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Endo International and American Medical Systems

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Endo International PLC is a global health care company whose roots stretch back nearly a century. One of its companies, American Medical Systems, paid nearly $1 billion to settle vaginal mesh lawsuits. Thousands of cases remain.

Its global headquarters is in Dublin, Ireland, with U.S. headquarters in Malvern, Penn. The company employs several thousand employees worldwide.

Endo develops manufactures, markets and distributes pharmaceutical products and medical devices through its four operating companies:

  • American Medical Systems (AMS): Pelvic health and continence-related devices
  • Endo Pharmaceuticals: Branded pharmaceuticals
  • Paladin Labs: Pharmaceutical products for Canadian and emerging markets
  • Qualitest: Generic and over-the-counter medications

The manufacturer also recently acquired Somar (pharmaceutical products for the Mexican market) and Boca Pharmacal (specialty generics).

Endo Pharmaceuticals is known for the narcotic Percocet, the migraine treatment Frova, and the Lidoderm patch and Voltaren Gel painkillers. It also contributes three products to the growing testosterone therapy market: Delatestryl, Fortesta and Aveed. However, thousands of men claiming they were harmed by testosterone products filed lawsuits against various manufacturers, including men claiming to be harmed by Endo products.

American Medical Systems also grabbed headlines over its controversial vaginal mesh implants. AMS products, which are used to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP), were the subject of more than 25,000 federal and state lawsuits.

In May 2014, AMS agreed to pay $830 million to settle 20,000 cases. It was AMS’s second major settlement after resolving a group of lawsuits for $54.5 million a year before.

Fast Facts about Endo International
Established: 1997
CEO: Rajiv De Silva
Headquarters: Dublin, Ireland, and Malvern, Penn.
Size: Several thousand employees worldwide
2014 Revenue: $2.8 billion

History

Endo got its start in 1920 as a company called Intravenous Products of America. The name changed to Endo Products in 1935, and in 1970, DuPont Merck acquired Endo. Then, in 1994, the company was made a separate entity, named Endo Laboratories and served as DuPont’s generic drug division.

In 1997, three DuPont Merck executives created the modern version of Endo through a $277 million buyout. They took control of 12 medicine brands, including Percocet.

Endo completed a number of acquisitions over the years:

  • July 2010: HealthTronics (later sold)
  • November 2010: Penwest Pharmaceuticals
  • December 2010: Qualitest Pharmaceuticals
  • June 2011: American Medical Systems
  • February 2014: Boca Pharmacal and Paladin Labs

AMS specializes in devices and services related to men’s health and women’s health, including prostate health and pelvic health. The company was founded in 1972 with the first urinary sphincter for male incontinence. It is headquartered in Minnetonka, Minnesota, a suburb of Minneapolis, with a second location in San Jose, California, plus international offices and affiliates.

AMS employs around 1,200 people in nine countries, with direct sales in 13 countries and distribution in 67 countries. The company claims to be the “leading brand name among urologists, gynecologists and urogynecologists.”

Transvaginal Mesh Devices

In recent years, AMS found itself mired in litigation over its vaginal mesh devices. Many of the lawsuits sought to hold both AMS and Endo International responsible for the products, which can result in serious complications.

American Medical Systems Vaginal Mesh Products
Prolapse Repair Incontinence Repair
Apogee (no longer available in U.S.) RetroArc Retropubic Sling
Perigee MiniArc Precise Sling
Elevate MiniArc
IntePro Y-graft Monarc Subfascial Hammock
In-Fast Ultra Transvaginal Sling
BioArc SP Sling
BioArc Transobturator Subfascial Hammock
SPARC Sling

Women claim these mesh devices caused injuries including severe pain, damage to organs, incontinence, and compromised sex lives. Many of the women who filed suit had to have multiple surgeries to try and undo the damage they say the mesh caused. In 2012, AMS was one of the mesh manufacturers ordered by the U.S. Food and Drug Administration to conduct safety studies on the devices.

In June 2013, AMS agreed to pay $54.5 million to settle some of the mesh lawsuits against the company. The company did not admit liability or fault, nor did it disclose the number of cases it was putting to rest. In May 2014, it settled 20,000 cases for a combined $830 million, also without admitting fault.

According to June 2015 federal lawsuits numbers, about 16,000 cases were still pending in the U.S. District Court for the Southern District of West Virginia under Chief Judge Joseph R. Goodwin.

Future

Endo said its 2014 acquisition of Paladin Labs (for $1.6 billion) “accelerates [its] strategic transformation into a leading global specialty healthcare company and creates a platform for future growth in North America and around the globe.”

The deal gave Endo access to the pharmaceutical drug market in Canada, where Paladin saw sales growing annually. Endo shares also jumped 29 percent on news of the acquisition, their biggest increase since the shares began trading in 2000.

Endo and AMS will be forced to deal with ongoing mesh and testosterone litigation.