Issue Management

Global Issue Management identifies, assesses and resolves patient safety concerns
by guiding the relevant corporate functions through an effective Issue Management
process. An Issue is:

Any (unanticipated) event or situation

That is capable of being perceived as a potential human safety issue among
individual Patients, patient groups, HCPs, health authorities, other
stakeholders or the general Public
That requires responsible handling, issue solving and communication to
external Stake holders

These include (but are not limited to):

Critical Safety Issues

Critical Quality Issues
Emerging Quality Issues

With the above background, can you give a brief analysis of the below news stories
(either one):
Evaluation criteria:
-

The candidate here is required to understand the news story and assess how
important or significant it is for the brands/companies mentioned in the
article
Is the news story likely to have an impact on the brand image (positive,
negative, neutral). If yes then we would like to understand how the candidate
is approaching the evaluation and analysis of the news story. It need not be
an exhaustive analysis but we want to understand the approach taken or the
candidates thought process in evaluation
How strong or accurate are the observations made from the data
Structure and flow of the content and thoughts in the slide
Any analysis or insights drawn
Accuracy of language
Formatting of the slides (given the time, this will not be a major criteria for
evaluation)

1) Lawsuit Says Mirena IUD Migration Caused Severe Injuries

http://topclassactions.com/lawsuit-settlements/lawsuit-news/44868-mirenaiud-lawsuit-2/
A young woman from California has filed a Mirena IUD lawsuit against Bayer,
alleging that their intrauterine device is flawed and caused her serious
complications.

The Mirena IUD is a type of birth control implant that is designed to be inserted
into the uterus where it can theoretically remain in place for up to five years,
preventing pregnancy by a combination of methods. However, Mirena lawsuits
like this one allege that the Bayer IUD can cause serious side effects like uterine
perforation and IUD migration, where the device punches through the walls of
the uterus and moves around inside of the body.
Plaintiff Marla O. filed a Mirena lawsuit against Bayer in October, alleging that
the IUD caused her serious pain and suffering. According to the lawsuit, the then
23-year old had the Mirena IUD implanted at her doctors office in California.
Follow-up appointments allegedly indicated no sign of Mirena complications until
the plaintiff went in to have the device removed.
The lawsuit claims it took the physician three separate attempts to remove the
IUD. In the course of these attempts, it was revealed that the Mirena IUD had
perforated Marlas uterus and migrated out of its original position.
In IUD migration, the device works its way through the walls of the uterus and
moves around within the body, potentially wrecking havoc. In this case, the
plaintiff required two surgeries to remove the IUD, which did include some
surgical complications.
This plaintiff is not alone in her Mirena lawsuit. Bayer currently faces hundreds of
Mirena lawsuits over similar IUD migration allegations. The U.S. legal system has
organized these various Mirena lawsuits into a single coordinated legal action
called a multidistrict litigation or MDL.

MDLs help streamline the legal system by combining tens, hundreds, or even
thousands of similar legal suits into a single coordinated action. Unlike a class
action lawsuit, individual Mirena lawsuits retain a degree of autonomy, and each
case typically has their own lawyer or legal team. Individual cases often result in
a higher award for plaintiffs should a settlement be reached.
The various Mirena lawsuits, like this one, typically seek to recoup the cost of
medical care, past present and future; compensation for pain and suffering; and
legal fees associated with the process of filing the Mirena lawsuit, which is
permissible under U.S. law.
Marlas individual Mirena lawsuit is Case No. 1594, filed in the US District Court
for the Eastern District of California. The Mirena IUD MDL is In Re: Mirena IUD
Products Liability Litigation, MDL No. 2434, in the Southern District of New York.
OR

2) Viagra, Cialis, Levitra May Increase Risk of Melanoma

http://topclassactions.com/lawsuit-settlements/lawsuit-news/45541-viagracialis-levitra-may-increase-risk-melanoma/
A recent study has linked the use of Viagra, Cialis, and Levitra to a greater
increased risk of developing melanoma skin cancer.
These new findings, reported by the Journal of the American Medical Association
(JAMA), were based on a study of more than 25,000 American men conducted
over a period of 10 years by researchers from Harvard, Brown and other leading
U.S. universities and hospitals.
The JAMA study found that men who had used the erectile dysfunction drug
Viagra even just once were 84 percent more likely to develop melanoma skin
cancers than those who did not use an ED drug. The researchers factored in and
ruled out other possible reasons that might account for the significantly higher
incidence of melanoma skin cancer including age, tobacco use, and physical
activity. Men who had erectile dysfunction but did not use Viagra did not show an
increased risk for melanoma.
Viagra and Skin Cancer
Viagra is part of a class of drugs known as phosphodiesterase-5 (PDG5A)
inhibitors. There are many other drugs in this class, including Cialis and Levitra.
According to the study, treatment with Viagra and the other drugs, Cialis and
Levitra, can promote melanoma cell invasion.
Physicians involved in the JAMA study explained that one of the key ingredients
in Viagra, sildenafil, may trigger melanoma development but they have not yet
established a direct cause. Viagra may increase the risks of melanoma because
it affects the same genetic pathway that allows the skin cancer to become more
invasive. That would make Viagra melanoma cancers even more dangerous.
What About Other ED Medications?

Although Viagra, manufactured by Pfizer, is the only ED medicine that contains

the drug sildenafil, which was the main subject of the JAMA study, other ED
medications such as Cialis and Levitra contain drugs that operate in a similar
way, and just as the sildenafil in Viagra, are also PDG5A inhibitors.
Skin Cancer Symptoms
Melanoma is a deadly skin cancer. Like most cancers, early detection and
treatment provide the best survival rates. According to Cancer Treatment
Centers of America, some signs of melanoma are:

New spots/freckles/moles on the skin

A change in size, shape or color of an existing mole
Sores that do not heal
Pigment, redness or swelling that spreads outside the border of a spot to the
surrounding skin
Itchiness, tenderness or pain
Changes in texture or scales, oozing or bleeding from an existing mole
Viagra Melanoma Lawsuits
In light of the recent JAMA study and other consumer reports linking Viagra and
other ED drugs to skin cancer, hundreds of men who have taken the erectile
dysfunction drugs Viagra, Cialis, or Levitra may file melanoma skin cancer
lawsuits or join skin cancer class action lawsuits against erectile dysfunction
drug treatment manufacturers.