Drug Injury Watch

Yasmin / YAZ Litigation Update: 11,300 Lawsuits Have Been Served Upon Bayer As Of February 1, 2012

Bayer 2011 Annual Report: Settlement Agreements: 70 Cases Settled As of Mid-February 2012; Negotiations Will Continue On Case-by-Case Basis

(Posted by Tom Lamb at DrugInjuryWatch.com)

From February 1, 2011 to February 1, 2012 the number of lawsuits in the U.S. served upon Bayer involving side effects allegedly from the use of Bayer’s oral contraceptive products Yasmin™ and/or YAZ™ or from the use of Ocella™ and/or Gianvi™ has increased from 6,850 (source: Bayer Annual Report 2010) to 11,300.

From the Bayer Annual Report 2011, which was released earlier today (2/28/2012):

• As of February 1, 2012, there were about 11,300 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 product liability relating to Gianvi™ product supplied by Bayer.
• Plaintiffs seek compensatory and punitive damages, claiming, in particular, that Bayer knew, or should have known, of the alleged risks and should be held liable for having failed to disclose them or adequately warn users of Yasmin™ and / or YAZ™.
• As of February 13, 2012, Bayer had reached agreements, without admission of liability, to settle the claims of approximately 70 plaintiffs in the U.S. at terms and conditions which Bayer views to be reasonable. Bayer will continue to consider the option of settling individual lawsuits in the U.S. on a case-by-case basis.
• Additional lawsuits are anticipated.
• Bayer believes that it has meritorious defenses and will continue to defend itself vigorously against all claims that are not considered for settlement. Based on the information currently available, Bayer has taken appropriate accounting measures for anticipated defense costs and agreed settlements.
• In December 2011 the MDL court stayed the first case set for trial and ordered the parties to participate in a mediation process.
• However, going forward and depending on further developments of the Yasmin™/ YAZ™ litigation, it is possible that the company’s global liability insurance program may not be sufficient or fully applicable to cover all expenses and potential liability (if any) resulting from this litigation.

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The mediation process ordered by the Judge Herndon, who is presiding over the federal court YAZ / Yasmin multidistrict litigation (MDL) -- MDL No. 2100, IN RE: Yasmin and Yaz (Drospirenone) Marketing and Sales Practices and Products Liability Litigation, pending in the Southern District of Illinois -- is still ongoing as of this time.  Accordingly, we will withhold any commentary on what Bayer has stated in its Annual Report for 2011.

To see how this YAZ / Yasmin litigation has developed over time, we refer you to our earlier article, "YAZ / Yasmin / Ocella Litigation: February 2011 Update".

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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)

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UPDATE: During pretrial hearings Judge Higbee severed the Flores case from the Sessner case.  Opening statements for the Sessner case will take place Monday, March 5.  The Flores case will now go to trial in June 2012.

Further, Merck's Motion for Summary Judgment (MSJ) in the Sessner case was denied, meaning that this trial will proceed on the theories of failure to warn and design defect.

These two Orders by Judge Higbee were issued from the bench, the severance ruling on February 28 and the MDJ denial on February 29.

(3/1/12)

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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).

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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.

 

P.S.  Statement on FOSAMAX® (alendronate sodium) Product Liability Trial in New Jersey

WHITEHOUSE STATION, N.J., Feb. 27, 2012 - Merck, known outside the United States and Canada as MSD, will vigorously defend itself in a jury trial set to begin today in the Superior Court for Atlantic County, New Jersey.
 
Merck believes the evidence will show that FOSAMAX® (alendronate sodium) did not cause the two plaintiffs, whose cases are being tried together, to develop dental and jaw-related problems as they claim, and that the company provided appropriate and timely information about FOSAMAX to the medical, scientific and regulatory communities. In Flores v. Merck and Sessner v. Merck, the plaintiffs allege they used FOSAMAX and suffered various jaw problems and complications following multiple tooth extractions....

(2/27/12)
 
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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.

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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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