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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Medical Malpractice

Drug Recall: Morphine Sulfate 60 Mg Extended Release Tablets

The FDA has issued a recall today for morphine sulfate tablets because a certain batch was found to contain double the dosage as found in a single pill. The warning from the FDA is as follows:

ETHEX Corporation notified health care professionals of a voluntary recall of a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762) due to a report of a tablet with twice the appropriate thickness. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The lot was distributed by ETHEX Corporation under an “ETHEX” label between April 16th and April 27th of 2008. Opioids such as morphine have life-threatening consequences if overdosed. Consequences can include respiratory depression (difficulty or lack of breathing), and low blood pressure. Many patients for whom this product is prescribed are likely to be highly debilitated with reduced strength or energy as a result of illness, and may be less likely to determine that a tablet is overweight or oversized than an unimpaired individual. If consumers have any questions about the recall, they should call their physician, pharmacist, or other health care provider.

Read the MedWatch 2008 safety summary, including a link to the firm’s press release regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Morphine

This “double thickness” issue also prompted the massive Digitek recall earlier this year. The heart drug was recalled after a wide range of disturbing side effects were noted in patients, including low blood pressure, reduced heart rate and death.

Obviously, double coated morphine has the potential to cause similar injuries in users. If you have noticed any of the side effects listed above after taking morphine, it is extremely important that you file a report with the FDA.

Furthermore, if you have been seriously injured as a result of taking this defective product, you may have rights against the drug manufacturer. To speak with a defective product attorney, please call (856) 833-0600 in NJ or (215) 567-2380 in PA or fill out the free case evaluation form on the left side of the page.
You will be contacted immediately for a free case evaluation.

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.

Medical Malpractice News: Cincinnati Man Sues Doctor for Unnecessary Castration

A Cincinnati, Ohio man is suing his doctor after what he claims to be an “unnecessary partial castration.” He is seeking damages against the doctor, Gary M. Kirsh, M.D., for lack of informed consent, battery and medical malpractice.

Apparently, Stephen M. Kosti was admitted to the hospital after experiencing pain in his groin. At his doctor’s recommendation, he underwent an exploration of the scrotum to find the problem. Dr. Kirsh then deicded to remove one testicle because he claimed it may have been cancerous and only his patient would only have six more months to live.

Just a few days after the surgery, Kosti sought a second opinion from an oncologist. The oncologist preformed a PET scan and determined that the testicle was not cancerous in the first place. As a result, Kosti is claiming damages for lost wages, additional medical expenses, pain and suffering, mental and physical anguish and loss of enjoyment of life.

Related InformatioN: New Jersey Medical Malpractice Lawyer

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.

Free legal advice:

Mininno Law Office

N.C Medical Board Seeks to Publish Medical Malpractice Info Online

The North Carolina medical board is seeking to post medical malpractice information online as a way to “protect people from troubled doctors.” This proposal stems from a new state law, which requires disclosure of medical malpractice information at the board’s discretion. If the board approves this plan on June 30th, North Carolina will be come the 23rd state to offer medical malpractice information to the public.

Obviously, North Carolina doctors are fighting this proposal. The N.C medical society states that the proposal is “unfair” and should not include medical malpractice settlement information prior to June 30th. They argue that some doctors only settle for “business reasons”, and may not have done this if they knew the information would be made public and held against them.

The board, however, has proposed measures to keep the disclosure of information fair to doctors and the public alike. The board would keep private the actual settlement amounts, as well as the identity of the patient that filed the suit. Doctors will also have the opportunity to leave a comment beneath the post to explain the reason for the lawsuit and settlement in their own words.

Click here to read the full story.

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New Jersey Medical Malpractice Attorneys

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

How To Treat A Bedsore

The development of a bedsore (or pressure sore) in an elderly or bedridden loved one can be a scary ordeal. Bedsores are painful and often require months of treatment before they heal. Bedsores can also be fatal if not cared for properly; therefore, it is important that family members are extremely involved in the treatment process.

The following list offers practical tips on how to treat a bedsore. Families can also use the list as a gauge to determine whether their loved one is receiving appropriate care from the nursing home or hospital staff. In addition, I encourage you to read ahead to the legal rights of a bedsore patient. Bedsores are a clear sign of neglect in nursing home or hospital setting. You have the legal right to hold these facilities accountable for the pain and suffering they have caused your loved one.

Bedsore Prevention Methods

Keep Moving– Ideally, a bedsore patient should move every 15 minutes to keep pressure off of the sore. If this frequency is not possible (as in the case of an immobile resident), the bedsore patient must be moved at least every two hours. He or she should also be kept off of the sore as much as possible. Special mattresses, foam blocks or special chairs may help keep your loved one comfortable during the repositioning process.
Keep it Clean– The bedsore should be cleaned with Saline solution and wrapped with an occlusive dressing. Occlusive dressing is a clear transparent bandage that can seal itself to the wound and is found at your local medical supply store. The bandage should also be left on for a few days before it is changed. If the dressing is changed too often, it will inhibit the body’s natural growth factors from connecting with the raw tissue.
Get Healthy– Malnutrition is common in bedsore patients. This condition contributes to the easy breakdown of the skin. To promote healing, the bedsore patient should eat plenty of protein, take 500 mg of Vitamin C supplements twice a day (as always, consult with a doctor before taking supplements) and drink 8 glass of water a day to prevent dehydration. It is a proven fact that patients who receive proper nutrition will not only heal faster, but will be less likely to get another bedsore in the future.

Legal Rights of a Bedsore Patient

Nursing homes and hospitals have specific guidelines aimed at preventing bedsores. Therefore, if a bedsore develops, it’s safe to conclude that someone was not following the rules. These sores are so unacceptable that insurance companies are now refusing to pay doctors for bedsore treatment.

The reason for this is simple—bedsores are easier to prevent than treat. In most cases, bedsores are just the result of carelessness and neglect. Fortunately, insurance companies are not the only ones taking a stand against such negligent behavior. Bedsore patients and family members have turned to the court system to hold hospitals and nursing homes responsible for the pain and suffering they have caused. And while the hospital or nursing home may insist that bedsores are unavoidable even under the best circumstances, nothing can be further than the truth.

How to Get Help

Your first priority is the physical health of your loved one. Once they are stable and being treated as recommended above, you should contact an elder abuse attorney to discuss your specific case. At Mininno Law Office, we use a unique team of medical and legal professionals that work together to cover every angle of your bedsore case. Our staff nurse will answer any medical questions you may have, while our team of elder abuse attorneys will fight aggressively for your rights in court.

To get started with our licensed RN, call toll-free (856) 833-0600 or fill out the case evaluation form on the right side of the page.

Related information:

New Jersey Nursing Home Abuse Lawyers

Mommy’s Bliss Nipple Cream Can Cause Respiratory Distress in Infants

The FDA has advised nursing mothers to stop using Mommy’s Bliss Nipple Cream, as it may cause respiratory distress, vomiting and diarrhea in infants. The FDA posted the following warning on their website:

The U.S. Food and Drug Administration is warning consumers not to use or purchase Mommy’s Bliss Nipple Cream, marketed by MOM Enterprises, Inc., because the product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants. The product is promoted to nursing mothers to help soothe and heal dry or cracked nipples. Product labeling specifically states that there is no need for mothers to remove the cream prior to nursing. However, the ingredients contained in the product may be harmful to nursing infants.

Potentially harmful ingredients in Mommy’s Bliss Nipple Cream are chlorphenesin and phenoxyethanol. Chlorphenesin relaxes skeletal muscle and can depress the central nervous system and cause respiratory depression (slow or shallow breathing) in infants. Phenoxyethanol is a preservative that is primarily used in cosmetics and medications. It also can depress the central nervous system and may cause vomiting and diarrhea, which can lead to dehydration in infants.

Mothers and caregivers should watch for a decrease in an infant’s appetite. More serious signs would be difficulty in awakening the child, limpness of extremities or a decrease in an infant’s strength of grip and a change in skin color. Please seek immediate medical attention if your child is showing these signs and symptoms.

“The FDA is particularly concerned that nursing infants are being unwittingly exposed by their mothers to this product with dangerous side effects,” said Janet Woodcock, M.D., director, FDA’s Center for Drug Evaluation and Research. “Additionally, these two ingredients may interact with one another to further compound and increase the risk of respiratory depression in nursing infants.”

Though the FDA has not received any reports of injury to infants, the agency is alerting the public because of the potential harm this product can have on a child.

Chlorphenesin can also harm the mother by causing dermatitis, a skin condition that can worsen the drying and cracking of nipple skin.

MOM Enterprises, Inc. is based in San Rafael, Calif. The company has stated that it has discontinued marketing the nipple cream with the potentially harmful ingredients. The FDA is advising consumers to discontinue use of Mommy’s Bliss Nipple Cream and to consult a health care professional if they experience problems or believe that their infant may have experienced problems due to this product. Nursing mothers with cracked, painful nipples, which is often a side effect of nursing, should speak with their health care professional or a certified lactation consultant if the problem is severe or for other treatment options.

Consumers are strongly encouraged to report adverse events related to this product or any FDA approved product to MedWatch, the agency’s voluntary reporting program, by e-mail at here, or by phone at 800-332-1088, or by fax to 800-332-0178. Consumers may also mail reports of adverse events to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20852-9787.

If you are a nursing mother and have observed any of these side effects after using Mommy’s Bliss Nipple Cream, I strongly encourage you to report these symptoms to the FDA using the contact information listed above. Drug investigations are sparked by consumer feedback, so it is important that you speak up if you have experienced any strange side effects after using the cream.

Alternatively, if your child has been hospitalized as result of using this cream for respiratory distress or dehydration due to severe vomiting or diarrhea, you may have rights against the product manufacturer. To speak with our licensed RN regarding your child’s medical history, please fill out the contact form on the right side of the page or call toll-free (856) 833-0600.
A medical malpractice professional will contact you within 12 hours to discuss your case.

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.