Category: Press Releases

Manufacturers Press for Low Dose Xarelto Market Expansion

By Uzma Rahman & Emily Cox

Low Dose Xarelto ProposedIn the face of more than 18,000 lawsuits over alleged life-threatening bleeding from the controversial blood thinner, manufacturers are now taking strides to expand their billion dollar baby’s market share even further by seeking FDA-approval to treat recurrent venous thromboembolism (VTE) with low dose Xarelto.

10 mg Xarelto only currently has FDA-approval to treat deep vein thrombosis (DVT) prophylaxis after hip or knee surgery. Of course, Xarelto manufacturers claim that this market expansion is purely altruistic to give patients more treatment options. However, given these companies’ track records, it seems more probable that they just want a piece of the action. With an estimated 900,000 cases of VTE in the U.S. each year, Xarelto manufacturers have much to gain by getting low dose Xarelto into the portion of the market deemed at high risk for higher dosage amounts of the drug.

Manufacturer Announces Low Dose Xarelto

In its Wednesday press release, Johnson & Johnson’s Janssen unit stated the FDA granted priority review of the supplemental drug dispensation for low dose Xarelto. Janssen hopes to gain considerable ground for the blockbuster anticoagulant by expanding its indications. The blood thinner is already phenomenally popular. Unfortunately, as more people use it, more reports of uncontrollable bleeding occur. Doctors are unable to stop the bleeding and serious, sometimes fatal side effects occurred.

Will Low Dose Xarelto Actually Help?

The drug company asserts 10 mg of Xarelto is more effective than aspirin at preventing recurring VTE. VTE is a condition that can cause deep vein thrombosis and pulmonary embolism, both of which can be fatal.

A study sponsored by the drug company shows taking low dose Xarelto reduced the risk of blood-clot recurrence by 70 percent when compared with aspirin. However, the study randomized patients to 20 mg or 10 mg Xarelto or to aspirin 100 mg daily. Recurrent VTE occurred in 17 of 1,107 patients taking 20 mg and in 13 of the 1,127 treated with the 10-mg dose. Among 1,131 patients receiving aspirin, 50 patients reported VTEs. Interestingly, the major bleeding rates were similar in both Xarelto doses (0.5% and 0.4% for 20 mg and 10 mg, respectively). The rate was also low, 0.3%, in the aspirin control group.

The FDA’s priority review designation means that the agency believes the low dose Xarelto version could offer significant health benefits. However, it also shortens the review period of the drug from the standard ten months to only 6 months. This accelerated review advances the FDA’s target date to October 28, 2017.

Xarelto Bleeding Risks

The FDA approved Xarelto in 2011 to treat atrial fibrillation and reduce risks associated with blood clots. The agency has expanded its indications several times since then. It quickly became one of the manufacturers’ star performers. Xarelto made $582 million in sales during its first full year on the market. In 2013, this figure rose to $2 billion for the fiscal year. Xarelto is now Bayer’s top-selling product, bringing in $3.24 billion in sales in 2016 and $2.5 billion in 2015. It is third on Johnson & Johnson’s product roster, generating $2.29 billion for the company in 2016. Like many meteoric climbs to come before it, sacrifices were made. Unfortunately, these sacrifices may have been the health of the very patients Xarelto was purportedly designed to help.

In 2014, the Institute for Safe Medicine Practices (ISMP) reported 3,331 individuals suffered adverse Xarelto events. Of these, 1,647 experienced hemorrhagic bleeding. According to FDA reports, the drug is also responsible for at least 370 deaths.

Xarelto Lawsuits

Many of these are injuries are due to the fact that the companies released the drug without a readily available antidote to stop emergency bleeding. Whereas, vitamin K will reverse the effects of the standard blood-thinner Coumadin (warfarin). Consequently, more than 18,000 individuals have filed product liability lawsuits against the manufacturers over serious uncontrollable bleeding. Two early Xarelto trials ended in victories for the defense. However, the primary determining factor of these trials was a Louisiana doctrine that holds if the doctors claim to be aware of the risks at the trial, then the manufacturer is freed from liability. Both doctors depositions practically read like primers on how to testify for a defensive win with this doctrine.

Luckily, the next two trials will take the litigation out of Louisiana and hopefully away from this damaging piece of legislation. The next trial begins August 7 in Mississippi.

 

New Study Finds Taxotere Has More Side Effects and Lower Survival Rate Than Tecentriq

By Emily Cox

A new study indicates that the controversial chemotherapy drug Taxotere causes more problems and has a lower survival rate than the competing treatment Tecentriq.

Tecentriq, or atezolizumab, is a fully humanized, engineered monoclonal antibody that was approved in October 2016 to treat certain individuals with metastic lung cancer. The new generation treatment was introduced by Roche Group’s Genentech subsidiary. Taxotere, or docetaxel, is a highly potent taxane-based chemotherapy treatment. It was developed by Sanofi-Aventis in 1996 as an alternative to existing low-potency chemotherapy drugs like Taxol.

The study, published in the medical journal The Lancet, showed Taxotere to be associated with more frequent and severe side effects when used for treatment of non-small cell lung cancer than Tecentriq. The Lancet’s study also indicated that those treated with Tecentriq had higher survival rates.

The study was a randomized, open-label, phase 3, and controlled trial (OAK), conducted in 194 academic or community oncology centers in 31 countries between March 11, 2014 and April 29, 2015. Of the 1225 participants with non-small cell lung cancer recruited, the primary efficacy analysis was done on the first 850 test subjects with 425 randomly assigned to receive Tecentriq and 425 assigned Taxotere. With Tecentriq, researchers found that individuals classified as intention-to-treat (ITT) had a median overall survival of 13.8 months compared to 9.6 months with Taxotere. 43 percent of Taxotere patients experienced severe treatment-related side effects, while only 15 percent of patients treated with Tecentriq reported similar side effects. The study was payed for by Tecentriq developers.

The developers of Taxotere are already facing a growing number of lawsuits involving the chemotherapy treatment and permanent hair loss as more consumers learn that permanent alopecia is a side effect of Taxotere. Sanofi-Aventis has known about this side effect for more than a decade but only updated the U.S. label warnings on November 24, 2015, while these label changes were made in Canada and Europe in 2005 and 2012 respectively. According the Judicial Panel on Multidistrict Litigation (JPML), there were 705 lawsuits involving Taxotere as of January 17, 2017. The centralized litigation in the Eastern District of Louisiana under U.S. District Judge Kurt D. Engelhardt started with 33 cases in October 2016.

The multidistrict litigation alleges that Sanofi-Aventis encouraged doctors to use Taxotere instead of Taxol for breast cancer but failed to warn doctors and patients about the connection between permanent hair loss and Taxotere. Many of the plaintiffs who had slow-growing cancers ascertain that they would have chosen a different chemotherapy drug had they been warned about the risk.

While the study didn’t divulge the types of complications researchers found with Taxotere, one of the biggest issues addressed in recent lawsuits filed by women who received the drug for breast cancer is that equally effective alternative treatment options were available.

If you or a loved one underwent Taxotere treatments and experienced permanent hair loss, you may be eligible for compensation. Please fill out the contact form on this page, call Arentz Law Group at 1-800-305-6000, or text 800-440-4400 to begim a free review of your claim.

Hernia Mesh Lawsuits Move Forward as Federal Litigation Issues First Case Management Order

New York, NY/PRNewswire – Hernia mesh lawsuits involving Atrium Medical Corp.’s C-Qur line of polypropylene surgical mesh are beginning to move forward in a recently established U.S. District Court, District of New Hampshire multidistrict litigation. The Court issued its first Case Management Order on January 13th, which will postpone discovery for all pending claims until the proceeding’s initial case management conference convenes on Friday, February 23, 2017 at 10:00am. A discovery schedule will be established at this time. (IN RE: Atrium Medical Corp. C-Qur Mesh Products Liability Litigation – MDL No. 2753)

There are at least 21 hernia mesh lawsuits pending in the New Hampshire Atrium C-Qur litigation. Last month’s U.S. Judicial Panel on Multidistrict Litigation granted all such federal claims to undergo coordinated pretrial proceedings. Plaintiffs allege that C-Qur mesh causes an inflammatory response that can result in bowel adhesions, improper fixation, and other severe complications. They also claim that Atrium was aware of these alleged design defects, yet concealed that knowledge and failed to provide adequate safety warnings to doctors and patients.

Claims against Ethicon, Inc’s Physiomesh Flexible Composite Mesh product continue to mount since the company issued a worldwide product recall on May 25, 2016, after unpublished registry data indicated that the mesh product was associated with higher revision and hernia recurrence raters than other simlar products. A Physiomesh lawsuit pending in the U.S. District Court, Southern District of Illinois, will likely be the first case to go to trial with jury selection scheduled to begin on January 22, 2018. (Case No. 3:16-cv-00368-JPG-PMF)

If you or a loved one was experienced complications as the result of a hernia mesh, you may be eligible for compensation. Please fill out the contact form on this page, call Arentz Law Group at 1-800-305-6000, or text 800-440-4400 to begin a free review of your claim.

Fourth Talcum Powder Cancer Lawsuit Heads to Trial

The Courtroom View Network (CVN) reports that the fourth lawsuit out of thousands filed against Johnson & Johnson over the alleged cancer risks from protracted use of the company’s personal hygiene products
containing talcum powder goes to trial in Missouri’s 22nd Judicial Circuit Court at the end of the month. The full trial will be webcast live by CVN.

According to the lawsuit, Nora Daniels, 56, developed ovarian cancer after using Johnson & Johnson’s talcum powder on her genital region for 36 years. Three similar trials in 2016 resulted in combined damages of more than $190 million. Judge Rex Burlison, the same judge who presided over the previous three trials, will be hearing Daniels’ case. Jury selection is scheduled to begin on January 30, 2017, and opening statements are scheduled for February 9, 2017.  A fourth victory could cement ovarian cancer victims’ already strong advantage heading into any potential large scale settlement. The pending case is captioned Valerie Swann, et al. v. Johnson & Johnson, et al. case number 1422-CC09326-01 in Missouri’s 22nd Judicial Circuit Court.

There are nearly 2,500 pending talcum powder cases in the U.S. with cases also pending multidistrict litigation consolidated in New Jersey and a rising number of state court cases in California. These lawsuits allege that Johnson & Johnson knowingly concealed the danger of ovarian cancer associated with its talcum-based products like Johnson & Johnson’s Baby Powder and Shower-to-Shower. The company is accused of protecting profits generated by its existing popular brands instead of protecting its consumers by switching to safer cornstarch-based body powders. Given the overwhelming popularity of talcum powder, this litigation could potentially develop into one of the largest mass torts in the U.S. in decades.

If you or a loved one was diagnosed with ovarian cancer after prolonged use of talcum powder for feminine hygiene, you may be eligible for compensation. Please fill out the contact form on this page, call Arentz Law Group at 1-800-305-6000, or text 800-440-4400 to begin a free review of your claim.

Bayer ordered to relabel Essure birth control amid mounting lawsuits

November 16, 2016

Pharmaceutical giant Bayer updated the labeling on its Essure permanent birth control device to include warnings that women could experience serious complications.

AboutLawsuits.com’s Irvin Jackson reported that the “black box” warning announced on Tuesday, with guidance from the U.S. Food & Drug Administration (FDA), will also include a patient checklist to inform women of the possible issues prior to having the device implanted.  It is the strongest action that the FDA could require of a company to print on a medical device.

According to the article, the labels inform women that removal of the Essure device must be done surgically.  

The Essure sterilization procedure involves the implanting of metal coils in the fallopian tubes causing scar tissue to form around them, therefore preventing pregnancy.  It is performed without general anesthesia on an out-patient basis.

Jackson reported that the FDA received nearly 10,000 adverse event reports from November 2002 (when Essure was first put on the open market) to the end of December 2015.  About 70% of the cases included abdominal pain or some other form of pain, while about a third of them involved heavy or irregular menstrual periods.  Many patients complained of multiple side effects.

Other more serious cases reported to the FDA included death, ectopic, unwanted, or lost pregnancies, and fracturing of the Essure coils.

The new FDA requirements come as Bayer faces an increasing number of legal complaints in state and federal courts related to the Essure device.  The birth control implant was originally developed by Conceptus and purchased by Bayer in 2013 for $1.1 billion.

The Arentz Law Group is offering free legal consultations to all women who have suffered negative health effects due to Essure Permanent Birth Control Implant. Essure Implant victims are encouraged to visit https://arentzlaw.com/essure-injury-lawyers/ or call 1-800-305-6000 for more information about their legal options.

Special Thanks To All Who Have Served

US President Woodrow Wilson named November 11th as a day of national commemoration of Armistice Day, which marked the formal end of hostilities in World War I. However, following the mobilization of millions of American servicemembers throughout the 20th Century, the word Armistice was changed to Veterans on June 1, 1954. Currently, there over 21 million current and former members

Currently, there over 21 million current and former members of the United States, Army, Navy, Air Force, Marines Corps, and Coast Guard, comprising approximately 6.5% of the US population. While the sacrifices of service members are well remembered for their on-going mission to bring peace and security around the world, in times of peace members of the military including the Reserves and National Guard have been responsible for the management and distribution of humanitarian aid. For instance, nearly 70,000 service men and women were activated to assist in humanitarian efforts following the landfall of Hurricane Katrina, the largest relief effort in US history.

Arentz Law Group would like to thank all current and former US servicemembers for their continued sacrifices both at home and abroad, and wish you all a safe and happy Veteran’s Day.

Federal Court Blocks Nursing Home Arbitration Ban

AboutLawsuits.com reports that US District Judge Michael Mills of the Northern District of Mississippi ordered an injunction on November 7, which stays efforts to ban forced arbitration requirements in nursing home facilities.

The motion made by the American Health Care Association and others argued that the US Centers for Medicare and Medicaid Services had overstepped its authority when it issued the Reform Requirements for Long-Term Care Facilities rule in September 2016. The rule applies to over 1.5 million people residing in 15,000 nursing homes and long-term care facilities would have gone into effect on November 29th of this year and included a provision eliminating forced arbitration in nursing home contracts.

Other provisions within the new rule concerned hiring standards, including forbidding the hiring of employees with disciplinary infractions on their licenses related to nursing home abuse or other care-related infractions. However, the primary concern of many impacted by the reform were the pre-dispute arbitration clauses present in many nursing home contracts which do not allow patients or their families to pursue lawsuits against facilities through the court system.

These forced arbitration clauses are common in a variety of contractual agreements, including contracts for mobile phones, loans, credit cards, and force entrants into waiving their right to the public courts in order to utilize the services provided. Opponents of forced arbitration argue that the system of private arbitrators unfairly favors nursing homes and those entities that required the use of forced arbitration.

While Judge Mills agreed with the motion filed by the American Health Care Association, that the CMS had overstepped its legal authority, he also supported the concerns of the CMS and opponents of forced arbitration in nursing homes.

“Many nursing homes will obtain signatures from residents in spite of grave doubts about their mental competency, or, more often, they will choose to have relatives of the residents sign the agreements, even when no power of attorney has been executed,” he said. “Many of these same nursing homes will later file motions to compel arbitration on the basis of those suspect arbitration agreements; and…The litigation of these arbitration actions can only be resolved in time-consuming litigation, which serves as a very significant incentive against filing suit in the first place. This court has repeatedly seen these facts play out in its courtroom, and it has seen these fact patterns repeatedly arise in published decisions from other Mississippi courts.”

Judge Mills indicated that there was a lack of precedent on either side of the issue when he granted the injunction.

“This case places this court in the undesirable position of preliminarily enjoining a Rule which it believes to be based upon sound public policy,” Judge Mills wrote. “[T]his court believes that nursing home arbitration litigation suffers from fundamental defects originating in the mental competency issue, rendering it an inefficient and wasteful form of litigation.”

FDA Sends Warnings to Evasive Drugmakers

Law 360 reports that since July 2016 the US Food and Drug Administration has issued at least five warning letters to pharmaceutical companies resisting inspection. In response, the FDA has begun preventing drug importation into the United States and using newer regulatory abilities.

The most brazen example of defiance shown by drug makers alleged by the FDA are the actions of Japan-based Nippon Fine Chemical C. Ltd. The company would not allow FDA inspectors to take photographs, would not release records, and had its employees stand side-by-side to physically block access to a section of a laboratory.

Letters sent by federal regulators cite a section of the FDA Safety and Innovation Act of 2012 that states that inhibiting inspections serves as grounds to declare a drug adulterated.

“The increase in warning letters and import alerts citing delay/limiting/refusal of FDA inspections relates to how recently FDA obtained this authority,” agency spokeswoman Lyndsay Meyer told Law360 by email on Friday. “The FDA will continue to aggressively enforce this provision when inspections are refused or otherwise obstructed.”

Most of the notified plants are overseas. One Chinese company, Beijing Taiyang Pharmaceutical Industry Co. Ltd., is accused of not allowing inspectors access to storage drums and then removing them, and not explaining where they were moved to. Another, Pan Drugs Ltd., of India noted an episode where an employee removed pages from the company’s annual report and putting the pages in his pocket before surrendering them.

Current laws provide the Food and Drug Administration with the authority to inspect manufacturing sites in a “reasonable” manner.

“All I can think of is that these are somewhat inexperienced companies in dealing with FDA, and not really appreciating what FDA can do and the impact of it,” Foley Hoag LLP partner Areta Kupchyk said.

Import warnings and bans, once in place can remain until a satisfactory inspection is completed, or other required steps are taken.

Some observers have noted that a company may elect to deny access to the FDA in full awareness of the consequences.

“It seems like the only reason you would do it is you know the alternative is failing,” Barnes & Thornburg LLP partner Lynn C. Tyler said. “So you’re basically taking your chances that maybe you’ll get a more lenient remedy if you just limit [the inspection], because you know if you let them see it, you’re definitely going to get hammered.”

Currently, there have not been many public statements from the companies receiving the warning letters although one US-based manufacturer, Mutual Pharmaceuticals Co. Inc., has acknowledged their mistakes.

“Mutual recognizes that the manner in which it provided information about this issue to the investigators during the inspection did not effectively convey Mutual’s process for product disposition or the rationale for its decisions,” the company reportedly said.

The FDA is expected to continue ramping up inspections in coming months.

US Chamber Report Claims AAJ Engaged in “Covert Lobbying”

Arentz Law Group would like offer support and join the American Association for Justice Leaders Forum in a statement made earlier today.

You may have seen this morning’s report by the U.S. Chamber’s Institute for Legal Reform. This report, while misleading, deceptive, and inaccurate, makes clear one thing: your team at AAJ is hard at work protecting your clients’ rights. Below, please see a message that AAJ President Larry Tawwater is sharing with AAJ members today regarding the report:

“We are under siege by corporate treachery:  GM faulty ignitions, defective guardrails and airbags, salmonella-laced peanut products, and the most recent revelation about Volkswagen diesel engines. And the U.S. Chamber’s response is to blame the American Association for Justice. It’s a new low even for the Chamber.

AAJ proudly stands with consumers, workers, patients, and those who represent them, while the Chamber stands with corporate miscreants.”

AAJ is responding today to the report in the media with a statement from AAJ CEO Linda Lipsen:

“We want to thank the Chamber for highlighting the hard work the American Association for Justice and trial lawyers across the country do every day to help protect consumers from the corporate scams and abuses of Wall Street  and multinational  corporations who put their bottom lines over consumer safety. From tobacco to asbestos, the Chamber has never met a defective product they didn’t like and have lobbied for decades to change the rules so they can’t be held accountable by the public. 

Last week, we saw the CEO of the Peanut Corporation of America receive a 28-year prison sentence for his role in a deadly salmonella outbreak, and now we’re working with our allies to stop a Chamber-backed bill in Congress that would immunize Volkswagen for knowingly defrauding its consumers. What the report details so well is that the American Association for Justice is fighting for a world with more accountability, less injury, and more justice for consumers.”

Thank you for your continued support of AAJ through Leaders Forum.

LindaLipsen_emailsignature.JPG LarryTawwater(1).jpg
Linda Lipsen
CEO
American Association for Justice
Larry A. Tawwater
President
American Association for Justice

Levaquin Manufacturer Unlawfully Solicited Customers by Fax

June 25, 2015

Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, is facing an ongoing class action lawsuit regarding its practice of sending unsolicited advertisements for its antibiotic medication Levaquin by fax. The company recently filed a motion for a summary judgment to avoid a trial, but the motion was denied by US District Judge Freda Wolfson on June 19, 2015. Judge Wolfson’s ruling was made after finding that a pair of faxes sent in 2008 could legally be considered advertisements.

The Telephone Consumer Protection Act (TCPA), which was enacted by the FCC in 1991, explicitly forbids businesses from sending automated, unsolicited advertisements through calls and faxes. Some companies are able to circumvent these regulations by merely providing information that may help a person or business. However, these companies are prohibited from discussing prices or making any attempt to sell a product, which would constitute an advertisement. Distributing automated advertisements to customers who have agreed to receive those materials is also acceptable, but Janssen did not secure any of these agreements.

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