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CPAP Medical Malpractice

Philips Respironics Issues Recall on V60 and V60 Plus Ventilators Following an Unrelated Active Recall on Similar Devices

Philips Respironics Issues Recall on V60 and V60 Plus Ventilators Following an Unrelated Active Recall on Similar Devices

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Philips Respironics Issues Recall on V60 and V60 Plus Ventilators Following an Unrelated Active Recall on Similar Devices

On June 18th, 2021, Philips issued an “Urgent Field Safety Notice” informing V60 and V60 Plus ventilators users that these devices may not be providing the user with enough oxygen. Then, on June 30, 2021, Philips issued an official recall of its V60 and V60 Plus ventilators over this exact issue. The June 30 recall is unrelated to Philip’s recall on June 14, 2021 of certain CPAPs, BiPAPs and other ventilators the company makes. The FDA has classified the most recent recall of Philips’ V60 and V60 Plus ventilators as the “most serious type of recall.”

The devices in question are Philips Respironics V60 (upgraded to versions 3.00 and 3.10 to enable for High-Flow Therapy) and V60 Plus ventilators distributed between May 1st, 2009 and June 2nd, 2021. In a statement provided by the FDA, the devices were recalled “due to the risk to the patients who rely on the ventilator to provide high-flow oxygen therapy if the system pressure reaches the default maximum limit.” This can occur if the oxygen flow is blocked (even partially) for any reason. According to the FDA, if the issue is not corrected immediately, the device will continue to provide the user with a “lower oxygen flow rate and issue a low priority alarm”, which “may cause serious injuries or even death.”

So far, there have been over 16,000 devices recalled in the US with reports showing at least 85 injuries or other incidents related to their use. At this time, no deaths have been reported.

Since the June 30 recall, the FDA advised the following instructions for users of V60 and V60 Plus ventilators:

The full list of the FDA instructions and other important information regarding this recall can be found in their official statement.

Boesen Law Firm prides itself on helping its clients review and pursue the best legal path forward with our 36 years of in-field expertise. Our experienced Philips Respironics lawyers at Boesen Law Firm can help individuals who are facing issues caused by Philips devices. 

 If you or someone you know has used, or is still using V60 or V60 Plus ventilator, call us at Boesen Law right away. Time is of the essence. (303) 999-9999.

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Covid 19 Vaccination Complications

CICP: A Legal Black hole for Injured Vaccine Recipients

CICP: A Legal Black hole for Injured Vaccine Recipients

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CICP: A Legal Black hole for Injured Vaccine Recipients

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If the Government is going to ask us, for the good of society, to take an experimental vaccine . . . and make no mistake, the COVID vaccines ARE experimental . . . it should stand behind us, promptly, and fully, compensating those of us who suffer severe life-threatening, and life-ending, complications from those vaccines.

According to the CDC’s own data, as of July 30, 2021, there have been 11,632 reported cases in which a person had a severe adverse reaction, and lived; and, another 11,805 reported cases in which the person had a severe adverse reaction and died.

Each one of those injured persons, or their surviving family members, should be fully and fairly compensated by the Government, but that will NOT happen under the Government’s current “Countermeasures Injury Compensation Program” also known as the CICP.

The underfunded, and understaffed, CICP, which is only set up to handle 50 claims a year, denying 9 out of 10 of those, is a legal “Black Hole” for people who have suffered severe adverse reactions to COVID-19 vaccinations.

A bipartisan group of Congressional Representatives has introduced a bill called the “Vaccine Injury Compensation Fund Modernization Act (HR-3655), which would bring COVID-19 vaccine injury claims under the fairer, more transparent, “Vaccine Injury Compensation Program,” the same compensation already used for all other, regularly-administered, vaccines – like the Flu vaccine, and the Measles vaccine.

Please take a moment to sign this petition to urge Congress to treat COVID-19 vaccine injury victims AT LEAST as well as we, the Boesen Law Firm already treat the victims of other vaccines.

https://www.change.org/p/united-states-department-of-health-and-human-services-petition-to-add-all-covid-19-vaccines-to-the-vaccine-injury-compensation-program-vicp?recruiter=1220005016&utm_source=share_petition&utm_medium=facebook&utm_campaign=psf_combo_share_initial&utm_term=469015466b0348bf80b021a029f14b1f&recruited_by_id=1db59bf0-f9ff-11eb-953a-3b516790d796&utm_content=fht-29046583-en-us%3A0&use_react=false&v2=false

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CPAP

PHILIPS RECALL OF BI-LEVEL PAP AND CPAP DEVICES FOR POTENTIAL HEALTH RISKS

PHILIPS RECALL OF BI-LEVEL PAP

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PHILIPS RECALL OF BI-LEVEL PAP AND CPAP DEVICES FOR POTENTIAL HEALTH RISKS

On June 14, 2021, Philips issued a recall of millions of sleep devices and ventilators over possible cancer risks. The recall focused on the following devices, but may not be limited to:

-Bi-Level Positive Airway Pressure (Bi-Level PAP);
-Continuous Positive Airway Pressure (CPAP);
-Mechanical Ventilator Devices.

In a press release, Philips “identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices.” According to the company, Philips found that degradation of the sound abatement foam used on some of the above devices has been exacerbated due to “unapproved cleaning methods” and “high heat and high humidity environments.” The degradation of the sound abatement foam can expose one to harmful, possibly cancer-causing, particles if inhaled. 

Philips also added that gases released by the degrading foam could be harmful. Additional side effects that may present as a result of exposure to the degrading foam are headache, irritation, inflammation, and respiratory issues. Please see below for the full press release.

Boesen Law is investigating this matter. If you or someone you know has been diagnosed with lung cancer or another medical condition relating to the use of a Philips B-Level PAP, CPAP, or has been treated using a Philips mechanical ventilator, please contact us at 303-999-9999.

https://www.philips.com/a-w/about/news/archive/standard/news/press/2021/20210614-philips-issues-recall-notification-to-mitigate-potential-health-risks-related-to-the-sound-abatement-foam-component-in-certain-sleep-and-respiratory-care-devices.html

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Covid 19 Vaccination Complications

COVID-19 Vaccine Injuries

COVID-19 Vaccine Injuries​

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COVID-19 Vaccine Injury - Boesen Law

** Boesen Law believes in vaccines; however, we feel compassion for the individuals who have suffered from complications due to the COVID-19 vaccine. **

As more and more Americans get vaccinated for COVID-19, news about vaccine complications are beginning to be reported. Here at Boesen Law, we are fighting around the clock for the people that have been injured by the vaccines.

The U.S. Food and Drug Administration and the CDC have reported severe complications and even death for some people after being administered the vaccine. The rate (reported on December 10th, 2020) for the Pfizer-Biontech COVID-19 vaccine was .6%. Ideally, the rate should be 0% percent.

Some of the complications that have been reported, according to Healthlin.com, are “rare and severe” types of blood clots that are found in the brain. Six recipients of the Johnson & Johnson vaccine reported severe blood clots. All six recipients were women between the ages of 18-48.

Many people don’t know it, but the government developed a program to compensate victims, and their families, who have suffered a serious injury, or even death, due to COVID-19 treatment and covered countermeasures.

The program is called the Countermeasures Injury Compensation Program, or CICP. It was created by the Public Readiness and Emergency Preparedness Act. The program allows for the government to compensate individuals who suffered injuries caused by COVID-19 treatments and countermeasures. According to the Secretary of the Department of Health and Human Service, the COVID-19 vaccine has been designated a “covered countermeasure”.

If you or someone you know has been injured by a COVID-19 vaccine, you may be eligible to receive reimbursement up to $50,000 in unreimbursed lost wages and also be reimbursed for out-of-pocket medical expenses. The program CICP also provides a death benefit in extreme cases where the vaccine causes death. The death benefit for designated surviving family members of those who have passed away due to the vaccine is $370,376.

Boesen Law is currently evaluating cases nationwide, involving COVID-19 vaccine-related serious injuries, and even death. Click HERE to learn more about CICP and the requirements needed to be eligible for compensation.

If you or someone you know has been seriously injured after receiving the COVID-19 vaccine, call us at (303) 999-9999 and also visit us to know more about it.

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Covid 19 Vaccination Complications

COVID-19 Vaccine Injuries

COVID-19 Vaccine Injuries​

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News

COVID-19 Vaccine Injuries

** Boesen Law believes in vaccines; however, we feel compassion for the individuals who have suffered from complications due to the COVID-19 vaccine. **

As more and more Americans get vaccinated for COVID-19, news about vaccine complications are beginning to be reported. Here at Boesen Law, we are fighting around the clock for the people that have been injured by the vaccines.

The U.S. Food and Drug Administration and the CDC have reported severe complications and even death for some people after being administered with the vaccine. The rate (reported on December 10th, 2020) for the Pfizer-Biontech COVID-19 vaccine was .6%. Ideally, the rate should be 0% percent.

Some of the complications that have been reported, according to Healthlin.com, are “rare and severe” type of blood clots that are found in the brain. Six recipients of the Johnson & Johnson vaccine reported severe blood clots. All six recipients were women between the ages 18-48.

Many people don’t know it, but the government developed a program to compensate victims, and their families, who have suffered serious injury, or even death, due to COVID-19 treatment and covered countermeasures.

The program is called the Countermeasures Injury Compensation Program, or CICP. It was created by the Public Readiness and Emergency Preparedness Act. The program allows for the government to compensate individuals who suffered injuries caused by COVID-19 treatments and countermeasures. According to the Secretary of the Department of Health and Human Service, the COVID-19 vaccine has been designated a “covered countermeasure”.

If you or someone you know has been injured by a COVID-19 vaccine, you may be eligible to receive reimbursement up to $50,000 in unreimbursed lost wages and also be reimbursed for out-of-pocket medical expenses. The program CICP also provides a death benefit in extreme cases where the vaccine causes death. The death benefit for designated surviving family members of those who have passed away due to the vaccine is $370,376.

Boesen Law is currently evaluating cases nationwide, involving COVID-19 vaccine-related serious injuries, and even death. Click HERE to learn more about CICP and the requirements needed to be eligible for compensation.

If you or someone you know has been seriously injured after receiving the COVID-19 vaccine, call us at (303) 999-9999.

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Zantac

Court Update for Zantac: The Popular Heartburn Medication- Continued

Court Update for Zantac: The Popular Heartburn Medication- Continued

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Court Update for Zantac: The Popular Heartburn Medication- Continued

Boesen Law is committed to providing critical court updates. This week, we continue our report on Zantac, the commonly used heartburn medication, and the suit that has been filed against it. Last week, we reported about the new arguments that Judge Robin L. Rosenberg had rejected from last year. We also discussed the new rulings (and several others) that Judge Rosenberg had made on New Year’s Eve of last year. Click here to read more about last week’s reporting.


We left off last week regarding the three separate master complaints that the Plaintiffs have filed against the defendants. The complaints include a personal injury complaint, a proposed nationwide consumer class action, and a proposed class action on behalf of the third-party payers. Judge Rosenberg commended the plaintiffs for correctly arguing that some state laws take a drug’s labeling into consideration as part of a design-defect claim.


If we recall the information that was shared last week, Judge Rosenberg rejected arguments stating that the claims and allegations of Zantac being misbranded were “preempted”. Consumers and third-party payers argued that because of excessive levels of nitrosodimethylamine (NDMA), a cancerous substance, Zantac should be labeled as mislabeled. Zantac’s formulation had already been approved by the FDA. To take the drug, update the formulation, and resell the improved medication would require for companies to resubmit the new formulation to the FDA. 

 

According to Judge Rosenberg, he reported that the plaintiffs “.. are granted leave to replead design-defect claims against the defendants that are based on the labeling of ranitidine products”. This means that the plaintiffs can reargue their claims due to the fact that there are now more paths to consider like in this instance, many states require for brand-name manufacturers to strengthen warnings on drug labels without waiting for the FDA to sign off on those reports.


In a statement, the Plaintiffs’ co-lead counsel said that, “Based on today’s orders and the orders issued in late December, Plaintiffs can re-plead all claims against certain groups of Defendants and other claims against all groups of Defendants. These rulings are especially important in light of the 60,000-plus individuals diagnosed with cancer who have already submitted claims to the MDL registry, as well as approximately 1,000 cases filed to date in federal and state courts across the country.”


Along with Judge Rosenberg allowing the plaintiffs to re-plead their case in light of new evidence, he also dismissed state law claims seeking compensation for monetary losses due to buying over-the-counter versions of the Zantac medication. It was found that Congress did not intend for any state to classify a claim as a product liability claim when the Plaintiff, themselves, were not personally injured due to the medication. However, now that the Plaintiff is allowed to replead some of their claims, it is possible that the monetary loss can be brought up again. We will have to see what Judge Rosenberg’s final ruling is.


Boesen Law is covering the updates as they occur. If you have any questions in regards to this case or if you are seeking legal advice and representation, please feel free to contact us at (303) 999-9999. Boesen Law is always available.

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Zantac

Court Update for Zantac: The Popular Heartburn Medication

Court Update for Zantac: The Popular Heartburn Medication

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Court Update for Zantac: The Popular Heartburn Medication

Boesen Law has been closely monitoring the lawsuit involving the popular heartburn medication, Zantac. We monitor medication and pharmaceutical companies because we believe that we can assist people who have been affected by faulty medications and pharmaceutical companies.

We have been made aware of an update regarding the ruling in Zantac’s multidistrict litigation (MDL) involving labeling claims of carcinogens found in the medication has reduced more claims from the litigation. This means that a Florida federal judge presiding over MDL is holding the defect claims to be barred by federal law.

The judge in question is U.S. District Judge, Robin L. Rosenberg. Judge Rosenberg reported that the defect claims against Zantac manufacturers like Pfizer Inc. and Sanofi-Aventis U.S. LLC are preempted by the Federal Food Drug and Cosmetic Act because it is impossible for the companies to change the formulation in Zantac without the approval of the FDA. Judge Rosenberg has this to say,

“ As with generic drugs, a claim based on an allegation that a brand-name drug’s FDA-approved formulation renders the drug misbranded is a pre-empted claim because the drug’s manufacturer cannot independently and lawfully change a drug formulation that the FDA approved.”

This means, not in legal jargon, that the claims being presented in court about Zantac being misbranded (though the FDA has approved the formulation) aren’t valid claims. The companies that make Zantac can’t go in and change the medication’s formulation because the FDA has approved the existing formula. If any changes are made to the current formulation, companies would have to obtain new approval by the FDA.

This new ruling comes after several rulings Judge Rosenberg made on New Year’s Eve. The ruling was that Zantac generic makers, packagers, retailers and distributors were preempted by federal law. What this means is that there were lawsuits, accusing companies such as Pfizer Inc. and Sanofi-Aventis U.S., as well as the above mentioned for false advertising and failure to warn people due to the discovery of nitrosodimethylamine (NDMA) which is a cancer-causing chemical. We have talked about this chemical before in our blog post regarding Metformin, a Diabetes medication that has been recalled due to NDMA. Here is the link if you’d like to read more: https://boesenlaw.com/2021/03/27/popular-diabetes-medication-metformin-recalled-due-carcinogenic-ingredient/

Back in September of 2019, the FDA issued a warning that there were trace amounts of NDMA in Zantac and similar generic drugs. However, in April of 2020, the FDA pulled all prescription and over-the-counter medication that featured ranitidine, the active ingredient found in heartburn medications. It turned out that the medication, when stored above room temperature, could produce an unacceptable amount of NDMA. According to the FDA, the allowable daily limit of NDMA is 96 nanograms but researchers found that in one dose of Zantac, there were more than 3 million nanograms of the carcinogen. It is important to note that NDMA is a naturally occurring chemical that can be found in things such as red meat, tobacco, and beer.

Since February of this year, plaintiffs for this suit have filed three more master complaints which are a personal injury complaint, a proposed nationwide consumer class action, and a proposed class action on behalf of the third-party payers. We will continue to monitor the lawsuits and update you with more information as soon as we receive it.

If you or someone you know has been affected by Zantac or would like more information about your rights, do not hesitate to call Boesen Law at (303) 999-9999. We are always more than happy to assist and we are always on standby for you.

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Medical Malpractice

The Paragard Intrauterine Device (IUD): How the Wrapped Copper is Harming Patients

It is imperative to be knowledgeable when it comes to women’s health and, in particular,  women’s reproductive health. Here at Boesen Law, a law firm of nearly 50% women, we strive to maintain knowledge in regards to women’s overall and reproductive health. 

What is the Paragard Intrauterine Device (IUD)? 

The Paragard IUD is a small T-shaped contraceptive that is implanted inside a woman’s uterus to prevent pregnancy. The device is made from flexible plastic and is wrapped in copper, the active ingredient for this specific contraceptive. According to the official website for the Paragard, (www.paragard.com), the contraceptive is “.. 100% hormone-free” and is “..over 99% effective at preventing pregnancy”. In addition, the website claims that the Paragard has a lifespan of 10 years and a patient can have the Paragard in for as little or as long as they like up to the 10-year mark. 

What are some of the side effects? 

There are several possible side effects of Paragard. Here is a list of a few: 

1. Ectopic pregnancy and intrauterine pregnancy risks

Ectopic pregnancies are pregnancies not in the uterus. It is a medical emergency that often requires surgery. Ectopic pregnancies can cause internal bleeding, infertility, and even death.

2. Embedment

It is possible for the IUD to be attached to the wall of the uterus. This just may make removal harder to do. Sometimes, surgery may be needed. 

3. Perforation

The Paragard can sometimes go through the wall of the uterus. If this occurs, one is not protected from pregnancy. After perforation, the Paragard may move outside the uterus and can cause scarring, infection, damage to organs, pain, or infertility. Perforation risks are increased for breastfeeding women. 

4. Expulsion

There is a risk of the Paragard partially or completely falling out of the uterus. It is rare (only happening in about 2 out of 100 women). One is not protected from pregnancy if this occurs. 

5. Changes in Bleeding

Menstruation may be heavier and longer with spotting in between. Please call your healthcare provider if bleeding remains heavier and longer. 

Are there more severe side effects? 

There are some reports of more severe risks when using the copper-wired Paragard. Below is a list of those risks:

1. Life-Threatening Infection

Within the first couple of days, after the Paragard is placed, life-threatening infection can occur. If one develops severe pain or fever shortly after the IUD is placed, please call your healthcare provider immediately. Antibiotics are usually prescribed for treatment but this infection can lead to other conditions that will be mentioned next.

2. Pelvic Inflammatory Disease (PID) or Endometritis 

This inflammatory disease starts off as an infection. It usually occurs within the first 20 days of the Paragard being placed. It is an infection that occurs in the uterus. Please be aware that PID and Endometritis are usually sexually transmitted meaning one and their partner are at a higher risk during intercourse. Fortunately, this can be treated with antibiotics as well; however, the diseases can cause problems such as infertility, ectopic pregnancy, and chronic pelvic pain. Some cases might require surgery and on rare occasions, PID can cause death.

There are more risks to keep in mind if you are considering using the Paragard. If you or someone you know has had the Paragard placed, had to have it removed, and had the contraceptive break apart upon said removal, call us here at Boesen Law (303) 999-9999. We are more than happy to provide you with a free consultation in regards to the Paragard. 

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Medical Malpractice

Popular Weight Loss Drug Recalled by the FDA

 

Belviq, First FDA Approved Weight Loss Drug in 13 Years, Recalled Due to Increased Cancer Risk

Here at Boesen Law, we pride ourselves on keeping up to date with all types of legal matters. Here is a quick summary of Belviq, a popular weight loss drug, that was recalled by the FDA due to an increased cancer risk the drug imposed. Call us at (303) 999-9999 for any of your legal needs.

What exactly is Belviq? 

Made by Arena Pharmaceuticals, Belviq is a weight loss drug that helps control appetite. The drug itself triggers the serotonin receptors in the brain to make the person feel full and satisfied. It is important to note that many antidepressants work due to the chemicals constantly targeting the serotonin receptors. The researchers at Arena Pharmaceuticals claim that Belviq only targets the receptors that affect a person’s appetite.

Does Belviq cause any side effects?

The most common side effects of Belviq are as follows: headaches, dizziness, fatigue, nausea, dry mouth, and constipation. For patients that reported being diabetic, side effects included low blood sugar, back pain, headaches, cough, and fatigue.

When was Belviq officially recalled?

Belviq was recalled by the FDA on February 13th, 2020.

Why was Belviq recalled by the FDA?

The reason the FDA recalled the popular weight loss pill was because it increases an individual’s cancer risk. A study conducted with 12,000 participants over the span of five years found that participants that took the medication were diagnosed with cancer more than the participants that were taking a placebo. Several types of cancers were reported like pancreatic, colorectal, and lung cancer.

Center for Drug Evaluation and Research. “FDA Requests Withdrawal of Belviq, Belviq XR.” U.S. Food and Drug Administration, FDA, http://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-withdrawal-weight-loss-drug-belviq-belviq-xr-lorcaserin-market.

Park, Alice. “Belviq: 5 Things You Need to Know About the New Weight-Loss Pill.” Time, Time, 28 June 2012, healthland.time.com/2012/06/28/belviq-5-things-you-need-to-know-about-the-new-diet-pill/.[:]

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Zantac

Zantac and Cancer Risk

FDA Inquiry and Request

The FDA has requested that all Zantac and other prescription-strength drugs containing ranitidine be removed from shelves as of April 2, 2020. The FDA launched an investigation into the popular heartburn relief drug in September 2019 after it found high levels of a human carcinogen known as N-Nitrosodimethylamine (NDMA). 

What is Zantac?

Zantac is the commercial name for the drug ranitidine. Ranitidine is an H2 blocker that works by decreasing the amount of acid created by the stomach. It is an over-the-counter (OTC) drug approved to prevent and relieve heartburn and a sour stomach. There is also prescription-strength Ranitidine available to treat ulcers and Zollinger-Ellison syndrome and GERD.

What is NDMA?

N-Nitrosodimethylamine or NDMA for short is a yellow oily liquid with a faint odor. It decomposes when exposed to light and gives off toxic nitrogen fumes.

It is primarily used in laboratory research to induce tumors in experimental lab animals. It was formerly used to make rocket fuel but this was stopped after high levels of the chemical were found in air, water, and soil samples near the fuel manufacturing plant. 

Cancer Risk

Zantac or the generic form of the drug ranitidine contains the chemical NDMA. NDMA can enter the body by inhalation, absorption of the skin, and ingestion. Since Zantac and another generic version of it are ingested, it can be linked to the following cancers:

  • Stomach Cancer
  • Colorectal Cancer
  • Bladder Cancer
  • Pancreatic Cancer
  • Gastric Cancer
  • Kidney Cancer
  • Prostate Cancer
  • Leukemia
  • Non-Hodgkin’s lymphoma

Lawsuits

Boesen Law, LLC is investigating claims relating to those who have used Zantac or any other product containing ranitidine and have been diagnosed with cancer.

Please contact us at 720-266-6700 to speak with our legal team.