Lawsuits continue to be filed against Johnson & Johnson and its subsidiary
Janssen Pharmaceuticals for injuries suffered by those taking the drug
Invokana, a drug used to treat Type 2 diabetes. Those who have suffered
severe injury due to the use of Invokana have filed claims in state court
in New Jersey—where J & J is based—as well as a federal
multidistrict litigation which is also based in New Jersey. Multidistrict
litigation is used by federal courts to streamline the process of managing
large numbers of lawsuits which have been filed across the country involving
the same issues.
How MDLs Are Used in Dangerous Drug and Defective Medical Device Claims
MDLs are frequently utilized in dangerous drug and defective medical device
lawsuits, as many of the plaintiffs have the same injuries and are asserting
the same claims against the manufacturer. An MDL places all the cases
before a single judge so the time and expense of mass lawsuits can be
coordinated. Bellwether trials on typical cases are held first in an MDL
to allow both sides to get a good idea of how the future trials may go,
and to give the manufacturer the opportunity to offer a settlement in
the remaining cases. The bellwether cases are chosen from all the filed
lawsuits as those being most representative of the cases as a whole.
Black Box Warning on Invokana
In the case of Invokana, as of December, 2017, 952 complaints were pending,
with the majority of those cases involving injuries other than amputations
(kidney injuries, stroke, serious ketoacidosis, and infections). The Invokana
MDL was created on December 7, 2016, and it was not until May 2017 that
the FDA highlighted the link between Invokana and amputations, subsequently
requiring the manufacturer to include a black box warning—the most
serious type of warning the FDA can issue—regarding the risk of
amputation. The FDA made this decision after two large Invokana clinical
trials concluded those who took the drug had twice the risk of leg and
foot amputations as those given a placebo.
Most Recent Invokana Amputation Cases
A Tennessee resident filed a recent lawsuit linking Invokana to amputations.
She began taking Invokana in May 2016; a month later, her doctor prescribed
Invokamet, which combines the active ingredient of Invokana (canagliflozin)
with metformin. About seven months later, she underwent surgery to amputate
the first toe of her right foot. Her lawsuit, filed on December 26, 2017,
alleges Janssen failed to adequately warn physicians and patients about
the potential risks of taking Invokana.
Two lawsuits were filed in New Jersey Superior Court in Middlesex County
on behalf of patients who also experienced amputations after taking Invokana.
A man from Alabama was prescribed Invokana in January 2015, undergoing
left foot and below-the-knee amputations a year later. Another began taking
Invokana in April 2015, then little more than eight months later he had
his right leg amputated below the knee. Four more Invokana amputation
lawsuits were filed in October 2017 in federal court.
Invokana On the Market for Four Years Before Adverse Event Reports Submitted
Invokana had only been on the market for four years when the FDA announced
the drug could potentially increase the risk of toe amputations, mid-foot
amputations, below-the-knee amputations, above-the-knee amputations and
even multiple amputations involving both limbs. Patients were advised
to speak to their doctor about the potential risks of Invokana amputations,
and to immediately seek medial assistance if they developed an infection,
ulcer, sore, or any area which was tender to the touch.
Invokana Clinical Trials
The first Invokana
clinical trial reported that 5.9 out of 1,000 patients being treated with Invokana suffered an
amputation, while only 2.9 out of 1,000 who received a placebo during
the clinical trial suffered an amputation. The
second clinical trial returned even higher numbers, with 7.5 out of every 1,000 patients receiving
Invokana suffering an amputation, and only 4.2 out of 1,000 patients receiving
a placebo suffering an amputation. In addition to the serious risk of
amputation for those taking Invokana, by June 2014 there had been at least
20 patient reports of ketoacidosis which required hospitalization and
emergency treatment. More adverse event reports continued to come in to
the FDA, claiming kidney failure, heart attack and diabetic ketoacidosis
as a direct result of taking Invokana.
Where to Turn for Help if You Have Been Injured by Invokana
The lawsuits currently filed against Johnson & Johnson & Janssen
for amputations and other serious injuries allege the manufacturers knew—or
should have known—about the serious side effects of the drug prior
to releasing it to consumers, and that since some of the side effects
of the drug are deadly, there was a definite failure to warn. If you or
a loved one has suffered injury as a result of taking Invokana, it could
be very beneficial for you to speak to an experienced, knowledgeable Pennsylvania
product liability attorney who can help you determine your best course
To learn more about your legal options or to schedule a free consultation call the
Philadelphia dangerous drug lawyers at Golomb & Honik today at
1-800-355-3300 or 1-215-985-9177 or fill out our confidential
The national product liability lawyers at Golomb & Honik have successfully
represented individuals in Philadelphia, Pennsylvania, New Jersey, and
throughout the United States.