Man unsure of the safety of his medicine

Breaking news and expert analysis on legal and compliance issues

[Back To Home][Back To Archives]

From Products Liability Law Daily, November 9, 2017

Preemption, causation issues end patient’s lawsuit against breast implant manufacturer

By Leah S. Poniatowski, J.D.

A products liability lawsuit filed against Mentor Worldwide, LLC, a manufacturer of saline breast implants, was disposed of on summary judgment in favor of the manufacturer in light of federal law preemption, insufficient causation pleadings, and non-compliance with the warranty procedures, a federal district court in California ruled (Laux v. Mentor Worldwide, LLC, November 8, 2017, Wright, O.).

Background. An individual had Mentor Worldwide-manufactured saline filled inflatable breast implants implanted in 2005. She alleged that she experienced several physical ailments thereafter, and in 2014, debris and bio-toxins from mold inside the implants were discovered. She underwent a surgical procedure to remove them and the surgeon determined that the implants were leaking. Another doctor examined the implants, concluding that the valves were defective and that the leaks from these valves caused the individual’s debilitating bio-toxin disease, auto-immune disorders, respiratory disease, and fibromyalgia. The individual filed a products liability, negligence, and breach of warranty lawsuit against Mentor Worldwide. However, the opinions of her experts were excluded by the court in a prior ruling, and the manufacturer filed the present motion for summary judgment.

Federal preemption. The individual’s state law-based products liability claims were expressly preempted by the Medical Device Amendments of 1976 to the federal Food, Drug and Cosmetic Act (FDC Act). First, the court concluded that specific federal requirements applied to the breast implants in this case because FDA-issued premarket approval of the implants imposed requirements under the Medical Device Amendments of 1976. Second, the manufacturing defect claim was not based on any state law requirement distinct from the federal requirements. The court found that the individual failed to state a parallel claim capable of surviving preemption because the individual’s references to the federal Current Good Manufacturing Practices (CGMP) to support her position were vague and unspecified. Case precedent held that the CGMP guidelines do not create federal requirements and cannot support a claim of a federal requirement violation.

Causation. In light of the prior ruling excluding the individual’s expert opinions, which was the only evidence proffered to establish causation, the court concluded that she failed to satisfy that necessary element of her negligence claim against the manufacturer.

Express warranty. Finally, the individual’s breach of express warranty claim failed because she did not comply with the warranty conditions. Specifically, the individual’s physician failed to contact the manufacturer to confirm that there was a covered event, the individual did not provide the serial numbers of the implants or sign a release, and the physician did not send the implants to the manufacturer’s product evaluation department pursuant to the warranty requirements. Further, there was no evidence that the manufacturer failed to repair, replace, or otherwise conform to the terms of the warranty. Therefore, the manufacturer’s motion for summary judgment was granted.

The case is No. 2:16-cv-01026-ODW (AGR).

Attorneys: Anita Laux, pro se. Mollie Fleming Benedict (Tucker Ellis LLP) for Mentor Worldwide LLC.

Companies: Mentor Worldwide LLC

MainStory: TopStory PreemptionNews CausationNews MedicalDevicesNews CaliforniaNews

Back to Top

Products Liability Law Daily

Introducing Wolters Kluwer Products Liability Law Daily — a daily reporting service created by attorneys, for attorneys — providing same-day coverage of breaking news, court decisions, legislation, and regulatory activity.

A complete daily report of the news that affects your world

  • View full summaries of federal and state court decisions.
  • Access full text of legislative and regulatory developments.
  • Customize your daily email by topic and/or jurisdiction.
  • Search archives for stories of interest.

Not just news — the right news

  • Get expert analysis written by subject matter specialists—created by attorneys for attorneys.
  • Track law firms and organizations in the headlines with our new “Who’s in the News” feature.
  • Promote your firm with our new reprint policy.

24/7 access for a 24/7 world

  • Forward information with special copyright permissions, encouraging collaboration between counsel and colleagues.
  • Save time with mobile apps for your BlackBerry, iPhone, iPad, Android, or Kindle.
  • Access all links from any mobile device without being prompted for user name and password.