturer's motion to dismiss, holding that plaintiffs asserting parallel state law claims may do so with no greater degree of specificity than otherwise required under Iannacchino v. Ford Motor Co., 451 Mass. 623, 636 (2008).Plaintiff sued Genzyme Corporation, asserting that Synvisc-One, a class III medical device subject to premarket approval under the Medical Device Amendments (MDA), 21 U.S.C. 360c et seq., was negligently manufactured, designed, distributed, and sold by Genzyme. Genzyme filed a motion to dismiss on the grounds that the allegations were preempted by federal regulation. The trial judge denied the motion to dismiss. The Supreme Judicial Court reversed, holding that while all of Plaintiff's state law claims properly paralleled the federal requirements, none of them was sufficiently pleaded under Iannacchino to survive Genzyme's motion to dismiss. View "Dunn v. Genzyme Corp." on Justia Law

In 2012, 41-year-old Karen Hubbard suffered a catastrophic stroke caused by a blood clot to her brain--a venous sinus thrombosis, a type of venous thromboembolism (VTE). She had been taking Beyaz, a birth control pill manufactured by Bayer. While she first received a prescription for Beyaz on December 27, 2011, Karen had been taking similar Bayer birth control products since 2001. The pills are associated with an increased risk of blood clots. The Beyaz warning label in place at the time of Karen’s Beyaz prescription warned of a risk of VTEs and summarized studies.The Eleventh Circuit affirmed summary judgment in favor of Bayer. Georgia’s learned intermediary doctrine controls this diversity jurisdiction case. That doctrine imposes on prescription drug manufacturers a duty to adequately warn physicians, rather than patients, of the risks their products pose. A plaintiff claiming a manufacturer’s warning was inadequate bears the burden of establishing that an improved warning would have caused her doctor not to prescribe her the drug in question. The Hubbards have not met this burden. The prescribing physician testified unambiguously that even with the benefit of the most up-to-date risk information about Beyaz, he considers his decision to prescribe Beyaz to Karen to be sound and appropriate. View "Hubbard v. Bayer Healthcare Pharmaceuticals Inc." on Justia Law

In 2003, Clabo underwent surgery to correct pelvic organ prolapse and urinary incontinence. Clabo’s doctor implanted her with a TVT transvaginal mesh sling device that the Defendants manufactured. By 2006, she began experiencing pelvic pain, urinary issues, scarring, and pain during sexual intercourse. After being notified by her doctor that the mesh from her device had eroded through her vaginal canal, Clabo had a procedure in April 2006 to remove the TVT implant. A month later, Clabo had surgery to implant a mesh sling similar to the one she had removed. In 2011, Clabo had another surgery to have pieces of her second implant removed and other parts repaired, again due to mesh erosion. Clabo alleges that it was not until July 2012 that she finally realized, after speaking with a physician-friend, that the TVT mesh product was the likely cause of her persistent pain and suffering.In May 2013, Clabo filed suit under the Tennessee Products Liability Act. The court dismissed Clabo’s claims as barred by Tennessee’s statute of repose, which prohibits product liability claims brought more than six years after the date of the injury that gave rise to the suit, finding that Clabo’s initial injury occurred during 2006. The Sixth Circuit affirmed; the record demonstrates that Clabo’s injuries occurred outside of the statute of repose period. View "Clabo v. Johnson & Johnson Health Care Systems, Inc." on Justia Law

The Second Circuit affirmed the district court's grant of summary judgment in favor of defendants and dismissal of plaintiffs' products liability claims after precluding, pursuant to Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), the opinions of plaintiffs' expert witnesses as to general causation.The court concluded that, not only was it appropriate for the district court to take a hard look at plaintiffs' experts' reports, the court was required to do so to ensure reliability. Furthermore, plaintiffs' contention that the district court impermissibly focused on plaintiffs' experts' conclusions instead of their methodologies is similarly unavailing. Even assuming that the district court required experts to back their opinions with studies definitely supporting their conclusions, the district court did not err in doing so. Therefore, the district court appropriately undertook a rigorous review of each of plaintiffs' experts, and based on that review reasonably found that the experts' methods were not sufficiently reliable and that their conclusions were not otherwise supported by the scientific community.The court also concluded that the district court correctly granted summary judgment in favor of defendants where no reasonable juror could find that it was more likely than not that general causation had been established based on plaintiffs' admissible evidence. The court was not persuaded that the district court erred in holding that there is a general causation requirement across all states. Furthermore, the court rejected plaintiffs' contention that the district court prevented them from obtaining and presenting evidence of general causation. In this case, plaintiffs failed to explain how admitting portions of the expert reports would have established general causation; the district court did not abuse its broad discretion in excluding differential-diagnosis evidence; and the district court did not abuse its broad discretion in managing discovery. View "In Re: Mirena IUS Levonorgestrel-Related Products Liability Litigation" on Justia Law

The Ninth Circuit affirmed the district court's judgment for plaintiff in an action alleging product-liability claims based on injuries she sustained from a medical device -- the G2 intravascular filter -- designed and manufactured by Bard. The jury found Bard liable for negligent failure to warn, awarding $1.6 million in compensatory damages and $2 million in punitive damages.The panel held that, because Bard's preemption defense presented a purely legal question, it would consider the merits of the district court's denial of its motion for summary judgment. The panel held that the preemption argument fails because Booker's claim rests on an asserted state-law duty to warn of the risks posed by the particular design of Bard's G2 Filter, and the FDA has not imposed any requirements related to the design of that device or how a device of that design should be labeled. In regard to the failure-to-warn claim, the panel held that Georgia courts had not adopted a categorical prohibition on basing a failure-to-warn claim on the absence of a comparative warning, and the district court correctly allowed the jury to decide the adequacy of the warning. Finally, the panel held that the evidence was adequate to support the jury's award of punitive damages. View "Booker v. C.R. Bard, Inc." on Justia Law