Endo International plc is a healthcare company that makes pharmaceuticals, both branded and generic, over the counter medications, and medical devices. The company came into being in 1997 through a buyout of certain products and other assets of DuPont Merck Pharmaceuticals. Endo International has five operating companies: Endo Pharmaceuticals, Par Pharmaceuticals, Paladin Labs, Litha, and SOMAR.
Over the years Endo has acquired and sold a number of different affiliate companies. One of those, American Medical Systems (AMS), made a transvaginal mesh product that has since proved dangerous to patients. Endo and AMS have paid almost $1 billion in settlements to those patients who have experienced dangerous complications.
Endo International – Overview
Endo International plc is a company employing over 6,000 people worldwide in several different countries. The U.S. headquarters are in Malvern, Pennsylvania and the international headquarters are in Dublin, Ireland. Through its five operating companies and other acquired affiliates, Endo makes brand name and generic prescription drugs, over the counter medications, and medical devices.
Some of Endo’s most well-known products include the opioid painkillers Percocet, Percodan, Zydone, and Opana. Endo also makes Lidoderm, a brand name lidocaine product, Carbidopa for treating Parkinson’s disease, Frova for migraines, and Moban, an antipsychotic used to treat schizophrenia, although this one was discontinued in 2010. Endo’s main areas of focus for research include allergy therapies, dermatology, insomnia, pain, urology, and infectious diseases.
One product in particular, the transvaginal mesh, has caused Endo a lot of problems. With serious complications for women who had this mesh implanted, including damage that requires multiple surgeries to correct, the company has faced many lawsuits and a large settlement. The mesh was made by AMS, but since Endo acquired that company, it became responsible for the product.
Although Endo International plc as it exists today only dates back to 1997, the true origins of the company go back to 1920. The original company was called Intravenous Products of America, Inc., and was founded as a family business in 1920. In 1935 the company name changed to Endo Products. In the decades leading up to the 1997 formation of Endo International, Endo Products created a number of important pharmaceuticals. These include Percodan and Percocet, widely used opioid painkillers.
DuPont acquired Endo in 1970. The formation of Endo International in 1997 was a management buyout. Several executives from DuPont Merck paid $277 million for certain products under the Endo name, including Percocet and Percodan. They named the new company Endo international plc. Since then the company has developed a number of new health care products, like Lidoderm, new strengths of Percodan and Percocet, Frova, Opana, and many others.
Endo also acquired a number of other companies since its 1997 buyout. It has purchased Indevus Pharmaceuticals, Penwest Pharmaceuticals, Qualitest Pharmaceuticals, Boca Pharmacal, Paladin Labs, SOMAR, and DAVA Pharmaceuticals. Endo bought American Medical Systems in 2011, but has since sold it to Boston Scientific.
AMS is where Endo’s problems began. AMS sold transvaginal mesh products, which were found to be harmful and risky. Surgical mesh is a material made either from synthetic components or biological materials. It can be used in surgery in a number of ways to support tissues, for instance supporting the abdominal wall to treat hernias.
Women who suffer from pelvic organ prolapse or urinary stress incontinence, have tissues and muscles in the pelvic area that have weakened and can’t fully support organs like the uterus or bladder. Traditional surgery to treat these conditions involves inserting mesh through abdominal incisions. The mesh provides support to hold the organs in place and relieve symptoms.
In the 1990s gynecologists began using surgical mesh, trimmed to the right size, to treat prolapse and incontinence by simply inserting the mesh vaginally. The idea was that this would be less invasive, and therefore safer, than traditional surgery. Companies like AMS started making and selling mesh in kits to be used for this specific purpose. These were called transvaginal mesh.
Transvaginal Mesh Complications
It wasn’t long before reports of the serious complications caused by transvaginal mesh surfaced. Women were experiencing pain, bleeding, infections, and sometimes a worsening of the original condition after having mesh inserted. The worst complications were erosion and perforation, in which the mesh migrated through tissues causing damage to other organs. Women who had these complications needed surgery to correct the damage and some were permanently harmed by the mesh.
AMS Transvaginal Mesh Products
AMS made several different vaginal mesh products. Those for treating organ prolapse included Apogee, Perigee, Elevate, and IntePro Y-graft. For treating stress urinary incontinence, AMS offered the RetroArc Retropubic Sling, the MiniArc, the BioArc, the Monarc Subfascial Hammock, and the SPARC Sling.
The first FDA warning of the risks of transvaginal mesh came out in 2008. The agency warned that it had received thousands of reports of adverse events, including erosion and perforation and numerous painful symptoms. The FDA required all makers of products like these, including AMS, to further test their devices for safety and effectiveness. The agency also reclassified transvaginal mesh as a high-risk medical device.
Because of its purchase of AMS, Endo International has had to face the consequences of the harm caused by its transvaginal mesh products. Thousands of women have filed lawsuits against the various makers of these devices, including AMS and Endo. They claim the companies are at fault for not adequately testing the mesh products and for marketing something known to be risky and dangerous.
AMS settled some of these lawsuits in 2013 by paying out $54.5 in settlement fees. Although it settled with many women, the company has never admitted fault or liability, nor has Endo. Another 20,000 cases were settled in 2014, for up to $830 million, and again in these cases no fault was admitted. Many more cases are still pending and many women who have suffered are waiting for settlements. If you have been harmed by an AMS and Endo transvaginal mesh product, you can still file a suit and seek the compensation you need.