Drug Injury Watch

The Rare Lymphoma (Blood Cancer) Linked To Breast Implants Which Has Caused Nine Patient Deaths

March 2017 FDA Report Provides Update On Emerging Safety Issue: Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) 

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

In March 2017 the FDA updated its "Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)" information page (accessed 3/31/17).

The most notable new facts are found in the Medical Device Reports part of this FDA breast implants - lymphoma page, specifically the most-current figures on the number of BIA-ALCL cases:

As of February 1, 2017, the FDA has received a total of 359 medical device reports (MDRs) of BIA-ALCL, including nine deaths. There are 231 reports that included information on the implant surface. Of these, 203 were reported to be textured implants and 28 reported to be smooth implants. Most of the reports contained no information about the surface textures of any previous implants. In addition, 312 of the 359 reports included information on implant fill types. Of these, 186 reported implants filled with silicone gel and 126 reported implants filled with saline.

From this March 21, 2017 article, "9 Deaths Are Linked to Rare Cancer From Breast Implants", published by The New York Times (NYT), we get some background information and observations regarding this still-emerging health problem:

About 290,000 women in the United States had implants for breast enlargement in 2016, and 109,000 received them for reconstruction after breast cancer, according to the American Society of Plastic Surgeons.

In many cases when the lymphoma occurs, just removing the implant and the tissue around it eliminates the disease. But some women may need chemotherapy and radiation.

Why there is a difference in risk related to the surfaces is not known, but the body’s reaction to textured implants is different from its reaction to smooth ones, according to Dr. Alex K. Wong, a plastic surgeon and researcher at the University of Southern California’s Keck School of Medicine. Tissue grows into microscopic grooves in the textured implants....

“We’re still trying to find out why the surface matters,” he said, adding that in some cases the cancer seems also to be associated with a certain bacterial infection.

Surgeons use textured implants if they want the implant to stick in place and not move, which is important for newer, anatomically shaped implants that would look bad if they were to shift or turn upside down.

__________________________________________________________________

Breast Implants Lymphoma / Cancer

Free Case Evaluation

Strictly Confidential, No Obligation.

__________________________________________________________________

 

One may wonder about the timing of this March 2017 FDA update report about a little-known and rare type of lymphoma, or blood cancer, developing in some women who have had breast implant procedures done for augmentation or reconstruction purposes. The same NYT news story provides some contextual information which seems to help understand that issue:

A spokeswoman for the F.D.A., Stephanie Caccomo, said Tuesday’s announcement was made because “in 2016, there were several advances in the description of the disease and treatment recommendations, including recognition of the disease by the World Health Organization and publication of diagnosis and treatment guidelines by the Plastic Surgery Foundation and National Comprehensive Cancer Network.”

Together with other law firms, we are currently investigating breast implant - lymphoma cases as possible products liability lawsuits against the responsible medical device companies.

Of course we will continue to monitor the medical literature and regulatory realm for further developments concerning breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

Breast Implants: Lymphoma / Blood Cancer Cases Overview

Free Breast Implants Case Evaluation

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)

 

---

 

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)

 

---

 

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

(9/9/17)

 

---

 

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)

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

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.

__________________________________________________________________

Pradaxa

Free Case Evaluation

Strictly Confidential, No Obligation.

__________________________________________________________________

 

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)

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

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.

 

____________________________________________

Invokana / Farxiga / Jardiance

Free Case Evaluation

Strictly Confidential, No Obligation.

____________________________________________

 

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) 

Pending Motion Requests Multidistrict Litigation (MDL) For Farxiga And Xigduo XR Lawsuits Filed In Federal Court

These New Diabetes Drugs Have Increased Risks Of Serious Side Effects Such As Diabetic Ketoacidosis (DKA) And Acute Kidney Injury

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

Farxiga (dapagliflozin) and Xigduo XR (dapagliflozin and metformin extended-release) are diabetes medicines in the Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors class of drugs.

These relatively new diabetes drugs are from AstraZeneca Pharmaceuticals and were initially approved in 2014 by the FDA.

In June 2016 the FDA announced it had strengthened the existing warning about the risk of acute kidney injury for Farxiga and Xigduo XR by means of issuing this document, "FDA Drug Safety Communication: FDA strengthens kidney warnings for diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR)".

Prior to that time the FDA was mostly investigating a connection between Farxiga and Xigduo XR with these several other drug side effects: diabetic ketoacidosis (DKA); ketoacidosis; and, ketosis.

Related to these various safety issues, in the legal realm, there have been drug injury lawsuits filed involving Farxiga and Xigduo XR.

 

____________________________________________

Invokana / Farxiga / Jardiance

Free Case Evaluation

Strictly Confidential, No Obligation.

____________________________________________

 

Those lawsuits recently gave rise to a request for the consolidation of all Farxiga and Xigduo XR cases pending in the various federal court districts around the country before one judge. This legal motion is scheduled to be heard by United States Judicial Panel On Multidistrict Litigation (JPML) on March 30, 2017.

From this court document we get the following information about this proposed federal court multidistrict litigation, or MDL, for Farxiga and Xigduo XR:

• This motion for transfer involves eighteen pending cases in six district courts asserting similar claims....
• Each of these Actions arise from the same or similar operative facts and wrongful conduct alleging that, as a result of ingesting Farxiga, Plaintiffs have suffered sudden onset of life-threatening diabetic ketoacidosis (often in the setting of normal blood glucose levels), and/or acute renal failure, and/or pyelonephritis (kidney infection) and/or urosepsis and continue to suffer from the sequelae of these injuries. Farxiga (dapagliflozin) is a pharmaceutical drug used to treat Type 2 Diabetes. All of these injuries were the subject of recent FDA safety advisories....
• ... Judge [Lorna G.] Schofield in the Southern District of New York is already presiding over the vast majority of the Farxiga cases filed nationally. She has already conducted a pretrial conference to attempt to coordinate the cases pending before her. Continuing with that process would prevent any further delay in those cases. Further, Defendant Bristol-Myers Squibb has its principal place of business in New York....
• If the Panel should decide that transfer to the Southern District of New York is not warranted, Plaintiff requests in the alternative, Transfer to either the Eastern District of Pennsylvania before Judge Mitchell Goldberg, or the Southern District of Illinois before Judge Nancy J. Rosenstengel.

We will watch for the JPML determination about whether or not to establish this Farxiga / Xigduo XR MDL and report that result in an update to this article some time after the hearing, which is scheduled for March 30, 2017.

We are currently investigating possible Xigduo XR and Farxiga drug injury lawsuits against AstraZeneca Pharmaceuticals, the responsible pharmaceutical company, 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)