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Composite image: Benicar bottles via www.empr.com; hourglass via www.lochgarry.wordpress.com.
Composite image: Benicar bottles via www.empr.com; hourglass via www.lochgarry.wordpress.com.

As reported Monday, a $300M settlement agreement was reached between Daiichi Sankyo and users of the popular high blood pressure drug, Benicar. The settlement agreement may be read on a website, Olmesartan Products Litigation Settlement, established to facilitate payment of claims. Plaintiffs opting to enroll in the Olmesartan Products Resolution Program (at the website) must comply with enrollment requirements as spelled out on the site.

However, there is another group of plaintiffs whose next steps must be taken relatively quickly. These are the plaintiffs who choose not to enroll in the Program, as well as those whose cases are either newly filed or newly transferred into the multi-district litigation (MDL). This article will present the next steps and deadlines affecting this group.

There is a final group of people, those who have not yet filed suit, that are facing an extreme deadline. This group must retain legal counsel and file necessary documents no later than 11:59pm on August 23, 2017. This group is not addressed in this article.

The litigation surrounded Daiichi Sankyo’s “olmesartan medoxomil, a popular prescription blood pressure medication marketed as Benicar®, Benicar HCT®, Azor®, and Tribenzor®.” According to one of the firms involved with the litigation, Robins Kaplan, over “2,000 individuals have alleged severe and sometimes life-threatening gastrointestinal injuries as a result of ingesting the medications containing the active ingredient olmesartan medoxomil, which has been linked to sprue-like enteropathy and celiac disease-like symptoms that inhibit a person’s ability to absorb nutrients.”

In a press release from the Plaintiffs’ Negotiating Committee, co-lead counsel for the plaintiffs, Christopher L. Coffin, said, “We are very pleased with the outcome of this hard-fought litigation. This is a gratifying resolution for thousands of patients who suffered severe gastrointestinal injuries while using these blood pressure medications.”


Note: The plaintiffs referred to from this point forward are only those who opt not to enroll in the Program. The information regarding next steps and deadlines beyond this point affects only this group.


Along with notice of the settlement agreement, District Court Judge Robert B. Kugler entered a Case Management Order #34 (CMO34) on August 1, 2017. This order affects only those plaintiffs who do not enroll in the Program. Failure to comply with the document filing requirements and deadlines in CMO34 could result in these cases being dismissed with prejudice. When a case is dismissed with prejudice, it can never be refiled.

CMO34 applies to those plaintiffs with pending cases as of August 1, 2017 that are currently part of the MDL, as well as those cases filed or transferred into the MDL after August 1.

The document filing requirements/deadlines are listed below. For your convenience, a chart is available by clicking here. Plaintiffs should seek the advice of their lawyers if they have questions about or need assistance with these requirements. Nothing in this article is to be construed as legal advice.

All documents listed must be sent to defendants, per CMO34, by plaintiffs or their lawyers using the following email addresses:

Susan Sharko: susan.sharko@dbr.com

Jessica L. Brennan: jessica.brennan@dbr.com

The filing deadlines are as follows:

For cases filed or transferred before August 1, 2017, sixty (60) days from the final Opt-In Deadline for the Olmesartan Products Resolution Program. Currently, the final Opt-In Deadline is 11:59pm on September 15, 2017. This may be extended per the settlement agreement if the parties agree. Plaintiffs’ filing deadline is currently 11:59pm on November 15, 2017.

For cases filed or transferred on or after August 1, 2017, within sixty (60) days from the date the case was filed or transferred. Note: Federal Rules of Civil Procedure #6 dictates how to “count the days.” In this case, do not include the date the case was filed or transferred; start with the following day. Include: Saturdays, Sundays, and legal holidays, as well as the last day of the period (the sixtieth day) unless the last day is on a Saturday, Sunday, or legal holiday. In that case, the end of the period is the next day that is not a Saturday, Sunday, or legal holiday. Example: Sixty days for a case filed or transferred on August 10, 2017 is October 10, 2017.

Note: The above deadlines apply to the majority of the documents required. There are two documents (#5 and #6 below) that have longer deadlines for filing. Plaintiffs have one hundred twenty (120) days to file documents #5 and #6.

For cases filed or transferred before August 1, 2017, plaintiff’s filing deadline is currently 11:59pm on January 14, 2018 due to the fact that the actual deadline is on Sunday, January 13, 2018.

For cases filed or transferred on or after August 1, 2017, please refer to the method of counting days per Federal Rules of Civil Procedure #6, mentioned above.

Medical records; image courtesy of www.med.navy.mil.
Medical records; image courtesy of www.med.navy.mil.

The documents required by the above deadlines are:

  1. All pharmacy records relating to dispensing drugs to the plaintiff for two (2) years before the date of the first diagnosis of the alleged personal injury, through two (2) years after the plaintiff stopped taking the Olmesartan products, OR, for two (2) years after the alleged personal injury (the digestive issues), whichever date occurs last.

2. A Plaintiff Fact Sheet (PFS) and authorizations for the release of records. All plaintiffs, even those who previously submitted a PFS, must file updated authorizations.

3. Medical records for two (2) years before the date of the first diagnosis of the alleged personal injury, through two (2) years after the plaintiff stopped taking the Olmesartan products, OR, for two (2) years after the alleged personal injury (the digestive issues), whichever date occurs last. The medical records include:

(a) All physicians, medical facilities, other healthcare providers and/or other providers who prescribed the plaintiff Olmesartan products, or gave the plaintiff samples of Olmesartan products.

(b)All medical records relating to the plaintiff from the plaintiff’s primary care physician(s)

(c) All medical records relating to the plaintiff from the plaintiff’s gastroenterologist.

(d) All medical records relating to the plaintiff from any other healthcare provider who treated the plaintiff for the personal injuries alleged in the plaintiff’s case.

(e)All medical records relating to the plaintiff from any hospital that treated the plaintiff for the alleged personal injury.

4. A certification signed by the plaintiff or the plaintiff’s lawyer stating that the following records have been collected and submitted per CMO34:

(a) All of the pharmacy records in #1 above;

(b) All of the medical records in #3a through #3e above.

(c) Note: If any of the above documents don’t exist or can’t be collected/submitted, the plaintiff or the plaintiff’s lawyer shall state that fact and the reason, if known, that the documents don’t exist or can’t be collected/submitted. This statement will be made as part of the certification, and must include a “No Records Statement” from the pharmacy or the healthcare provider.

5. A report that complies with Federal Rule of Civil Procedure 26(a)(2) on general causation. For general causation, this report must be from a medical expert expressing the opinion (to a degree of medical or scientific certainty) that Olmesartan products pose an increased risk for the development of the type of injury alleged by the plaintiff.

6. A report that complies with Federal Rule of Civil Procedure 26(a)(2) on specific causation. For specific causation, this report must be from a medical expert expressing the opinion (to a reasonable degree of medical certainty) that using Olmesartan products caused or substantially contributed to the plaintiff’s alleged injury.

7. Note: Plaintiffs should consult their lawyers regarding the reports mentioned in #5 and #6 above to ensure that the reports comply with the Rule’s requirements.

The list of documents required is extensive. However, CMO34 outlines what will happen if plaintiffs do not comply:

  1. Plaintiff will be notified by the defendant’s lead counsel or representative via fax or email of their failure to comply.
  2. Plaintiff will be given a thirty (30) day “Cure Period” to allow them more time to comply.
  3. If the plaintiff still does not comply, defendant’s lead counsel or representative shall meet and confer with the plaintiff.
  4. If that meeting doesn’t result in a cure, the defendant’s liaison counsel may file a Motion to Show Cause as to why the plaintiff’s case should not be dismissed with prejudice.
  5. Plaintiff will have thirty (30) days to respond to that Motion to Show Cause.
  6. If the plaintiff does not respond within that thirty (30) day period, the plaintiff’s case will be dismissed with prejudice, except for good cause shown for failure to respond.

LegalReader is providing this information in the hopes that it will benefit those injured parties who choose not to enroll in the Program or whose cases are newly filed or transferred. It cannot be stressed enough that it is crucial that these plaintiffs consult their lawyers as soon as possible in order to preserve their rights. Nothing in this article is to be construed as legal advice.

Sources:

Case Management Order #34
Robins Kaplan Press Release

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