FAQ
- What is the amount of the settlement?
- Who can make a claim in the settlement?
- How does the settlement work?
- When does the claims period begin? When is the claims deadline?
- Do claimants require a lawyer to make a claim?
- What information do I need?
- What type of information must be in a claimant's medical records to qualify as ONJ?
- What type of information must be in a claimant's medical records to qualify as AFF?
- Where can I find the claim form?
- How do I file a claim?
- How will I know the Claims Administrator received my claim?
- How will payments to individuals be determined under the Agreement?
- When will I receive payment?
- What is a Derivative Claim?
- What is the amount of the settlement?
The Settlement is for C$6,375,000 and includes payments to individuals, provincial health insurers, payments towards class counsel fees and payments for notice and claims administration. More specifically, the settlement amount of $6,375,000 includes:
(i) Funds for eligible claimants of: C$3,225,000, comprised of:
1. C$3,063,000 for alleged osteonecrosis of the jaw (ONJ) and alleged atypical femur fracture (AFF); and
2. A fund of C$162,000 for alleged lost income;
plus
ii) Fixed cost of C$3,150,000, comprised of:
1) Payments to the provinces and territories totaling C$650,000;
2) Canada Wide Class Counsel Fees and Costs of up to C$2,000,000; and
3) Class Notice and Claims Administration Fees and Costs of up to C$500,000
Top - Who can make a claim in the settlement?
To be eligible, a claimant must be a resident of Canada (or the estate of a deceased Canadian resident), who has not opted-out and who took alendronate for at least 12 months, at least 6 months of which was Fosamax and/or Fosavance. At least 8 weeks of the alendronate ingestion must have occurred within 1 year prior to the onset of the alleged ONJ and AFF. To be eligible, the claimant must also demonstrate at least 8 complete and consecutive weeks of Fosamax and/or Fosavance ingestion within his or her medical history.
Top - How does the settlement work?
Persons who took Fosamax or Fosavance for a sufficient period of time, and have taken alendronate (whether Fosamax, Fosavance or generic alendronate) within sufficient proximity to ONJ or an AFF, are eligible to make claims and potentially receive payment.
To be eligible, a claimant must be a resident of Canada (or the estate of a deceased Canadian resident), who has not opted out and who took alendronate for at least 12 months, at least 6 months of which was Fosamax and/or Fosavance. At least 8 weeks of the alendronate ingestion must have occurred within 1 year prior to the onset of the alleged ONJ and AFF. To be eligible, the claimant must also demonstrate at least 8 complete and consecutive weeks of Fosamax and/or Fosavance ingestion within his or her medical history.
These claims must be submitted to the Claims Administrator, a third party organization that is not affiliated with either the plaintiffs or Merck, which reviews the submitted claims against the criteria in the Settlement Agreement and determines which claims are eligible and how much each eligible claimant is to receive as payment.
For qualifying ONJ and AFF claims, the Claims Administrator will award "points" to each such eligible claimant, based on the agreed upon settlement criteria identifying event levels. Once the final number of total eligible claimants is known, a monetary value will be determined by the Claims Administrator on a per-point basis (up to a cap as explained in the Answer to Question 1 above) and payments will be calculated and paid out accordingly.
Top - When does the claims period begin? When is the claims deadline?
The first day of the claims period was March 18, 2017. This is the date the Notice of Approval was published in the Globe & Mail and other major newspapers. The claims deadline is July 17, 2017.
The Claim Forms, fully completed and properly signed, and all documentation must be submitted (as proven by either the post-mark date (if standard lettermail service is used) or the date the submissions were received by the Claims Administrator (where same-day or overnight courier service is used) or the date the submission is capable of being accessed from the Claims Administrator's online repository (if an electronic submission is made)) NO LATER THAN JULY 17, 2017. FAILURE TO SUBMIT THESE MATERIALS BY THE DEADLINE WILL RESULT IN LOSS OF ANY RIGHT TO POTENTIALLY RECEIVE AN AWARD.
Top - Do claimants require a lawyer to make a claim?
Claimants can file claims on their own, by completing the claim form, obtaining and providing the required medical documentation on or before July 17, 2017.
The Claims Administrator will be able to answer questions about the claim form and required documentation, but they are not able to assist the claimant in obtaining the medical records that must accompany the claim form.
Otherwise, potential claimants can contact any of the law firms involved in the Settlement or any other lawyer of their choice.
If the claimant decides to enlist the help of a lawyer, there will be a fee charged by that lawyer for this assistance and the claimant will be responsible for the payment of that fee.
Top - What information do I need?
A claim form will be required to be completed by both Fosamax and/or Fosavance claimants as well as family-member ("derivative") claimants.
The claim form for the Fosamax and/or Fosavance claimant requires that certain medical records (including pharmaceutical records and records establishing ONJ or AFF) and information also be provided along with the claim form, by the claims deadline.
The claim form for derivative claimants requires that proof of relationship to the Fosamax and/or Fosavance claimant (e.g. a marriage or birth certificate) also be provided along with the claim form, by the claims deadline.
Top - What type of information must be in a claimant's medical records to qualify as ONJ?
In addition to meeting all other criteria, the claimant must submit medical records that establish:
1. contemporaneous Medical Record containing a diagnosis of ONJ;
OR
2. at least 6 consecutive weeks of exposed bone;
OR
3. at least 8 consecutive weeks of non-healing of an extraction socket or other oral or dental surgical site.
Top - What type of information must be in a claimant's medical records to qualify as AFF?
In addition to meeting all other criteria, the claimant must submit medical records that establish:
1. contemporaneous Medical Record containing a diagnosis of AFF;
OR
2. satisfaction of the case definition of AFF in the ASBMR Task Force's report published in JBMR Vol. 29, Issue 1, p. 14, Table 3 (2014).
Top - Where can I find the claim form?
The claim form can be found here. The claim form can be printed or a fillable PDF can also be found here.
Top - How do I file a claim?
In order for your claim submission to be considered timely you must file a claim by July 17, 2017. You may file a claim by mail addressing your claim(s) submission to:
Fosamax Claims Administrator
PO Box 3355
London, ON N6A 4K3
Alternatively, you may courier a claim package to the Claims Administrator using the following address:
Fosamax Claims Administrator
1480 Richmond Street, Suite 204
London, ON N6G 0J4
Submissions can also be made electronically by uploading your claim form and supporting documents using our online repository found here.
Top - How will I know the Claims Administrator received my claim?
Within 7 days of receipt of your claim the Claims Administrator will send you a postcard to confirm receipt of your submission. If you choose to provide your claim submission electronically you will be provided confirmation of your submission immediately.
Top - How will payments to individuals be determined under the Agreement?
Payments to individuals will depend on the final number of eligible claimants and are subject to a maximum amount for each category of alleged event. Claims for ONJ and AFF will be evaluated on an individual basis by an independent administrator based on objective criteria. To be eligible for payment a claimant's application must pass both the Usage Gate and the Event Gate criteria, as determined by the independent administrator. The maximum payment for an atypical femur fracture in one leg is CAD 17,500. Any individuals passing the Usage Gate who allege separate atypical femur fractures in both legs must pass the Event Gate separately for each leg and if so would be eligible for a maximum payment of CAD 42,500; only one event per leg will be considered. The maximum payments for ONJ are set forth in the below chart. In all cases, the maximum payments are subject to downward adjustments based on the number of eligible claimants which will not be known until all claims packages have been considered.
Event Level
“Points”
Maximum Payments ($500 cap per Point)
ONJ Group 4
86
$43,000
ONJ Group 3
35
$17,500
ONJ Group 2
20
$10,000
ONJ Group 1
16
$8,000
AFF Group B
85
$42,500
AFF Group A
35
$17,500
ONJ Event Category 4: a pathologic fracture, severe refractory osteomyelitis, resection (total or partial), currently draining external fistula, or disfigurement; or meets the ONJ Event Category 3 injury criteria and required hospitalization for a total of five or more days for treatment of those injuries or due to emotional disturbance directly attributed by the claimant's treating physician to the claimant's dental condition.
ONJ Event Category 3: necrotic and exposed bone for at least eight consecutive weeks' duration requiring treatment of multiple debridements or surgical intervention for the ONJ; or (a) resolved, external fistula; or (b) internal fistula requiring surgery to resolve.
ONJ Event Category 2: satisfaction of one of the three criteria for ONJ Event Category 1, and treatment of a single debridement or spicule removal(s); or resolution of claimant's ONJ upon the administration of intravenous antibiotics, or in response to other non-surgical treatment other than that described in Event Category 1.
ONJ Event Category 1: (1) necrotic and exposed bone for at least six consecutive weeks' duration; (2) non-healing of at least eight consecutive weeks after a tooth extraction or other dental or oral procedure; or (3) medical or dental records that document a final ONJ diagnosis contemporaneous with the condition.
AFF Event Category B: Atypical femur fractures in both legs. To be eligible to receive an AFF Event Category B payment (which is one payment for both fractures), the fracture in each leg must independently satisfy the AFF Event Gate Criteria and Usage Gate Criteria described elsewhere in the Settlement Agreement. In addition, no claimant will be eligible for a payment for more than one fracture in a leg.
AFF Event Category A: Atypical femur fracture in one leg.
Top - When will I receive payment?
Although the Claims Administrator will proceed as quickly and as efficiently as possible, the claims administration will likely take a significant amount of time. Claims must be submitted on or before July 17, 2017. After this time, the Claims Administrator will review each submitted claim, notify claimants of any deficiencies in the claims submitted and provide a certain time to address those deficiencies, and review any supplementary material provided by claimants to address identified deficiencies. There is also an appeal process, once the Claims Administrator has made its decisions about eligibility of a claim. It will likely be many months before payments are made to the qualifying individuals.
Top - What is a Derivative Claim?
A Derivative Claims is a claim sent on behalf of a spouse (including common law or same-sex spouses) or child (by birth, marriage or adoption) of a Product User Claimant who had an eligible AFF or ONJ Event.
To be eligible to make a claim, you must have been the spouse or child of the Product User Claimant at the time of the Eligible Event.
Derivative Claimants are required to prove your relationship to the Product User at the time of the Eligible Event with supporting documentation (i.e. marriage certificate, long-form birth certificate, etc.).
A Finally Determined Eligible Derivative Claimant will be entitled to receive a payment pursuant to the Settlement Agreement only if the related Product User Claimant becomes entitled to receive such a payment as a Finally Determined Eligible Product User Claimant.
You are encouraged to submit a Derivative Claimant Form(s) and proof of relationship together with the Claims Package submitted by your related Product User Claimant for ease of administration.
The Derivative claim form can be found here. The claim form can be printed or a fillable PDF can also be found here.
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