Abbot is a manufacturer of medical devices, nutrition products, and medical diagnostic equipment. In 2013 it spun off the company called AbbVie, which now focuses on the research and development of pharmaceutical products. AbbVie makes the testosterone therapy product called AndroGel, which has been the subject of a number of complaints, reports of adverse events, and lawsuits, largely because of the risk of heart attack and stroke in users.
AbbVie and Abbot have also faced other controversies over the years, including recalls of intravenous bags that contributed to the deaths of patients, as well as illegal and unethical marketing of several medications, including AndroGel and Depakote, an anti-seizure medication. If you have been harmed by an Abbot or AbbVie product or medication, you can file a lawsuit to seek compensation.
History and Corporate Profile
Abbot was founded by Wallace C. Abbot, a doctor and pharmacist who produced medications beginning in the 1880s. Abbott was one of the world’s earliest drug makers, beginning in the People’s Drug Store in Chicago. Over the years the company has developed several synthetic and unique medications and has acquired smaller companies, growing larger and expanding throughout the U.S. and the world.
As the company grew, it made sense in 2013 to spin off AbbVie. The spin-off focuses on research and development of pharmaceuticals, while the parent company focuses on devices and equipment. Abbott had previously spun off Hospira, a business focusing on hospital products.
As the company responsible for pharmaceuticals, AbbVie took over the marketing and selling of drugs like AndroGel, Vicodin, Kaletra, Tricor, and Humira, among others. AbbVie is headquartered in Chicago, but employs thousands of people worldwide and generates tens of billions of dollars in revenue each year.
AndroGel and Low Testosterone
One of AbbVie’s most popular products is AndroGel, a testosterone supplement used to treat male hypogonadism, also known as low testosterone or low T. AndroGel is a top seller for AbbVie, with only Humira, an arthritis medication, bringing in more revenue, according to 2013 revenue reports. AndroGel revenues in 2013 were over $5 billion.
As men age their levels of testosterone naturally decrease, which can cause some mild symptoms. Hypogonadism, or low T, is unnaturally low levels of the hormone, lower than what is expected for a man as he ages. Symptoms of this condition include infertility, erectile dysfunction, enlarging of the breasts, loss of facial hair and body hair, bone loss, and loss of muscle mass. Men with low T may also experience a lowered sex drive, fatigue, hot flashes, and difficulty concentrating, much like what women experience going through menopause.
Sometimes an underlying cause for low T can be found and treated, but for most men a cause isn’t obvious and testosterone therapy is the best choice for treatment. AndroGel is one product that can be used to for testosterone therapy. It is a gel that is rubbed onto the skin. Testosterone is absorbed through the skin as the gel is applied.
AndroGel is not supposed to be used for men whose testosterone levels have not been measured and found to be too low. Some doctors, though, will prescribe it to men who experience normal signs of aging without ever testing levels of the hormone in their blood.
AndroGel Side Effects
There are risks associated with using testosterone, which is why products like AbbVie’s AndroGel are only supposed to be given to men with measured low levels of the hormone. These products can cause high blood pressure, skin irritation, mood swings, and prostate enlargement or a worsening of a pre-existing enlarged prostate.
AndroGel has also been controversial because there is a risk that its use can cause the formation of blood clots, which in turn increases the risk of having a heart attack or a stroke. In one study into the safety and effectiveness of testosterone therapy had to be concluded early because the older men participating were showing significantly more signs of heart problems than a control group. The FDA announced in 2015 that there was this risk and that more studies would be done to clarify why the risk exists and how serious it is.
Recalls and Bad Marketing
AndroGel is not the only trouble spot in AbbVie’s product line. Parent company Abbot has also experienced difficulties, including the recall of intravenous (IV) bags that occurred between 1969 and 1971. Nearly 400 people suffered blood poisoning, a life-threatening infection, because of contaminated IV bags produced by the company. Later investigations by the FDA found that the screw caps on a few hundred of the bags were contaminated with bacteria that were then sent into patients’ bloodstreams as they received IV fluids and medications.
The investigation also found that the cause of the contamination could be traced to a manufacturing plant in North Carolina. There the FDA report found that the conditions were unacceptable and contributed to the bacterial contamination. Several officials from Abbot were indicted for shipping the contaminated IV bags across state lines, but ultimately the charges were dropped.
Abbott and AbbVie have also been found to be at fault for bad marketing practices. In 2012 the company had to pay $1.6 billion in a settlement for illegally marketing Depakote, an anti-seizure drug. They then had to pay another $524 million in fines for giving kickbacks to doctors to use Depakote for unapproved uses. While doctors are allowed to prescribe drugs off-label, the drug makers are not allowed to market, advertise, or push for the use of their medications for any purpose other than that approved by the FDA.
Men who have used AndroGel and suffered adverse outcomes, like a heart attack or stroke have filed lawsuits against AbbVie and Abbot, claiming that the companies did not communicate the risks to doctors and patients. There are also accusations that the companies used unethical marketing practices, advertising AndroGel knowing it was risky and emphasizing benefits while playing down risks. Thousands of lawsuits are awaiting trial or settlements.
AbbVie has seen its share of problems, but it also produces many important drugs, including those that prevent and treat devastating diseases like HIV, rheumatoid arthritis, and hepatitis C. Humira, the company’s best-selling drug, in an anti-inflammatory drug that treats rheumatoid arthritis, Crohn’s disease, colitis, psoriasis, and other terrible autoimmune disorders. The patent on Humira will run out soon, so the company’s profits are expected to drop with generic forms coming on the market.
If any of the medications or products created by AbbVie or Abbott, especially AndroGel, has caused you pain or suffering, you have the right to seek compensation. Consult with a lawyer to find out what your options are and how you can get started.