ISSUE: Regeneca Worldwide a division of VivaCeuticals, Inc., is conducting a voluntary nationwide recall of its appetite controldietary supplement, lot # EX0616R15814 and lot #11414RE5516, because FDA analysis confirmed the presence of DMAA. DMAA, also known as 1,3-dimethylamylamine, methylhexanamine, or geranium extract, is commonly used as a stimulant, pre-workout, and weight loss ingredient in dietary supplement products. FDA has warned that DMAA is potentially dangerous to health as it can narrow blood vessels and arteries, which can cause a rise in blood pressure or other cardiovascular problems such as shortness of breath, arrhythmias, tightening in the chest, and heart attack.
Bloomberg news just reported that Johnson & Johnson’s first trial concerning its “Pinnacle” hip replacements will begin today. There are a total of approximately 6,000 cases alleging that the Pinnacle hip replacements were defectively designed causing metal debris to be absorb into patient’s blood stream.
We are currently handling both these cases and other similar cases involving J&J’s “ASR” hip replacements. Please let us know if you have received either hip implant, as you may be unknowingly suffering from metal poisoning. If you or a loved one has received a hip replacement between the years of 2005 – 2013, I would strongly advise you to contact your doctor to determine the exact make and model of the implant. Let us know if you need help finding this out. All initial consultations are free.
Johnson & Johnson JNJ, which set aside $2.5 billion last year to resolve claims that 8,000 of its artificial hips were defective, faces a new round of lawsuits over another line of hip implants blamed for poisoning patients.J&J’s DePuy unit is starting its first trial of allegations that the metal-on-metal version of the Pinnacle hip was defectively designed and caused metal debris to leech into patients’ bloodstreams. The cobalt-and-chromium material caused an infection that forced Kathleen Herlihy-Paoli to have her artificial hips surgically removed, she said in court filings.
Image Credit: Wall Street Journal
J&J just announced that it is voluntarily pulling its power morcellators globally. J&J’s decision comes in the wake of the FDA’s April 2014 warning to doctors that this device may spread, and consequently accelerate, the growth of undetected cancer cells in women. The FDA found that as many as 1 in 350 woman who undergo this procedure may have cancer that this machine could spread outside the uterus.
Power morcellators are robots that are used to preform minimally invasive robotic hysterectomies. The American Medical Association estimates that as many as 20,000 woman have these types of procedures preformed on an annual basis.
Our firm is currently reviewing cases where woman have had robotic hysterectomies and experienced injuries or the spread of cancer.
Bloomberg News published a good article on this: http://www.bloomberg.com/news/2014-07-31/j-j-withdraws-hysterectomy-device-tied-to-cancer-spread.html
FDA has identified an emerging trend where over-the-counter products, frequently represented as dietary supplements, contain hidden active ingredients that could be harmful. Consumers may unknowingly take products laced with varying quantities of approved prescription drug ingredients, controlled substances, and untested and unstudied pharmaceutically active ingredients. These deceptive products can harm you! Hidden ingredients are increasingly becoming a problem in products promoted for weight loss.
Cleveland.com [http://www.cleveland.com/healthfit/index.ssf/2014/07/fda_warns_of_prescription_drug.html] reported that the FDA has warned consumers NOT to use the following weight loss supplements due to them containing a dangerous drug known to cause heart attacks and strokes:
1. Mix Fruit Slimming sold on Amazon
2. Lingzhi Cleansed Slim Tea sold on Amazon
3. Trim Fast
4. 24 ince
5. Sliming (sic) Diet by Pretty White sold on ebay
FDA’s List of additional products just for 2014 with “hidden drugs:”
- 07/08/2014 Public Notification: Mix Fruit Slimming Contains Hidden Drug Ingredients
- 07/08/2014 Public Notification: Lingzhi Cleansed Slim Tea Contains Hidden Drug Ingredient
- 07/08/2014 Public Notification: 24 Ince Contains Hidden Drug Ingredient
- 07/08/2014 Public Notification: Lipo 8 Burn Slim Capsules Contain Hidden Drug Ingredient
- 07/08/2014 Public Notification: Sliming (sic) Diet By Pretty White Contains Hidden Drug Ingredient
- 07/08/2014 Public Notification: Trim-Fast Slimming Softgel Contains Hidden Drug Ingredient
- 06/17/2014 Public Notification: Sport Burner Contains Hidden Drug Ingredient
- 06/17/2014 Public Notification: Toxin Discharged Tea Contains Hidden Drug Ingredient
- 06/17/2014 Public Notification: Sliming Diet Contains Hidden Drug Ingredient
- 06/10/2014 Public Notification: La Jiao Shou Shen Contains Hidden Drug Ingredient
- 06/05/2014 Public Notification: B-Perfect Contains Hidden Drug Ingredient
- 05/16/2014 Public Notification: Asset Bold Contains Hidden Drug Ingredient
- 05/12/2014 Public Notification: Asset Bee Pollen Contains Hidden Drug Ingredient
- 05/05/2014 Public Notification: Natural Body Solution Contains Hidden Drug Ingredient
- 05/05/2014 Public Notification: Slim Trim U Contains Hidden Drug Ingredient
- 04/10/2014 Public Notification: Lite Fit USA Contains Hidden Drug Ingredient
- 04/10/2014 Public Notification: Infinity Contains Hidden Drug Ingredient
- 04/02/2014 Public Notification: New You Contains Hidden Drug Ingredients
- 03/19/2014 Public Notification: Vitaccino Coffee Contains Hidden Drug Ingredient
- 01/28/2014 Public Notification: Citrus Fit Gold Contains Hidden Drug Ingredient
- 01/28/2014 Public Notification: Tonic Life BP Contains Hidden Drug Ingredient
- 01/28/2014 Public Notification: Hot Detox Contains Hidden Drug Ingredient
- 01/28/2014 Public Notification: Thinogenics Contains Hidden Drug Ingredient
- 01/21/2014 Public Notification: Dream Body Slimming Capsule Contains Hidden Drug Ingredient
- 01/21/2014 Public Notification: Magic Slim Contains Hidden Drug Ingredient
You can watch the FDA’s video on “Tainted Weight Loss Products” here: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm234592.htm.
The FDA just notified health professionals and caregivers of infants that prescription oral viscous lidocaine (2% solution) should not be used to treat infants and children with teething pain. The FDA will now require a “Boxed Warning” to the drug labeling that will highlight this warning.
This year the FDA reviewed 22 case reports of serious adverse reactions in infants and children. The adverse reactions noted were seizures, severe brain damage, heart problems, and even death. The age range for the reviews was 5 months to 3.5 years old.
The FDA further advised that viscous lidocaine should NOT be prescribed by doctors, and warned parents that even over-the-counter topical medications should not be used due to potential harmful side effects.
You can find the FDA’s Drug Safety Communication Notice here: http://www.fda.gov/Drugs/DrugSafety/ucm402240.htm
You can find the FDA’s Consumer Update Notice here: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm385817.htm
On June 6, 2014, the FDA dropped its hammer on both the maker (Akrimax Pharmaceuticals) and the marketing company (Citius Pharmaceuticals) of the diet drug Suprenza. The website for Suprenza apparently completely failed to list ANY of the contraindications or adverse reactions. The FDA’s letter states that the website “fails to disclose any of the other warnings and precautions associated with the drug. By omitting serious and frequently occurring risks associated with Suprenza, the webpage misleadingly suggests that Suprenza is safer than has been demonstrated.”
The FDA letter further admonishes the website for implying that people taking Suprenza will become “lean.” The FDA states that it “is not aware of substantial evidence or substantial clinical experience to support this implication…” The FDA stated that such implication is misleading absent substantial proof, which apparently doesn’t exist for this drug.
This information was first reported by the Wall Street Journal, and can be found here: http://blogs.wsj.com/pharmalot/2014/06/16/a-diet-drug-website-is-lean-on-important-information-fda-says/.
You can read a complete copy of the FDA’s letter here: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM400708.pdf
If you are considering taking Suprenza – Ask yourself why a manufacture would fail to disclose any of the known contraindications and adverse reactions and why it would attempt to mislead you. Then ask yourself is this really something I want to put in my body.
June 2, 2014 – Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) today announced that it is initiating a voluntary recall of certain lots of Soliris® (eculizumab) 300 mg/30 mL concentrated solution for intravenous infusion that were manufactured using a process component during vial filling identified in the November 2013 recall to the hospital/user level. This recall has been initiated due to the presence of visible proteinaceous particles detected in a single lot during periodic stability testing for Soliris. This lot was distributed only in the U.S.
The recalled lots pose a potential safety risk to patients in two general areas: immune reaction and blood clots. Particulates could cause blockage of flow of blood in vessels, which could be life-threatening.
The single affected Soliris lot is #10007A. Although these lots currently remain in specification, Alexion is including the following remaining lots, which were produced with the same process component during vial filling, within the scope of the U.S. recall: 10002-1, 00006-1, 10003A, 10004A, 10005A, 10005AR, 10006A and 10008A.
Soliris is primarily used in treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two ultra-rare and life-threatening disorders. If you or a loved one is being treated for either condition, make sure your doctor is aware of this recall.
You can find the FDA Recall Notice here: http://www.fda.gov/Safety/Recalls/ucm399527.htm
The FDA announced yesterday the launch of “openFDA” website. This website will allow you to search over 3 million reported adverse drug side effects dating back to 2004.
Here is how the FDA envisions it being a very usual tool for you:
According to FDA’s Chief Health Informatics Officer, Dr. Taha Kass-Hout, “Using this data, a mobile developer could create a search app for a smart phone, for example, a consumer could then use to determine whether anyone else has experienced the same adverse event they did after taking a certain drug.” Dr. Kass-Hout further stated, “OpenFDA will make our publicly available data accessible in a structured, computer-readable format.” It provides a “search-based” Application Programming Interface – the set of requirements that govern how one software application can talk to another – that makes it possible to find both structured and unstructured content online.
This is an incredibly important first step in making it easy for consumers to both report adverse side effects and to check to see if anyone else has experienced similar reactions. It also allow the FDA and drug manufacturers to monitor patient side effects and issue more accurate drug warnings or decide whether or not a safety recall is warranted. This database could essentially create a social media outlet for patients to anonymously report side effects – informing other users of previously unreported reactions.
Previously, only adverse side effects reported to the FDA or the manufacturer (assuming the manufacturer actually passed this information on to the FDA) were made public. And, even then, a consumer would have to search the FDA website for reported side-effects to find this information – a task that is cumbersome at best.
You can find the openFDA website here: http://open.fda.gov/index.html
1. Coverage for Tort Claims – Many policies automatically include coverage for you or a family member who resides in the same household for tort claims filed against you. Make sure to check your policy if you find yourself in this unfortunate position.
2. “Replacement Value” isn’t Paid Until You Replace the Item – Most polices won’t pay you “replacement value” until you actually replace the item. What they pay you is the “actual value” (“fair market value” minus depreciation). Then, and only then, if you replace the item, they will pay you the remainder. Here is an example of why this is unfair:
Assume your house burns down and everything in it is destroyed (“complete loss”). The insurance adjuster comes out and determines the “actual case value” of everything in the house. The adjuster determines that your refrigerator’s “actual cash value” (factoring in depreciation for age, condition, etc.) is $200, but the cost to replace it (“replacement value”) is $800. He then hands you a check for $200 and tells you that you need to come up with the remaining $600 and go buy the refrigerator before he will write you another check for the same $600. He then proceeds to go through all your destroyed possessions and do the same thing. By the time he’s done, he’s written you a check for $25,000 for $150,000 worth of destroyed items leaving you to figure out a way to pay the rest before he kicks in the rest.
Keep in mind that you are paying a higher premium for a “replacement cost” policy. So why do insurance companies do this? Because they know most people won’t replace the item because they can’t afford to. Why can’t they afford to? Because the insurance company won’t pay them the “replacement cost” up front, leaving you holding the bag.
And no, I’m not making this stuff up.
3. Don’t Trust Your Adjuster’s “Depreciation” Analysis – This is where insurance companies really hammer you. Whenever you have a loss, adjusters come in an depreciate everything in your house, including your actual house (structure). They use their own internal depreciation schedules to come up with these values (see #3 above). DO NOT TRUST THEIR DEPRECIATION DETERMINATION. Challenge the adjuster on these schedules. Demand to see the depreciation schedule he/she used FOR EACH ITEM HE/SHE DEPRECIATED. And, don’t let the adjuster tell you that he’s not allowed to send you the schedules – because thats crap. You are entitled to see the schedule and know exactly how much each item is being depreciated.
We recently represented a couple from Florida who had a vacation home here in Georgia. Their Georgia home burned down and was a complete loss. The adjuster initially tried to tell me that their home and possessions were worth only $60,000 factoring in depreciation. After jumping through six months of hoops, the insurance company finally relented and paid $140,000 for the loss. If they will do it to me, they will do it to you.
4. In the Event of a Loss, Read your Policy Closely – I can’t stress this one enough. The first thing you need to do after a loss is get a copy your policy and go over it with a fine tooth comb. One of the main ways insurance companies avoid paying you for your loss is by claiming you “failed to cooperate” or failed to provide the required notice. I would highly recommend immediately taking your policy to a lawyer who handles these types of cases for review. This is not a time to figure it out on your own.
Almost every policy requires that you provide written notice of the loss within a certain time period (typically 30 days) after the loss. This notice is normally required to be sent on a specific form, sent to a specific address, and itemizing the items destroyed to include estimated values. Don’t send it on the right form – claim denied. Don’t provided all the required information – claim denied. Send it a day late – claim denied. Remember, insurance companies don’t make money paying claims. Give them a reason, and they will deny your claim.
Once you provided the required written notice, then be prepared for the dog and pony show. You may be required to: itemize everything in your home, provide the date every item was purchased, provide the amount paid for every item, provide the condition of every item, give a recorded statement the adjuster or their lawyer, tell them whether or not you have ever had a claim on any other policy, give them financial information (bank statements, credit card statements, etc.), as well as a host of other information. God forbid the adjuster “suspects” foul play, as the list of hoops you will have to jump through will grow exponentially. And, if you don’t do everything they require, claim denied for “failure to cooperate.”
5. Insurance Companies Routinely Increase the Value of Your Home, Increasing Your Premiums – Keep an eye on this. Because home value fluctuate, and because your premium is largely based on the value of your home, monitor the value the insurance company places on your home. Make sure it coincides with the actual value of your home based upon the market. It it doesn’t, let the insurance company know and demand a correction.
Let me know if you have any questions about your policy. I’m happy to review it free of charge and point out the important areas you need to be mindful of. While most polices have similar standard language, all policies will differ to some degree. Similarly, not all insurance companies are created equally. Some are especially more problematic than others.
Nathan T. Williams