Why Do Motorcycle Accidents Peak in the Spring and Summer?

As the weather gets nicer and the sun comes out during the spring and summer, more people venture outside and the roads get busier. With the busier roads comes an increased risk of getting into a motorcycle accident

Spring and Summer Factors Leading to Dangerous Roads: 

  • Increased amount of traffic congestion due to road trips and vacations
  • Increased amount of new drivers on the road 
  • Road construction due to the favorable weather
  • Increased risk of drinking and driving, especially around holidays such as Memorial Day and the Fourth of July 

In America, the majority of fatal motorcycle accidents occur in June, July, and August. Minnesota’s fatal motorcycle accident statistics are no exception. 

Below are the 2019 motorcycle crash statistics from the Minnesota Department of Public Safety

    • January: 1 crash 
    • February: 0 crashes
    • March: 14 crashes
    • April: 43 crashes
    • May: 132 crashes
    • June: 181 crashes
    • July: 172 crashes
    • August: 179 crashes 
    • September: 127 crashes
    • October: 73 crashes
    • November: 7 crashes
    • December: 1 crash 

Although the Minnesota Department of Public Safety has not released the official 2020 crash statistics, the preliminary results show that motorcycle deaths increased by 43% since 2019. 

How GoldenbergLaw Can Help

Motorcycle injuries are often life-altering and treatment can be extremely expensive. Our team of experienced and compassionate Minnesota accident lawyers understands the challenges faced after a motorcycle injury and will stand up for you.

The Minnesota Personal Injury Attorneys at GoldenbergLaw have been providing the Gold standard of advocacy for more than 35 years! If you or a loved one was injured in a motorcycle accident, contact the team at GoldenbergLaw today and leave the sleepless nights to us.

FDA Xeljanz Safety Evaluation Timeline

What is Xeljanz?

Xeljanz is a medication intended to treat moderate-to-severe forms of rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. It is an immunosuppressant with the active ingredient tofacitinib and is part of the class of drugs known as Janus kinase (JAK) inhibitors.

How Does Xeljanz Work?

Xeljanz works by decreasing a substance called cytokines. Cytokines are proteins that help control the immune system. People with rheumatoid arthritis make more cytokines than needed, which leads to inflammation and pain. Xeljanz disrupts cell signals in the Janus kinase (JAK) pathways to decrease the production of cytokines.

Background on Xeljanz

The U.S. Food and Drug Administration (FDA) approved the medication in 2012 for rheumatoid arthritis patients who were not responding to other medications on the market at the time. In 2017, the FDA expanded its approval of Xeljanz and allowed the drug to be prescribed to patients with psoriatic arthritis, a condition that causes joint swelling or pain. The FDA expanded its approval once again in 2018 to treat ulcerative colitis. 

Despite the FDA’s continued approval, however, the FDA had lingering concerns about Xeljanz and ordered a phase IV, post-market study to be conducted by Xeljanz’s manufacturer, Pfizer.

FDA Xeljanz Clinical Safety Study

The FDA’s study began in March 2014 and recently concluded. It included patients with active moderate-to-severe rheumatoid arthritis who were 50 years or older and had at least one cardiovascular risk factor. 

The final results have not been published publicly. However, preliminary data shows that rheumatoid arthritis patients have up to six times the risk of developing a pulmonary embolism when taking the drug’s 10mg dose twice a day compared to patients taking another medication. Patients taking the 5mg twice daily dose have approximately three times the risk of pulmonary embolism.

Pulmonary embolisms are dangerous blood clots that travel to the lungs. Those who suffer from pulmonary embolisms may have an irregular heartbeat, experience chest pain and trouble breathing, feel faint or lightheaded, cough up blood, and experience pain, swelling, tenderness, and redness in parts of the body where the blood formed or traveled. These blood clots can be life-threatening, and those suffering from pulmonary embolisms should seek immediate medical attention. 

The FDA announced that it will continue to review the study’s results and communicate its final conclusions and recommendations in the future.

Xeljanz FDA Safety Clinical Trial Timeline

February 25, 2019: The FDA found that patients taking a dose of 10mg of Xeljanz twice daily may experience an increased risk of developing blood clots in the lungs and therefore issued a safety announcement. Participants in the study were all over 50 years old and each had at least one cardiovascular risk factor. The participants were taking either the 5mg twice daily dose or the 10mg twice daily dose of Xeljanz and were then compared to a similar group of participants on a tumor necrosis factor (TNF) inhibitor. Three days after the safety announcement from the FDA alerting the public to the increased risk of pulmonary embolism and death, Xeljanz’s manufacturer, Pfizer, sent a letter advising healthcare providers of the same risks. 

July 26, 2019: The FDA issued a Black Box Warning for the 10mg twice daily dose of Xeljanz. The black box warning focused on the increased risk of blood clots and death in people with rheumatoid arthritis over 50 years old with at least one cardiovascular risk factor. The black box warning limited the use of the 10mg twice daily dose of Xeljanz to treating ulcerative colitis patients whose condition was not already being sufficiently managed by other medications. As a result, the FDA discontinued the evaluation of the 10mg twice daily dose of Xeljanz in the ongoing clinical trial and switched the participants to the 5mg twice daily dose. 

February 4, 2021: The FDA issued a safety communication warning the public about the initial results from the ongoing Xeljanz study. The initial results found that there is an increased risk of heart-related problems and cancer in patients taking Xeljanz. The trial compared patients taking the 5mg twice daily and 10mg twice daily doses of Xeljanz to patients taking a tumor necrosis factor (TNF) inhibitor. The participants were all over age 50 and had at least one cardiovascular risk factor. Full results from the clinical trial are not yet available. However, the FDA is recommending that patients continue taking Xeljanz as they were prescribed by their physicians but also to consult their healthcare providers if they have questions or concerns.

How GoldenbergLaw Can Help

If you or a loved one suffered harm after taking Xeljanz, contact the Minnesota Xeljanz Attorneys at GoldenbergLaw today for a free consultation. We have provided Gold standard advocacy for more than 30 years! Contact us today, and you can leave the sleepless nights to us!

Why Was the Penumbra JET 7 Xtra Flex Catheter Recalled?

On December 15, 2020, the U.S. Food and Drug Administration (FDA) announced Penumbra, Inc.’s recall of all Penumbra JET 7 Xtra Flex catheters due to the “risk of unexpected death or serious injury.” Penumbra, Inc.’s recall included a warning that all medical facilities who used the Penumbra JET 7 Xtra Flex catheter should remove them from their inventory.

How the Penumbra JET 7 Xtra Flex Catheter Is Supposed to Work

The Penumbra JET 7 Xtra Flex catheter is part of the Penumbra System which was designed to work in tandem with the Penumbra Aspiration Pump, Penumbra Aspiration Tubing, and the MAX delivery device to restore blood flow by removing blood clots. This intended to be achieved by using continuous aspiration (a method that uses suction to remove a blood clot) in patients who have suffered from an acute ischemic stroke within 8 hours of symptoms appearing. The Penumbra JET 7 catheter series was intended to deliver deeper vacuum aspiration power to allow the practitioner to safely extract blood clots in acute ischemic stroke patients.

During a catheter-based thrombectomy procedure, the surgeon makes an incision in the groin and advances a catheter through an artery all the way to the blood clot. The surgeon uses an X-ray to guide the catheter to the blood clot. The catheter then removes the blood clot from the blood vessel in order to restore blood flow. 

Penumbra JET 7 Xtra Flex Catheter Resource Center

Penumbra JET 7 Xtra Flex Catheter Defects

The FDA has received more than 200 medical device reports associated with the Penumbra JET 7 Xtra Flex catheter. The reports include complications such as death, serious injuries, and malfunctions. The report listed device failure modes as “ballooning, expansion, rupture, breakage or complete separation, and exposure of internal support coils near the distal tip region of the JET 7 Xtra Flex catheter.” 

The distal tip is located at the very top of the catheter and is what makes contact with the blockage within the vessel. However, in the case of the Penumbra JET 7 Xtra Flex catheter, the distal tip may expand to become several times the diameter of the blood vessel. This expansion can put undue pressure on the weakened blood vessel and can lead to an increased risk of rupturing. If the blood vessel ruptures within the brain, the brain tissue can be flooded with excess blood which causes damage to the brain and may result in a serious brain bleed (a hemorrhagic stroke) or even death. 

Penumbra, Inc. conducted testing that confirmed this potentially fatal complication. To come to this conclusion, the manufacturer compared the Penumbra JET 7 Xtra Flex catheter to its other aspiration catheters. It determined that the Penumbra JET 7 Xtra Flex catheter’s distal tip could not withstand as much pressure as the other aspiration catheters before failing–resulting in the distal tip expanding and potentially causing the blood vessel to rupture. This means that the Penumbra JET 7 Xtra Flex catheters have an increased risk of failure compared to other aspiration catheters. The FDA confirmed these concerning findings in its December 15, 2020 announcement of Penumbra, Inc.’s voluntary recall of the Penumbra JET 7 Xtra Flex catheter.

GoldenbergLaw Can Help

If you or a loved one have been harmed by a Penumbra JET 7 Xtra Flex catheter malfunctioning, contact the Hemorrhagic Stroke Attorneys at GoldenbergLaw who have more than thirty years of experience in fighting for justice. Contact us today for a free Penumbra Jet 7 lawsuit consultation and let us give you the Gold standard of advocacy you deserve!