Chief of Cardiac Surgery at Northwestern University Admits Patient Heart Attack under Oath After Years of Denials

Chicago (ots/PRNewswire) -

Dr. Patrick McCarthy of Northwestern recently admitted under oath
in a malpractice lawsuit that a patient he operated on in 2006 had a
heart attack while receiving an investigational heart device called
the Myxo 5100. This admission comes amid years of denials from
McCarthy, the hospital and Northwestern University about human
experimentation during cardiac surgery without consent from patients.

Despite the recent admissions by McCarthy and the hospital, the
FDA when asked, does not plan to contact any other patients operated
on during the investigational time period.

"In light of these letters [Northwestern sent to patients] and
the subsequent clearance of the device, reflecting FDA's
determination that the device meets applicable safety and
effectiveness standards, (the) FDA believed that further and direct
patient communication may needlessly raise concerns among patients
implanted with the device," said the FDA.

From 2003 to 2009, patients across the country thought they were
receiving FDA approved devices during open heart surgery. However FDA
was unaware of the implantations going on in major academic centers,
including New York, Chicago, and Cleveland, until Dr. Nalini
Rajamannan, the Valve Director at Northwestern brought it to the
FDA's attention in 2008. This revelation was discovered when her
patient, Antonista Vlahoulis, informed her that she was unaware of
the experimental nature of the device.

Three months later, the FDA mandated a voluntary recall pursuant
to 21 CFR 7 to remove the Myxo and a second device, the IMR, by the
manufacturer Edwards Life Sciences, Irvine CA, from all hospital
shelves. Neither the Myxo nor the IMR had FDA clearance between 2003
and 2009.

Since 2008, Northwestern has publicly denied McCarthy's human
experiments. These denials are confirmed in a letter sent to the
patients during the voluntary recall period by the CEO of
Northwestern Memorial Hospital, Dean Harrison, endorsing claims that
the device was not experimental. This is the same letter that the FDA
is relying upon in 2012 to defend their position. Northwestern failed
to comment on the issue when recently contacted.

So far, there are 667 patients with the investigational Myxo
device who are still unaware of the surgical experiment. Since 2008,
Rajamannan has requested meetings with the University and Hospital to
get the proper health care for these patients. These requests have
been denied. The Nuremberg and Common Rule laws, adjudicated by the
International Tribunal of the Hague, are intended to protect human
subjects from unauthorized experimentation.

For further information:
Rob Amaefule
Rna19999@gmail.com
+1-773-606-1885

ots Originaltext: Rob Amaefule
Im Internet recherchierbar: http://www.presseportal.de