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

McNeil Consumer Healthcare and the FDA are notifying consumers that McNeil is expanding its recent drug recall of TYLENOL Arthritis Pain Caplets to include all lots of 100 count bottles with the red EZ-OPEN CAP.

Last month, five lots of the product were recalled after consumers reported unusual moldy, musty, or mildew-like odors associated with nausea, stomach pain, vomiting and diarrhea. The odor is caused by the chemical 2,4,6-tribromoanisole, which is believed to be created through the breakdown of a chemical used to treat wooden pallets that were used for transporting and storing packaging materials.

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The Houston trial law firm Arnold & Itkin LLP has filed five lawsuits against the makers of defective pain pumps and related medications based on claims that many of the company’s defective medical devices  are causing irreversible shoulder damage among patients. Currently, medical attorneys at Arnold & Itkin LLP represent 28 people who received pain pumps to manage pain following shoulder surgery. The pumps utilize a catheter to deliver continuous doses of medication directly into the shoulder. According to the lawsuits, pain pump manufacturers were denied approval by the U.S. Food and Drug Administration to use the pumps to mitigate pain in shoulder joints, but the companies continued to promote their use in that way. Many former pain pump users say the companies were negligent in designing, researching and selling pain pumps that they should have known were dangerous. The legal filings include claims of fraud, breach of warranty and products liability against the defendant manufacturers.

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Everyone has heard the clichés: “We’re all human.” “Everyone makes mistakes.” “Nobody’s perfect.”
Those answers are just fine when they come from a waiter explaining an overcooked filet or a child offering a reason behind a less-than-perfect spelling test. But when it’s your doctor?

The fact is that those go-to answers actually are valid, even for doctors … who are human … and therefore are not perfect … and sure enough, make mistakes, many of which fall under the umbrella of medical malpractice. But none of those answers does anything to appease the feelings of patients (and their families) who bear the brunt of errors ranging from the improper administration of medications to sponges (or other items) being left inside a body during surgery to surgery performed on the wrong part of the body. 

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Bayer AG has begun the process of settling medical injury lawsuits regarding its Magnevist contrast agent; Magnevist contains gadolinium.

The company is one among several, including General Electric Company and Tyco International Limited, being sued over complaints that the gadolinium-containing contrast agent was responsible for causing a potentially fatal organ hardening disease, called Nephrogenic Systemic Fibrosis (NSF).  Since May 2007, the U.S. Food and Drug Administration (FDA) has required that gadolinium-containing contrast agents carry a black box warning.

Bayer’s Magnevist is used during magnetic resonance imaging scans to define tissues clearly. Gadolinium was approved for use in imaging scans in 1999, but the compound was found to increase the risk of NSF in patients who have weak kidneys. NSF is a rare debilitating disease that affects the skin, eyes, joints, and internal organs, causing them to harden. The disease can be fatal. Symptoms of NSF, include:

• Burning or swelling
• Tightening of skin
• Changes in skin texture
• Muscle weakness
• Stiffness in the joints

Since the link between NSF and gadolinium became clear, many patients seriously injured by the drug have hired medical injury lawyers to recover compensation for their injuries.

Bayer has begun negotiating approximately 40 cases that linked Magnevist contrast agents with NSF. Apart from Magnevist, there are 4 other contrast agents containing gadolinium - Ominiscan, OptiMARK, MultiHance, and Prohance.

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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 attorneys 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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