Tag: FDA

Yasmin Birth Control is a Money Maker but is it truly Safe?

Every one might remember the catchy “We’re Not Gonna Take it” and “balloons” commercials for the Yasmin or Yaz Birth Control pill. We may even remember all the benefits the pill was said to provide the consumer with, but what we may not remember is the listing of the dangerous side effects the Yasmin or Yaz pill could cause. This is because the commercials for Yaz overstated the pill’s effectiveness and understated the serious side effects that go along with it. This violates the Food, Drug, and Cosmetic Act as well as the Food and Drug Administration’s guidelines.

The marketing by Bayer Healthcare for Yaz or Yasmin was great. It brought in millions of dollars for the company and it may have been some of the company’s best marketing. What the company failed to market or to take into consideration is that all birth control pills including this one have serious side effects including: blood clots, stroke, heart attack, and even death. These commercials failed to let consumers know the seriousness of these side effects and now the company may pay in a big way.

For more information on Yasmin or Yaz you may click on this link.

More info

If you or someone you love may have experienced a serious side effect from taking Yaz or Yasmin, please contact a medical malpractice lawyer right away. They will make sure you get the care you deserve and that your voice is heard.

Tylenol voluntarily recalls Some Medications due to Possible Contamination

Tylenol has recently decided to voluntarily recall more than a dozen infant and children’s medications due to possible contamination.  Bacteria was detected in one of the inactive ingredients and though it was not detected in the finished product, Tylenol decided to recall the products after consulting with the Food and Drug Administration as just a precaution.  B cepacia bacteria was detected in a portion of raw material that was not used in the finished product, but as a precaution Tylenol decided to pull any product containing this raw material from the shelves and recall it. These recalls were made between April and June of 2008 and include the following Tylenol products: Children’s Tylenol plus Cold MS suspension grape, Children’s Tylenol Suspension Grape, Children’s Tylenol Suspension Bubble Gum and Strawberry, Infant’s Suspension Drop 1 ounce grape, and Children’s Tylenol plus Cough and Runny Nose Cherry. The recall is only on liquid Tylenol products.

If you have questions about this recall, please call the McNeil Consumer Call Care Center at: 1-800-962-5357.

For more information about this and other recalls you may click here or here.

More info.

If you feel that you or a loved one has suffered due to a defective consumer product, please contact a Posted on Author Angela LeoneCategories blog, Dangerous DrugsTags , , , , , , , , , , , Leave a comment on Tylenol voluntarily recalls Some Medications due to Possible Contamination

FDA requires Strongest Warning Label on Nausea Drug

On Thursday September 17th the Food and Drug Administration required that the strongest warning label be placed on a nausea drug known as Phenegran. This new warning label is due to the fact that after Diane Levine took this drug through an IV push for migraine related nausea and it then led to infection and gangrene. This caused her to have to have her lower right arm amputated. She sued the drug company Wyeth claiming that the warning label was not sufficient enough to warn against the effects of this drug especially in an IV push. This case made it to the Supreme Court and won Diane 6.7 million dollars. This then led to the FDA requiring this strong warning. This will warn users and medical professionals about the possibility of gangrene and also to let them know that IV drugs should be used in low doses and low concentration. This warning is the FDA’s strongest and is called a “black box” warning. The Court agreed that having the Food and Drug Administration’s approval and new warnings help cut down on medical device lawsuits.

For more information on Food and Drug Administration and  improper warning labels you may visit:

This link.

If you or a loved one have experienced a situation similar to this or have been injured due to a medical device or product, please contact a defective product lawyer right away. They will help you fight for your rights to be heard and get the care you or loved one  deserve.

Help Pass The Medical Safety Device Act

In February 2008, the Supreme Court of the United States ignored Congressional intent and disregarded 30 years of experience under the 1976 Medical Device Amendments (MDA), during which FDA regulation and state tort law worked together to protect consumers from dangerous devices. The court’s recent decision in Riegel v. Medtronic gave total immunity to device manufacturers who fail to adequately warn consumers about device risks. The court, failing to understand that FDA approval does not mean a device is entirely safe, sided with the corporate world over the rights of its citizens, preventing the public from suing when a medical device fails and causes serious harm.

When patients with devastating injuries are unable to hold the negligent manufacturer accountable, the patient and the taxpayers are left footing the bill. For a patient with private health insurance, the health insurance would most likely cover the additional surgery. However, true to the nature of the beast, the price of that patients coverage will most likely increase, leaving that patient stranded to find a way to pay for their increasingly unaffordable health insurance, with no compensation for the physical limitations caused by the device’s failure.

For Medicare or Medicaid-covered patients, the costs of the additional medical care are passed to, that’s right, you, the taxpayers. And for patients who can no longer work, they may need additional taxpayer supported programs, such as Social Security disability. All this cost shifting does nothing to help the injured patient, drains public funds, and does not encourage the manufacturer of the faulty device to fix the problem.

So what can be done? Write to your state and federal representatives and let them know you support the Medical Device Safety Act of 2008. What will it do? The bill simply does two things:

1) It restores Congressional intent by explicitly stating that actions for damages under state law are preserved.
2) It makes the amendment retroactive to the date of enactment of the Medical Devices Amendment of 1976.

The court took the decision-making process out of the hands of Congress and of the court system and put it completely in the hands of FDA bureaucrats. State legislators and attorneys general are joining the cause of rolling back the situation to before the Supreme Court’s decision and restoring the status quo in effect for decades. An American who thinks people should have some access to the courts – any access at all – should be for the act, because right now, in these situations, there is no access, and that’s not the American way.

For more information, please click here.

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DRUG ALERT : Ethex Corporation Recalls Overdosed Propafenone Tablets

As first reported on November 11th, there has been a Propafenone recall by the ETHEX Corporation because the pills may have been oversized, which could result in overdose of the drug Propafenone.

Three different strengths were recalled, all of them Propafenone HCI tablets made by the ETHEX Corporation. They were 150mg, 225mg and 300mg pills from any of the following lots with expiration dates ranging from 6/2009 to 3/2011.

Below are the recalled lot numbers:

150 mg – 73761, 78184, 79373, 81240, 81241, 81242, 83470, 84357, 90525, 90526
225 mg – 71720, 74831, 76014-15, 81243-45, 89731, 90527-29, 90657
300mg – 72834, 76016-18, 81246, 89092, 89732, 90530, 90532, and 91641-42

The 150 mg Propafenone Hydrochloride pills are white, scored round film coated tablets with “ETH” on one side and “331? with a bisect on the reverse. The 225 mg Propafenone Hydrochloride pills are white, scored round film coated tablets with “ETH” on one side and “332? with a bisect on the reverse. The 300 mg Propafenone Hydrochloride pills are white, scored round film coated tablets with “ETH” on one side and “333? with a bisect on the reverse. Life threatening consequences of overdosing on Propafenone Hydrochloride includes heart arrhythmias (irregular heartbeat) and dangerously low blood pressure.

If you or someone you know is prescribed Propafenone, please call your physician immediately.An overdose of this substance is very serious, and can cause severe harm.

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Sen. Arlen Spector Sharply Criticizes the FDA

Senator Arlen Spector has sharply criticized the FDA for failing to ask for more funding beyond that which was requested by President Bush in this year’s budget.  Apparently, the FDA was hesitant to reveal their true financial needs because of an administrative rule that forbids any public disagreement with the budget.  As a result, the FDA has become ineffective at policing food and drug supplies– as shown by the recent influx of tainted heparin, dog food, salmonella tomatoes, and lead paint toys.

Sadly, after months of public outrage regarding the failures listed above, FDA officials finally began to drop hints concerning their true financial needs.   They further attempted to thwart the public outrage by blaming Congress for their dragging their feet regarding their untimely $275 Million request.  This week, representatives of the FDA told reporters that they “would like to once again strongly urge Congress to act quickly to enhance the safety of food and medical products.”

However, correcting the record regarding the FDA’s own failure to act was Senator Arlen Spector, who hand wrote a letter to HHS Secretary Michael Levitt stating, “I am really surprised by your comment quoted in the NY Times today urging Congress to act quickly when the Administration is drastically hindering NECESSARY IMMEDIATE RELIEF by delaying the funding for 8-9 months.  The FDA NEEDS this money now to save lives.”

I’m glad Sen. Spector publically exposed the FDA’s inefficiency as an agency designed to protect the American public from dangerous food and drugs.  If they can’t handle making budget requests or making sure that they have the necessary capital to operate effectively, then its clear they can not be trusted with our health and safety.  We can only hope that this open criticism from Sen. Spector will put the pressure on the FDA to shape up and take their job of policing imports and dangerous products seriously.

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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.

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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.

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The Latest Heparin News: Hillary Speaks Out On Dangerous Chinese Imports

After learning that Heparin from China has been contaiminated with a cheap man made chemical substitute (which has now been linked to 62 deaths and a whole host of other illnesses) Presidential Candidate Hillary Clinton has issued the following press release on her website:

“When it comes to the threat of unsafe drugs from China, the Bush administration is sitting on its hands and rolling the dice with our safety. Heparin is the latest example. Americans have a right to know that their government is taking their health and safety seriously.

With news accounts of a potentially tainted Chinese supply of the blood-thinning drug, heparin, and a new FDA report that the drug has caused hundreds of adverse reactions and 62 deaths, there is an urgent need for the administration to take decisive steps to protect patients from unsafe imported drugs. If George Bush won”t start that process now, I will when I am president.

As I laid out in my import safety agenda, I will require that foreign drug makers produce a certification that they have met American safety standards as a condition of import into the United States, confirmed by independent testing and inspection. I will open permanent FDA oversight offices in at-risk countries like China so that episodes like this one are not repeated. I will require foreign drug makers to accept random, surprise inspections, rather than notifying them in advance – and giving them a chance to clean up their act — as we do now. And I will stiffen civil and criminal penalties for violators.

It is a basic obligation of government to protect its citizens. Americans can count on me as President to protect the food we eat, the toys our children play with and the drugs we take to make us healthy, not sick.”

Its about time someone in Washinton spoke up about the influx of dangerous chinese imports that are hurting American consumers. And while most of us can choose not to buy Chinese toys or Chinese dog food, hospitalized Americans do not have that same freedom. Patients with heart conditions and those on dialysis depend on Heparin to prevent life threatening blood clots. How patheitc is it that these poor people have to worry about getting sick from Heparin because drug manufacturers wanted to save a few bucks. That my friends is greed at its worst.

John R.Mininno, Esq. is a New Jersey and Pennsylvania trial lawyer representing clients in medical malpractice, defective products and other serious injury claims. He also writes about issues concerning patient safety. His offices are in Collingswood, NJ and Philadelphia, PA.
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