FDA Issues Guidance for Applying Human Factors and Usability Engineering to Medical Devices to Ensure Safety and Effectiveness

In an effort to assist the medical device industry in maximizing the likelihood that new medical devices will be safe and effective for intended users, the U.S. Food and Drug Administration recently released Guidance for Industry and FDA Staff on Applying Human Factors and Usability Engineering in Medical Devices. While this FDA guidance document does not establish legally enforceable responsibilities for manufacturers, it is the FDA’s intent to support manufacturers in improving the design of medical devices to minimize potential use errors and resulting harm, as well as allowing manufacturers to assess and reduce risks associated with the use of medical devices. In this release, the FDA recommends that manufacturers follow human factors engineering, or usability engineering (HFE/UE) processes during the development of new medical devices. Human factors engineering is ...
Continue Reading...


“Symptom Threshold Methodology” Rejected by Court of Appeals of New York Pursuant to Frye

In an opinion decided February 11, 2016, the Court of Appeals of New York precluded two causation experts put forth by a plaintiff in a toxic tort case. The case involved allegations that a minor was born with severe mental and physical disabilities caused by in utero exposure to unleaded gasoline vapor. The vapor was allegedly emitted into the car from a defective fuel hose. The automobile manufacturer subsequently recalled the vehicle at issue due to defects in the feed fuel hoses. In support of his claims, the plaintiff put forth numerous expert witnesses, including Linda Frazier, M.D., M.P.H. and Shira Kramer, M.H.S., Ph.D. Applying what the court termed a “symptom threshold methodology” those experts reached the conclusion that the in utero exposure to gasoline vapor proximately caused the birth ...
Continue Reading...

Plaintiffs’ Product Case Trumped by the Learned Intermediary Doctrine

A large pharmaceutical manufacturer recently won a fundamentally important victory both within the mass tort it is facing and for all life science companies needing to rely upon the learned intermediary doctrine. In the consolidated litigation proceeding in New Jersey state court, the plaintiffs’ claim the manufacturer failed to properly warn its users of known gastro-intestinal complications associated with the drug. Relying on the learned intermediary doctrine, the judge granted the manufacturer summary judgment in some cases because the treating physicians testified they prescribed the drug with knowledge of the allegedly associated GI issues. Drug manufacturers have a duty to warn consumers directly of all material, foreseeable risks associated with the use of their product. Such warnings are generally rendered in a label applied to the product and on the ...
Continue Reading...

FDA Draft Guidance for Postmarket Management of Cybersecurity in Medical Devices Puts Manufacturers on Notice of Potential Cybersecurity Risks

This post also appears on Goldberg Segalla’s Product Liability Playbook blog.  On January 22, 2016, citing cybersecurity threats to medical devices as a growing concern, the United States Food and Drug Administration issued draft guidance for industry and FDA administration staff for postmarket management of cybersecurity in medical devices. Public comments on the draft guidance will be open for 90 days. According to the FDA release, a growing number of medical devices are designed to be networked to improve and facilitate patient care. However, the FDA notes that networked medical devices incorporate software that may be vulnerable to cybersecurity threats, which may represent a risk to the safety and effectiveness of medical devices. The FDA notes that while manufacturers can incorporate controls in the design of a product to help ...
Continue Reading...

District Court Judge Denies Manufacturer of OTC Pain Reliever Summary Judgment Based on Preemption

Judge Lawrence Stengel of the United States District Court for the Eastern District of Pennsylvania denied summary judgment to the manufacturer of an over-the-counter pain reliever. The manufacturer had sought to dismiss the plaintiff’s fraud and fraudulent misrepresentation claims as preempted by federal law. The Food and Drug Administration (FDA) regulates how OTC drugs should be labeled and sold. The Federal Trade Commission regulates whether an OTC drugs advertising is misleading. In the case before Judge Stengel, the OTC manufacturer argued that the fraud claims were either expressly preempted pursuant to 21 U.S.C. Sec. 379r (Food, Drug, and Cosmetic Act or FDCA) or impliedly preempted under Buckman Co. v. Plaintiff’s Legal Committee, 531 U.S. 341, 121 S. Ct. 1012, 148 L. Ed. 2d 854 (2001). Judge Stengel explained that express ...
Continue Reading...

Ninth Circuit Outlines for Plaintiff How to Meet the Twombly/Iqbal Standard in a Third Amended Complaint

In this case, the plaintiff, Nicole Weber, appealed the United States District Court for the District of Arizona’s dismissal of her second amended complaint pursuant to Federal Rule of Civil Procedure 12(b)(6). The issue on appeal before the Ninth Circuit panel was whether Weber’s allegations were sufficient to survive a 12(b)(6) motion under the Twombly/Iqbal standard requiring a complaint to set out a plausible claim. Since the Supreme Court’s rulings in Bell Atlantic v. Twombly and Ashcroft v. Iqbal, federal district courts have seen more motions to dismiss filed. In turn, district courts have often given plaintiffs a chance to file an amended complaint. Weber’s case involves allegations that breast implants were defective, raising product liability claims. Rather than simply affording Weber the opportunity to re-plead, the Ninth Circuit panel outlined ...
Continue Reading...

Illinois Federal Court Considers Whether Plaintiff Expert’s Methodologies Were Sufficiently Reliable under Daubert in a Pharmaceutical Case

GlaxoSmithKline has attempted to knock out the plaintiff’s experts in Dolin v. GlaxoSmithKline, in its latest round of Daubert motions. Wendy Dolin is suing GSK after the suicide death of her prominent lawyer husband, who had been taking the generic form of Paxil, paroxetine, an antidepressant.  This case made national news just a year ago when Judge Zagel of the Northern District of Illinois held that GSK could be liable for Dolin’s death under a negligence theory, not a product liability theory, even though he only consumed the generic equivalent manufactured by Mylan and did not consume a GSK product. That decision was in stark contrast to 90 other court decisions that have all rejected brand-name manufacturer liability for generic products. In light of that decision, GSK’s defense of the case ...
Continue Reading...

Drug Promotion on Social Media By Consumers: Can It Be Regulated?

Kim Kardashian recently used social media to promote the use of a prescription drug. In her Instagram post, Ms. Kardashian told her followers that a physician recommended use of the drug Diclegis to alleviate her symptoms of morning sickness. Ms. Kardashian is not the only public figure to recently deal with morning sickness as the Duchess of Cambridge also dealt with this issue, reported here. Having experienced positive results following the use of this drug, Ms. Kardashian posted her intent to pair with the maker of Diclegic to “raise awareness about treating morning sickness.” Other than noting that studies have shown no increased risk to the baby due to the use of this drug, Ms. Kardashian did not reference any potential complications or known side-effects of the drug in her ...
Continue Reading...

Preemption Ruling: Federal Appeals Court Strikes Strict Liability and Warranty Claims As to “Off-Label” Use of Bone Graft Device

Last week, the U.S. Court of Appeals for the 10th Circuit in Denver, in a 2-1 decision, upheld a trial court ruling dismissing a complaint on the grounds that federal law preempted a plaintiff’s state law breach of warranty and design defect claims. The claims stem from complications following the alleged “off-label” manner of implantation of a spinal bone graft system. Click here for the opinion in Caplinger. Background As the majority explained, under the Food, Drug, and Cosmetics Act, and the Medical Device Amendments thereto, a medical device manufacturer’s products and labeling must receive prior approval. Once approved, changes are not usually permitted without FDA consent. Although Congress expressly provided for the supremacy of federal law regarding medical devices, 21 U.S.C. §360k(a), legal challenges frequently arise when plaintiffs seek to ...
Continue Reading...

Texas Court Holds that Compounding Pharmacies are Subject to Requirements of the Texas Medical Liability Act

On April 24, 2015, in a significant win for pharmacies in the State of Texas, the Texas Supreme Court dismissed a plaintiff’s product liability action that alleged that the lipoic acid treatment she received caused her to go blind. The court held that the defendant compounding pharmacy that provided the supplement was entitled to protection under the Texas Medical Liability Act (TMLA) and dismissed the case. The decision is available here. In 2011, Ms. Miller was undergoing weekly injections of lipoic acid with her physician to treat a medical condition. She had no reaction to the first 9 weeks of treatment, but while receiving the tenth treatment she had a severe adverse reaction and was hospitalized. She is now permanently blind in both eyes. A licensed compounding pharmacy in Arlington, Texas ...
Continue Reading...