J & J Attempting to Expand the Use of Xarelto Despite Lawsuits
On the heels of a recent $27.8M jury verdict, and with lawsuits rising
in number, Johnson & Johnson is attempting to obtain a label change
to include additional uses associated with Xarelto. A new drug application
was submitted to the FDA, seeking approval to add a cardiovascular risk
reduction claim as well as an acute limb ischemia risk reduction claim
to Xarelto labeling.
Serious Risks Associated with Xarelto
Since some very serious risks have been associated with Xarelto, it seems
almost unbelievable that the FDA will allow the pharmaceutical giants
to expand the uses for the drug. Xarelto potentially has very serious
risks regarding uncontrolled bleeding, particularly because there is no
antidote doctors can use when the drug does cause an uncontrolled bleed.
Older blood thinners, like Warfarin, had certain drawbacks as far as the
need for frequent blood monitoring, and the inability to eat certain foods
with the drugs, however a simple shot of Vitamin K could effectively halt
an uncontrolled bleed caused by one of those older drugs.
No such antidote exists for Xarelto, and in some cases, patients have bled
to death while at the hospital, while doctors were able to do nothing
other than watch helplessly. The FDA previously rejected three attempts
on the part of Bayer and Johnson & Johnson to obtain additional indications
for Xarelto, however it remains to be seen whether they will approve the
Jury Awards $27.8 Million in Xarelto Lawsuit
Little more than a month ago, a Philadelphia state jury ordered Bayer AG
and Johnson and Johnson—two of the biggest pharmaceutical corporations
in the world—to pay $27.8 million to an Indiana couple after the
plaintiff in that lawsuit was prescribed Xarelto for her diagnosis of
atrial fibrillation. She took the drug for about a year, then was hospitalized
with severe gastrointestinal bleeding. Although Hartman eventually recovered,
she blamed her uncontrolled bleeding on Xarelto.
Thousands of Xarelto Cases Pending
This trial was the first of more than 1,400 Xarelto cases which are pending
in the Philadelphia court, along with more than 18,500 federal cases which
have been consolidated into an MDL in the Eastern District of Louisiana.
This was the first Xarelto win, as juries cleared J & J and Bayer
of liability in three prior Xarelto trials. In the recent Hartman Xarelto
settlement, the jury awarded $1.8 million in compensatory damages to the
Hartmans and a staggering $26 million in punitive damages.
Bayer, J & J and Janssen Say They Will Appeal the Decision
A Bayer spokesman stated there was no basis for the verdict and that the
company would almost certainly appeal. Janssen, a subsidiary of Johnson
& Johnson, also issued a statement, saying the verdict was contradictory
to years and years of scientific studies, and noted that the FDA approved
the drug, therefore must believe in its safety.
On the flip side, lawyers for the Plaintiff believe Xarelto is one of the
very worst in this relatively new class of blood thinners, since thousands
of patients taking the drug have experienced serious health complications.
Many believe these health issues could have been avoided entirely if Bayer
AG, J & J and Janssen had informed doctors of the potential risk of
uncontrolled bleeding associated with the drug—and the fact that
no antidote existed for such an event. If the pharmaceutical companies
were aware of those risks, they could be charged with failure to warn
in the upcoming Xarelto lawsuits.
Xarelto Brings in Billions of Dollars Per Year for Manufacturers
For those who wonder why a huge corporation would knowingly continue to
market a drug which could potentially cause uncontrolled bleeding, remember
that Xarelto is Bayer’s best-selling drug. In 2016, Xarelto netted
$3.41 billion in revenues for Bayer, and $2.2 billion for J & J and
Janssen. Xarelto was approved by the FDA in 2011, as a treatment not only
for atrial fibrillation, but also as a means of reducing the risk of deep
vein thrombosis and pulmonary embolism.
If you or a loved one have been injured by a drug or medical device manufactured
by J & J or one of its subsidiaries, it could be beneficial to speak
to a product liability attorney as soon as possible.
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.