Drug Injury Watch

Fosamax Trial In New Jersey State Court Scheduled To Start Monday, February 27, 2012

The Flores Case And The Sessner Case Involve Incidents Of ONJ Jaw Injury, Not The Femur Fracture Side Effect

(Posted by Tom Lamb at DrugInjuryWatch.com)

The trial for two Fosamax lawsuits -- Jo Ann Sessner vs. Merck Sharp & Dohme Corp., ATL-L-3394-11 (MT) and Amelia Flores vs. Merck Sharp & Dohme Corp.,ATL-L-744-09 (MT) -- is scheduled to start in the Superior Court of New Jersey, Atlantic County, on February 27, 2012.  Judge Carol Higbee will be presiding over this NJ state court Fosamax trial.

According to her January 26, 2012 Case Mangagement Order (CMO), jury selection will begin on February 29, 2012 and opening statments will be on March 1, 2012.  As seen at the end of this January 26 CMO, Judge Higbee has set certain time limitations on opening statements (two hours for each side) and has also limited the amount of time that attorneys for the plaintiffs and the defendant will have to present their respective evidence as regards the Flores case and the Sessner case.

These Sessner and Flores Fosamax lawsuits in the New Jersey state court Mass Tort "consolidation" involve the serious jaw injury osteonecrosis of the jaw (ONJ).

As for what is going on in the federal court Fosamax MDL for ONJ jaw injury cases, in late 2011 United States District Court Judge Joseph F. Keenan established this trial schedule for 2012:

Boles v. Merck & Co., Inc., 06 Civ. 9455 (JFK), is set for trial on damages on March 26, 2012;

Jellema v. Merck & Co., Inc., 09 Civ. 4282 (JFK), is scheduled for trial on May 7, 2012; and,

Spano v. Merck & Co., Inc., 09 Civ. 6948 (JFK), is scheduled for trial on September 10, 2012.

About a month later, Judge Keenan issued a second Order in which he appointed John D. Feerick, Esq., Dean Emeritus of the Fordham University School of Law, as the Special Settlement Master for the entire Fosamax ONJ MDL litigation.

More details about those developments can be found in our earlier article, "Fosamax Osteonecrosis Of The Jaw (ONJ) Federal Court MDL Litigation: A Mixed Forecast For 2012".

Returning to the New Jersey Fosamax litigation, we will be monitoring the Sessner / Flores ONJ jaw injury trial and report its outcome here as soon as it becomes available.

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Yasmin / Safyral / Beyaz: February 2012 Label Change Non-Specific To These Bayer Birth Control Pills

Same General Warning About All COCs Was Added To YAZ In March 2011; And Why The One Year Delay, We Wonder

(Posted by Tom Lamb at DrugInjuryWatch.com)

The February 14, 2012 email captioned "What's New on the FDA Drugs Site" let us know that there was a new version of the Package Insert for Yasmin, Safyral, and Beyaz which consisted of four new sentences being added to the WARNINGS AND PRECAUTIONS section:

5.1 Thromboembolic Disorders and Other Vascular Problems

... The risk of VTE in women using [combined oral contraceptives (COCs)] has been estimated to be 3 to 9 per 10,000 woman-years. The risk of VTE is highest during the first year of use. Data from a large, prospective cohort safety study of various COCs suggest that this increased risk, as compared to that in non-COC users, is greatest during the first 6 months of COC use. Data from this safety study indicate that the greatest risk of VTE is present after initially starting a COC or restarting (following a 4 week or greater pill-free interval) the same or a different COC.

Source: Yasmin Package Insert (Revised 2/2012)

As you can see, there is nothing specific in this new warning about Yasmin, Safyral, nor Beyaz.

Moreover, this very same change was made to the YAZ label in March 2011, almost a full year ago, something we wrote about in this earlier article, "Another Rather "Odd" YAZ Label Change By Bayer: March 2011":

The bottom line is this:  There is nothing specific about YAZ in the new warning language added to the YAZ label by Bayer in March 2011.   Instead, these new warnings pertain to ALL combined oral contraceptives (COCs), or birth control pills.

Moreover, one expects a similar "odd" label change will be done for the several other Bayer birth control pills which contain drospirenone (DRSP) and ethinyl estradiol (EE), namely Yasmin, Safyral, and Beyaz -- while, again, stating nothing that is specific to each.

Well, that label change for Yasmin, Safyral, and Beyaz is finally here and, like the warning added in March 2011 to YAZ, it is odd that this new warning is non-specific to these particular Bayer birth control pills.  

Lastly, what took Bayer and the FDA so long to make this simple label change...?

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Pradaxa: Excess Number Of Severe Bleeding Events In Certain Patient Populations And Settings

At Increased Risk Are Patients Who Are Older, Have Altered Renal Clearance, Or Undergoing Atrial Fibrillation (AF) Ablation

(Posted by Tom Lamb at DrugInjuryWatch.com)

We first reported about Pradaxa (dabigatran) back in October 2011 in this article "New Heart Drug Pradaxa May Be Sending "Early" Drug Safety Signals".

Our source back then and now, for this 2012 update, is the ISMP Quarterwatch publication, which monitors FDA MedWatch Reports for emerging drug safety issues.

From the ISMP Quarterwatch 2011 Quarter 1 edition, which was published January 12, 2012, we get this summary of what has been reported to the FDA as regards the "substantial bleeding risks" associated with Pradaxa:

[Pradaxa] accounted for 505 reported cases of severe bleeding resulting in death, disability, hospitalization or other serious outcome in the first quarter—more than any other drug we regularly monitor. The hemorrhage cases were occurring in the oldest patients with a median age of 80, and 25% of patients experiencing hemorrhage were 84 years or older, raising the question of whether the oldest patients are getting too high a dose.

In particular, gastrointestinal hemorrhages and hemorrhagic strokes were identified as some of these serious side effects in this elderly patients using Pradaxa.

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Returning to the January 2012 ISMP Quarterwatch report:

Declining or impaired kidney function—which also occurs in older patients—is a second and potentially related safety issue associated with possible overdose and bleeding. In pharmacologic studies of dabigatran, patients with mild kidney impairment had dabigatran blood levels that were 50% higher than patients with normal kidney function, and moderately impaired kidney function could result in blood levels that were three times higher.

We turn next to a February 8, 2012 article, "More bleeding, thromboembolic events with dabigatran in AF ablation", published online at theheart.org:

A feasibility study testing the potential periprocedural use of [Pradaxa] during radiofrequency ablation of atrial fibrillation (AF) has shown the new anticoagulant increases the risk of bleeding or thromboembolic complications compared with uninterrupted warfarin therapy....

"The lack of any recommended acute reversal agents for dabigatran, at present, makes the risk of excessive bleeding complications all the more important," write [Dr Dhanunjaya Lakkireddy] and colleagues in their report, published online February 1, 2012 in the Journal of the American College of Cardiology ["Feasibility and safety of dabigatran versus warfarin for periprocedural anticoagulation in patients undergoing radiofrequency ablation for atrial fibrillation"].

Of course, we will continue to watch for further developments regarding the safety of this relatively new anticoagulant drug Pradaxa, especially those involving the serious bleeding events that have been reported to the FDA.

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Gianvi Lawsuits Against The Drug Companies Still Possible After 2011 Supreme Court Preemption Ruling Re: Generic Drug Injury Lawsuits

Reason Is That Bayer Has Been Supplying Teva And Barr With The Product For Their Gianvi Pills Since December 2010 (Agreement Is Similar To Ocella Deal)

(Posted by Tom Lamb at DrugInjuryWatch.com)

Gianvi, a generic version of YAZ, is marketed by Teva Pharmaceuticals and Barr Laboratories, which are commonly referred to as generic drug companies.  Likewise, Ocella is a generic version of Yasmin that is sold by Teva and Barr.

Unfortunately, most women who used the Gianvi birth control pills and suffered a pulmonary embolism (PE), deep vein thrombosis (DVT), stroke (CVA), or heart attack (MI) have heard from lawyers and others that they cannot file any personal injury (or wrongful death) lawsuit against these generic drug companies because of a legal defense called "federal preemption".

In more detail, the Pliva, Inc., et al. v. Mensing case was decided by the Supreme Court of the United States (SCOTUS) on June 23, 2011.  Justice Clarence Thomas delivered the majority opinion of the Court, concluding that federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus pre-empt, state law claims (see pp. 4 to 14 and pp. 17 to 20 of the Pliva v. Mensing opinion).

The bottom line is that the US Supreme Court ruled in favor of the generic drug company and against the injured patient such that at the present time any "failure to warn" lawsuit involving a generic drug would be dismissed based on this Mensing case ruling.

It turns out, however, that there may still be a legal claim available for some women who experienced a serious Gianvi side effect because Bayer has been manufacturing the Gianvi birth control pills for Barr and Bayer may share some of the legal liability for drug injury lawsuits involving Gianvi, as seen below.  This is similar to the arrangement that Bayer has with Teva and Barr with regard to Ocella, which Bayer makes for those generic drug companies, also.

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The following information comes from the Bayer Annual Report for 2010 (last updated: February 28, 2011):

• In June 2010, Teva announced that it had commercially launched Gianvi™, a generic version of YAZ™, in the United States. Litigation between Bayer and Teva/Barr in several U.S. federal courts on infringement of certain of Bayer’s patents by the distribution of Gianvi™ was settled in December 2010.  ...and Bayer has supplied Barr with the product for Gianvi™ since December 2010.
• As of February 1, 2011, there were about 6,850 lawsuits pending in the United States served upon Bayer on behalf of persons alleged to have suffered personal injuries, some of them fatal, from the use of Bayer’s oral contraceptive products Yasmin™ and/or YAZ™ or from the use of Ocella™ and/or Gianvi™, generic versions of Yasmin™ and YAZ™, respectively, marketed by Barr Laboratories, Inc. in the United States....  Pursuant to agreements in 2008 and 2010, Bayer manages product liability litigation for Ocella™ and Gianvi™, Bayer retains product liability for Ocella™ product supplied by Bayer with certain exceptions, and the parties have allocated potential future product liability relating to Gianvi™ product supplied by Bayer.

This arrangement whereby Bayer is manufacturing the Gianvi for Teva can also be seen in the Package Insert, or drug label, for Gianvi (accessed 2/6/2012).

We have been investigating possible Gianvi cases for women who developed serious blood clot side effects like a PE or DVT since this generic version of YAZ first came on the market in June 2010 and we represent numerous individuals for their intended Gianvi lawsuits.

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Pneumonia Trial Of Janssen / J&J Antibiotic Doribax Was Stopped In May 2011 -- We Learn From The FDA In January 2012

"Significant Safety Concern": Higher Death Rate For Doribax In Ventilator-Associated Pneumonia When Compared To Patients Receiving Imipenem Therapy

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE: "Doribax (doripenem for injection) - Higher Mortality Rate and a Lower Clinical Cure Rate Observed During a Comparative Clinical Trial - Notice to Hospitals"  [Health Canada, 1/31/12]

The product monograph for Doribax will be updated to reflect findings from a study showing a higher mortality rate and a lower cure rate among patients taking Doribax 1g every 8 hours in a fixed 7-day course as compared to those taking a fixed 10-day course of imipenem-cilastatin....

(1/31/12)

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On January 5, 2012 the FDA issued a drug safety alert about the antibiotic Doribax, from the Janssen division of Johnson & Johnson (J&J), that that provided us this information:

The U.S. Food and Drug Administration (FDA) is informing the public that a recent clinical trial with Doribax (doripenem) was stopped early because of significant safety concerns. This trial, which was evaluating the effects of Doribax on treatment of patients with ventilator-associated pneumonia, demonstrated excess mortality and a numerically poorer clinical cure rate among subjects treated with Doribax compared to those treated with imipenem-cilastatin. FDA is reviewing the trial results and will communicate any new information that results from this investigation.

Source: "FDA Statement on recently terminated clinical trial with Doribax (doripenem) Safety Announcement"

This January 2012 FDA Statement also said that Janssen is issuing a so-called "Dear Doctor" letter about this Doribax - pneumonia clinical trial.

Doribax is approved for urinary and abdominal infections in the U.S. but not for any type of pneumonia.  However, in Europe Doribax use is approved for ventilator-associated pneumonia and the stopped study was being conducted to fulfill a post-marketing commitment from Janssen / J&J to the European Medicines Agency (EMA).

We learned from this January 6, 2012 Dow Jones Newswire article, "Trial Of J&J Antibiotic Stopped Early On Safety Concerns", that, in fact, there had been a seven-month delay between the time when the Doribax - pneumonia clinical trial was stopped and when the FDA issued its January 2012 safety alert:

After 28 days from the start of treatment, 21.5% of patients who received Doribax had died, compared with 14.8% of patients in the imipenem group, according to the FDA. Also, Doribax was associated with lower cure rates than the imipenem group, the FDA said....

J&J spokesman Shaun Mickus said the company terminated the trial in May 2011 based on the recommendation of an independent data monitoring committee.

Mickus said J&J notified the FDA, global health regulators and study investigators promptly in May 2011 about the interim findings. The company had additional discussions in the ensuing months, and a more complete data analysis was only recently completed, Mickus said.

We also learned from that same Dow Jones article, by reporter Peter Loftus:

J&J, New Brunswick, N.J., previously applied for FDA approval to market Doribax for treatment of hospital-acquired pneumonia, including ventilator-associated pneumonia, but the FDA has declined to approve the application.

We are not currently aware of when the EMA first alerted the public in Europe about this emerging safety issue concerning Doribax nor whether any regulatory action has been undertaken by the EMA to withdraw its previous approval for Doribax use in patients with ventilator-associated pneumonia.

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YAZ / Yasmin January 2012 Update: Minutes And Transcripts For FDA Advisory Committees 2011 Meeting Now Available Online (And More)

11 Of The 26 FDA Panel Members Voted There Were No Sufficient Unique Benefits For YAZ / Yasmin That Cannot Be Found In Other Hormonal Contraceptives

(Posted by Tom Lamb at DrugInjuryWatch.com)

On December 8, 2011 the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee held a joint meeting to discuss YAZ and Yasmin as well as several other relatively new birth control pills.

In more detail, from the Summary Minutes of this YAZ / Yasmin December 2011 FDA meeting:

Issues: The committees discussed the benefits and risks of drospirenone-containing oral contraceptives in light of the emerging safety concern that the risk of venous thromboembolism (blood clots that can break loose and move within the circulatory system) associated with use of these products may be higher compared to oral contraceptives that contain the progestin, levonorgestrel. Drospirenone-containing oral contraceptives for the primary indication of pregnancy prevention include: YASMIN, YAZ (drospirenone/ethinyl estradiol tablets), BEYAZ, SAFYRAL (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets), Bayer HealthCare, and the generic equivalents for these products.

Of most interest to many observers is the following information for Item #4 of the Questions to the Committee, which we get from the Minutes:

VOTE: Do you believe that, in the general population of women who desire contraception, the benefits of the DRSP-containing oral contraceptives for prevention of pregnancy outweigh their risks?

a. If not, are there subpopulations of women for whom the risk/benefit profile would be favorable?

Yes: 15         No: 11         Abstain: 0

Overall summary comments from those who voted “Yes” included:

a. The small elevation in risk is outweighed by the risk of pregnancy.

b. The data was not sufficient in regards to defining the risk.

c. The committee expressed concern with decreasing availability of a contraceptive that provides effective prevention of pregnancy.

 

Overall summary comments from those who voted “No” included:

a. There are not sufficient unique benefits for DRSP-containing OCPs that cannot be provided by other hormonal contraceptives.

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For more information about this critical vote and what else went on during the full-day long December 2011 FDA YAZ / Yasmin meeting, see: "Transcript for the December 8, 2011 Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee"  (PDF: 440 pages - 762KB).

Of course, in more recent weeks the attention has gone from the voting results to certain advisory panel members whom did the voting:

• POGO Letter: FDA Advisors on Yaz and Yasmin Have Industry Ties (1/11/12, Project on Government Oversight)
• The Yaz Men: Members of FDA panel reviewing the risks of popular Bayer contraceptive had industry ties (1/9/12, The Washington Monthly)

Meanwhile, as regards the federal court YAZ / Yasmin MDL litigation, on December 31, 2011 Judge David Herndon postponed the first bellwether, or test, case trial which was scheduled to start on January 9, 2012 and ordered mediation to explore possible settlement of the MDL lawsuits.

Of course, we will continue to monitor all the various goings-on concerning YAZ, Yasmin, and the several other birth control pills containing dropsirenone (DRSP).

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Safety Profile Of New Stroke Drug Pradaxa Has Been Tarnished By Various Adverse Event Reports

FDA Reviewing Serious Side Effects Associated With Pradaxa Ranging From Heart Attacks To Serious Bleeding or Hemorrhages

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE:  Pradaxa label change: This January 17, 2012 FDA approval letter shows the revisions being made to current label.

(1/19/12)

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Patients who use the new stroke drug Pradaxa (dabigatran) have slightly increased risks for heart attack, or myocardial infarction (MI), and acute coronary syndrome (ACS) relative to those patients who used another anticoagulant medication warfarin or a placebo, according to new study report published in early January 2012 by the Archives of Internal Medicine.

As reported by Jennifer Corbett Dooren in her January 10, 2012 Wall Street Journal (WSJ) article, "Study Finds Risk in New Stroke Drug":

The original Pradaxa study the company used to gain FDA approval suggested a small increased risk of heart attack with the use of the drug compared to warfarin. Researchers since then have been trying to figure out whether there's really an increased risk. The study found the drug cut the risk of strokes by 35%.

According to an analysis by two Cleveland Clinic researchers published online in the Archives of Internal Medicine, Pradaxa boosted the risk of a heart attack and a condition known as acute coronary syndrome by 33%....

The study's lead researcher Ken Uchino, a Cleveland Clinic neurologist, said the actual increase in the number of heart attacks and acute coronary syndrome events was very small and is outweighed by the benefit of the drug's ability to reduce the number of strokes.... Dr. Uchino and other researchers called for more study of the drug's potential to increase heart-attack risk.

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As regards what weight should be given this latest Pradaxa medical journal article, we turn to another January 10 news report, "Blood-thinning drug Pradaxa is linked to heart attack risk":

... Dr. Jeremy M. Jacobs, a senior physician at Hadassah Hebrew University Medical Center in Jerusalem, said doctors should ratchet down their enthusiasm for dabigatran until more research can be done to clarify the potential heart attack risk.

"I think caution is needed especially among patients with known active ischemic heart disease," said Jacobs, who co-wrote an editorial published with the report.

Recent history has taught medical professionals that the full effects of a new medication may not be apparent until it is in widespread use - sometimes years after FDA approval, Jacobs noted. For example, the painkiller Vioxx was on the market for almost five years before it became clear that it was associated with an increased risk of heart attacks and strokes; it was withdrawn in 2004.

As regards other types of adverse event reports concerning Pradaxa, we refer you to these two relatively recent Drug Injury Watch articles:

• "Pradaxa: FDA Investigating Possible Higher Than Expected Incident Rate Of Serious Bleeding Side Effects"  (December 15, 2011); and,
• "New Heart Drug Pradaxa May Be Sending "Early" Drug Safety Signals"  (October 13, 2011).

We will continue to monitor the safety of Pradaxa and report what the FDA determines following its current review of the Adverse Event Reports (AERs) which the agency has received to date.

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Prescription Drug Medication Errors Can Be Prevented By Taking Some Common Sense Precautions

Ten Strategies Intended For Pharmacists Can Help Patients Stay Safe, Also

(Posted by Tom Lamb at DrugInjuryWatch.com)

It is relatively well-accepted in the healthcare community that medication errors involving prescription drugs happen more often than they should but the incident rate could be reduced if both pharmacists and patients took certain precautions.

The following set of precautions, from the an article "Pharmacy Dispensing Mistakes: 10 Strategies for Minimizing Dispensing Errors" that was published online by Pharmacy Times a couple of years ago, is intended for pharmacists but includes some points that can be helpful to patients.

Before we get to the list of ten ways that pharmacists might reduce the risk of causing or contributing to medication errors, here is some background about the problem generally from this Pharmacy Times article:

Dispensing errors include any inconsistencies or deviations from the prescription order, such as dispensing the incorrect drug, dose, dosage form, wrong quantity, or inappropriate, incorrect, or inadequate labeling. Also, confusing or inadequate directions for use, incorrect or inappropriate preparation, packaging, or storage of medication prior to dispensing are considered to be errors. Errors occur at a rate of 4 per day in a pharmacy filling 250 prescriptions daily, which amounts to an estimated 51.5 million errors out of 3 billion prescriptions filled annually nationwide.  [footnotes omitted]

Now, here is the list of strategies for pharmacists to adopt in order to reduce the risk of causing a patient possible harm by means of a medication error:

1. Ensure correct entry of the prescription.

2. Confirm that the prescription is correct and complete.

3. Beware of look-alike, soundalike drugs.

4. Be careful with zeros and abbreviations.

5. Organize the workplace.

6. Reduce distraction when possible.

7. Focus on reducing stress and balancing heavy workloads.

8. Take the time to store drugs properly.

9. Thoroughly check all prescriptions.

10. Always provide thorough patient counseling.

This last point is especially important and, for the reasons set forth below, it is unfortunate that many patients are in too much of a hurry to take advantage of this service which is routinely offered and declined daily in pharmacies large and small.

Approximately 83% of errors are discovered during counseling and are corrected before the patient leaves the pharmacy. Therefore, it is important to go beyond offering to counsel and provide counseling for each patient. It is considered good practice to open the container and show the actual medication to the patient during counseling rather than deliver it to the patient in a sealed bag. Completing this process will provide an opportunity for the patient to see the medication and ask questions if it looks different from what he or she has been taking. Counseling should also include the instructions on how to take the medication and appropriate route of administration. Many dispensing errors are attributed to misunderstood directions for use. Educating patients about safe and effective use of their medication promotes patient involvement in their health care, which will likely reduce medication errors.  [footnotes omitted]

In closing -- and this is the real take-away point for patients as regards the above list of prescription drug safety strategies -- while it may take a few more moments before leaving the pharmacy, one should always take advantage of the pharmacist-patient counseling session as the best final precaution for preventing possible harm from medication errors.

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Fosamax Osteonecrosis Of The Jaw (ONJ) Federal Court MDL Litigation: A Mixed Forecast For 2012

Three More Lawsuits (Boles, Jellema, and Spano) Set For Trial, And A Special Master Appointed To Conduct Settlement Talks

(Posted by Tom Lamb at DrugInjuryWatch.com)

There are currently more than 900 Fosamax lawsuits pending against defendant Merck Sharp & Dohme Corp. (“Merck”) in the federal court multidistrict litigation (MDL) concerning the osteonecrosis of the jaw (ONJ) and other jaw injury side effects.

In the fourth quarter of 2011 United States District Court Judge Joseph F. Keenan, who is presiding over IN RE: FOSAMAX PRODUCTS LIABILITY LITIGATION, MDL No. 1789 (Southern District of New York), issued two Orders that provided a somewhat mixed forecast for what will be taking place in 2012 as regards this particular Fosamax MDL -- as opposed to a separate Fosamax MDL having to do with femur fractures as the alleged side effect (see NOTE, below).

First, in October 2011 Judge Keenan established the Fosamax - jaw injury / ONJ trial schedule for 2012:

• Boles v. Merck & Co., Inc., 06 Civ. 9455 (JFK), is set for trial on damages on March 26, 2012;
• Jellema v. Merck & Co., Inc., 09 Civ. 4282 (JFK), is scheduled for trial on May 7, 2012; and,
• Spano v. Merck & Co., Inc., 09 Civ. 6948 (JFK), is scheduled for trial on September 10, 2012.

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Further, in the October 20, 2011 Order by Judge Keenan -- when declining the requests of both plaintiff and defense counsel to select a replacement case for the Raber bellwether trial that was suppose to have started on November 7, 2011 (but did not proceed as scheduled after this claimant informed the Court that she would not appear for trial) -- we find this observation from Judge Keenan about the current litigation status of this Fosamax - ONJ MDL litigation:

A range of issues common to cases that comprised the original pool twenty-five cases selected for discovery have now been litigated in several cases tried to verdict (Boles, Maley, Graves, and Secrest) and one dispositive summary judgment motion (Flemings). Additionally, the Court will be trying Boles for a third time on March 26, 2012, to determine damages. Therefore, the Court will not replace Raber with any case, and instead the next stage of the Fosamax MDL will concern two cases presenting novel legal and factual issues: [Spano and Jellema].

About a month later Judge Keenan issued a second Order in which he appointed John D. Feerick, Esq., Dean Emeritus of the Fordham University School of Law, as the Special Settlement Master.  From the November 22, 2011 Order by Judge Keenan:

During the past year, the Court has discussed with the parties to this multidistrict litigation the possibility of appointing a special master to conduct settlement discussions of the over 900 cases in this docket....

As Special Settlement Master, Mr. Feerick is authorized to conduct any proceedings permissible under [Federal Rules of Civil Procedures] Rule 53 that are necessary to resolve all or any part of this multidistrict litigation in a fair and efficient manner.

So it appears, from the additional Fosamax trial settings in combination with the initiation of Fosamax settlement discussions presided over by Special Master Feerick, that this federal court Fosamax MDL concerning jaw injury side effects, principally osteonecrosis of the jaw (ONJ), is headed to some type of conclusion during 2012 or soon thereafter.

Stay tuned for further developments as regards these Fosamax lawsuits next year....

NOTE:  All pending Fosamax femur fracture cases filed in the federal court system were transferred in May 2011 to the District of New Jersey and assigned to the Honorable Garrett E. Brown, Jr., for coordinated or consolidated pretrial proceedings. This second Fosamax multidistrict litigation (MDL) case is IN RE: FOSAMAX (ALENDRONATE SODIUM) PRODUCTS LIABILITY LITIGATION (NO. II), MDL No. 2243.

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Women Who Use Bisphosphonates Like Fosamax And Boniva Have Increased Risk Of Femur Fracture / Thigh Bone Breaks

December 2011: Some Recent Medical Studies About These Bisphosphonate-Related Subtorchanteric Or Atypical Femoral Fractures

(Posted by Tom Lamb at DrugInjuryWatch.com)

Here are some recent reports about medical studies concerning the association, or link, between bisphosphonate drugs such as Fosamax and Boniva that are used to treat osteoporosis and the risk of a rare but serious type of thigh bone fracture known as an "atypical femur fracture."

(1)  "Older women who use bisphosphonate for longer than 5 years may have increased odds of a subtrochanteric or femoral shaft fracture, but absolute risk is low" (full text), from the Evidence Based Medicine medical journal;

(2)  "Are Screening Radiographs Necessary to Detect Incomplete Atypical Femoral Fractures in Asymptomatic Patients on Long-term Bisphosphonate Therapy?" (Abstract, found at page 64 of 215 page PDF -- large file), presented at the Radiological Society of North America's 2011 annual meeting;

(3)  "Classification of Hip, Femur, and Atypical Femur Fractures in a Contemporary Population of Older Women"  (Abstract, found at page 64 of 215 page PDF -- large file), presented at the Radiological Society of North America's 2011 annual meeting.

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For some background about this significant but still-developing drug safety issue, we refer you to some of our past articles, here, about how Fosamax, Boniva, and various other bisphosphonate drugs have been linked to atypical, or low stress, femur fractures in women:

How One Might Determine Whether The Femur Fracture Is Related To A Bisphosphonate Such As Fosamax

 

September 2011: Two FDA Advisory Committees Will Discuss The Safety Of Long-Term Use Of Fosamax, Boniva, And Actonel

Fosamax: Femur Fractures And Osteonecrosis Of Jaw: Medical Journal Articles: May 2011 Update

 

Thigh Bone Leg Fractures In Older Women Using Fosamax, Boniva, Or Reclast For Five Years Or More

 

We will continue to monitor the medical literature for new information pertaining to bisphosphonate-related femur fractures and report significant developments.

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