Drug Injury Watch

Pradaxa: February 2013 Update: Federal Court MDL Litigation Now Involves About 200 Lawsuits

This Number Of Pradaxa Cases Is About Ten Times What It Was When The Pradaxa MDL Was Created And Assigned To Judge Herndon In August 2012

(Posted by Tom Lamb at DrugInjuryWatch.com)

As we reported previously in "Increasing Number Of Pradaxa Lawsuits Against Boehringer Are Consolidated In Federal Court MDL":

On August 8, 2012 the United States Judicial Panel on Multidistrict Litigation (JPML) issued an Order(PDF) which consolidated all federal court Pradaxa drug injury lawsuits into the following case: IN RE: PRADAXA (DABIGATRAN ETEXILATE) PRODUCTS LIABILITY LITIGATION, MDL No. 2385.

This federal court Pradaxa MDL is situated in the United States District Court for the Southern District of Illinois, with Chief Judge David R. Herndon presiding over the litigation.

In August when this MDL was created for all Pradaxa lawsuits which had been filed in the federal court system as of that point in time, there were only 21 cases.

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As of February 1, 2013, about six months later, there are 199 Pradaxa drug injury cases that have been transferred to or filed directly in the Southern District of Illinois and made part of this Pradaxa MDL litigation.

The next Pradaxa MDL Status Conference before Judge Herndon is scheduled for February 7, 2013 at the East St. Louis Courthouse located in East St. Louis, IL.

To learn more about the safety problems associated with Pradaxa as well as the types of Pradaxa cases that are getting filed as lawsuits, you can visit the Pradaxa Information page over at our Drug Injury Law web site.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free & Confidential  (Review done by attorney Tom Lamb)

"Selling Sickness 2013" Conference In February Will Focus On Various Aspects Of Pharmaceutical Industry

Academic Medical Reformers, Consumer Activists, Health Journalists, And Others Will Gather In Washington, DC To Discuss Big Pharma Conduct and Practices

(Posted by Tom Lamb at DrugInjuryWatch.com)

I want to let you know about an event we will covering next month that should be of great interest to many of you: Selling Sickness 2013 - People Before Profits.

This conference about the pharmaceutical drug industry, with a focus on several different facets of its conduct and practices, will be held in Washington, DC, during February 21-22, 2013.  Its origins and purpose are described on the SellingSickness.com website as follows:

First, there was the 2006 Inaugural Congress on Disease Mongering in Australia which marked a watershed in networking among health care reformers and drug industry critics.  Then, the 2010 Selling Sickness conference in Amsterdam expanded the network and updated the work. Now, Selling Sickness 2013: People before Profits is coming to Washington, DC in February, 2013 to continue the challenge and the international networking.

This conference will bring together academic medical reformers, consumer activists, and health journalists to examine the current scope of disease mongering and to develop strategies and coalitions for change. Topics will include misleading marketing, journalistic standards, over-treatment, over-diagnosis, whistleblowers, new roles for advocates, pharmacovigilance, clinical trials, activist narratives, new conflict of interest areas, evidence-based screening, igniting citizen outrage, and more.

For those interested learning more about this Selling Sickness 2013 event:

• Organizers and Steering Committee
• Schedule for 2/21/13 and 2/22/13
• Speakers at Conference

I am scheduled to attend this conference next month and, afterward, there will be a report posted here about what transpired during these two days in DC. 

Lastly, if you are going to be at this Selling Sickness 2013 conference and would like to meet in person, please feel free to send me an email in advance of the event so that I can look for you there. ______________________________________________________________________________

DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects  (All website content by attorney Tom Lamb)

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Atypical Femur Fractures: Due To Fosamax Or A Bisphosphonates Drug Class Side Effect?

Is The Fact That Fosamax Has Been The Most Prescribed -- More Often Than Actonel, Aredia, Boniva, Etc. -- Blurring The Answer To This Drug-Safety Issue?

(Posted by Tom Lamb at DrugInjuryWatch.com)

In June 2012 the (then) Archives of Internal Medicine published an article "Atypical Femoral Fractures Associated With Bisphosphonate Use", which has raised the issue of whether this femur bone break is a side effect specific to Fosamax (alendronate) and, perhaps, Aredia (pamidronate) or whether it is an adverse event for all bisphosphonate drugs, i.e., class effect.

This drug-safety issue concerning Fosamax-related atypical femur fractures is discussed in the January 14, 2013 edition of the medical journal JAMA Internal Medicine (formerly Archives of Internal Medicine). From the Editor's Correspondence section, we start with "Are Bisphosphonates Associated With an Increased Risk of Atypical Femoral Fractures as a Class?", which makes the inquiry whether the authors of that June 2012 bisphosphonate femoral fracture study article failed to distinguish between the increased risk which could be attributed to the several different bisphosphonate drugs.  This January 2013 letter by Michael Pazianas, MD, seems to base its inquiry on this point:

It is now well recognized that individual bisphosphonates differ in their pharmacological properties.  [The authors of the June 2012 article], however, conclude that the use of bisphosphonates (as a class) is associated with an increased risk of atypical fractures, despite the fact that in Table 1 of their article, most of the listed atypical fractures occurred in [Fosamax (alendronate)] users.

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In turn, the authors of that June 2012 article -- Raphael P. H. Meier, MD; Rene Rizzoli, MD; Robin E. Peter, MD -- address this new inquiry in their piece, "Are Bisphosphonates Associated With an Increased Risk of Atypical Femoral Fractures as a Class?—Reply":

We agree that bisphosphonates differ in their pharmacological proprieties and should therefore be individually analyzed, particularly when looking at their potential adverse effects. In our study, [Fosamax (alendronate)] and [Aredia (pamidronate)] use was associated with significantly higher odds ratios (ORs) for atypical fractures compared with the classic fracture group, with ORs of 44.7 (95% CI, 19.9-100.3) and 18.2 (95% CI, 2.9-112.3), respectively. Both [Actonel (risedronate)] and [Boniva (ibandronate)] were associated with a nonsignificant OR of 5.7 (95% CI, 0.5-64.7). Nevertheless, the 95% confidence intervals are wide, and it is therefore not possible to classify these agents according to this adverse effect. Regarding [Didronel (etidronate)] and [Zometa (zoledronic acid)], ORs could not be calculated because there were no patients treated with these agents in the atypical fracture group. Therefore, on the basis of our results, we cannot conclude that there is a potential risk of atypical fractures with [Actonel (risedronate)], [Boniva (ibandronate)], [Didronel (etidronate)], and [Zometa (zoledronic acid)] use, likely owing to a lack of statistical power. Indeed, these drugs were prescribed far less often than alendronate. However, some evidence is available in the literature....   [Footnote omitted]

In fact, here, we have heard from women who used Actonel, Boniva, and Fosamax (alone or is some sequential combination) for five years, at least, that have been diagnosed with single leg or bilateral low-stress atypical femur fractures -- albeit this is not the basis for a medical or scientific determination as regards this controversial and still developing drug-safety issue.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects  (All website content by attorney Tom Lamb)

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January 2013 Fosamax Federal Court MDL Trial: Scheinberg vs. Merck: ONJ / Jaw Injury Case

This May Be The Final Bellwether Case Trial For IN RE: FOSAMAX PRODUCTS LIABILITY LITIGATION, MDL No. 1789

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE: This just in: $285,000 plaintiff verdict on failure to warn cause of action.

Merck hit with $285,000 verdict in Fosamax trial  (2/5/13, Reuters)

(2/5/13)

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The trial of RHODA E. SCHEINBERG, Plaintiff, vs. MERCK & CO., INC., Defendant, Civil Action No.: 1:08-cv-4119, is scheduled to start on January 14, 2013 in the United States District Court for the Southern District of New York ("SDNY")

United States District Court Judge Joseph F. Keenan, who is presiding over IN RE: FOSAMAX PRODUCTS LIABILITY LITIGATION, MDL No. 1789 (SDNY), will be the judge for what may be the final bellwether case trial in this so-called Fosamax - ONJ / Jaw Injury MDL.

Before proceeding, we point out that all pending Fosamax femur fracture cases filed in the federal court system were transferred in May 2011 to the District of New Jersey for coordinated or consolidated pretrial proceedings. This second / separate Fosamax multidistrict litigation (MDL) case is IN RE: FOSAMAX (ALENDRONATE SODIUM) PRODUCTS LIABILITY LITIGATION (NO. II), MDL No. 2243.

As background, in February 2011 Judge Keenan ordered that there will be two additional bellwether trials conducted in this Fosamax MDL. As seen below, on March 28, 2012 Judge Keenan selected Scheinberg v. Merck as the next Fosamax case to be tried and set the trial date for January 14, 2013.

According to the May 1, 2008 Complaint filed for the Scheinberg case, Plaintiff Rhoda Scheinberg "used FOSAMAX from approximately October 25, 2000 through approximately September 2006." The Complaint goes on to allege that:

As a result of the defective nature of FOSAMAX, persons who were prescribed and ingested FOSAMAX, including Plaintiff RHODA E. SCHEINBERG, have suffered and may continue to suffer severe and permanent personal injuries to the jaw bone, including osteonecrosis of the jaw and other diagnoses of irreversible damage to the jaw.

Osteonecrosis of the jaw, often referred to as "ONJ", is a serious medical event and ONJ can result in severe disability for those who develop this painful condition.

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Notably, the Scheinberg lawsuit is the only federal court Fosamax MDL ONJ case currently set for trial.

Going back to the February 2011 Order by Judge Keenan:

The Court believes it is necessary to conduct two additional bellwether trials involving issues not yet litigated, before considering remand of the MDL to the transferror courts.... One case must involve Fosamax use beginning before the July 2005 label change with a claimed onset of injury after the July 2005 label change. The other case must involve commencement of Fosamax use and a claimed injury date that both post-date the July 2005 label change. [emphasis added]

As indicated above, the Scheinberg trial fits into the first category, with this plaintiff having started her Fosamax use in October 2000.

In a March 29, 2012 Order, however, Judge Keenan later cast some doubt on whether there would be another Fosamax - ONJ trial after the Scheinberg case:

The Court has previously discussed with the parties the Court's belief that at least one additional bellwether trial should be conducted prior to any consideration of a motion to remand to the transferor courts, to address issues arising in cases where the alleged injury date is after the July 2005 change in the Fosamax label....

On March 28, 2012, in open court, Scheinberg v. Merck & Co., Inc., No. 08 Civ. 4119 (JFK) , was first selected by lot.... [emphasis added]

We expect, based on earlier Fosamax - ONJ trials, that it will be at least a month before we will get a jury verdict for the Scheinberg v. Merck trial.

Of course, to the extent that we get reports of significant developments along the way, we will let you know, here.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects  (All website content by attorney Tom Lamb)

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Some Newer Contraceptive Methods Such As NuvaRing And YAZ / Yasmin Are Under Increasing Scrutiny Over In Europe

Is The FDA Doing Enough About Birth Control Products That Contain Third Generation Or Fourth Generation Progestins And Are Associated With Higher Risks Of Blood Clots

(Posted by Tom Lamb at DrugInjuryWatch.com)

A January 3, 2013 Reuters article, "France may curb use of riskier oral contraceptives", has us thinking about whether the FDA should be doing more on the drug-safety front as regards the popular birth control products YAZ / Yasmin and NuvaRing.

From this recent Reuters article:

An inquiry launched this week by the ANSM health regulator will review prescription practices by doctors, whom it says may be over-prescribing higher-risk third and fourth-generation pills.

While all oral contraceptives are associated with a risk of blood clots, a number of studies suggest the most recent brands, known as third and fourth-generation pills, carry a higher risk than their predecessors.

The European Medicines Agency says the risk of an embolism, or blood clot, is twice as high for women using third and fourth-generation pills than for those using earlier versions, although it remains low. The risk of a stroke is the same.

On Wednesday, France's health ministry said it would stop reimbursing prescription costs of third-generation pills from March 31, bringing forward a cut-off date from Sept. 30.

The moves comes weeks after Marion Larat, 25, sued Germany's Bayer and a French official over a stroke she suffered following use of the third-generation contraceptive pill Meliane.

An inquiry found that her use of the pill could have been responsible for her stroke, which led to partial paralysis. Larat's lawyers argue that Bayer should have withdrawn its pill from the market.

While Meliane (gestodene 75 mcg, ethinylestradiol 20 mcg) is not available in the U.S., these relatively "new" contraceptive methods are:

• The birth control pills YAZ, Yasmin, Beyaz, Safyral, Ocella, and Gianvi (as well as the lesser known Zarah, Loryna, Syeda, and Vestura), all of which contain drospirenone (DRSP), considered to be a fourth-generation progestin (also known as progesterone); and,
• NuvaRing, a vaginal ring used for birth control that contains ethinyl estradiol and etonogestrel, a metabolite of desogestrel; the third-generation class of progestins includes desogestrel, gestodene, and norgestimate.

In comparison, most older oral contraceptives use the second-generation class of progestins, which includes levonorgestrel and norgestrel.

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As regards the birth control pills containing DRSP, such as YAZ, Yasmin, Beyaz, Safyral, Ocella, and Gianvi, here is an article about how the medical researchers have found that drospirenone (DRSP) can increase the risk of developing a deep vein thrombosis (DVT) and/or pulmonary embolism (PE): "Two More Medical Studies Show Increased Risk Of Blood Clots With Use Of YAZ, Yasmin, And Ocella".

And, next, here is an article concerning what the FDA has done thus far regarding that increased risk of blood clots that cause DVTs and PEs: "April 2012 Yasmin / YAZ Label Change: FDA Warns About Increased Risk Of Blood Clots Possible Due To Drospirenone".

Now turning to NuvaRing, the following text was extracted from the "WARNINGS, 1. THROMBOEMBOLIC DISORDERS AND OTHER VASCULAR PROBLEMS, a. Thromboembolism" section of the current NuvaRing Prescribing Information, or label, (accessed 1/4/13 at http://www.nuvaring.com) -- which has remained the same since at least August 2007:

Several epidemiology studies indicate that third generation oral contraceptives, including those containing desogestrel (etonogestrel, the progestin in NuvaRing®, is the biologically active metabolite of desogestrel), are associated with a higher risk of venous thromboembolism than certain second generation oral contraceptives. In general, these studies indicate an approximate two-fold increased risk, which corresponds to an additional one to two cases of venous thromboembolism per 10,000 women-years of use. However, data from additional studies have not shown this two-fold increase in risk. It is unknown if NuvaRing® has a different risk of venous thromboembolism than second generation oral contraceptives.

In fact, an FDA study back in 2001 found that the NuvaRing was associated with a significantly higher risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) relative to standard low-dose estrogen birth control pills, as reported in this article: "NuvaRing Update: October 2011 FDA Study Finds Increased Risk Of Pulmonary Embolism (PE) And Deep Vein Thrombosis (DVT)".

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Many had hoped that those new study findings about NuvaRing side effects like PE and DVT, as well as strokes and heart attacks, would be presented by the FDA to its Reproductive Health Drugs and Drug Safety and Risk Management advisory committees at a joint meeting in December 2011.

When I attended the December 9, 2011 FDA advisory committees meeting we heard the tearful parents of a 24-year old woman who had just died on Thanksgiving Day of a massive pulmonary embolism (PE) while using the NuvaRing ask the FDA panelists why the NuvaRing has been allowed to remain on the market despite the many serious blood clot related side effects like PE's, deep vein thrombosis (DVT), and strokes that have been suffered by women and reported to the FDA.

Now, more than a year later, one continues to wonder whether the FDA should be doing more -- especially in view of this action now being taken in Europe -- as regards the persistent and serious drug-safety issues surrounding YAZ / Yasmin and NuvaRing.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects -- All content by attorney Tom Lamb

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