United States District Court, E.D. California
KRISTI LAURIS, Individually and as Successor In Interest to the Estate of DAINIS LAURIS; KRISTI LAURIS as Guardian Ad Litem for L.L.; and TAYLOR LAURIS, Plaintiffs,
NOVARTIS AG, a Global Healthcare Company; NOVARTIS PHARMACEUTICALS CORPORATION, a Delaware Corporation, Defendants.
REQUEST FOR INTERNATIONAL JUDICIAL ASSISTANCE LETTERS
SAM E. HADDON, UNITED STATES DISTRICT JUDGE
United States District Court for the Eastern District of the
State of California, United States of America, presents its
compliments to the appropriate judicial authority having
jurisdiction over civil causes in the City of Dorval, Quebec,
Canada, and requests international judicial assistance to
obtain evidence to be used in a civil proceeding pending
before this Court in the above entitled matter. A trial is
scheduled on this matter for January 23, 2018 in Fresno,
California, United States of America.
Court requests the assistance described herein as necessary
in the interests of justice. The assistance requested is that
the appropriate judicial authority of Quebec, Canada, compel
the production of documents from the below listed Canadian
entity and to allow service of process to be effected as is
customary in your jurisdiction:
Novartis Pharmaceuticals Canada Inc. ("Novartis
Canada"), with corporate address at 385 Bouchard Blvd.,
Dorval, Quebec, Canada H9S 1A9.
above entitled matter pending before this Court is a
commercial dispute between Plaintiffs and Novartis
Pharmaceuticals Corporation and Novartis AG concerning
alleged atherosclerosis-related events associated with
Tasigna®. It has been suggested to us that there are
witnesses residing within your jurisdiction with documents
relevant to this dispute.
documents to be produced are business records of the company.
Specifically, we request documents related to Novartis
Canada's actions around its knowledge of atherosclerotic
disease associated with the prescription drug, Tasigna®.
Plaintiffs allege that defendants in this matter, Novartis
Pharmaceuticals Corporation and Novartis AG, knew of risks
atherosclerotic-related conditions caused by Tasigna® but
failed to warn American doctors and patients of these risks.
In April 2013, Novartis Canada issued advisories to Canadian
health care professionals and the Canadian public. These
advisories warned of possible risks of atherosclerosis
associated with Tasigna® and that patients taking
Tasigna® should be monitored for signs of
atherosclerosis-related conditions when taking Tasigna®.
At or around that time, Novartis Canada updated its Canadian
Product Monograph-the reference document that Canadian health
professionals use when prescribing medication-to add
information about atherosclerosis-related conditions.
on this information, Plaintiffs seek documents dated January
1, 2011 through December 31, 2013, from two Novartis Canada
employees relating to atherosclerotic events associated with
on search terms agreed to by counsel in this case designed to
identify relevant documents without undue burden or expense,
Plaintiffs seek the following:
1: Clinical Study Data reports on Tasigna clinical trials
including (i) the quantification of Peripheral Artery
Occlusive Disease (PAOD) in chronic myeloid leukemia; (ii)
status updates on the ENEST study; (iii) pharmacokinetic
study of nilotinib and midazolam; (iv) hepatocellular
carcinoma risk in murine models and (v) risk benefit analysis
of Cardiovascular risk associated with Tyrosine Kinase
Inhibitors. This category further includes study protocols,
patient consent forms and amendments to same for CAMN1072303
entitled: "Phase III multi-center open label, randomized
study of imatinib versus nilotinib in adult patients with
newly diagnosed Philadelphia chromosome positive chronic
myelogenous leukemia" and study AMN107 entitled
"Open label, multi-center nilotinib roll-over protocol
for patients who have completed a previous Novartis sponsored
nilotinib study and are judged by the investigator to benefit
from continued nilotinib treatment."
2: Screening Acceptance Letter and correspondence on the
modifications to the Product Monograph by the Health Canada
Regulatory Project Manager and relevant Product Monographs.
3: Various internal correspondence including (i) Dear Health
Professional letter warning of the Atherosclerosis related
disease risk with Tasigna (ii) Request for clarification on
changes risk factors for Tasigna by the FDA; (iii) response
to regulatory on changes to Gleevec product monograph; (iv)
marketing documents for patient centered websites relating to
Tasigna and (v) Gleevec regional meeting agenda.
therefore, request in furtherance of justice that you, by the
proper and usual process of your court, cause the
aforementioned witnesses, or their agents or attorneys, to
produce the aforementioned documents.
advise the Parties presenting this request with a statement
of Costs incurred in executing these Letters ...