Ethicon
Ethicon is a subsidiary of health care giant Johnson & Johnson. It operates globally and sells its products worldwide. Its products include surgical tools, sutures and mesh products. Some of its hernia and pelvic mesh products have led to injury lawsuits and million-dollar settlements and verdicts against the company.
Ethicon Inc. is part of the Johnson & Johnson family of companies. It manufactures medical devices and surgical instruments.
The company reported $4.9 billion in revenue in 2021.
Ethicon is well-known for its sutures and other wound closure products. It also makes hernia mesh and transvaginal mesh.
Some of Ethicon’s popular mesh products have caused patient injuries. This has led to lawsuits, financial setbacks and a voluntary recall.
About Ethicon
Ethicon has its headquarters in Bridgewater, New Jersey and Cincinnati, Ohio.
The manufacturer sells its products in 52 countries. It has a large majority of market shares in surgical sutures in the U.S.
Johnson & Johnson’s surgery franchise made $8.2 billion in sales in 2020, according to Johnson and Johnson’s 2020 annual report. The figure is down from $9.5 billion in 2019.
Ethicon History
Ethicon started in 1915 in Edinburgh, Scotland. It began as a factory that manufactured, packaged and sterilized catgut, silk and nylon sutures. The factory was founded by Scottish pharmacist George F. Merson.
Merson developed eyeless needled sutures with a single strand of material pre-attached through the butt of the needle. This invention greatly reduced tissue damage caused by pulling double strands through the skin.
Johnson & Johnson bought G.F. Merson Limited in 1947.
Ethicon Suture
Under Johnson & Johnson’s control, G.F. Merson Limited became Ethicon Suture Laboratories in 1949. And in 1953, it became Ethicon Inc.
Merson stayed involved in the company until his death in 1958.
For years before his death, Merson invited the company’s directors to a yearly dinner in January. They would talk about Ethicon’s accomplishments and future plans. This tradition continued after his death.
Ethicon Inc.
In the 1990s, Ethicon Inc. formed four different companies with unique product specialties under the Ethicon name. The companies were to help Ethicon explore new and more advanced technologies.
In 2008, the company sold its wound management business to One Equity Partners. The former division of Ethicon became Systagenix Wound Management Limited.
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2009
Mentor – breast implant maker
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2010
Acclarent – ear, nose, throat technology company
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2016
NeuWave Medical – maker of probes that use microwave energy to remove cancerous tumors
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2017
Megadyne – Innovative portfolio of electrosurgical tools
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2019
TachoSil — Fibrin patch business from Takeda Pharmaceutical
Ethicon Products
Ethicon manufactures a range of surgical products. The company’s motto is “shaping the future of surgery,” according to the Ethicon website.
Ethicon started with the creation of the first sutures. It expanded into biosurgical tools, and infection control and wound closure products. It also makes hernia mesh, and pelvic meshes and slings.
- Evicel/Evarrest
- Fibrin sealants
- Surgicel
- Absorbable hemostats to manage surgical bleeding
- Surgifoam
- Absorbable gelatin sponge or powder intended for hemostatic use by applying to a bleeding surface
- Harmonic
- Surgical shears
- Enseal
- Tissue sealers
- Endopath
- Electrosurgery probes and other surgical tools including trocars
- Megadyne
- Surgical tools (i.e. tissue dissector, electrosurgical generator, electrosurgical smoke evacuators)
- Proximate
- Skin staplers and surgical tools (i.e. linear cutters)
- Stratafix
- Tissue control devices
- Vicryl
- Coated sutures
- Dermabond
- Topical skin adhesives
- Physiomesh
- Mesh device
- Proceed/Prolene
- Surgical mesh products
- Gynecare
- Uterine and pelvic meshes and slings
- Biopatch
- Protective disk – infection control dressing
- Endopouch Retriever
- Specimen retrieval bag
Ethicon Recalls
Ethicon pulled its popular Physiomesh Flexible Composite Hernia Mesh from the market worldwide in 2016. Unpublished data from two large studies determined possible safety risks to patients.
Ethicon issued hernia mesh recalls in Europe and Australia. It issued a market withdrawal in the U.S.
The studies showed that Physiomesh had higher rates of revision surgeries compared to other hernia meshes used for hernia repairs. There was also a greater possibility of the hernia returning.
The company blamed the hernia mesh complications on possible “product characteristics” as well as “operative and patient factors,” according to one publication.
Ethicon has not issued a transvaginal mesh recall. But, in 2012, the company stopped selling four of its Gynecare mesh products.
Ethicon Lawsuits
Ethicon is involved in lawsuits over several of its products. These include transvaginal mesh, surgical staplers and hernia mesh.
Transvaginal Mesh
At one time, Ethicon faced more than 40,000 transvaginal mesh lawsuits over its Prolift transvaginal mesh device and Gynecare TVT-Obturator bladder sling complications. Several lawsuits ended in jury verdicts or settlements.
As of March 15, 2021, the company faces three federal lawsuits in West Virginia. It “settled or otherwise resolved” the majority of these claims for undisclosed amounts, according to J&J’s 2020 Annual Report.
The MDL court in West Virginia has remanded some cases back to its local state jurisdictions. Cases continue to be filed, but they remain outside the MDL. Ethicon still faces 14,900 pelvic mesh lawsuits, according to the 2020 annual report.
Ethicon agreed to pay $117 million to 41 states and the District of Columbia to settle claims for deceptive marketing of its pelvic mesh products in October 2019.
Surgical Staplers
Ethicon recalled nearly 92,500 of its Endo-Surgery surgical staplers in 2019 after staplers misfired in two patients, injuring them.
Patients who were injured by these malfunctioning devices are filing surgical stapler lawsuits against the company.
Hernia Mesh
Ethicon faces thousands of hernia mesh lawsuits related to its Physiomesh Flexible Composite, Proceed and Prolene hernia meshes. Lawsuits claim Ethicon and Johnson & Johnson manufactured and sold a defective product.
Some lawsuits have ended in verdicts or settlements.
As of March 15, 2021, Ethicon faced 3,365 Physiomesh lawsuits in multidistrict litigation in Georgia. It also faces cases in multicounty litigation in New Jersey.
Proceed and Prolene hernia mesh cases are pending in separate multicounty litigations in New Jersey.
The first Physiomesh trial for Jim B. and Diane Crumbley is set to take place on March 18, 2021. The second bellwether will go to trial on June 7, 2021. The third is tentatively scheduled for September 13, 2021.
Ethicon Verdicts and Settlements
Lawsuits against Ethicon have resulted in millions of dollars in payouts to injured patients. This includes multiple verdicts and settlements involving pelvic meshes.
Despite repeated losses, the company has not yet agreed to a large-scale settlement.
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December 2015
A Philadelphia jury awarded $12.5 million to a woman who said Ethicon’s Prolift mesh implant caused her to have pain during sex and required surgeries to correct.
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January 2016
Johnson & Johnson agreed to pay $120 million to settle thousands of mesh lawsuits. Some of these lawsuits involved mesh products manufactured by Ethicon.
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February 2016
A jury awarded $4.4 million to a Florida resident injured by Mentor’s ObTape sling for urinary incontinence. Ethicon acquired Mentor in 2009.
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February 2016
A New Jersey jury awarded $13.5 million to a patient who received Ethicon’s transvaginal tape (TVT) for stress urinary incontinence (SUI).
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April 2017
A Philadelphia jury awarded $20 million to a patient who received Ethicon’s TVT-Secur and suffered transvaginal mesh complications.
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September 2017
A Philadelphia jury awarded $57.1 million to a patient injured by two of Ethicon’s pelvic mesh implants.
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December 2017
A New Jersey jury awarded $15 million to a patient who needed revision surgery after receiving a Prolift mesh implant. Ethicon lost its attempt at an appeal to overturn the verdict.
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March 2018
An Indiana jury awarded $35 million to a patient injured by Ethicon’s Prolift mesh implant.
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April 2019
A Philadelphia jury awarded $120 million to a woman who received Ethicon’s TVT-O mesh implant.
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May 2019
A Pennsylvania jury awarded $80 million to a woman who had a Prolift mesh implant.
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