Paul Tassin  |  September 23, 2016

Category: Legal News

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Essure-Pregnancy-LawsuitA federal judge has decided a couple who became pregnant with twins despite using Essure birth control may continue their Essure pregnancy lawsuit against the device’s manufacturer, though with fewer claims than they originally pled.

U.S. District Judge B. Lynn Winmill will allow plaintiffs Susan and Brian R. to continue their Essure pregnancy lawsuit based on claims that defendant Bayer Healthcare Pharmaceuticals failed to warn them about the risks associated with the company’s implantable birth control device.

Judge Winmill will also allow the couple to fix defects in their claims that Bayer failed to properly train the doctor who implanted Susan’s Essure birth control devices.

The rest of the couple’s state law claims are preempted by the 1976 Medical Device Amendments to the federal Food, Drug, and Cosmetic Act, the judge decided.

The Essure birth control system consists of a pair of inserts that a doctor implants inside the fallopian tubes.

Over the next few months, and if the implants work as intended, the inserts stimulate the growth of new tissue that occludes the fallopian tubes and prevents fertilization.

Bayer allegedly represents that Essure is nearly 100 percent effective.

Non-Preempted Claims Keep Essure Pregnancy Lawsuit Alive

Court papers from this Essure pregnancy lawsuit say Essure is considered a Class III medical device under the Medical Device Amendments to the FDCA.

As Judge Winmill describes it, bringing a state law claim over a medical device covered by the Medical Device Amendments can be tricky.

“Essentially, ‘the plaintiff must be suing for conduct that violates the FDCA . . . but the plaintiff must not be suing because the conduct violates the FDCA,’” the judge said.

State claims that don’t meet those requirements are likely to be preempted by the federal law.

Most of Susan and Brian’s state law claims fail to make it through that narrow window, the judge determined.

Claims for defective manufacturing, defective design, breaches of express and implied warranties, and misrepresentation all address behavior by the defendants that is governed under the FDCA and as such are preempted by federal law.

Their claims for failure to warn are not so preempted, however. Judge Winmill allowed the Essure pregnancy lawsuit to continue based on those claims.

As for the couple’s claims that Bayer failed to properly train Susan’s physician, Judge Winmill dismissed those claims because they fail to allege a causal connection between the couple’s injuries and any improper use of the implanting equipment.

However, the judge gave Susan and Brian leave to amend their pleadings to fix that defect because, if properly pled, these claims would not be preempted under the Medical Device Amendments.

In part, the theory behind these claims is that Bayer improperly entrusted doctors to use specialized equipment that was not subject to FDA approval, unlike the Essure implants themselves.

If the federal law does not regulate that particular equipment, state claims based on its misuse would not be preempted, the judge said.

The Essure Pregnancy Lawsuit is Case No. 4:15-cv-00443, in the U.S. District Court for the District of Idaho.

In general, Essure lawsuits are filed individually by each plaintiff and are not class actions.

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Join a Free Essure Class Action Lawsuit Investigation

If you or a loved one were injured by Essure birth control complications, you may have a legal claim. See if you qualify to pursue compensation and join a free Essure class action lawsuit investigation by submitting your information for a free case evaluation.

An attorney will contact you if you qualify to discuss the details of your potential case.

Please Note: If you want to participate in this investigation, it is imperative that you reply to the law firm if they call or email you. Failing to do so may result in you not getting signed up as a client, if you qualify, or getting you dropped as a client.

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