Catch 22 for Generic Drug Labeling

Although a final ruling from the U.S. Supreme Court isn’t expected until this summer, things aren’t looking good for generic drug manufacturers. At issue is whether their labeling has to reflect important medical warnings – even when those warnings aren’t required by the FDA.

This is especially important for drugs that are sold without a prescription but which may be taken on the recommendation of a physician. Drugs like Motrin (ibuprofen), aspirin and Tylenol (acetaminophen) would fall under this category. A physician may tell someone to take an over-the-counter preparation as part of his or her therapy. The patient then has to rely on the package information available at the point of purchase – without the input or oversight of a pharmacist.

The latest case involves a minor child who was prescribed Motrin following surgery to remove two moles. The pain reliever was purchased by his parents as a generic in the over-the-counter version. Subsequently, the child developed a high fever and liver failure. This was determined to be due to an interaction between the ibuprofen and the anesthetic used in the mole surgery.

Although ibuprofen is known to cause liver problems with some anesthesia drugs, this information is not printed on the package label and without the intervention of a pharmacist the parents had no way of knowing about the risks. The manufacturer claims their liability is limited because the package label is approved and certified by the FDA and isn’t required to list all the possible drug interactions. In fact, to produce a label that isn’t approved by the FDA is a violation of federal law by itself.

Previous rulings hold that manufacturers cannot escape liability with this excuse. The courts point out that companies do not normally submit such labeling and if they did, the FDA might approve it. In other words, simply meeting the minimum standards of the FDA doesn’t allow them to avoid lawsuits.

Billings personal injury attorney, Solomon Neuhardt, expressed it this way, “If a drug manufacturer cannot adequately communicate the risks to consumers, they have no business selling it outside the framework of medical supervision. This is a case of profits driving out common sense. Imagine how devastated the parents are – they thought they were doing the right thing, completely unaware that their own child would end up needing a liver transplant because they purchased something off the shelf.”

Click here for more information on personal injury and dangerous drugs.

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About Solomon Neuhardt:

Solomon Neuhardt is the owner and lead attorney at Neuhardt Law Firm, a member of the American Bar Association, the American Association for Justice, and represents individuals and families in personal injury cases, including accidents, medical malpractice, defective products, dog bites, and insurance disputes.

They Don’t Say “Scam”

Bad faith claims against insurance companies


Scam is such a harsh word. The proper way to say it, in polite company, is “bad faith” or even “unfair trade practices”. What it amounts to is a situation where there has been a loss – and this part isn’t even contested, everyone agrees here – and the insurance company essentially says, “We aren’t going to pay, sue us.”


Shocking? Yes. This is exactly the sort of practice that commonly happens during a disaster; the kind of misbehavior that arose when New Orleans was hit by hurricane Katrina. Insurance carriers flatly denied claims and put the burden of proof on the homeowners – the very people who were in no position to pursue extended legal action against them.


Fast forward to now. Jump several thousand miles to Montana. No hurricane, no flooding, but guess what? The same technique turns out to work just as well -- outright denial of a valid claim just to pressure a financially strapped claimant.


But why do it if they know they will lose the case against them? Read on to find out the real trick here.


A hypothetical and two victims


Let’s take a simple case to see how it works. Suppose you slip and fall on someone’s property because they created a hazardous condition. Maybe it’s even on film. You’ve documented the injury and are seeking compensation for medical bills and loss of wages because you couldn’t work while your broken leg healed. There is also some nerve damage which adds to the cost.


Everything is cut and dried and you have a claim against the property owner’s insurance company. In fact, you are willing to settle for the limit of the property owner’s liability coverage, say $100,000. In a fair and just world, the negotiation would proceed without too much delay and the claim would be settled.


Now, consider the matter from the insurance company’s point of view. They could settle for the policy limit, but if they delay or deny the claim, the worst that can happen is that they will be sued. And if they lose the lawsuit, they won’t have to pay a penny more than the policy limit anyway.


They can pressure you to settle for less, knowing that a judgment for more than the policy maximum will have to be paid by the homeowner. That’s the second victim. An insurance company that refuses to act in good faith doesn’t have to pay more and by threatening to take it all the way to a trial, they might get you to settle for less than you deserve. Why? Because you know going to court will result in a higher judgment, but a judgment you might never collect if the homeowner doesn’t have serious cash available.


Fighting bad faith


Because the issue isn’t hypothetical, but actually happens, Montana law has addressed the circumstance.


Under the Montana Unfair Trade Practices Act, the second victim in the above scenario, the policy holder, can sue their own insurance company for bad faith actions. The third party claimant can also sue for damages above the policy limit as well. Some of the unfair trade practices covered under the act:

• Misrepresentation of facts or insurance coverage – saying something isn’t covered when it is.
• Failure to pay claims without conducting a reasonable investigation.
• Withholding or delaying a decision on whether or not something is covered after a proper submission of a claim.
• Refusing to negotiate or attempt to settle a claim when the facts are reasonably clear.

While the statute is an important tool to keep insurance companies from “playing the system” against their own clients and third party claimants, there are important deadlines to be aware of. Policy holders have two years to file after a violation has occurred. Third parties have only a year to file after a settlement or judgment has been entered.


If you think you have been a victim of bad faith: Make sure you bring the issue up with your attorney!

Neuhardt Law in the Billings Gazette

Neuhardt Law recently assisted a Billings woman in her personal injury case against her neighbors.

Ms. Person was set upon and attacked by their 3 boxer dogs in July 2009. The attack resulted in numerous bite wounds and a series of rabies shots.

We produced a successful settlement for Ms. Person and the Billings Gazette recently wrote about our story, read it here.

Lethal Litter: Road Debris Accidents

A case of a fertilizer spill brings up negligence and driving safety issues.

Earlier this month, a commercial truck hauling a load of fertilizer up Interstate15 into Montana brought up some interesting issues about fault in road debris cases. The type of truck is called a ‘belly dump’. These are container type semi-trucks that funnel down on the bottom so that opening a slide will release the contents. In this case, the driver claimed he stopped suddenly at a construction zone and this jarred the door on the bottom of the truck, resulting in a steady leak of the contents. The green fertilizer leaked for more than a mile along I-15 until the driver pulled over and resealed the opening.

Thankfully, and perhaps because it happened in a construction zone, no accidents occurred. But we’ve all either seen debris on the road or even been hit by truck cast offs. The question an accident attorney needs to determine is really two-fold: Was there negligence by the trucking company and, can negligence be proven?

For the fertilizer, these translated into whether the material was inherently hazardous – it was, after all, a commercial chemical fertilizer – and did the material alter driving conditions enough to make the road unsafe. Pelletized fertilizer can act like little ball bearings, much like a gravel spill would. Stopping on what amounts to little rolling balls can be nearly impossible. In this case, the fertilizer was deemed not to be hazardous and it was in a powdered form, both would tend to help the trucking company avoid a lawsuit.

The general principles

If your vehicle is damaged by road debris, whether or not it leads to an accident, you may have a valid negligence claim. This will depend on several factors, and your lawyer will examine all of these.

• Could you have avoided striking the object? This usually translates into whether the object was moving or stationary and how visible it was. Because drivers are responsible for keeping their vehicle at a safe speed, they are assumed to have enough distance to either stop or go around any debris in the roadway. In practice, this isn’t always the case. A black piece of tire on a dark road surface at night can be very hard to see – however, drivers do have a responsibility whenever an object is stationary on the road.
  
  Objects that are moving – wither because they just fell off a truck or because they were kicked up by another vehicle – can be impossible to dodge, and in this circumstance, the fault is clearly not with the driver of the damaged car.

• How long was the item on the road before you struck it? While it can be difficult to determine this, cameras, accident reports, and other data might be available to show that the debris was in the roadway an inordinate amount of time. Municipalities have a duty to keep road hazards cleared off of public highways. If they are not performing this function, they have some share in the negligence when an accident happens.
  
  In many cases, it is difficult to prosecute a claim in court against a government entity. They will argue immunity and you would have to demonstrate they were lax in their duty to an excessive degree. These cases are more likely to be won when the actual condition of the road is the problem – a pot hole or road marker that is flawed. Even in these cases, you would have to show the municipality both knew about it and that they had time to fix it but didn’t.

• Can you reliably identify the vehicle that the object fell off of? Without this critical piece of information, the case may not be able to go forward. In the best situation, there will be witnesses who can verify the incident or the item will be so unique that it must have come from the truck you claim it did. Seeing the item fall is the strongest connection.
  
  When there is a commercial carrier involved, your attorney may be able to subpoena trip logs and manifests to show that the truck was where you said it was, when you said it was, and was carrying the type of item that struck your vehicle.

• Do the damages and injuries suffered rise to the level of legal action? In negligence suits, there is a rule of, “No harm, no case.” In practice, this means that if the damages were slight, there is probably not much point in pursuing the case beyond a request to the carrier’s insurance company. Such a request, when it appears on an accident attorney’s stationery is likely to get a quick response. However, some commercial carriers feel victimized by the public – they suspect that many claims are inflated or fabricated to take advantage of their deep pockets.
  
  Another reason why a commercial trucking company might wish to fight even a legitimate claim is that these are recorded and can lead to increased premiums from their insurance carrier. The best course is to be truthful and have all the relevant facts available. With the facts in hand, your attorney will help you decide how to proceed.

Other factors

Was the load properly secured? The assumption is that if something fell off, it wasn’t.

If other vehicles and drivers were involved, this strengthens the case tremendously. Each is a potential witness and combined, the testimony makes a very good case.

Did you file a police report? Again, this helps establish credibility and confirms the date and time of the incident. On-scene photographs of the debris and any damage will also help.

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About Solomon Neuhardt:

Solomon Neuhardt is the owner and lead attorney at Neuhardt Law Firm, a member of the American Bar Association, the American Association for Justice, and represents individuals and families in personal injury cases, including accidents, medical malpractice, defective products, dog bites, and insurance disputes.

Can I Save a Child’s Life Today?

Action you can take to help stop the number one killer of young children.

The leading cause of death in young children in the United States is accidental death. And the highest number of deaths occurs as the result of motor vehicle accidents. The rate is even higher in rural states like Montana. And the stunning fact is that about half of these deaths can be prevented.

The reason? Improperly used or defective child restraint systems. A study by the National Highway Traffic Safety Administration found more than 70% of car seats, booster seats and other restraints were being used improperly and would fail to prevent injury. Termed “critical misuse” by the NHTSA, the problems fell into several categories:

• Inappropriate restraint system for the age and weight of the child;
• Car seat facing in the wrong direction;
• Misplacement with respect to air bags;
• Car seat or booster not secured properly in the vehicle;
• Harness or crotch strap not properly adjusted;
• Missing or unused locking clip on safety belts.

How to save a life

With more than two-thirds of child restraint systems being misused, it is obvious that if even one caregiver, parent, grandparent or other family member takes action, we can save some lives and prevent the almost unimaginable tragedy of a child’s death. Auto accidents happen. No one can prevent them and you don’t have to be at fault to suffer the consequences. But there is help available:

• Manufacturer’s website. Many manufacturers provide instructions for proper installation and use of their products on the web. This is helpful if you no longer have the original guide that came with the seat. Some even put up videos that show the same information. Here is an example of an excellent video of this type: Britax Booster Seat
• Two general resources on the web that describe age and weight appropriate restraints: HealthyChildren.org and NHTSA.gov.
• Contact your local police department. Police officers are trained on the proper use of child restraints and will inspect yours for free. They are happy to give instructions on proper use because they have seen the heartbreaking results of misuse.

You can save a life…

… but not by reading an article. You need to take action. If it is your child at risk, don’t assume you are in the one-third who know how to use a car seat properly, get a second opinion. If it is your friend’s child, or your grandchild or even just someone you know who has a child restraint in the vehicle – bring the matter to their attention. Car crashes happen every day and every hour of every day. Waiting is a gamble that not only isn’t necessary, but is foolish.

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About Solomon Neuhardt:

Solomon Neuhardt is the owner and lead attorney at Neuhardt Law Firm, a member of the American Bar Association, the American Association for Justice, and represents individuals and families in personal injury cases, including accidents, medical malpractice, defective products, dog bites, and insurance disputes.

Avandia Risks

Type II diabetes (sometimes called adult onset diabetes) is characterized by a gradual resistance to the effects of insulin in the body. In short, the amount of insulin secreted by the pancreas doesn’t control blood sugar levels. In the earlier stages, patients may take oral medications that change the body’s response to insulin. In the later stages, patients usually have to have insulin injections.

Avandia (generic, rosiglitazone) acts on cells to sensitize them to insulin so that patients who have become resistant to the effects of their own insulin can return to a more normal state. The drug is sold in three different products, all manufactured by Glaxo-Smith-Kline. Avandia is a single ingredient form; Avandamet is a combination with metformin; and Avandaryl is a combination with glimepiride. The combinations are with drugs that increase insulin secretion with the strategy of both increasing production of insulin and increasing the sensitivity to the hormone.

Problems emerge

A study published in May of 2007 showed an increased risk of heart attack in patients taking Avandia – a serious blow to Glaxo-Smith-Kline, who in 2006 had an estimated 2.5 billion in sales for the three products.

The FDA reacted quickly and recommended the drug be restricted to patients without a history of heart failure and that patients should be followed up to see if any cardiac problems developed while on the drug.

Later in 2007, another warning, about increased risks of bone fractures in women was added to the drug packaging information. This is an important warning, because overweight women are at higher risk for bone fracture from stress or falls even without the side effects of Avandia and this population is also more likely to develop type II diabetes. (FDA updates to warnings can be found here.)

The story didn’t end there. By February of 2010, some FDA officials were recommending that Avandia should be pulled from the market entirely (ABC news report).However, the drug is still being sold.

Controversy remains

Why is the drug still being sold? Because different studies have come to different conclusions. While the risks of heart attacks is clearly greater, they may be no greater than other drugs used in type II diabetes and no worse than someone who has untreated diabetes. It is the very fog of the unknown that allows the medication to be sold.

Instead of having to prove a substance entirely safe, drug manufacturers are allowed to warn doctors about possible side effects and then the physician is entitled to use their good medical judgment and assume liability. There is one important consideration though: when a drug company withholds information from the medical community or the FDA. In this case, the manufacturer is not only liable, but can be found criminally negligent.

If you or someone you know has experienced adverse effects while taking Avandia, you can report them to Glaxo-Smith-Kline at 1-888-825-5249 or the FDA at 1-800-FDA-1088. The Consumer Complaint Coordinator for prescription drugs in Montana -- 800-353-3965.

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About Solomon Neuhardt:

Solomon Neuhardt is the owner and lead attorney at Neuhardt Law Firm, a member of the American Bar Association, the American Association for Justice, and represents individuals and families in personal injury cases, including accidents, medical malpractice, defective products, dog bites, and insurance disputes.

Dying for a Swim – Pool Tragedies

Summer in Montana gets us out in the sun and anxious to cool off in the many private, public and semi-public pools. (Highs in Billings, Montana hover around a hundred degrees in June!) Unfortunately, along with the summer fun there will be an appreciable number of accidents and injuries – many due to improper maintenance or negligence of the swimming facility.

Responsibility for harm

Commercial and public pool owners have a responsibility to keep their facilities up to standards. A hotel or motel pool is a money-maker for the business. The operators have a duty to look after their patrons and provide a safe environment. If they are negligent, in whole or part, a lawsuit is the likely remedy. A number of cases handled by Billings law firms every year are preventable, but it is too late after a personal injury attorney becomes involved.

Common causes or contributions to injury:

• Improper surfaces for walking – either because they are not well maintained and slippery, or because of obstructions that might cause a fall.
• Lack of proper supervision – lifeguards that are properly trained are often required and supervisory personnel have to be able to manage risky behaviors as they occur.
• Poor water quality – too high chlorine levels can cause skin and eye problems; levels that are too low can mean infections or disease transmission.
• Manufacturing problems – water in pools must be circulated through approved outflow fittings that do not catch fingers, bathing suits or long hair. The slope from the shallow end of the pool toward the deep end must be within regulated limits. Diving boards, slides and ladders must meet approved standards.
• Maintenance issues – even the best equipment must be kept in proper shape; lights may burn out and cause visibility problems, loose cement or steps that need repair are dangerous.

Any business or government entity that allows the public to use their swimming pool has to meet minimum standards for upkeep and safety.

Tragic outcomes

One of the worst things that can happen, and a tragedy that seems to play out every year, is the death of child because of a swimming pool mishap. Owners and operators of swimming pools have a special duty when it comes to children and a wrongful death might be the result. The law obligates a layered protection when it comes to children. While the primary caregiver is the first line of defense, society at large is responsible to protect children from any foreseen harm.

Another layer of protection is securing a pool area against entry when there isn’t proper supervision available. Codes require a fence or locked door to keep inquisitive children out. Pool covers have to be designed so that a child will not slip under them and drown. Drains and outflows have to have grates that do not allow small fingers, hands or feet to get trapped.

Even manufacturers of pool related equipment have a duty to provide child-safe products. Water wings, flotation devices and toys meant for pool use can cause injury or death if they are improperly designed or come with misleading instructions.

With the summer heat, the draw of a cooling swim is undeniable, for children and adults alike. With care and consideration, an enjoyable time can be had by everyone. But if an accident or injury results from the negligence of the pool owners, do not hesitate to contact an attorney that specializes in personal injury claims. This is one of the ways we help keep pools safe for everyone who wants to use them.

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About Solomon Neuhardt:

Solomon Neuhardt is the owner and lead attorney at Neuhardt Law Firm, a member of the American Bar Association, the American Association for Justice, and represents individuals and families in personal injury cases, including accidents, medical malpractice, defective products, dog bites, and insurance disputes.