Drug Injury Watch

Elmiron Lawsuits Federal Court MDL is Created in December 2020, Assigned to Judge Martinotti

Legal Cases Involve Elmiron Causing Eye Damage and Retinal Injury Such as Atypical or Pigmentary Maculopathy

 

(Posted by Tom Lamb at Drug Injury Watch)

 

On December 15, 2020, the Judicial Panel on Multidistrict Litigation (JPMDL) granted a plaintiffs’ motion to centralize all currently filed federal court lawsuits involving the bladder drug Elmiron and assigned that multidistrict litigation (MDL) to the U.S. District Court for the District of New Jersey. This Elmiron MDL was assigned to U.S. District Judge Brian Martinotti, who oversee these Elmiron lawsuits which allege that Elmiron -- a pill used to treat chronic bladder infection called interstitial cystitis -- can cause Elmiron-related eye problems that can lead to vision loss or blindness.

In this September 2020 article, "Elmiron-Related Eye Problems Are Causing Patients to File Elmiron Lawsuits Against Pharmaceutical Companies", we explained the factual basis for the Elmiron lawsuits which will be included in this new Elmiron MDL:

Elmiron (pentosan polysulfate sodium / "PPS") was approved by the FDA in 1996 for the treatment of interstitial cystitis ("IC"), also known as “bladder pain syndrome” or “painful bladder syndrome”. In recent years, however, there have been reports of patients who used Elmiron developing vision loss due to Elmiron-related maculopathy. But there were not any warnings about these Elmiron eye problems in the Elmiron Prescribing Information document, or drug label, until June 2020, when the FDA mandated an Elmiron label change. This situation has resulted in Elmiron lawsuits filed by patients who have vision loss due to Elmiron.

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From the Transfer Order issued for In Re: Elmiron [Pentosan Polysulfate Sodium] Products Liability Litigation, MDL Docket No. 2973, we get the following legal information:

Plaintiffs in the District of New Jersey Dobbins action move under 28 U.S.C. § 1407 to centralize this litigation involving retinal injuries associated with the use of Elmiron (pentosan polysulfate sodium)....

No responding party opposes centralization....

After considering the argument of counsel, we find that centralization of these actions in the District of New Jersey will serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation. The actions involve common factual issues concerning the propensity of Elmiron to cause retinal injuries, notably atypical or pigmentary maculopathy. Several defendants have marketed Elmiron since its approval in 1996. This litigation likely will implicate complex scientific and regulatory issues. Centralization will eliminate duplicative discovery; avoid inconsistent pretrial rulings; and conserve the resources of the parties, their counsel and the judiciary. [Footnote omitted.]

We are currently investigating possible Elmiron lawsuits for patients diagnosed with Elmiron-related eye problems such as:

• wither pigmentation maculopathy
• pigmentation macular degeneration
• pigmentation maculitis
• retinal maculopathy
• dry macular degeneration

We point out that a person does not need to have been using Elmiron at the time when their eye damage or retinal injury was diagnosed by a doctor in order to be in a position to file an Elmiron lawsuit.

If we can be of assistance to you or someone else regarding a possible Elmiron lawsuit, you can send an email to Tom Lamb or you can call us on our toll-free number: 800-426-9535.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review is done by attorney Tom Lamb)

Beovu Lawsuits Filed Against Novartis for Patients Who Have Suffered Vision Loss Side Effects

Beovu Legal Cases Involve Retinal Artery Occlusion, Retinal Vasculitis, Intraocular Inflammation, Other Eye Problems

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

Beovu (brolucizumab) is prescribed for the treatment of neovascular (wet) age-related macular degeneration (AMD). Since being approved by the FDA in late 2019, Beovu has been associated with vision loss and blindness due to occlusive retinal vasculitis, retinal artery occlusion, intraocular inflammation, and other serious eye problems. In turn, Beovu lawsuits will likely be filed against Novartis, the manufacturer of Beovu, alleging this drug company failed to warn doctors about those serious Beovu side effects. Such drug injury Beovu legal cases might involve one or more of the following Beovu eye-related side effects:

Vision Loss
Blindness
Occlusive Retinal Vasculitis
Retinal Vasculitis
Retinal Artery Occlusion
Intraocular Inflammation
Eye Inflammation
Endophthalmitis
Retinal Detachment
Uveitis

These Beovu side effects can develop soon after the very first Beovu injection a patient receives or following a few Beovu injections, according to medical case reports submitted to the FDA.

We have created a Beovu timeline which indicates why Beovu lawsuits could be filed against Novartis.  The points of interest included in this Beovu timeline are the discovery of Beovu side effects that can lead to vision loss and blindness. statements by Novartis about Beovu drug safety issues, and more. Our Beovu timeline is kept up to date as we learn more about this Beovu drug injury situation.

You can get a quick overview of Beovu lawsuits for vision loss, blindness, and other serious eye problems on the Beovu information page for our Drug Injury Law website.

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If you want more in-depth information about the Beovu side effects situation, here are links to our earlier Drug Injury Watch articles:

• A Closer Look at the Vision-Related Side Effects Warnings Added with June 2020 Beovu Label Change (October 6, 2020)
• Safety of Beovu: A Lingering Issue Which Novartis Attempts to Counter with Recent Study Results (September 22, 2020)
• Beovu Retinal Vasculitis Case Report Is Presented In August 2020 Medical Journal Article (August 7, 2020)
• Possible Beovu Side Effects Discussed At American Society of Retina Specialists Annual Meeting In July 2020 (July 28, 2020)
• Beovu Safety Signal Found By External Review Committee Which Evaluated Beovu Post-Marketing Adverse Events (July 1, 2020)
• Beovu Label Change: Warnings About Possible Permanent Vision-Loss Side Effects Added In June 2020 (June 17, 2020)
• Beovu Vision-Related Side Effects Warnings Label Change Request By Novartis: News Report (April 9, 2020)
• Novartis Contends Beovu Safety Should Not Be In Dispute As Current Drug Label Provides Sufficient Warnings (March 4, 2020)
• Beovu Side Effects Include Retinal Vasculitis, Eye Inflammation: Safety Issues For Macular Degeneration Drug (February 27, 2020)

Our law firm is investigating possible Beovu lawsuits for patients who have been diagnosed with vision loss, blindness, or other serious eye problems which are Beovu side effects. Please feel free to send an email to Tom Lamb if we can be of assistance to you or someone else regarding these drug injury Beovu legal cases. Or you can call us on our toll-free number: 800-426-9535.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review is done by attorney Tom Lamb)

Four Distinct Diabetes Drugs MDL Cases: Byetta / Januvia / Victoza; Onglyza / Kombiglyze; Invokana; Farxiga

Current Number Of Drug Injury Lawsuits Filed In Each Of These Ongoing Federal Court MDL Cases: February 2018 JPML Report

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

At the present time there are four federal court Multidistrict Litigation (MDL) cases for drug injury lawsuits concerning several different types of diabetes medicines with unique sets of side effects.

From the February 15, 2018 version of this document, "MDL Statistics Report - Distribution of Pending MDL Dockets by Actions Pending" (accessed 2/21/18), published by the United States Judicial Panel on Multidistrict Litigation (JPML), we get the current number of cases filed in each of these diabetes drugs MDL cases.

We supplement that information provided by the JPML with the primary side effects that are the subject of personal injury lawsuits and wrongful death lawsuits filed in each of these diabetes drug MDL cases.

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IN RE: Incretin-Based Therapies Products Liability Litigation  MDL-2452

Number of lawsuits pending: 936

Diabetes drugs in this MDL case: 

• Byetta (exenatide)
• Bydureon (exenatide)
• Victoza (liraglutide)
• Januvia (sitagliptin)
• Janumet (sitagliptin)
• Janumet XR (sitagliptin)
• Juvisync (sitagliptin)

Primary side effect for these cases:

• Pancreatic Cancer, also known as Pancreas Cancer

Get more information about these drug injury cases and/or free case evaluation.

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IN RE: Invokana (Canagliflozin) Products Liability Litigation  MDL-2750

Number of lawsuits pending: 985

Diabetes drugs in this MDL case:

• Invokana (canagliflozin)
• Invokamet (canagliflozin and metformin)
• Invokamet XR (canagliflozin and metformin extended-release)

Primary side effects for these cases:

• Diabetic Ketoacidosis (DKA)
• Ketoacidosis
• Ketosis
• Leg Amputation
• Foot or Toe(s) Amputation

Get more information about these drug injury cases and/or free case evaluation.

 

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IN RE: Farxiga (Dapagliflozin) Products Liability Litigation  MDL-2776 

Number of lawsuits pending: 51
Diabetes drugs in this MDL case:

• Farxiga (dapagliflozin)
• Xigduo XR (dapagliflozin and metformin extended-release)
• Qtern (dapagliflozin and saxagliptin)

Primary side effects for these cases:

• Diabetic Ketoacidosis (DKA)
• Ketoacidosis
• Ketosis

Get more information about these drug injury cases and/or free case evaluation.

 

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IN RE: Onglyza (Saxagliptin) and Kombiglyze XR (Saxagliptin and Metformin) Products Liability Litigation  MDL-2809 

Number of lawsuits pending: 84
Diabetes drugs in this MDL case:

• Onglyza (saxagliptin)
• Kombiglyze XR (saxagliptin and metformin)

Primary side effect for these cases:

• Heart Failure

Get more information about these drug injury cases and/or a free case evaluation.

 

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We will continue to monitor the number of pending lawsuits in these four distinct diabetes drugs MDL cases and watch for significant developments in each of these federal court MDL litigations.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review done by attorney Tom Lamb) 

Kombiglyze And Onglyza MDL For Federal Court Lawsuits Filed Against Responsible Drug Companies

This Diabetes Drugs Litigation Involves Heart Failure, Myocardial Infarction, And Other Cardiovascular Problems

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

In February 2018 the United States Judicial Panel on Multidistrict Litigation (JPML) established MDL No. 2809, IN RE: ONGLYZA (SAXAGLIPTIN) AND KOMBIGLYZE XR (SAXAGLIPTIN AND METFORMIN) PRODUCTS LIABILITY LITIGATION.

According the the February 2, 2018 Transfer Order issued by the JPML:

[W]e find that these actions involve common questions of fact, and that centralization under Section 1407 in the Eastern District of Kentucky will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation. All actions share numerous factual questions, inasmuch as plaintiffs allege that the use of Onglyza or Kombiglyze XR caused them or their decedent to develop heart failure or other conditions such as congestive heart failure, myocardial infarction and/or cardiovascular injury.

According to that JPML Transfer Order the Defendants -- AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb Co., and McKesson Corp. -- opposed centralization of approximately 80 Onglyza and Kombiglyze lawsuits into this new MDL:

Defendants oppose transfer by arguing that plaintiffs’ allegations are supported by a single study (the SAVOR study), which itself supports only claims regarding heart failure – not the various other injuries (congestive heart failure, acute hypoxic respiratory failure, coronary artery disease and cardiovascular injury) plaintiffs allege. They argue that, as a consequence, these cases likely will turn on unique issues that are applicable to, at most, a small subset of other cases. Defendants also assert that informal coordination among the actions is a feasible alternative to centralization. These objections are insufficient to overcome the significant advantages that centralization will afford.

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Diabetes Drugs Side Effects
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Continuing, this Kombiglyze / Onglyza MDL Transfer Order sets forth the JPML's take on that contention by AstraZeneca, Bristol-Myers Squibb, and McKesson:

Defendants concede that most cases involve allegations of heart failure, which is squarely in line with the results of the SAVOR study and the subsequent label change for Onglyza and Kombiglyze XR in April 2016. If defendants are convinced that plaintiffs’ claims regarding heart failure or other injuries lack scientific support, then centralization affords them a single forum in which to seek summary judgment, which might be applied to other similar cases.

As background, in April 2016 the FDA took regulatory action by mandating label changes with new warnings about an increased risk of heart failure for these relatively new diabetes medicines in the dipeptidyl peptidase-4 (DPP-4) inhibitor class of drugs:

• Onglyza (saxagliptin)
• Kombiglyze XR (saxagliptin and metformin)
• Nesina (alogliptin)
• Kazano (alogliptin and metformin)
• Oseni (alogliptin and pioglitazone)
• Qtern (dapagliflozin and saxagliptin)

As indicated above, MDL No. 2809 involves only Onglyza and Kombiglyze lawsuits filed in the federal court system.

However, at the present time we are investigating heart failure cases for patients who used Onglyza or Kombiglyze as well as patients who used Nesina, Kazano, Oseni, or Qtern.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review done by attorney Tom Lamb) 

Merck Wants The US Supreme Court To Reverse A Federal Appeals Ruling In Fosamax - Femur Fractures Litigation

At Issue Is Whether Failure-To-Warn Claims By Plaintiffs Are Blocked By Federal Preemption Legal Doctrine, As Merck Contends

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

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UPDATE: U.S. Supreme Court Hearing For Fosamax Appeal Set For January 7, 2019

The U.S. Supreme Court will hear oral arguments for the Fosamax - femur fracture MDL litigation appeal on January 7, 2019, according to a hearing schedule released December 3, 2018.

(12/3/18)

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UPDATE: Justices Ask [US Solicitor General] To Weigh In On Merck's Fosamax MDL

The U.S. Supreme Court on [December 4, 2017] asked the [US Solicitor General] to weigh in on an attempt to end multidistrict litigation against Merck Sharp & Dohme Corp. over its alleged failure to warn about fracture risks from its osteoporosis drug Fosamax that hinges on a U.S. Food and Drug Administration decision.

The court asked the [US Solicitor General] to file a brief explaining the government’s position on Merck’s request that the court end the suit alleging a failure to warn about potential femoral fractures...

[Article continues at original source (subscription required)]

(12/5/17)

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In March 2017 the Third Circuit Court of Appeals decided to reverse a ruling by U.S. District Court Joel Pisano which had dismissed all the federal court Fosamax - femur fracture cases on federal preemption grounds. In turn, hundreds of those Fosamax lawsuits have been reinstated at the trial court level.

Now, by means of an August 2017 legal filing, Merck wants the U.S. Supreme Court to reverse this appeals court decision reinstating those cases.

As background, from our article about that development, "Fosamax - Femur Fracture Lawsuits In Federal Court MDL: March 2017 Appellate Court Ruling Reinstates Lawsuits":

Essentially, the Third Circuit held that the ultimate question of whether the FDA would have rejected a Fosamax label change by Merck to warn about an increased risk of femur fractures is a question of fact for the jury -- rather than for Judge Pisano -- to decide....

Certainly the Third Circuit's ruling on the Fosamax appeals is a positive development for the patients who suffered femur fractures after long-term Fosamax use and filed drug injury lawsuits against Merck.

However, it is just a first step in terms of the Fosamax - femur fracture litigation moving forward. Significantly, at the present time we do not know Merck’s plans regarding any further appeal to the United States Supreme Court.

Thereafter, the Third Circuit denied Merck’s motion for rehearing and rehearing en banc on April 24, 2017.

On June 23, 2017, Samuel Alito, an Associate Justice of the Supreme Court of the United States, extended the time for Merck to file a certiorari petition to the Supreme Court until August 22, 2017.

It was on the final day of this extension of time when attorneys for Merck filed their Petition For A Writ Of Certiorari, which sets the stage for Merck's Fosamax appeal to the Supreme Court with the following:

The question presented is: Is a state-law failure-to-warn claim preempted when the FDA rejected the drug manufacturer’s proposal to warn about the risk after being provided with the relevant scientific data; or must such a case go to a jury for conjecture as to why the FDA rejected the proposed warning?

We get some contextual information from an August 23, 2017 article, "Merck Wants SCOTUS to Review Decision Reviving Fosamax Suits", by reporter Julie A. Steinberg, which was published in Bloomberg BNA's Product Safety & Liability Reporter:

The U.S. Court of Appeals for the Third Circuit said warning claims involving a branded drug are preempted, or barred by federal law, only if a jury finds it “highly probable” the Food and Drug Administration would have rejected the warning a plaintiff sought....

Its ruling is the latest in a series of plaintiff-friendly decisions that misconstrued the Supreme Court’s landmark 2009 ruling in Wyeth Inc. v. Levine and gutted the pharmaceutical industry’s critical preemption defense, Merck says in an Aug. 22 petition for certiorari, or Supreme Court review.

Levine said failure-to-warn claims are blocked by federal law if a drug company can show “clear evidence” the FDA would have nixed a proposed warning....

But here, Merck submitted data and analysis to the FDA suggesting that Fosamax may be associated with certain bone fractures, and proposed a warning. The FDA rejected the proposed addition, saying it wasn’t supported by the data, Merck says.

The Third Circuit, though, said a jury could find the FDA might have allowed a differently phrased warning.

That decision displaces the court as the gatekeeper applying the rule of law, and invites a lay jury to speculate about why an expert federal agency did what it did, Merck argues.

We will watch to see whether Merck's request for review is granted by the Supreme Court.

If it is, then counsel for plaintiffs in the Fosamax - femur fracture litigation will have an opportunity to tell the Supreme Court why these drug injury products liability lawsuits against Merck should be allowed to go forward.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review done by attorney Tom Lamb) 

Prilosec / Prevacid / Nexium Federal Court Lawsuits For Kidney Injury Consolidated By MDL Established In August 2017

These Proton-Pump Inhibitors (PPIs) Are Linked To Acute Interstitial Nephritis, Chronic Kidney Disease, End Stage Renal Disease, And Kidney Failure

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

In February 2017 the United States Judicial Panel on Multidistrict Litigation (JPML) denied a motion for centralization or consolidation of federal court lawsuits brought by plaintiffs in six proton-pump inhibitors (PPIs) cases alleging kidney injury. All of the defendant pharmaceutical companies in those lawsuits opposed that first effort to set up a Multidistrict Litigation (MDL) for these cases.

But six months later, with more Prilosec, Prevacid, and Nexium cases filed and with some of the drug companies no longer in opposition, the JPML established IN RE: PROTON-PUMP INHIBITOR PRODUCTS LIABILITY LITIGATION (NO. II) – MDL No. 2789.

From the JPML’s Transfer Order filed on August 2, 2017 we get these details:

In the complaints in these 161 personal injury and wrongful death actions, plaintiffs allege that as a result of taking one or more proton-pump inhibitors (PPIs), they or their decedents suffered kidney injury (e.g., chronic kidney disease (CKD), acute interstitial nephritis, end stage renal disease, or kidney failure). Plaintiffs allege that defendants failed to adequately warn of the negative effects and risks associated with PPIs....

In support of this new motion, plaintiffs, AstraZeneca, and Pfizer argue that the number of involved actions, districts, and plaintiffs’ counsel has increased significantly since [our ruling in February], that many more cases likely will be filed, that there now are a significant number of related state court actions, and that informal coordination and cooperation are not practicable to manage litigation of this scope. After careful review of the record, we agree with this assessment. [footnotes omitted]

 

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Nexium / Prevacid / Prilosec

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Notably, during this second time around the drug company Takeda was still opposed to the creation of any PPIs federal court MDL for various reasons. But the JPML was not convinced by their arguments, as seen from this excerpt from the Transfer Order:

And, although it is true that AstraZeneca is sued in far more actions than Takeda, a significant number of actions are “mixed use” cases in which the plaintiffs allege use of more than one PPI, and sue Takeda and one or more other PPI manufacturers, including AstraZeneca. The prospect of additional cases against Takeda does not seem far-fetched [10]. Given these circumstances, including the seemingly indivisible nature of plaintiffs’ alleged injuries in the “mixed use” cases, we decline to carve out from the MDL cases or claims against Takeda. [footnotes omitted]

Lastly, this point – which may have been a factor for the JPML when ruling this time on the Prilosec / Prevacid / Nexium federal court MDL consolidation – was mentioned in a footnote for the August 2017 Transfer Order:  "The variety of alleged kidney injuries arguably has diminished, as most plaintiffs allege that they suffer from [chronic kidney disease (CKD)]...."

We are currently investigating Prilosec, Prevacid, Nexium, and other brand name proton pump inhibitors (PPIs) heartburn drugs, by prescription and/or over-the-counter, involving:

• Acute Interstitial Nephritis
• Chronic Kidney Disease (CKD)
• End-Stage Renal Disease (ESRD)
• Severe Renal Impairment
• Kidney / Renal Failure
• Acute Kidney Injury

We encourage you to submit a Nexium / Prilosec / Prevacid Case Evaluation online – it is free, confidential, and there is no obligation.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review done by attorney Tom Lamb) 

Farxiga MDL Created In April 2017; Assigned to Federal Court Judge Lorna Schofield In New York

This Consolidated Litigation Involves Farxiga And Xigduo XR; Side Effects Include Diabetic Ketoacidosis And Kidney Damage

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

By means of this post, we are updating our March 8, 2017 article, "Pending Motion Requests Multidistrict Litigation (MDL) For Farxiga And Xigduo XR Lawsuits Filed In Federal Court".

On April 6, 2017 the United States Judicial Panel On Multidistrict Litigation (JPML) issued this document, "IN RE: FARXIGA (DAPAGLIFLOZIN) PRODUCTS LIABILITY LITIGATION TRANSFER ORDER -- MDL No. 2776", from which we get the following information:

The eighteen actions involve allegations that ingestion of the drug Farxiga may cause a variety of injuries, including diabetic ketoacidosis and kidney damage, and that defendants Bristol-Myers Squibb Co., AstraZeneca Pharmaceuticals LP, AstraZeneca LP, AstraZeneca PLC, and AstraZeneca AB (collectively, Bristol-Myers/AstraZeneca), which developed, manufactured, and marketed the drugs, failed to adequately test the drugs and warn of their risks. Farxiga and its sister drug Xigduo XR belong to a class of diabetes drugs known as Sodium Glucose Cotransporter 2 (SGLT2) inhibitors. Other SLGT2 inhibitors include Invokana (canagliflozin) and Jardiance (empagliflozin)....

On the basis of the papers filed and the hearing session held, we find that these actions involve common questions of fact, and that centralization of these cases will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation. The actions share factual questions arising from allegations that taking Farxiga or Xigduo XR may result in patients suffering kidney-related injuries, such as diabetic ketoacidosis and kidney damage. The actions thus implicate numerous common issues concerning the development, manufacture, testing, regulatory history, promotion, and labeling of the drugs.

The JPML went on to assign this new Farxiga MDL to Judge Lorna G. Schofield, who will preside over this consolidated litigation in the Southern District of New York federal court.

 

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The FDA is investigating a connection between Farxiga and Xigduo XR -- as well as Invokana, Invokamet, Jardiance, Glyxambi, Synjardy, and Qtern -- with the following medical complications as drug side effects:

• Diabetic Ketoacidosis (DKA)
• Ketoacidosis
• Ketosis
• Acute Kidney Injury
• Kidney Failure / Renal Failure
• Kidney Damage
• Pyelonephritis (kidney infection)
• Urosepsis (blood infection)
• Urinary Tract Infection (UTI)
• Heart Attacks / Myocardial Infarctions (MI)
• Ischemic Stroke / Cerebral Vascular Accident (CVA)
• Deep Vein Thrombosis (DVT)
• Pulmonary Embolism (PE)
• Heart Failure
• Leg Amputation
• Foot or Toe(s) Amputation

All of these diabetes drugs are Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors, a new class of diabetes medicines.

We will continue to monitor legal and drug safety developments regarding Farxiga, Xigduo XR, and the several other SLGT2 inhibitor diabetes drugs.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review done by attorney Tom Lamb) 

Fosamax - Femur Fracture Lawsuits In Federal Court MDL: March 2017 Appellate Court Ruling Reinstates Lawsuits

Third Circuit Panel Reverses Earlier Dismissal Of Plaintiffs Cases By District Court Judge Pisano On Federal Preemption Grounds

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

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UPDATE: Supreme Court Agrees To Review Fosamax MDL Revival

On June 28, 2018 the U.S. Supreme Court agreed to consider a Third Circuit ruling that revived the federal court Fosamax MDL for hundreds of lawsuits concerning Merck's alleged failure to warn about a risk of femur fractures from its osteoporosis drug Fosamax.

(6/28/18)

 

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UPDATE:  "Merck Wants The US Supreme Court To Reverse A Federal Appeals Ruling In Fosamax - Femur Fractures Litigation"

(9/9/17)

 

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In a lengthy and long-awaited Opinion issued March 22, 2017, the Third Circuit Court of Appeals decided to reverse a ruling by U.S. District Court Joel Pisano which had dismissed all the federal court Fosamax - femur fracture cases on federal preemption grounds. In turn, hundreds of those Fosamax lawsuits have been reinstated at the trial court level.

Essentially, the Third Circuit held that the ultimate question of whether the FDA would have rejected a Fosamax label change by Merck to warn about an increased risk of femur fractures is a question of fact for the jury -- rather than for Judge Pisano -- to decide.

From a March 22, 2017 Reuters news report, "Merck must face renewed Fosamax warning claims: U.S. appeals court", we get these basic facts about this recent appellate decision in the Fosamax - femur fracture MDL litigation:

In a 3-0 decision, the 3rd U.S. Circuit Court of Appeals in Philadelphia said the plaintiffs may proceed to trial on their failure-to-warn claims, and a lower court judge erred in finding the claims pre-empted by federal law.

Merck said it is reviewing its options, and that a judge, not a jury, should decide the pre-emption question. It also said it remains "confident" in Fosamax's safety and effectiveness....

[Plaintiffs] said Merck knew about the risk for more than a decade before adding it to the Fosamax warning label in January 2011.

[Merck] changed the label four months after an outside task force hired by the U.S. Food and Drug Administration published a report associating Fosamax with the fractures....

[U.S. District Judge Joel Pisano] cited a 2009 U.S. Supreme Court decision that state law-based failure-to-warn claims were pre-empted when there was "clear evidence" that the FDA would not have approved a warning that plaintiffs requested.

Writing for the appeals court, however, Circuit Judge Julio Fuentes found enough evidence for a reasonable jury to conclude that the FDA would have approved "a properly-worded warning" about Fosamax, "or at the very least, to conclude that the odds of FDA rejection were less than highly probable."

Fuentes said a jury could also find that some doctors would not have prescribed Fosamax had Merck discussed the risk of fractures on a warning label.

In more detail, the so-called federal court Fosamax MDL is properly titled: In re: Fosamax (Alendronate Sodium) Products Liability Litigation.

The following excerpt from "Suits Over Fosamax Link to Femur Fractures Get New Life", by reporter Charles Toutant, which was published by the New Jersey Law Journal on March 22, 2017 provides a more in-depth legal analysis of this significant ruling:

In the Fosamax case, Third Circuit Judges Jose Fuentes, Michael Chagares and L. Felipe Restrepo said Merck failed to prove that it is entitled to the affirmative defense of pre-emption.

The appeals court said U.S. District Judge Joel Pisano erroneously granted summary judgment to Merck in June 2014 in a suit by Bernadette Glynn after wrongly concluding that the clear evidence standard had been met in that case. In 2009, the FDA rejected Merck's proposed revision of language on the Fosamax label to warn of the potential danger of bone fractures. Pisano ruled that Glynn's case was pre-empted because the FDA's 2009 decision was "clear evidence that the FDA would not have approved a label change" prior to her injury. After that ruling was issued, Merck then was granted summary judgment on all cases stemming from injuries that occurred before September 2010, the date of a task force report linking Fosamax usage to femur fractures.

Courts have struggled with the "clear evidence" standard, which is "cryptic and open-ended," Fuentes wrote for the court. The Fosamax case requires the court to address what "clear evidence" is and who should decide when it exists, he wrote. The panel wrote that "clear evidence" applies solely to the applicable standard of proof, and that the question of whether the FDA would have rejected a label change is a question for the jury and not a judge.

Certainly the Third Circuit's ruling on the Fosamax appeals is a positive development for the patients who suffered femur fractures after long-term Fosamax use and filed drug injury lawsuits against Merck.

However, it is just a first step in terms of the Fosamax - femur fracture litigation moving forward. Significantly, at the present time we do not know Merck’s plans regarding any further appeal to the United States Supreme Court.

Once the further appeal issue is resolved, we will have a better idea about what comes next for the many femur fracture lawsuits which are part of this Fosamax MDL.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

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Pradaxa Lawsuits And Settlements: Past, Present, And Future Aspects Are Explained In This 2017 Update Report

The Bottom Line: Pradaxa Is Still Associated With Serious Bleeding Events, Including Patient Deaths, And New Pradaxa Drug Injury Cases Are Still Being Filed

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

Pradaxa (dabigatran) is a relatively new blood thinner, or anticoagulant, medication used to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AF). It was approved for use by the US Food and Drug Administration (FDA) in October 2010. Boehringer Ingelheim Pharmaceuticals, Inc. markets this prescription anticoagulant drug.

Pradaxa is part of a class of novel oral anti-coagulants (NOACs), which includes Xarelto (rivaroxaban), Eliquis (apixaban), and Savaysa (edoxaban).  These NOACs are alternatives for patients who had been or would have been treated with Coumadin or warfarin in the past.

As can be seen from the following set of drug safety alerts, Pradaxa has caused significant concern among doctors and patients since soon after it first became available for use in the US.

In early December 2011 the FDA announced it would evaluate reports of bleeding in patients taking Pradaxa that have been submitted to the agency's Adverse Events Reporting System (AERS) database to determine whether serious side effects are occurring at a higher rate than should be expected.

From the ISMP QuarterWatch 2011 Quarter 1 edition, which was published January 12, 2012, we get this summary of those adverse event reports to the FDA as regards the "substantial bleeding risks" associated with Pradaxa:

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

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

The next Pradaxa safety "update" came from the ISMP QuarterWatch 2011 Quarter 2 edition, which was released April 5, 2012:

[Pradaxa], a new anticoagulant intended to reduce the risk of stroke, was a suspect drug in 856 reported cases, more than any other regularly monitored drug, but showed a decrease from 931 reports in the previous quarter. The new quarterly total included 117 reported patient deaths. With 511 reported cases of hemorrhage, and a median patient age of 80 years, these new bleeding reports reinforce our concern that vulnerable older patients may be receiving an overdose of this one-size-fits-all drug.

Due to these serious side effects, beginning in 2012 a growing number of personal injury and wrongful death Pradaxa lawsuits were filed against Boehringer Ingelheim Pharmaceuticals, Inc.

In August 2012 the United States Judicial Panel on Multidistrict Litigation (JPML) issued an Order 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, or case consolidation, was placed in the United States District Court for the Southern District of Illinois, with Chief Judge David R. Herndon presiding over the Pradaxa MDL litigation.

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Pradaxa

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Returning to the drug safety realm for a moment, in December 2013 the FDA posted for public comment on a proposed protocol of a new study intended to be a one-time assessment of selected safety outcomes in adults with atrial fibrillation who are new users of Pradaxa as opposed to Coumadin or warfarin.

In May 2014, following several years of legal proceedings in the Pradaxa MDL, the defendant Boehringer Ingelheim agreed to settle most if not all of the approximately 4,000 filed Pradaxa lawsuits. This so-called "global-settlement" deal was reached just as the first federal court Pradaxa cases were set to go to trial in September 2014.

In a statement issued by Boehringer at that time, the drug company said that it stood behind the safety and efficacy of Pradaxa and it continued to believe that the thousands of Pradaxa lawsuits lacked merit, but that settling those drug injury cases allowed the company to move on with its business interests.

Reportedly, Pradaxa had been prescribed to an estimated 850,000 patients in the United States as of May 2014, and is still widely used in the US, today.

In May 2015 U.S. District Judge Herndon issued an Order which disbanded and ended the federal court Pradaxa MDL litigation he had presided over since August 2012. His reason for doing so: There were no active federal court Pradaxa lawsuits pending other than those which were part of the 2014 global settlement by Boehringer.

But at about the same time as Judge Herndon's Order, there began to be a number of new Pradaxa lawsuits being filed in various state courts around the country. And this was the start of what has been referred to as a "round two" or the “second wave” of Pradaxa drug injury litigation.

These more recent Pradaxa lawsuits claim that Boehringer Ingelheim has continued to provide inadequate warnings about the risk of bleeding from Pradaxa side effects. Put otherwise -- despite the drug company's effort to buy its peace by means of the earlier large Pradaxa MDL settlement back in 2014 -- Boehringer is still, to this point in time, being sued for its alleged failure to warn about the full and real extent of the substantial bleeding risks associated with Pradaxa.

The only difference, essentially, is that this round two or second wave of Pradaxa litigation is being pursued at the state court level.

The bottom line is this: If you experienced serious side effects from the use of Pradaxa, or a person died due to an adverse reaction while taking Pradaxa, you may still have a claim for legal compensation. Such claims involving a serious injury or death caused by the use of Pradaxa are made by filing a lawsuit in court. It is important to know that all states have certain filing deadlines, or statutes of limitations, by which to file lawsuits involving Pradaxa side effects.

Of course, we will continue to monitor the legal, medical, and regulatory aspects of this Pradaxa situation, and report significant developments here.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

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Federal Court Invokana MDL: Judge Martinotti Is Presiding Over These Drug Injury Lawsuits In New Jersey

A December 2016 Judicial Panel for Multidistrict Litigation (JPML) Order Consolidated All Invokana And Invokamet Cases

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

In September 2016, pursuant to 28 U.S.C. § 1407, a motion was filed to establish IN RE: INVOKANA (CANAGLIFLOZIN) PRODUCTS LIABILITY LITIGATION, MDL Docket No. 2750.

In October 2016 the attorneys for Defendant Janssen Pharmaceuticals, Inc. (“Janssen”) indicated, in their legal document filed as a response to this MDL motion, that all Invokana cases filed in the federal court system should be consolidated. Further, they agreed that federal Judge Brian Martinotti, of the District of New Jersey, would be an appropriate choice by the Judicial Panel for Multidistrict Litigation (JPML) for the so-called "transferee judge" presiding over this Invokana MDL.

In December 2016 the JPML issued an Order establishing this consolidation of all Invokana federal court lawsuits.

From a December 8, 2016 New Jersey Law Journal article, "Invokana Kidney Damage MDL Established in New Jersey" (free registration required), we get the following information about this legal case development:

The panel said in its order that the cases have enough in common to warrant centralization.

"On the basis of the papers filed and the hearing session held, we find that the Invokana/Invokamet actions involve common questions of fact, and that centralization of these cases will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation," the panel said. "The actions share factual questions arising from allegations that taking Invokana or Invokamet may result in patients suffering various injuries, including diabetic ketoacidosis and kidney damage. The actions thus implicate numerous common issues concerning the development, manufacture, testing, regulatory history, promotion, and labeling of the drugs."

The suits all claim that the diabetes drug causes kidney failure and a condition called diabetic ketoacidosis, which is caused by the buildup of acids in the blood.

 

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Invokana (canagliflozin) was approved by the FDA in 2013.

Invokamet (canagliflozin and metformin) was approved by the FDA in 2014.

In December 2015 the FDA issued this Drug Safety Communication: “FDA revises labels of SGLT2 inhibitors for diabetes to include warnings about too much acid in the blood and serious urinary tract infections”. In part, it warned about the risk of ketoacidosis, a serious medical condition caused by having too much acid in the blood, for a class of newer diabetes drugs which include Invokana and Invokamet. To read more, see our earlier article: "FDA Adds Ketoacidosis Warnings To Diabetes Drugs Invokana, Farxiga, And Jardiance As Well As Other SGLT2 Inhibitors".

In May and June 2016 the FDA announced it had strengthened the existing warning about the risk of acute kidney injury for Invokana and Invokamet. To read more, see our earlier article: "Invokana, Invokamet, Farxiga, Xigduo: Warnings About Acute Kidney Injury Risk Are Increased On Revised Drug Labels For These Diabetes Medicines".

In August 2016 the FDA sent letters to Janssen for Invokana and Invokamet label changes concerning fatal cases of ketoacidosis. To read more, see our earlier article: "FDA Mandates Label Change Warning About Fatal Cases Of Ketoacidosis For All Diabetes Drugs Known As Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors".

Lastly, we refer you to this earlier article, "Diabetes Medicine Invokana Gets New Warning About Lower Limb Amputation Added To Drug Package Insert In Canada". Interestingly, this December 2016 label change mandated by Health Canada did not apply to Jardiance, Farxiga, and the rest of the SGLT2 inhibitors class of drugs.

We are currently investigating possible Invokana and Invokamet lawsuits against the drug company Janssen for diabetes patients who have developed any of the medical conditions listed above.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review done by attorney Tom Lamb)