COVID Vaccinations, Problems, and Potential Injuries

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Part I

COVID Vaccinations, Blood Clots, and Legal Liability: Your Risks and Rights Under the Law

On April 7th and 8th my mom underwent emergency surgery to address blood clots that rapidly developed shortly after she received one of the new and novel Covid-19 vaccines – if these blood clots were not discovered by emergency room physicians and addressed immediately, she would have died. Apparently, my mom’s condition is not uncommon and, as reported today, the FDA halted the use of Johnson & Johnson’s Covid-19 vaccines to investigate recent reports of people developing blood clots, other health issues, and even dying. As you will read below, this article is focused on posing questions related to these new vaccines, the pharmaceutical companies’ liability, the government’s liability, and other issues relevant to current events.

I, like you, am keenly aware of the havoc caused by Covid-19 which started about a year ago at the beginning of 2020 and still impacts us today. Late last year, in 2020, several pharmaceutical companies announced that they developed vaccines to help combat Covid-19, with the goal of allowing Americans to get back to living a normal life. However, the development of vaccines has created several other issues such as whether you should be forced to take the vaccine (such as the MMR – measles, mumps, and rubella – vaccine children are required to take to attend public school) or if the government can require US citizens to obtain a “Covid-19 vaccine passport” in order to travel, etc.

As we know from history, medical breakthroughs which help the general public also create other issues for a small group of people; we are now seeing these issues arise surrounding these new and novel vaccines – such as blood clots that have led to people needing surgery and even causing death.

My Mom’s Story

David Shiner and Family

In fact, the issues related to these “new vaccines” recently hit home for me and my family. A few weeks ago, my parents – both of whom would be considered “high risk” – were administered the Pfizer vaccine; they too wanted to try and get some normalcy back into their lives. Unfortunately, last week my mom started to feel pain in her left leg and noticed it was swollen. At first, she thought nothing of the issues, however, over the course of approximately a few days the swelling increased substantially. What was worse was that the leg pain became unbearable to the point she had trouble walking. The combination of the leg pain and the swelling prompted us, as a family, to take my mother to the hospital… and thankfully we did.

When my mom presented to the hospital the emergency room doctors immediately noticed her concerns and began running several different types of tests to determine what was causing her left leg to swell and the resulting pain. Turns out that after an ultrasound was performed, doctors diagnosed her with Deep Vein Thrombosis (“DVT”) which occurs when a blood clot forms in a vein deep inside the body – usually the legs. The DVT she developed was so severe that she was admitted, and two separate emergency surgeries were performed – she will now need an third surgery in approximately a month to insert a stent.

Thankfully, after spending nearly a week in the hospital, my mom is now home and recovering. However, the vascular surgeon and other medical professionals are perplexed as to why my mother developed blood clots in the first place, especially since she does not have any of the “precursors” that would typically lead to blood clots.

COVID Vaccinations Problems and Injuries

FDA “pauses” the use of certain Covid-19 vaccines

As we turned the television on today (April 13, 2021) we saw multiple news reports that advised the Johnson & Johnson (“J&J) Covid-19 vaccine was being suspended by the FDA due to reports of people (especially women) developing blood clots after they received the vaccine. And, these reports sounded eerily similar to what we just experienced with my mom.

Which brings me to the next important question, are Covid-19 vaccines safe and if not do the companies who have developed and manufactured the vaccine have any liability when it comes to serious injuries and death; what about the Federal Government which permitted these vaccines through an emergency approval process; and, finally would there be any medical malpractice lawsuits if medical professionals who treat patients do not take into considerations all aspects of a patient’s medical history such as recent vaccinations during treatment and possibly fail to diagnose a vaccine complication.

Given how impactful Covid-19 has been on everyone, and the more recent continuous news about the development of several different vaccines, we wanted to put together a post about these current events. Inside this article we discuss the ability to sue the pharmaceutical companies for liability due to adverse reactions to the vaccine, technology utilized to develop some of the vaccines, the emergency use order of the vaccine, employee liability if they force their employees to take the vaccine in order to maintain their position, the current issues surrounding the single dose Johnson & Johnson vaccine, the recent history about the AstraZeneca blood clot issues in Europe, potential product liability issues and medical malpractice injuries.

Our jobs as, lawyers, is to examine the facts and to ensure justice for our clients is served, we have not taken any sides, yet have asked pertinent questions, that are on the minds of many. This article is meant to be informative and to start a conversation. We are interested in listening to you as well, let us know your thoughts and if you have been injured, do not hesitate to contact the lawyers at Shiner Law group.

Can you sue pharmaceutical companies for liability due to adverse reactions to the COVID vaccination?

Under the Public Readiness and Emergency Preparedness Act (“PREP Act”), companies such as Pfizer, Moderna, Johnson & Johnson, and Astrazeneca have total immunity from liability if or when something unintentional happens as a result of the vaccination. Blanket immunity is rare especially for pharmaceutical companies, however the Trump administration utilized the PREP Act, which is a 2005 law which gives the Health and Human Services (“HHS”) secretary the ability to provide legal protections to corporations creating, producing and distributing critical medical supplies.

It is believed that the Trump Administration extended this classification to these pharmaceutical companies, due to the expediated nature in which these companies were asked to create and produce a vaccination for the COVID-19 crisis. Since Covid-19 pandemic literally “shut down the world” it was feasible that the United States and other countries wanted – and needed – to develop a vaccine and/or treatment as quickly as possible. Without this type of protection many pharmaceutical companies may have decided not to develop a vaccine – especially since they would need to work quickly and possibly bypass several well-established milestones before releasing it to the public.

The Trump administration would have been hard pressed into getting these companies to come on board to this endeavor without taking the liability risk off of the pharmaceutical companies. As an example, the quickest vaccine ever developed, prior to the COVID-19 vaccine, was for the mumps which took four years and was finally approved in 1967; the COVID-19 vaccines were developed in less than a year.

However, this begs the question regarding recent headlines from high ranking pharmaceutical representatives, doctors and government officials which have touted how safe the vaccines are and that the technology used to create the vaccines have been around for decades, if that is the case why would the government need to provide blanket liability protections?

USA Today wrote a story in January 2021 which details how the technology used to develop the vaccine was based on research dating back nearly 100 years. An article from November 2020 in The Scientist discusses the concept of utilizing mRNA to produce proteins to fight disease has been around for decades.

If the technology utilized to develop the vaccine has been around for decades and everyone from the FDA to Dr. Fauci has stated that the vaccine is safe, why do the pharmaceutical companies still have blanket immunity and why would they fight so hard to keep it, would they not all stand up and back all they have told the American people about how safe the vaccine is? And, interestingly, if this type of “technology” was around for decades, then did scientists and healthcare professionals (including Dr. Fauci) know that mRNA type treatment could cause blood clots? On an aside, it does seem interesting that the FDA, J&J, and AstraZeneca were prepared to address these concerns so quickly.

Perhaps, because of this blanket immunity provided to these pharmaceutical companies reduce the overall cost of the vaccine thus reducing the amount of money the government needs to pay for each dose, there is an incentive to keep the blanket immunity in place, even with the claims of the safety with taking the vaccine.

What about those that have approved the emergency use of this vaccination?

You cannot sue the Food and Drug Administration which authorized and issued emergency use orders for the use of the vaccinas because of Sovereign immunity. Sovereign immunity is a legal doctrine whereby the government (whether it is a local municipality, state government, or the federal government) that holds that the government is immune from civil or criminal liability. For instance, sovereign immunity is addressed in Florida law and provisions regarding this are not only found in Florida’s Constitution (Section 13 of Article) and in statutes. And, the statute of limitations to bring a claim against the government in Florida is 3 years.

Can you sue your employer if they force you to get vaccinated?

Currently, you cannot hold your employer accountable if they mandate vaccinations as a condition of employment. Requiring the vaccine can be a health and safety work rule which employees have the legal ability to mandate, with few exceptions such as if the workforce is unionized and under a collective bargaining agreement, and under certain anti-discrimination laws (Americans with Disabilities Act) workers may invoke medical reasons to request an exemption and finally, under Title VII of the Civil Rights Act of 1964 workers can invoke a religious justification to request an exemption. There still may be some recourse under Workers Compensation rules if workers suffer debilitating side effects following work mandated COVID vaccinations.

The question, then arises what if these companies knew or should have know the risks with the vaccines and still forced their employees to get the vaccine in order to come back to work, would that create a liability issue?

Dr. Fauci discussed the safety of the AstraZeneca Vaccine on March 22, 2021 a few days after many European nations (France, Germany, Italy, Portugal and Spain) which have previously issued an order to pause the use of this vaccine due to alleged adverse reactions, specifically blood clots, resumed the use of the vaccines. Thus providing documented evidence that there may be a risk with taking the vaccine in regards to blood clouting.

What is happening now?

On April 13, 2021 the US, specifically the Centers for Disease Control (“CDC”) and the FDA is recommending a pause in the use of the single dose Johnson & Johnson vaccine, in order for the government to study recent reports of blood clots arising from the vaccination. The statement from these agencies stated that there have been numerous reports that blood clotting may occur 6 to 13 days after vaccination. The 6 cases identified by the CDC and the FDA were in woman aged between 18 and 48 years old. Although these cases appear to be similar to the blood clotting issues raised in March in several European countries and linked to the AstraZeneca vaccine, which is not approved to be used in the US at this time, there doesn’t appear to be any relationship between the two clotting disorders at this time.

So far in the United States, the Johnson & Johnson COVID vaccine has been given to approximately 6.8 million Americans, which makes the 6 cases reported about 0.00000086% out of all of the J&J vaccines provided. However, what we do not know is what has not been reported – and for the FDA, Dr. Fauci, and the pharmaceutical companies to be able to pivot so quickly on this new information makes one wonder what they knew, or should have known could happen when using this new technology involving the vaccines. We only know of these 6 cases at this time, have doctors been advised to report cases of blood clots to the CDC based on their patients’ medical history, for example have doctors noticed that between 6 to 13 days after vaccination patients have been complaining about blood clots, will medical professional go back and examine their files to determine if there have been additional cases which may have not been reported to the FDA and the CDC?

Do the benefits of taking the J&J vaccine outweigh the overall risks which have been recently reported, or is 6 out of 7 million cases worth the risks? It all depends on several factors, one being a review by medical professionals to determine if there are more cases which have not been reported and most importantly the risks do not seem to be so severe until it is happening to you. Right now, there is enough concern by the FDA and the CDC to pause the use of the J&J vaccine until a more detailed evaluation is conducted. Perhaps they know more about this then they are telling us as a country.

What is this rare Blood Clot being discussed?

With the AstraZeneca’s vaccine there have been several rare and severe blood clotting cases reported, it is called thrombosis with thrombocytopenia or blood clotting with a low platelet count, most of the European cases reported that the blood clots occurred in veins in or around the brain area, called cerebral venous sinus thrombosis, however some have occurred in other veins. It has been reported that a unique reaction occurs involving the platelets and white blood cells which makes the blood denser leading to blood clots. This occurs between 4 and 20 days after the administration of the AstraZeneca Vaccine. Although scientists and medical professional still do not know the reason why it has been happening, theories have been identified, yet still not proven. Similar to the J&J vaccine, the blood clotting issues caused by the AstraZeneca Vaccine occur predominantly in people under 49, the difference being that the blood clotting with the J&J vaccine have been reported for woman only.

Our Job, at Shiner Law Group!

Generally, we are not here to pass judgement, nor take sides. Frankly, our Firm’s mission is to bring attention to possibly dangerous products, situations, or issues and to always protect our clients! Again, our goal is to be informative and to start a conversation and be open to listening to all sides. However if there were failures during the development stages which put the citizens of the US in danger and the developers as well as government official knew or should have known about these risks, then the citizens have a right to address these failures, did their medical professional have knowledge or should have had the knowledge to examine the effects or potential effects of the vaccine and failed to adequately treat their patients, leading to certain conditions which adversely affected their health, should they be held accountable?

The top rated personal injury attorneys at Shiner Law Group will be examining these questions and others as we learn more about the process, the risks known at the time of development as well as the response to the latest issues with the vaccines and the vaccination process. If you or someone you know suffered from an injury – whether it was related to the Covid-19 vaccine or any other reason – our trial attorneys are here to help you; feel free to contact us by phone (561) 777-7700 or filling out our free online consultation form.

Part II

This article is a follow-up to our COVID Vaccination and Problems discussing the suspension of the Johnson & Johnson Covid-19 vaccine due to reported blood clots and the legal liability surrounding the vaccination process. In part II, we wanted to provide additional information about the various vaccines being used, the differences in the technology used to create the vaccines, and continue our discussion into the vaccinations’ liability matters.

As lawyers, our job is to examine the facts, ensure justice for our clients is served, and ask pertinent questions. Our articles are meant to be informative, not to take sides, and most importantly, to start a conversation. As always, we are interested in listening to you as well; please let us know your thoughts. If you have been injured, do not hesitate to contact the lawyers at Shiner Law Group.

COVID Vaccinations Blood Clots and Legal Liability Your Risks and Rights Under the Law

Which Vaccines Should you take?

Government health officials, the FDA, CDC, and Dr. Fauci, have all stated that you should take whichever vaccine you can get; however, if you can decide which vaccine you should take, you should know the differences between them.

The J&J vaccine is a single dose, which is much easier than having to sit and wait in line twice. The Pfizer and Moderna vaccines are a double dose vaccine, meaning you take the first shot and then make an appointment for three to four weeks to take the second dose.

Only the Pfizer vaccine is “cleared” for children 16 years and older, and the Moderna shot is “cleared” for those 18 years and older. J&J was previously cleared for use in those 18 years and older; however, it is still currently paused while health officials investigate the current risks attributed to the vaccination, mentioned in our previous article, serious blood clotting issues.

Both the Pfizer and Moderna vaccines require their doses to be kept at a specific temperature during storage to prevent them from “spoiling.” In contrast, the J&J vaccines do not need this extra step and expense, making it easier to store, transport, and maintain.

The Pfizer and Moderna vaccines are also created using technology using messenger RNA (“mRNA”). This technology delivers a genetic code to the cells, which then activates the immune system teaching it to attack the Covid-19 protein as foreign and activate antibodies and other immunity weapons to fight the Covid-19 virus.

To break this down in layman’s terms, mRNA vaccines provide an “instruction manual” to your body on how to make the protein on the casing that holds the virus. So, when you get the vaccine, your body will make the protein that is harmless but will respond to it as if it’s foreign; our body doesn’t know that we just made the protein. Now, when you come into contact with the virus, the body recognizes the casing as an enemy and attacks it before the virus can let loose and reproduce in our bodies and make us sick (an infectious disease doctor will explain that this is a very elementary explanation of how the vaccine works, and they would be correct, they will try and provide you with a much more complicated answer; however we believe in helping better understand the basics surrounding the vaccines this explanation makes more sense).

The J&J uses technology that takes a different approach than the Pfizer and Moderna vaccines, and they take a method similar to how the flu vaccine is created. Their vaccine instructs the human cells to make the COVID protein which then triggers an immune response, and this is commonly referred to as a viral vectored vaccine.

To break this down into layman’s terms, the J&J vaccine gives you a piece of the virus that helps your body fight the virus by creating a mild response at the time of the vaccination, so when your body does encounter the actual virus, it can mount a massive response and fight the virus preventing you from getting sick.

What are the known vaccine side effects?

The most common side effect for all the vaccines discussed above is pain in the injection area, fatigue, headaches, muscle pains, and joint pains, with some reporting fever. Medical professionals tell us that these are common with most vaccinations, and it is a sign that our immune systems are kicking into gear accepting the vaccine.

According to reports, there have been severe allergic reactions to the Pfizer and Moderna vaccines due to the ingredients used to create them. One of the ingredients is called polyethylene glycol, which has been associated with rare allergic reactions. Both the Pfizer and Moderna vaccinations have been known to trigger anaphylaxis, a severe and potentially life-threatening reaction. Those that develop anaphylaxis must be treated immediately, typically with an EpiPen, and may need to be hospitalized. This is why the CDC has issued orders that those vaccinated must be monitored for at least 15 to 30 minutes after the vaccine to ensure an allergic reaction is treated immediately. Most of those who have had an allergic reaction have a history of severe allergies or previous episodes of anaphylaxis.

A small number of those receiving the J&J vaccine have developed thrombotic events – such as DVT – as discussed in our previous article. The blood clots formed are unusual because they combine the blood clots and low platelet levels, which can be dangerous if not appropriately treated; typical treatment for blood clots, a blood thinner called heparin, appears to make this even worse. The FDA has warned medical professionals to ask patients for Covid-19 vaccination history.

Are these vaccines safe for those who are pregnant or lactating?

To our knowledge, at the time of this article, none of these vaccines have been tested for the woman who is pregnant or those who are lactating, and the CDC recommends that until these studies are complete, the choice to take the vaccine or not should rest with the patient.

How long are you vaccinated for?

At this time, no one knows the length of protection one has once vaccinated. Health officials are currently evaluating this, and once enough data is collected, a better determination could be made.

What about the AstraZeneca Vaccine?

There have been similar blood clouting instances with the AstraZeneca vaccine, which has not been approved for use here in the United States at this time. Interestingly on March 22, 2021, Dr. Fauci discussed the AstraZeneca vaccine at the time it was suspended from use in several European countries, and that the FDA would be examining the results identified by the European Union Health Officials before approving it for use here in the United States, less than a month later, though, on April 13, 2021, Dr. Fauci stated that in all likelihood, the US would not need to use the AstraZeneca vaccine because we already have an adequate supply. It seems too coincidental that the “authoritative figure” on Covid-19 in the US so quickly backtracked on his previous statements. The question that should be asked is: “What is Fauci and the government or pharmaceutical companies not telling us, especially since the Europeans have resumed vaccinations using the AstraZeneca vaccine.”

Is there a Product Liability Case?

One of the items we mentioned in our previous article was that the HHS Secretary had provided the manufactures and the developers of the vaccine immunity from liability; however, there was one exception, if it could be proven that the companies developing the vaccination and those manufacturing the vaccines did so knowing there may be problems or willful misconduct; in other words, these companies cannot mislead, deceive, or hide information about the development or production of the vaccine.

Did the pharmaceutical companies know, or should have known, about the adverse effects regarding blood clots during their testing? A deeper dive into the research used to develop these vaccines, the studies conducted during the trial phases, and the results being fed back during the process would need to be done to identify if alleged knowledge was known. If this technology has been around for decades, have there been other identifiable cases where experiential vaccines caused blood clots? If that has occurred, then it should have been discussed during the development stages and the approval stages of the Covid-19 vaccine?

Dr. Fauci, who has been at the forefront of the Covid-19 response, may have known about these issues before releasing the vaccine and was duty-bound to report such concerns, had he had known. He failed to address these issues and mislead the government and the people of the United States. Does he bear any responsibilities, and is the protected by immunity as a government employee of the National Institute of Allergy and Infectious Diseases? Here again, if he knew about these issues and withheld this vital information from those approving the vaccine and the American people, he may be held accountable.

What about Medical Malpractice?

What about those administrating the vaccine or examining patients after their vaccination? Have doctors and other medical personal identified common symptoms with their patients who have taken the vaccine? After the issues with the AstraZeneca vaccine in Europe, where it had been widely reported in Europe, and here in the US, medical professionals took note of the symptoms being discussed and looked for similar symptoms with the vaccinations and their patients? Did they inquire about a patient’s vaccination history during their diagnosis? Should they have considering the differences between the vaccines? These questions and more must be investigated and discussed openly to gain the trust of the public. Transparency is essential here, more so when we are talking about risks associated and people’s lives.

This said, if a professional medical misdiagnosis an issue that occurred as a result of a patient taking the vaccine, then you may have a medical malpractice case. For instance, if a patient presents to the hospital with pain in their legs. And, their legs were swollen and “hot” to the touch, then a reasonably prudent healthcare professional should know to perform an ultrasound to determine if there are blood clots in the legs. If that healthcare professional fails to perform the ultrasound and happens to send the patient home and develops a pulmonary embolism, you could bring a case. In any potential medical malpractice claim, the facts will determine whether there is a cause of action. Most importantly, any cause of action related to a medical malpractice case must be brought within the applicable statute of limitations.

Our Job at Shiner Law Group!

Generally, we are not here to pass judgment nor take sides. Frankly, our Firm’s mission is to bring attention to possibly dangerous products, situations, or issues and always protect our clients! Again, our goal is to be informative, start a conversation, and listen to all sides. However, suppose there were failures during the development stages that put the US citizens in danger, and the developers and government officials knew or should have known about these risks. In that case, the citizens have a right to address these failures. Did their medical professional have knowledge or should have had the ability to examine the effects or potential effects of the vaccine and failed to adequately treat their patients, leading to certain conditions which adversely affected their health? Should they be held accountable?

The top-rated personal injury attorneys at Shiner Law Group will be examining these questions and others as we learn more about the process, the risks known at the time of development, and the response to the latest issues with the vaccines and the vaccination process. If you or someone you know suffered from an injury – whether it was related to the Covid-19 vaccine or any other reason – our trial attorneys are here to help you; contact us at (561) 777-7700 or fill out our free online consultation form request.

Part III

This article is a follow-up to our previous two articles, Part I and Part II, discussing the suspension of the Johnson & Johnson Covid-19 Vaccine due to reported blood clots and the legal liability surrounding the vaccination process. In part III, we wanted to expand on the AstraZeneca vaccine, which has not been approved for use in the United States.

Our job, as lawyers, is to examine the facts, ensure justice for our clients is served, and ask pertinent questions. Our articles are meant to be informative, not to take sides, and most importantly, to start a conversation. As always, we are interested in listening to you as well; please let us know your thoughts. If you have been injured, do not hesitate to contact the lawyers at Shiner Law Group.

What is so interesting about the AstraZeneca Vaccine to us!

On March 22, 2021, Dr. Fauci discussed the AstraZeneca vaccine, which was suspended from use in several European countries. He stated that the FDA would be examining all the data identified during the review conducted by the European Union Health officials before approving it for use here in the United States. Interestingly, less than a month later, on April 13, 2021, Dr. Fauci stated that in all likelihood, the U.S. would not need to approve the use of the AstraZeneca vaccine because we already have “an adequate supply of vaccinations.” It seems strange that the face of the Covid-19 response for the U.S. so quickly backtracks on his previous statements. What is he not telling us or the Europeans, which have resumed vaccinations using the AstraZeneca vaccine?

AstraZeneca had expected a Spring approval for use here in the U.S.!

Previously, AstraZeneca had expected to apply for approval in the United States, based on the interview posted above of Dr. Fauci.

In early March 2021, Chicago’s “top” doctor, Dr. Allsion Arwady, stated the following about the AstraZeneca vaccine:

“It has performed well broadly… There has been some extra attention sort of looking at the vaccine in that context, but it has generally also been a perfect vaccine,” [referring to concerns that it was not as effective against the South African Variant]

Dr. Arwady added that she believes it would appear before the FDA sometime in April for approval for use here in the U.S. and then stated: “In addition to the three that have been approved or have been authorized here in the U.S., we’re keeping our eye on AstraZeneca.”

When did the world know about Blood clots in the Covid-19 vaccines?

On March 15, 2021, approximately 37 cases of blood clotting were reported in 27- European Union countries and Britain. The AstraZeneca stated that there was “no evidence the vaccine carries an increased risk of clots.” And the company also said, “the incidence of clots is much lower than would be expected to occur naturally in a general population of this size and is similar to that of other licensed COVID-19 vaccines.”

AstraZeneca stated clearly in March that European regulators suspended their vaccine for use, that “there was no evidence the shot is to be blamed” for the reported blood clotting issues.

This statement alone is interesting to note since the U.S. seems to have known about blood clotting issues regarding the AstraZeneca vaccines as recently as mid-march 2021; however, it was only reported to the general public here in the U.S. on April 13, 2021, with the suspension of the Johnson and Johnson vaccine.

If that is to be believed regarding the AstraZeneca vaccine, then:

  1. Why did the European regulators suspend the vaccine for use?
  2. Why did Fauci and others come out and discuss the identified risks? Would they have not come out and inform the public and continued the use of the vaccine rather than suspend it during their review?

Did they lift the suspension for political reasons?

Just five days prior, on March 15, 2021, E.U. regulators suspended the AstraZeneca vaccine due to concerns over blood clots developing in patient’s receiving this vaccine, however only four days later, on March 18, the European Medicines Agency, E.U. health regulatory body, stated the following their review came to the firm conclusion that the vaccine was “safe and effective.” They also said that they would continue to watch for “connections to the disorders,” “any threat would be minimal, and that the shots will prevent vastly more deaths than they might cause.” In our opinion, not a ringing endorsement.

On March 19, 2021, the European Union “raced” to lift the AstraZeneca suspension amid a new wave of infections and tirelessly reassuring their citizens that the vaccine was safe.
The French government resumed utilizing the vaccine; however, it recommended the use only for people over 55 because initial studies indicated that the blood clotting developed for those younger than 55.

Dr. James Bussel, a professor emeritus at Weill Cornell Medicine based in New York, stated that the occurrence of abnormal blood clotting and low platelets in people under 50 is “uncommon” he also indicated that researchers in Europe “identified antibodies produced by the immune system — possibly in a highly unusual response to the vaccine — that may have activated the platelets and started a cascade of abnormal clotting and bleeding.”

This is similar to the findings of the six people identified with blood clotting disorders who had taken the Johnson and Johnson vaccine.

The very fact that there is widespread hesitancy across Europe, as well as a very poorly developed vaccination plan which is also hampering efforts to vaccinate Europe, on its face, it appears this move was more political than anything else. The attempts by political leaders to rush out and receive the AstraZeneca vaccine seem to be a proactive effort to reassure the public that vaccinations are safe.

We question the logic of resuming vaccinations of the AstraZeneca vaccine less than a week after blood clotting developments appeared to be affecting the public. And, based on current reports, it is clear that there are similar issues with the Johnson & Johnson vaccine, which was created utilizing the same technology.

A recent article in Science Magazine, published April 11, 2021, suggests that only four weeks prior, there was suspicion regarding the safety of the AstraZeneca vaccine – it is now widely accepted that there may be severe side effects for some people. The publishers also note that at the time of the suspension in Europe, the “rare” blood-clotting disorders affected 34 individuals, now less than a month later, there are 222 suspected cases with at least 34 deaths out of a total of 34 million doses given. Yes, these scientists still insist that the benefits of the vaccine still outweigh the risks; of course, that is easy to state while taking a hands-off approach, but what happens when that issue hits closer to home, such as your own family?

Johnson & Johnson Vaccine approved on February 27, 2021!

What happens when the same disorders appear to be affecting those taking a vaccine developed using the same technology (the Johnson & Johnson Vaccine)? Would the blanket liability discussed in Part 1 of this series still apply, even though Johnson & Johnson, as well as the Federal Government, should have known or knew about these developments with the AstraZeneca Vaccine at the time of its approval for use here in the U.S. on February 27, 2021, or shortly after that?

What’s more, in our opinion, J&J may have had an obligation to voluntarily pause vaccinations when they did become aware of the blood clot disorders. Even if they did not know about these issues before approval in the U.S., they knew about the problems on March 15 when the news about the AstraZeneca problems was widely reported here in the U.S. and worldwide. Should the FDA, CDC, and the Federal government have taken the proper precautions at the time, did they have an obligation? Indeed, I think you would agree, Dr. Fauci had a responsibility to share these concerns with the general public; however, shortly after the European Union lifted their suspension of the AstraZeneca vaccine on March 31, 2021, Dr. Fauci stated:

“The data that they made public, most recently, indicates to me that this is a good vaccine that is going to have a significant role in the global response to this outbreak.”

However, Dr. Fauci recently reiterated his prior positions and stated that he believes this pause to last weeks, not months (similar to the European Pause), pointed out that this move was made “out of an abundance of caution” and that “… it’s a very, very rare event.” He also stated that these developments occur between 6 to 13 days after the vaccine. Those who had the J&J vaccine over that period should not be worried or, as he stated, “can mostly rest easy,” but those between that period should watch out for symptoms.

He believes that “At the end of the day, it could diminish hesitancy by saying, “Boy, those people they are looking at that very carefully, and when they say something’s safe you can believe it’s safe.” This appears to be the mindset of the European Union which started with 34 cases and now has more than 222 suspected cases.

Our Job at Shiner Law Group!

Generally, we are not here to pass judgment nor take sides. Frankly, our Firm’s mission is to bring attention to possibly dangerous products, situations, or issues and always protect our clients! Yes, our Firm does specialize in cases involving product liability lawsuits, MASS torts, and Class Action legal cases – which is why we are so interested in what these pharmaceutical companies knew, when they knew it, and what they did to notify the public or address these issues.

Again, our goal is to be informative, start a conversation, and listen to all sides. However, suppose there were failures during the development stages that put the citizens of the U.S. in danger, and the developers and government officials knew or should have known about these risks. In that case, the citizens have a right to address these failures. Did their medical professional have knowledge or should have had the ability to examine the effects or potential effects of the vaccine and failed to adequately treat their patients, leading to certain conditions which adversely affected their health? Should they be held accountable?

The top-rated personal injury attorneys at Shiner Law Group will be examining these questions and others as we learn more about the process, the risks known at the time of development, and the response to the latest issues with the vaccines and the vaccination process. We would certainly appreciate your feedback and let us know how you found us – for instance, did you search for a product liability lawyer near me, or did you find our injury law firm through social media? If you or someone you know suffered from an injury – whether it was related to the Covid-19 vaccine or any other reason – our trial attorneys are here to help you.

Part IV

This article is a follow-up to our previous three articles, Part I, Part II, and Part III discussing the suspension of the Johnson & Johnson Covid-19 Vaccine due to reported blood clots and the legal liability surrounding the vaccination process. In part IV, we wanted to expand on the Johnson & Johnson vaccine, which has recently been reapproved for use in the United States.

Our job, as lawyers, is to examine the facts, ensure justice for our clients is served, and ask pertinent questions. Our articles are meant to be informative, not to take sides, and most importantly, to start a conversation. As always, we are interested in listening to you as well; please let us know your thoughts. If you have been injured, do not hesitate to contact the lawyers at Shiner Law Group.

When did Johnson & Johnson know of the Risks to their Vaccine?

Approximately a week before the “pause” of the J&J vaccine on Tuesday, April 13, 2021, executives at J&J reached out to the other drug manufacturers, Pfizer, Moderna, and AstraZeneca, to collaborate and study the risks of blood clotting and to “speak as one voice about safety” of the vaccines. Pfizer and Moderna both declined as they did not see a need for group action, as their vaccines appeared safe. However, AstraZeneca was interested. According to the Wall Street Journal, Pfizer and Moderna did not want to duplicate efforts of regulators and companies already looking for and investigating blood clot cases.

Pharmaceutical companies have worked together in the past and continue to do so to combat the effects of the Coronavirus. Pharmaceutical companies have joined with each other to develop vaccines, share research, manufacture the vaccines, get more vaccines in the arms of people globally, and help calm public fears over the fast-paced development and approval process of these vaccines.

The one hiccup in their collaborative efforts seems to be when it comes to safety issues with a particular vaccine. Both Pfizer and Moderna have had considerable risks regarding allergic reactions; hence a mandated observation period of 15 to 30 minutes after vaccination. Additionally, one of the reasons stated by Pfizer and Moderna for declining to join J&J and AstraZeneca in a review of blood clots was they did not want their vaccines tarnished by association.

This new information leads us to believe the pharmaceutical companies knew about these risks before April 13, the only question which remains is when did they know about these risks, and why are we just finding out about them now? Finally, if these risks were such a significant concern that J&J determined a need to join forces to investigate these risks, why did they not reveal their worries on their Weekly Friday call with consultants and attorneys on April 9?

After Tuesday’s announcement from US health authorities regarding the pause in the J&J vaccine, Moderna stated that a comprehensive analysis they conducted did not find an association between its Vaccine and cerebral venous sinus thrombosis or other blood clotting events. This appears to show that these issues may have been known before a) the request from J&J to join forces to research these issues and b) before the announcement from US health officials to pause the use of the Vaccine here in the US.

We believe that the pharmaceutical companies and government officials should be transparent with the public to avoid concerns about the rapid development of these vaccines and the hesitance from some to get the Vaccine. As these credible stories seep into public debate, it creates more of a reluctance by the public.

What are their concerns?

As mentioned in Part II and Part III of our series, we discussed the reports from European countries in early March about blood clotting issues surrounding the AstraZeneca Covid-19 vaccination. It was reported that a small number of people who had received the AstraZeneca vaccine developed rare blood clotting disorders. This month Health officials in Europe advised against using the AstraZeneca vaccine for people under 30.

The main concern from the pharmaceuticals, health professionals, and government officials is a rare type of blood clot called cerebral venous sinus thrombosis combined with low levels of blood platelets.

AstraZeneca has been looking at their data which details that severe blood clots, including the reported brain blood clotting issues, seem to be a symptom of Covid-19.

Issues of the J&J Pause

While the J&J vaccine is not a significant component of the more substantial vaccination response, to date, as there have been around 7 million J&J vaccines given compared to the 193,000,000 doses of the Pfizer and Moderna vaccines, they are still a critical piece of the government Coivd-19 response and vaccination roll out for a variety of reasons. The J&J vaccines are cheaper to produce and easier to transport to their final destinations; however, the most important reason is the “One Shot & Your Done” advantage of this Vaccine compared to the two doses needed by Pfizer and Moderna.

People do not have to make another appointment, and wait three to four weeks to take their second dose has a significant impact on the decision of which Vaccine to take. The advantage for government officials and educational systems is it allows for a smoother vaccination process. It provides the ability to get everyone done quickly and not have to worry about setting up an appointment for another dose. For example, vaccinating a college campus of 1000 students and faculty can take a day, and then the campus does not have to worry about the vaccination process again.

The government response to rural communities is also more accessible with the J&J vaccine because they do not have the transportation issues they would typically have with the Pfizer and Moderna vaccines (keeping them at their required temperatures before giving the shots to the people of those communities). The same can be said for the homeless population, where a single dose is more accessible than trying to track down the homeless/ transient a second time for their next dose.

The question which seems to come up then, is, did these decisions play a role in the ultimate response from the government during their “investigation” of the J&J vaccine? Is it worth the risk to a) save money since the J&J vaccine is cheaper to purchase than the other vaccines, b) cheaper to maintain and transport and c) more straightforward to administer and forget about those that have just been vaccinated, “thank you, sir, now move along please.”

Our Job at Shiner Law Group!

Generally, we are not here to pass judgment nor take sides. Frankly, our Firm’s mission is to bring attention to possibly dangerous products, situations, or issues and always protect our clients! Again, our goal is to be informative, start a conversation, and listen to all sides. However, suppose there were failures during the development stages that put the US citizens in danger, and the developers and government officials knew or should have known about these risks. In that case, the citizens have a right to address these failures. Did their medical professional have knowledge or should have had the ability to examine the effects or potential effects of the Vaccine and failed to adequately treat their patients, leading to certain conditions which adversely affected their health? Should they be held accountable?

The top-rated personal injury attorneys at Shiner Law Group will be examining these questions and others as we learn more about the process, the risks known at the time of development, and the response to the latest issues with the vaccines and the vaccination process. If you or someone you know suffered from an injury – whether it was related to the Covid-19 Vaccine or any other reason – our trial attorneys are here to help you.

Part V

This article is a follow up to our previous four articles, Part I, Part II, Part III, and Part IV, discussing the suspension of the Johnson & Johnson Covid-19 Vaccine due to reported blood clots as well as the legal liability surrounding the vaccination process. In part V we wanted to discuss the Vaccine Adverse Event Reporting System (“VAERS”) and a J&J Update.

Our jobs, as lawyers, is to examine the facts, to ensure justice for our clients is served and to ask the pertinent questions. Our articles are meant to be informative, not to take sides and most importantly to start a conversation. In addition, if the content is not cited it is the pure opinion of our law firm. As always, we are interested in listening to you as well, please let us know your thoughts. If you have been injured, do not hesitate to contact the lawyers at Shiner Law Group.

The VAERS System, what is it?

The Vaccine Adverse Event Reporting System, better known as “VAERS” is a system co-managed by the Centers for Disease Control and Prevention (“CDC”) and the US Food and Drug Administration (“FDA”), to act as an early warning system to detect possible safety issues in the US for licensed vaccines. This system reviews and analysis reports about possible adverse events after a person has been vaccinated, anyone can report an event, healthcare administrators are required to report certain events, and vaccine manufactures are required to report all adverse event which comes to their attention.

If you believe you or a loved one had an adverse reaction to a vaccine, you should consider reporting it immediately to your primary care physician as well as to VAERS at https://vaers.hhs.gov/esub/index.jsp. In fact, if you think you may have had an adverse reaction or condition as a result of a vaccine we encourage you to contact our office to discuss your potential ability to receive a monetary recovery from the government.

If you believe you are injured by a vaccine can you file a claim?

If you believe you may have been injured by a vaccine you may be eligible to file a claim through the Vaccine Injury Compensation Program (“VICP”) which is a separate program administered through the US Government Health Resources & Service Administration. Information to file a claim can be found at the following link: https://www.hrsa.gov/vaccine-compensation/index.html.

If you believe you have been injured by the Covid-19 vaccine, you are not eligible to file a claim through VICP.

Vaccines developed by Pfizer, Moderna, Johnson & Johnson, and AstraZeneca are not covered by this program. However, they maybe covered through another program. If one believes to have been injured by one of the Covid-19 vaccination programs an individual maybe entitled to certain compensation from the Countermeasures Injury Compensation Program (“CICP”). This program was created in the rare event you are injured form a covered countermeasure vaccine, “medication, device or other item recommended to diagnose, prevent or treat a declared pandemic, epidemic or security threat”.

You have one year form the date the vaccine was administered to you to file for benefits. Those who are eligible to seek compensation are:

  • Persons who are administered or used the covered countermeasure.
  • Representative of an injured countermeasure recipient
  • The Administrator of the Estate of a deceased injured countermeasure recipient.
  • Survivor of a deceased injured countermeasure recipient.

The CICP is not authorized to provide reimbursement for any attorney fees, you are however, responsible for any costs incurred by the attorney representing you during the recovery process for a covered injury.

Benefits include:

  • Medical Expenses
  • Lost Employment Income
  • Benefits to the Estate
  • Survivor Death Benefits

If you or a loved believe you may have been injured by the administration of one of the Covid-19 vaccines or a loved one may have died due to a Covid-19 vaccination, call the law offices of Shiner Law Group and speak to one of our personal injury lawyers today to start the recovery process at 561-777-7700.

Reported Death of a 5-Month-Old Baby?

On April 4, 2021, it was reported through the VAERS system that a 5 month old baby may have died because his mother was just vaccinated, it is believed that due to his mother breastfeeding him he caught a rash, refused to eat, and had a fever within 24 hours of her vaccination. The baby was brought into the ER and tests indicated that he had elevated liver enzymes. The baby was hospitalized but unfortunately passed away. The mother received the vaccine on March 17, 2021, less than 24 hours later the baby started to show systems and passed away on March 20, 2021. The only known variant was the vaccine. According to reports, this same blood enzyme levels were found in a local doctor who also died shortly after receiving the vaccine.

And, please do not forget that the reason we decided to investigate these reported issues regarding possible dangers related to the Covid-19 vaccines was because my mom sadly developed serious blood clots shortly after receiving the second dose of the Pfizer vaccine.

In fact, it begs the question, all other reported side-effects from these vaccines – such as headaches, sore arms, etc. may possibly be attributed to the adverse effects from the vaccines and how they are reporting that it causes possible damage to people’s circulatory system, etc. Remember, a headache (or stroke) certainly can occur when someone’s blood vessels in there head are “inflamed” or additional pressure is caused.

The cause of death was ruled as thrombotic thrombocytopenic purpura or TTP, which is blood clots forming in small blood vessels throughout the body, this results in low platelet and low red blood cells. These symptoms are consistent with the recent disclosures found in injuries with AstraZeneca and the Johnson & Johnson Covid-19 vaccines described in Part III and Part IV of our ongoing series. However the vaccine the mother took on March 17, 2021 was listed as the Pfizer Covid-19 vaccine, which is similar to the story related in Part 1 of our series.

Update on the J&J Pause

On April 23, 2021, the FDA reauthorized the use of the Johnson & Johnson (“J&J”) Covid-19 vaccine, with a special warning for woman aged 18 to 49. The J&J Covid-19 vaccine was paused on April 13, 2021, due to several reports of sever blood clotting events. As predicted by Dr. Fauci this would not be a month’s long pause to investigate these events, it would be a week to two week pause to review the data as previously discussed in Part III of our ongoing series.

Based on our research we find it incredibly difficult to believe that a pause of less than two weeks gave the CDC and the FDA enough time to properly investigate these events and make an informed decision. In fact since the Johnson & Johnson Covid-19 vaccine has resumed, there have been additional reports of severe blood clotting events. We encourage you to read our previous articles on this issue to make your own informed decision.

Our Job, at Shiner Law Group!

Generally, we are not here to pass judgement, nor take sides. Frankly, our Firm’s mission is to bring attention to possibly dangerous products, situations, or issues and to always protect our clients! Again, our goal is to be informative and to start a conversation and be open to listening to all sides. However if there were failures during the development stages which put the citizens of the US in danger and the developers as well as government official knew or should have known about these risks, then the citizens have a right to address these failures, did their medical professional have knowledge or should have had the knowledge to examine the effects or potential effects of the vaccine and failed to adequately treat their patients, leading to certain conditions which adversely affected their health, should they be held accountable?

The top-rated personal injury attorneys at Shiner Law Group will be examining these questions and others as we learn more about the process, the risks known at the time of development as well as the response to the latest issues with the vaccines and the vaccination process. If you or someone you know suffered from an injury – whether it was related to the Covid-19 vaccine or any other reason – our trial attorneys are here to help you.

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