The Bayer Group is a German corporation focused in the life science fields of healthcare and animal science. It is the parent company for 392 consolidated companies with operations in 87 countries which includes the giant division, Bayer U.S. with operations in the United States.
Bayer U.S. has four operating units:
- Consumer Health – over-the-counter-medicines, supplements, and prescription dermatology products
- Pharmaceuticals – prescription medications in cardiology and hematology, oncology, neuroscience, infectious diseases, and men’s and women’s health
- Animal Health –veterinary medicines and grooming products for large and small animals
- Crop Science – high-value seeds, chemicals, and pest management solutions much of which was acquired in a 2016 acquisition of Monsanto
The Bayer U.S. pharmaceutical division manufactures successful medications such as:
- Betaseron – interferon for Multiple Sclerosis
- Gadavist, Eovist – gadolinium radiopaque for imaging procedures
- Mirena, Kyleena, – levonorgestrel hormonal IUD
- Yaz / Yasmin – hormonal birth control
- Xarelto – rivaroxaban anticoagulant marketed by Janssen
- Kogenate, Kovaltry – recombinant antihemophiliac medications
Bayer has a worldwide presence with operations in 87 countries, manufacturing locations on every continent and over 104 thousand employees worldwide. In 2019, the Bayer Group had estimated global revenue of $52 billion with Bayer Healthcare bringing an estimated $25 billion $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.
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.
In 2014, Bayer acquired Merck & Co.’s consumer healthcare business, adding a number of over-the-counter medications and products such as Claritin and Coppertone and in 2018, Bayer acquired Monsanto, producer of Roundup herbicide and a number of high-value, GMO crops and pesticides. Bayer has also divested its Diagnostics, Diabetes Devices, Chemicals and Material Science divisions.
Since 2007, Bayer has been notably active in environmental awareness, children’s issues, women’s health, and other social projects, 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 and has inherited other issues through some of its acquisitions, most recently with Bayer’s acquisition of Monsanto, manufacturer of Roundup (glyphosate) herbicide.
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, drospirenone. Drospirenone 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 drospirenone 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 drospirenone 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 several 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 two federal multidistrict litigation (MDL) groups in New York but many more remain in local and state courts including a state multicounty litigation (MCL) group in New Jersey..
Another product, Essure, a non-hormonal, permanent birth control product has also resulted in hundreds of lawsuits and has been withdrawn from the market. No settlements regarding Essure have been announced.
Bayer acquired agricultural and chemical giant, Monsanto, in 2018, inheriting liability for a flagship product, Roundup. Roundup is the brand name of the chemical, glyphosate, which is an herbicide that has seen wide-spread use in agriculture, industry, business and commercial lawn management and home property maintenance.
Roundup has been linked to a type of cancer, non-Hodgkin’s lymphoma, along with a possible link to other types of cancer. Monsanto, and now, Bayer are facing thousands of lawsuits filed by people or family members of those who were diagnosed with Roundup-related cancer. One jury has already awarded the plaintiff $2 billion, which is under appeal, however the company has set aside more than $10 billion in anticipation of settlements.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.