Acetaminophen Alert from FDA

A Jan. 15, 2014 Acetaminophen TylenolAlert from FDA announced that half of Acetaminophen product makers have failed to meet the new 325 mg requirements. Half the makers of prescription painkillers have missed a January 14 deadline to restrict doses of acetaminophen to 325 milligrams per pill or capsule. The FDA had ordered, in Jan. 2011, that any company making medicine containing acetaminophen restrict doses to just 325 mg. by Jan. 14, 2014.

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Beware of Identity Theft in your Drug Case

Identity Theft is ID Theft pictureAmerica’s fastest growing crime, according to FBI statistics. Identity theft and fraud that involves stolen identities is also the fastest-growing category of complaints according to the Federal Trade Commission (FTC) which receives them. People injured by dangerous drugs or devices have also been victimized by identity theft. You would be wise to beware of identity theft in your drug case. This FDA Scam Letter was sent to some of our clients by someone calling himself Peter Williams. Please read it, but realize that any scam you see may vary. The person(s) pulling this FDA scam had the client’s social security number and knew what surgery she had had regarding her lawsuit and even the product used.

Identity theft is sometimes perpetrated by persons working under the color of authority. Some of our clients have reported receiving calls from people claiming to have money to deliver for a settlement. The client is then asked to give bank account, social security or other numbers in order to receive funds by deposit. Other clients have reported phone calls from people claiming to be FDA agents reviewing our client’s drug or device case. If you receive such a call, we strongly recommend you do not share any personal information. If possible, write down the name and phone number of the person calling, and let that person know you need to check with your lawyer  before revealing any information.

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Fosamax Settlement of $28 Million

Merck would settle some Fosamax Lawsuits

In September, a federal judge ordered hundreds of lawsuits which charge that Merck’s Fosamax caused osteonecrosis – a painful death of jawbone tissue – be moved for trial to courts around the country. Because so many separate trials would greatly increase Merck’s court costs, the company on Monday proposed paying nearly $28 million to settle nearly 1,200 lawsuits of some 5,000 outstanding.

A lawyer for Merck, Paul Strain, handling the proposed Fosamax settlement for the company, said, “We hope to bring this to a successful conclusion.” Strain spoke in a Manhattan federal court room before Judge John Keenan, who is presiding over the growing Fosamax litigation. According to Reuters, Merck noted that the proposal would require 100 percent of the roughly 1,200 people to participate. That is a tall order.

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Monsanto FDA Monsanity

Monsanto FDA Monsanity is alive and well in Washingtonmonsanto millions against

The revolving door between FDA employment and private enterprise – greased at the hinges with millions of dollars in cash and connections – virtually assures us that the system will fail us, that industry-sponsored “science” will be tainted and people will continue to cross back and forth from promoting industry profits to “serving” in government.  Many FDA executives, scientists or lawyers move through this revolving door to lobby for the same private contractors or drug companies they were once entrusted to regulate or “watchdog.” The story of Michael R. Taylor is a perfect – and perfectly sad – example of this conflict of interest in action and how it comes to affect us all.

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Risperdal Fraud & Risperdal Lawsuits

The FDA reported in a news release last month that Janssen Pharmaceuticals, Inc. would plead guilty and pay more than $1.6 billion to resolve charges the company misbranded Risperdal and filed false claims for its uses.

On behalf of FDA, the U.S. Dept. of Justice announced a guilty plea agreement with Janssen Pharmaceuticals, Inc., (JPI) – a division of Johnson & Johnson –  of Titusville, N.J. The company agreed to pay $400 million in criminal fines for placing a misbranded drug –  Risperdal (risperidone) – in interstate commerce. JPI must also pay $1.25 billion as part of a Risperdal civil settlement. The plea and civil settlement penalties top $1.67 billion.

FDA Commissioner Margaret A. Hamburg, M.D. said, “When pharmaceutical companies ignore the FDA’s requirements, they not only risk endangering the public’s health but also damaging the trust that patients have in their doctors and their medications. . . Today’s announcement demonstrates that pharmaceutical manufacturers that ignore the FDA’s regulatory authority do so at their own peril.”

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Lipitor Lawsuits and Statins for All

Everybody knows that Lipitormoney taints politics, but few understand just how powerfully it can impact “scientific” findings and organizations we might otherwise count on to help us. A recent study of more than 2 million statin users showed that statins harm more people than they help. The whole nature of cholesterol – its biological purpose, makeup, and the calibrations and mechanisms used to measure it, are all open-book subjects of debate for anyone who can find an hour to study the subject for herself. Nevertheless, the American Heart Association (AHA) and the American College of Cardiology (ACC) recently released new cardiovascular disease prevention guidelines that trumpet the wonders of statins and recommend them to an additional 13.6 million people not yet popping them daily.

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Babies strangled by Angelcare Monitors Recalled

After two infants were strangled to death by baby monitor cords made by Angelcare Monitors, Inc., the Canadian company announced last week that it was recalling 600,000 of its baby monitors.

A cord attached to a movement-monitoring sensor pad beneath the crib mattress poses a strangulation risk if a baby tugs the cord into the crib, according to the U.S. Consumer Product Safety Commission (CPSC). Besides the two babies strangled by Angelcare monitor, two others were reportedly found entangled in the cord, though not fatally.

AP reports Angelcare Movement and Sound Monitors with Sensor Pads were sold between 1999 and 2013 (for $100 – $300) by U.S. retailers Babies R Us, Toys R Us, Burlington Coat Factory, Sears, Walmart, Meijer, Amazon.com, Target.com, Overstock.com and some 70 specialty stores.

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Beware of scam FDA, IRS Phone Calls

If you have a drug case, beware of what may be scam phone calls from someone posing as an FDA, IRS or other government representative. Several of our clients have told us they have received mysterious phone calls from a 202 area code (Washington D.C.). The caller identifies himself (or herself) as an FDA or IRS representative investigating their pharmaceutical drug case. We don’t know who these callers are, but these individuals could be posing as government officials. The best course of action is to politely decline to answer any questions. Then take all the caller’s contact information and the reason for the inquiry. Tell the caller you will have an attorney return the call. Then report this call to us immediately.  

We always recommend that you do not tell anyone anything regarding your case or potential case.

Please email or call us if you get such a call, and we would be happy to investigate this matter further.

Be wise.

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FDA: Trans fats cause Heart Disease

The U.S. FDA made a long overdue observation last week that partially hydrogenated oils (PHOs), the primary processed food source of artificial trans fat, are not “generally recognized as safe.” The FDA web site says that this “preliminary determination is based on available scientific evidence and the findings of expert scientific panels.” See the full FDA News Release.

It’s too late for the hundreds of thousands of people who have died of heart disease from trans fat consumption over the last 100 years or so (trans fats are as old as the FDA), but at least the FDA is doing something worthwhile now. Comments to the FDA are welcomed for 60 days on what it calls its “preliminary determination” to collect more data and knowledge on the time that may be needed for food processors to reformulate products that now contain artificial trans fat.

FDA Commissioner Margret A. Hamburg said, “While consumption of potentially harmful artificial trans fat has declined over the last two decades in the United States, current intake remains a significant public health concern. The FDA’s action today is an important step toward protecting more Americans from the potential dangers of trans fat. Further reduction in the amount of trans fat in the American diet could prevent an additional 20,000 heart attacks and 7,000 deaths from heart disease each year – a critical step in the protection of Americans’ health.”

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Potiga can cause Blindness

GlaxoPotiga (Ezogabine) linked To Eye Damage and Skin Discoloration

The FDA updated today its earlier announcement of a black box warning  placed on Potiga, a seizure or epilepsy medication made by GlaxoSmithKline. A black box warning is the most serious drug warning the agency can place.

The FDA approved changes to Potiga’s label to alert consumers to the risks of damage to the retina, possible vision loss, skin discoloration. All these problems could be permanent. Hence, the FDA advises that Potiga be limited to “patients who have not responded adequately to several alternative therapies to decrease the frequency of seizures, or epilepsy, and for whom the benefits of treatment outweigh the risks.”

Health professionals, especially neurology experts as well as patients are urged to take note.

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