What Attorneys Need to Know About Essure Lawsuits

What Attorneys Need to Know About Essure Lawsuits

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About the Authors

Steven Gacovino & Edward Lake met while students at the Touro College Law Center. They opened their firm after graduation.

Gacovino Lake started in 1993. We successfully litigated more than 20,000 cases and have over 20 years mass tort experience.

We have experience in marketing, lead generation, and contract follow-up. We work with top trial law firms in the U.S.

1.About Essure

What is Essure?

▸ A non-hormonal, non-surgical permanent birth control implant.

▸ Only FDA-approved permanent birth control device on market.

▸ Manufactured by Bayer.

How Essure Works

▸ Doctors place metal coils in fallopian tubes.

▸ No need for general anesthesia.

Complications of Essure

▸ Heavy or multiple periods▸ Severe pelvic, abdominal, and back

pain▸ Unintended pregnancy▸ Severe headaches▸ Weight fluctuations▸ Fatigue

2.Problems with Essure

Complaints▸ Over 5,000

complaints filed between Nov. 2002 and May 2015.

Complaints & Deaths

Deaths▸ Blamed for at

least 11 deaths.

▸ Blamed for 5 fetal deaths after implantation.

Implant May Displace

Displacement may cause:▹ Perforated bowel▹ Perforated fallopian tubes▹ Emergency hysterectomy▹ Abdominal abscess

3.FDA & Congressional Action on Essure

FDA Actions

September 2015: Panel review; released additional use guidelines.

November 2015:Update states it is reviewing panel discussion and additional medical literature.

February 2016:Requires black box warning on label. Tells Bayer to monitor safety of device.

FDA Requires Black Box Warning

Black box warnings are the most serious type. ▸ They “call attention to serious or

life-threatening risks,” per the FDA.

Source: FDA Press Release, February 29, 2016

Bayer Must Monitor Risk

FDA ordered Bayer to conduct surveillance study. ▸ Will help assess “risks of the device in a real-

world environment.”▸ FDA will use results to decide if it should take

further action.

Source: FDA Press Release, February 29, 2016

Congressional Actions

November 2015: Congressman Mike Fitzpatrick introduces H.R. 3920, the “E-Free Act.”

▹ Would require FDA withdraw approval of Essure.

▹ In House Committee for Energy and Commerce. (As of February 2016.)

4.Essure Lawsuits

Failure to Warn?▸ Lawsuits allege Bayer failed to

warn about side effects and risk of displacement.

▸ Several lawsuits pending against Bayer.

▸ Additional lawsuits against Conceptus (original manufacturer).▹ Allege violation of FDA premarket

approval terms and withholding data.

Lawsuits

5.Add Essure Lawsuits to Your Portfolio

▸ February 2016 FDA report likely to increase publicity of complications.

▸ More women may come forth alleging injuries.

▸ Testimony exists; several women spoke at FDA panel.

Why?

▸ Many injuries due to improper initial placement of implant.

▸ Potential for medical malpractice claims.

Possibility of Medical Malpractice Lawsuits

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