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product liability lawsuits

Stryker Defibrillator Recall

By | Business Litigation, product liability lawsuits

On February 1, 2019, Stryker issued an “URGENT MEDICAL DEVICE SAFETY NOTICE & CORRECTION ACTION REQUIRED” regarding its LIFEPAK® 15 Monitor/Defibrillator, stating that “Stryker is conducting a voluntary Field Action for specific LIFEPAK 15 Monitor/Defibrillator devices that may lock-up after a defibrillation shock is delivered.”

The recall notice states that the issue is limited to LIFEPAK 15 Monitor/Defibrillator devices with certain System Printed Circuit Board Assemblies, and that Stryker has become aware that certain LIFEPAK 15 Monitor/Defibrillators were reported to experience a lock-up condition after a defibrillation shock was delivered. This condition is defined as a blank monitor display with LED lights on, indicating power to the device, but no response in the keypad and device functions. A device in this condition has the potential to delay delivery of therapy, and this delay in therapy has the potential to result in serious injury or death.

Stryker states that since the initial commercialization of LIFEPAK 15 in 2009, it has become aware of 58 complaints reported globally for this issue, including 6 events in which the patient died following a delay in therapy. In all six of these cases, at least one shock was delivered prior to the device experiencing the lock-up condition. There are 13,003 devices potentially affected by this issue and within scope of the recall.

Stryker warns that the device automatic self-tests do not identify this fault, as it occurs during defibrillation. Stryker states that customers should continue to perform the daily check as described in the Operator’s Checklist, specifically, the QUIK-COMBO therapy cable check as described in the General Maintenance and Testing Section (pages 10-4 and the LIFEPAK 15 Monitor/Defibrillator Operator’s Checklist, number 7), and that customers continue to use their LIFEPAK 15 Monitor/Defibrillator according to the Operating Instructions until the correction can be completed.

Stryker instructs that if a device exhibits the lockup condition during patient use, the steps from the General Troubleshooting Section (page 10-18) of the LIFEPAK 15 Monitor/Defibrillator Operating Instructions should be followed:

1. Press and hold ON until the LED turns off (~5 seconds). Then press ON to turn the device back on.

2. If the device does not turn off, remove both batteries and disconnect the device from the power adapter, if applicable. Then reinsert batteries and/or, reconnect the power adapter, and press ON to turn the device back on.

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LIFEPAK 15 Monitor/Defibrillator

Stryker describes its LIFEPAK 15 on its website as follows:

LIFEPAK 15 is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols.

INTENDED USE: LIFEPAK 15 intended for use by trained medical personnel out-of-doors, in indoor emergency care settings, and is designed to be used for ground transportation. Monitoring and therapy functions may only be used on one patient at a time. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation (AED) mode intended for use on patients ≥8 years of age.

INDICATIONS FOR USE – MANUAL DEFIBRILLATION: Indicated for termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of energy in synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia and, in relatively stable patients, ventricular tachycardia.

CONTRAINDICATIONS – MANUAL DEFIBRILLATION: Contraindicated in treatment of PEA and asystole.

AED MODE: To be used only on patients in cardiopulmonary arrest. Patient must be unconscious, pulseless, and not breathing normally before using defibrillator to analyze patient’s ECG rhythm. In AED mode, the LIFEPAK 15 is intended for use on pediatric patients ≥ 8 years of age.

CONTRAINDICATIONS – AED MODE: None known.

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If you or a loved one suffered harm due to a defective medical device or defibrillator in the United States, you should promptly consult with a medical device claim lawyer in your U.S. state who may investigate your defective medical device claim for you and represent you or your loved one in a medical device claim, if appropriate.

Email us at info@businesslitigationcontingencylawyers.com or telephone us toll-free in the United States at 800-756-2143 to find product liability lawyers in your state who may assist you.

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Federal Judge Limits Evidence To Be Admitted In Bayer AG’s Roundup Cancer Trial

By | Business Litigation, product liability lawsuits

As reported by Reuters on January 4, 2019, a federal judge overseeing lawsuits alleging Bayer AG’s glyphosate-based Roundup weed killer causes cancer declined to reconsider a ruling that limits evidence the plaintiffs in the litigation consider crucial to their cases. During a hearing in federal court in San Francisco, U.S. District Judge Vince Chhabria denied a plaintiff lawyer’s request to review the decision, saying trials before him should focus on scientific evidence.

On January 3, 2019, Judge Chhabria granted Bayer unit Monsanto’s request to split an upcoming trial into two phases. The order initially bars lawyers for plaintiff Edwin Hardeman from introducing evidence that the company allegedly attempted to influence regulators and manipulate public opinion. That trial is scheduled to begin on February 25, 2019, along with two other bellwether trials intended to help determine the range of damages and define settlement options for the rest of the 620 Roundup cases pending before the Judge.

The plaintiff’s lawyer argued during a hearing on January 4, 2019 that the Judge’s ruling is “unfair” as the plaintiffs’ scientific evidence allegedly showing glyphosate causes cancer is inextricably linked to Monsanto’s alleged wrongful conduct: “The science doesn’t exist in some isolated, untouched world,” adding that evidence of Monsanto’s alleged attempts to manipulate, misrepresent and intimidate scientists has to be included.

The plaintiffs’ lawyers contend that such evidence, including internal Monsanto documents, showed the company’s misconduct and were critical to a California state court jury’s August 2018 decision to award $289 million in a similar case. That award was subsequently reduced to $78 million and was then appealed.

Judge Chhabria advised the plaintiffs’ lawyers that he did not want plaintiffs to “focus on misrepresenting statements” by Monsanto employees: “My point is you’re mischaracterizing what Monsanto people have said, you’re putting your own spin on (it).”

Bayer denies that glyphosate causes cancer, contending that decades of independent studies have shown Roundup, the world’s most widely used weed killer, to be safe for human use. However, Bayer faces more than 9,300 U.S. lawsuits over Roundup’s safety in state and federal courts across the United States.

Pursuant to Judge Chhabria’s order, evidence of Monsanto’s alleged misconduct would be allowed only if glyphosate was found to have caused Hardeman’s cancer and the trial proceeded to a second phase to determine Bayer’s liability.

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Class Action Lawsuit Filed Against Walmart And Drug Companies Regarding Adulterated High Blood Pressure Medication

By | Class Action Lawsuits, product liability lawsuits

On December 1, 2018, a proposed class action  lawsuit was filed in the U.S. District Court for the Middle District of Florida Tampa Division (“federal court”) regarding Walmart and the other defendants’ (Aurobindo Pharma Ltd., ScieGen Pharmaceuticals, Inc., and Westminster Pharmaceuticals, LLC)  “manufacturing, distribution, and sale of generic irbesartan prescription medications containing an active pharmaceutical ingredient (“API”) adulterated with N-nitrosodiethylamine (“NDEA”), a probable human carcinogen.” Irbesartan is a prescription medication mainly used to treat high blood pressure and diabetic nephropathy.

The federal class-action lawsuit alleges: “Due to manufacturing defects originating in Defendant Aurobindo Pharma Ltd.’s (“Aurobindo”) facility in India, certain batches of irbesartan active pharmaceutical ingredient were supplied to Defendant ScieGen Pharmaceuticals, LLC (“ScieGen”), and thus introduced to the United States market, that were adulterated with the probable human carcinogen, NDEA (the “Adulterated Irbesartan”). After ScieGen used the Adulterated Irbesartan to manufacture and produce finished generic prescription irbesartan tablets, ScieGen shipped the tablets containing Adulterated Irbesartan to Defendant Westminster Pharmaceuticals (“Westminster”) in or about Tampa, Hillsborough County, Florida. Westminster, in turn, further manufactured, labeled, packaged, and
distributed the tablets containing Adulterated Irbesartan to pharmaceutical retailers nationwide, including Defendant Walmart Inc. (“Walmart”).”

The federal class action lawsuit further alleges: “Plaintiff and the putative class members were injured by paying the full purchase price of their medications containing Adulterated Irbesartan and by paying for incidental medical expenses. These medications are worthless because they are contaminated with carcinogenic and harmful NDEA and are thus not fit for human consumption.”

What Is Irbesartan?

Irbesartan is a generic drug generally used to treat high blood pressure and diabetic nephropathy, a complication of type 2 diabetes which affects the kidneys. Irbesartan is the generic form of the brand-name drug Avapro. Avapro was initially approved by the FDA and marketed in the United States in 1997.

The federal class action lawsuit alleges: “As a result of Aurobindo’s poor quality-control measures and failure to comply with cGMPs [current Good Manufacturing Practices], its irbesartan API became adulterated and contaminated by NDEA. NDEA is not an FDA-approved ingredient for branded Avapro or generic irbesartan. None of Defendants’ irbesartan products (or any irbesartan product, for that
matter) identify NDEA as an ingredient on their products’ labels or elsewhere … By introducing their irbesartan products into the United States market under the name “irbesartan” as a therapeutic equivalent to Avapro and with the FDA-approved label that is the same as that of Avapro, Defendants represented and warranted to end users that their products are in fact the same as and are therapeutically
interchangeable with Avapro … The presence of NDEA in the Adulterated Irbesartan: (1) renders Defendants’ irbesartan products non-bioequivalent (i.e., not the same) to Avapro and thus non-therapeutically interchangeable with Avapro, thus breaching Defendants’ express
warranties of sameness; (2) was the result of gross deviations from cGMPs thus rendering Defendants’ irbesartan products non-therapeutically equivalent to Avapro, and thus breaching Defendants’ warranties of sameness; and (3) results in Defendants’ irbesartan
containing an ingredient that is not also contained in Avapro, also breaching Defendants’ warranty of sameness (and warranty that the products contained the ingredients listed on each Defendants’ FDA-approved label) … Due to its status as a probable human carcinogen as listed by both the International Agency for Research on Cancer (“IARC”) and as determined by pharmaceutical regulators such as the European Medicines Agency and the FDA, NDEA is not an FDA-approved ingredient in irbesartan. The presence of NDEA in the
Adulterated Irbesartan results in Defendants’ irbesartan products being non-merchantable and not fit for its ordinary purposes (i.e., as a therapeutically interchangeable generic version of Avapro), breaching Defendants’ implied warranties of merchantability and/or
fitness for ordinary purposes.”

The FDA announced on October 26, 2018 that Aurobindo had recalled several  batches of irbesartan API that it had dispatched to ScieGen.  Aurobindo recalled 22 Batches of its irbesartan API, all supplied to ScieGen, and all contaminated with NDEA. The FDA announced that on October 30, 2018, ScieGen had issued its own recall of irbesartan that it supplied to Westminster as well as Golden State Medical Supply, Inc.

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If your business is presently or may soon be involved in class action litigation in the United States, email us at info@businesslitigationcontingencylawyers.com or telephone us toll-free in the United States at 800-756-2143 to find class action lawyers who may handle your class action litigation matter on a contingency basis.

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Stryker Hip Implants Multidistrict Litigation Settlement Announced

By | Multidistrict Litigation (MDL), product liability lawsuits

On November 2, 2018, Stryker and National Plaintiff’s Leadership in MDL 2768 of the consolidated proceedings before Judge Talwani announced in Court a proposed Master Settlement Agreement (MSA) for eligible claimants. The Stryker Hip Settlement includes those cases filed in the MDL 2768 in Massachusetts, the MCL 624 consolidated proceedings in New Jersey and/or other jurisdictions for cases already filed and pending. It is believed the eligibility of the failed implants include both recalled and unrecalled cobalt chromium V40 heads and compatible stem system configurations including Accolade TMZF, Accolade 2, Citation, Meridian and Rejuvenate.

The initial settlement terms are confidential and were not publicly disclosed. The settlements amounts are believed to vary and criteria for amounts of individual offers will be based upon varying factors including the degree of harm and components necessitated to be removed. It was stated that the settlement will not settle all filed claims. It is believed, however, to be a substantial step to begin resolving claims in the underlying Stryker hip litigation. It is believed that this settlement will resolve the first cases picked for the initial Bellwether trials and discovery will be stayed through the Summer of 2019.

If your business is presently or may soon be involved in multidistrict litigation (MDL) in the United States, email us at info@businesslitigationcontingencylawyers.com or telephone us toll-free in the United States at 800-756-2143 to find MDL lawyers who may handle your MDL litigation matter on a contingency basis.

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