Sweetland et al v. GlaxoSmithKline Inc.
Nova Scotia Supreme Court File: Hfx No. 315567
A Notice of Action and Statement of Claim were filed on August 18, 2009.
Various amendments to the claim have been filed, the most recent of which was on June 5, 2015.
The case was certified as a class proceeding on December 7, 2016.
The Defendants filed a Notice of Application for Leave to Appeal; currently the date for the appeal remains to be scheduled.
Avandia is an oral diabetes medication and is manufactured by GlaxoSmithKline. Since its introduction in 1999 more than 6 million people have taken Avandia or Avandamet.
Avandia is used in the prevention of Type 2 diabetes in high-risk patients who are not controlled by diet and exercise alone, to reduce insulin resistance and to lower elevated blood glucose in patients. This class of drug is known as thiazolidinediones (TZDs) or glitazones. Avandia (Rosiglitazone) is a TZD and was approved for dispensing in Canada on March 30, 2000.
Drugs of this class can cause fluid retention that may progress to congestive heart failure. In addition to cardiovascular issues, other symptoms include swelling (edema), shortness of breath, weakness, fatigue, or excessive weight gain.
An Advisory was posted by Health Canada in November of 2001 indicating that there were safety concerns associated with the use of this class of drug. More recently new concerns have been raised about the link between Avandia and the risk of heart attack. More than one million prescriptions for Avandia were filled in Canada in 2006, ranking it the third most popular oral diabetes drug.
A study published in the New England Journal of Medicine in May, 2007 showed that the use of Avandia caused a significant increase in the risk of heart attack and possible death. The NEJM analysis of 42 studies revealed that there was a 43 per cent higher risk of heart attack for those taking Rosiglitazone compared to people taking other diabetes drugs or no diabetes medication at all. The report further stated that there is a 64 percent increase in the risk of death due to cardiovascular issues as a result of ingesting the drug. Dr. Steven Nissen, a cardiologist with the Cleveland Clinic, estimates that tens of thousands of deaths are attributable to Avandia.
On June 1, 2007, in response to the NEJM article, Health Canada issued a new warning. Physicians were advised about the use of Avandia in combination with other drugs. Health Canada also made recommendations for the handling of patients and indicated there was a need by the physician to weigh the overall
benefits of prescribing Avandia to their patients.
On June 6, 2007, the United States Food & Drug Administration announced it was calling for a black box warning on Avandia based on data that the diabetes drug is associated with an elevated risk of cardiovascular problems.
A further study published in the September 12 issue of the Journal of the American Medical Association indicated that one in 30 patients taking Avandia over the course of a year had heart failure and one in 220 had a heart attack.
Data obtained from Health Canada by the Winnipeg Free Press through an Access to Information request shows that 57 Canadians reported serious side-effects while taking Avandia and that 33 Canadians suffered heart failure, heart attack or stroke, and at least four people died.
Health officials were aware of heart risks linked to GlaxoSmithKline’s widely prescribed diabetes drug Avandia for a number of years. In 2002, for example, the FDA requested reports of congestive heart failure to be included on the label of Avandia.
GlaxoSmithKline has known of the cardiovascular risks of Avandia for an extended period of time. In August 2006, the company conducted a similar analysis of clinical trials and estimated the heart risk increased by 31 percent among Avandia patients.
GlaxoSmithKline continues to tout the safety of their product despite these finding and disclosures.
Recently there has been further controversy concerning GlaxoSmithKline and Avandia as a report surfaced that a medical expert, John Buse, M.D., was threatened with a lawsuit by GlaxoSmithKline’s executives when he initially raised doubts about the drug as far back as 1999.
Patients taking Avandia are encouraged not to stop taking Avandia without first consulting with their physicians.
Several lawsuits have been launched in Canada and the United States over the medication’s adverse effects, and drug safety regulators in both countries have been investigating its safety.
Wagners Law Firm have filed a Notice of Action and Statement of Claim with respect to the adverse effects caused by the prescription drug Avandia.
Update – March 13, 2017
The Defendants have filed their Defence to the class action. A copy of the Defence may be viewed under the Court Documents tab.
Update – February 23, 2017
On December 7, 2016, an Order for Certification was filed with the Supreme Court of Nova Scotia. The Order certified the action as a class proceeding pursuant to sections 4(3) and 7 of the Class Proceedings Act.
The Order defined the classes as:
(a) All persons in Canada, including their estates, who were prescribed and ingested Avandia (the “Primary Class”); and
(b) The spouses (including common-law spouses and same-sex spouses), children, grandchildren, parents, grandparents and siblings of deceased members of the Primary Class (the “Family Class”).
On December 22, 2016, the Defendants filed a Notice of Application for Leave to Appeal and Notice of Appeal (Interlocutory). These documents were filed with the Nova Scotia Court of Appeal by the Defendants (Appellants) in an effort to reverse and dismiss the certification of this action as a class proceeding.
On January 27, 2017, a Consent Order was filed with the Nova Scotia Court of Appeal which granted the Defendants (Appellants) application for leave to appeal from the Certification Order.
As such, the Defendants (Appellants) will have an opportunity to argue in an effort to reverse and dismiss the certification of this action as a class proceeding. Wagners, as Counsel and Respondents for the Plaintiffs and Class Members, will, in turn, argue to uphold the certification of this class proceeding.
Below is a schedule of events leading up to the day on which both Counsel for the Defendants (Appellants) and Plaintiffs (Respondents) will attend the Nova Scotia Court of Appeal to make their respective arguments.
March 10, 2017 – Due date for the Appellants’ Appeal Book
June 2, 2017 – Due date for the Appellants’ Factum (written submissions)
August 4, 2017 – Due date for the Respondents’ Factum (written submissions)
October 5, 2017 10:00 am – Full day appeal in the Nova Scotia Court of Appeal
Copies of the above noted Court filed documents will be made available under the Court Documents tab.
Update – June 2, 2016
On June 1, 2016, the Honourable Justice Michael Wood of the Supreme Court of Nova Scotia released his supplemental decision with respect to certification of the Avandia class action.
Justice Wood’s latest decision reaffirms the certification of this lawsuit as a class action proceeding.
Both the original certification decision and this latest supplemental decision may be viewed under the Court Documents tab.
Update – February 26, 2016
A copy of the Plaintiffs’ Supplemental Submissions was filed on today’s date with the Nova Scotia Supreme Court. Supporting affidavits were also filed pursuant to the direction of Justice Wood.
Update – January 19, 2016
On January 15, 2016, the Honourable Justice Michael Wood of the Supreme Court of Nova Scotia released his decision with respect to the Plaintiff’s motion to certify the lawsuit as a class action.
Justice Wood’s decision provides for a further 45 days for the Plaintiff to file additional evidence with a view to perfecting some minor deficiencies with the proceeding. Justice Wood has instructed the Plaintiff to supplement the evidence previously filed concerning the criterion of two or more class members required by s.7(1)(b) of the Class Proceedings Act and to file a revised list of common issues. Written submissions may also be provided. The Defendants will have a further 20 days to file any counter or responding evidence after the Plaintiff has submitted the supplemental information.
The decision of Justice Wood is available for viewing under the Court Documents tab. The additional evidence which will be filed by the Plaintiffs on or before the expiry of the 45 day extension will also be made available once it has been sent to Justice Wood.
Update – December 10, 2015
We continue to await the release of the decision of the Honourable Justice Michael Wood with respect to the Plaintiff’s motion to certify the proceeding as a class action.
Once released, the decision will be made available under the Court Documents tab.
Update – September 23, 2015
Counsel appeared before the Honourable Justice Michael Wood for four days last week for the hearing of the Plaintiffs’ motion for certification.
Justice Wood has reserved his decision. Once released, a copy of the the decision will be available for viewing under the Court Documents tab.
Update – September 15, 2015
The Plaintiffs’ motion for certification, which commences today, will be live streamed at the Nova Scotia Courts website.
Interested persons may view the proceedings at:
Update – September 4, 2015
The Plaintiffs’ motion for certification of the proposed class proceeding as a class action is scheduled for September 15 – 18, 2015 in the Nova Scotia Supreme Court in Halifax.
Documentation pertaining to the motion for certification may be viewed under the Court Documents tab.
Update – May 26, 2015
A case management conference was held today before the Honourable Justice Wood. The following dates have been scheduled for the filing of the Briefs with respect to the certification motion scheduled for hearing over 4 days, from September 15 to 18, 2015:
- July 3, 2015 – Applicant’s Certification Brief
- August 7, 2015 – Respondent’s Certification Brief
- August 21, 2015 – Applicant’s Reply Brief, if any;
Justice Wood also ordered that if there are any evidentiary objections to the admissibility of the evidence which has been filed, any objections must be raised no later than June 30, 2015.
Update – April 27, 2015
All Counsel are in the process of scheduling dates for examinations of the experts who have provided affidavits regarding certification concerning the Avandia class action.
Update – March 27, 2015
The Defendants have provided Wagners with copies of three affidavits which they have filed with respect to certification.
The affidavits may be viewed under the Court Documents tab.
Update – February 25, 2015
Wagners have filed motion documents with the Supreme Court of Nova Scotia today with respect to amending the Statement of Claim.
The documents are available under the Court Documents tab.
Update – January 29, 2015
The case management conference before Justice Wood was held on January 28th via conference call.
Issues concerning amendments to the Statement of Claim and certification evidence were discussed.
Justice Wood scheduled the date of March 12, 2015 for the hearing of the Plaintiff`s motion to amend the Statement of Claim should an agreement with the Defendants not be reached. Various filing deadlines were scheduled.
The deadline for the filing of the Defendants evidentiary record on certification is March 27, 2015, with discovery examinations to be completed by May 22, 2015.
Update – January 20, 2015
The Defendants’ have sent correspondence to the Court requesting that a date be scheduled for a case management conference before Justice Wood.
Update – January 14, 2015
The Defendants will be filing their response to the Plaintiffs’ certification documents in the near future with respect to the Avandia class action.
Copies of the Plaintiffs’ certification documents may be found under the Court Documents tab. Copies of the Defendants’ materials will also be uploaded once they have been received.
Update – July 14, 2014
On May 21, 2014, Counsel appeared before Justice Wood for the hearing of the Defendants’ motions to strike out an affidavit exhibit and to have the Representative Plaintiffs disclose medical records.
On July 9, 2014, Justice Wood released his decision in favour of the Defendants. A copy of the decision and other documents pertaining to the motions may be found under the Court Documents tab.
Update – January 20, 2014
On January 8, 2014, a further case management conference call was held before Justice Wood.
At that time, dates were assigned for preliminary motions which are scheduled for May 21, 2014. A schedule of the filing timelines was also arranged as follows:
- March 21, 2014 – Notice of Motions and Submissions
- April 11, 2014 – Reply Submissions
- April 25, 2014 – Rebuttal Submissions
At present it is undetermined what the particulars of the motions or what their scope may be.
The relevant documents to be filed by the parties, will be made available for review under the Court Documents tab.
Update – November 7, 2013
A case management conference call was held before the Honourable Justice Michael Wood on November 1, 2013 to discuss the Nova Scotia proceedings as well as proceedings in other Provinces of Canada. Counsel for the Defendants was also involved in the call.
Lawyers from Wagners will be reappearing before Justice Wood on January 8, 2014 for a further case management conference call.
Update – August 21, 2013
A Justice with the Supreme Court of Newfoundland and Labrador has been assigned to case manage the NL proceedings. The Order has been uploaded and may be found under the Court Documents tab.
Update – June 20, 2013
Wagners Law Firm has filed its Notice of Action and Statement of Claim with the Court of Queen`s Bench in Moncton, New Brunswick on today’s date. A copy of the pleading is available for viewing under the Court Documents tab.
Update – May 16, 2013
We filed a Statement of Claim in the Province of Prince Edward Island on today’s date. A copy of the proposed class proceeding may be located under the Court Documents tab.
Update – May 10, 2013
We filed a Statement of Claim in the Province of Newfoundland and Labrador on today’s date. A copy of the newly filed proposed class action may be viewed under the Court Documents tab.
Update – December 5, 2012
We understand that Ontario Counsel are in the process of obtaining expert reports for certification purposes.
Update – March 7, 2012
We are continuing our efforts to develop our certification motion documents.
Update – February 13, 2012
The litigation concerning this medication remains ongoing. Procedurally, the next process in the proceeding will be to file our documentation so that we may obtain a date for the hearing of our motion to certify the proceeding as a class action. All proposed class proceedings must be certified by the Court if they are to proceed as a class action. If we are successfully certified, then the case will continue in accordance with the Nova Scotia Class Proceedings Act.
Copies of our certification motion documents will be made available under the Court Documents tab page once they have been filed with the Court.
Update – July 27, 2010
An Amended Statement of Claim was filed with the Nova Scotia Supreme Court today. The amended claim may be viewed under the Court Documents tab.
Update – August 18, 2009
Wagners commenced a proposed class proceeding on behalf of individuals affected by the use of the Avandia medication. Read the Press Release here.
Update – June 30, 2009
Wagners is continuing to explore the potential of commencing a proposed class proceeding with respect to the adverse effects of Avandia.
The following documents concerning the class action which Wagners has filed as a result of the serious and adverse side effects associated with the use of the diabetes medication Avandia are also available for viewing in PDF format:
- June 1, 2016 – Supplemental Decision re: Certification
- January 15, 2016 – Decision re: Certification
- June 5, 2015 – 2nd Fresh Amended Statement of Claim
- July 9, 2014 – Decision re: Strike and Disclosure
- June 20, 2013 – Notice of Action & Statement of Claim (NB)
- May 16, 2013 – Statement of Claim (PEI)
- May 10, 2013 – Statement of Claim (NL)
- July 27, 2010 – Amended Statement of Claim (NS)
- August 18, 2009 – Notice of Action & Statement of Claim (NS)
Wagners is presently accepting enquiries from residents of Canada who have suffered serious cardiovascular problems associated with the use of Avandia.
If you, or a member of your family, have suffered congestive heart failure or other cardiac effects as a result of taking Avandia and injury, death or other losses have resulted, you may be eligible for inclusion as a Class Member in our proposed class action lawsuit.
To sign up and determine if you qualify, please fill out this registration form: