Bristol-Myers Squibb is one of the largest pharmaceutical entities in the
world. It began in the 1800s when a Navy doctor became fed up with poor
quality medications available during the Mexican War. Edward Robinson
Squibb began his own laboratory to create pure medicine. William McLaren
Bristol and John Ripley Myers joined Squibb to create Sal Hepatica, a
successful natural salt laxative. By 1943, Squibb was responsible for
the largest penicillin plant in the world. In the 1960s, the company expanded
its focus to more antibiotic production. Although the company has experienced
great success and fame for products like Coumadin, it has faced adversity
from its advertising methods, FDA violations, and numerous lawsuits against
some of its most popular products.
Products Recalled by Bristol-Myers Squibb
In 2011, Bristol-Myers Squibb issued a voluntary recall of Coumadin lots.
Tablets distributed in certain bottles were found to be higher in potency
than expected. This drug is used to prevent blood from clotting, especially
in people who are at high risk for heart attacks or strokes. Too much
active ingredient could increase the likelihood of hemorrhaging, and too
little active ingredient could increase risks of clotting.
The same year, the drug manufacturer recalled lots of Avalide, its blood
pressure medicine. Once again, problems stemmed from questions surrounding
the amount of active ingredients being released. It was believed not enough
potency was reaching the body. Certain bottles contained tablets unable
to properly dissolve in the stomach.
In 2013, Bristol-Myers Squibb issued a voluntary recall of 92,000 vials
of Bydureon, its type 2 diabetes treatment. This drug was a joint venture
between BMS and AstraZenica. Many vials were released without being fully filled.
Lawsuits and Other Problems Facing Bristol-Myers Squibb
Along the way, Bristol-Myers Squibb has come under fire for a few scandals.
In 2001, the company allegedly persuaded wholesale customers to buy a
surplus of approximately $2 billion in drugs to meet its sales quotas.
This gimmick, called “channel stuffing,” led to an SEC investigation.
In 2007, BMS was accused of overcharging the government for drugs and
promoting off-label uses of Abilify, its antipsychotic medication.
In 2009, BMS faced lawsuits over Taxol, a chemotherapy drug found to increase
the risks of neuropathic pain in breast cancer survivors. An article in
the “Journal of Pain” uncovered two-third of breast cancer
patients who were prescribed Taxol experienced extreme discomfort during
treatment. Patients complained of stabbing aches, numbness, and burning
of the hands and feet.
Plavix, a popular drug used to prevent heart attacks and strokes, was linked
to serious side effects, including intestinal bleeding. A study published
in “The New England Journal of Medicine” found individuals
taking Plavix experienced 12 times the number of ulcers as patients taking
similar drugs. Also, when Plavix is combined with aspirin, it doubles
the risks of death from heart attacks or strokes.
Coumadin and Eliquis are two of the most well-known drugs produced by BMS.
Both of these products are anticoagulants and bring possible negative
side effects. Injuries associated with these medications include stroke,
pulmonary embolism, deep vein thrombosis, adrenal bleeding, and death.
Lawsuits have been filed claiming the manufacturer did not adequately
warn patients about these risks. Today, the FDA requires these drugs to
carry a warning of potentially fatal bleeding.
In 2012, Bristol-Myers Squibb purchased Amylin, a drug company based out
of San Diego. This manufacturer produced Byetta, a diabetes drug known
to increase risks of developing chronic pancreatitis, which could lead
to pancreatic cancer. No warnings were issued to the public regarding
the importance of monitoring for the early symptoms of pancreas problems.
If these warnings were made available, users could have stopped the medication
to avoid more serious injuries. Instead, many people continued to use
the injection with severe consequences. These innocent victims have filed
numerous lawsuits to receive fair compensation for pain and suffering.
Verdicts Against Bristol-Myers Squibb
As restitution for fraud charges related to its “channel stuffing,”
BMS paid $839 million. To resolve a wide variety of cases involving its
marketing purchases and pricing, it paid another $515 million.
In September 2003, BMS reached a $62.5 million settlement for a class action
lawsuit filed against Taxol. The suit claimed the company conspired to
keep less expensive generics off the market. In a similar case, Bristol-Myers
Squibb paid $41.7 million in a case filed against the drug BuSpan, a treatment
for anxiety. The suit alleged the manufacturer worked with a competitor
to prevent a generic version of the medicine from reaching the public.
Bristol-Myers Squibb faced litigation for Abilify as well. The company
was forced to pay approximately $515 million for a whistleblower lawsuit.
It was uncovered BMS gave kickbacks to doctors who prescribed the medicine
for off-label uses. The FDA had not approved Abilify for treatment of
age-related dementia, but the drug company encouraged doctors to use the
medicine for this purpose. This was blatant disregard for the black box
warning that explains the heightened risks of death in elderly patients
who use this medication.
Although little is known about verdicts surrounding Eliquis, manufacturers
of similar drugs have faced numerous lawsuits. Some pharmaceutical giants
paid over $650 million to settle with victims. This may be a wake-up call
to BMS for what is to come.
Most recently, in August 2014, Amylin Pharmaceuticals agreed to an undisclosed
settlement to end 84 California lawsuits involving Byetta. Plaintiffs
claimed the product caused pancreatitis, pancreatic cancer, and thyroid cancer.
Sanctions Facing Bristol-Myers Squibb
In 2010, the FDA sent a warning letter to Bristol-Myers Squibb over compliance
issues. The federal agency uncovered problems with contamination of drug
products, environmental facility contamination, and a lack of standard
sampling practices and test procedures. Many of these infractions occurred
multiple times between 2005 and 2009. This shined a negative light on
the company and left questions about how BMS regarded customer safety.
Red flags were also raised about the company’s marketing practices.
Although lawsuits have been mounting, and the company lost some lucrative
patents, BMS intends to concentrate on future discoveries and developments
of new therapies. By partnering with pharmaceutical competitors, it hopes
to grow bigger and better than ever.