It’s not often the US Supreme Court gets to issue a ruling on labels, but the case of Wyeth-v-Levine (06-1249) provided just that opportunity.  The case revolved around whether Federal approval of a drug label gave protection to pharmaceutical manufacturers and retailers for adverse health effects and whether victims could sue under local State laws.  The ruling demonstrates that drug labels which warn of the effects of a drug do not protect the manufacturer or supplier from being sued for adverse side-effects.

In brief, drug warning labels telling you of potential side effects can still be bad for your health, and for pharma companies, bad for their wealth!

Drug label warnings, dosage and side-effect notifications are a very ripe area for litigation, and certainly a highly profitable one, though victims and pharmaceutical companies appear to be the also-rans in the financial stakes; as usual when matters come to a court, it is the lawyers who are set to clean up.  Tort lawyers are the most financially rewarded of the entire legal profession, and highly profitable pharmaceutical companies with deep pockets provide very tempting targets for hungry lawyers.

In the Wyeth-v-Levine case, there were three notable dissenters from the verdict – Justices Alito and Scalia being joined by Chief Justice Roberts who noted, quite accurately, that the case turned “a common law tort case into a frontal assault on the FDA’s regulatory regime for drug labeling”.

Before proponents for tort reform start citing this case as a reason why such lawsuits should be restrained, we should take a look at the underlying case which gave rise to the matter coming before the US Supreme Court.

Diana Levine was a musician who attended a health clinic in Montpelier, VT in 2000, complaining of severe migraine headaches with nausea.  She received an injection of Phenargen without success, and returned the next day where she received a further injection.  Unfortunately, the injection was made into an artery and caused gangrene, resulting in Ms Levine’s arm needing to be amputated.  The drug warning label, approved by the FDA, clearly indicated that injection of the drug into an artery could cause gangrene (but did not state that the particular type of injection she received, known as a “push injection” would result in this risk).

Ms Levine sued the health clinic and successfully won damages of $700,000 against the clinic augmented as a consequence of the loss of her career as a musician.

Madame Levine then sued Wyeth, the drug-manufacturer for failure to note the risk associated with the “push injection” and a jury awarded her $6,774,000.  Wyeth appealed the decision to the VT Supreme Court which ruled they had a duty to comply with a Vermont common law responsibility not to use a risky method of injection, i.e. push injection.  The FDA approved labeling did not protect Wyeth and this exposed the pharma company to tens of thousands of potential claims representing potentially billions of dollars in costs and reparations.

The US Supreme Court verdict upholds Ms Levine’s multi-million dollar damages, but of broader concern is that not only is the duty owed for clear labeling and avoidance of risk demanded by VT’s own laws shown to be permanent, but that of the 46 other States who listed their interest in the case.  Even when following federal labeling legislation and guidelines, even to the extent of gaining federal approval, manufacturers and suppliers are not protected from damaging actions or effects which result from the use of their products.

RFID tags (Radio Frequency Identification) are used to track assets using a radio signal which can be received and used to determine the exact location of the asset to which they are attached.  Modern developments have now made it possible for RFID tags to be much smaller and even more effective in their tracking function while the cost has also dramatically dropped.  This allows FRID tags to be used in ever more situations and the medical field is a perfect example of how RFID tags can be used to track multiple assets and provide enhanced security and identification protection.

Medications, specimens, laboratory samples and even patients can now be tracked – and tracking time sensitive assets, such as an organ for transplantation, or a patient who needs to be continuously monitored, say someone suffering from Alzheimer’s Disease, is now practical and cost effective.

RFID tags also possess the ability to contain information, including patient data, but also information on dates of manufacture, application, dosage and warning information.  RFID tags also provide the ultimate level of authentication; many medicines used in developing countries are in fact counterfeited by unscrupulous criminals looking to make huge sums of money which many drugs command on the market.  An RFID tag is almost impossible for counterfeiters to replicate, so the presence of such a tag is a good indicator that the medicines are in fact genuine.

RFID tags come in two main forms: a short-range tag, known as an HF tag (High Frequency), and UHF tag (Ultra High Frequency) with a longer scanning range.  HF tags are suitable for use in tracking medical samples and specimens such as blood and tissue samples because they work effectively in proximity to liquids and human samples.  UHF tags are affected by close proximity to liquids and can be affected by close proximity to tissue samples (the human body is primarily made up of water), and it is also important for proper “tuning” of UHF tags in a medical environment because they are also affected by proximity to metals and radiation (some things which are commonly found in hospitals and medical laboratories).

RFID tags being used for patient tracking has caused some controversy in terms of the invasion of patient privacy, however, where patients are at risk to themselves, such as those suffering from dementia or temporary mental incapacity, they are invaluable for securing identification and monitoring patient status.  Certainly, one use of RFID tags appears to have gained the seal of approval from patients when used to track newborn infants – there can be no doubt that the baby you take home from the hospital is the child which you gave birth to with no possibility of hospital mix-ups!

Patient safety can also be significantly enhanced using RFID tags; for instance, when you need to locate a crash cart (a defibrillator) for a patient in cardiac arrest, you need to find it fast.  RFID tags provide the ability to accurately and quickly pinpoint the location of the cart which can be brought into action much faster for patient assistance.

In terms of hospital administration, RFID tags help to automate inventory management and reduce the administration costs of managing a broad range of sometimes, extremely expensive items, many of which are used as commodity stock items but which are in fact, extremely expensive.  Simple scalpels for instance, are a commonly used item in hospitals and medical institutions, however they are very costly and need to be tracked and managed effectively to avoid wasting money.  RFID tags open the door to significant cost savings by ensuring all instruments and equipment are accounted for at the end of an operation or medical procedure.

Asset Labels Tracking the War on Terror

In 2003, the U.S. Department of Defense (DoD) instituted an asset tracking program in order to track DoD property under the control of external contractors.  This arose amidst claims of of contractors misappropriating assets, employing wasteful practices and generally charging exorbitant sums for work which should not have been charged.  Some readers may recall the issues associated with $200 hammers or thousand dollar toilet seats which plagued NASA, and in the realm of defense spending, there were many instances of inappropriate billing by contractors which was met by the extremely large budget of the Dod and ultimately, the taxpayer was footing the bill.

The Unique Identification program (UID) ensures that government property and assets are all marked by a special asset tag – the individual asset is allocated an Individual UID (known as the IUID – the military are renowned for their use of acronyms) and this in turn produces a Unique Identification Identifier (UII).  All equipment delivered to the DoD by an external supplier must bear a UII which comes in the form of a 2D matrix (a barcode), and this in turn feeds into the billing program of the external contractor which must be managed and presented in a format which meets DoD standards.

With the “War on Terror” commencing in 2003, the DoD is taking delivery of equipment throughout the sphere of operations as well as its main logistics deployment establishment established in Richmond, VA.  There are numerous problems associated with ensuring that equipment is delivered and gets to where it is needed most, especially for those operations involving combat and security duty in high risk areas such as Afghanistan.  At the same time, while the focus is on combat and operational effectiveness, it is very difficult to effectively manage equipment and supplies which are delivered direct into the sphere of operations by external contractors.  When you are getting shot at, you are less likely to be concerned with accounting for equipment!

The UII tags remove the need for such intensive management by personnel in the field, and simplifies the entire tracking and inventory management process.  The program has already resulted in savings worth several billions of dollars in the 6 years which it has been in operation, and has also been used as the  basis for billing adjustments with external contractors who otherwise would have billed for equipment and supplies not delivered as well as reversing overcharges.

One application of the UID program has seen enormous savings in the area of containerization.  The  DoD is the largest customer for cargo containers in the Middle East area with enormous amounts of cargo being transported and stored at a variety of ports and externally managed supply centers prior to onward transportation to the “front”.  Cargo containers are extremely expensive pieces of kit, and they are not in fact owned by the DoD – the containerization system relies upon them being leased or rented (typically for a $2,000 per week).  These containers are spread around a huge geographical area, greater than the size of the U.S., and in a large number of disparate locations.  It is vital to track them and establish which are in use and which are nt being used – by ensuring that idle use is minimized, and advising the owner of non-use, significant savings have been incurred by not paying for containers which are in fact, sitting idle in the owners depot or are still on the lease book but in fact, are not being employed.

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Reading labels on medicines has been identified as one cause of phantom illnesses ranging from serious diseases, such as cancer, to minor ailments such as a bout of flu – the latest is the rise in the number of cases of swine flu which fortunately, turn out to be nothing more than a sniffle.

One warning sign is when the doctor writes on your prescription, “Oink, Oink, Boom!”, which is the sound a flying pig makes breaking the sound barrier!

Medications are big business in the US with billions of dollars spent on drugs which are prescribed or are available over the counter.  By law, every medication must come with a label which highlights what the medicine is to be used for and possible side effects or contra-indications.  Frequent side effects are quoted as headaches, fatigue, dizziness, feeling sleepy or having difficulty concentrating.  All are vague in their nature but when they are coupled with warnings that some patients may suffer from an increased risk of something more serious, a stroke or cardiac episode, the effect of reading the label combined with an overactive imagination can lead people to believe they have something  more sinister.

The culprit is how the mind works, and psychiatrists have identified a condition termed the “nocebo effect”.  This is the opposite of a placebo – a placebo will make you feel better though it may be a pill containing nothing more medical or therapeutic than powdered milk.  Nocebos actually invoke feelings of ill-health even though there is, in fact, nothing wrong with the patient, but before you think this is quackery, nocebos can be fatal!

One example of the effect of a nocebo is contained in a study conducted in the 1960’s.  Patients were given a glass of sugar water and told that this would make them vomit as part of a procedure to study their stomachs.  Though there was nothing in the glass except sugar and water, 80% of those taking the drink did in fact throw up immediately afterwards.

Research into nocebos has been limited, not least because with a study group, illnesses will be induced because of the power of suggestion.  The Framingham Heart Study followed a group of women over several decades who believed they were part of a high risk group for heart attacks.  The result of the study was that those women who believed they were in a high risk group had a fatality rate four times higher than those women in the same risk category but who were not told of this fact.  Fear played a part in bringing about the condition precisely because they had been informed of the fact.

An Italian study into men and the taking of medication, found that those men who read the label on the medicine which had been doctored to warn of “erectile dysfunction”, reported a far higher incidence of the condition.  Reading the label and especially, reading about the side effects and what the medication is designed to prevent does in fact result in a far greater incidence of the conditions warned of than those who remain blissfully ignorant – a case of “Don’t Read the Label!”

Mark Trumper

Labels and stickers have never been cheaper or easier to source and no matter what you need, you should be able to find a print and design partner who can deliver what you need, at the price you demand and without sacrificing quality.  You are only restricted by your own imagination though many printers will offer a very wide range of designs and templates for you to use if you want something quickly – still, there is always scope for your own personal touch given the technology available today.

Many online websites are offering cheap printed labels and other services but you should establish who you are dealing with before you place the order and part with your hard earned cash. You are strongly advised to deal with a US based supplier who will also be directly responsible for producing your order; many online web suppliers are actually sub-contracting the print work overseas, particularly to the Far East, where print work is conducted on old presses (usually sold off as obsolete from the US and elsewhere back in the 1970’s and 1980’s) – the quality is poor, the environmental impact is extremely high and you have very little control over the print process with extended turnaround times and almost no recourse if something goes wrong.

The moral of this story is to buy American!

Many people never even consider how a label can help them in the first instance so here is a brief list of typical label orders which can be fulfilled by a competent print and design partner – remember it will serve you well if you can keep work with the same supplier because it will reduce lead times, decrease design team input and as a supplier gets to know you better, they will be able to help you that much better too.

Here’s the list:

• Barcode labels
• Anniversary labels and seals
• Shipping labels
• Cheap or Value Labels
• Control Panel Graphic Overlays
• Custom integrated Shipping Labels
• Bespoke or Custom Labels
• Custom Wine Labels
• Parking Permits and Stickers
• Custom Short Run Labels
• Embossed Labels
• Four Color Process or CMYK Labels
• Hang Tags
• Medical and Veterinarian Office Labels
• Oil Change Stickers
• Personalized ID Tags
• Short Run Custom Labels
• Waterproof Labels
• Window Decals

In addition there is a growing interest in the personal use of labels and stickers.  It is quite common for orders to be placed for personalized stickers for kids; anniversary and birthday occasions; Christmas, Thanksgiving, 4^th July and New Years celebratory tags and sometimes any old occasion just for the fun of it such as a personalized beer label when you are having a family get-together.  Wine buffs have been getting in on the cheap label act by personalizing their wine for serving at table or weddings and such – it is a lot cheaper and is easier than you may think!

As we said at the very beginning, you are only restricted by your imagination in terms of what you have on the labels and stickers you want and what you are going to use them for – and it is definitely not going to break the bank either.

Full color label ordering has become a whole lot easier with new technology and the internet making communication so much faster.  Now you can expect to submit your order and receive proofs for the job the next day with a short turnaround time to order fulfillment.

CMYK (which stands for Cyan, Magenta, Yellow and Key (which stands for Black because the other colors are “keyed” against this one) present certain technical issues for the print partner when it comes to ordering, proofing and production.  As a result, many online websites offering full-color printing tend to outsource the work to third parties which is not cost-effective for you as someone else is increasing the margin at your expense and you have less direct control over the process than when you are dealing with the printer fulfilling the order.

Today, all you need is your artwork and access to the internet and with a few clicks you’ll be on your way.  Make a list of what you need to do. You can start your order with as little as 250 units for a standard print run though you can get less than this if you consult with your print partner.  You can also expect a very fast turnaround time from proof acceptance to delivery typically between 3 and 5 days.

You can streamline the design process for your full-color labels by using the template designs and shapes which many established online printers and design shops now offer.  Don’t be afraid to use your own imagination but you can drastically reduce the turnaround time by sticking to templates and established designs which will help you print partner to fulfill the order that much faster.

You can also include one-time or variable data such as serial numbers with or without barcode labels or variable text which will include a different data record, for example a vehicle registration number.  If you have specific requirements which may at first sight appear to be problematic you should always  consult with your print and design partners because they will most likely have encountered the same or similar issues many times before with other clients.

You should also consider the use of laminate materials for superior finish and to increase the life of the label and the laminate process will also avoid smearing of the inks used to maintain a crisp image over the working life of the piece. you can of course, choose a non-laminate finish but there is also a UV varnish which can provide the same look but give the same anti-smear protection as a laminate.

Finally, you also should consider whether you are going to have these labels applied by hand or by machine; this will in turn determine whether you want the labels supplied in roll labels or as separate pieces.  Machines use roll technology to apply the labels in many instances but you will also need to determine the core size of the rolls you will need to have them wrapped around – typically 1 and 3 inch cores are used but again, consult with your print and design partner if you have a different set of requirements.

Buying labels and stickers has never been easier with the advent of the internet and now there are more reasons than ever to click the mouse and place an order – it is really so simple and so very, very cheap!

Sourcing your stickers and labels online is convenient because you can do this whenever you want to – you don’t need to set time aside in a busy, hectic work schedule to get what can be a mundane chore done – order in the middle of the night, first thing in the morning or anytime you want to – the choice is all yours.  When it comes to convenience, nothing beats the internet for putting you in control.

The price is another major reason for sourcing labels online – a good printer will use the internet to reduce their own production costs and in turn will pass on the enormous savings created to you, the customer, in the form of big discounts.  It is not unusual for discounts of 50% or more to be found using online based print and design partners when compared to traditional shop-based suppliers.

A note of caution here – price is important but so is quality, delivery and customer service.  You have to be careful because many online suppliers are actually simply acting as a middleman and outsourcing the orders they receive to third party printers so they can take a cut – this does not pass on the full discounts available in the pricing and you lose control of the quality aspect of the order.  Turnaround times are also longer in these instances and if there is a mistake in the order you are unlikely to have effective or practical recourse.

Online ordering is very simple and provides an enormous amount of flexibility as well as reducing the lead time involved in putting the design and artwork together.  Artwork can now be simply emailed to the printer (though you should check with each supplier for any particular requirements they have for file formats and sizes) and the resulting proof can be rapidly turned around and emailed straight back to you.  You should note that the colors that are produced by proofs may not be truly replicated by your computer monitor but this is usually very marginal and does not impact on the process or finished products.

In addition to the ordering and proofing process, you should be able to gain access to past orders you have made with the print supplier using the online portal – this will allow you to use previous files, designs and proofs from past projects which will result in faster turnaround times and the potential for reduced costs to you.  You may also need to have labels and bumper stickers delivered to multiple delivery addresses and in varying quantities and frequency for repeat orders – a good quality online portal will provide this functionality with simple one- or two-clicks of your mouse.  Once you have finalized your design and agreed the proofs and the order has been placed and is on the way to being fulfilled you will want to track the order through production and delivery and again, nothing beats an online system for enabling you to do this.

Let’s be clear – America is hurting and American jobs have been axed by the millions over the last twelve months and it is not going to get easier any time soon.  If we are to put America back on track we have to start thinking about creating jobs and keeping work right here at home first before cheaper and poorer quality plants are established overseas to siphon off more jobs and create more inferior imports to be shipped back here.

Buying American should be the first choice and necessity for every business and consumer here at home and the best way we can encourage buyers to buy American is making sure they know it’s American to begin with!  That means labeling every product and package which is shipped out of your plant and sold from your shop so the consumer knows who made it – American workers!

Sourcing “Made in America” labels is extremely cheap but there is a massive demand for American products right now because the consumer knows buying home-produced goods is on a par with being environmentally friendly.  Labeling your goods as “Made in America” is a positive marketing tool to use right now because you can channel the patriotic consumerism to your benefit which is something many foreign importers have been trying to do in increasing numbers as they too have felt the economic squeeze on their margins.

Do not make the foul mistake of sourcing your “Made in America” labels from overseas – there’s usually something about them which will give you away and in any event, you are asking your customers to buy American and you should too!

Sourcing labels is easy – go online – but beware, because many online label sources and printers are simply outsourcing the printing work to cheap, overseas outlets who sacrifice quality in order to deliver on the price promise.  For a crisp printing rendition of Old Glory, make sure you use a quality printer who operates modern printing techniques and can offer price with a fast turnaround.

You can also customize your Made in America labels and stickers by including your company name and your choice of wording, typically the town and state where your business is based is usual but there is no real restriction on this except your imagination.  You should be looking to pay no more than $100 for a 500 minimum order and certainly no more than $650 for a bulk order of 25,000 which brings the unit cost down to less than 3 cents per label.  For this you will be getting a quality embossed Made in USA sticker, using silver leaf foil with patriotic red, white and blue colors and a wide variety of styles for you to quickly design your own label and you should also expect free reprinting if the printer gets the wording wrong (but be careful because there are usually no proofs used in these instances to keep the prices down).

by M. Trumper, Mavericklabel.com,  buy your labels online

Hands up please because we’ve all done it!

“Read the Label First” is a common phrase which is too often ignored and sometimes with less than funny results.

In 2007, a s a keen but novice gardener I applied a fertilizing lawn feed together with a weed suppressant (as an Englishman I am fanatical about a lush green lawn).  Unfortunately for me, and especially for my lawn I applied a neat weed suppressant which should have been diluted down to 3 parts per 100.  In the following week I watched my lawn deteriorate to a nice shade of pale green and eventually purple and brown as I killed almost everything in sight.

I was less than amused.

Back in 2006, Clorox launched a hard surface cleaner which they claimed was “gentler than water” – many consumers were quick to yank the product off the store shelves until some astute label-reading ninja took the time to point out that this Clorox product was gentler than water precisely because it was water – 99% with 1% Clorox solution added and yet sold for $1.50 and even $2.67 for the spray version.

Read the label before buying is probably a better way of putting it to the consumer at large.

In 2008, a national chain of grocery stores added complimentary disinfectant wipes to its store entries so people could use them to disinfect the handles of pushcarts.  Again, this sounds like a fantastic idea until someone at public relations received a very terse letter from a member of the public that if they really were serious about disinfecting the handles they would have to supply enough wet wipes to saturate the surface to be cleaned i.e. pull wet wipe, squeeze the disinfectant out and repeat until totally soaked – nowhere near as convenient as it all sounded.

Mr. (or Mrs., or probably Ms.) Angry from Somewhere Out There quoted the label instructions on the wet wipes being supplied which backed up their claim making it an even more pointed case that before we, the consumers, read the labels, perhaps the retailer ought to be too (a case of read the labels minus a first).

MRSA is a serious hazard because it is resistant to antibiotics as are an increasing number of bacteria which have historically been treated with them.  The implication for us as humans who are looking to medical science to cure us is clear – if you catch these antibiotic-resistant bugs you are going to have get better on your own!

Prevention is certainly better than cure in this instance and medical labels are riding to the rescue once again.

A major source of transmission of infection takes place where there are concentrations of ill people with a range of different infectious illnesses – going to a hospital will bring you into close proximity with these bugs if not directly, then certainly with doctors, nurses and other staff who are themselves constantly exposed to these bacteria.  This is why personal and environmental hygiene are so important and a great deal of time and money is spent on ensuring everyone washes their hands and does so in a thorough manner (seriously, washing your hands in a “medical fashion” is something which is taught and not at all instinctive as you and I would perform it after a visit to the bathroom).

Now consider this scenario – a nurse is told to give a patient with a bacterial infection a dose of antibiotics to a patient – the pills are in a bottle kept just for that patient and the nurse is conscientious and gives the patient the dose.  They replace the bottle of pills and then wash their hands before moving on to the next patient – there is no way the next patient is catching the bug from this nurse right?

Wrong!

The bug is still on the pill bottle and it will come into contact with other pill bottles or medication or the nurse, or some other person who will the transfer the bug.

Unless the bottle and label of the medication container are themselves acting as antibacterial agents and are eliminating the bugs which come into contact with them.  Increasingly, hospitals and medical facilities are picking up on the use of containers and labels which are manufactured with highly effective anti-bacterial properties built into them.  It has been estimated that 90% of bacterial transfers by medical staff can be cut completely by simply adopting the practice of using an anti-bacterial label, but let’s hope you never have to find out for yourself in practice!

There is a distinct cottage industry that has sprung up around bottling antique scents and marketing them, typically using online auction sites such as eBay.  When we say, “Antique Scent” we are not talking about a 100 year old pong but rather the production of scents and perfumes from a bygone age or era produced to order in many instances and which has carved out a specialist but growing niche in the billion dollar perfume market.

An issue for the suppliers has been to really differentiate their product from the mass marketed scents and perfumes which are backed by multi-million dollar marketing campaigns, tanned supermodels and exotic locations and situations.  All try to promote individuality with a huge price tag but antique scents can do this far more effectively and enhance the wearer (or giver’s) reputation for individual personality and flair.

No wonder that this cottage perfume industry has latched onto bespoke labels to enhance the differentiation from the mass market with their offering.   Not only has this led to modern designs aiming at a “bygone days” theme but a resurgence in original label designs resurfacing for use today – the designs are frequently as refreshing as the often simpler scents in the bottles they adorn.

While the perfume industry has almost universally been influenced by the French it has not always been the case in history with many distinguished “perfumiers” based in London, England and especially during the Victorian era:

Look a little closer though and you’ll see this example is from New York, USA !