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Seeking truth, transparency, and resolution for injured consumers

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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With over 20 years in health advocacy, we stay abreast of the latest medical complications to educate the public and petition congress for scalable change.

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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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The Step-By-Step Guide To Taking Action

How to File for Financial Settlement After Injury from an Unsafe Drug or Device

LATEST ARTICLES

Why Are There So Many Drug and Medical Device Recalls?

As an advocacy group that strives to keep the FDA and big pharmaceutical companies accountable, we’ve seen our share of hundreds of thousands of people angry, disillusioned, and scared because their medicine or medical device has been recalled. They trusted that their doctor or surgeon chose the best decision for their condition. They put their faith in the company that produced their drug or implant to monitor their materials for safety. The believed that the FDA would only approve products that were properly tested and proven safe. Now many of these patients are living in a new normal where they’re worried about whether their pills are safe or they’re in excruciating pain from an implant that can’t be removed. How can this happen? Why does it seem that drugs and medical devices are being recalled more than ever before?

Why Are There So Many Drug and Medical Device Recalls?

Reasons for Recalls

Drug and medical device recalls can either be required by the FDA based on reports they’ve been receiving or it can be voluntary on behalf of the company when their product(s) are potentially unsafe. Here are the main reasons for recalling a medical product:

  • Health Risks – If a medicine or implant is found to harm patients and causes a high potential for injury, then it could be recalled. For example, phenylpropanolamine (PPA), a drug that was used in decongestants and weight loss medicines, was recalled because it was found to increase the risk of hemorrhagic stroke (bleeding in the brain).
  • Poor labeling or packaging – If the dosing instructions are confusing, if the dosing device is faulty, or perhaps the packaging proves not to be childproof, then it could be recalled.
  • Mislabeled – Let’s say that you purchased a generic medication that was labeled gluten free but it in fact did contain gluten, then the company would have to rectify this error.
  • Compromised Manufacturing – This has been in the news a lot lately. Recently (January 2019) it was found that the popular blood pressure medication Valsartan was contaminated with N-nitrosodimethylamine, or NDMA, a possibly cancer-causing substance and an additional contaminant called nitrosodiethylamine, or NDEA.  

2018 – The Year of the Recall

Let’s look at some of the stats for 2018 from R&D Magazine to see how they were broken down into the above categories:

Pharmaceuticals (percentage of total drug recalls)

  • Failure to meet product specifications: 25%
  • Deviations from current Good Manufacturing Practice (cGMP): 23.9%
  • Sterility: 12%
  • Mislabeling: 10.9%
  • Foreign Materials: 7.6%

Medical Devices (number of recalls per cause)

  • Software issue: 79
  • Mislabeling issue: 43
  • Quality issue: 36
  • Sterility issue: 27

A Few of the Top Drug and Medical Device Recalls of 2018:

Other Important Facts to Know

  • Five companies reported ten or more recalls in the quarter. This is the highest number since Q3 2016 and the second highest since Q3 2013.
  • You can check the FDA’s website to see if your medication or implant has been recalled by clicking here.

Why Are There So Many Drug and Medical Device Recalls?

There are many reasons why the number of recalls are increasing. First of all, we’ve talked a lot about how the FDA and pharmaceutical companies fast-track medical devices to market without testing using the 510(k) process. Another problem is that many products and drugs are produced overseas (learn more here).  A third broken part in the system is that Big Pharma funds not only the FDA, but politicians who monitor this appendage of the government. An additional glitch is that the FDA is overworked and underfunded; they can’t keep up with all the applications, adverse effect reports, and follow-up documents causing many issues to fall into the cracks.

Clearly the FDA is broken at the cost of innocent patients and their health. It’s time we voice our concerns, educate ourselves about our health, and hold the FDA and Big Pharma accountable for harming millions of people.

 

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Sources
“Drug Recalls Increased, Medical Device Recalls Decreased in Q3”. R&D Magazine. Accessed April 2, 2019. https://www.rdmag.com/news/2018/11/drug-recalls-increased-medical-device-recalls-decreased-q3
“What Is a Drug Recall?”. WebMD. Accessed April 2, 2019. https://www.webmd.com/a-to-z-guides/what-is-a-drug-recall#1

IVC Filter Use is Declining; What Does This Mean for Patients?

There are many drugs and medical devices that start out innocent enough: they are designed to help patients address difficult medical conditions and the benefits outweigh the risks in these specific situations. However, a common problem has occurred in which products become overused, over-marketed, and either used off-label or not according to manufacturer’s directions. This is certainly the case for IVC filters. Not only were they overused, but many times they were left in patients causing added risks to patient health.

IVC Filter Use is Declining; What Does This Mean for Patients?

Fortunately, a study published in the American Journal of Roentgenology found that IVC filter sales have dropped drastically over the past decade. “Between 2009 and 2015, IVC filter utilization across the United States declined by 36.3% in the Medicare population and by 26.6% in the privately insured population,” explained a statement from the Harvey L. Neiman Health Policy Institute.

This decline in sales is a win for patients due to the overuse and risks that these devices pose. IVC filters are prongs that form a tent-like structure to trap blood clots in the inferior vena cava, a large vein that carries blood to the heart. If a blood clot enters the heart or lungs, irreparable damage could take place.

IVC filters were supposed to be used in patients who were diagnosed with blood conditions that would be harmed from use of anticoagulants. “Filters should be considered for patients who cannot be anticoagulated and for those who fail anticoagulation for proximal DVT [deep vein thrombosis] or PE [pulmonary embolism],” states Akhilesh Sista, MD, FSIR, section chief and associate professor at New York University Langone School of Medicine.

IVC filters should only be used in these extreme circumstances due to the added risk they bring to patients. IVC filter prongs may break and migrate causing tissue damage and can even lodge in the heart. It has also been found that even though these medical devices have been labeled “retrievable” – meaning they should be removed after 29 to 54 days in most cases – many doctors fail to take these devices out of their patients putting them in danger.

Clearly the decline of IVC filter sales is a win for patients. These new statistics mean that doctors are carefully analyzing patient health verses the danger of using this device. If you have one of these medical devices or have an upcoming surgery which may involve an IVC filter, be sure to discuss any questions you may have with your doctor to ensure that this is the best option for your health.

 

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Sources
“The decline of state-level IVC filter utilization”. EurekAlert!. Accessed April 8, 2019. https://www.eurekalert.org/pub_releases/2019-04/hlnh-tdo040419.php
“IVC filter overuse declining, but retrieval rates remain low”. Healio. Accessed April 8, 2019. https://www.healio.com/cardiac-vascular-intervention/venous/news/online/%7Bc384ddb8-e89b-4c26-9ee4-f514e48567da%7D/ivc-filter-overuse-declining-but-retrieval-rates-remain-low

Invokana’s Lethal Side: Giacomo Lo Re’s Story

Many experts, including the Center for Disease Control (CDC), have been calling diabetes one of the greatest “epidemics” of our time. While that may sound dramatic, consider that 30 million Americans have been diagnosed with type 2 diabetes and the number of patients is predicted to increase to nearly 55 million over the next decade. It’s no wonder that new treatments and products are being introduced to market. Unfortunately, some of these newer medications like Invokana may cause more harm than good.

Invokana’s Lethal Side: Giacomo Lo Re’s Story

Giacomo Lo Re’s Story

Giacomo Lo Re left Sicily 50 years ago and “came from sleeping a family of six in one bed to coming to the U.S. and grabbing everything this country has and saying, ‘I’m going to provide a life for my family,’” explained his daughter-in-law Maria Lo Re.

Lo Re was in his late 60’s and was retired when he was diagnosed with type 2 diabetes. He was given Invokana, not insulin, to “improve his quality of life.” Lo Re started using Invokana in August 2016 and by the end of September, he knew that something wasn’t quite right. He complained of mild discomfort while urinating and genital skin irritation, so his primary physician recommended basic anti-itch skin creams and suggested a follow-up visit in three months.

On Jan. 27, 2017 Lo Re rushed to the hospital with symptoms including fever, diarrhea, vomiting, chills and headache, as well as worsening pain, thought to be urinary stones connected to diabetes. Lo Re was sent home with prescriptions for a painkiller and urinary aid, but went to the emergency room the next morning. He died later that day. An autopsy revealed sepsis as the cause of death.

Lo Re ended up having Fournier’s gangrene, a rare but serious genital infection, that has been linked to Invokana use. Unfortunately, Lo Re and his doctors weren’t told about the potential for this horrible condition at the time.

Problems With Invokana

Invokana was approved by the FDA in 2013 and while the researchers did test for glucose levels, they failed to determine the long term effects that could occur. This is an important point to know because Invokana (canagliflozin) is an SGLT2 inhibitor and works in a totally different way than traditional diabetic medications. This is why the original label didn’t have warnings that included the additional risk of lower leg and foot amputations or Fournier’s gangrene (the warnings came out in May 2017 and August 2018, respectively). There still isn’t a warning about sepsis.

The FDA reported that “from March 2016 through September 2018, there were 4,891 reported cases of infections and infestations associated with SGLT2 inhibitors, including 248 cases of sepsis, 1,326 cases of fungal infection and 591 cases of gangrene,” cited news magazine Democrat & Chronicle.

If you took Invokana between March 2013 to August 2018 and experienced Fournier’s gangrene or if you took this drug between March 2013 to May 2017 and suffered a lower leg or foot amputation, call Periscope Group today at (800) 511-3838. We want to help you if we can.

 

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Sources
“Lawsuit claims Johnson & Johnson misled public about diabetes drug that killed New Yorker”. Democrat & Chronicle. Accessed April 3, 2019. https://www.democratandchronicle.com/story/news/health/2019/03/27/lawsuit-johnson-johnson-diabetes-drug-death/3166571002/
“Diabetes: Biggest epidemic in human history”. Optum. Accessed April 3, 2019. https://www.optum.com/resources/library/diabetes-backgrounder.html
“FDA Drug Safety Podcast: FDA confirms increased risk of leg and foot amputations with the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR)”. FDA. Accessed April 3, 2019. https://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm560492.htm
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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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