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, July 3, 2014

IUD removal surgery triggers patient’s knowledge of injury

By Pamela C. Maloney, J.D.

Both the Texas and Indiana two-year statutes of limitations barred a patient’s products liability action against the manufacturers of an intrauterine device (IUD) because she should have known at the time the device was surgically removed that she had a cause of action, a federal district court in New York determined. The court refused to apply the discovery rule to delay the triggering of the limitations until the patient saw a commercial linking her injuries to the device (In re: Mirena IUD Products Liability Litigation (Truitt v. Bayer), July 2, 2014, Seibel, C.).

Background. In July 2011, the patient underwent surgery to remove a Mirena IUD that had perforated her uterus and migrated into her abdomen. The surgeon informed the patient that in addition to perforating her uterus, the IUD had caused her cervix to thin and ovarian cysts to form. In September 2013, the patient filed lawsuit asserting products liability and negligent failure-to-warn, breach of warranty, negligent misrepresentation, and fraud claims against Bayer HealthCare Pharmaceuticals Inc., Bayer Pharma AG, and Bayer OY, the three related companies that manufacture, design, formulate, and packaged the IUD after she saw a commercial that linked her injuries to the IUD. The companies moved to dismiss the action as barred by the applicable statute of limitations.

Statutes of limitations. Explaining that under Texas choice of law rules, the patient’s claims must be timely under both Texas law, the place where the action was filed, and Indiana law, the place where the patient resided and her treatment occurred. The statute of limitations for personal injury actions in both Texas and Indiana is two years. However, both states apply similar discovery rules which tolled the limitations period until the patient discovered, or through the exercise of reasonable diligence should have discovered, the nature of her injuries. The patient alleged that the perforation of her uterus by the IUD and the removal surgery caused her sever pain. She also alleged that the IUD caused her cervix to thin and ovarian cysts to form. The manufacturers argued, and the court agreed, that these events were sufficient to trigger the statute of limitations, making her claim untimely.

The court rejected the patient’s arguments that (1) she did not know the IUD had harmed her; (2) she had no reason to suspect that the IUD had harmed her because she had received no warnings regarding post-insertion events and, thus, suspected only that the device had been inserted improperly; and (3) no doctor specifically informed her that the IUD had malfunctioned and/or that the product’s design or a product defect was the reason the device perforated her uterus. The court found that once the patient learned that the IUD had perforated her uterus and would have to be removed, that knowledge was sufficient to trigger the statute of limitations. According to the court, “when an IUD is found somewhere in a woman’s body where it is not supposed to be ... and surgery is required to remove it, a diligent individual would know, at the very least that there was a ’reasonable possibility’ ... that the IUD harmed her and she should therefore make further inquiry to determine her legal rights.” Further, the knowledge was sufficient to put the patient on notice regardless of what the warning label indicated regarding possible migration.

The patient’s claim that she suspected she had been injured because of her doctor’s negligence did not provide sufficient basis to toll the limitations period. Once she learned that the IUD had perforated her uterus and that surgery was required to remove it, she should have inquired into why. Whether that inquiry revealed that the perforation was caused by her doctor’s malpractice or the product’s failure was irrelevant to the issue of when the statute of limitations was triggered on the products liability claims, the court explained.

Timeliness of other claims. The court also determined that the patient’s negligent misrepresentation claim was barred under both Texas and Indiana statutes of limitations for the same reasons set forth under its products liability analysis. With regard to her claim for breach of implied warranty, the court concluded that because the applicable four-year limitations period began to run on the date the device was inserted, this claim was time-barred as well. The court did not reach the issue of timeliness of the patient’s fraud claims because those claims failed to meet the federal pleading standards.

The case numbers are 13-MD-2434 (CS), 13-MC-2434 (CS), and 13-CV-7811 (CS)

Attorneys: Shezad Malik (Dr. Shezad Malik Law Office PC) for Amanda Truitt. Elmore James Shepherd III (Shook Hardy & Bacon LLP), and Brian P. O'Donoghue (Goldman Ismail Tomaselli Brennan & Baum LLP) for Bayer HealthCare Pharmaceuticals Inc.

Companies: Bayer HealthCare Pharmaceuticals Inc.; Bayer Pharma AG; Bayer OY

MainStory: TopStory SofLReposeNews MedicalDevicesNews IndianaNews TexasNews NewYorkNews

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.