Medical Injury Lawyer Blog : Houston Medical Injury Lawyer & Attorney : Arnold & Itkin Law Firm : Pharmaceutical Injuries, Medical Devices : Texas, Dallas, Fort Worth, San Antonio

New York-based company, Universal ABC Beauty Supply International Inc., recalled 34 weight loss products after the U.S. Food and Drug Administration (FDA) warned of risks from consuming the products.

The FDA informed the company that the diet pills and supplements contain Sibutramine, a drug that can lead to a substantial increase in blood pressure and an accelerated heart rate. This could cause health risks in people with a history of cardiac problems. None of the products have been approved by the FDA, although, Sibutramine has been approved by the agency for use as a weight loss drug. Because these weight loss products have not received FDA approval, there can be no guarantees of the safety and effectiveness of the products.

The list of weight loss products, includes:

1. ProSlim Plus
2. 3 DAYS fit
3. EIGHT FACTOR DIET
4. 24hours Diet
5. Slim 3 in1 M-18 ROYAL DIET
6. 3X SLIMMING POWER
7. Extrim Plus 24hours Re-BURN Formula
8. Slim 3in1 EXTRA SLIM FORMULA
9. Slim 3in1 SLIM WAIST FORMULA
10. SLIM EXPRESS 360 C
11. SLIM EXPRESS 4in1
12. ROYAL SLIMMING FORMULA
13. BODY CREATOR
14. Slim Waistline
15. BODY SHAPING
16. PERFECT SLIM
17. Perfect Slim 100% Natural Herbal Essence
18. IMELDA Perfect Slim
19. Slim Waist Formula
20. Super Slimming
21. 2 DAY DIET
22. Powerful Slim
23. BODY SHAPING
24. SUPER FAT BURNER
25. SLIMMING FORMULA
26. SLIM FAST 2
27. SLIM FAST
28. Slim up
29. 7 DAYS DIET
30. Perfect Slim Up
31. JM Fat Reducer
32. SlimBurn
33. 21 Double SLIM
34. TRIM PLUS 2

There have been no reports of illness or injury related to these products; the company said it will discontinue the recalled defective drugs. The company is offering refunds on unused pills. If you have any of these weight loss supplements in your home, discontinue use and contact the company.

Diet pill and supplement companies make up a billion dollar industry. However, some pills may have side effects, including nervousness, diarrhea, accelerated heart rate, tremors, increase in blood pressure, and cardiac arrest. Just because pills promise to give you a slim figure does not mean they are completely harmless and contain no side effects. Medical injury lawyers advise people who use these drugs to follow all dosage instructions carefully and consult their physician before they begin taking them.

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Last week, U.S. Food and Drug Administration (FDA) officials held what the New York Times called a “rare” meeting to discuss the many controversies surrounding the agency's device safety record; medical injury lawyers think the meeting is past due.

The director of the FDA’s Office of Device Evaluation, Dr. Donna-Bea Tillman, called for an “all hands meeting,” to include all scientists in the device evaluation section. Shockingly, a meeting like this has not been held at the FDA in years. Then again, when you consider the agency's medical device safety record, it really is not very surprising.

The meeting is the most recent in a series of developments surrounding the FDA's record in approving devices. At least 9 scientists this year wrote to Principal Deputy Commissioner, Dr. Joshua Sharfstein, alleging that approval procedures in the device section were being "severely distorted." The letter also alleged that scientists at the agency, who were raising their voice against such unethical practices, were facing retaliation by FDA higher-ups. The matter has been serious enough to warrant a Congressional investigation. Soon, the Institute of Medicine could also begin probing these serious concerns about the device section.

Things seem to be heating up at the medical device section of the FDA. Two things are apparent at this point:

• There are serious failures in the medical device division of the FDA.
• These problems are not going to be solved by mere patch-up work.  Rather, the section needs a complete overhaul to root out unethical practices, and make approval processes corruption-proof.

Any changes that come about at the medical device division cannot be a day too soon.

Defective Medical Devices

It is the FDA's responsibility to protect American consumers from dangerous medical devices. If they fall down on the job and let corrupt individuals get in the way of important safety evaluations, we are all at risk.

If you or a loved one has been injured by a defective medical device, a medical injury attorney can help you recover physically, emotionally, and financially.

Contact a medical injury lawyer, at Arnold & Itkin LLP for a free consultation and to find the answers to any questions you might have.

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On the heels of the Hepatitis B contamination crisis at a New Jersey clinic and the Nevada clinic Hepatitis C scandal, comes another incidence of medical malpractice at a South Dakota urology clinic that could have exposed patients to Hepatitis B, C, and HIV.

This month, the Siouxland Urology Center sent a letter to patients asking them to visit the clinic for free testing of HIV, Hepatitis B, Hepatitis C, and other infectious diseases that could have been contracted by the use of contaminated medical equipment at the center. Now, five residents of Iowa have filed a class action lawsuit against the Siouxland Urology Center and its owners. The clinic is in Dakota Dunes, on the South Dakota - Iowa border.

Last week, the South Dakota Department of Health stated that it identified a possible risk for infection from cystoscopy procedures performed at the facility. A survey of the center revealed that staff used saline solution bags and other single use products on more than one patient before discarding them. According to the Health Department, it has not identified any blood borne infections due to the lack of safe medical practices at the facility.

What is frightening is that the center admitted that since it opened in 2002, more than 5,000 cystoscopy procedures have been performed at the facility.

Inviting patients who you could have exposed to dangerous, possibly deadly diseases by your own negligence, for "free testing" is a like closing the stable gates after the horses are out. These infectious diseases have no known and permanent cure. Patients who contract these diseases can only maintain a lifestyle that keeps symptoms under control. It is appalling that the six doctors who owned the Siouxland Urology Center failed to stop the negligent medical practice of reusing disposable medical equipment. That is the kind of negligence you might expect from a jungle clinic in a Third World country, not from a specialty medical center in the U.S.

Siouxland Urology Center has challenged the health department's statement that using bladder exam equipment on more than one patient can expose them to the risk of disease.

Medical Malpractice

Medical injury attorneys often come across instances in which health care professionals who have been accused of malpractice, continue to remain in a state of denial even when their negligence has been exposed.

If you or a loved one has been infected with a dangerous disease or injured by the negligence of a doctor or clinic, a medical injury attorney can help you find the resources you need to recover.

Contact a medical malpractice attorney, at Arnold & Itkin LLP for a free evaluation of your case. 

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Quest Diagnostics has agreed to pay $302 million as part of a settlement in a case involving both civil and criminal charges. The Quest settlement is one of the largest involving a medical device.

The agreement also calls for a Quest subsidiary, Nichols Institute Diagnostics, to plead guilty to criminal mis-branding charges. Both New Jersey-based Quest and Nichols will pay $262 million plus interest, to settle charges against them stating they made misleading product claims under the Federal False Claims Act. Nichols will also pay a fine of $40 million. Also, Quest has agreed to compensate state Medicaid programs with $6.2 million to settle claims of misleading marketing. Nichols, as part of the criminal resolution of the case, pled guilty to felony mis-branding and marketing ”unproven advantages” of the Advantage Chemiluminescence Intact Parathyroid Hormone Immunoassay. As part of the settlement, Quest entered into a no prosecution agreement with the government.

Earlier this year, the company was involved in another medical injury scandal in which defective diagnostic kits used for monitoring vitamin D levels, caused botched test results. Thousands of people were believed to have been impacted by the defective results. A high reading of vitamin D levels could result in patients not taking as high a dose of the vitamin D supplement as they needed, while an erroneous low reading could result in patients taking higher doses of vitamin D supplements than required, ultimately resulting in Vitamin D toxicity. The company issued a massive recall of its lab tests and sent letters to thousands of doctors asking them to get their patients retested. Quest has also faced criticism from medical injury lawyers and patient safety advocates because it waited nearly two years to announce the test recall.

Medical Injury Prevention

Medical companies have a responsibility to keep consumers safe by informing them when there has been a mistake or if they find a defect in one of their products. Failure to do this can result in the company being fine great amounts of money and, more importantly, injuries to innocent patients.

If you or a loved one has been injured due to the neglect of a medical company, a medical injury attorney can help you find the resources you need.

Contact an experienced medical injury attorney at Arnold & Itkin LLP for a free consultation.

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Last month, the Food and Drug Administration (FDA) sent letters to major pharmaceutical companies, warning them that their Google search ads will be removed unless they start including information about the risks of the drugs.

Most of the top pharmaceutical companies received the letter, which included two pieces of information the agency expects pharmaceutical search ads to have:

• The full name of the drug
• Risk factors associated with the drug

Until now, pharmaceutical marketing companies followed the “One Click" rule. As long as all risk information was provided on the page users were directed to after clicking the ad once, risk information was considered sufficient. Now, the agency is demanding that ads include the risks and explains that, laws for print or television marketing are the same for internet marketing. Many pharmaceutical companies have complied, but argue that the FDA should look further into internet advertising and understand that including the risks of a drug is, not only impossible considering Google's guidelines, but also more confusing for consumers. The FDA set April 9th as the deadline for companies to change their ads.

Medical injury lawyers support the FDA's decision to regulate pharmaceutical companies' internet advertising. After all, if a company has is able to describe a product in glowing terms within the Google character limit, it should have no problem including risk information within the character limit as well. However, what we would like is for Google, the FDA, and pharmaceutical companies to come up with ways in which consumers would have all pertinent information about the drug, including risks, when a search ad catches their attention. Currently, the FDA’s new system has online pharmacies showing up as the top listings in text ad results; this is not very helpful for consumers.

This is one more example of good intentions, but flawed methods. The FDA needs to put a little more effort into defining the rules clearly, and pharmaceutical companies must work with the agency to ensure that customers have all risk information at a glance. This is all new territory for the agency. Clear guidelines will give companies no excuse for disobeying the rules and will provide consumers with all the information they need.

Pharmaceutical Attorney

Pharmaceutical companies are required to disclose the risks of their products. Failure to do so can result in seriously injured consumers and even death. Luckily, the FDA is doing what they think is best to protect American consumers, lets just hope they are not confusing the situation even more.

If you or a loved one has been injured by a defective pharmaceutical drug an experienced medical injury lawyer can help you find the answers and resources you need to recover. For a free evaluation of your case, contact a medical injury attorney at Arnold & Itkin LLP.

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Patients in Nevada who have suffered medical injuries due to malpractice by doctors will now be able to claim unlimited damages for pain and suffering.

Last week, a Nevada assembly judiciary committee voted to approve a bill that lifts the cap on medical malpractice court judgments. The bill, which is supported by medical injury lawyers, will protect patients who have been exposed to medical negligence. Propelling Bill 495 forward was the recent Hepatitis C scandal in the state, in which more than 50,000 patients were believed to have been exposed to the deadly disease as a result of poor standards of hygiene at two Las Vegas clinics. Health officials confirmed that 9 patients who were treated at the Endoscopy Center of Southern Nevada and the Desert Shadow Endoscopic Center, both owned by Doctor Dipak Desai, tested positive for Hepatitis C.

The scandal resulted in several malpractice lawsuits filed by medical malpractice attorneys against the facilities. There has also been severe criticism of the state board of medical examiners for its failure to correct errant doctors and punish them accordingly.

The experience of these patients, who have been exposed to a potentially fatal infection due to the utter negligence of doctors, has no doubt spurred the committee to move quickly to approve Bill 495. Patients who have filed lawsuits have demanded changes in the law which currently places a $350,000 cap on malpractice lawsuits. However, Bill 495 does not apply retroactively to the Las Vegas Clinic Hepatitis C cases.

Opponents of the bill have been staging protests in the days leading up to the vote. Their argument? The bill would raise doctors' insurance premiums and force doctors to leave Nevada. The bill will be sent to the general assembly this week. We hope law makers will do the right thing and return patients' rights to justice.

Medical Malpractice Attorney

Doctors' failure to keep their facilities cleaned properly and free of dangerous diseases puts, not only their patients at risk, but also the family and friends of those patients and so on. A medical injury attorney can hold negligent physicians accountable for their recklessness.

If you or a loved one has been injured due to a doctor's negligence a medical malpractice attorney can help you recover physically, mentally, and financially. Contact a medical malpractice attorney at Arnold & Itkin LLP for a free evaluation of your case.

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You can add yet another medical injury to the long list of risks associated with Avandia – this time it is the increased likelihood of developing an eye disorder called Diabetic Macular Edema (DME). According to studies, people who take a group of anti-diabetes drugs called glitazones, including Avandia, are at a greater risk of contracting the disorder.

Avandia and DME

The research was conducted at the Southern California Permanente Medical Group, and was published in the April issue of the American Journal of Ophthalmology. The study is not the first one suggesting a link between glitazone use and DME, but has confirmed a "modest" association between the two. DME is linked to the accumulation of fluid in the eye and swelling, and may eventually lead to loss of vision.

The study, which was conducted on a total of 996 DME patients, revealed that people who took glitazone-containing drugs, like Avandia, were up to 2.6 times more likely to develop the disorder than those who were not taking the drugs. In fact, the risk of developing DME for glitazone users was up to 68% higher than for non-glitazone users. Avandia contains rosiglitazone, which belongs to the glitazone family.

According to the authors of the study, the safety of a drug is as important is its efficacy in treating a disease. However, current safety evaluations for drugs do not take into account long-term safety because approvals are based on short term clinical drugs. This lack of intensive study could result in the release of a potentially defective pharmaceutical drug into the market. The authors have found enough of a link between DME and glitazone use to advise ophthalmologists treating DME patients to consider glitazone use during diagnosis.

Dangers of Avandia

Recently, a study by the Canadian Medical Association Journal found a link between Avandia and a higher incidence of bone fractures in women. Previous clinical studies have also linked the anti-diabetes drug to chest pain, heart failure, and other heart problems. Medical injury lawyers have been pursuing lawsuits against GlaxoSmithKline, the company that markets Avandia, for these injuries.

The list of risks associated with Avandia use continues to grow. Eye problems are one of the effects of uncontrolled diabetes which, ironically enough, Avandia is supposed to keep under control. If you are currently taking Avandia, you should consult your doctor about the risks of DME. Your doctor may be able to prescribe a less risky substitute.

If you or a loved one has been injured by the use of Avandia or any other pharmaceutical drug, contact a medical injury attorney at Arnold & Itkin LLP for a free consultation.

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A New Jersey board of medical examiners temporarily revoked the license of an oncologist whose clinic is suspected to be the source of a Hepatitis B outbreak. At least five of Dr. Parvez Dara's patients contracted Hepatitis B, provoking an investigation and a safety alert by New Jersey health officials.

Health inspectors described seeing unsterilized and unsanitary conditions at the doctor's Toms River clinic. There was blood on the floor of the room where Dr. Dara administered chemotherapy treatments to his patients. Inspectors also found blood inside the bin used to store blood vials. The saline and gauze were unsterilized, and medication vials had been left open. Inspectors also found violations that involved the use of contaminated pens, counter tops, and refrigerators; misuse of antibiotics, and other violations. In March, health officials sent a letter to more than 3,000 patients who were being treated by Dara asking them to get themselves tested for hepatitis B and C, and for HIV. At least five of his patients tested positive for hepatitis B.

Attorneys for the doctor insisted that there is no direct evidence linking the five hepatitis cases to Dr. Dara’s office. They also suggested that the patients could have contracted the disease at a hospital shared by them. The attorney is asking for Dara’s license to be reinstated or, at least, for him to be allowed to conduct examinations and consultations.

Hepatitis B is a highly infectious disease that affects the liver. It is up to one hundred times more infectious than the HIV virus, and can result in liver cirrhosis, inflammation, and liver cancer. It is primarily transmitted through contact with the bodily fluids of an infected person. Common modes of transmission include:

• Unprotected sex with a person who has Hepatitis B
• Sharing needles
• Sharing tooth brushes and razors
• Transfusion of infected blood
• Perinatal infections in which the disease is transmitted from the mother to a baby at birth       

Treatment for chronic hepatitis B can include medications that can be very expensive. People who develop liver cancer as a result of prolonged hepatitis B infection may die within a few months of being diagnosed.

It appears that the staff at Dr. Dara's clinic lacked training in handling sterile medications and surgical products. Such negligence could well have exposed several of his patients to an infectious disease. Patients should not have to worry that being treated in a doctor’s clinic will expose you to a deadly infection.

Medical Malpractice

A medical malpractice lawsuit can help hold a healthcare worker accountable for negligence that results in medical injuries to patients. It is common for people to blame medical malpractice attorneys for a lot of ills, including the rising cost of insurance, and the flight of doctors outside the state, but all too often, unfortunately, it is only the risk of a lawsuit that ensures health care professionals exercise care in the treatment of their patients.

If you've been injured by the negligence of a doctor, nurse, or other healthcare professional, a medical malpractice attorney can help you obtain justice and recover your rightful compensation.  The experienced attorneys at Arnold & Itkin LLP have helped thousands of victims of negligence receive justice. Contact a medical malpractice attorney at Arnold & Itkin LLP for a free consultation.

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Zoll Medical Corporation recalled its AED Plus Defibrillators because of battery defects in some of the units, and malfunction of self testing software that fails to detect faulty batteries. Approximately, 180,000 units have been included in the recall.

The company sent a letter to customers in February warning them that the defibrillators were prone to a malfunction that has already been linked to the deaths of two people.

The Zoll AED Plus Defibrillator is used by emergency personal, medical personnel, and those who have received CPR AED training. The device is used to treat patients having a cardiac arrest. It works by analyzing the heartbeat of an unconscious patient and instructing the user to press a button that can deliver an electrical shock to the heart, and restore a normal cardiac rhythm. The recalled defibrillators failed to deliver an electrical shock to patients' heart.

In the letter it sent to customers in February, the company asked customers to get their batteries replaced every three years. In March, the company sent a follow up letter asking customers to download new testing software to test the devices. According to that letter, the defibrillators could be prone to failure because of defective battery test software that does not detect flawed batteries.

The recalled devices were manufactured from May 2004 to February 2009, and distributed during the same period. The company asked customers not to stop at changing the batteries, as that will not correct the problem, also, the device software must be downloaded for the defect to be corrected. The company also confirmed that it received two reports of death from the failure of the device. The U.S. Food and Drug Administration (FDA) has classified this as a Class I recall, meaning there is a ‘’reasonable probability’’ that using the product could cause injury or death.

Medical Injury Attorney

Complex medical devices like defibrillators have been responsible for saving thousands of lives, but when these are sent out into the market with a defect, the resulting injuries can be extremely serious. Medical injury lawyers can help victims, who have been injured because of these defects, recover compensation.

If you have been injured by the use of a defective medical device, contact a medical injury lawyer at Arnold & Itkin LLP for a free consultation.

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