About Bayer HealthCare
Bayer HealthCare is a pharmaceutical manufacturer and subsidiary of Bayer
AG, a German chemical corporation. The operating company also includes
Bayer Pharmaceuticals, Bayer Consumer Care, Bayer Medical Care, and Mayer
Animal Health division. Each year, all four entities earn over $24 billion
in sales. The company’s goal is to discover and manufacture innovative
products that protect and improve the health of humans and animals throughout
Originally founded in 1863, Bayer began as a manufacturer of chemical dyes.
In 1888, Bayer Pharmaceuticals was launched. It quickly became famous
for producing aspirin, “the drug of the century.” Other popular
products created by Bayer include Alka-Seltzer and One-A-Day vitamins.
By 2006, Bayer introduced Yaz, the best-selling birth control pill in
Verdicts Against Bayer HealthCare
Bayer has been forced to payout millions of dollars in settlements. In
2012, Bayer paid $15 million to settle a lawsuit claiming it illegally
marketed aspirin products combined with supplements, especially its “Women’s
Low Dose Aspirin with Calcium” and “Bayer Aspirin with Health
Advantage.” Besides these cases, Bayer agreed to settle 300 claims
related to Magnevist. However, the pharmaceutical giant refused to admit
liability. Under the same conditions, Bayer agreed to pay 1,100 claims
against Trasylol. At request of the FDA, Trasylol was withdrawn from the
market after a study linked the drug to kidney failure. Dr. Dennis Mangano,
independent researcher, claims over 22,000 innocent lives could have been
saved if the medicine was taken off the market two years earlier. What
caused the most upset was uncovering Bayer performed private research
that confirmed the dangers of the drug but continued to market it.
On a larger scale, Bayer has battled a tremendous amount of lawsuits against
its two top birth control pills. Yasmin and Yaz settlements are estimated
to have cost the company over $2.65 billion. These cases claimed the medications
caused blood clots in women. Bayer quickly resolved 651 cases to avoid
the possibility of a large jury award. These contraceptives contain a
synthetic hormone, which causes blood clot problems. The cases were settled
without admission of wrongdoing, just like most of the company’s
other lawsuits. Besides blood clots, many plaintiffs have suffered gallbladder
problems after taking Yasmin as well.
Lawsuits Filed Against Bayer HealthCare
Thousands of personal injury lawsuits have been filed against Bayer pharmaceuticals,
especially against Yaz, its birth control pill. This product contains
dropsirenone, an ingredient linked to deep vein thrombosis, retinal thrombosis,
pulmonary embolism, heart attack, and stroke. The lawsuits accuse the
company of numerous negligent behaviors, including failure to warn, fraud,
fraudulent concealment, misrepresentation, and manufacturing defects.
Damages are sought to recover compensation for medical treatment, lost
wages, physical pain, emotional suffering, and wrongful death.
Bayer is also being hit with a number of complaints about injuries from
its Mirena intrauterine device. Plaintiffs claim the device migrates during
the normal use span, which is a risk not listed on the product’s
warning label. This has caused pain and danger from uterine perforation
and the likelihood of unwanted pregnancy. Women suffering with perforations
must undergo surgery to remove the IUDs.
Two other products manufactured by Bayer, Magnevist and Trasylol, are facing
lawsuits as well. Magnevist is used during MRIs and is thought to cause
nephrogenic systemic fibrosis, a possibly fatal disorder. Trasylol is
used to manage bleeding during heart bypass operations. It has been linked
to injuries, including renal failure or death.
Drugs or Medical Devices Recalled Against Bayer HealthCare
Throughout the years, Bayer has experienced a number of minor recalls for
various drugs. For instance, 2009 saw a recall on one lot of Alka-Seltzer
cold medication for an error in labeling. Another recall dealt with aspirin
tablets that contained acetaminophen. In 2011, Bayer HealthCare recalled
all retail stock of its Contour diabetes test strips over packaging problems,
which caused compromised glucose readings.
A more pressing issue for Bayer involves its most popular birth control
pills. Yaz is marketed by the manufacturer as safe and effective. However,
recent studies have shown it may heighten the risk of blood clots by 74
percent, which can lead to stroke, DVT, or pulmonary embolisms.
Although there has not been an official Yaz recall, experts in the healthcare
industry are pushing the FDA to reconsider banning this product. The Institute
for Safe Medicine Practices reported this drug ranked second in 2011 for
the high amount of complications it is known to bring. Since the release
of Yaz, the FDA received over 50 reports of death from the use of this
drug. The FDA ordered Bayer to change its labels by adding information
regarding Yaz’s dangerous risks.
FDA Sanctions Against Bayer HealthCare
The FDA has received numerous complaints against Bayer Pharmaceuticals
and all its related divisions. Current regulations prevent recalls on
all troublesome drugs, but the FDA has given warnings to the company several
times for failing to disclose safety risks to patients. Also, the FDA
warned the manufacturer against promoting “unapproved new drugs,”
especially over-the-counter aspirin products. Janet Woodcock, M.D. is
director for the FDA’s Center for Drug Evaluation and Research.
She believes Bayer’s disregard for policies placed numerous consumers
at risk. OTC medicines are commonly taken without a physician’s
supervision or consent, which means misuse of aspirin-containing products
can lead to a higher likelihood of internal bleeding or other negative