Essure Medical Device Lawsuit
Lawsuits involving the permanent sterilization device Essure is costing its maker, the multinational conglomerate Bayer AG.
In 2016, Germany-based Bayer sustained losses of $413 million in connection with the Essure gadget, according to its yearly report launched Wednesday.
In general, Bayer had a record year for earnings. The company posted net income of $4.8 billion on profits of $48 billion in 2016 compared with net income of $4.3 billion on revenue of $48 billion in 2015.
Bayer’s pharmaceutical segment likewise published gains. Revenues prior to interest and taxes for its pharmaceutical segment increased by 11.9% from 2015, to $3.58 billion.
More than 3,700 women have actually filed lawsuits against the Bayer Group in the U.S., declaring harm from the device. Essure includes 2 metal coils implanted in the fallopian tubes that induce scarring to block egg pathways and prevent fertilization.
Those losses added to a boost in unique charges from $316 million (EUR299 million) in 2015 to just under $590 million (EUR558 million) in 2016. The losses were based on Bayer’s assessment of the market environment and “lower profits expectations.”
Overall, Bayer’s gross revenue prior to interest and taxes for its pharmaceutical segment increased by 11.9% from 2015, to $3.58 billion (EUR3.389 billion).
Bayer affirms the safety and efficacy of the Essure gadget, amidst mounting claims in the U.S. and Canada, a black box warning released last year by the FDA, and the news today that Brazil suspended the device from its market.
The yearly report acknowledged the lawsuits, specifying that roughly 3,700 users had submitted them as of Jan. 23, 2017 and that more were most likely to come.
“Plaintiffs allege accidents from the use of Essure, including hysterectomy, perforation, pain, bleeding, weight gain, nickel sensitivity, anxiety and undesirable pregnancy,”the yearly report stated. “Additional suits are prepared for … Bayer believes it has meritorious defenses and intends to protect itself vigorously.”
The scope of the claims and the damage they have actually inflicted on the Essure brand may have exceeded Bayer’s expectations.
Although the business was guaranteed against “statutory product liability claims … to the level traditional in the particular industries,”the yearly report said, “the accounting steps connecting to [contraceptive pill] Yasmin/YAZ and Essure claims surpass the offered insurance coverage.”
The company said that $277 million (EUR262 million) in costs for “considerable legal threats”mainly consisted of accounting steps tied to legal proceedings connected to three products, including Essure.
It is not clear whether Essure’s revenues, sales and circulation have actually declined recently as more Essure-associated injuries are reported to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database and a growing number of women file suit. Up until now, the FDA has received about 10,000 reports of injuries or damage linked to Essure.
Since 2002, when the FDA authorized the gadget in the U.S., Bayer has offered 750,000 Essure units all over the world, most of them in the U.S., Bayer representative Jennifer Brendel informed Modern Healthcare in January. Per company policy, Bayer does not supply country-level sales data.
The company has been presenting the exact same number for a minimum of 4 years. In a 2013 filing to the Securities and Exchange Commission by Conceptus, the company that developed Essure prior to being obtained by Bayer in 2013, it said it had actually distributed 750,000 gadgets.
The Essure device is marketed as being a simpler option for sterilization than approaches such as tubal ligation or hysterectomy. It has been billed as a non-surgical procedure that requires local rather of general anesthesia and can be performed in a medical professional’s office instead of the healthcare facility, so that the majority of women can be discharged within 45 minutes and go back to regular activities within 24 hr.
Reports to MAUDE paint a various picture. Patients and physicians have actually reported allergies and autoimmune actions to the device, gadget migration and persistent pain.
Anecdotal proof recommends strongly that less ladies are choosing the procedure.
Dr. James Greenberg, an OB/GYN at Brigham-Faulkner OB/GYN Associates in Boston, stated need from clients for Essure had declined over the last few years. He initially implanted Essure in a client in 2004 and for a time was implanting two or 3 a month, till recently.
“If I put in one in the previous year, I’d be amazed,” Greenberg said. Need started falling “when the lawsuits began going up,” he added.
“Whether you’re seeing a doctor, or getting a new procedure, or doing anything, I think the average medical consumer today goes right to the Internet,”Greenberg stated. “You put in Essure, and the very first thing that shows up is suits. That’s not something that makes you very delighted to have that done to you.”
Other elements might have contributed to declining need for Essure, Greenberg said. Long-acting reversible contraceptives, like IUDs and hormonal implants, are increasingly accepted, he pointed out.
A survey of doctors carried out by e-mail in February for Modern Healthcare by SERMO, a social media network website for doctors, discovered that a bulk of OB/GYNs polled had actually seen a decrease in the number of Essure devices implanted in the previous 5 years.
Out of 387 OB/GYNs who responded to the survey, 272 said they had implanted a patient with Essure. Of those, 217 stated the variety of devices they implanted annually had decreased in the past 5 years, 29 stated the number had not changed, and 26 said the number had increased.
Edward Lott, Ph.D., M.B.A.
President and Managing Partner
ForLawFirmsOnly Marketing, Inc.
Medical Injury Help, LLC