Drug Injury Watch

Higher Risks Of Birth Defects Spina Bifida And Hypospadias Found To Be Dose-Related For Depacon / Depakene / Depakote / Stavzor

Amount Of These Valproate Medications For Seizures, Epilepsy, Bipolar Disorder, And Migraines Taken During First Trimester Of Pregnancy Is A Factor

(Posted by Tom Lamb at DrugInjuryWatch.com)

We have posted two articles about Depakote / Depakene / Depacon (valproate) related birth defects thus far in the summer of 2013:

(1) Depakote Or Depakene Taken During Pregnancy May Cause Congenital Malformations Or Birth Defects Such As Neural Tube Defects Like Spina Bifida  (May 31, 2013)

(2) Depacon / Depakene / Depakote: 400% Increased Risk Of Birth Defects Compared To Other Anti-Seizure Medications Used By Mothers With Epilepsy  (July 12, 2013)

In the second article we reported that in May 2013 the FDA required a so-called "Black-Box" warning and several other significant label revisions about serious risks for children whose mother used the following anti-seizure medications during pregnancy which were added to the Prescribing Information by FDA and the drug company AbbVie Inc. (formerly Abbott), specifically:

• Depakote (divalproex sodium) Delayed Release
• Depakote ER (Extended Release) Tablets
• Depakote Sprinkle Capsules (divalproex sodium coated particles in capsules)
• Depacon (valproate sodium) Injection
• Depakene (valproic acid) Capsules and Oral Solution

In that second article we failed to mention Stavzor (valproic acid), a lesser known medication from Noven Therapeutics, LLC which was approved by the FDA in 2008 and which had a June 2013 label change similar the the AbbVie / Abbott drugs listed above.

Now we have some new relevant medical findings to report from this recent article, "Dose dependence of fetal malformations associated with valproate", published by the Neurology medical journal, which reports on an analysis of data in the Australian Register of Antiepileptic Drugs in Pregnancy collected from 1999 to 2012. 

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For this study, several Australian medical researchers looked at the specific type of fetal malformation, or birth defect, in offspring exposed to valproate drugs such as Depacon in utero.  In turn, the each specific birth defect type was correlated with the dose of valproate taken by the mother in the first trimester of pregnancy.

From the Abstract for this September 2013 (published online before print in August 2013) Neurology medical journal article:

• Objective: To study the relationships between maternal valproate dose in pregnancy and the pattern of various fetal malformations.
• Results: Compared with other malformations, the mean dose of valproate taken during the first trimester was higher in mothers whose offspring had spina bifida (2,000 ± 707 vs 1,257 ± 918 mg/d) and hypospadias (2,417 ± 1,320 vs 1,235 ± 715 mg/d) (both p < 0.05). The overall mean maternal valproate dosage taken by women in the Register decreased over the last 5 years of the study period. This was paralleled by a statistically significant decrease in the rate of occurrence of spina bifida and hypospadias, but not other malformations.
• Conclusions: Human fetal malformations associated with valproate exposure during pregnancy do not all seem to bear the same quantitative relationship to drug dose, and reduction in valproate dose in earlier pregnancy is likely to offer greater dividends in protecting against spina bifida and hypospadias than against other types of fetal malformations.

The Drug Safety Monitor blog from AdverseEvents has a good article about this recent Neurolgy journal article about Depacon / Depakene / Depakote / Stavzor, "New Findings Demonstrate Specific Valproate Birth Defects Dependent on Dose Strength", and we give them a so-called "hat-tip" for drawing our attention to it.

As we stated in our previous valproate - birth defects article, we will continue to monitor this emerging drug safety issue and report new medical findings as well as any further FDA regulatory action concerning these several medications for seizures, epilepsy, bipolar disorder, and (until recently) migraine headaches: Depacon / Depakene / Depakote / Stavzor.

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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)

Legal Claims May Be Possible In California For Gianvi, Zarah, Loryna, Syeda, And Vestura (Generic YAZ / Yasmin) Blood Clot Side Effects Due To Pikerie v. Teva Case Ruling

California Appellate Court In June 2013 Said Alendronate (Generic Fosamax) Lawsuits Against Companies Like Barr, Teva, And Watson Not Pre-empted

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE: "Supreme Court Rejects Teva Appeal in Drug Labeling Case" (1/20/15, The Am Law Litigation Daily)

Excerpt: The [US Supreme Court] denied cert Tuesday in Teva v. Superior Court of California, Orange County, [an appellate case concerning the Pikerie v. Teva lawsuit involving the drug alendronate, a generic equivalent of Fosamax]. Teva had asked the justices in February to review a California state court ruling allowing patients to proceed with claims that Teva and other companies failed to warn about dangers associated with its version of the osteoporosis drug Fosamax....

The underlying case was brought by Olga Pikerie, who fractured her thighbone and claimed the injury stemmed from prolonged use of generic Fosamax. Pikerie alleged that Teva and other generic makers hadn't brought their warnings in line with an update to branded Fosamax's label. Teva and its co-defendants countered that Pikerie's claims were preempted under [the Supreme Court's 2011 decision in Pliva v. Mensing].

(1/21/15)

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There is now a potential opportunity in California to obtain legal compensation where a woman who is a resident of California suffered a deep vein thrombosis (DVT), pulmonary embolism (PE), or blood clot-related stroke while using Zarah, Loryna, Syeda, Vestura, or "pre-April 2012 Gianvi" / "non-Bayer Gianvi", i.e., taking one of these generic drospirenone (DRSP) birth control pills in the days leading up to the side-effect event.

In order for you to understand why this is a good and important development -- but, unfortunately, unique to California residents -- we provide you with the following background information.

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 opinion of the Court, concluding that federal drug regulations applicable to generic drug manufacturers directly conflict with, and therefore pre-empt, state law claims in a drug injury lawsuit.

The bottom line is that in this Mensing case 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" drug injury lawsuit involving a generic drug would be dismissed.

Due to the Mensing ruling, since June 2011 people who have suffered a serious side effect while using the generic version of a prescription medication have not been able to successfully bring a claim for legal compensation against the responsible drug company.

But in June 2013 a California state appellate court issued a significant ruling which effectively changed that situation for certain people in California who, the court said, can sue generic drug companies like Teva Pharmaceuticals, Barr Laboratories, and Watson Pharmaceuticals for the alendronate (generic Fosamax) related femur fractures they suffered while using that osteoporosis drug.

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From a June 18, 2013 online Thomson Reuters news report "Claims against generics not pre-empted, California court rules" (subscription required):

In a closely watched test case, the California Court of Appeals for the Fourth Appellate District in San Diego on June 13 refused to dismiss a lawsuit brought by a woman accusing several generic drugmakers of failing to adequately warn consumers and doctors about the risk of thighbone fractures from their versions of the osteoporosis drug Fosamax.

The appeals court affirmed the Orange County Superior Court in finding that the claims of the named plaintiff in the case, Olga Pikerie, were not pre-empted by federal law....

Taking the lead for the generic defendants, Teva asked the trial court to dismiss Pikerie's suit, arguing that her claims were barred by the U.S. Supreme Court's Mensingdecision. In addition, the company argued, her suit was an attempt to enforce a federal labeling requirement, a power reserved to the FDA.

FAILURE TO ADVISE ABOUT RISKS

The trial court denied the company's request, allowing Pikerie's suit to proceed, and the California appeals court upheld that decision last week.

In Mensing, the Supreme Court found that it would have been impossible for a generic drugmaker to provide stronger warnings when their labels already matched the brand, as required by federal law. That was not the case here, the California appeals court found.

In this case, "it was possible for the Teva Defendants to comply with both a federal duty to make their labels match the Fosamax label, and a state tort law duty to prevent harm to the consumers," Judge Richard Fybelwrote for a unanimous three-judge panel. "Therefore, the impossibility preemption doctrine does not bar Pikerie's claims."

The panel also found that Pikerie was not encroaching on the FDA'sauthority by trying to enforce labeling requirements. It refused to follow a decision from an Iowa appeals court, cited by the generic drug companies, which found that a failure-to-update claim was a private attempt to enforce the Food, Drug, and Cosmetic Act, and therefore pre-empted.

In addition to her failure-to-update claims, the panel also allowed Pikerie to sue the generic companies for allegedly failing to advise healthcare professionals of the risks identified in the 2010 and 2011 Fosamax label changes.

As pointed out in that news report, this Pikerie case ruling is a setback for generic drug companies involved in drug injury lawsuits filed in California. 

And, as I suggested above, this "new" situation for generic drug companies may well include those California drug injury cases which are related to the so-called YAZ / Yasmin / Ocella litigation that has been going on since 2009 and continues to date.

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Generic YAZ/Yasmin: Gianvi/Zarah/Loryna/Syeda/Vestura
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Zarah is a generic version of Yasmin.  Vestura is a generic version of YAZ.  The Zarah and Vestura oral contraceptives are made by Watson Pharmaceuticals, which is now known as Actavis, Inc. (as of January 2013).

Loryna, a generic version of YAZ, and Syeda, a generic version of Yasmin, are made and sold by Sandoz, Inc.

Further, for a period of time Gianvi birth control pills were made by Teva Pharmaceuticals and Barr Laboratories.  Generally, those Gianvi pills were dispensed prior to April 2011.  The drug injury cases involving these particular Gianvi pills are often referred to in the YAZ / Yamsin / Ocella litigation as the "pre-April 2012 Gianvi" or the "non-Bayer Gianvi" claims.

The bottom line: This June 2013 Pikerie appellate court ruling means that generic pharmaceutical manufacturers are no longer immune from California state law tort suits involving a prescription drug injury under the federal pre-emption doctrine.

And that is why the recent Pikerie case appellate opinion is a potentially good development for drug injury cases involving a California woman who suffered a DVT and/or PE, or blood clot-related stroke, while using Zarah, Loryna, Syeda, Vestura, or "pre-April 2012 Gianvi" / "non-Bayer Gianvi".

Let us know if we can be of any assistance to you as regards one of these generic DRSP birth control - blood clot drug injury cases in California.

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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)

Fosamax - Femur Fracture Lawsuits Filed Against Merck Said To Total 3,940 As Of June 30, 2013

Drug Company Reports 2,660 Cases In New Jersey State Court Consolidation, 1,075 Cases Are Part Of Federal Court MDL, And 470 In California

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE: "Merck Faces More Than 4100 Fosamax - Femur Fracture Lawsuits As Of September 30, 2013 According To SEC Corporate Filing"

(12/5/13)

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About five months ago we posted "March 2013 Fosamax Product Liability Litigation Update: Femur Fracture Cases Against Merck -- December 31, 2012 Totals: 2,075 New Jersey (NJ) State Court Lawsuits, With 820 Cases Pending In Federal Court Fosamax MDL And 420 California Claims".

As seen in Merck's SEC filing for the second quarter of 2013, the number of Fosamax cases alleging femur fracture as the drug injury -- as opposed to osteonecrosis of the jaw (ONJ) -- is growing albeit at a relatively modest rate.

And that total number will certainly get higher as we and other law firms around the country continue to investigate for litigation new Fosamax - femur fracture cases that will eventually be filed as lawsuits.

From the Merck SEC filing we get this update for the New Jersey consolidated Fosamax litigation:

As of June 30, 2013, approximately 2,660 cases alleging Femur Fractures have been filed in New Jersey state court and are pending before Judge Higbee in Atlantic County Superior Court. The parties have selected an initial group of 30 cases to be reviewed through fact discovery. The first trial of the New Jersey state Femur Fracture cases, Su v. Merck, began on March 11, 2013, but a mistrial was declared on March 28, 2013 after the plaintiff suffered a serious medical issue unrelated to her use of Fosamax that prevented her from proceeding with the trial. The next trial, Unanski v. Merck, was set to be tried beginning November 4, 2013, but has been continued and is expected to be tried in 2014.

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And from that same Merck document, as regards the Fosamax MDL for femur fracture lawsuits:

... approximately 1,075 cases were pending in the Fosamax Femur Fracture MDL as of June 30, 2013.... The first bellwether case, Glynn v. Merck, began on April 8, 2013, and the jury returned a verdict in Merck’s favor on April 29, 2013.... The second bellwether case, Zessin v. Merck, which was set to be tried in September 2013, is currently being held in abeyance, as are the trial dates for the remaining bellwether cases, Young v. Merck and Johnson v. Merck.

As usual, Merck includes the customary statement that "the Company intends to defend against these [Fosamax] lawsuits."

We will continue to monitor developments in the Fosamax - femur fracture litigation and report the more significant happenings here.

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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)

NuvaRing: Merck Updates On The Number Of Cases Filed Against Drug Company As Of June 30, 2013

Federal Court NuvaRing MDL Developments: Judge Moves First Bellwether Trial Date To January 2014 With Mediator Involvement Mentioned

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE:  "Merck to pay $100 million in NuvaRing contraceptive settlement" (2/7/14, Reuters)

(2/10/14)

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From Merck's Quarterly Report for the period ended June 30, 2013, at page 19, we get this NuvaRing lawsuits update:

As of June 30, 2013, there were approximately 1,500 NuvaRing cases. Of these cases, approximately 1,285 are or will be pending in the NuvaRing MDL in the U.S. District Court for the Eastern District of Missouri before [NuvaRing MDL] Judge Rodney Sippel, and approximately 200 are pending in coordinated proceedings in the Bergen County Superior Court of New Jersey before Judge Brian R. Martinotti....

Pursuant to orders of Judge Sippel in the NuvaRing MDL, the parties originally selected a pool of more than 20 cases to prepare for trial and that pool was then narrowed to seven cases from which the first trials in the NuvaRing MDL will be selected. Judge Sippel recently denied the Company’s motion for summary judgment in the first NuvaRing MDL trial which is expected to take place in January 2014.

According to the Merck 2012 Annual Report / Form 10-K (PDF), at page 110, there were approximately 1,315 NuvaRing cases filed against Merck at the start of January 2013, with about 1,105 of those NuvaRing lawsuits being part of the federal court NuvaRing MDL.

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As regards Judge Sippel's ruling on Merck's motion for summary judgment, from this July 17, 2013 article, "Mo. Federal Judge Denies Organon Summary Judgment on NuvaRing Punitive Damages Claim", from HarrisMartin Publishing (subscription required):

A Missouri federal judge has denied Organon USA Inc.’s motion for summary judgment on a NuvaRing plaintiff’s punitive damages claim, finding the device's label does not foreclose punitive damages because it does not explicitly warn of the difference in risk of venous thromboembolism and pulmonary embolism.

On July 12, Judge Rodney W. Sippel of the U.S. District Court for the Eastern District of Missouri also rejected Organon’s assertion that New Jersey, rather than Missouri, law applies to the claim.

And concerning the first NuvaRing MDL trial date being moved from October 2013 to January 27, 2014 by means of Judge Rodney Sippel's July 30, 2013 Order.  From the conclusion of this Order we get an interesting mention of a development that suggests possible settlement negotiations:

IT IS FURTHER ORDERED that the parties are ordered to maintain regular and frequent contact with the mediator who will report the status of any negotiations to the Court.

We will continue to provide NuvaRing lawsuits updates and report on any developments as regards a possible settlement of the NuvaRing litigation by Merck.

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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)

Benicar Cardiovascular-Related Deaths: FDA Safety Review Which Started In June 2010 Is Still Ongoing In August 2013

When Will Daiichi Sankyo And FDA Report On Additional Studies And Analyses Of Clinical Studies About Cardiovascular Mortality Increased Risks Of Benicar

(Posted by Tom Lamb at DrugInjuryWatch.com)

In June 2010 the FDA issued a Drug Safety Communication letting doctors and patients know that two clinical studies found that patients with Type 2 diabetes taking Benicar had a higher rate of death from a cardiovascular cause compared to patients taking a placebo.

Three years later this Benicar (olmesartan) FDA safety review is still ongoing.

Benicar -- as well as Benicar HCT, Azor, and Tribenzor -- is an angiotensin II receptor blocker (ARB) used as a blood pressure medication.  The drug company Daiichi Sankyo makes Benicar.

There was an April 2011 interim report about this cardiovascular mortality aspect of Benicar's safety profile issued by the FDA:

This safety review update is in follow-up to the FDA Drug Safety Communication: Ongoing Safety Review of Benicar (olmesartan) and cardiovascular events on 6/11/2010.

After reviewing the results of the ROADMAP and ORIENT trials, FDA has determined that the benefits of Benicar continue to outweigh its potential risks when used for the treatment of patients with high blood pressure according to the drug label....

Daiichi Sankyo, the makers of Benicar, have agreed to work with the FDA to perform additional studies, as well as conduct additional analyses of completed clinical studies, to obtain more complete information about the cardiovascular risks or benefits of Benicar in various clinical settings. FDA will update the public when new information is available.

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Now, more than two years after that latest FDA update about the cardiovascular side effects of Benicar -- not to be confused with the intestinal side effects such as severe diarrhea and sprue-like enteropathy -- one wonders when we will hear back from Daiichi Sankyo and the FDA on those additional studies and analyses of clinical studies about the cardiovascular risks of Benicar.

In the meanwhile, we will watch for new medical journal articles about any statistical and clinically significant increase in cardiovascular mortality associated with Benicar.

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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)

Blood Pressure Drug Benicar Causes Serious Intestinal Side Effects Such As Chronic And Severe Diarrhea Months Or Years After Starting Drug

Olmesartan-associated Sprue-like Enteropathy FDA Warning Also Applies To Benicar HCT, Azor, And Tribenzor From Drug Company Daiichi Sankyo

(Posted by Tom Lamb at DrugInjuryWatch.com)

The FDA has found clear evidence of an association between the blood pressure drug Benicar (olmesartan) and a serious intestinal condition known as sprue-like enteropathy, which is characterized by severe diarrhea or diarrhea that does not go away and, often, significant weight loss.

It is important to note that some patients developed this serious intestinal side effect enteropathy, which can require hospitalization, months to years after first starting to take Benicar.

From a July 3, 2013 MedPage Today news report, "FDA Adds GI Warning to Benicar Label":

The connection between sprue-like enteropathy and [Benicar (olmesartan)] was first reported in June 2012 by Mayo Clinic researchers who, from 2008-2010, had seen 22 patients with symptoms suggestive of celiac disease but antibody blood tests that did not support the diagnosis.

Later in October 2012, researchers at the American College of Gastroenterology meeting noted that [Benicar (olmesartan)], an angiotensin II receptor blocker, or ARB, had been linked to another 40 such cases of sprue-like enteropathy.

"We believe it is the tip of the iceberg," said Margot Herman, MD, at the GI meeting.

Symptoms of sprue-like enteropathy include severe, chronic diarrhea with substantial weight loss.

The 22 initial patients reported by the Mayo Clinic were on average 69 years old and had a duration of diarrheal illness for an average of 19 months.

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In early July 2013 this FDA Drug Safety Communication was issued, "FDA approves label changes to include intestinal problems (sprue-like enteropathy) linked to blood pressure medicine olmesartan medoxomil [(e.g., Benicar, Benicar HCT, Azor, and Tribenzor)]". It began by informing that the FDA has approved changes to the labels of these drugs in include the fact that these drugs can cause serious intestinal problems.

The Warnings and Precautions part of the July 2013 revised Benicar Prescribing Information, or drug label, sets forth this new warning about these serious intestinal side effects:

5.5  Sprue-like Enteropathy

Severe, chronic diarrhea with substantial weight loss has been reported in patients taking olmesartan months to years after drug initiation. Intestinal biopsies of patients often demonstrated villous atrophy. If a patient develops these symptoms during treatment with olmesartan, exclude other etiologies. Consider discontinuation of Benicar in cases where no other etiology is identified.

Previously the Daiichi Sankyo drug labels for Benicar, Benicar HCT, Azor, and Tribenzor included a mention of diarrhea in the Adverse Reactions section.

According to the July FDA Drug Safety Communication about Benicar and similar blood pressure medications containing the same active ingredient:

In 2012, a total of approximately 10.6 million prescriptions were dispensed, and approximately 1.9 million patients received a dispensed prescription for olmesartan-containing products from U.S. outpatient retail pharmacies. 

Further, it states that the FDA will continue to evaluate the safety of olmesartan-containing products such as Benicar, Benicar HCT, Azor, and Tribenzor.

As regards legal cases, we are investigating some Benicar-related enteropathy reports from patients as drug injury claims against the pharmaceutical company Daiichi Sankyo.

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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)