Rebando et al vs. Coopersurgical, Inc., et al

Case Background

On January 28, 2022, Plaintiff Shelby Marie Rebando and others filed a Product Liability lawsuit in the Florida State District Court of Orlando Division (Case number:  6:22cv177). This Case was assigned to Judge Carlos E. Mendoza and referred to Magistrate Judge Leslie Hoffman Price.

Cause

Plaintiffs Shelby Marie Rebando, Cassondra Caputo, Danielle Debra Hanse, and Nakeia Webbe underwent tubal ligation procedures using Filshie Clips, which the defendants CooperSurgical, Inc., The Cooper Companies, Inc., Femcare, Ltd., and Utah Medical Products, Inc. manufactured and sold. The Filshie Clips were implanted on the plaintiffs’ fallopian tubes as permanent birth control. However, the medical device migrated from its original site, causing serious complications.

The defendants knew or should have known about the significant risk of device migration but failed to warn patients and doctors. They misrepresented the safety of the device, claiming a migration risk of only 0.13%, even though studies showed rates as high as 25%. Despite this, the defendants aggressively marketed and sold the device without disclosing the true risks. They also failed to conduct adequate pre- and post-market testing or establish proper quality assurance and surveillance programs.

The complaint alleges the defendants intentionally concealed the defects and dangers from the FDA, healthcare providers, and patients. The defendants had a duty to report adverse events and update warnings under FDA regulations but failed to do so. They prioritized economic interests over patient safety by continuing to sell the defective device

Injuries

The plaintiffs suffered severe and permanent injuries when the Filshie Clips migrated. This migration caused chronic pain, damage to internal organs, and required additional surgeries to locate and remove the clips. The plaintiffs endured significant physical trauma and ongoing medical complications, including potential reproductive organ damage, bowel perforations, and other internal injuries. They also experienced severe emotional distress, anxiety, depression, and a loss of enjoyment of life due to these complications.

Damages

The plaintiffs incurred substantial medical expenses for surgeries, hospitalization, diagnostic imaging, medications, and ongoing care. They lost wages during recovery and faced diminished earning capacity due to their health issues. The injuries also impacted their ability to engage in daily activities and maintain relationships. Their spouses claimed loss of consortium.

The plaintiffs sought compensation for economic losses (medical expenses, lost income) and non-economic losses (pain, suffering, emotional distress). They also request punitive damages to punish the defendants for their misconduct.

Key Arguments and Proceedings

Legal representation

  • Defendant(s):Coopersurgical, Inc. | Femcare, Ltd., UK subsidiary of Utah Medical Products, Inc. |

 

Claims

The plaintiffs filed multiple product liability claims, including:

Design defect: The Filshie Clips were inherently dangerous and defectively designed.

Manufacturing defect: The clips contained manufacturing flaws that made them dangerous.

Failure to warn: The defendants failed to adequately warn about migration risks.

Strict liability: The clips were unreasonably dangerous as designed and marketed.

Negligence: The defendants breached their duty in the design, manufacture, testing, and marketing of the Filshie Clips.

Gross negligence: The defendants’ reckless conduct showed disregard for patient safety.

Violation of consumer protection laws: The defendants engaged in deceptive practices regarding the Filshie Clips.

Defense

Both CooperSurgical, Inc. (CSI) and Femcare Ltd. denied all allegations. CSI positioned itself as a product seller, while Femcare claimed it neither marketed nor sold the device in the U.S. during the relevant time. Both companies raised affirmative defenses, including federal preemption, failure to state valid claims, and statutes of limitations. They argued any damages resulted from the plaintiffs’ negligence or third-party actions and invoked the learned-intermediary doctrine. They maintained their products met scientific standards, and Femcare also challenged venue propriety.

Expert Testimony

Plaintiff experts included Dr. Harris, who testified on general anatomy, Filshie Clips, clip migration, related injuries, published literature, and the state of the art in contraception. Dr. Sharlin, a former FDA reviewer and regulatory compliance expert, also provided testimony. Dr. Wheeler, an expert in clinical epidemiology and reproductive health, and Dr. Rosenzweig, an expert in Urologic Gynecology and Obstetrics & Gynecology, both offered their insights as well.

For the defense, Mr. Silverman, an attorney with FDA experience, testified on FDA regulations and compliance. Dr. Hoyte, an Obstetrician Gynecologist, and Dr. Gupta provided testimony regarding Filshie Clip safety, the rare occurrence of migration, UK experience, and the accuracy of the instructions for use (IFUs

Jury Verdict

On September 9, 2024, the jury returned a verdict in favor of the defendants, ruling against the plaintiffs.

Court Documents:

Available Upon Request