According to an article in the NY Times, Amber Suriani had just turned 40 when she noticed she was experiencing urinary discharge. As an avid athlete, Suriani didn’t want these embarassing occurrences affecting her active lifestyle so she sought medical advice. Her doctor diagnosed the problem as stress urinary incontinence and recommended surgery to correct the problem. After being assured that it was a fairly minor procedure that would correct the problem, Suriani agreed to have a vaginal sling inserted under her urethra. The surgery was performed with no complications and Suriani returned to a normal lifestyle until a few months later she noticed bloody vaginal discharge. She was understandably concerned that she may have cancer so she went back to her doctor. Surgery was performed to remove part of the offending sling that, according to her doctor, was causing the problem. Unfortunately, Suriani’s difficulties only grew worse. The sling continued to cause problems and growing pain. Since then, she’s endured four more surgeries to remove the offending portions of the sling.
The vaginal sling, manufactured by ObTape (acquired by Johnson & Johnson), was designed to treat female urinary incontinence. It didn’t fix the problem in Suriani’s case. It exacerbated the problem to the point she decided to take legal action against the company. The medical device company stopped selling the device in 2006 but insists that it was a good device that helped thousands of women.
As the Times article points out, the problems encountered with this medical device bring more scrutiny upon the FDA’s guidelines and methods for allowing medical devices to be sold in this country. Unlike pharmaceutical drugs, the FDA “clears” medical devices rather than approves them. The criteria for clearance is minimal. The new device need only be similar in design and use as previously cleared medical devices. In other words, the medical device is never tested or approved as safe and effective, a standard by which drugs are approved.
This is a clear gap in the FDA’s regulatory process. Medical devices should be approved only after they are demonstrated to be safe, reliable, and effective. Hopefully, passage of the 2009 Medical Device Safety Act will spur agency action to toughen standards for medical devices.

I’ve just been informed by a reliable source that a special committee of the NY State Legislature will consider both the Markey bill and the Lopez bill. As I’ve written in previous posts, the Markey bill is pro-justice and pro-survivor. It allows survivors a one year window to pursue justice against sexual predators and the institutions that protected them. The Lopez bill is nothing more than a bill that protects predators, hurts victims, and insulates institutions from their bad behavior.
According to my source, the committee will hear from both Markey and Lopez and either recommend one bill move forward, seek compromise legislation, or kill the measures outright. If you were sexually abused in NY and seek justice, please urge your legislators in NY to do the right thing and vote for the Markey bill.

Hydroxycut, voluntarily recalled from the marketplace on Friday, is just one of literally thousands of fat burning, weight loss, muscle producing diet supplements manufactured by an unregulated, multi-million dollar supplement industry. You only need visit a fitness store like GNC or a local gym to find a multitude of products that promise weight loss or muscle mass without supporting those claims through scientific fact or FDA oversight.
While the FDA has its hands full with the job it presently has, we need federal oversight of this industry before consumers are seriously and permanently injured.

While complaints about the dangers of the dietary supplement Hydroxycut have been around for years, the FDA never issued a consumer warning about the weight loss drug until yesterday. According to the FDA, the complaints were infrequent and were not definitively linked to liver damage or other health concern.
Unfortunately for consumers, diet supplements and weight loss pills and formulas are not regulated by the FDA. Unlike prescription drugs, these products don’t have to be evaluated or approved by the FDA prior to market launch. As a result, they are marketed as “all natural” and “healthy” even though there is no scientific evidence to support such claims. Additionally, people are often mislead to believe that a product marketed as “natural” is automatically safe. This is patently false. Many natural products are toxic and can cause serious harm to the human body and its internal organs.
In prior doses, Hydroxycut even contained the banned Ephedra. In fact, Ephedra was part of the chemical ingredients that comprised Hydroxycut until 2004 when it was removed.
The FDA is still evaluating what chemical, herb, or natural extract has caused the liver toxicity. In fact, it may be a combination of ingredients that have caused liver injury. Furthermore, the FDA does not know if its a problem with dosage, chemical ingredients, or the length of time that one is exposed to Hydroxycut. These answers should be forthcoming in the next weeks or months as the federal agency studies the weight loss formula. In the meantime, if you’ve used Hydroxycut stop using it immediately. If you show signs of liver disease such as jaundice, brownish urine, or light-colored stools, contact your healthcare professional.

A class action lawsuit will most likely be the result of today’s recall of the popular diet drug Hydroxycut. The fat burner has been highly and aggressively touted on television, radio, and the Internet for years. Many people who have tried to lose weight as well as health and fitness disciples have taken the drug in order to sculpt their bodies or lose weight.
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However, like Fen-phen and Ephedra, Hydroxycut has serious health consequences. Fen-phen caused cardiac problems including primary pulmonary hypertension. Hydroxycut has been linked to liver toxicity. Our firm has already been contacted by consumers who’ve been advised by their healthcare professionals that they have liver problems.
Diet drugs such as Hydroxycut are marketed as quick fixes and miracle drugs but they are not regulated or approved by the FDA. This lack of regulation has led to needless suffering for those who’ve taken these harmful drugs.
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FOR IMMEDIATE RELEASE
Recall attorney Saunders & Walker with FDA Warns Consumers to Stop Using Hydroxycut Products recall
Dietary Supplements Linked to One Death; Pose Risk of Liver Injury and will likely result in lawsxuits
The U.S. Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall Hydroxycut products from the market.
The FDA and lawyers has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to the FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.
Liver injury, although rare, was reported by patients at the doses of Hydroxycut recommended on the bottle. Symptoms of liver injury include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite.
“The FDA urges consumers to discontinue use of Hydroxycut products in order to avoid any undue risk. Adverse events are rare, but exist. Consumers should consult a physician or other health care professional if they are experiencing symptoms possibly associated with these products,” said Linda Katz, M.D., interim chief medical officer of the FDA’s Center for Food Safety and Applied Nutrition.
Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names. The list of products being recalled by Iovate currently includes:
Hydroxycut Regular Rapid Release Caplets
Hydroxycut Caffeine-Free Rapid Release Caplets
Hydroxycut Hardcore Liquid Caplets
Hydroxycut Max Liquid Caplets
Hydroxycut Regular Drink Packets
Hydroxycut Caffeine-Free Drink Packets
Hydroxycut Hardcore Drink Packets (Ignition Stix)
Hydroxycut Max Drink Packets
Hydroxycut Liquid Shots
Hydroxycut Hardcore RTDs (Ready-to-Drink)
Hydroxycut Max Aqua Shed
Hydroxycut 24
Hydroxycut Carb Control
Hydroxycut Natural
Although the FDA has not received reports of serious liver-related adverse reactions for all Hydroxycut products, Iovate has agreed to recall all the products listed above. Hydroxycut Cleanse and Hoodia products are not affected by the recall. Consumers who have any of the products involved in the recall are advised to stop using them and to return them to the place of purchase. The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. The products contain a variety of ingredients and herbal extracts.
Health care professionals and consumers are encouraged to report serious adverse events (side effects) or product quality problems with the use of these products to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.

I was watching MSNBC’s Hardball with Chris Matthews the other night and happened to catch conservative political commentator Pat Buchanan discuss the issue of swine flu. During his commentary, Buchanan linked swine flu with illegal immigration noting that the first cases of swine flu originated in Mexico. If you think that may be a stretch, wait for his next comment. Buchanan also attributed the growing problems with bed bugs on illegal immigration! I haven’t seen that the mainstream media or the blogosphere caught the comment but he actually argued for the connection.
Bed bugs have re-surfaced in this country as a result of a dearth of effective agents to kill the pesky insects. In addition, the bed bugs multiply rapidly and can go undetected until they start feeding on the blood of human beings. None of this has anything to do with the immigration issue. Bed bugs aren’t even restricted to the warmer weather climes of the border states. Bed bug problems have been noted in Chicago, New York, Boston and other northeastern cities.
As an attorney who handles bed bug cases, I thought it was suprising, almost comical to have Pat Buchanan trying to blame bed bugs on immigration.

A bill introduced by Senators Chuck Grassley and Edward Kennedy would provide more funding for inspections of manufacturing plants that produce medical devices and pharmaceutical drugs. The proposal would give the FDA broad new powers in detaining questionable drugs or medical devices, allow the federal agency to issue subpoenas, and collect inspection fees from the company they are investigating.
The legislation comes in response to the contaminated Chines heparin as well as problems with manufacturing processes in medical device plants that make Stryker hip implants and Zimmer Durom Cup him implants.
While Congress has complained that the FDA has done a poor, ineffective job at regulating and inspecting medical devices and pharmaceutical drugs, the agency has argued that it is woefully understaffed and underfunded to complete the consumer safety tasks the federal government demands of the agency. This bill is widely seen as a corrective measure that would give the FDA the money and regulatory power to ensure better adherence to safety guidelines for both drugs and medical devices.

St. Jude Medical Inc. has received a warning letter from the FDA regarding its manufacturing practices at its Minnesota plant. The plant makes medical devices designed to correct atrial fibrillation disorders.
In its letter, the FDA made mention of St. Jude Medical’s Safire ablation catheter which is designed to disengage electrical signals that cause atrial fibrillation. The warning letter was issued as a result of a December FDA inspection of the Minnesota facility. Such a warning letter can result in the termination of production of the medical device in question if the company does not correct the problems cited in the warning letter.
Other medical device companies such as Stryker Corporation, Boston Scientific, and Johnson & Johnson have received similar warning letters in the recent past concerning other medical device products.

The president of Paraguay Fernando Lugo was a Catholic bishop prior to his resignation in 2004 in order to run for the presidency of Paraguay. In the last few weeks, Lugo admitted fathering one child while he was a bishop. Now it seems that Lugo fathered more than one child while a Catholic bishop. A former episcopal colleague of his, Most Rev. Rogelio Livieres, spoke out yesterday. Bishop Livieres spoke to the media and revealed that when Lugo was confronted with two complaints of sexual activity in 2004, he didn’t deny the accusations. In fact, Lugo stated that at least in one instance the child was most likely his.
If you think this is bad, wait, it gets worse. The women who are now accusing the former bishop of fathering their children were minors at the time. According to Bishop Livieres, two of the women wrote letters in 2004 to the Vatican informing them of their allegations. Livieres claims “everyone” knew about Lugo’s sexual activity with the minors but it was covered up so as not to hinder his presidential chances.
So, once again, the church knew about sexual abuse and covered it up. It covered up this behavior by a bishop who was preying on poor women who looked to him for guidance, spiritual assistance, and fatherly love. Instead, he abused his authority and role as a bishop to sexually prey on these young women. When notified of the bishop’s behavior, the Vatican officials turned a blind eye to it. I guess they didn’t want to create scandal!