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The medical literature about breast implant-associated ALCL (BIA-ALCL) grew considerably in 2015, and reflected a better understanding of the diagnosis and treatment aspects of this rare form of lymphoma.
In February 2015 this article, “Breast Implant-associated Anaplastic Large Cell Lymphoma: Updated Results from a Structured Expert Consultation Process”, was published in Plastic and Reconstructive Surgery-Global Open. From the Abstract for this article:
[A multidisciplinary panel] agreed that (1) this disease should be called “BIA-ALCL”; (2) late seromas occurring >1 year after breast implantation should be evaluated via ultrasound, and if a seroma is present, the fluid should be aspirated and sent for culture, cytology, flow cytometry, and cell block to an experienced hematopathologist; (3) surgical removal of the affected implant and capsule (as completely as possible) should occur, which is sufficient to eradicate capsule-confined BIA-ALCL; (4) surveillance should consist of clinical follow-up at least every 6 months for at least 5 years and breast ultrasound yearly for at least 2 years; and (5) BIA-ALCL is generally a biologically indolent disease with a good prognosis, unless it extends beyond the capsule and/or presents as a mass. They firmly disagreed with statements that chemotherapy and radiation therapy should be given to all patients with BIA-ALCL.
Next, in the March 2015 edition of Plastic and Reconstructive Surgery, came this report, “Anaplastic large cell lymphoma occurring in women with breast implants: analysis of 173 cases”, which provided this information:
[Anaplastic large cell lymphoma (ALCL)] lesions first presented as late peri-implant seromas, a mass attached to the capsule, tumor erosion through the skin, in a regional node, or discovered during revision surgery. The clinical course varied widely from a single positive cytology result followed by apparent spontaneous resolution, to disseminated treatment-resistant tumor and death. There was no preference for saline or silicone fill or for cosmetic or reconstructive indications. Where implant history was known, the patient had received at least one textured-surface device.
In October 2015 Clinics in Plastic Surgery published “Coming of Age: Breast Implant-Associated Anaplastic Large Cell Lymphoma After 18 Years of Investigation”, from which we get this excerpt:
Breast implant associated anaplastic large cell lymphoma (BIALCL) is a distinct clinical entity that can present in patients receiving either reconstructive or cosmetic breast implants. Presenting symptoms include onset of a delayed (>1 year after implantation) fluid collection, mass of the capsule, or lymphadenopathy. Treatment has progressed in recent years and most commonly includes implant removal and total resection of the tumor, including capsule, mass, and involved lymph nodes.
Given the developments medical researchers have made in understanding this breast implants lymphoma cancer situation, in March 2017 the FDA provided a summary of updated information it had collected in a new document, “Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)”.
We continue to monitor the medical literature for articles about the diagnosis and treatment of BIA-ALCL as well as the various theories about how this rare form of lymphoma (blood cancer) develops in some women with breast implants.
In March 2017 the British Journal of Clinical Pharmacology published this article, “Risk of myocardial infarction in patients with atrial fibrillation using vitamin K antagonists, aspirin or direct acting oral anticoagulants”, which reports on the first retrospective cohort study to compare the risk of acute myocardial infarction (AMI), or heart attack, with use of direct-acting oral anticoagulants (DOACs) with that associated with vitamin K antagonists (VKAs), e.g., warfarin.
The bottom line is that the medical researchers conducting this study found a two-fold increase in the risk of heart attacks with use of Pradaxa (dabigatran) and Xarelto (rivaroxaban) in comparison with warfarin in patients using those drugs for atrial fibrillation (AF) therapy.
Specifically, from the Results section of the Abstract for this March 2017 medical journal article: “The risk of AMI was doubled when we compared current use of DOACs with current use of VKAs [adjusted HR 2.11; 95% confidence interval (CI) 1.08, 4.12]….”
And from the Discussion part of the full article:
In conclusion, our cohort study identified a twofold increase in the risk of AMI when using DOACs, [Xarelto (rivaroxaban)] or [Pradaxa (dabigatran)], in comparison with VKAs, in AF therapy in real-world patients. In addition, our results showed that in AF patients, the risk of AMI with current use of aspirin as monotherapy is higher than with current use of VKAs. VKAs probably have greater beneficial effects on AMI than DOACs. Ongoing research is needed as the use of DOACs increases in the population.
While this observational study reports that there is a correlation between the use of Xarelto (rivaroxaban) or Pradaxa (dabigatran) with an increased risk for myocardial infarction (MI), or heart attack, it is important to keep in mind that correlation does not prove causation.
Rather, in order to definitively answer the question “Do direct oral anticoagulants (DOACs) increase the risk for myocardial infarction (MI), or heart attack”, we will need a well-designed study. One hopes that Boehringer Ingelheim Pharmaceuticals (Pradaxa) or Janssen Pharmaceuticals (Xarelto), as the responsible drug companies, have such a drug-safety study currently underway or planned to begin soon.
You may have heard about the March 2017 FDA update report concerning a little-known and rare type of lymphoma, or blood cancer, which has been developing in some women who have had breast implant procedures done for augmentation or reconstruction purposes.
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 basic information 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.
In more detail, the FDA updated its “Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)” information page in March 2017.
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.
The earlier referenced March 21 NYT news story also provides some contextual information which seems to help us understand the timing of this recent FDA announcement about breast implants and lymphoma:
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.”
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).
A recent ruling on the long-pending appeals in the so-called federal court Fosamax MDL — In re: Fosamax (Alendronate Sodium) Products Liability Litigation — is a positive development for the patients who suffered femur fractures after long-term Fosamax use and filed drug injury lawsuits against Merck.
On March 22, 2017 the Third Circuit Court of Appeals reversed an earlier ruling by U.S. District Court Joel Pisano which had dismissed all the federal court Fosamax – femur fracture cases on federal preemption grounds. By means of this appellate court decision, hundreds of those Fosamax lawsuits have now been reinstated at the trial court level.
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….
[In dismissing the Fosamax lawsuits, 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.
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 (and not Judge Pisano) to decide.
However, this 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.
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. 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 this federal court Pradaxa MDL, or case consolidation, was created: IN RE: PRADAXA (DABIGATRAN ETEXILATE) PRODUCTS LIABILITY LITIGATION, MDL No. 2385.
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 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.
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.
Invokana (canagliflozin) was approved by the FDA in 2013. Invokamet (canagliflozin and metformin) was approved by the FDA in 2014. Both of these drugs were approved for use by patients with Type 2 diabetes.
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 Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors, a class of newer diabetes drugs which include Invokana and Invokamet.
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.
In August 2016 the FDA sent letters to Janssen for Invokana and Invokamet label changes concerning fatal cases of ketoacidosis.
Due in part to these FDA drug safety alerts, there have been lawsuits filed on behalf of diabetes patients who used Invokana or Invokamet. Those lawsuits recently gave rise to a request for the consolidation of all Invokana and Invokamet cases pending in the various federal court districts around the country before one judge.
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, it agreed 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 and Invokamet federal court lawsuits.
We are currently investigating possible Invokamet and Invokana lawsuits against the drug company Janssen for diabetes patients who have developed any of the medical conditions listed above.
Of course, we will continue to monitor the Invokana / Invokamet legal cases and report significant developments here.
There have been drug injury lawsuits filed involving Farxiga (dapagliflozin) and Xigduo XR (dapagliflozin and metformin extended-release), which are relatively new diabetes medicines in the Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors class of drugs.
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.
Be assured we will be watching for the JPML determination about whether or not to establish this Farxiga / Xigduo XR MDL.
A recent medical study done by medical researchers in St. Louis, Missouri indicates that more than half of those patients who develop chronic kidney damage (CKD) while using proton pump inhibitors (PPIs) heartburn drugs and acid reflux medicines do not experience acute kidney problems before their CKD diagnosis.
These researchers published their findings in this February 2107 article, “Long-term kidney outcomes among users of proton pump inhibitors without intervening acute kidney injury”, published in the Kidney International medical journal.
A February 22, 2017 ScienceDaily news report, “Popular heartburn drugs linked to gradual yet ‘silent’ kidney damage”, provides a good analysis of this recent safety study concerning Nexium, Prevacid, Prilosec, and other PPI heartburn drugs and acid reflux medicines.
From that ScienceDaily news report we get this information:
The onset of acute kidney problems is not a reliable warning sign for clinicians to detect a decline in kidney function among patients taking proton pump inhibitors, said Ziyad Al-Aly, MD, the study’s senior author and an assistant professor of medicine at Washington University School of Medicine. “Our results indicate kidney problems can develop silently and gradually over time, eroding kidney function and leading to long-term kidney damage or even renal failure…. [M]ore than half of the cases of chronic kidney damage and end-stage renal disease associated with PPI use occurred in people without acute kidney problems….
We are currently investigating possible drug injury lawsuits against the responsible pharmaceutical companies for people who have developed any of the kidney-related medical problems listed above.
Of course, we will continue to monitor the medical literature for developments concerning serious kidney-related side effects of popular heartburn drugs and acid reflux medicines like Nexium, Prilosec, and Prevacid.
In February 2017 a so-called “black-box” warning was added to the drug labels for Harvoni, Sovaldi, Technivie, Viekira Pak, and other direct-acting antivirals, warning doctors and patients that cases of hepatitis B virus (HBV) reactivation have been reported. Further, it states that some of those cases resulted in fulminant hepatitis, hepatic failure, and death.
For more details, we get the following from the Warnings and Precautions part of the February 2017 revised Sovaldi drug label:
5.1 Risk of Hepatitis B Virus Reactivation in Patients Coinfected with HCV and HBV
Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals, and who were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death….
HBV reactivation is characterized as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA level. In patients with resolved HBV infection, reappearance of HBsAg can occur. Reactivation of HBV replication may be accompanied by hepatitis, i.e., increases in aminotransferase levels and, in severe cases, increases in bilirubin levels, liver failure, and death can occur.
Back in December 2016 Health Canada issued this document, “Summary Safety Review — Direct-acting antivirals – Assessing the Potential Risk of Hepatitis B Virus Reactivation”, from which we get the following key points:
- Health Canada carried out a review of the potential risk of hepatitis B virus (HBV) reactivation with the use of DAAs. The review was triggered by reports that patients infected with both HBV and HCV may experience a reactivation of their HBV infection if DAAs are used to treat their HCV infection. These reports were identified by the European Medicines Agency (EMA).
- Health Canada’s review concluded that there is a potential risk of HBV reactivation in patients coinfected with both HBV and HCV, and the use of DAAs. Health Canada has recommended that the safety information for all DAAs be updated to inform about this potential risk.
We will continue to monitor this aspect of the safety profile of Harvoni, Sovaldi, Technivie, Viekira Pak, and other direct-acting antivirals (DAAs) used increasingly in the US and elsewhere to treat the hepatitis C virus (HCV).
In the federal court system, there are now more than 50 Eliquis lawsuits filed, and more of these drug injury and death cases are expected. Given this situation, in early February 2017 the United States Judicial Panel on Multidistrict Litigation (JPML) established this consolidation of all federal court Eliquis cases, IN RE: ELIQUIS (APIXABAN) PRODUCTS LIABILITY LITIGATION — MDL No. 2754.
From the February 7, 2017 JPML Order establishing this Eliquis federal court MDL we get this information about the litigation:
[W]e find that these actions involve common questions of fact, and that centralization will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation. All the actions share common factual questions arising out of allegations that plaintiffs suffered severe bleeding and related injuries as a result of taking Eliquis (apixaban), that defendants did not conduct sufficient testing of the drug, and that defendants’ warnings and instructions as to the alleged risks, including the unavailability of a reversal agent to counteract bleeding, were inadequate. Issues concerning the design, testing, manufacture, regulatory approval, labeling, and marketing of Eliquis thus are common to all actions….
We conclude that the Southern District of New York is an appropriate transferee district for this litigation. Common defendants BMS and Pfizer both have their corporate headquarters within the district, and therefore relevant documents and witnesses are likely to be located there. Sixteen actions on the motion and three potential tag-along actions are pending there.
In addition to the federal court Eliquis cases, there are a significant number of Eliquis lawsuits filed in the California state court system. As a result, a petition to coordinate those California Eliquis cases was submitted to the Chair of the Judicial Council seeking to establish a consolidation, there, which would be similar to the federal court Eliquis MDL.
In California, if that petition to coordinate the Eliquis lawsuits — which was submitted to the Chair of the Judicial Council (the Chief Justice) and then assigned to a motion judge for determination — is granted, its result would be called the California Eliquis JCCP (Judicial Council Coordination Proceedings).
It is currently expected that the determination about the creation of this California Eliquis JCCP will be made in the next couple of months.
In January 2017 liver injury was added to the Warnings and Precautions part of the Prescribing Information document, or drug label, for Tecfidera (dimethyl fumarate), which was approved by the FDA in 2013 as a treatment of patients with relapsing forms of multiple sclerosis (MS).
We get background information and some commentary from this February 1, 2017 Medscape Medical News article, “Dimethyl Fumarate for MS: Liver Injury Warning Strengthened”:
The prescribing information for the oral multiple sclerosis (MS) medication dimethyl fumarate (Tecfidera, Biogen) has been updated to include a warning of potential liver injury that could require hospitalization.
The new information notes that clinically significant cases of liver injury have been reported in patients treated with the drug in the postmarketing setting. The onset has ranged from a few days to several months after initiation of treatment….
MS experts contacted by Medscape Medical News did not think the labeling change would make much difference to its use.
“The incidence of liver function abnormalities appears to be rare, but the new labeling informs prescribers that monitoring will be necessary,” said Edward Fox, MD, MS Clinic of Central Texas, Round Rock. “I would expect that this will lead to more frequent laboratory testing early in the course of treatment, but would be very unlikely to affect prescribing patterns. Personally, it won’t change what I have already been doing. Most disease-modifying treatments for MS, including all approved oral therapies, have labeling reflecting a risk of hepatic injury.”…
But Mark S. Freedman, MD, Ottawa Hospital, Ontario, Canada, noted that this was another side effect to have shown up with the drug since it reached the market.
“Tecfidera is not the ‘honey’ it was reported to be from the clinical trials,” he commented. “Progressive multifocal leukoencephalopathy and other opportunistic infections (herpes), hepatotoxicity, renal toxicity, and other issues have all surfaced since the trials were reported.”
We will continue to monitor the medical literature and adverse event reports for significant cases of liver injury associated with the use of Tecfidera by MS patients.
All content by attorney Tom Lamb