Justia Products Liability Opinion SummariesArticles Posted in Medical Malpractice
Johnson v. C. R. Bard, Inc.
Hoping to minimize her risk of suffering serious complications from future blood clots, Johnson underwent surgery to implant a retrievable intravascular filter–a medical device that is placed in the inferior vena cava to prevent blood clots that develop in the lower body from flowing into the heart and lungs. Johnson’s doctor selected the Meridian filter, which was supposed to be temporary and easily removable. Johnson’s filter migrated and fractured, leaving shards embedded in the wall of her heart and elsewhere. Her surgeon was unable to remove the device safely and fully. As a result, Johnson faces an ongoing risk of infection, pain, and other complications.Johnson sued the manufacturers of the Meridian filter (Bard), claiming that they defectively designed the Meridian filter and failed to warn medical providers about the device’s risks, in violation of Wisconsin law. A jury rejected most of Johnson’s theories but returned a $3.3 million verdict in her favor on her strict liability failure-to-warn count. The Seventh Circuit affirmed, stating that its decision “should not be misinterpreted as our endorsement of some of Johnson’s counsel’s trial tactics.” There was no reversible error in instructing the jury or in permitting certain testimony, in alleged violation of expert witness disclosure requirements. View "Johnson v. C. R. Bard, Inc." on Justia Law
Hrymoc v. Ethicon, Inc.
In this products liability matter involving “pelvic mesh” medical devices, the New Jersey Supreme Court considered whether defendant C.R. Bard, Inc., was denied a fair trial by the trial court’s determination that defendant could not present 510(k) clearance evidence -- evidence that, pursuant to 21 U.S.C. § 360c, the devices were allowed to be marketed without premarket clinical trials -- to counter the product liability claims brought by plaintiffs Mary and Thomas Walsh McGinnis. North Carolina surgeon Dr. Elizabeth Barbee implanted Bard’s “Align TO” and “Avaulta Solo” pelvic mesh devices. In the months following surgery, McGinnis had to undergo numerous invasive surgeries to remove the mesh and repair internal damage, with limited success. In 2011, plaintiffs filed suit against defendant Bard under North Carolina law. Counsel agreed that the substantive issues would be tried under the law of North Carolina but that the issue of damages would be tried under New Jersey law. Plaintiffs moved in limine to bar defendant from presenting any evidence of the devices’ 510(k) clearance to the jury. The trial court found the 510(k) evidence inadmissible. The Appellate Division reversed, holding that the exclusion of any 510(k) evidence deprived defendant of a fair trial on the issue of negligence. The Supreme Court agreed that 510(k) evidence was generally inadmissible because the 510(k) clearance process solely determines substantial equivalency, and not safety and efficacy. However, in a products liability claim premised on the reasonableness of a manufacturer’s conduct in not performing clinical trials or studies, the Court held evidence of 510(k) clearance had significant probative value under N.J.R.E. 401 that was not substantially outweighed by the risk of prejudice and potential juror confusion under N.J.R.E. 403. Therefore, under the specific facts and circumstances of this case, the Supreme Court affirmed the Appellate Division and remanded for a new trial. The Court disagreed with the Appellate Division’s decision regarding the scope and admissibility of 510(k) evidence and a Rule 104 hearing. To this, the Supreme Court believed the scope and admissibility of 510(k) evidence should be resolved at the hearing on a motion in limine, which was how the issue was and, presumably, would be raised. View "Hrymoc v. Ethicon, Inc." on Justia Law
Parton v. Cook Medical, LLC
The Judicial Panel on Multidistrict Litigation (MDL) centralized cases arising out of alleged defects in Cook’s inferior vena cava (IVC) filters, 28 U.S.C. 1407(a). Many plaintiffs in the MDL claim that Cook’s filters cause pain and suffering, disabilities, emotional injuries, lost earnings, increased medical bills, and in some cases death. To help manage the litigation, the district court adopted direct filing and case categorization procedures. Parton and Sykes were each implanted with a Cook IVC filter. Years later, CT scans revealed that their filters had perforated their IVC walls. They experienced no pain or other symptoms, but they pursued product liability claims against Cook. The direct-filing procedure did not require Parton or Sykes to file a standard complaint; each filed a short-form complaint, which incorporated allegations from a master complaint that ostensibly applied to all direct-filing plaintiffs.The district court granted Cook summary judgment. The Seventh Circuit dismissed an appeal for lack of federal subject-matter jurisdiction. Jurisdiction in these cases is based solely on diversity of citizenship, which requires the amount in controversy in each case to exceed $75,000, 28 U.S.C. 1332(a). Parton and Sykes allege the proper amount in controversy, but the nature of their alleged injuries indicates that no more than $75,000 is at stake in either case. They have not suffered the injuries alleged in the master complaint; the allegations in their short-form complaints were inadequate. View "Parton v. Cook Medical, LLC" on Justia Law
Blackburn v. Shire U.S., Inc., et al.
The United States Court of Appeals for the Eleventh Circuit certified a question of law to the Alabama Supreme Court. Dr. Dino Ferrante, a gastroenterologist, prescribed LIALDA, which is manufactured by Shire U.S., Inc., and Shire, LLC (referred to collectively as "Shire"), to help patient Mark Blackburn with his Crohn's disease. "LIALDA is the brand name for Shire's mesalamine drug, which is an anti-inflammatory drug specifically aimed at the gut. LIALDA is not approved by the FDA to treat Crohn's, but it is approved to treat ulcerative colitis, Crohn's 'sister' disease." After taking LIALDA for between 12 to 16 months, Blackburn discovered that he had developed kidney disease, specifically advanced chronic interstitial nephritis, which had resulted in irreversible scarring and had diminished his kidney function to 20% of normal capacity. As a result, Blackburn is awaiting a kidney transplant. The federal appellate court asked: (1) consistent with the learned intermediary doctrine, may a pharmaceutical company's duty to warn include a duty to provide instructions about how to mitigate warned-of risks?; and (2) might a plaintiff establish that a failure to warn 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? The Supreme Court answered both questions in the affirmative. View "Blackburn v. Shire U.S., Inc., et al." on Justia Law
Thacker v. Ethicon, Inc.
Ethicon manufactures a mesh sling, used to treat stress urinary incontinence, and a posterior mesh “Prolift, “designed to treat pelvic organ prolapse. In 2009, Dr. Guiler surgically implanted both devices to treat Thacker. Before the surgery, Thacker reviewed and signed an informed consent form that listed several risks, including: “infections and/or erosions of the mesh” which could require additional follow-up surgeries, urinary retention, “[p]ainful intercourse and vaginal shortening,” and treatment failure. After the surgery, Thacker’s incontinence worsened, and she suffered from shooting pain in her groin area and severe abdominal swelling and bloating. In 2010, Thacker started experiencing severe and unbearable pain during intercourse.Thacker ultimately sued Ethicon, alleging strict liability and negligence claims under the Kentucky Product Liability Act for design defect and failure to warn. The district court granted Ethicon summary judgment. The Sixth Circuit reversed. Dr. Guiler’s testimony suggested that he likely would have recommended a different course of treatment had Ethicon given adequate information. Thacker’s expert testified that no reasonable physician would have used the Pelvic Mesh Devices to treat Thacker had Ethicon given adequate information in 2009. A jury could accept that expert’s opinion that a feasible alternative design would have prevented Thacker’s injuries. View "Thacker v. Ethicon, Inc." on Justia Law
Divino Plastic Surgery, Inc. v. Superior Court
A surgeon and his clinic sought a writ from the Court of Appeal directing the trial court to vacate its order allowing the survivors of a patient who died from a surgical procedure to amend their complaint to assert a claim for punitive damages. The Court of Appeal determined the evidence of the misconduct of the surgeon and the employees of his clinic that the survivors submitted with their motion for leave to amend, if believed by the trier of fact, might well support an award of punitive damages. Nevertheless, because the survivors did not move to amend within the time mandated by statute, the Court granted the requested relief. View "Divino Plastic Surgery, Inc. v. Superior Court" on Justia Law
Gall v. Smith & Nephew, Inc.
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
Hubbard v. Bayer Healthcare Pharmaceuticals Inc.
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
Robinson v. Davol, Inc.
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
Dalton v. Teva North America
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