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Seeking truth, transparency, and resolution for injured consumers

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Periscope Group provides information, resources, and compassionate legal counsel, advocating on behalf of those facing injustice due to prescription drug complications and medical device failures.

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Our in-house legal counsel, Matthew J. Daher, earned his Bachelor of Arts degree from the University of Utah and his law degree from the University of Missouri – Columbia School of Law. Matt has devoted his entire practice to civil litigation, and has spent his career representing the rights of individuals who have been injured by pharmaceuticals, medical devices, medical malpractice, defective products, and motor vehicle accidents. As in-house counsel for Periscope Group, Matt leads our internal legal team and liaises with our external partners.

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Periscope Group provides information, resources, and compassionate legal counsel, advocating on behalf of those facing injustice due to prescription drug complications and medical device failures. Contact us today to see how we can help!

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LATEST ARTICLES

How Could I Get Cancer from My Blood Pressure Medication?

On January 3, 2019, the Food and Drug Administration (FDA) posted an updated notice to consumers explaining that Torrent Pharmaceuticals was expanding its recall to eight (8) additional lots of its high blood pressure medication Losartan. This recall is a continuation of what started over the past summer on July 27, 2018. The FDA initially warned that certain batches of the high blood pressure drug Valsartan had been contaminated with the chemical N-nitrosodimethylamine (NDMA). To date, there have been numerous recalls issued to multiple manufacturers of these specific high blood pressure drugs.

To date, there have been numerous recalls of popular high-blood-pressure drugs—sourced internationally from dubious manufacturers. How can you really trust the source of your drugs?

The FDA’s recall this past July came after 22 other countries issued recalls involving 2,300 valsartan batches sent to Germany, Norway, Finland, Sweden, Hungary, the Netherlands, Austria, Ireland, Bulgaria, Italy, Spain, Portugal, Belgium, France, Poland, Croatia, Lithuania, Greece, Canada, Bosnia and Herzegovina, Bahrain and Malta.

Based on additional findings by the FDA, the NDMA contained in these recalled products was manufactured by a company in China called Zhejiang Huahai Pharmaceuticals.

NDMA is known to cause cancer as well as liver damage. The FDA believes “the NDMA is related to changes in the way the active substance was manufactured” and that “some levels of impurity may have been in the valsartan containing products for as long as four years.”  

The recall itself is frightening. The folks taking these medications are already dealing with cardiovascular issues and high-blood pressure. Plus, how many people in this country understood at the time they were given their prescriptions that the drugs they were ingesting were being manufactured or had traveled all over the world from places like Israel, India, or even China.

Let’s say, for example, you live in a small rural community in the Midwest. Like so many other people in this country, you suffer from high-blood pressure. You’ve tried changing your diet, you’ve been exercising regularly, and you’ve tried anti-anxiety therapies as well. After exhausting numerous options to bring down your blood pressure, your doctor finally tells you it’s time to get on some medication. So, that’s what you do. Over the next year or two, you get your blood pressure under control and feel like your life is back to normal. Then the FDA issues the recall this past July and you find out that the medication you’ve been taking to manage your blood pressure was contaminated with a potentially cancer-causing ingredient. Also, it came from China.  

This Valsartan and Losartan recall speak to a bigger issue we all currently face when we take a prescription drug or have a medical device implant. Where exactly are all of these prescription drugs or medical devices being manufactured or sent before we ingest them or have them implanted in our bodies?

A pharmaceutical consulting group called Evaluate recently issued a report this past June predicting where global pharmaceutical sales would be by 2024. After conducting exhaustive research with the world’s leading 7,000 pharmaceutical and biotech companies, the report concluded that, globally,total prescription sales are expected to be $1.2trn in 2024.

Similarly, this past April, a research consulting group called Lucintel conducted a similar study to the global medical device market. The results from that study predicted enormous amounts of future sales across the world: “the global medical device market is expected to reach an estimated $409.5 billion by 2023.”

Yes, it may be our local doctor in our local community who is giving the prescription. Yes, it may be a local surgeon who performed our medical device implant surgery. We may know the doctor, but what do we know about the pill(s) they prescribe us or the medical device(s) they implant us with? Even scarier, given the fact that so many prescriptions were issued for these contaminated high-blood pressure medications, how much information do your healthcare providers have as well?  

 

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Essure has Been Removed From the Market. What is the FDA Doing to Monitor Patients?

As of December 31, 2018, Bayer voluntarily removed its Essure birth control medical device from the market due to lagging sales and the controversies surrounding it’s safety. However, just because it’s no longer an active product on the market doesn’t mean the the FDA is putting this issue to rest. There are several ways that the FDA intends to stay informed concerning patient health and monitor postmarket safety. If you have an Essure implant, here’s some important information to be aware of.

Essure has Been Removed From the Market. What is the FDA Doing to Monitor Patients?

Why Did Bayer Take Essure Off the Market?

Essure was fast-tracked through the FDA in 2002 and by 2015 had over 15,000 adverse reports filed in the U.S. alone. This paperwork involved patients and doctors reporting medical complaints and complications. These problems included allergic reactions to nickel which led to autoimmune disorders, the coil-like device breaking apart and moving to other parts of the body where they punctured and sliced organs, and possibly even being linked to patient and fetus deaths. In 2016, the FDA required that Bayer – the makers of Essure – conduct a mandatory clinical study on the product, add a warning to the label, AND create a patient checklist listing all of the risks that have been associated with this specific birth control device. Over a million devices were sold worldwide before 2015. After this new protocol, sales dropped by 70 percent in the U.S. Bayer said in a public statement, “Our decision to discontinue sales is for business reasons, and not for any safety or efficacy concerns about Essure.

Will the FDA Monitor This Off-Market Implant?

Yes. While the FDA may have approved Essure too quickly for market, they are at least trying to monitor some of the complications left in the wake of this dangerous medical device. Remember that mandatory study that the FDA required of Bayer back in 2016? The FDA is ensuring that Bayer finishes this study with a few new guidelines:

  • Instead of monitoring the patients in the study for just three years, the time period has increased to five years. “This extension will provide us with longer-term information on adverse risks of the device, including issues that may lead women to have the device removed,” explained FDA Commissioner Dr. Scott Gottlieb.
  • One common complaint involving these patients included symptoms associated with inflammation and autoimmune diseases. This could very well be allergic reactions to the nickel that is found in these medical devices. Studies have shown that approximately 15% of women are allergic to nickel. (When you consider that around 1 million women had an Essure implant, that’s 150,000 who are struggling from just this one complication. Also, consider that testing wasn’t done to see if these patients were allergic to nickel BEFORE they were implanted with it!)

The FDA is requiring additional blood tests for the women in the study to track inflammation against inflammatory markers to analyze their symptoms with allergic reactions.

  • “The FDA is also requiring Bayer to continue to enroll patients who might still opt to receive Essure in advance of its full discontinuation from the U.S. market, and to continue to submit more frequent reports to the FDA on the study’s progress and results,” Gottlieb said.
  • The FDA has stated that they will continue to monitor the performance of Essure in women and will make interim study results and updates available on their Essure Postmarket Surveillance Study page.

What Should You Do If You Have an Essure Implant?

If you have an Essure implant and aren’t experiencing intense lower back or pelvic pain, fatigue, brain fog, painful intercourse, heavy periods, and other symptoms, then the FDA advises that you leave your implant in place. Listen to your body and educate yourself on the signs to be aware of if something should unfortunately go wrong. However, if you are experiencing these symptoms, talk to your doctor right way. He or she may discuss various options with you so that you can take back control of your health.

 

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Sources
“UPDATE: FDA updates on post-market study revisions, oversight for Bayer’s Essure”. Mass Device. Accessed January 17, 2019. https://www.massdevice.com/fda-updates-on-post-market-study-revisions-oversight-for-bayers-essure/?spMailingID=14841927&spUserID=Mjk4ODUzMDA1MTY5S0&spJobID=1541789487&spReportId=MTU0MTc4OTQ4NwS2
“FDA Activities: Essure”. FDA. Accessed January 17, 2019. https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/ucm452254.htm
“F.D.A. Panel Weighs Complaints on Essure Contraceptive Implant”. The New York Times. Accessed January 17, 2019. https://www.nytimes.com/2015/09/25/health/fda-panel-discusses-essure-contraceptive-implant.html
“Bayer To Take Birth Control Device Essure Off the U.S. Market”. Managed Care. Accessed January 17, 2019. https://www.managedcaremag.com/news/20180724/bayer-take-birth-control-device-essure-us-market

“FDA Announces Safety Monitoring for Essure”. WebMD.  Accessed January 17, 2019. https://www.webmd.com/sex/birth-control/news/20181224/fda-announces-safety-monitoring-for-essure

Arbitration Clauses… Not Just Limited to Your Credit Card Contracts

On January 8, 2019, Justice Brett Kavanaugh authored his first opinion as the newest member of the Supreme Court of the United States (“SCOTUS”). An opinion that matters to everyone in this country and one that will have an enormous impact on our consumer culture moving forward. Last year we watched Kavanaugh’s nomination process unfold. At times it was hard to watch. We listened to the arguments and promises that were made to all of us in this country. And since Kavanaugh’s confirmation and swearing in, we’ve sat back waiting and asking ourselves “what will be next?”  

Arbitration Clauses . . . They Aren’t Just Limited to Your Credit Card Contracts

Mark Twain once uttered this simple phrase: “actions speak louder than words, but not nearly as often.” Sadly, based off the explosive text of this recent decision, it could be a sign of bad things to come.

We often see arbitration clauses contained within transactional contracts like credit card agreements or certain loans. For example, when you need a line of credit to pay your bills and you’re in the process of reviewing a credit card agreement, there isn’t much room for negotiation. We all sign the dotted line because we need that money to pay our bills and we don’t have other options.  

But what happens when these same arbitration clauses and provisions start seeping over into all other areas of our lives?  Including the potential to create a healthcare system where a majority, if not all, of your medical treatment and procedures are bound by mandatory arbitration – even any and all personal injuries that may arise from hospital or physician malpractice.

If you were in the middle of a healthcare crisis or if you or a loved one were in need of emergency medical treatment, do you want to be faced with that same position you’re in with your credit card company when it comes to signing off on medical treatment and care? This may sound like an extreme comparison, but given the recent decision from SCOTUS, what’s to stop specialists and private medicine from making themselves only accessible to those who agree to never sue them in a court of law for any malpractice they may commit?  

The case is Henry Schein v. Archer & White (“Schein”), and the SCOTUS greenhorn authoring the opinion, held that when two parties enter into a contract that delegates the questions of what can and should be arbitrated to an arbitrator: a court may not override the contract, even if the court thinks that the arbitrability claim is wholly groundless.” SCOTUS went on to clarify in its opinion that there is no “wholly groundless” exception to the Federal Arbitration Act’s enforcement of delegation clauses.

So what exactly are “delegation clauses” within an arbitration agreement? And why is the ruling from SCOTUS relevant to something like . . . my healthcare treatment and healthcare providers?

Let’s say you are looking at a contract and there is an arbitration provision or clause contained within stating “any and all disputes arising from this contract” will be go before an arbitrator and not before a judge and jury in a traditional court of law. What exactly does that mean? Better yet, where do you draw the line or determine what types of claims you could file a lawsuit on in a traditional court of law and what types of claims would you be forced to take before an arbitrator?

For example, you purchase a new home improvement product and part of the transaction requires you to sign a contract discussing the return policies and warranties on the product that also contains an arbitration provision with that “any and all” broad language. At the time you sign the contract, you are only thinking about the warranties included with the product and the possibility of having to return or exchange it with the seller if it fails to work as intended. Worst case scenario, you may find yourself in front of an arbitrator if your purchase is a dud and the seller won’t make you whole again, right?

But what if a personal injury arises and you or a loved one are injured somehow while using the product exactly as intended? You may not have been considering any personal injury claims when you entered the contract to purchase that item, but does that personal injury claim also fall under that broad language in the arbitration provision stating: “any and all disputes arising from this contract”?

Prior to Schein, courts had a mixed view on how to handle situations such as those discussed above. Folks would get injured and file personal injury claims in court arguing that those were not supposed to be included under the arbitration provisions in their contract. Many courts in this country would take that opportunity to review the original contract and arbitration provisions, and from there, a judge would decide which claims would be forced into arbitration and which claims could stay before he or she in a traditional court of law. For years, these courts and judges have taken on a gatekeeper role of deciding what claims the parties intended to arbitrate and which claims were not intended to go before an arbitrator. Those claims the judge felt did not fall under the arbitration agreement were “wholly groundless” and could continue to proceed before a judge in a traditional court of law.

With the decision in Schein, SCOTUS makes it clear that moving forward these decisions fall within the hands of an arbitrator and not those of a judge sitting in a traditional court of law. From there, the arbitrator can determine what remains in arbitration and what may or may not move forward separately in a traditional court of law.

Generally, in emergency situations, you cannot be refused medical care by declining to sign off on an arbitration agreement. But you should never hesitate to ask about the paperwork you are signing at your doctor’s office or even when you’re meeting with a lawyer. Although this proves more difficult when dealing with big banks or large financial institutions, you can always ask your local doctor or lawyer if you have to agree to arbitration prior to soliciting their services. You may be surprised to find out that, when simply asked, some will remove the provision altogether and move forward without it. Protect yourself and your future because you never know what could happen or what options you’ll need at your disposal before just signing them all away.

For more information on the legal background discussed in this article, please see the following link: https://www.periscopegroup.com/legal/medical-arbitration-clause-legal

Image Source: The Nation

Periscope Group is not owned by or operated on behalf of any attorney or law firm. We are not affiliated with any drug or medical device companies. We do not host advertisements nor do we accept advertising requests. We are here to help YOU, the consumer, become better educated and supported. You pay absolutely nothing for our help. It’s as simple as that.

Periscope Group is not owned by or operated on behalf of any attorney or law firm. We are not affiliated with any drug or medical device companies. We do not host advertisements nor do we accept advertising requests. We are here to help YOU, the consumer, become better educated and supported. You pay absolutely nothing for our help. It’s as simple as that.

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