Janssen, the manufacturer of the diabetic drug Invokana is now facing a
Canadian class-action lawsuit, according to court documents filed at the
Ontario Superior Court of Justice. These documents allege Invokana could
be responsible for kidney damage or death among those taking the drug.
Under Canadian law, the action must be certified as a class action before
it can proceed, which typically takes six to seven months. Invokana was
approved by Health Canada in May 2014, but by June 2015, an investigation
into the safety of the drug had been instigated.
At that time Health Canada found diabetic ketoacidosis—which is more
commonly seen in those with Type 1 diabetes—was occurring more and
more among those with Type 2 diabetes taking an SGLT-2 inhibitor drug
like Invokana. Health Canada expected to determine whether changes in
prescribing information were required for Invokana. The Canadian courts
are also hearing arguments for the certification of a class action lawsuit
against another Type 2 diabetic drug, Avandia. Avandia is not in the same
class of drugs as Invokana, rather is an insulin sensitizer.
The Woman at the Center of the Canadian Class-Action Lawsuit
One woman, Rosalba Joudry, is at the center of the Canadian Invokana class-action
lawsuit. Joudry used Invokana for eight months, stopping only after she
heard there was an Invokana class-action lawsuit in the U.S. Tests showed
Joudry was experiencing kidney failure after taking Invokana. The lawsuit
is claiming $1 billion in damages on behalf of all Canadian consumers
harmed by Invokana. The lawsuit alleges Janssen failed to adequately test
Invokana, and failed to warn doctors and patients of potentially serious
side effects. While some are calling for Invokana to be removed from the
Canadian market, a consultant for Janssen, Dr. Debbie Knight, is confident
there is no harm to kidneys from Invokana. The Canadian class-action suit
also claims there is an increased risk of ketoacidosis among patients
taking Invokana.
What is Diabetic Ketoacidosis?
Diabetic ketoacidosis is an extremely serious condition, which can result
in extreme dehydration, swelling of the brain, diabetic coma, or even
death. When the cells in the body don’t receive the glucose needed
for energy, the body burns fat which produces ketones. This occurs when
there is insufficient insulin produced by the body. The ketones build
up in the blood, making it more acidic. SGLT-2 drugs like Invokana do
not metabolize insulin the same way as older diabetic drugs, rather they
target the kidneys. The excretion of sugar through the urine is increased,
and those sugars are prevented from reabsorbing into the kidneys. This
process created by Invokana is considered by many doctors to be an unnatural
process for the kidneys. Early symptoms of ketoacidosis include excessive
thirst, frequent urination, dry mouth, stiff muscles, unusual aches and
pains, rapid breathing, decreased alertness, dry skin, vomiting which
lasts more than two hours and fruity-smelling breath.
Did Janssen and Johnson & Johnson Exhibit a Failure to Warn?
Janssen is a subsidiary company of giant Johnson & Johnson. Many are
asking whether the potentially dangerous side effects of Invokana were
not communicated to consumers by the manufacturers. If it is found the
manufacturers were aware of the dangers associated with Invokana, yet
continued to market the drug without warnings, they may be held liable
for consumer injuries. Even if Janssen and J & J claim they were unaware
of these dangers, they were aware of the adverse event reports related
to Invokana collected by the FDA. If you feel you have suffered injury
or harm after taking Invokana, speaking to a knowledgeable product liability
attorney could be helpful. You may have serious injuries as a result of
the drug, and need time to heal while your attorney advocates for your rights.