The Bayer Group is a Germany-based corporation that is the umbrella organization for Bayer HealthCare. The Bayer Group also has subsidiaries of Bayer CropScience, Bayer MaterialScience, Bayer Business Services, Bayer Technology Services, and Currenta.
Bayer HealthCare has four operating units:
- Animal Health – with veterinary medicines and grooming products
- Consumer Care – over-the-counter-medicines, supplements and prescription dermatology products
- Medical Care – blood glucose monitoring devices and radiology contrast agents
- Pharmaceuticals – prescription medications in cardiology and hematology, oncology, neuroscience, infectious diseases, and men’s and women’s health
The Bayer HealthCare pharmaceutical division manufactures successful medications such as:
- Nexavar – chemotherapeutic agent
- Betaseron – interferon for Multiple Sclerosis
- Avelox – antibiotic
- Xarelto – anticlotting agent
- Mirena – hormonal IUD (intrauterine device)
- Yaz / Yasmin / Beyaz – hormonal birth control
- Kogenate – antihemophiliac
Bayer has a worldwide presence with manufacturing locations on every continent and over 113 thousand employees worldwide. In 2013, the Bayer Group had estimated global revenue of $56 billion with the pharmaceuticals division alone bringing in an estimated $14.5 billion.
Several of Bayer’s pharmaceutical products have resulted in multiple personal injury lawsuits. The progesterone ingredient in Yaz and Yasmin (and Beyaz) has been linked to an increase in the risk of fatal blood clots and Mirena has caused uterine perforation in some women. Xarelto, the company’s new blood thinner, has been linked to a number of serious side effects that may result in permanent injury or death.
Bayer faces lawsuits over its birth control products including the Yaz line of oral contraceptives and the IUD Mirena. Recently lawsuits have been filed against Bayer for injuries caused by Xarelto as well and the company may face lawsuits for the Erectile Dysfunction drug, Levitra in the future as manufacturers of other ED drugs have been sued for medical injuries.
History of Bayer
Bayer was founded in 1863 to manufacture and sell synthetic dyes for the textile industry in Germany but by 1913, the company had operations in Russia, France, Belgium, the UK and the United States and had expanded beyond textiles into chemicals and pharmaceuticals. During World War I, sales of dyes and pharmaceuticals dropped dramatically due to frozen export markets and the company began producing war materials such as explosives and chemical weapons. During the war, most of the foreign assets were lost or confiscated such as U.S. patents and trademarks including heroin and aspirin.
Bayer became a part of I.G. Farbenindustrie AG in the mid 1920’s due to changing global markets and economies, developing synthetic rubber and polyurethanes but discovering sulfonamide antibiotics in the process. I.G Farben was split into 12 companies by the Allied Forces, leading to the reemergence of Bayer in 1951 as Farbenfabriken Bayer AG.
Under Allied control, Bayer was allowed to reestablish international sales activities and focused on the U.S. and Latin America as well as expanding operations in Germany and Europe. During this period, Bayer continued development on the chemical and agricultural products but also introduced cardiovascular medicines, antifungals, and antibiotics.
In the 1970’s, the company acquired U.S. based Cutter Laboratories and Miles Laboratories which allowed Bayer to gain position in the U.S. pharmaceutical market. Bayer’s research labs produced the cardiovascular drug Adalat and the first quinolone antibiotic Cipro which were marketed in the U.S. under the Miles name.
In 1994, after the radical political changes had taken place in Germany and Eastern Europe, Bayer acquired U.S. based Sterling Winthrop, a self-medication company which came with regained access to the Bayer name in the U.S. For the first time in 75 years, Bayer could use its own name and logo in the United States and Miles Inc. was renamed Bayer Corporation.
In 2001, Bayer began a long period of reorganization, establishing operating units as independent subsidiaries under the Bayer Group Umbrella. In 2005, Bayer acquired the consumer products division of Roche, making it one of the world’s top three non-prescription medication manufacturers. In March of 2006, Bayer announced a public takeover of Schering AG and renamed the company Bayer Schering AG. Bayer Schering is later completely incorporated into Bayer Healthcare.
Since 2007, Bayer has been notably active in environmental awareness, children’s issues, and social project, receiving multiple awards and accolades including a celebratory meal with German Federal Chancellor Angela Merkel in 2013 at its 150th anniversary.
Bayer Product Issues
Bayer has a history of innovation and healthcare solutions but not all of these inventions have proven beneficial.
Bayer chemists Heinrich Dreser and Felix Hoffman produced diacetylmorphine, an acetylated form of morphine that was believed to be less addicting for use as a cough suppressant. It was named “heroin” and was introduced in 1898 exported to 23 different countries including the U.S. By 1913, the company had stopped manufacturing the medication after numerous reports of hospitalizations and abuse. During World War I, Bayer’s U.S. and other foreign assets, patents and trademarks were seized but the introduction of heroin had started an avalanche of addiction and it was outlawed by Congress in 1920.
Yaz Oral Contraceptives
Bayer has produced several oral contraceptives with the progesterone type ingredient, drosperinone. Drosperinone is contained in the birth control pills Yaz, Yasmin, Yasminelle, several generic versions, including Ocella, a newer contraceptive, known as Beyaz and a medication to manage menopausal symptoms, Angeliq. Studies have shown that drosperinone may triple the risk of blood clot formation from deep vein thrombosis, which may result in pulmonary embolism, stroke, or heart attack and may cause death.
Yaz was introduced in 2006 and has resulted in multiple disciplinary warnings by the FDA regarding advertising practices. The FDA has required drosperinone containing products to include warnings regarding a higher risk of dangerous blood clots and stopping the medication before surgery.
Over 12,000 lawsuits have been filed against Bayer because of Yaz blood clot side effects. Approximately 8,250 lawsuits were settled, costing the company an estimated $1.7 billion but thousands more remain. In addition, the company has faced multiple claims by women who have suffered from gallbladder disease due to Yaz or Yasmin.
Mirena is a hormone-emitting intrauterine device or IUD. It is a reversible form of birth control that may cause pelvic inflammatory disease, device expulsion, or ectopic pregnancy. The greatest danger is apparently caused by device migration from its placement location to perforate the uterine wall.
It may also endanger abdominal organs or blood vessels and expose the patient to infection, pain, and permanent organ damage and everal women have recently claimed that Mirena caused neurological conditions because of the hormone levonorgesterel, eluted from the device.
More than 1,500 lawsuits have been filed against Bayer by injury caused by Mirena. Some of these migration lawsuits have been consolidated into federal multidistrict litigation in New York but many more remain in local and state courts. The court has refused to consolidate nine lawsuits regarding neurological complications and one lawsuit was filed recently by a woman who had exploratory surgery to locate the device after it migrated but the device was ultimately removed from her rectum.
Xarelto (rivaroxaban), was developed by Bayer and is marketed by Johnson & Johnson. It is an anti-coagulant medication used to prevent clot development in patients with irregular heartbeat. It is one of a newer group of medications that do not require blood testing as older medications did. Other members of the class include Pradaxa and Eliquis.
This class of medications has resulted in serious adverse events such as uncontrollable bleeding and death. Unlike older medications such as Coumadin, Xarelto and the other Xa inhibitors, Pradaxa and Eliquis, do not have an antidote.
The manufacturer of Pradaxa is facing thousands of lawsuits regarding serious injury. Bayer has admitted to facing at least ten lawsuits in the U.S. regarding injury caused by Xarelto. No specifics or settlement news has been issued by Bayer or Johnson & Johnson though more lawsuits are expected.
Levitra (tadalafil) is a medication used to treat erectile dysfunction in men. It is related to the “little blue pill”, Viagra which has resulted in multiple lawsuits due to side effects.
No lawsuits against Bayer regarding Levitra have yet been acknowledged but the medication may cause serious side effects that have resulted in Viagra lawsuits such as:
- Sudden loss of vision or visual impairment
- Sudden loss of hearing or ringing of the ears
- Heart complications including fainting, heart attack or stroke
Bayer in the Future
Bayer has announced tentative plans to divest the MaterialScience division and focus concentration on HealthCare and CropScience divisions. New medication approvals such as the macular degeneration medication, Eylea and the cancer drug, Stivarga are expected to provide additional revenue and the company has recently diversified its women’s health unit with the acquisition of Conceptus, producers of a non-surgical birth control device Essure.
Essure has already caused problems for some women and though the FDA has thus far concluded that Essure labeling is clear about potential issues, trouble may be just around the corner regarding the product.