What is PIP Insurance Coverage - and How Insurance Companies Just Lost Their Latest Try at Getting Florida to Gut PIP Coverage

Personal Injury Protection, or "PIP" coverage, is something offered to Floridians as part of their automobile insurance policy. Right now, under Florida law, every car owner and driver must have at least $10,000 PIP coverage.

If you are in a car accident in Florida, this PIP coverage kicks in, never asking who's to blame. The $10,000 coverage is there, ready to help. Since the insurance company isn't allowed to assess blame here, Florida is called a "no fault" state.

PIP will cover up to 80% of your medical bills and up to 60% of your lost wages - up to that $10,000 cap. No questions asked.

Insurance companies are against PIP coverage because they are arguing that too many people take advantage of it, setting up fake insurance claims just to get the money. We've discussed this before; now, however, Tampa's Fox 13 Investigative Reporter has just published its own expose on PIP coverage fraud, which may help drive those pushing the legislature for change in the future.

Florida is No. 1 in the USA for Fraud PIP Claims

According to Tampa Bay reporter Doug Smith, Florida is actually number 1 in the United States for these kinds of fraud -- and Tampa is tops within the state for filing fake PIP claims.

According to the Fox story, many of these fake PIP claims are professional jobs where there are staged wrecks and clinics are set up to handle the filings. The crashes are set up to have lots of folk involved, so that $10,000 cap can be milked. Eight people can mean close to $80,000 from one scam. The news story goes on to interview those in the know, including police detectives who suggest that these big crash scams are orchestrated by organized crime.

Florida Legislature Nixes Reform - No Changes to PIP Laws for Now

In January, we discussed PIP reform proposals that were being talked about up in the state capital and the efforts of insurance carriers to push reforms through, from bill to law. They've failed.

The insurance industry had gone so far as to build up proposed comprehensive reforms to Florida's PIP laws, creating one big comprehensive personal insurance coverage reform bill.

Around ten days ago, that all fizzled out when the Florida House committee hearing the proposal voted against it. Specifically, HB967/HB1411 - the biggest attempt at changing PIP laws here in Florida in the past 4 years - died as it was voted down by the Florida House Subcommittee on Health Care and Human Services.

Read the dead bill's language here -- and see for yourself that what didn't succeed into turning into law this year was not only an attempt at altering your insurance coverage (instead of boosting regulations to stop criminals via criminal investigation, etc.) but an attempt to:

1. give the insurance companies the right to cap the charges they would cover under PIP for medical services;

2. limit the amount of money that attorneys could charge for their work regarding these crashes; and

3. granting the insurance company even more time (read that delay) in investigating claims before they pay.

It's one thing to fight crime. It's another thing to hurt all Floridians who unfortunately are involved in an accident. Sounds like lots of Florida accident victims may have just dodged a bullet.

By Bryant Esquenazi on May 10, 2011 3:41 PM

Charlie Sheen Isn't Stupid: An Example of How Lawsuits Are Built

Tonight, Charlie Sheen will appear on ABC for a lengthy interview on its 20-20 show - though if you've been following the news, you've probably already heard Mr. Sheen's loud and long protests against the cancellation of his CBS comedy, Two and a Half Men.

If you think that Charlie Sheen is a nut for roaming around and pontificating to Piers Morgan (CNN), Howard Stern, the crew at Good Morning America, TMZ.com, - well, the list goes on and on (the Washington Post calls this his "media storm") -- then you'd be wrong. Wrong.

Because while some may think that Sheen is crazy, he may well be crazy like a fox. Why? From a legal perspective, Charlie Sheen is doing a fine job of getting positioned for a big, fat lawsuit where millions (if not billions) will be on the line.

Lawsuits are Strategically Built, They Don't Spring Up Fully Formed

All lawsuits arise from a formal pleading (the petition or complaint) being filed down at the courthouse with the appropriate clerk, the original being placed in the public record and then copies being given to those who have been sued through a procedure called "service of process." However, that lawsuit didn't just start that day or that week.

Lawsuits are prepared and planned and built for weeks or months before that filing occurs. Facts are gathered, legal research is done. Evidence is made ready through the gathering of documents and the accumulation of witness statements.

You get ready for the fight in an aggressive, thorough manner. The claims that appear in that first filing are supported by lots of hard work and shrewd planning.

All plaintiffs work with their attorneys in this process. They gather evidence. They position themselves for the fight. They are an integral part of the team. And, if they're wise, they work with the potential defendants in an attempt to negotiate a resolution of the controversy before the legal war in the courtroom begins.

Which is exactly what Charlie Sheen is doing. Consider these things that we know and what they may well mean:

1. Charlie Sheen is represented by the Los Angeles law firm of Lavely & Singer - and Radar Online has published a letter that Sheen's lawyers have sent to Warner Brothers and CBS warning that Sheen has legal claims - that Sheen considers himself to be legally wronged.

Translate this to: Sheen's lawyers have given legal notice that a lawsuit - based on contractual damages as well as personal injury - may be forthcoming. Sheen's pondering and perhaps planning litigation - here's his formal notice to the parties he's considering suing. He's letting them know he has legal representation and they are letting the potential defendants know what these legal claims are.

2. Charlie Sheen is doing things now to counter any defense that might be asserted by these defendants. He's doing drug tests in front of the media - blood, urine - and coming out clean.

Translate this to: evidence that Steen is not operating under the influence through lab tests taken before witnesses who can testify that the tests were not fixed. Evidence here, not some stunt.

3. Charlie Sheen is ready to work. Sheen has repeatedly announced he's ready to continue with his TV show duties - even going so far as telling anyone who will listen that he would be showing up for work.

Translate this to: Sheen is letting everyone knows he's ready to continue with his contractual duties. He's not breaching here.

4. Charlie Sheen is actively seeking other projects. Movies, talk shows, etc. These don't seem to be panning out according to media reports.

Translate this to: Sheen is investigating whether or not he has been harmed by the things that have been said about him - has he been professionally injured, has he been legally defamed?

Say what you want about Charlie Sheen. Hate his show, or like it. Disapprove of his lifestyle or revere him as the new Hugh Hefner -- bottom line, Sheen is exemplifying an involved plaintiff preparing for a legal war and there are lessons to learn here.

By Bryant Esquenazi on March 1, 2011 1:32 PM

Stop Smoking Drug Chantix Has Huge Link to Violence, Suicides According to Researchers

For many, the cravings that come with trying to stop smoking alone may bring with them the feeling of wanting to bust someone's chops, but you'd expect a drug heralded as a stop-smoking aid would help with all that stress. Once again, don't assume anything about a drug sold today in the American marketplace!

Researchers at the Institute for Safe Medication Practices, Cambridge University, and Wake Forest University have studied the Food & Drug Adminitration's adverse events reports (we've written about them, here) for a period covering 2004 - 2009. They've been looking at Chantix, specifically.

Last week, they published their findings in PLoS ONE -- and their findings are scary. It seems that Chantix has more than TWICE the number of violence acts reported for it than any other drug on the market today. Specifically, Chantix had 408 acts of violence; the next highest number is Paxil's at 177.

And by violent acts, we are including suicides and attempted suicides. All from taking a drug that is meant to help you stop smoking!!!

There already were a number of plaintiffs who had filed lawsuits against Pfizer, the manufacturer of Chantix, because of injuries they are arguing have resulted from Pfizer's failure to warn of Chantix' psychological side effects. With this new study, we should expect more to be filed - many by families who are grieving the loss of a loved one at their own hands while under the influence of a drug marketed to help people stop a habit that was hurting them.

For more information, check out the product webpage as well as the FDA site page on Chantix. Do either of these informational pages give you enough warning when you consider the newly released study (which was based upon the FDA's own data)?

You decide:

Chantix's website

FDA website page on Chantix

By Bryant Esquenazi on December 23, 2010 9:46 PM

Today's Recall of Breast Cancer Drug Avastin: Scandalous FDA Drug Recall That Many Deem "Death Panel" Decision

The Sun-Sentinel is one of a huge number of news media sources covering today's announced recall by the Food and Drug Administration (FDA) of Avastin, a drug designed for breast cancer treatment. (Read the FDA Announcement here.)

The FDA's reason? "Drug not shown to be safe and effective in breast cancer patients."

Already, there is a growing outcry across the country:

• The Washington Examiner brings up this as an example of government death panels;
• Chicago Now also points to this as the beginning of death panels, here targeting women suffering from breast cancer;
• And, as of this posting there were already 9710 signatures on an online petition whose goal was 10,000 signatures, asking the FDA NOT to pull Avastin from the marketplace.

Here's the key, Miami: for some folk, this drug helps. It's one thing for the FDA to monitor and regulate bad drugs or defective products -- but what about those cancer patients who find that Avastin helps them?

Is this the beginning of the death panels?

And, why isn't the FDA spending more time cleaning up the greed that we have overwhelming evidence of (see our posts here), reining in Big Pharma?

Finally, no. You can't sue the FDA. As much as there are many personal injury attorneys out there that would love to help women already fighting breast cancer in their fight to keep Avastin, under the doctrine of "sovereign immunity," you cannot sue the FDA for their actions. No matter how much you would like to do so.

By Bryant Esquenazi on December 16, 2010 10:39 AM

Miami Dentists and Mercury Fillings: FDA Revisits Whether Traditional Amalgam Dental Fillings Are Safe

Mercury is a metal that is toxic for humans. Mercury has been part of those metal fillings that dentists put into your teeth when you have cavities -- and they've been doing this for the past 150 years. Last week, the Food and Drug Administration (FDA) finally began revisiting its March 2009 assertion that mercury dental fillings were safe.

This isn't something that the FDA does very often, so why are they bothering with dental amalgams? Because lots of people think they aren't safe -- as in, they can seriously injure and kill people.

Other Countries Ban or Severely Limit Mercury Fillings for Dental Cavities

Mercury fillings are banned in Norway, Denmark, and Sweden. In Canada, France, Germany, and Italy, mercury fillings are legally limited. In each of these countries, mercury amalgams are not to be used for dental patients who are kids; women who are either pregnant or breast feeding; anyone suffering from kidney problems; and people with a sensitivity to mercury.

What's the big deal?

Apparently, the FDA decided to have a meeting on this issue because of the Petition for Reconsideration it received from the International Academy of Oral Medicine and Toxicology (IAOMT). The petition challenged the FDA's research and its assumptions regarding mercury usage, and included analysis that mercury vapor from dental fillings is transfered from the fillings in a person's mouth into every organ of their body -- and this absorption by the brain could result in Alzheimer's disease or worse. From Matthew Young DDS, IAOMT President:

"The cumulative dose and health effects of mercury from all sources will eventually force a ban on all optional use of this toxic metal. Mercury based fillings are the greatest contributor to mercury exposure in humans according to this recent risk assessment and the World Health Organization's Mercury Policy Report."

To read the IAOMT reports, download the pdf versions from their site.

What Should You Do?

If you or your loved ones have had cavities filled, then odds are high that you have mercury in your mouth. Many dentists will tell you this is not a problem, and that it's just not scientific to think otherwise. Still, it's your life and your teeth, so you be the judge.

If you have dental amalgams in your mouth, you can consider having them removed. Read more about that process here. If you need a filling, then consider the options: gold, composite resins, or porcelain fillings are all available to you.

And, if you are having symptoms of illness -- nauseous, fever, headaches, a general feeling or malaise, dizzyness, earaches, etc. then remember, it may be a dental issue. Trust your instincts and get help from a health professional, and if a dentist has been at fault remember -- the law is there for you: dentists can be held liable for malpractice just like doctors can.

By Bryant Esquenazi on December 14, 2010 10:26 AM

The Mazda SeatBelt Case: Will the U.S. Supreme Court Remove Federal Protection From Car Makers in Wrongful Death Cases?

The U.S. Supreme Court has a very important decision to make regarding your ability to sue manufacturers for injuries sustained by their products, specifically personal injury wrongful death in car crashes. It's a biggie.

The Justices just heard the lawyers' oral arguments in the wrongful death case of Williamson v. Mazda Motor of America, Inc. (08-1314) and their decision is expected to come down sometime during Spring 2011. (Read the briefs and listen to the oral argument here, at the High Court's official website). Across the country, plaintiffs' lawyers and insurance defense firms are monitoring this case with great anticipation.

Why Williamson is a big deal to all of us: our right to sue for damages is at issue

Back in 2002, Thanh Williamson, 32, was riding in the center of the rear passenger seat of a Mazda 1993 MPV minivan when there was a crash. Mrs. Williamson was twisted and bent by the lap seat belt she was wearing, sustaining serious internal injuries. Mrs. Williamson died as a result, and her husband filed a wrongful death lawsuit against Mazda, as the maker of the minvan.

In the wrongful death case, Mazda has stood by its legal defense that at the time of the car wreck, Mazda met the safety regulations of the National Highway Traffic Safety Administration (NHTSA). In 2002, only a lap belt was required for that rear passenger seat according to 2000 federal law. It was only in 2007 that the regulations changed to require shoulder strap seat belts here.

Mazda has relied upon the old federal law to protect itself against financial responsibilty for the death of Mrs. Williamson, a monetary award which it would undoubtedly otherwise have to pay under state wrongful death law.

What the Supreme Court will tell us is if Mazda, and other manufacturers, can hide behind federal law when they are sued for wrongful death liability under state law (i.e., will federal preemption apply). If a majority of the Justices agree, then the Williamson case may mean that you or someone you know will be able to seek justice from car manufacturers (and arguably other manufacturers as well) for personal injury and wrongful death even if the cars (or other products) involved in the accidents technically met federal safety law requirements in effect at the time.

Will the Supreme Court rule in favor of plainfiffs hurt or killed by unsafe products? Will it side with the big corporations with savvy defense lawyers who argue legal tecnicalities? Williamson is a case that impacts all of us: we'll see what happens.

By Bryant Esquenazi on November 27, 2010 11:00 AM

ER Visits by Babies Dropped by 50% After Infant Cold Medicine Recalls - Read the New CDC Study Just Published in Pediatrics

A new CDC report was published online by Pediatrics magazine yesterday, revealling that the Centers for Disease Control and Prevention (CDC) have found that after drug manufacturers recalled all those infant cold medicine products from the marketplace, emergency rooms (ERs) across the country saw the number of visits by babies and infants up to 2 years old DROP BY HALF. (Read the full CDC report in Pediatrics here as a pdf download.)

Remember the Infant Cold Medicine Recalls?

Around three years ago (2007), after more and more chatter about the dangers of infant cold and cough over the counter medicines, there was a huge voluntary recall by the drug companies taking all the OTC medications for kids from newborn to 4 years old off the shelf.

Seems the Food & Drug Administration was becoming more and more suspicious that these children cold and cough medicines were harmful to the growing respiratory systems of tiny ones -- and issued its opinion that infants, babies, or toddlers shouldn't be given OTC cold and cough medicine. The FDA didn't recall, though: the companies voluntarily did this pulling of product - the FDA opinion came out MONTHS AFTER the companies recalled their products themselves.

Another Example of Our Message: Do Not Blindly Trust Over the Counter Medicines

These new CDC findings are important and worthy of our concern and consideration -- but the bigger message remains: Miami, drugs and medicines are simply products made and sold by big companies for a profit. You cannot blindly trust that they are safe. It's a fact proven time and again.

If you or a loved one has taken a prescription drug or over the counter medicine and you have a gut call that something's not right -- don't dismiss it. Get to a doctor or an ER and make sure that everything's okay, or get help if it's not.

And, once again, Miami -- there are laws out there that apply to bad drugs and greedy drug companies. Use them.

By Bryant Esquenazi on November 23, 2010 12:45 PM

Florida Four Loko Wrongful Death Lawsuit: Fun in the Sun Gone Bad as College Kid Dies

Florida is supposed to be a fun place: here in Miami we take pride in being a favorite vacation destination for young and old alike.

The Unnecessary and Tragic Death of Jason Keiran After Partying With Four Loko (under $3/can)

Which makes the death of 20 year-old college student Jason Keiran all the more tragic: apparently after drinking a lot of an alcoholic product called Four Loko and marketed as a festive beverage to the young and young at heart (read that "partiers"), Mr. Keiran was playing around, put a .22-caliber pistol to his head, and fired. (It's reported that Four Loko had a street nickname of "blackout in a can.")

So sad. So unnecessary.

Jason Keiran died on a day of partying in Tallahassee almost two months ago now. At first, as it should be, the focus of family and friends was on this horrific incident and their loss. Their grief. Saying goodbye.

But justice is patient, and this week, the news focus is moving toward the maker of Four Loko, and how the heck this product contributed to the death of this young man. Where did the system fail Jason and his loved ones?

Jason Keiran bought lots of Four Loko at a Tallahassee store. Witnesses report that Jason was drinking Four Loko all day on the day of his death. Apparently, Jason liked Four Loko: witnesses will testify that he told them that even though it was an alcoholic drink, he "felt fine" because of its caffeine component.

Which is the problem.

Experts have come forward now to explain that when you put big amounts of caffeine together with alcohol, the caffeine blocks the human body's ability to recognize being drunk - the person doesn't realize how soused they are - and the natural inclination to avoid risky behavior is impaired. Hence, the playing around with the pistol that day.

Four Loko itself is supposed to have 12% alcohol content as well as three (3) times the amount of caffeine as a cup of coffee. It's fruit-flavored and sold for under $3. Quite a cheap high - perfect for a college kid vacationing on a budget.

Jason Keiran Wrongful Death Suit Has Been Filed

On November 12, 2010, Jason's father and mother filed a wrongful death lawsuit in Orange County, Florida, suing Phusion Projects Inc. under Florida's Wrongful Death law (for details on that statute, see our previous post).

And only after they grieved, and then moved forward with this litigation, did the Kieran family see the federal government react to the dangers they understand all too well from alcohol-caffeine drinks like Four Loco. Just yesterday, on November 17, 2010, the Federal Drug Administration (FDA) issued warning letters to Phusion Projects, Inc. and three other companies who make similar kinds of beverages (see the warning letter here).

FDA Warning Letter Sent Re: Four Loco and Similar Drinks

The warning letters applies to the following companies and the following products:

• Core High Gravity HG by Charge Beverages Corp.
• Core High Gravity HG Orange by Charge Beverages Corp.
• Lemon Lime Core Spiked by Charge Beverages Corp.
• Moonshot made by New Century Brewing Co., LLC
• Four Loko made by Phusion Projects, LLC (doing business as Drink Four Brewing Co.)
• Joose made by United Brands Company Inc.
• Max made by United Brands Company Inc.

It's reported that the FDA warning letters may well close the currently popular alcoholic energy drink industry nationwide.

To be fair, the FDA wasn't hiding behind the log here: they were investigating Four Loco and its bretheren for over a year (remember our post on FDA online notices of potential dangers?). Now, the FDA efforts will hopefully ban these dangerous drinks (which are, of course, really tasty liquid drugs).

It's too late for Jason, though, and perhaps others like him across the country who were harmed by these types of festive alcoholic beverages. However, it's not too late to seek justice and vindication from the 27 or so manufacturers who put these dangers out into the marketplace -- and from what we've seen lately, hitting corporate pocketbooks is the only thing that some companies seem to understand. No one stopped making Four Loco or similar drinks after Jason died two months ago, did they?

Once again, Miami remember -- just because a product is on the shelf doesn't mean it's safe. And, if you've been harmed there are laws in place to fight against these types of injuries. Use them.

By Bryant Esquenazi on November 18, 2010 11:33 AM

GlaxoSmithKline Lawyer Lauren Stevens Charged With Federal Crimes: Miami, Can We Blindly Trust the Drugs We Take?

The blind trust in prescription drugs (and OTC medicines) that we here in Miami Beach as well as elsewhere across the country have may be very much misplaced, and the more lawsuits that are filed, the more obvious the scullduggery appears to be.

Last week, we were pondering the number of cases filed by former drug company employees, whistleblowing about the bad stuff they were seeing happening regarding both prescription drugs as well as over the counter medicines. Part of that involved GlaxoSmithKline admitting guilt to a crime and paying over $750,000,000 in settlement of both criminal and civil claims against it.

Miami and the Nation - We Are All So Dependent Upon the Integrity of Doctors and Drug Companies

Drugs that we take, and give our loved ones, we're thinking that doctors know best and that these medicines will help them get better, and have less pain as they recover. We're all so dependent upon the kindness (and integrity) of strangers here, aren't we?

Well, now there's a new battlefield in the war against dishonest drug companies as the federal government has brought a criminal action against Lauren Stevens, 60, in-house attorney for Glaxo Smith Kline. (Read the complete news release by the Justice Department here.) According to the New York Times, filing criminal charges against Ms. Stevens is part of the federal government's "long-promised crackdown" on pharmaceutical company executives.

Glaxo Smith Kline's lawyer has been charged by the Department of Justice with:

• one (1) count of obstructing an official proceeding
• one (1) count of concealing and falsifying documents to influence a federal agency and
• four (4) counts of making false statements to the Food and Drug Administration (FDA).

The first two charges each carry a maximum penalty of 20 years in prison. The four charges of making false statements each carry a maximum penalty of 5 years in prison.

Meanwhile, GlaxoSmithKilne wasn't named in the indictment and so far, hasn't been charged with a crime by the feds.

Do you use drugs made by GlaxoSmithKline? Odds are high that you do.

Curious about whether or not you or a loved one takes a drug or medicine manufactured by GlaxoSmithKline? Easy enough to check, just go down the list of drugs and vaccines they have listed on their web site. On there, you will see such well-known drug products as:

• Advair
• Amoxil
• Avandia
• Boniva
• Dexedrine
• Flonase
• Lamictal
• Paxil
• Valtrex
• Wellbrutin
• Zantac

Miami - Be Safe and Be Careful

As always, please remember that if you have a gut instinct that something isn't right with a pill or capsule or syrup - call your doctor. (Don't just automatically stop taking the medication until you speak with a health care professional, however, because cold turkey might have its own damaging repercussions.)

If harm has occurred take care of it first - safety and security are number one. After that, consider calling a lawyer. It's becoming glaringly obvious that lawsuits and money damages are what these drug companies respect, not the basic concepts of doing the right thing because it's the right thing to do.

By Bryant Esquenazi on November 11, 2010 1:01 PM

Space Heaters Kill People - Yes, Even Here in Sunny Miami



Already it's begun: today's Miami Herald is reporting thatfive kids died in an overnight fire caused by a space heater. Seems that their mother, we have to assume with the best of intentions in caring for her family, set up a space heater to combat the cold snap that hit their home over in Citra. Sometime during the night, a fire started and while the mother survived, her five children ranging in age from 15 to 6 all perished in the blaze.

It Does Get Cold Enough for Space Heaters in South Florida

Most of the country watches TV shows like CSI:Miami and assumes that we're all here in sunny, balmy bliss every month of the year. That's why the snowbirds and vacationers flock to our Miami beaches, right? Well, it's a nice promotional spin but it's not true.

It can get really chilly here in South Florida, and for lots of folks that means running to WalMart or HomeDepot and grabbing a space heater or two for the house. (We've even been known to have runs on stores during cold snaps, these heaters can be so popular.)

Miami-Dade Fire Rescue reports that they generally have a significant increase in fire calls when a cold front hits our area -- and that most of these calls are asking fire trucks to rush to homes (including apartment buildings, condos, etc.) where a fire has started. And, every year there are tragic news stories where people die in these fires -- just like today's sad story out of Citra.

Safety Tips Regarding Space Heaters Here in Miami Beach and South Florida

Using portable heaters in your home is not a bad idea in and of itself: but only if Florida space heater buyers are aware of how dangerous space heaters can be. The Miami-Dade County Fire Rescue Safety Tips (for more, check out their informative site) suggest the following regarding space heaters:

1. Choose electric space heaters and use only those that are UL approved. Look for models that include safety features such as an automatic shut-off when tipped over.
2. Avoid the use of extension cords with space heaters, but if you must use one, make sure it is the proper size and length. Never run cords under rugs or carpets.
3. Keep your heater at least three feet away from furniture, curtains and other flammable items.
4. Install recommended smoke and carbon monoxide detectors and replace batteries regularly.
5. Never use charcoal or other fuel-burning devices indoors, such as grills that produce carbon monoxide.
6. Make sure all equipment is clean and dust free.
7. Keep a close eye on children and pets whenever a space heater is being used.
8. Always turn off heaters when leaving home.

Defective Products - Space Heaters Recall

Space heaters are just like any other product. They can be defective from the moment you bring them home. What's a defective product? Some products are manufactured with a flaw so that all units sold are defective. Other products are generally fine but there is the occasional unit that has a defect.

Since space heaters can be dangerous, it's important to check online to insure that the particular model you're using hasn't been subject to recall. Don't assume that because it's a reputable name (like Holmes, who had a big space heater recall recently) that your heater is safe. Make sure. This is especially true if you're using a portable heater that someone gave you, that you bought at a yard sale, or that you got for a bargain on eBay.

Be careful out there, Miami.

By Bryant Esquenazi on November 9, 2010 11:25 AM

Maybe Dangerous Drugs - the FDA's AERS Online Database: Miami, Are You Aware of This List?

Here in Miami, I'm betting this list is news to many - not to mention folk living elsewhere in the country. However, there it is online and ready for viewing on the FDA's website: the Adverse Events Registry Service (AERS ), where drugs that might be dangerous are listed. That's right -- they're not recalled, they're not pulled from the stores, but they ARE listed here for possible bad juju as reported by someone who had a very bad experience with the prescription drug or over the counter medicine.

The AERS - Adverse Events Registry Service - Reports of Bad Drug Experiences Every Three Months

Online, the federal government is giving you notice of possible bad drugs or OTC medicine by listing reports coming in over a three-month period. Here's the list of medications from April to June 2010 (the latest one available when this post was published):

• Clindamycin injection (Cleocin)
• Dronedarone hydrochloride (Multaq)
• Etonogestrel implant (Implanon)
• Everolimus (Afinitor)
• Febuxostat (Uloric)
• Ferumoxytol injection (Feraheme)
• GnRH Agonists (Androgen Deprivation Therapy)
• Lanthanum carbonate (Fosrenol)
• Omeprazole products
• Simvastatin (Zocor)
• Saquinavir mesylate (Invirase)
• Tapentadol hydrochloride (Nucynta)
• Tetracycline products
• Trastuzumab (Herceptin)

These things sound pretty serious: hallucinations (Nucynta), convulsions (Implanon), "Serious cardiac disorders," (Feraheme) - whatever that means. Wow.

FDA Warns About Its Warning

Of course, above this listing there's lots of verbiage explaining things like "[t]he appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk." Not to worry, right?

Because, the list just "...means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk." Testing, testing, testing for that causal link - gotcha.

And, of course: "... [the] FDA wants to emphasize that the listing of a drug and a potential safety issue on this Web site does not mean that FDA is suggesting prescribers should not prescribe the drug or that patients taking the drug should stop taking the medication. Patients who have questions about their use of the identified drug should contact their health care provider. FDA will complete its evaluation of each potential signal/new safety information and issue additional public communications as appropriate."

Obviously, the FDA has lawyers, too.

Meanwhile, once again please remember that a drug is simply a product entering into the marketplace from a for-profit manufacturer. It can be defective, just like a child's car seat or a car's tire. There are laws in place to protect you and your loved ones from defective drugs -- but most importantly, if you or someone in your family has a concern that an over the counter medication or a prescribed drug is not doing as it should, then get to a doctor and get things checked out.

Be careful out there. It's not smart to be paranoid, but it's equally foolish to be too trusting of a drug these days.

By Bryant Esquenazi on November 4, 2010 2:30 PM

Who is Big Pharma? Naming Names: The Big Drug Companies That You Trust With Every Pill You Take

Miami Beach is an international community: we're much more sophisticated and cosmopolitan than other metropolitan areas around the country. Still, many of us are naive regarding who is responsible for the drugs we take, or give to our kids.

And those over the counter medications as well as the prescription drugs are made by huge, for-profit corporations that more and more often are brought into courtrooms to defend against accusations that they have put profits before people.

In fact (as we wrote about last week), in a scary amount of instances that has almost become a pattern, the evildoing of these big companies has been revealed not by government inspection but by internal whistleblowing by brave employees who risked their careers (and maybe more) by blowing the whistle on bad and often illegal activities by big drug manufacturers.

Why would these companies knowingly sell bad drugs to people? Money, apparently. The amount of money these companies bring in each year is astronomical. Consider the list shown below - and this is just for the top 12 (there are many more big, big, big drug manufacturers that aren't included in this list).

Generic Drug Case Pending Before the US Supreme Court

For example, just this week the United States Supreme Court ordered the U.S. Solicitor General to provide the High Court with President Obama's opinion on whether the Supreme Court should consider the appeal of generic drug manufacturers Teva Pharmaceutical Industries Ltd., UDL Laboratories, and other petitioning companies who are urging that the lawsuits filed against them for mislabelling their products are preempted by federal law. (The 8th U.S. Circuit Court of Appeals has already ruled against them, and allowed state litigation to proceed.)

The Top 12 Drug Manufacturers and Their Annual 2009 Revenue - Millions of Dollars Made Each Year

Here are the 12 biggest pharmaceutical companies in terms of money they made (reference: their 2009 annual reports).

1. Johnson & Johnson ($60,000,000+ revenue in 2009)
2. Pfizer ($50,000,000+ revenue)
3. Roche ($47,000,000+ revenue)
4. GlaxoSmithKline ($45,000,000+ revenue)
5. Novartis ($44,000,000+ revenue)
6. Sanofi-Aventis ($42,000,000+ revenue)
7. Astra-Zeneca ($32,000,000+ revenue)
8. Abbott Laboratories ($30,000,000+ revenue)
9. Merck & Co. ($27,000,000+ revenue)
10. Bayer Health Co. ($22,000,000+ revenue)
11. Eli Lilly ($21,000,000+ revenue)
12. Bristol Meyers Squibb ($18,000,000+ revenue)

The point? Here in Miami Beach - as well as the rest of the State of Florida and across the country, it's time we stopped blindly trusting the drugs we take and give to our loved ones as being effective and accurate. They are a product sold off a shelf just like any other product, and more and more often we're seeing lawsuits advancing factual claims that these products are defective and dangerous.

If you or a loved one is suspicious that a drug or over the counter medication isn't quite right, trust your gut. Call a doctor. And, if you've been harmed in some way, call a lawyer.

By Bryant Esquenazi on November 2, 2010 11:35 AM