More than 55 Invokana lawsuits were consolidated in a New Jersey federal
court. These lawsuits claim that Johnson & Johnson’s Type 2
diabetes drug, Invokana, can cause serious ketoacidosis, injuries to the
patient’s kidneys, and other severe injuries. The judge in the case
acknowledged the commonalities among the filed lawsuits, and cited enhanced
efficiency when similar lawsuits were consolidated. Invokana lawsuits
from New Jersey, Minnesota, Louisiana, Kentucky, Illinois, Georgia and
California were consolidated.
Plaintiffs in these cases allege Johnson & Johnson was aware of the
potential for Invokana use to result in kidney damage and ketoacidosis,
yet failed to warn patients, and, in fact, continued to heavily promote
this drug despite being aware the drug had not been adequately tested.
The next step in these consolidated Invokana lawsuits is to choose bellwether
cases—those which best represent the claims as a whole—and
set dates for those trials.
Invokana was approved in 2013 as a new treatment for Type 2 diabetes. The
drug belongs to a class of drugs known as SGLT2, or sodium-glucose co-transporter
2. A diabetic’s body fails to produce sufficient insulin, which
can lead to dangerous blood sugar spikes. These blood sugar spikes damage
the body over the course of time. Older diabetic drugs simply increased
insulin levels in the body, however the newer SGLT2 inhibitors reduce
the amount of sugar reabsorbed into the body via elimination of the sugar
through the urine, potentially leading to kidney problems.
Invokana is also linked to cardiovascular risks, amputations, increased
risk of bone fractures, and ketoacidosis—potentially fatal excessive
levels of blood acids. Although the FDA strengthened the warnings on Invokana
in the summer of 2016, the drug is still being sold to consumers. In 2015,
Invokana sales netted Johnson & Johnson $1.3 billion, so the pharmaceutical
giant has little incentive to remove the drug from the market.
Understanding Diabetic Ketoacidosis
Most commonly, only patients who have the more serious Type 1 diabetes,
or juvenile diabetes will experience diabetic ketoacidosis. Ketoacidosis
can occur when fat is used as a fuel source, rather than the body using
glucose. The lack of glucose in the body is due to an inability to use
sugar as a fuel due to a limited amount of insulin—a problem for
those with more serious diabetes.
As the fat in the body is broken down, ketones (blood acids) build up in
the urine and the blood of the patients, leading to severe vomiting, stiff
muscles and muscle cramps, pain in the stomach, severe headache, decreasing
alertness, a flushed face, frequent urination, dry skin and mouth, and
“fruity” smelling breath. Those with severe cases of ketoacidosis
can go into kidney failure, or can have fluid buildup in their brain,
bowel tissue death and even heart attacks.
“Payments and Perks” from Drug Manufacturers to U.S. Doctors
Diabetic drugs dominated the “payments and perks” from drug
manufacturers to U.S. doctors and hospitals in 2014. Invokana, a prescription
drug used to treat Type 2 diabetes, was second on a list detailing which
companies paid out the most money to promote their drug. Johnson &
Johnson and its subsidiaries, Bayer and Janssen, paid out $19.8 million
in 2014 to doctors and hospitals, topped only by AstraZeneca’s diabetes
drug Bydureon, with payments of $22.5 million. AstraZeneca defended the
practice, saying all patients benefit when physicians are well informed
about medications. Many people feel these payments are more of a payoff
to doctors and hospitals for prescribing one drug over another.
Did Johnson & Johnson Exhibit a Failure to Warn Consumers?
Because there have been so many adverse event reports regarding serious
side effects of Invokana, it is reasonable to assume Johnson & Johnson
and its subsidiary, Janssen, were aware of the potential risks associated
with the drug. Knowing the dangers, however, did not convince the companies
to forego profits over patient safety, as no labeling changes were made
to Invokana until the FDA stepped in.
No warnings or recalls were issued by J & J or Janssen despite the
fact that several medical journals concluded that SGLT-2 drugs such as
Invokana, have an unfavorable harm-benefit balance. It remains to be seen
how the Invokana bellwether trials will go, but typically when a large
pharmaceutical company loses the first few bellwether trials, they are
more likely to consider settling the remaining lawsuits.
Contact Our National Dangerous Drug Lawyers
At Golomb & Honik, our dangerous drug lawyers have considerable experience
and success representing patients and families that have been injured
by a negligent drug manufacturer. If you or someone you love has suffered
injury after taking the dangerous drug Invokana, we can help. We believe
in holding negligent pharmaceutical companies responsible for their actions
and will fight aggressively for you and your family.
To learn more about your rights and legal options, call the Philadelphia
defective drug lawyers at Golomb & Honik today at
1-800-355-3300 or 1-215-985-9177 or fill out our confidential