Plaintiffs' Experts Can Testify at Xarelto Trial

With the first Xarelto bellwhether trial starting this week, several Daubert motion rulings by presiding Judge Fallon will surely have an impact on the outcome. Judge Fallon admitted four of the Plaintiff’s key expert witnesses in two of the upcoming bellwether trials.

Defendants Janssen and Bayer unsuccessfully tried to block the admission of key expert witnesses. The expert witnesses admitted to testify are Dr. Suzanne Parisian, an expert in the field of FDA regulation; Dr. Laura Plunkett, who will testify about drug pharmacology, general causation, regulatory matters and the adequacy of labels for both prescription and non-prescription drugs; Dr. David Kessler, who will be offering testimony in regards to the conduct of pharmaceutical companies; and Dr. Nathaniel Winstead, who will be called to support the Plaintiff’s position on the probable cause of the Plaintiff’s gastrointestinal bleed.

The Court also allowed the Plaintiffs’ expert witnesses to express opinions regarding the bleeding risk of Xarelto and how it would be reduced if a doctor monitored their patients. “Because of Xarelto’s short half-life and the variability in patients, some patients will retain more Xarelto in their system and will be subject to a greater bleeding risk,” Judge Fallon said.

Judge Fallon also excluded defense expert Dr. James A. Reiffel, who was going to offer the preposterous testimony that patients might have abruptly stopped taking Xarelto due to attorney-led advertising.

The Plaintiffs did not win every Daubert battle, however. Ruling for the pharmaceutical giants, the Judge said that their experts could testify about what might have happened to the Plaintiffs if they had taken a different anticoagulant. The court also will allow several other defense experts to testify, but did limit the extent of their opinions.

Farxiga MDL Created

The Judicial Panel on Multidistrict Litigation established MDL No. 2776 in the Southern District of New York to hear claims of diabetic ketoacidosis and kidney damage caused by the Farxiga and Xigduo diabetes drugs. The cases were assigned to Judge Lorna G. Schofield.

The defendants are Bristol-Myers Squibb and AstraZeneca. The JPML stated that the 18 actions currently pending in six federal district courts share common questions of fact and would benefit from a centralized pre-trial MDL docket.

Farxiga, and its sister drug Xigduo XR, belong to a class of diabetes drugs known as Sodium Glucose Cotransporter 1 2 (SGLT2) inhibitors. Other SLGT2 inhibitors include Invokana (canagliflozin) and Jardiance (empagliflozin). The FDA approved Farxiga for treatment in type 2 daibetes on January 8, 2014. Xigduo XR was approved shortly after Farxiga, on October 29, 2014.

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.

Plaintiffs are claiming the following injuries:

•           sudden onset of life-threatening diabetic ketoacidosis (often in the setting of normal blood glucose levels)
•       acute renal failure
•        pyelonephritis (kidney infection)
•        urosepsis (life-threatening blood infections)
•       death

Some of these injuries were the subject of recent FDA safety advisories. In fact, On December 4, 2015, the FDA issued a safety communication disclosing they had found 73 adverse events reported between March 2013 and May 2015 that required hospitalization due to ketoacidosis in SGLT2 inhibitor users.

Based on this disclosure, the FDA changed the label for Farxiga and Xigduo XR to include a warning “about the risks of too much acid in the blood” and urged patients taking SGLT2 inhibitors to stop taking the drug and seek immediate medical attention if they have any symptoms of ketoacidosis. The FDA also required a label change to warn of urosepsis and pyelonephritis.

On June 14, 2016, the FDA issued a safety announcement that advised that the existing warning about the risk of acute kidney injury on the Farxiga and Xigduo labels would be strengthened.

Pittman, Dutton & Hellums, P.C., is currently investigating claims against the manufacturers of Farxiga. If you or a loved one believe you were injured as a result of taking Farxiga, please contact Booth Samuels at booths@pittmandutton.com or call toll free 1-866-515-8880.

First Xarelto Trial To Begin April 24th

The first bellwether trial in the Xarelto MDL is about to begin and the Plaintiffs have won several import legal motions which will help bolster their claims. Judge Fallon, the Louisiana federal judge overseeing the litigation, denied partial summary judgments from the Defendants on some claims against Bayer AG and Janssen Pharmaceuticals Inc., saying they cannot necessarily blame or use FDA red tape for their lack of label updates or for any noncompliance with Louisiana law. The motions dealt with federal preemption of several of Plaintiffs’ claims.

The first MDL trial is set to begin April 24^th, which is one of four set to occur in the coming months. There are more than 16,000 cases pending in the Xarelto MDL, with other cases consolidated in Pennsylvania.

Xarelto (rivaroxaban) is an oral blood thinner medication used to reduce the risk of blood clots and strokes in patients with atrial fibrillation and to treat blood clots in the leg and lungs. However, unlike other blood thinners like Coumadin, Xarelto does not have reversal agents to counteract its anticoagulation effects, according to the FDA.

Plaintiffs who have filed suit have alleged the following injuries:

            Intracranial hemorrhages

            Abdominal hemorrhages

            Retinal hemorrhages

            Epidural hematoma

            Adrenal bleeding

            Excessive blood loss

            GI bleeds

            Death

Pittman, Dutton & Hellums, P.C., is currently investigating and filing Xarelto cases. If you or a loved one were prescribed Xarelto and suffered an irreversible internal bleeding that lead to hospitalization and/or death, contact Booth Samuels at toll free 1-866-515-8880 or by email at booths@pittmanudutton.com.

Zimmer Biomet Recalls Comprehensive Reverse Shoulder Implants

Zimmer Biomet is recalling 3662 of their Comprehensive Reverse Shoulder implants. These prosthetics are used to treat rotator cuff tears, particularly when conventional surgery has failed. The device aids in helping to restore movement of the shoulder, which is often lost because of the injury. The Zimmer products have a higher fracture rate than the company’s warnings indicate. If the device fractures, revision surgery becomes necessary.

The FDA has labeled this recall as a Class 1 recall, which is the most serious class of recall that can be issued and are classified as urgent. Zimmer Biomet sent notices out December 20, 2016. The FDA did not announce until February 2017 that Zimmer Biomet issued a recall.

The Zimmer shoulders that are recalled were manufactured between August 25, 2008, and September 27, 2011, and distributed between October, 2008, and September, 2015.

Pittman, Dutton & Hellums, P.C., is currently investigating claims against Zimmer Biomet over their Comprehensive Reverse Shoulder implants. If you or a love one was adversely affected by this product, please contact Booth Samuels at booths@pittmandutton.com or call toll free 1-866-515-8880.

11th Circuit Affirms Wright Verdict

The 11th US Circuit Court of Appeals upheld a $2.1 million judgment by a jury in the first bellwether trial in a multidistrict litigation involving the Wright Medical Conserve “metal-on-metal” hip replacement device. Wright today faces approximately 585 lawsuits in an MDL over its metal-on-metal hip replacement in Wright Medical Technology, Inc., Conserve Hip Implant Products Liability Litigation.

The jury found that the hip devices were defectively designed and unreasonably dangerous and that it caused the plaintiff’s injuries. They awarded $1.1 million in compensatory damages and $10 million in punitive damages. The punitive damages award was later reduced to $1.1 million by the judge.

In related litigation, Wright settled 1,292 claims in November 2016 in consolidated litigation in Georgia federal court and California state court for $240 million, putting an end to the majority of the pending claims against Wright.

Patients who had revision surgery within eight years of their original Conserve, Lineage or Dynasty hip implant are eligible for the settlement. Conserve Cup devices claims can receive up to $170,000, while those patients implanted with the metal-liner Dynasty and Lineage devices can receive up to $120,000 – per reports.

Wright is also facing 74 lawsuits involving fractures of its Profemur long titanium modular neck hip device. It has been marketed by MicroPort Orthopedics, Inc. of Arlington, TN, since 2013. On June 21, 2016, MicroPort recalled its Conserve Shell, Dynasty® Metal Liner, Procotyl® Metal Liner and Lineage® Metal Liner because of “an increasing overall trend in revisions from 2009 to present, and it was found that there was a specific hazard/harm for “suspected tissue reaction to metal debris.”

If you or a loved one have had hip replacement surgery and have been implanted with a defective hip, you may be entitled to compensation for medical bills, pain and suffering, lost wages and other injuries. Our firm is currently investigating claims for those people who have been implanted with hip replacement devices, including Wright, DePuy ASR, and DePuy Pinnacle. If you would like a free case evaluation, please contact Booth Samuels toll free at 1-866-515-8880 or by email at booths@pittmandutton.com.