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Archive for September, 2011

Brenda Fulmer

Patients Should Reap the Benefits of Data Collected by the FDA

Published by Brenda Fulmer in Miscellaneous

Over the past decade, the Food & Drug Administration has made great efforts to provide improved safety information to patients and consumers.

The FDA web site includes a number of helpful materials:

  • warning labels, podcasts
  • white papers prepared for scientific panels that summarize complex medical and scientific data
  • Power Point presentations made to scientists and FDA employees
  • “Dear Doctor” letters informing physicians of changes in drug labeling
  • DDMAC enforcement letters for violations of federal law in marketing products

The Agency started publishing watch lists and frequent Safety Alerts regarding drugs and medical devices with potential safety issues, which has directly benefited patients who were able to choose better options for their healthcare and avoid harm.  Consumers can also request email updates and an RSS feed from the FDA.  Pictures of food and drug products recalled by the FDA are included on flickr, and there are videos and other materials in multiple languages available to consumers at www.fda.gov.

For years, the MAUDE (Manufacturer and User Facility Device Experience) database has been available online to help patients and others search for information about adverse event reports for defective medical devices.  The MAUDE database includes data submitted by patients, doctors, manufacturers, and others with regard to various FDA-approved medical devices that have malfunctioned or were found to be defective and caused a patient death or serious injury.  The medical device database includes reports going back to approximately 1991.  The publicly-accessible materials from the FDA do not include compilations or analysis of the data, but are nevertheless very helpful in analyzing the safety and performance of various medical devices.

While patients can submit adverse event reports directly to the FDA for serious reactions, injuries, and side effects associated with prescription drugs directly to the FDA through online submissions, the data from those AERs is not readily available to the public, physicians, lawyers, and others who are interested in drug safety.  Historically, lawyers who were involved in lawsuits against the manufacturers of defective drugs would have to fight through the court system to obtain adverse event report forms and compilations from the manufacturers and then engage in the tedious process of piecing together the reports in order to substantiate trends and signs of red flags that should have motivated the drug companies to recall a particular unsafe drug or at least enhance the warnings to patients and prescribing physicians.  Third party vendors were often used to tap into the FDA’s drug safety databases and translate the archaic and confusing data.  Hopefully, the FDA will work in coming years to provide the public with access to all the information available on medical devices in the MAUDE database, rather than just some of the information.

This week two companies announced that they would work to demystify the FDA’s drug and medical device safety and adverse event databases and make that information readily available to the public, with some of this information being provided for free while more in-depth analysis would require a subscription.

Clarimed’s website will focus on safety reports with regard to more than 125,000 medical devices, while AdverseEvents Inc. will help to shed light on prescription drug-related adverse event reports.  This is a significant step towards resolving a crisis that currently exists in this country, where patients are being prescribed drugs based upon improper and unsubstantiated claims of benefits made by aggressive manufacturer marketing. Consumers are denied ready access to unbiased, truthful information about hazards, risks, and emerging safety issues; leaving them only with information conveyed through drug company ads.

Hopefully, our drug safety system will continue to evolve and improve through the efforts of consumer advocates, lawyers, physicians, regulators, and patients to ensure that physicians and their patients are able to make the very best and informed decisions (including a thorough weighing of risks versus benefits) regarding the use of medical devices and drugs.

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Brenda Fulmer

Prescription Drugs –Do you understand what you are taking?

Published by Brenda Fulmer in Miscellaneous

Today, it is routine to approach your local pharmacy counter and complete your transaction in five minutes or less, if you even bother to get out of your car.  You get to the counter, ask for your prescription, and barely hear the pharmacist ask you: “Do you have any questions about the medication?” before you nod or answer “no.”  Without thinking, you find yourself signing your name on the pharmacy notepad, acknowledging  that you are aware of ALL the warnings and side effects associated with the prescription you are about to take and that you have no other questions for the pharmacist.

But, honestly, did you really understand the instructions for your prescription? Did you understand the side effects you may be exposed to once you consume the drug?   Have you read the real warning label for your drug – and had a conversation with your pharmacist or physician about the drug being prescribed? Sadly, most would have to answer “no” to these important questions.  However, the truth is that patients need to be more proactive in protecting themselves, because, sadly, they may be the only one with the desire and motivation to ensure that safety.

The first step in ensuring your safety is to know where to look for information.  Here are some starting points:

Prescription drug warning label – a sticker on the vial that contains information about your medication and usually, critical warnings, such as the ability for the drug to cause drowsiness.  This label or sticker contains, at best, a couple highlights and is nowhere near the full information about the safety risks of a particular product.

Prescription information sheet/receipt – an information sheet that is printed by your pharmacy and attached to your prescription package as a part of the receipt.  This is often authored by a third party vendor and, often, these warnings are outdated and fail to include very significant risks from the actual drug warning label.

Patient Package Insert or Medication Guide – usually included inside your prescription packaging.   This is written by the drug manufacturer and provides a summary of the characteristics of the drug, how it is to be taken, and includes a number of warnings, precautions and disclosures regarding side effects.  These Patient Package Inserts are relatively new, and are only required to be given to patients for certain drugs, such as hormone products (oral contraceptives, hormone replacement therapy, etc.).   In an effort to improve drug safety, there has been a movement at the Food & Drug Administration to require the preparation and dissemination of Patient Package Inserts for a number of new drugs.

Professional Monograph of Package Insert – actual full warning label that is produced for a medication and subject to review by the FDA.  These warnings are available upon request at the pharmacy and are often folded multiple times into a very compact document with tiny print that is included in the drug packaging.  These package inserts are not written in an easy-to-understand format and can contain as many as 30 to 40 pages.  Some package inserts may also include a Patient Medication Guide that is written in laymen’s terms.  These package inserts are available online through the FDA and can also be obtained from the manufacturer’s web sites.   This document is the warning label that drug manufacturers rely upon in defending themselves in lawsuits relating to defective drugs and failure to properly warn of the side effects associated with their products

According to The Institute of Medicine, about 90 million Americans have trouble understanding health information, including the instructions on prescription drug labels.  Staffers from Consumer Reports performed a sample study to see how well retail pharmacies inform patients of the instructions, risks, and side effects associated with their prescription, with disheartening results.

When Consumer Reports staffers filled prescriptions for Warfarin – a blood thinner with known, dangerous side effects – at Costco, CVS, Target, Walgreens and Wal-Mart pharmacies, they found that the information included with the drugs was confusing, hidden or incomplete.  In comparing warnings, they found that Target did the best job of communicating safety risk with four clearly-conveyed warnings to patients.  Walgreens also conveyed four warnings, although not as well as Target.  CVS only conveyed three warnings to patients, and Costco’s patient information only included two essential warnings.  Wal-Mart, one of the biggest retailers of prescription drugs, failed to convey any warnings to consumers in this study, although later visits by Consumer Reports researchers noted that Wal-Mart’s patient information for the drug included three warnings.   As exhibited by this study, patients are not receiving critical information about their drugs from the FDA, manufacturers, or retailers, all of whom share responsibility for products they sell.

[youtube]http://www.youtube.com/watch?v=vmpDjhijH3Y&feature=player_embedded#![/youtube]

The ideas behind labeling are that, (1) patients are entitled to information about known and potential side effects to make an informed decision about taking the medication; (2) when patients make an informed decision about a drug, they are likely to follow directions for product use; and (3) educated decisions ultimately will result in increased effectiveness of the medication. Universal requirements for disclosures to patients, including the requirement of formal Patient Medication Guides, would greatly enhance the consumer’s ability to understand their medications, take them as directed, be able to properly weigh risks vs. benefits, and identify potential drug safety issues that may have been missed by their healthcare providers, pharmacists, and others responsible for their health and welfare.  The study by Consumer Reports also found that that the warnings and information would be difficult for the average person to understand. For example, medication information and warning labels were difficult to understand, filled with medical jargon, typed in “fine” print, and too-closely spaced together.

When pharmacies fail to properly label prescription drugs with key safety warnings or include the medication guides required by the FDA, patients are left unaware of the dangers associated with their prescription drug use.  When consulting with your physician, ask questions, lots of questions, about each of the medications that you are prescribed:

  • Whether the warning label has changed over time;
  • How it should be taken;
  • What possible drug interactions should be watched or avoided;
  • Whether there is information in the medical literature that raises questions about the safety or effectiveness of the drug;
  • Whether there are safer alternatives; and
  • How does your prescriber keep abreast of the latest information on drug safety issues.

The next time you are picking up a prescription at your local pharmacy, take a moment to speak with the pharmacist about your medications, as they may be your best source for reliable information about drug safety issues.

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Hopkins

Better Health Through Shoes and Drugs

Published by John Hopkins in Corporate Fraud, Mass Torts, Product Defect

Wow, the federal regulatory agency, Federal trade Commission (FTC), has taken a firm stand on products that promise “a better way to a better butt”. The FTC has reached a settlement with shoemaker, Reebok, over its claims concerning the popular EasyTone shoes.

I must confess that until reading the article in The Washington Post, I had not heard of EasyTone shoes and the claims Reebok was making about them. Apparently both the claims and the advertising were something that hit home with consumers because Reebok reportedly sold over $500 million of them in 2010.

I wanted to do a little investigating since I had never seen any of the commercials for EasyTone or the shoes that make similar claims made by Skechers. Here is one of the commercials:

[youtube]http://www.youtube.com/watch?v=dPI3yNnhAP4&feature=related[/youtube]

I can understand why the FTC would get so worked up about the claims if they are false. I mean assuming they do not do what they claim; we could have sagging all over America. What if you actually had to exercise? I mean its absolutely outrageous.

Okay, I agree that if any manufacturer makes a claim about a product and it is not true (although Reebok and Skecher claim theirs is true), they should have to pay a price for false advertising. In this case, the FTC settled with Reebok for $25 million; probably representing some fraction of their profit margin in a single year. That is significant and important – and, it is exactly what the Federal Trade Commission is in the business to do.

I guess my “tongue in cheek” reaction results from comparing the FTC nailing Reebok for sagging butts, while drug manufacturers play in advertising Shangri-La on a regular basis. Take a look at the Reebok ad again. See all the imagery and visual suggestion? Drug companies do exactly the same thing; except drug companies are selling drugs, not the newest “uplift” device.

Ask yourself, what does attractive, successful, professional women sitting in a very expensive bar, have to do with Yaz birth control medication? Or, what does Humira have to do with planting sun flowers? How does Vioxx really relate to walking down a beach to go fishing as the sun rises radiantly over the ocean?

Drug manufacturers spend billions every year trying to tell us about the latest disease and, oh yeah, sell us their latest cure for the latest disease. In 2005 alone drug companies spent over $58 billion for promotion of pharmaceutical drugs to consumers. Drugs consumers can not just go buy, but must get a prescription from their doctor in order to obtain them.

In 2005, drug companies only spent $32 billion on research. That is nearly 50% of what they spent on advertising and that is both a startling and telling statistic.

What are the priorities for Big Pharma? They need the latest, greatest disease so they can tell you about it, suggest you may have it and convince you that they have the answer for you. And, the pressure is on them, because they have to do all of this before the studies come out that tell us the latest cure is simply making people sicker, killing people or that it simply does not really work. The profit must be made before the truth is known.

[youtube]http://www.youtube.com/watch?v=81DmeC_EXKI[/youtube]

Be sure that drug companies are in the profit business. Although I know there are plenty of well-intentioned scientists employed by Big Pharma companies who are interested in helping people, finding the great cure for the worst disease. But, at the end of the day, drug companies make decisions based from profit motives and their marketing departments drive decisions a whole lot more than their research and science departments.

So, I am happy that the FTC takes their job seriously and, if Reebok’s claims were untrue, I am happy that they were forced to pay some penalty.

But when will the Food & Drug Administration take some pages from the FTC’s playbook and start bringing down real regulation on drug company advertising to consumers. When will the FDA put a stop to advertising that dilutes drug complications, expands drug benefits and suggests to consumers that if they do not feel sick, maybe they should think about it a little more

I went back and took a look at many of the drug companies advertisements and I seem to have remembered seeing every one of them. The Reebok ad, though, is one I missed and, I am reasonably certain I would have remembered it.

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Hopkins

Lawmakers and Tort Reform — Omnipotence or Arrogance?

Published by John Hopkins in Miscellaneous

Tragically, your wife, your husband, your child suffers severe injury or death because someone else did not exercise reasonable care.

Your elderly mother dies because a for profit nursing home demonstrating millions in profit fails to provide sufficient staff to care for its residents.

A stage collapses and kills several people, injures many, many more.

How do we value a life or an injury? What value should we place on the loss of a wife or a child because someone else was careless?

What is your child worth?

These are the questions asked of jurors all across the country every year. Sadly, in many states, the law makers have taken this decision from out of the hands of a jury. Law makers, many leading blessed lives, have decided what your child is worth, what your spouse is worth, what your mother is worth. And, that is whether you like it or not – whether a jury likes it or not.

The constitution created a right for all citizens to have redress (a chance for justice) of any wrongs by taking the aggrieved party into a court and having a jury decide right from wrong and the amount of any damages that may have been caused.

In Indiana, much like Florida, the law makers decided that when they (the state) are negligent, they should never have to pay more than $5 million. Sounds like a great deal of money and, the fact is that it is a great deal of money; at least until you begin to look at the details of the losses:

  • Alina Bigjohny, 23 years old. Alina was a school teacher.
  • Christina Santiago, 29 years old. Christina managed a care project at the Howard Brown Health Center.
  • Tammy Vandham, 42 years old. Present to celebrate her birthday, she left a young daughter without a mother.
  • Glenn Goodrich, 49 years old. Glenn was a reserve police officer and left a wife and two sons.
  • Nathan Byrd, 51 years old. Loved by family, 300 people gathered to mourn him.
  • 40 people injured.

Our sympathies go out to the family members of those who lost their lives and to the injured who have suffered in this tragic event.

The question of whether someone’s negligence caused these tragedies and what damages should be recovered in the vain effort to compensate families for the loss of loved ones and the injured for their injuries should appropriately be a question for jurors after hearing all the relevant evidence.

The real question in this and similar cases is: why does the state of Indiana, like so many other groups of law makers, take out of a jury’s hands the question of how much compensation should be paid. What value to fix to the loss suffered by Tammy Vandham’s young daughter who will live without her mom or Glenn Goodrich’s wife and two sons who will live without him. How should we value the loss of a 23 year old girl who never got the chance to grow up at all?

What should we do to compensate 40 injured people, some of them critically injured?

The question is whether the evaluation of these losses should be taken out of the hands of jurors who will hear evidence and transfer those decisions to lawmakers who in an arbitrary fashion will decide what those lives are valued at before an injury occurs, before any evidence is heard?

Do law makers see themselves so omnipotent that they are empowered to look into the future and make these kinds of decisions?

What has happened is money and marketing. Special interests in our society have decided they know best and they have spent billions of dollars to convince many of the public and most law makers that very smart people who show good judgment in most every aspect of their lives, suddenly become blithering idiots when sworn is as jurors. Groups in our country, largely funded by drug companies, insurance companies and corporate interests have invested big bucks to sell the notion that jurors are incompetent to hear evidence and make good, well thought decisions.

The plain fact is that a good reason existed and continues to exist for a system involving jurors hearing evidence and making well thought decisions. Are jurors always perfect? Well, I have certainly disagreed with decisions of juries over the years, but I have always respected that agree or disagree, I believed the jury tried it’s very best to do the right thing, to reach justice. In this age of massive lobbying influences, that is a great deal more than I think we can say about many of our lawmakers.

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Hopkins

Dangerous Drugs — Why can’t testing be done BEFORE profits?

Published by John Hopkins in Defective Design, Mass Torts, Product Defect

Your blood needs to clot, but it is a delicate balance. Insufficient clotting leads to excessive bleeding and too much clotting leads to obstructed blood flow, pulmonary embolism and strokes.

So, it is understandable that the Food & Drug Administration became worried about reports that birth control medications containing drospirenone were causing excessive clotting in women taking them. The FDA decided to conduct a review of literature and investigate the potential risks associated with birth control drugs such as, Yasmin, Zarah, Syeda, Safyral, Ocella, Yaz, Loryna, Gianvi, and Beyaz.

The Food & Drug Administration has now reached some preliminary conclusions that would be disturbing to me if I were a woman taking these medications. The FDA believe s that the increased risk for blood clots, pulmonary embolism and stroke are around 1.5 times more in women taking the drugs than in women taking other types of similar medications for birth control.

The manufacturer of Yaz and Yasmin agreed with the FDA in 2010 to amend its labeling to alert users of the potential for venous thromboembolism (VTE), but also indicated the risk was no greater than with other oral contraceptive preparations.

There are really two central issues.

The study and investigation being conducted by the Food & Drug Administration is exactly the same evaluation which should have been conducted by the manufacturers of these drugs BEFORE they were placed on the market. Where were the manufacturers when these drugs were being evaluated through clinical testing? Were risks of VTE suppressed during clinical trials? Were all the data of clinical trials provided to the FDA at the time the drug was submitted for final approval?

When Bayer began producing its commercials for Yaz depicting young, successful, attractive women talking about the miracles of Yaz, did they know? When Bayer began pushing the envelope by trying to promote Yaz as a treatment for acne in young women, did they know about the increased risks of stroke? When Yaz commercials with their fun loving, balloon flying commercials tried to lure young women to Yaz, did Bayer know that each person faced a potential one and one half times greater risk they would develop a stroke or risk death as a result of a pulmonary embolus?

So, it is great that the FDA is now evaluating these dangers of medications like Yaz, Yasmin and Beyaz; but where were these investigations and studies when manufacturers were making billions of dollars through the sale of them to young women?

[youtube]http://www.youtube.com/watch?v=Tl06C30nuTI&feature=player_embedded[/youtube]

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Hopkins

Statistical Analysis — Taken with a grain of salt?

Published by John Hopkins in Miscellaneous

Like the United States as a whole, Florida is one of those “melting pot” states. We get people moving here from all across the country in hopes of enjoying the Florida sunshine and slower life style. It is true that we have lots of sunshine…not so much with the whole slower life style thing.

As a result, the driving in the traffic traveling along our thoroughfares can be a very interesting adventure. Many studies of national traffic statistics have been done and each has been interpreted in their own, sometimes unique, ways. I recently read about three very interesting, if dubious, studies.

The Daily Beast has reported that a study found the deadliest, least skilled drivers on the road are apparently young (18 to 20 year old) Republicans. The Beast reports that:

“What was more surprising: how the breakdown between states with more dangerous drivers and safer drivers fell almost completely along the lines of the 2008 McCain-Obama election, with the Republicans again coming up on the short end. Nine of the 10 worst-performing states went for McCain, while nine of the 10 best performers voted for Obama. (Delaware and Mississippi were the respective outliers.)”

The Beast concluded that the most dangerous state for fatal crashes and bad drivers was North Dakota with 116 fatal crashes where the most dangerous age group is 18 year olds.

GMAC recently published a study attempting to set forth a list by state of the most dangerous to least dangerous drivers. The good news for Floridians? We are not number one. The bad news? Florida ranks at 11 for the worst drivers in the nation.

Who were the 10 worst states for bad drivers:

1. (WORST) New York

2. New Jersey

3. Dist. of Columbia

4. California

5. Rhode Island

6. Louisiana

7. West Virginia

7. Hawaii

9. New Hampshire

10. Kentucky

The additional bad news for Florida is that we have a great many residents and drivers on our roads from the following top ten states: New York, New Jersey, California, and New Hampshire.

The MailOnline, a UK newspaper reported results of a research study that evaluated 6.5 million crashes in the United States and found a higher than expected number of crashes involving female drivers than male drivers. But, the researchers conducting the study reported that the differences may, at least in part, be attributable to height differences between female and male drivers.

So, if you get into a car in Florida, ask the driver their height, the state they came from, what political party to which they belong and how old they are. Consider whether to continue, at least based on these studies, if they are a Five foot, female, under 21 years old, Republican from New York.

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Leonard

Can We Evaluate Florida Teen Driving Laws By Looking at Other States?

Published by Vincent Leonard in Motor Vehicle Accidents

A new study published on September 14, 2011 by the Journal of the American Medical Association concluded that although fatal car crashes for 16-year-old drivers has dropped, fatalities in 18-year-old drivers has increased.  The research analyzed more than 130,000 fatal teen crashes over 22 years.

The study found that tougher licensing laws have led to 1,348 fewer fatal car crashes involving 16-year-old drivers, but, sadly, during the same period, fatal crashes involving 18-year-old drivers increased by 1,086 more fatal accidents.

Motor vehicle crashes are the leading cause of death for teens in the United States.  In fact, from 2000 to 2008, more than 23,000 drivers and 14,000 passengers aged 16 to 19 were killed as a result of teen driving.

Because of these high fatality rates, there was a push for Graduated Driver Licensing (“GDL”) systems in the 1970’s by the National Highway Traffic Safety Administration; however, it was not until the late 1990’s that states began to adopt these systems.  GDL systems require drivers under the age of 18 to complete a lengthy learner period and require teens to start driving only when supervised by an adult.  Teens then enter an intermediate license period that allows unsupervised driving but continues protection against highest risks such as night driving, driving with multiple passengers, or both.  Additionally, young teens in some states must complete driver’s education prior to obtaining their license.

According to the study, older teens are now putting off getting their learners permit because of the extensive measures 16 and 17-year-olds must take to get there licenses.  Ironically it would seem that the measures intended to increase safety may have resulted in older teens waiting to avoid these requirements and consequently, obtaining their licenses with less experience and resulting in more accidents.  For example, California has seen a big drop in 16-year-olds getting their driver’s license; in 1986, 27 percent got their licenses. In 2007, the figure dropped to just 14 percent.

So how do we fix this? New Jersey came up with one solution. They have one of the toughest programs for teenage drivers of any state.  In New Jersey, all first-time drivers under 21 must adhere to graduated driver restrictions.

The author’s of the study noted, “New Jersey’s approach has been associated with significant reductions in the crash rates for 17 and 18-year-olds and virtually eliminates crashes among 16-year-olds without adversely affecting crash rates for 19-year-old drivers.”

But, is New Jersey just putting off the increased fatality rates until 21?  Some think so.

A study of deadly crashes in New Jersey did not look specifically at 21-year-olds; they were mixed into a larger group of 20 to 24-year-olds. The research still found a 10 percent increase in deadly crashes in that group after New Jersey’s tougher graduated driver licensing program was instituted, suggesting that 18, 19 and 20-year-olds may be waiting out the tough restrictions there as well.

In Florida, the Learner License statute (§ 322.1615) currently sets forth:

(1) The department may issue a learner’s driver’s license to a person who is at least 15 years of age and who:

(a)  Has passed the written examination for a learner’s driver’s license;

(b) Has passed the vision and hearing examination administered under s. 322.12;

(c)  Has completed the traffic law and substance abuse education course prescribed in s. 322.095; and

(d) Meets all other requirements set forth in law and by rule of the department.

(2) When operating a motor vehicle, the holder of a learner’s driver’s license must be accompanied at all times by a driver who:

(a)  Holds a valid license to operate the type of vehicle being operated;

(b) Is at least 21 years of age; and

(c)  Occupies the closest seat to the right of the driver of the motor vehicle.

(3) A person who holds a learner’s driver’s license may operate a vehicle only during daylight hours, except that the holder of a learner’s driver’s license may operate a vehicle until 10 p.m. after 3 months following the issuance of the learner’s driver’s license.

(4) A licensee who violates subsection (2) or subsection (3) is subject to the civil penalty imposed for a moving violation as set forth in chapter 318.

What do you think? Should Florida change its laws? Is the solution implemented in New Jersey the answer?

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Cal Warriner

Another Report About Metal on Metal Joint Implant Failure

Published by Cal Warriner in Defective Design, Mass Torts, Product Defect

The evidence condemning Metal on Metal (MOM) implants continues to grow. In a recent announcement by the National Joint Registry for England and Wales (NJR), it was revealed that 30% of MOM implants manufactured by DePuy Orthopaedics, Inc., a division of Johnson & Johnson require removal and revision within six years of implantation. The industry standard is 15 years or more.

In its report, the NJR revealed that MOM hip devices experience “by far” the highest rate of revision including removal and replacement. NJR data indicates that these devices are failing at double or triple the rate of others at five years. In addition, the report indicates that as time passes, the failure rate increases when compared to other hip implants. The data also tell us that women fared worse than men.

This report follows DePuy and Johnson & Johnson’s recall of both its ASR XL Acetabular and ASR Hip Resurfacing systems in August of 2011. It appears the recall was warranted. At the time of the recall, the reported failure rate for these two systems was 13%. This new data suggests the failure rate was even higher at 17%. At six years the NJR reported that 29% or almost one third of these devices required revision. Even a lay person with no medical training should recognize that failure rate as staggering. It also calls into question how the company and regulators would fail to identify this problem before doctors started pounding these rods and cups into the hips of thousands of patients!

The sad truth is they didn’t. Even if the company did, it’s unclear what they would have done with the information. A DePuy “spokesperson” said in response to the reported 1/3 failure rate that it, “shouldn’t necessarily be taken as gospel.”

Unlike other consumer recalls, dealing with the problem is not as simple as taking your car into the dealership for repairs. These patients have the defective devices implanted in their bodies. Fixing the problem requires undergoing painful revision surgery. Doctors are on record saying that revision surgery is much more complicated than the original surgery and carries far more risks. Many are unsuccessful leaving the patient with permanent disabilities.

In addition to regulatory action in Europe, the FDA has ordered 21 manufacturers of MOM implants to carefully study the issue of whether patients with these implants are being poisoned by the release of metal shavings or debris that is cast off when the device fails. Studies of patients with MOM implants have reported abnormally high blood levels of Cobalt and Chromium which are potentially dangerous. The FDA is studying the long term effects of heavy metal poisoning in these patients.

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Mariano Garcia

Mariano Garcia — A “Melting Pot” Lawyer

Published by Mariano Garcia in Miscellaneous

I am proud and privileged that I can count myself a citizen of the world’s “melting pot” – the United States of America.

I am equally proud that I have a rich and varied heritage founded in the Latin culture. Both my mother and my father came to this country with hopes of improving the futures of their children. They found jobs, worked hard and proudly became American citizens. My mom was honored to be a school teacher, helping to build the futures for children and my dad was a mechanic, proud to keep vehicles on the road and people mobile.

Although I moved to this country from Argentina when I was eight years old, I grew up for a part of my life in New York City – truly a “melting pot” city in this country. Some of my fondest memories and dearest friends can still be found in that city.

I recently joined the law firm of Searcy Denney Scarola Barnhart & Shipley, PA and I am humbled to now be practicing law with many of the truly great attorneys of our time.

Searcy Denney is dedicated to championing the cause of those who could not otherwise do it for themselves. We have fought some of the biggest defendants and won great victories for our clients. It is my intention to continue this history of advocating for the rights of injured victims and wronged people; especially those in the Latino/Hispanic communities.

I think it is important that you as a client be able to communicate to your lawyer in whatever way makes you the most comfortable. For those comfortable in the English language, I am here; for those most comfortable speaking Spanish, estoy aqui!

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Patrick Quinlan

Health Careless

Published by Patrick Quinlan in Miscellaneous

Much of the time, the two political parties seem virtually indistinguishable.  But, every once in a while, something happens that draws a stark contrast between the Democratic and Republican views of the world.  Such a moment came during the GOP presidential debate last night, when Rep. Ron Paul was asked about how to deal with an uninsured 30-year-old man who needed medical care and without it he would die.  Rep. Paul answered that the young man needed to take responsibility for his decision not to purchase insurance.  When Wolf Blitzer asked, in a follow-up question, whether he was saying that society should just “let him die,” a portion of the audience members whooped, hollered, and yelled “yeah.”

[youtube]http://www.youtube.com/watch?v=b4Am2bWQRNw&feature=player_embedded#![/youtube]

It is truly a sad time when any American would believe that the sacrifice of a man’s life is a just “punishment” for his failure or his financial inability to purchase insurance. This cold attitude should remind those who are Republican or Tea Party members or any other American, who identify as Christian and believe in the “right to life”: that “there but for the grace of God, go I.” Any politician should be appalled, regardless of party affiliation, with supporters endorsing the belief that uninsured people with catastrophic illnesses should be left to die.  These are people who could only be called “compassionless conservatives.”

Rep. Paul, a doctor himself and quite familiar with the Hippocratic Oath neither jumped on the “let him die” bandwagon nor voiced any discouragement of it.  But, in the course of his answer, he did make another statement that illustrates a fundamental difference between the political parties.

Rep. Paul said that one of the major problems with medicine is that there is no competition, because “everyone is protected by licensing.”  Having watched legislative sessions in Tallahassee this summer, I know that an anti-licensing movement has taken hold in the GOP.  Dozens of licensing requirements were eliminated this year by the Florida legislature, including ones enacted when Jeb Bush was Governor.  Some of these requirements were targeted to very specific societal evils, such as the problems with child exploitation and sexual abuse that had led to a (now-repealed) licensing requirement for talent agents.  When it comes to alternative medicine, there may be room for improvement in licensing practitioners and approving new procedures.

Apparently, in Ron Paul’s world, any one of us should be able to open up a medical office, with no licensing authority to determine whether we possess the moral character or basic technical skill necessary to practice medicine.  I do not want to live in this world.  If you do, feel free to call me to schedule your next surgery.

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