Popular arthritis drugs causing cancer in children?

The FDA is investigating a possible link between arthritis drugs, Humira, Remicade Enebrel, and cancer in children and young adults. The FDA has received approximately 30 reports of lymphoma, leukemia, melanoma and organ cancer in children who were given the drug to combat arthritis or Chrohn’s disease.

The drugs in question are known as tumor necrosis factor blockers, which are designed to block a chemical in the body that causes inflammation. Although the safety labels do disclose a possible association with cancer; the warnings do not disclose the specific impact that the drug could have on children and young adults. Consequently, FDA will now begin an in depth investigation into claims of childhood cancer, with the findings to be released in November of this year.

I would advise parents of children with arthritis or Chrone’s disease to discuss this potential side effect with your child’s doctor. If your child is experiencing mild pain or inflammation, it might be best to push off drug therapy until the findings are published in November. If drug therapy is absolutely necessary, ask your doctor what specific side effects would indicate that your child is having a negative reaction to the drug. Obviously, the earlier you catch childhood cancer, the easier it is to combat with traditional drug therapy and/or surgery.

FDA Alert: Infant Formula Recall

The FDA issued an alert today regarding Calcilo XC Low Calcium/Vitamin D-Free Infant Formula with iron powder. The alert states as follows:

Abbott notified consumers and healthcare professionals of the recall of two lots of Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula with Iron powder, a low-calcium and Vitamin D-free infant formula specifically designed for the nutritional support of infants and children with hypercalcemia. The product, distributed in the United States between 06/06/06 and 04/17/08, is being recalled because small amounts of air may have entered the can, resulting in product oxidation. Consumption of highly oxidized foods can cause gastrointestinal symptoms such as nausea, vomiting, and diarrhea. Parents should contact their healthcare professional if they have any questions or concerns.

Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer’s press release regarding this issue at: This link.

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Mininno Law Office

Mininno Law Office: In The News

The following is a letter from John Mininno the Courier Post (South Jersey), published on May 24, 2008:

Re: “White House moves to make it harder to sue businesses” (C-P May 13).

Thanks to the Courier-Post for highlighting the Bush administration’s latest “war” — this one against people who have been injured by defective products. As reported, big business, pharmaceutical giants and insurance lobbyists have spent their considerable resources lobbying the White House to use federal agencies such as the Food and Drug Administration (FDA) to implement rules making it virtually impossible for victims to be compensated when injured, killed or maimed by defective or dangerous products.

Congress and the courts have both previously rejected this back-door tactic. Why? Probably because of the outrage from American consumers who, this year alone, have seen toxic dog food, poison toothpaste, lead paint toys, unsafe child seats, contaminated heparin and dangerous drugs such as Vioxx and Trasylol. Every day, hundreds of lives are lost and thousands are injured from defective products, drugs and malpractice.

The Bush administration’s secretive tactics seek to take away our constitutional right to a trial by jury in civil cases. Juries make our community safer by ensuring defective product manufacturers, drug companies and negligent doctors meet their full responsibility for any harm they cause. If a drunk driver chooses to get behind the wheel of a car and kills a working father, shouldn’t his family have the right to go to a jury and seek full compensation? Why, then, should a large corporation be shielded from a jury when it produces a dangerous or defective product that hurts our loved ones?

If the insurance lobbyists and the Bush administration truly want to use federal agencies such as the FDA or the Consumer Product Safety Commission to “curb lawsuits,” then I suggest they require these agencies to focus on their real mission. Ensuring that products and drugs are thoroughly tested and deemed safe before making their way to American consumers. Safe consumers have no reason to file a lawsuit. It’s really just that simple.

JOHN MININNO

Collingswood

Could your child’s anxiety, depression or cutting be linked to Singulair?

We have begun collecting medical information this week from parents whose children experienced negative side effects after taking the drug Singulair. The data so far has been shocking to say the least.

There are so many striking similarities among the side effects experienced by kids all over the country. So far, the most common side effects include:

suicide
severe depression
panic disorder/social anxiety
severe nightmares
suicidal thoughts
self-mutilation
violence or aggressive behavior.

A large majority of these children have visited psychiatrists, been prescribed very strong medication and have fallen behind in school as a result. And while some doctors have acknowledged the connection between Singulair and these behaviors, others have dismissed the concerns of Singulair moms —thus forcing them to take matters into their own hands.

While I certainly do not recommend stopping a drug treatment without consulting a doctor, its interesting to note the results of discontinuing the drug. 99% of the parents I have talked to reported having a “completely different kid” after stopping Singulair. Grades began to improve, the aggression, suicidal thoughts and terrors stopped and most of them were able to come off of their anti-psychotic medicine.

Sound familiar? How to get help:

If these stories sound strikingly familiar to you, its important to know that you are not alone in this struggle. There is an excellent forum/support group going on over at medications.com. Furthermore, while there are no definitive studies linking the drug to these side effects as of yet, I highly recommend that you send a complaint to the FDA regarding your experience. One of the mother’s at medications.com has found a contact person at the FDA who is looking into reports of suicide and suicidal behavior. You can share your Singulair story with her by emailing sarah.sellers@fda.hhs.gov .

Finally, if you are interested in taking legal action against Merck, please email us your story as well. If we can compile enough data to show this is a real problem, we may be able to get the ball rolling on a class action lawsuit. You can email me personally filling this form.

Unless we as parents make this an issue, the drug companies will continue to make billions at the expense of our children’s health. Its time that we all work together and put a stop to the pharmaceutical giants that could care less about us or our families.

Where and When Was Contaminated Heparin Given in the US?

How Do I Know If My Reaction Was Linked To Heparin?

Every patient that has been hospitalized in the last year wants to know where and when contaminated heparin was administered in the United States. Sadly, no one knows. To date, the most concrete information issued by the FDA suggests that contaminated vials may have been introduced to the market as early as 2006. However, the FDA notes that the majority of injuries have been reported between January 2007 and the recall in early 2008.

Patients who have experienced weird reactions after heparin use can only wonder what, (if any) effect did the heparin have on their body. This is especially true in the case of high-risk pregnant mothers who were given heparin regiments to prevent clotting and dialysis patients who have died instantly during treatment. Families are scared, and at the very least, they want answers.

My Personal Investigation Into Heparin Contamination

Like many people who have had a loved one mysteriously die this year or experience strange reactions after heparin use, I too have become very suspicious of the drug and the allergic reaction my mother had following her abdominal hysterectomy in 2007.

My mother came through the surgery with flying colors, but became strangely ill during the recovery process. During that time, it is believed she was given heparin to prevent blood clots while she was on bed rest. Shortly thereafter, she started experiencing chest pains, irregular heartbeat and a swollen throat that affected her ability to breathe. Consequently, she was hospitalized, given every test in the book, but the doctors could not figure out what was causing these serious reactions.

For months, she swore something happened during that surgery. She insisted to every doctor on her case that the surgeon must have left behind a sponge or a tool in her body that was making her sick. Needless to say, now our family is in the same boat as many of you in trying to figure out if contaminated heparin could have caused this problem.

What Do I Do If I Was Given Bad Heparin?

Based on my own personal experience with the heparin problem, I can tell you that people are calling product liability lawyers such as those in our firm. They want answers, they want explanations-but they just are not getting them from the FDA. As a result, these people turn to lawyers to help them investigate. Again, based on my own experience, I understand the desire to hold the drug companies accountable for the pain and suffering of a loved one. In my opinion, purposely including a deadly contaminant in heparin to save a buck is unacceptable and the Chinese and American manufacturers should have to pay for the harm it has caused our families.

As I have said before, if you or a loved one is a dialysis patient, a heart patient, or was placed on heparin during a high-risk pregnancy or during a period of bed rest, contaminated heparin may be to blame for serious reactions including swollen throat, shortness of breath, blood pressure problems, shock or death. Our firm is aggressively looking for answers and we encourage you to contact us if you have any questions regarding tainted heparin and the reactions it has caused in you or a loved one. Our nurse will evaluate your medical history to determine whether a link exists between your symptoms and contaminated heparin.

If you wish to speak to someone about this issue, call toll-free (856) 833-0600 in New Jersey, (215) 567-2380 in Pennsylvania. You can also fill out the case evaluation form on the right side of the page and our nurse will contact you as soon as possible.

Should Tainted Heparin and Trasylol Victims Be Concerned With The Upcoming Drug Case Before The Supreme Court?

There is no doubt that tainted Heparin victims, Trasylol victims and lawyers alike are concerned with the upcoming decision on Wyeth v. Levine, which is scheduled for a ruling by the Supreme Court this fall.

The issue in this case is whether drug companies should be immune from product liability suits concerning dangerous or defective products if they had prior approval from the FDA. Specifically, the appeal filed in Wyeth v. Levine seeks to overturn a $6.8 million judgment awarded to a Vermont woman that lost part of her arm after doctors injected her with a nausea drug. The lawyers for the drug manufacturer claim that the company is not liable for her injuries because the drug met all necessary FDA requirements and ultimately received FDA approval.

One can only hope that the Supreme Court will see this argument for what it is-just another attempt by a billion dollar drug company to avoid responsibility for a defective product. I heard someone recently put it this way, “So because I passed my driver’s test and the State gave me a license, you can’t sue me if I carelessly wreck your car.” I think that analogy shows just how ridiculous this argument is. Even if you break it down to the issue of “fairness”– no person in their right mind can justify how a woman who is permanently disabled because the FDA and a multi-billion dollar pharmaceutical company released a dangerous product on the market should be faced with economic hardship because her disability check barely pays the bills. Where is the justice in that?

Furthermore, lets consider the people who’s loved ones were killed after receiving a lethal injection of contaminated Heparin. Consider the anxious mothers who became seriously ill after they were placed on a Heparin regiment during pregnancy and are now scared to death of the effects it may have had on their unborn child. How about the patients that sailed through heart surgery, only to die in the recovery room after a lethal dose of Trasylol?

Clearly, a Supreme Court ruling in favor of the drug companies will be nothing more than a license to push questionable drugs through the understaffed FDA and make billions of dollars at the expense of the American people. This is not justice and we can only hope that the Court rules in favor of the little guy in this situation.

Free Legal Advice: Medical Malpractice

Heparin Update: FDA Says Contamination May Be Intentional

While I am not surprised by this news, it still saddens me to report that the FDA and CEO of Baxter announced this week that the contamination of Heparin (which has been linked to 81 deaths and over 700 allergic reactions), may have been intentional. (The full story can be found on USA Today”s website.).

Ironically, that same report states that the Chinese plant accused of intentionally contaminating the Heparin supplies passed an audit by Baxter International just months before the recalls. The FDA then conducted an audit of its own after Baxter broke the news, only to find the facility lacked the appropriate equipment to remove impurities from the drug. And what was Baxter’s pathetic response? Apparently, Baxter CEO, Robert Parkinson, testified before a Congressional hearing that “the Baxter audit was ‘routine,’ while the FDA”s was an ‘inspection for cause.'”

So what exactly was the purpose of Baxter’s “routine” audit? An executive vacation to China? A networking event? Obviously it has nothing to do with patient safety or the contaminant would have been found before it made its way into 11 countries and killed 81 people so far. This is especially true when you look at the details surrounding the contamination. According to USA Today, an investigator for the House subcommittee found that:

…the chemical mimics the effect of manufactured heparin but costs one-hundredth as much. The heparin case has similarities to last year”s recalls of Chinese-made flour used in pet food. The ingredient was contaminated with the industrial chemical melamine, which makes the flour appear more protein-rich than it was. As with melamine, standard industry tests for heparin were not designed to find the contaminant.

Clearly, the goal in China is to use the cheapest materials possible and make the highest profit possible at the expense of consumers. And since the FDA essentially allows drug companies to police themselves until complaints begin to surface, this continues to be a successful plan for Chinese manufacturers and US pharmaceutical companies. Maybe when Baxter’s CEO is faced with the death of a loved one because of a dangerous drug product, then consumers might be afforded better protection than what they are receiving now.

Medical Malpractice and Serious Injury Page

Your Opinions on the Recent Trasylol and Heparin Recalls

I wanted to highlight a comment posted by one of our readers over at My Fox Philly regarding our recent post, “Lessons Learned From Vioxx: Why Trasylol and Heparin Victims Must File Suit To Ensure Honest Marketing and Safer Drug Products. I believe this comment reflects most of the feedback that we have gotten concerning the recent drug recalls and the questionable inspection standards of the FDA. The comment is as follows:

“I”m not a fan of trial lawyers, but when it comes to the FDA and drug companies, you go for it! Clindamycin is another dangerous antibiotic drug in which the FDA and drug companies know there are serious and potential side effects, yet they will do nothing about it. And those who have suffered are often no longer in any condition to be able to sue or to afford to sue. It”s pretty odd that nurses would all know as common knowledge the risks of prescribing this drug and see the potential results first-hand. But the FDA, doctors, drug companies and pharmacies are in denial. And the side affects are most often not reversible. Same with Lipitor. Many have no problem. But those that do find that once they experience side effects, they are irreversible, even if they stop taking the drug, which again doctors, drug companies, pharmacies and the FDA will deny! It”s a racket. I know they do lots of good, but they”ve created an over-drugged and unnecessarily drugged society in which many times the cure is worse than the disease itself they are trying to treat.” – Stever2258

I find this comment to be such an honest and genuine assessment of the drug crisis happening in our nation. This is more than a “get rich quick scheme” by “sue happy people and lawyers“. The real “get rich quick scheme” is an invention of the multi-billion dollar drug companies who produce a questionable product, offer incentives to doctors to market the drug and issue a recall as soon as people start dying. So remember, the next time drug companies post record high profits from drug sales, real people are suffering irreversible and permanent injuries at their expense.

So thank you to our readers for sharing your comments. Hopefully trial lawyers and consumers can work together to put an end to this problem in the near future.

Free Legal Advice: Mininno Law Office

When Should I Call a Lawyer About My Heparin Side Effects?

What Do We Really Know About Bad Heparin?

For the past month, popular search engines such as Google have been inundated with anxious people typing in questions such as, “Was contaminated Heparin given in NJ or PA hospitals?” or “What are the side-effects of contaminated Heparin?” Unfortunately, the FDA and Heparin manufacturer, Baxter, have been reluctant to release such information to the public. All we really know for sure is that the contaminant came from China and has been linked to 81 deaths and over 700 severe allergic reactions. With such vague answers, it”s easy to see why anyone who has been hospitalized in the past few months would have concerns.

Even more disturbing is the latest hypothesis from the FDA that the contamination of Heparin may have been intentional. Baxter president, Robert. L. Parkinson Jr., told members of a Congressional subcommittee this week that he is “greatly concerned that our Heparin product appears to be the target of a deliberate adulteration scheme.” And while no further information was given to elaborate on this theory, Heparin victims are speaking out. In fact, dozens of families participated in Congressional hearings this week to share stories about their Heparin side effects and to plead with lawmakers regarding stricter inspection standards.

Should I Call A Lawyer?

Here at Mininno Law Office, we have received numerous phone calls from NJ & PA residents whose loved ones were given Heparin and died shortly thereafter or became violently ill after using the drug. And while they are not 100% positive that the events are connected, they would still like answers for their own peace of mind. We understand the anxiety associated with this issue, so we have tried to compile a list to help you decide when to call a lawyer. And while we can not cover every circumstance or side effect, as a general rule of thumb you should call a lawyer if:

You or a loved one is a dialysis patient and has suffered unusual side effects after treatment. Some of these side effects include severe abdominal pain, diarrhea and swollen throat that affects the ability to breathe.
Your loved one is an otherwise healthy dialysis patient and died shortly after a recent treatment.
You or a loved one is a heart patient and has suffered the same side effects listed above.
You were given Heparin for a high risk pregnancy and suffered chest pains, shortness of breath and required hospitalization after using the drug.
You or a loved one has undergone routine a surgical procedure and experienced the same potentially deadly side effects listed above.

If you can identify with any of these scenarios, there is a good chance that you may have been given contaminated Heparin. I highly suggest that you contact a lawyer immediately to begin an investigation with trained medical professionals. Furthermore, if you would like to speak with our licensed RN and staff doctors regarding your symptoms, fill out the form on the left side of the page or call (856) 833-0600 in New Jersey or (215) 567-2380 in PA.
Our lawyers and medical malpractice professionals are available to answer any questions you may have regarding Heparin and the Heparin recalls.

Lessons Learned From Vioxx: Why Trasylol and Heparin Victims Must File Suit To Ensure Honest Marketing and Safer Drug Products

Byron Richards from medicationresources.com has written a very interesting post entitled, “Vioxx Shocker-Merck Wrote Many Of the Published Studies.” Needless to say, he had me at hello on this one. After a few weeks of researching the cover-ups and shoddy scientific testing of dangerous drugs such as Heparin and Trasylol, this post solidified in my mind why it is so important for victims of these drugs to come forward and file suit.

Richards reports:

The lawsuits over Vioxx have forced very uncomfortable documents into public view, exposing that Big Pharma has massively corrupted the scientific database with what amounts to promo pieces written by its own employees who then pay for prestigious doctors to attach their names to the studies as if they are legitimate – hiding the fact the drug companies wrote their own studies and conclusions in the first place.

The interesting thing about this post is that Richards is not a lawyer. He is an unbiased author writing on medical wellness. Yet he clearly sees the link between Vioxx lawsuits and the exposure of documents that clearly show the corruption behind the marketing of dangerous drug products. Sadly, without the constant probing from lawyers and the courts, who knows what other incriminating studies actually exist regarding popular prescription drugs.

And while its already too late for the thousands of people that have died from dangerous drugs such as Vioxx, Trasylol and now Heparin, it”s not too late to demand better scientific research and honest marketing procedures by holding these companies accountable via the court system. Admittedly, litigation is not fun. It”s often a long and emotional process for families and attorneys alike. But it”s the only solution. As I noted in my previous post on the Trasylol recalls, Congress will not get involved unless it is in their best interest to do so. Right now it”s in their best interest to let shady testing and marketing procedures continue because the “donations” from drug companies keep them in office. So if we can’t count on Washington, we have to go right to the source and demand more from these pharmaceutical giants by filing suit and making it financially impractical to continue doing business this way.

Unfortunately, what these companies do not realize is that when safety is put first, the profits will come. Look at Volvo. Their cars are ugly, they are expensive but they are known to be safe. And because of their clear desire to protect people, they are tremendously successful. Pharmaceutical companies may have to spend a bit more at the onset of a drug launch for better testing, etc., but the profits will be huge because Americans will put their trust behind the product. So if there are any Big Pharma executives reading this post, consider a consumer friendly way of doing business before the public forces you out of the market via lawsuits and bad press.

Free Legal Advice: Medical Malpractice