Drug Injury Watch

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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Generic YAZ/Yasmin: Gianvi/Zarah/Loryna/Syeda/Vestura
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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
Free Case Evaluation 
Strictly Confidential, No Obligation.

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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)

July 2013 Update: New FDA Action To Be Taken In Or About September On Issue Of Drug Label Revisions By Generic Manufacturers

Allowing Supplemental Applications For Proposed Labeling Changes Might End Federal Preemption Shield From Legal Liability That Came With Mensing Ruling

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE: The FDA’s long-awaited proposed rule on generic drug labeling is now public.  You can access it using this link. 

From a November 7, 2013 FDA email "announcement":

A proposed U.S. Food and Drug Administration rule would speed the dissemination of new safety information about generic drugs to health professionals and patients by allowing generic drug makers to use the same process as brand drug manufacturers to update safety information in the product labeling.
 
Under the proposal, generic drug manufacturers would be able to independently update product labeling (also called prescribing information or package inserts) with newly-acquired safety information before the FDA’s review of the change, in the same way brand drug manufacturers do today. Generic manufacturers would also be required to inform the brand name manufacturer about the change.
 
The FDA would then evaluate whether the proposed change is justified and make an approval decision on the generic drug labeling change and the corresponding brand drug labeling change at the same time, so that brand and generic drug products would ultimately have the same FDA-approved prescribing information.

(11/7/13)

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This July 3, 2013 headline from a New York Times (NYT) article by Katie Thomas, "F.D.A. Rule Could Open Generic Drug Makers to Suits", was much welcomed news to many patients who have been harmed by serious side effects from generic drugs yet prevented from filing any drug injury products liability lawsuit for legal compensation.

Here is just one example. At the present time Bayer is settling YAZ, Yasmin, and Ocella lawsuits, as well as certain Gianvi cases. YAZ and Yasmin are brand-name drugs made and sold by Bayer. Ocella and Gianvi are generic drugs but were made by Bayer -- which is why Bayer is paying settlements on those cases -- and sold by Teva / Barr.

As background, like all of the drospirenone (DRSP) containing birth control pills, the YAZ, Yasmin, Ocella, and Gianvi types have been associated with an increased risk of blood clots that can cause serious side effects such as a deep vein thrombosis (DVT) and/or pulmonary embolism (PE).

If at the time of her DVT and/or PE event a woman was taking one of the "true" generic DRSP birth control pills like Zarah, Loryna, Syeda, or Vestura, i.e., made by a generic (not brand-name) manufacturer, however, there is a completely different legal outcome for her. This is because no such drug injury cases are being filed for those women, much less settled, because at the present time one cannot successfully sue a generic drug manufacturer due the Pliva, Inc., et al. v. Mensing case decided by the Supreme Court of the United States in 2011 (the so-called "Mensing ruling"), which is explained in these earlier posts:

March 2012 Update: Generic Drug Manufacturers Immunity By Means Of Mensing Preemption Ruling

Public Citizen Group Files FDA Petition To Fix Problems Exposed By Mensing Case Ruling

Generic Drug Company Should Not Be Allowed To Use Federal Preemption To Defeat Lawsuits

Returning to that July 3 New York Times article mentioned at the outset:

The Food and Drug Administration on Wednesday signaled its intention to permit generic drug makers to make changes to their safety labels, a move that could open the door to lawsuits against generic drug companies for the first time since a Supreme Court decision barred such suits two years ago.

Consumer advocates applauded the development, calling it a necessary fix for a system that they say is unfair to patients who take generic medicines.

“It’s common sense,” said Dr. Sidney M. Wolfe, a senior adviser to the Health Research Group at Public Citizen, which in 2011 petitioned the F.D.A. to pass just such a rule. “It will obviously end this situation where people are being harmed physically and yet, although they are harmed, they have no right to go into court and get redress for serious damages.”...

The F.D.A.’s intentions came in the form of a bureaucratic step in which the agency must notify the Office of Management and Budget [(OMB)] of its plans to publish a proposed new rule. In a summary posted Wednesday on the budget office’s Web site, the F.D.A. said the proposed rule would “create parity” between generic and brand-name drug makers with respect to how they update their labels — the lengthy list of a drug’s uses, dosages and risks.

Under the current system, brand-name manufacturers can change the label if they receive important new information about their drug. If the F.D.A. agrees that the label change is necessary, the generic manufacturers of the drug must also change their labels. The rule change could also allow generic manufacturers to change their labels if they became aware of safety concerns, which could make them liable if a court were to find they failed to warn patients about potential harms.

The required notice which was posted by FDA July 3 on the OMB website -- "Title: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products" -- indicates the FDA’s intent to publish such a proposed rule by September 2013, when the public would be asked to comment.

We certainly look forward to learning more about what these changes in the FDA regulations might be as regards prescription drug label revisions by generic manufacturers.

We know already that these changes are long overdue and, unfortunately, most likely too late for many patients whose statute of limitations for filing their respective drug injury lawsuit expired during the time when the Mensing ruling was the law of the land -- with its federal preemption shield from legal liability that it afforded generic drug companies and, in turn, prevented those patients from receiving any legal compensation for their serious side effects.

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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)

 

Despite FDA Regulations, Generic Drug Labels Often Failed To Match Brand Name Drug Safety Warnings

Two-Thirds Of The Generics Did Not Have Identical Labeling, And Up To 9% Showed Differences Of More Than 10 Side Effects

(Posted by Tom Lamb at DrugInjuryWatch.com)

A disturbing new study about drug labeling for generic medications reveals that warnings for some adverse reactions are different from brand name prescription drugs, causing a potential drug safety problem and having possible legal liability ramifications for the generic manufacturers.

These study findings were reported in this article, "Consistency in the safety labeling of bioequivalent medications", which was published in the Pharmacoepidemiology and Drug Safety medical journal.  From the Abstract:

Purpose: Bioequivalent medications are required by the Food and Drug Administration to have identical warnings on their labels. This requirement has both clinical and legal importance, yet has never been validated. We sought to determine the real-world consistency of electronic labeling for bioequivalent drugs from different manufacturers....

Results: 68% of multi-manufacturer drugs had discrepancies in ADR labeling.... Overall, 77.9% of generic manufacturers produced labels differing from brand. Causes of inconsistency included missing tables, outdated post-marketing reports, and formatting issues.

Conclusions: Despite FDA mandate, bioequivalent drugs often differ in their safety labeling. Physicians should be aware of such differences and regulators should consider new strategies for harmonizing bioequivalent labels.

A December 13, 2012 Indiana School of Medicine press release concerning this recent article, "Regenstrief study finds that generic drugs often have incorrect safety labeling", provides us with some commentary from the lead author of this new generic drug study:

The majority of generics showed relatively small differences across their labels, but nine percent showed differences of more than 10 side effects. Errors included out-of-date information, incomplete data and, in one case, information for the wrong drug altogether.

"Physicians frequently use labeling information, either directly or indirectly, to make prescribing decisions. They need to know about side effects, drug interactions and other safety issues," said Regenstrief Institute investigator Jon Duke, M.D., M.S., assistant professor of medicine at the Indiana University School of Medicine, who led the study. "We found that generic drug labels may contain incomplete or incorrect safety information. Until this problem is resolved, physicians and patients should rely on brand drug labeling only, even when the patient is getting a generic version of a drug."...

Safety studies are conducted by the brand name manufacturer before the medication goes on the market. The FDA does not require that the generic manufacturer duplicate these studies....

"The solution to the problem of labeling inconsistency may be a centralized listing of drug side-effects, maintained independently of individual manufacturer labels. Drug labels would simply reference this common repository rather than attempting to maintain all the information within a single document. Clinicians could refer to this resource for the most up-to-date safety information regardless of generic manufacturer," Dr. Duke said.

The findings of this new pharmacoepidemiology study bring to mind the "consensus" label idea which was discussed in another relatively recent article "Risk, Responsibility, and Generic Drugs", published in November 2012 by The New England Journal of Medicine (NEJM). 

Earlier this month I wrote a piece concerning that recent NEJM article: "Generic Drugs Post-Mensing Ruling: One Proposed Solution To The Legal Compensation And FDA Drug Safety Problems Supreme Court Created".

As some may be aware, the Pliva, Inc., et al. v. Mensing case decided by the Supreme Court of the United States in 2011 estabalished that federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus pre-empt, state law claims.  Accordingly, the 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.

In more detail, generic-drug companies successfully argued in the Mensing case that they should not be held to the same legal standard as brand-name manufacturers -- which can be sued in drug-injury "failure to warn" state court lawsuits -- because federal law requires the label, or package insert, for a generic medication be the exact same as the package insert for the equivalent brand-name drug, i.e., identical.

Put otherwise, the generic manufacturers took the position that federal law should prohibit (by means of the federal preemption legal doctrine) drug injury lawsuits in state courts seeking to hold generic-drug companies legally liable for using the identical warning that the FDA and federal law required.

So what about when the generic drug company fails to use the identical label and a patient suffers from one of the serious side effects that was missing from the generic label?

It seems that this new study published by the Pharmacoepidemiology and Drug Safety medical journal -- finding that generic drugs often have different, or not identical, safety labeling -- would put some momentum behind efforts aimed to "fix" the current situation created by the Mensing decision.

Here are two past articles about this Mensing preemption problem which I have written:

• "March 2012 Update: Generic Drug Manufacturers Immunity By Means Of Mensing Preemption Ruling"
• "Public Citizen Group Files FDA Petition To Fix Problems Exposed By Mensing Case Ruling"
  

Of course, we will continue to monitor both the drug safety and the legal compensation aspects of this generic drugs warning labels issue.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

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Generic Drugs Post-Mensing Ruling: One Proposed Solution To The Legal Compensation And FDA Drug Safety Problems Supreme Court Created

At Least, This November 2012 Article In The New England Journal Of Medicine Makes The Point That Something Needs To Be Done Soon, Rather Than Later

(Posted by Tom Lamb at DrugInjuryWatch.com)

The June 2011 ruling by our United States Supreme Court in Pliva v. Mensing essentially held that patients who suffered serious side effects could not file drug injury lawsuits to hold generic drug manufacturers liable in state court for failing to update their drug labels to integrate new safety warning information. Fundamentally, the Court's rationale for this ruling was that any such legal "duty" was preempted by statutory requirements that generic drug manufacturers must keep their drug labels identical to those of the brand-name drug manufacturers.

In a relatively recent article "Risk, Responsibility, and Generic Drugs", by Aaron S. Kesselheim, M.D., J.D., M.P.H., Jerry Avorn, M.D., and Jeremy A. Greene, M.D., Ph.D., and published in the November 1, 2012 edition of The New England Journal of Medicine (NEJM), the authors reach this conclusion as to the practical effect of the Pliva decision (which others, like me, refer to as the Mensing ruling):

It is unfair to patients injured by unanticipated adverse drug effects for their right to reparations to depend on whether they received a brand-name or generic version of the same medication, a choice that may have been entirely out of their control. The existing Pliva decision also removes incentives for generic-drug companies to perform pharmacovigilance and monitor late-emerging safety risks related to the products they make.

In this November 2012 NEJM Perspective piece the authors propose some solutions to the legal compensation and the drug safety problems created by the Supreme Court's decision in the Pliva v. Mensing generic drugs case.

Starting with the legal compensation side, the authors propose:

... to create a fund for compensating patients injured by adverse events that are recognized only after a brand-name drug has lost its market exclusivity. Such a system could be structured like the one for vaccine-related injuries.... In the case of generic drugs, patients could qualify for similar compensation by demonstrating that they had been harmed by a generic-drug side effect that was not properly addressed in the label. Generics manufacturers that joined the program would bear additional liability only if their labels did not match the consensus version.

And that reference to a "consensus" label takes us to the drug safety side:

A central repository of information on adverse drug events could be used to study late-arising side effects and to assess the need for changes to drug labels. This repository could be based at the FDA and managed by its Sentinel program, the Patient-Centered Outcomes Research Institute, or another organization with pharmacoepidemiology expertise. Such a database would make it possible to conduct more active oversight of the safety of generic drugs by assessing pooled adverse-event reports, which would lead to additional primary research as needed. The FDA would be responsible for overseeing the integration of new findings into a centrally written consensus label.

At the outset of their article the authors acknowledge that a bipartisan group of lawmakers has introduced legislation seeking to "fix" the Mensing ruling, i.e., to make generic drug companies legally responsible for updating their labels just as brand-name drug companies are by means of drug injury lawsuits in the court system. Here is how the authors view this proposed legislation, which remains under consideration in both the House and the Senate:

Current legislative proposals to impose liability directly on generics manufacturers for discovering and reporting new adverse effects are unlikely to solve the problem, and such an approach disregards the special position that generics hold in the pharmaceutical marketplace.

Ultimately, I disagree with the authors on their outcome as regards whether generic drug companies should be held legally liable for serious side effects that they failed to warn about in their drug labels, for reasons that are apparent in some of my earlier articles about the Mensing ruling:

• March 2012 Update: Generic Drug Manufacturers Immunity By Means Of Mensing Preemption Ruling
• Public Citizen Group Files FDA Petition To Fix Problems Exposed By Mensing Case Ruling

I do, however, applaud the authors for pointing out the drug safety and legal compensation problems for generic drugs that patients live with after the Pliva v. Mensing ruling in 2011, and then going on to offer some possible solutions to those problems.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

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March 2012 Update: Generic Drug Manufacturers Immunity By Means Of Mensing Preemption Ruling

One Year After The Hearing In Pliva v. Mensing, Some Momentum Builds For (Once Again) Allowing Drug Injury Lawsuits On All Prescription Medications, Generic As Well As Brand Name

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE:  "July 2013 Update: New FDA Action To Be Taken In Or About September On Issue Of Drug Label Revisions By Generic Manufacturers"

(7/9/13)

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UPDATE:  Introduction of the “Patient Safety and Generic Labeling Improvement Act”  legislation in late April 2012

The Senate bill, S. 2295, was introduced by the Chairman of the Judiciary Committee, Senator Patrick Leahy (D-VT) and is cosponsored by Senators Al Franken (D-MN), Jeff Bingaman (D-NM), Sheldon Whitehouse (D-RI), Sherrod Brown (D-OH), Christopher Coons (D-DE), Richard Blumenthal (D-CT), and Mark Begich (D-AK). 

The companion House bill is H.R. 4384, introduced by Representatives Chris Van Hollen (D-MD) and Bruce Braley (D-IA). 

These bills would permit manufacturers of generic drugs to provide additional warnings about their drugs in the same manner that the Food and Drug Administration (FDA) allows for brand name manufacturers.

(5/15/12)

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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 thus pre-empt, state law claims (see, in particular, pages 4–14 and 17–20 of this Pliva v. Mensing SCOTUS opinion). 

The bottom line is that the U.S. Supreme Court ruled in favor of the generic drug company and against the injured patient.

Justice Sonia Sotomayor, in her dissent opinion, did well in pointing out the apparent absurdity of this new Supreme Court ruling about generic drug company lawsuits:

As a result of today’s decision, whether a consumer harmed by inadequate warnings can obtain relief turns solely on the happenstance of whether her pharmacist filled her prescription with a brand-name or generic drug. The Court gets one thing right: this outcome "makes little sense."

For background, you may also want to look at the Transcripts of Oral Arguments to U.S. Supreme Court on March 30, 2011.

A year after the oral arguments in the Pliva v. Mensing case, there are some positive and significant developments to report concerning drug safety as well as patients rights.

On March 9, 2012 the FDA deferred making a determination on a Citizen's Petition submitted by the consumer advocacy group Public Citizen in August 2011 which seeks to require the FDA to update its regulations to allow generic manufacturers to utilize the Changes Being Effected (CBE) process.  This recent agency decision suggests that the FDA may be considering revisions to its regulations in order to address the Mensing decision by the U.S. Supreme Court.

A week earlier the American Association for Justice (AAJ) filed comments in support of the Public Citizen petition.  In his March 2, 2012 letter to the FDA, AAJ President Gary M. Paul set forth the reasons why generic drug makers should be required to update their warning labels independent of brand name manufacturers.

On March 21, 2012 The New York Times ran this article, "Generic Drugs Prove Resistant to Damage Suits", which told us about the negative consequences that the Mensing decision has had on Debbie Schork, of Indiana, and Camille Baruch, of Maryland -- both of whom suffered serious side effects after using generic drugs, as opposed to brand name medications.

In the March 26, 2012 edition of the Washington Drug Letter (subscription required) there appeared this article, "Labeling Preemption for Generics Could Be Threatened in Appeals", which was summarized by the publisher as follows:

Generic-drug makers are seeing product liability cases thrown out left and right, with judges ruling they're not required to change labels to reflect new safety concerns until after the brand drugmaker changes its labeling. But they shouldn't rejoice just yet as a so-called reference listed drug (RLD) theory of liability could come to life in an appellate case, an attorney tells WDL.

And, finally, in the March 27, 2012 edition of the Drug Industry Daily (subscription required) there appeared this article, "Bill Allowing Generic Safety Labeling Changes Is Coming, Senator Says", which was summarized by the publisher as follows:

The generic-drug industry's freedom from liability for safety labeling issues could soon disappear if a key Democratic lawmaker has his way. Senate Judiciary Committee Chair Patrick Leahy (D-Vt.) plans to introduce a bill that would permit generic manufacturers to proactively improve warning information in labeling even before the brand drugmaker does. The legislation could come as early as this week, Leahy said Monday.

Now, a year after the March 30, 2011 oral arguments in the Pliva v. Mensing case, it seems there may be some momentum building for taking the steps necessary to create a solution to the real and serious problems that were created by the Mensing ruling by the U.S. Supreme Court.  Let's hope that this momentum continues, for the sake of drug safety and patients rights, both.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

Drug Injury Case Evaluation - Free & Confidential

Public Citizen Group Files FDA Petition To Fix Problems Exposed By Mensing Case Ruling

Generic Drug Companies Should Have To Update Side Effect Warnings Or Face Drug Injury Lawsuits

(Posted by Tom Lamb at DrugInjuryWatch.com)

On August 29, 2011 the consumer advocacy group Public Citizen took action in an attempt to (1) require generic drug companies to warn about serious side effects caused by their prescription medications, and (2) to gain back for patients harmed by a generic medicine the right to file a drug injury lawsuit.

As background, the Pliva, Inc., et al. v. Mensing case was decided by the Supreme Court of the United States on June 23, 2011.  As reported by this Reuters article, "Supreme Court rejects generic drug labeling suits", the bottom line is that the Supreme Court ruled in favor of the generic drug company and against the injured patient.

Justice Sonia Sotomayor, in her dissent opinion (at page 26 of this PDF of the Court's Opinion), did well in pointing out the apparent absurdity of this new Supreme Court ruling about generic drug company lawsuits:

As a result of today’s decision, whether a consumer harmed by inadequate warnings can obtain relief turns solely on the happenstance of whether her pharmacist filled her prescription with a brand-name or generic drug. The [majority opinion of this] Court gets one thing right: this outcome "makes little sense."

The essence of this August 2011 Citizen Petition submitted to the FDA by the Public Citizen group is set forth in the title and sub-title of their press release:

Generic Drug Manufacturers Should Be Able to Warn of Products’ Risks, Public Citizen Tells FDA -- To Improve Drug Safety, FDA Should Revise Outdated Regulations That Prevent Generic Drugmakers From Updating Product Labeling and Immunize Them from Liability

In more detail, their basic arguments are found in the three parts, below, which make up the "STATEMENT OF GROUNDS" section of this 11-page Citizens Petition:

A. MANUFACTURERS OF GENERIC DRUGS PRODUCE A MAJORITY OF THE PRESCRIPTION DRUGS SOLD IN THE UNITED STATES.

B. POST-APPROVAL MONITORING IS ESSENTIAL TO THE SAFETY OF DRUGS AND IS A SHARED RESPONSIBILITY OF THE FDA AND MANUFACTURERS.

C. GENERIC MANUFACTURERS’ LACK OF RESPONSIBILITY FOR ENSURING THE POST-APPROVAL ADEQUACY OF PRODUCT LABELING THREATENS PATIENT SAFETY.

From this third part, we excerpt the following passage, which seems to make a compelling case as to why the FDA should take those steps necessary to rectify the negative effect of this recent Mensing case ruling by the Supreme Court:

Generic manufacturers’ immunity from state common-law suits is contingent on the Court’s finding that the manufacturers’ cannot change their products’ labeling under current FDA regulations, even if they learn about new risks. According to the Court, the inability to change labeling renders it impossible for generic manufacturers to comply with both federal and state obligations, giving rise to implied preemption of state law. Amending FDA regulations to permit generic manufacturers to make use of PAS and CBE procedures in response to new risk information would undo this impossibility. In that event, common law could once again complement the FDA’s mandate to monitor drug safety across the full range of drugs, rather than just the decreasing portion occupied by brand-name drugs. The action requested in this petition would not only eliminate the absurd inconsistency in common-law protections based on the happenstance of whether the patient ingested the generic or brand-name form of the drug, it would also restore marketplace equality, as both types of manufacturers would face the same potential liability for failures to adequately warn of hazards associated with their products.

We will end with this query:  Generic drugs may save consumers money at the pharmacy, but at what cost?

Feel free to let us know what you think about the Supreme Court's Mensing ruling and/or this August 2011 Citizen Petition sent to the FDA from the consumer group Public Citizen by submitting a Comment, below.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

Drug Injury Case Evaluation - Free & Confidential

Generic Drug Company Should Not Be Allowed To Use Federal Preemption To Defeat Lawsuits

U. S. Supreme Court Will Hear Oral Arguments On This Legal Issue In Drug Injury Lawsuit Involving Gladys Mensing

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE:  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 thus pre-empt, state law claims (see, in particular, pages 4–14 and 17–20 of this Pliva v. Mensing SCOTUS opinion). 

The bottom line is that the US Supreme Court ruled in favor of the generic drug company and against the injured patient.

Justice Sonia Sotomayor, in her dissent opinion, did well in pointing out the apparent absurdity of this new Supreme Court ruling about generic drug company lawsuits:

As a result of today’s decision, whether a consumer harmed by inadequate warnings can obtain relief turns solely on the happenstance of whether her pharmacist filled her prescription with a brand-name or generic drug. The Court gets one thing right: this outcome "makes little sense."

For background, you may also want to look at the Transcripts of Oral Arguments to U.S. Supreme Court on March 30, 2011.

(6/23/11)

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On March 30, 2011 the U.S. Supreme Court will hear oral arguments in a drug injury case which presents this important legal issue:  Whether federal law preempts a tort claim under state law that a generic drug approved by the Food and Drug Administration was inadequately labeled. 

This generic drug case involves a woman, Gladys Mensing, who developed a severe neurological disorder called tardive dyskinesia (TD) -- which is generally characterized by involuntary movements of the mouth, tongue, lips, and extremities -- after taking the generic version of a prescription drug called Reglan (metoclopramide).

In her lawsuit, Ms. Mensing alleges that the Prescribing Information, or label, for this generic Reglan drug understated the risk of developing tardive dyskinesia to Mensing and to her doctor who prescribed it to her.

The generic drug manufacturers named as the defendants in this drug injury lawsuit, Actavis Elizabeth and Pliva, essentially take the position that adequacy or sufficiency of their drug label warnings does not matter -- by asserting that they should be shielded altogether from legal liability in this Mensing case by operation of what is commonly called the "federal preemption doctrine".

As background, in March 2009 the Supreme Court held in Wyeth v. Levine that federal law does not preempt, i.e., bar or eliminate, personal injury lawsuits against name brand drug manufacturers for failing to adequately warn about the serious side effects of their drug. 

Now, however, Actavis and Plivaare arguing that federal law does preempt lawsuits for failing to warn of the dangers which involve generic drugs, and thereby immunizes those generic drug companies from any legal liability for the drug side effect which Ms. Mensing has suffered. 

This Mensing Supreme Court case is especially significant given the somewhat remarkable fact that over 70 percent of prescription drugs sold today are generic drugs.

Moreover, several months ago the U.S. Solicitor General told the Supreme Court a federal appeals court which heard the Mensing case last year was correct in its ruling that the generic drug companies can be found liable for not providing sufficient warnings of about side effect risks -- even if such warnings are not found on the brand product’s labeling -- and had urged the Supreme Court not to take up the drug company's appeal of the lower court's ruling in this Mensing case.

As for the plaintiff's position on this issue of federal preemption in generic drug cases, here are the first few paragraphs of the 96-page legal brief filed on behalf of Ms. Mensing:

[In Wyeth v. Levine, the U.S. Supreme Court] held that the manufacturer, not the Food and Drug Administration (FDA), bears primary responsibility for ensuring that labeling for its drug adequately warns of the product’s risks. This conclusion applies equally to the manufacturers of generic drugs. Under the federal regulatory scheme, the manufacturer of a generic drug shares responsibility with the manufacturer of its brand-name counterpart to ensure that the labeling for both products adequately warns prescribers and protects consumers.

Defendants seek a special immunity from state tort liability for generic drug companies, an immunity that would create an arbitrary and irrational distinction between classes of patients based on the vagaries of pharmacy practice: those whose prescriptions were filled with brand-name products would retain their right to sue, while those whose pharmacies substituted generic drugs would lose that right. Not only would such a regime make no sense, but it would also create a disincentive for consumers to take generic drugs, which is precisely the opposite of what Congress intended when it passed the Hatch-Waxman Amendments to the Food, Drug, and Cosmetic Act (FDCA) in 1984. Try as they might, Defendants cannot muster any evidence that Congress ever intended such a bizarre result.

Today, seventy percent of prescriptions in this country are filled with generic drugs. And, contrary to Defendants’ claims, the fact that a drug has “gone generic” does not mean that it is safe. In reality, as the facts of this case demonstrate, drug risks frequently do not become clear until years after a drug has been on the market. The drug that injured Gladys Mensing and Julie Demahy, for example, had been available as a generic for more than fifteen years at the time it was first prescribed to them, and it was just two years ago that FDA finally mandated a “black box” warning of the risks of long-term use. If generic drug companies are granted immunity for failing to warn of known risks of their drugs, they will have very little incentive to strengthen their warning labels as new risks emerge, even though federal law mandates that they do so....

As regards the Reglan black-box warning mentioned above, see "FDA Requires Boxed Warning and Risk Mitigation Strategy for Metoclopramide-Containing Drugs -- Agency warns against chronic use of these products to treat gastrointestinal disorders", which was issued in February 2009.

For our prior coverage of the Levine v. Wyeth case and the issue of federal preemption in the context of drug injury lawsuits, see the Federal Preemption of Drug Injury Lawsuits page at our Drug Injury Law web site.

Of course, we will continue to monitor this Mensing case and report what the Supreme Court ultimately decides about whether the federal preemption doctrine should be available to generic drug companies so as to shield them from legal liability, or accountability, for serious side effects caused by their products.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

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Generic Drug Manufacturer ETHEX Corp. Is Being Shut Down By KV Pharmaceuticals

Troubled Company Pleads Guilty To Criminal Charges, Pays $27.6 Million In Fines And Restitution For Its Conduct Related To Quality-Control Issues

(Posted by Tom Lamb at DrugInjuryWatch.com)

We last wrote about the troubled generic drug manufacturer ETHEX Corp. a little more than a year ago, when we posted this article: "January 2009: ETHEX Corp. Issues Voluntary Recall Of All Pills Due To Suspected Manufacturing Problems".

Now, in February 2010, we know how the story ends for ETHEX -- for the most part, at least.

From a February 25, 2010 article, "KV Pharmaceutical to plead guilty, pay $27.6M, close generics business", published by the St. Louis Business Journal:

KV Pharmaceutical Co. must pay $27.6 million in fines and restitution, and plans to cease its generic drugs business after pleading guilty to criminal charges for not disclosing problems with two of its drugs.....

Bridgeton, Mo.-based KV said Thursday its subsidiary, Ethex Corp., plans to plead guilty to two felony counts of failure in 2008 to file field alerts for the generic drugs Dextroamphetamine, a stimulant used to treat ADHD, and Propafenone, which treats rapid heart beats. The company then plans to cease operations of Ethex. The U.S. Food and Drug Administration requires that companies file field alerts to quickly identify drugs that pose potential safety threats from problems such as contamination or mislabeling.

KV’s interim Chief Executive David Van Vliet declined to disclose the specifics of what the problems with the drugs exactly were.

Van Vliet said the company will now focus on regaining FDA compliance so it can return to making both branded and generic drugs under Ethex's parent company, KV, which retains all related intellectual property, including drug applications and the ability to conduct marketing and distribution of all of its previously approved products.  [Emphasis added]

It remains to be seen whether the U.S. Attorney for the Eastern District of Missouri, the U.S. Department of Justice (DOJ), or the U.S. Food and Drug Administration (FDA) will release details about the extent of the quality control problems at ETHEX and whether those problems resulted in any known-cases of harm to patients using any of the sub-standard generic drugs made by ETHEX.

If you are aware of a drug injury case involving an ETHEX generic drug, we would be interested in hearing about it.  You can do so by posting a Comment below or sending me a private email.

For more articles about quality-control issues at various generic drug companies, view our collection of stories at the Generic Drug Safety part of our blog Archives.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

Generic Drug Maker Caraco Fails To Correct Manufacturing Problems First Discovered In May 2008

FDA And U.S. Marshals Seize Drug Products From Caraco’s Three Michigan Facilities Due To Continuing Lack Of Quality Controls

(Posted by Tom Lamb at DrugInjuryWatch.com)

On June 25, 2009 the FDA issued a press release, "U.S. Marshals Seize Drug Products Manufactured by Caraco Pharmaceutical Laboratories Ltd. -- FDA acts to prevent repeated drug quality problems", which began as follows:

U.S. Marshals, at the request of the Food and Drug Administration, today seized drug products manufactured by Caraco Pharmaceutical Laboratories Ltd. (Caraco), at the company’s Michigan facilities in Detroit, Farmington Hills, and Wixom. The seizure also includes ingredients held at these same facilities....

This action follows Caraco’s continued failure to meet the FDA’s current Good Manufacturing Practice (cGMP) requirements, which assure the quality of manufactured drugs. Through this seizure, the FDA seeks to immediately stop the firm from further distributing drugs until there is assurance that the firm complies with good manufacturing requirements.

Since January 2009, Caraco has initiated voluntary recalls of drug products to protect the public from potentially defective medications. The recalls involved manufacturing defects, including oversized tablets and possible formulation error.

On March 31, 2009 Caraco recalled its digoxin pills due to the possibility that some of those pills might be oversized and contain too much active ingredient.  Because digoxin is known to have a narrow therapeutic index, it is possible that oversized Caraco digoxin pills caused digitalis toxicity, or digoxin poisoning, in patients using that product.

Earlier, the FDA issued a warning letter to Caraco in October 2008 after FDA inspectors had discovered failures to conform to current Good Manufacturing Practices (cGMP) at some of the companies facilities.

The FDA has provided a list of the 33 Caraco drugs that may be affected by the June 25, 2009 seizure at the company's three Michigan plants.

May 2009 Digoxin Recall By AS Medication Solutions Seems To Be About Six-Weeks Late

This Company Repackaged Caraco Digoxin Tablets That Were Recalled March 31, 2009; Why Did They Delay Their Recall Notice?

(Posted by Tom Lamb at DrugInjuryWatch.com)

On May 11, 2009 AS Medication Solutions, LLC -- which is a drug repackage company --announced that it has recalled all tablets of Caraco digoxin tablets because those pills may differ in size and therefore could have more or less of the active ingredient, digoxin.

If this sounds vaguely familiar, it should.  On March 31, 2009 Caraco Pharmaceutical Laboratories issued a recall notice for all of its digoxin tablets due to pill-size problems.

Why did it take AS Medical Solutions until mid-May to issue its recall notice for the Caraco digoxin tablets that it simply repackaged and distributed when Caraco recalled its digoxin pills at the end of March 2009?

From the company's May 11 press release, "AS Medications Solution LLC. Announces a Nationwide Recall of All Lots of Digoxin Tablets 0.25mg Due to Size Variability":

Digoxin is a drug product used to treat heart failure and abnormal heart rhythms. It has a narrow therapeutic index and the existence of higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure. Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and slow heart rate. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of heart failure and abnormal heart rhythms.. Consequently, as a precautionary measure, A S Medication Solutions, LLC is recalling these tablets to the consumer level to minimize any potential risk to patients.

Consumers with the products with the following NDC codes that are within expiration should return these products to the place of purchase.

Product Identification

Caraco Digoxin
A-S Medication Solutions, Digoxin 0.25 mg is a scored round biconvex white tablet imprinted with “441”

NDC Numbers:
Digoxin Tablets, USP, 0.25 mg
54569-5758-0 (30-count)

As seen above, the company's press release suggests that patients who have any remaining A-S Medication Solutions digoxin 0.25 mg tablets should return those pills to the pharmacy where they were purchased.

If, however, a patient suffered from digitalis toxicity, low blood pressure, cardiac instability, or bradycardia (slow heart rate) while using A-S Medication Solutions digoxin pills, I urge you not to return those pills because they may be important evidence in any possible personal injury or wrongful death case.

In closing, I will ask once again:  What took this drug repackaging company so long to issue its digoxin recall knowing that the A-S Medication Solutions digoxin 0.25 mg tablets it was distributing were the Caraco digoxin pills that had been recalled at the end of March 2009?