Merck and it’s Organon subsidiary face a product liability lawsuit brought by a group of women who suffered complications with Implanon birth control, where the implant became lost in their body and was unable to be removed.
The complaint (PDF) was filed in the U.S. District Court for the Northern District of Ohio, indicating that three separate women experienced problems after Implanon was implanted in their arm for birth control, becoming irretrievable and exposing them to a continuing risk of potential side effects.
After the Implanon lawsuit was filed on March 2, the parties reached an agreement to extend the deadline for Merck and Organon to file responsive pleadings while the parties explored a possible settlement or alternative dispute resolution. After a settlement conference scheduled for last month was canceled, the judge presiding over the case issued an order (PDF) on July 30, requiring the parties to file a joint status report by October 1.
Implanon is a small, toothpick sized implant that is placed just under the skin in a woman’s upper arm. It is designed to release the progestin etonogestrel to prevent pregnancy for a three-year period. The birth control implant was approved by the FDA in July 2006, and an estimated 500,000 American women have had the birth control implant inserted.
Concerns have been raised over the safety of the device, following reports of unwanted pregnancies and Implanon migration. In 2011, U.K. officials reported that nearly 600 women had indicated that they got pregnant even with the birth control device.
The pending Implanon migration lawsuit was brought by Brook Reynolds, Robert Reynolds, Julie Reynolds, Jenni Akins, Major Akins and Ruby Ginns. Brook Reynolds, Ruby Ginns and Jenni Akins.
Brook Reynolds, joined in the lawsuit by her parents, received an Implanon in her left arm in May 2012. When she went to have it removed in July 2014, her physician could not find it. To date it has not been located in her body and has been irretrievable, meaning she cannot have it removed and is unable to avoid any health side effects the device roaming through her body may cause, which could include ectopic pregnancy and vascular damage.
Ruby Ginns, who had the implant inserted in November 2012, and outlines a virtually identical story, as does Jenni Akins, who had the device implanted in February 2012.
The women and their family members claim that the manufacturers failed to adequately warn that the devices could migrate and become irretrievable.
The lawsuits accuse Merck and Organon of manufacturing and designing a defective medical device, failure to warn, strict liability, negligence, fraud by concealment, fraudulent misrepresentation, breach of warranty, infliction of emotional distress, and loss of consortium. The lawsuit seeks both punitive and compensatory damages.