Additional Case Studies

Drug
Company Medicine Use Impact on Human Life Consequences Reported
Device Name

Abbott-Thoratec Recalls HeartMate II LVAS

Pocket System Controller Due to Risk of
Patient Injury and/or Death during Backup
Controller Exchange.
Recalled 28,882 controllers for the HeartMate
Implantable heart pump to II left ventricular assist device follows 70
circulates blood throughout reports of “incidents in which the controller
the body when the heart is Cause heath failure change to their backup has malfunctioned after an exchange,”
Thoratec HeartMate II too weak to pump blood back-up system controller during the course of including 19 injuries and the 26 deaths
Abbott controllers adequately on its own ventricular assist therapy Source: FDA. Medical Devices Recalls

Abbott Laboratories, Inc., agreed to pay $5.5

million to resolve civil FCA allegations
regarding false claims submitted to Medicare
for surgical procedures involving carotid and
peripheral vascular and biliary stents. The
government alleged that Abbott knowingly
paid prominent physicians unlawful kickbacks
with the expectation that these physicians
would arrange for the hospitals with which
they were affiliated to purchase Abbott's
Carotid and Peripheral Vascular products for use in vascular products for use in treating Medicare
vascular and Biliary treating Medicare beneficiaries.
Abbott Laboratories, Inc. Stents beneficiaries No adverse impact on health reported Source: The Pharma Letter

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 Additional Case Studies
Drug
Company Medicine Use Impact on Human Life Consequences Reported
Device Name

Novelion's Aegerion resolves U.S. drug

probes for $40 million. Under the agreements,
Aegerion will plead guilty to two misdemeanor
drug misbranding violations of the Food, Drug
and Cosmetic Act, pay $36 million to resolve
cases by the Justice Department and pay $4.1
million to settle the SEC’s lawsuit.The Justice
Department said Aegerion’s promotion of
Juxtapid for patients without the genetic
condition also led to false claims for payment
Bad drug can cause Stomach problems to be submitted to government health care
Aegerion including diarrhea, nausea, vomiting, programs including Medicare.
Pharmaceuticals Juxtapid Cholesterol medication cramps/pain, indigestion and liver problems. Source: Reuters

The Food and Drug Administration has

ordered Baxter International Inc. to recall
200,000 of the company's Colleague brand
pumps, escalating its scrutiny of infusion
pumps used primarily in hospitals to deliver
fluids to patients.
In the last five years, the FDA said it received
Used to deliver fluids, more than 56,000 reports of adverse events
including nutrients and that have included serious injuries and more
Colleague infusion medications, into a patient's Adversely stopped infusion due to battery than 500 deaths linked to infusion pumps..
Baxter pumps body in a controlled manner. failure and leakages during patient treatment Source: Chicago Tribune
52 deaths (31 in the US) worldwide; 385
Rhabdomyolysis (breakdown of muscle fibers nonfatal cases with most requiring
that results in myoglobin being released into hospitalization.
Bayer Baycol (Cerivastatin) Cholesterol reduction the bloodstream) which led to kidney failure. Source:Procon.org

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 Additional Case Studies
Drug
Company Medicine Use Impact on Human Life Consequences Reported
Device Name

Boston Scientific and its Guidant subsidiaries

to pay $30 million for Guidant’s Sale of
Defective Heart Devices for Use in Medicare
Patients. Boston Scientific Corp. and its
subsidiaries, Guidant LLC, Guidant Sales LLC
and Cardiac Pacemakers Inc. (Guidant), have
agreed to pay $30 million to settle allegations
that, between 2002 and 2005, Guidant
knowingly sold defective heart devices to
health care facilities that in turn implanted the
devices into Medicare patients, the Justice
Department announced today. Boston
Scientific acquired Guidant, a medical device
manufacturer, in 2006.“This settlement, along
with the prior criminal prosecution of Guidant,
demonstrates that there will be significant
A device implantable inside consequences when companies engage in
the body, able to perform Promotion of a drug prescribed of other conduct that threatens health and safety and
Boston Scientific and its cardioversion, defibrillation, symptoms may lead to adverse impact on the violates the law.”
Guidant subsidiaries Implantable Defibrillators and pacing of the heart health. Source: The Department of Justice, US

Celgene to Pay $280 Million to Settle Fraud

Suit Over Cancer Drugs. The pharmaceutical
company Celgene has agreed to pay $280
million to settle claims that it marketed the
cancer drugs Thalomid and Revlimid for
unapproved uses. Under the terms of the
settlement, which resulted from a lawsuit filed
by a whistle-blower — a former sales
representative at Celgene — the company will
pay $259.3 million to the United States and
Bad drug can lead to problems like Low white $20.7 million to 28 states and the District of
Used for the treatment of blood cell, red blood cell, or platelet counts, Columbia.
Celgene Corporation Revlimid and Thalomid multiple myeloma. Fatigue, Pneumonia, Blood clots Source: The New York Times

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 Additional Case Studies
Drug
Company Medicine Use Impact on Human Life Consequences Reported
Device Name

The Cutter Incident: How America's First Polio

Vaccine Led to a Growing Vaccine Crisis.
In April 1955 more than 200 000 children in
five Western and mid-Western USA states
received a polio vaccine in which the process
of inactivating the live virus proved to be
defective. Within days there were reports of
paralysis and within a month the first mass
vaccination programme against polio had to
be abandoned. Subsequent investigations
revealed that the vaccine, manufactured by
the California-based family firm of Cutter
Laboratories, had caused 40 000 cases of
polio, leaving 200 children with varying
The process of inactivating the live virus degrees of paralysis and killing 10.
Cutter Laboratories Polio Vaccine Oral use for Children proved to be defective Source: NCBI.

Italian study suggested, of the 155 people who

had taken Permax, 23.4% of them developed
Valve regurgitation (a condition that causes Permax heart problems, 11,417 Patients in
the valves to not close tightly, which allows the British study were 37 times more probable
blood to flow backward over the valve) in the to develop Permax heart damage problems,
mitral, tricuspid, and aortic heart valves, which Reported five patient deaths in which a Sprint
can result in shortness of breath, fatigue, and Fidelis lead fractured and was one of the
heart palpitations Lead fractures cause possible or likely contributing factor.
Eli Lily Permax (Pergolide) Parkinson's disease inappropriate shocks and/or loss of output. Source: Procon.org

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 Additional Case Studies
Drug
Company Medicine Use Impact on Human Life Consequences Reported
Device Name

Glaxo to Pay $750 Million for Sale of Bad

Products. GlaxoSmithKline, the British drug
giant, has agreed to pay $750 million to settle
criminal and civil complaints that the company
for years knowingly sold contaminated baby
ointment and an ineffective antidepressant —
the latest in a growing number of whistle-
blower lawsuits that drug makers have settled
with multimillion-dollar fines.
Altogether, GlaxoSmithKline sold 20 drugs
with questionable safety that were made at a
huge plant in Puerto Rico that for years was
Kytril/Bactroban/Paxil Contaminated baby ointment and an rife with contamination.
GlaxoSmithKline CR/Avandamet Avandia for diabetes ineffective antidepressant Source: The New York Times

Johnson & Johnson agreed to pay $1.391

billion to resolve false claims resulting from its
off-label promotion of Risperdal, Invega and
Natrecor. Risperdal was approved only to treat
schizophrenia, yet Janssen, a Johnson and
Johnson (J&J) subsidiary, promoted Risperdal
to physicians and other prescribers who
treated elderly dementia patients by urging the
prescribers to use Risperdal to treat
Promotion of a drug prescribed of other symptoms such as anxiety, agitation,
Risperdal, Invega and symptoms may lead to adverse impact on the depression, hostility and confusion.
Johnson & Johnson Natrecor Treat Schizophrenia health. Source: The Department of Justice, US

About 27,785 heart attacks or sudden cardiac

deaths reported between May 20, 1999 and
2003
Merck Vioxx (Rofecoxib) A pain reliever for arthritis Increased risk of heart attack and stroke Source: Procon.org

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 Additional Case Studies
Drug
Company Medicine Use Impact on Human Life Consequences Reported
Device Name

Novartis to pay $422.5 million for off-label

marketing. Swiss drugmaker Novartis AG will
plead guilty and pay a total of $422.5 million to
settle criminal and civil charges of improperly
marketing its epilepsy drug Trileptal, the U.S.
government said on Thursday.The payment
consists of $185 million of criminal fine and
forfeiture and $237.5 million to resolve civil
allegations
The penalties are the result of an investigation
that found Novartis promoted Trileptal for
unapproved uses, including for pain and
psychiatric conditions, such as bi-polar
Promotion and use of a drug for other disorder. The government also accused
symptoms such as Pain and psychiatric Novartis of paying illegal kickbacks to
Anti-epilepsy drug conditions may lead to adverse impact on the healthcare providers.
Novartis Trileptal Treat Partial Seizures health. Source: Reuters
Medical Device Manufacturer NuVasive Inc. to
Pay $13.5 Million to Settle False Claims Act
Allegations.
California-based medical device manufacturer
NuVasive Inc. has agreed to pay the United
States $13.5 million to resolve allegations that
the company caused health care providers to
submit false claims to Medicare and other
federal health care programs for spine
surgeries by marketing the company’s
CoRoent System for surgical uses that were
not approved by the U.S. Food and Drug
Administration (FDA).The settlement further
resolves allegations that NuVasive caused
false claims by paying kickbacks to induce
physicians to use the company’s CoRoent
Non approved device can impact patient System.
NuVasive Corpectomy device Surgical uses health Source: The Department of Justice, US

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 Additional Case Studies
Drug
Company Medicine Use Impact on Human Life Consequences Reported
Device Name

Medical Equipment Company Will Pay $646

Million for Making Illegal Payments to Doctors
and Hospitals in United States and Latin
America.The United States’ largest distributor
of endoscopes and related equipment will pay
$623.2 million to resolve criminal charges and
civil claims relating to a scheme to pay
kickbacks to doctors and hospitals and a
subsidiary of the distributor will pay $22.8
an instrument which can be million to resolve criminal charges relating to
introduced into the body to the Foreign Corrupt Practices Act (FCPA) in
give a view of its internal Latin America.
Olympus Endoscopes parts. No adverse impact on health reported Source: The Department of Justice, US

Stryker Corp.’s OtisMed unit pleaded guilty to

selling devices used in knee-replacement
surgeries in September 2009 without
regulatory approval and will pay more than
Non approved device can impact patient $80 million to resolve the case..
OtisMed Corp Otis Knee devices Knee replacement device health Source: Bloomberg

Pfizer and its subsidiary, Pharmacia &

UpJohn, were fined nearly $1.2 billion. It is
A pain reliever meant to one of the largest criminal fines imposed on a
treat arthritis and other Increased risk of heart attack ,stroke and U.S. drug company.
Pfizer Bextra inflammation in the body cause a fatal skin condition Source: Procon.org

Over 7,000 lawsuits were filed against the

Increased risk of birth defects, miscarriages, manufacturer over the side effects including a
and premature births when used by pregnant $10.5 million verdict and two $9 million
women; inflammatory bowel disease; suicidal verdicts.
Roche Accutane ((Isotretinoin) Acne tendencies Source:Procon.org

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 Additional Case Studies
Drug
Company Medicine Use Impact on Human Life Consequences Reported
Device Name

36 deaths; at least 500 cases of severe liver

and kidney damage
Smith Kline & French Selacryn (Tienilic acid) Blood pressure Severe liver and kidney damage Source: Procon.org

At least 90 liver failures; at least 63

deaths About 35.000 personal injury claims
Antidiabetic and anti- were filed against the manufacturer.
Warner-Lambert Rezulin (Troglitazone) inflammatory Links with hepatitis and liver failure Source: Procon.org

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