Drug Injury Watch

Osteoporosis Medication Aclasta Associated With Renal Impairment And Kidney Failure

Novartis Sends "Dear Doctor" Letter To Canadian Physicians With Health Canada Endorsed Safety Information

(Posted by Tom Lamb at DrugInjuryWatch.com)

In 2007 Aclasta (zoledronic acid 5mg) was approved by the FDA under the brand name Aclasta® Injection as the first and only once-yearly medicine for postmenopausal osteoporosis.  Aclasta is given as a once-yearly 15-minute intravenous (IV) infusion.

From this August 22, 2007 news article, "Aclasta Receives US FDA Approval As First And Only Once-Yearly Treatment For Women With Postmenopausal Osteoporosis", we get some background about the efficacy and safety information known at the time of FDA approval in 2007:

The US approval comes a few weeks after the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval for the medicine in the European Union. The European Medicines Agency (EMEA) generally follows the CHMP's recommendations and is expected to issue marketing authorisation within three months.

The regulatory submissions were based on efficacy and safety data from the three-year Pivotal Fracture Trial, which showed that Aclasta increases bone strength and reduces fractures in areas of the body typically affected by osteoporosis, including the hip, spine and non-spine (i.e. hip, wrist, arm, leg, rib). Aclasta is the only treatment proven to reduce fractures across all of these key sites.

Coming forward to the present time, on October 14, 2010 Health Canada issued a MedEffect e-Notice, "ACLASTA (zoledronic acid 5mg/100mL) solution for intravenous infusion - Association with renal dysfunction - Novartis Pharmaceuticals Canada Inc.", which provided this new safety information about Aclasta:

Novartis in collaboration with Health Canada, is notifying healthcare professionals and the public of reports of renal impairment and renal failure requiring dialysis or with fatal outcome that occurred in patients with history of renal impairment or other risk factors receiving ACLASTA (zoledronic acid).

The Health Canada web site also provided links to a so-called "Dear Doctor" letter about Aclasta sent by Novartis to Canadian health care professionals on or about October 12, 2010 and a public information page about this kidney / renal side effect alert intended for patients.

Reclast is the U.S. name for this zoledronic acid osteoporosis drug sold by Novartis; put otherwise, Reclast is identical to the Aclasta which Novartis sells in Canada.

We will be watching for a similar MedWatch Alert about Reclast from the FDA and/or a "Dear Doctor" letter from Novartis to American health care professionals about the 265 spontaneous reports of renal impairment -- ranging from renal dysfunction manifested as deterioration in renal function to acute renal failure, or kidney failure, requiring dialysis or resulting in death -- that prompted Health Canada to issue its Aclasta MedEffect e-Notice in mid-October 2010.

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YAZ And Yasmin MDL: First Trial In Federal Court Set By Judge Herndon To Start September 2011

A Pulmonary Embolism Bellwether Case Will Be Followed By Gallbladder And Venous Thromboembolic Lawsuit Trials

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE:  The January 9, 2012 Sims v. Bayer "bellwether", or test, trial has been postponed indefintely, and Judge David Herndon has ordered mediation for the entire Yasmin and YAZ MDL litigation in order to see if some or all of these federal court lawsuits can be settled. 

See:  CASE MANAGEMENT ORDER NUMBER 53 -- Regarding Bellwether Plan

(1/4/12)

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UPDATE:  Yasmin / YAZ MDL: First Trial Moved From September 2011 To January 2012 Per Plaintiffs' Request

(5/17/11)

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On October 13, 2010 Judge David Herndon, who is presiding over the federal court YAZ and Yasmin MDL, entered an Order which ended with this statement:

Having found that this litigation will benefit from the establishment of bellwether trials, the Court has set firm trial dates and means and method for selecting the cases for trials.

In more detail, AMENDED CASE MANAGEMENT ORDER NO. 24 -- BELLWETHER TRIAL SELECTION PLAN (PDF file) for IN RE YASMIN AND YAZ (DROSPIRENONE) MARKETING, SALES PRACTICES AND PRODUCTS LIABILITY LITIGATION -- MDL No. 2100 (3:09-md-02100-DRH-PMF) established three "early trial" dates, as seen below:

VI. TRIAL SELECTION

13. The first trial is set September 12, 2011. This will be a pulmonary embolism (PE) case.

14. The second trial is set January 9, 2012. This will be a gallbladder (GB) case.

15. The third trial is set April 2, 2012. This will be an additional thromboembolic (VTE) case.

This Amended Order No. 24 also shows how Judge Herndon changed his initial plan for the YAZ and Yasmin MDL bellwether cases following the October 2010 monthly status conference, where the Plaintiffs Steering Committee (PSC) "aired a number of issues which it takes with the original order", to use Judge Herndon's words.

Of particular interest is this part of Judge Herndon's Order concerning the bellwether trial selection plan:

III. SELECTION PROCESS

5. The pool of cases, with which discovery will be pursued, from which the bellwether trials will be drawn will consist of fifty (50) twenty-four (24) cases. This reduction in the number of cases should adequately address the Plaintiffs concerns regarding the ability to get the cases ready for trial. The Court does not accept the assertion from Plaintiffs that the only way to insure a list of cases that can be ready for trial is to let them control the list. Assuring true representative cases for a bellwether plan requires bipartisan input. Twenty-five (25) Twelve (12) Plaintiffs will be selected by each side, the PSC and Bayer Defendants.

Counsel discussed at length the nature of the alleged injuries pled in the complaints on file. While stroke and heart attack cases make up nine to ten percent of the cases, the parties have agreed not to include that group in the bellwether trials, in part, because those numbers pale in comparison to the other alleged ailments. Venus thromboembolisms (VTE) (which include pulmonary embolisms and deep vein thromboses) make up forty to forty-one percent; while gallbladder injuries account for the remaining forty-three percent of the alleged harms caused by the pharmaceuticals at issue. The Plaintiffs would have the Court put off the gallbladder cases until the end of the bellwether process in a second wave. The Court disagrees with that suggestion. Therefore, when the parties select this pool, equal numbers of venous cases and gallbladder cases should be chosen.

[NOTE: Striking through words and underscoring per the original; footnote omitted.]

Of course, this bellwether trial selection plan for the YAZ and Yasmin MDL is subject to further revision as this litigation develops further going forward.  We will watch for any changes to the trial dates for the first three federal court cases and let you know if that September 2011 gets re-scheduled for a later date.

Lastly, we want to point out that personal injury and wrongful death lawsuits involving serious side effects possibly due to the use of Ocella birth control pill, which contains drospirenone (DRSP) as its progestin component (just like YAZ and Yasmin), are part of this federal court MDL litigation, also.

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Aredia / Zometa Jaw Injury Lawsuit In New Jersey Ends In Defense Verdict For Novartis

This October 2010 New Jersey Trial Result Is In Stark Contrast To $3.2 Million Verdict In 2009 Montana Zometa Case

(Posted by Tom Lamb at DrugInjuryWatch.com)

In early October 2010 the New Jersey state court jury which heard the evidence in the case of Bessemer v. Novartis Pharmaceuticals Corp. found in favor of the Defendant and against Jane Bessemer, who alleged she developed osteonecrosis of the jaw (ONJ) as a result of using Aredia and, thereafter, Zometa, two bisphosphonate drugs made by Novartis.

More precisely, from this October 6, 2010 Bloomberg article, "Novartis Wins Trial Over Jaw Injury Blamed on Drugs":

By a 7-2 vote, the panel answered “No” to the question: “Did Novartis fail to provide an adequate warning to Mrs. Bessemer’s prescribing physician concerning the risks of jaw problems from Aredia and/or Zometa that Novartis either knew or should have known prior to Mrs. Bessemer discontinuing use of the drug(s)?”

At this Bessemer trial in New Jersey, which had started on September 23, the lawyer for Novartis made two primary arguments in defense of the drug company:

(1)  Novartis adequately warned Ms. Bessemer’s doctor of risks known at the time; and,

(2)  Ms. Bessemer's jaw condition was unrelated to her use of Aredia and Zometa but, instead, was caused by a bone infection known as osteomyelitis, and not ONJ.

It is unclear from the October 6 Bloomberg article, above, whether the jury voted on this second issue concerning "causation" or not.

The Bessemer case is the second Zometa products liability lawsuit that has gone to a jury verdict, but the first case ended quite differently with a $3.2 million Plaintiff's verdict back in October 2009.

That earlier Zometa trial was in a Montana state court and involved Peggy L. Stevens, who allegedly developed osteonecrosis of the jaw (ONJ) due to her use of Zometa and sued Novartis for failure to warn adequately about this serious jaw injury side effect.  The jury in that Montana case obviously came to a different determination on this "warning" issue than the New Jersey jury.

The October 6 Bloomberg article estimates that the Zometa / Aredia litigation currently consists of 550 lawsuits in the federal court MDL and about 150 lawsuits in the New Jersey state court "Mass Tort" consolidation pending in Middlesex County, NJ, where the Bessemer trial took place.

We will continue to monitor the Aredia and Zometa Products Liability Litigation (MDL No. 1760), pending in the Middle District of Tennessee, Nashville District, as well as the New Jersey state court cases, and will report significant developments here at Drug Injury Watch.

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