Monthly Archives: April 2014

Reversed Bottles and Nuisance Lawsuits

On a Friday, Caregiver picked up two prescriptions for Patient at Patient’s regular pharmacy. Upon reaching her office, where she had to make a stop before delivering the prescriptions, Caregiver noted that the medications, which she had administered many times over a significant period of time, were reversed.  Drug A was in Drug B’s bottle with instructions to take 1 BID.  Drug B was in Drug A’s bottle with instructions to take 1 QD.

Caregiver called and complained to the pharmacist.  Pharmacist apologized and asked Caregiver to return the bottle so she could set things straight.  Instead, angry Caregiver delivered the bottles and made no comment to Patient or Patient’s family about the error.  The family, who took care of Patient over the weekend, gave the wrong doses to Patient for two and a half days.  Patient was injured and required hospitalization.

The family sued the pharmacy and pharmacist.  At trial, Pharmacist told of the phone call between herself and Caregiver.  Upon giving her testimony, Caregiver denied the phone conversation occurred until faced with her phone records.  In a startling court moment (wish I could have been there), Caregiver broke down and admitted she made the call and did not warn the family of the error.  She claimed she was so angry over the meds being wrongfully bottled that she wanted to teach the pharmacy a lesson.

The jury, despite this revelation, found for the injured Patient and awarded damages to the tune of $100,000.  Lawyers for the pharmacy and Pharmacist immediately moved the court to give the jury an instruction on comparative negligence.

Comparative negligence can be employed where the fault for harm caused can be shared between different parties.  It is a means for a defendant—here the pharmacy and Pharmacist—to reduce their fault and thus their liability.  Usually the other party is the plaintiff herself, but as in this case, it can be a third party.  Where comparative negligence is permitted, the jury, after deciding for the plaintiff, then allots blame or fault in a percentage manner.

Here, the jury found the pharmacy and Pharmacist to be 5% at fault for the error and 5% at fault for not following up after Caregiver’s failure to bring the medications back to the pharmacy.  The other 90% of fault was assigned to Caregiver.  Having only a total of 10% of the fault, pharmacy and Pharmacist were only required to pay Plaintiff Patient $10,000, 10% of the $100,000 awarded.

This is in contrast to a legal doctrine known as contributory negligence.  In such cases, the plaintiff must be the other party contributing to the negligent act.  For example, a patient receives a refill for his medication and the tablets do not look like those he got in the past.  Trusting his pharmacist, patient does not question the change in appearance and takes the tablets, which are the wrong medication. Plaintiff contributed to the negligence.

Even if the plaintiff is found to only be 1% at fault, most jurisdictions utilizing contributory negligence then deny the plaintiff any relief or award.  The slightest contribution to the negligent act negates any damages

Defenses That Aid Comparative Negligence

When a pharmacist is accused of negligence and she reasonably believes the patient may have contributed to his injury, she has available defenses that aid in shifting the blame from pharmacist to patient.  Let us look at a few:

Assumption of the risk—this occurs where the plaintiff either expressly or impliedly assumes the risk for a known danger.  An example: Patient refuses counseling but while transacting the sale, pharmacist warns, “Do not drink or drive while taking this medication.”  Patient does drive and has a wreck.  Patient expressly assumed the known risk because of the pharmacist’s words as well as by refusing counseling.

Last clear chance doctrine—here the harmed patient has the last clear chance to avoid harm that is about to occur. An excellent example of this is the one I used above: patient gets home from the pharmacy and prepares to take a tablet of a prescription she has taken for many months or years.  The tablet looks different; no one at the pharmacy mentioned a change in appearance or substitution.  Patient has the last clear chance to avoid harm by checking with the pharmacy to make sure this is not a mis-fill.

Intervening cause—this doctrine applies where the harm could be lessened or avoided but an intervening person or event vitiates the attempt to lessen or avoid.  John looks at his tablets and they appear different.  As he picks up the phone to check with the pharmacy, his friend says, “Put down the phone.  There are new generics all the time.  Take your pill and quit worrying.”

Superceding cause—this doctrine applies where a superceding event worsens the harm.  John takes his prescription tablet and begins vomiting horribly.  His wife checks with the pharmacy and finds out John has the wrong medication.  Pharmacist assures her that John ought to recover in a few hours but to take him to the ER just to be on the safe side.  Wife runs a red light and is t-boned by a car that had the green light.  John is critically injured with multiple fractures, lacerations, broken ribs, and a ruptured spleen.  These injuries far outweigh the vomiting and supercede the initial negligent event of the mis-fill.  (The issue of foreseeability is also germane here but that is for another time.)

The Nuisance Lawsuit

We have all heard of them.  But what is a “nuisance lawsuit”?

Just that.  It is a nuisance.

OK, but how about being more specific?

A nuisance lawsuit is a lawsuit filed that seeks recompense for an alleged (not even established as real in many cases) harm but the case is cheaper and easier to settle than to go through the time and effort and expense of litigating the suit.  Quite often, if a pharmacist is alleged to have done a mis-fill that caused harm and the plaintiff is seeking less than $75,000, the malpractice carrier will choose to settle the case rather than litigate it.  There will probably be a minimal effort exerted merely to negotiate down the offer to settle some thousands of dollars, but that is it.

In these cases, it costs less to throw a few thousands (and again, a “few” these days can be up in the direction of $100K) at the patient than to take up an attorney’s time, engage in discovery, do depositions, file documents, write briefs, make motions, etc etc.

The down side to this is for the pharmacist who is sure or pretty sure she did not err.  Getting out from under a lawsuit by throwing money at the patient makes you want to grit your teeth and cuss a blue streak.  The pharmacist is the one who decides whether or not to just let a case go, if private insurance is involved, but that pharmacist will get a gentle warning that costing the insurance carrier $20K in legal expenses for  a $10K claim is not going to be looked upon well at policy renewal time.  And if it is a chain’s or employer’s malpractice, your part in the decision-making process is going to be nil.

Still, insurance carriers and employers do keep records of these lawsuits, even and especially when nothing is ever filed in court.  First, this serves as a database against patients who move around and try to create nuisance suits as a source of income (“living by screwing the man”).  Second, it is a database against unscrupulous attorneys who serve those people.

Pharmacists Carrying Guns:   A Legal Review

Last week’s killing of a pharmacist in Virginia during the course of a robbery has brought back into sharp focus the oft discussed issue of pharmacist carrying guns.  “I want to protect myself and I have a right to carry a gun.”

Do you really?  Let’s review the law.  The Second Amendment states “A well regulated Militia, being necessary to the security of a free State, the right of the people to keep and bear Arms, shall not be infringed.”   Unlike the First Amendment rights, which are actually a limit on the government’s ability to interfere with those rights, the way the Second Amendment is written it would appear as if the Founding Fathers meant that no entity could interfere with the right to keep and bear arms, a long-standing argument of the pro-gun advocates.  The Second Amendment lacks the First’s “Congress shall make no law” preamble.

However, the Supreme Court has weighed in and held that the right is not unlimited. For example, certain felons may not own guns.  Some states limit gun ownership to persons over the age of 18.  People with documented mental disease may not own a gun.  In these cases, almost everyone agrees that these are legitimate exceptions to the Second Amendment.

 As more gun cases came before the SCOTUS, the court moved deeply in the direction of permitting both government and private entities the right to limit access and ownership to guns.  From this has arisen the right of employers to ban the carrying of guns into the workplace.  A prime example here is that all the major pharmacy chains forbid their pharmacists and other personnel from keeping or carrying a gun at work. (Until recently, this prohibition existed for all property belonging to the employer, but courts have changed their direction and many now hold that leaving a gun in a car trunk or glove compartment of a locked automobile is something employers may not ban.) 

With the law behind them, the chains have stated to their employees that bringing a gun to work is a basis for instant termination.  The chains are rightfully concerned that a gun battle could erupt between pharmacist and robber in which other innocent people could be shot/killed in the crossfire.  Further, the chains, again rightfully, push cooperation with robbers: give them what they want and then let them leave—lives are more important than drugs.  The chains are concerned that an armed pharmacist might exacerbate a bad situation by pulling a gun where cooperation would peacefully end the episode with no one being harmed. Finally, employers are concerned over pharmacists carrying guns without even a basic education in firearms safety and use.

Pharmacists respond by the use of statistics which show the number of pharmacist and technicians injured or killed at work has increased 250% in the last eight years.  Opponents, employers and anti-gun advocates for the most part, respond that while this is true the number of people killed or injured eight years ago was quite few so the increase is still not a large enough number to warrant employees being armed on duty.  Going on, pharmacists argue that more and more robbers are entering the store already under the influence of drugs and the probability of a peaceful end is considerably less than with a sober thief.  A robber who is “high” may not be open to cooperation and may overreact to even a slight innocent movement.   And pro-gun pharmacists agree that only people who know how to use a gun and practice regularly should bring one to work.

The chains are sticking to their policy, though these days they do so with a much lower profile. Many of you remember the Wa***een’s pharmacist in Michigan who was the subject of a robbery attempt.  The would-be robbers jumped the counter, firing their pistols as they did so, with no word of warning.  The pharmacist pulled his gun and returned fire.  Wa***een’s fired the pharmacist but the community rallied for the pharmacist and against Wa***een’s.  Now, following the bad publicity from that and other similar incidents, the chains will mention their policy to employees but nowhere near as loudly as before.

These same chains are currently either changing or considering changing the wording in their policy against guns to a policy against weapons.  With guns banned, pharmacists carry knives, Tasers, Mace, dart pistols, guns but with rubber bullets, etc etc.  Their claim is that the ban is on guns and not on other forms of defense and protection.

And, despite the prohibition, many pharmacists are carrying guns.  Their justification is that following a company policy is not worth risking your life, an understandable attitude.  However, the courts support the chains on this, and the discovery of the gun can lead to a legitimate dismissal from employment.

The question is how this attitude will change over time.  The Newtown shooting, like the Colorado theater shooting, has done little or nothing for anti-gun advocates, while each killing of a health care professional seems to gather strength for their opponents.  For now, we wait and see.

To BMI or Not To BMI

That is the question (with apologies to William Shakespeare).

I have long recommended that all prescriptions for anorexiants have the BMI written on them.  If the prescriber has not done so, I want the pharmacist to call and get the BMI before filling.

The Board of Pharmacy says there is no legal requirement for pharmacists to do this.  I agree, and I am the first to say that my stance on this issue is more CYA than a legality.

Why do I push for BMIs?

  1.  Prescribers who do not know the legal requirements for anorexiant prescriptions.  Not a majority of prescribers, but a substantial minority are not even aware that phentermine requires a BMI of 27 with no co-morbidities, 25 with co-morbidities.  The new drugs are even stricter, with required BMIs of 30 and 27, respectively.  Get caught filling one of these and face a significant punishment from the Board as well as a permanent black mark on your file that is open to the public (ie, potential employers).
  2. Unscrupulous prescribers who write Rxs in exchange for cash and don’t care for legal requirements.  Same issue with the Board, who probably has knowledge of these prescribers and looks for their Rxs when doing your pharmacy’s inspections.
  3. A growing problem in pharmacy: the “patient” who seeks out prescriptions and fills them in the desire to create an issue with the prescription that will serve as the basis for a lawsuit (a lot of the “failure to counsel” cases are from these people).

Documentation is not a 100% shield against liability or Board action in any of the cases.above, but a prescription with the BMI present is solid evidence that you have taken reasonable steps to ensure legitimacy.  Boards of pharmacy are reluctant to act against pharmacists exercising reasonable professional judgment.  And lawsuits are harder to win where the expert witness says “she exercised reasonable professional judgment” as well as “I would not have done anything differently.”

Negligence: A Review

NEGLIGENCE, A REVIEW

OK, so let’s get this thing started.

The number one reason pharmacists and pharmacies are sued is mis-fills, a form of negligence.  The second most reason is failure to counsel, also a type of negligence.  The number one reason I get phone calls, e-mails, texts and FB posts is regarding negligent acts (the number two reason—questions regarding the proper filling and dispensing of controlled substances—used to run a far second but is closing the gap, a topic for the future).  And looking back over ten years of Pharmacy Law Notes, my newsletter from years past, most scenarios there described negligent acts or cases.

So that takes care of that.  This first blog will be a review of negligence.  That way, it can be accessed later when I am writing about issues related to the topic.

Negligence is defined as performing an act that one should not have performed or failing to perform an act one should have performed.  An example of an act one should not have performed would be mis-filling a prescription for penicillin with atenolol.  An example of not performing an act one should have performed would be failing to include a common and clinically significant adverse effect in patient counseling.

In order for a plaintiff (one who is suing for harm or damages) to prevail in a negligence action, four criteria must be met: duty, breach of duty, causation, and damages.

A duty is an obligation to act or not to act on the behalf of another person in a manner that that person can not do for themselves.  A primary duty of a pharmacist is to correctly and legally fill prescriptions.  Patients can not fill their own prescriptions; thus, they must ask and trust another person to do this for them. By accepting their prescription to fill it, the pharmacist assumes the duty.

A breach of duty is a failure to live up to that obligation.

Causation is the link between the breach of duty and damages.  In any negligence case with difficulty, this is almost always the issue.  Proving the breach led to the damages incurred is the hardest part of a lot of negligence cases.  In law school, it is sometimes called the “but for” test.  Imagine, if you will, a [insert appropriate derogatory adjective or three] plaintiff’s attorney puffing before a jury, “BUT FOR the outrageous negligence of Jim Pharmacist in filling a prescription for my poor pitiful client, a drug to which she was allergic to, an allergy screen on his computer he ignored and bypassed, my poor pitiful client would not have had an anaphylactic reaction, had to stay in the hospital, miss time at work, and incur all kinds of unnecessary medical bills!!”

In my example right there, the link is easily established when the patient was given a drug she was allergic to, by a pharmacist who bypassed the allergy screen on his computer.  This link is often more difficult to establish.    For example, Pat Patient decides to take his atenolol intermittently rather than regularly, because he “knows” when his blood pressure is high.  His use becomes more irregular and he suffers a stroke.  Pat then sues the pharmacist for not stressing in his counseling that regular use of the drug was very important.  Pharmacist claims he did make a statement about the need to take the atenolol regularly, but not stressing that point above and beyond any other point in his counseling.  The link here is more tenuous—in two separate cases that match this fact scenario, one judge threw the case out for lack of causation while the other let the issue of causation be determined by the jury (which found for the pharmacist).

Finally, damages must exist and be established by the injured party.  Damages must be compensable, which means that they must be measurable.  As from the puffing lawyer above, health care costs (that are attributable to the negligence) and missed wages are two good examples of compensable damages.  Replacement of lost property, measurable benefits from a known entity, cost of interrupted lifestyle (for example, the patient was hospitalized and missed a Final Four basketball game—the cost of the game tickets and any unrefundable portion for plane tickets or hotels) are also examples.  Sentimental damages are not recoverable—too hard to ascertain.  However, loss of companionship is something juries can be charged to measure.

Let me reiterate the point I made above.  To win, a plaintiff must meet all four criteria.  Three out of four will not even get you into a courtroom.  All or nothing.

In most states, negligence and malpractice are interchangeable terms.  Some states do define them differently but the differences are usually—you see this coming, don’t you?—negligible.

When I taught, I usually got good reviews from my students over my use of examples, so let’s go with a few.

Patient fills a prescription for trazodone and is counseled.  Two weeks into therapy he experiences priapism.  By the time he seeks medical care, surgery is required and he loses all sexual function.  He sues the pharmacy over priapism not being included in the counseling.  Will he prevail?

Patient gets prescription for penicillin despite being allergic to it and the pharmacy having this knowledge.  Patient gets rash and itches a lot.  Patient calls pharmacy; pharmacist recommends diphenhydramine. Patient recovers, discovers the error, and sues.  Will Patient prevail?

Patient gets prescription for medication he is allergic to.  No harm results.  Patient sues pharmacy after discovering the error.  Why won’t Patient prevail?

Pharmacist fails to counsel Patient on adverse effects of medication being dispensed.  Patient drives after taking the drug, which causes drowsiness, and downs the pills with a beer.  Big car wreck follows.  The harm is not to the patient, but the car is totaled.  It was Patient’s grandfather’s 1932 Duesenberg, which grandfather, son, and Patient all held dear to their hearts.  Since the patient is unharmed, can Patient recover anything from the pharmacist?

No, I am not going to keep you hanging.  The answers are below.

TRENDS

Two things worth mentioning in pharmacy these days, one good and one not so good.

First, pharmacy chains are moving away from long-held positions that were not always conducive to good practice.  Here, following two of the Big Three chains getting fines for issues with the sales of PSE, the chains are telling their stores to hide these products again.  Even better, the (subtle and denied) pressure placed on pharmacists to sell these products is in definite decline.

Along this same line, the chains that always took the line “we want every customer” are now supporting pharmacists who deny service to questionable patients.  And the problem may not be the individual patient, but his or her prescriber.  Beware of overdoing this, ladies and gentlemen.  Step cautiously.  Reasonable professional judgment and weighing issues in the best interests of the patient should always be your guideposts.

Now, if we can just get the chains to address the “we apologize for everything all the time even when it is not our fault” attitude, that will be real progress.

Second, I received two e-mails regarding this, followed by a third a few days later.  Suboxone and pain treatment clinics are now handing out complaint forms to the Board of Pharmacy.  If a pharmacy refuses to fill their (questionable prescriptions, the patients threaten to fill out the form and report the pharmacist and pharmacy to the Board.

My response to the pharmacists contacting me was “Let them.”  At least currently, the Board is as interested in protecting your professional judgment as you are.  The Board is required to investigate all complaints, so keep a documented record of whose prescription you refused and why: questionable patient, questionable prescriber, patient lives far away, prescriber practices far away, etc.  With a ready response based on professional judgment, the Board will back you every time.

Answers:

Trazodone.  Since priapism is not a common and clinically significant adverse effect of trazodone, not counseling on that side effect was not a breach of duty.  Pharmacy wins.

Penicillin allergy.  If you want to sue somebody over the cost of a box of diphenhydramine, go ahead, but if you hire me to do so I am getting a big fat retainer check first.  Damages here are pretty much non-existent.  They do exist, maybe up to $5 total, but these are what lawyers call “nominal damages” and when they are this low there is no case.

No harm results.  This one is more interesting than it looks.  Two criteria are met: duty and breach of duty.  But you actually get stuck at causation.  While the “but for” test is essentially met, there are no damages to show for the mis-fill—the breach of duty does not extend to any damages.  Lawyers are plagued with people who discover errors before harm occurs and who also want a million dollars just for finding the error.  They want money for harm that could have been.  As a pharmacist, I deplore the error and have compassion for the patient who escaped injury, but as an attorney it is plainly “no harm, no foul.”

Duesenberg.  Of course damages can be collected.  Just not what grandfather et al may think the worth of the car is.  Naturally, a car in the same family for over 80 years is going to have sentimental value and they are going to want to zillion bucks for what they lost.  What they can obtain is an appraiser’s value of the car in the current market.

Pharmacy Law Notes

Hello and welcome to my blog.  My name is Peter P. Cohron.  I am a pharmacist and an attorney.  I practice pharmacy for one of the Big Three chains currently and have a private law practice I run out of my home.  Though I have done legal work in many areas, most of my time is spent on pharmacy law, most but not all of this on Kentucky pharmacy law as I live and practice in the Bluegrass State.

I taught pharmacy and health law part time at a Top Ten college of pharmacy for nine years.  Since 1998, I have presented Kentucky pharmacy law reviews for new pharmacy school graduates, with a pass rate for attendees of 98%.

For ten years, I did an e-mail newsletter titled “Pharmacy Law Notes” before it was considered by the bar association as advertising.  PLN had, if I may brag, a good following until I had to cancel it.  Well, the same bar association has now decided that blogs are not advertising.  I am not advertising for clients here–I am seeking to provide a means for pharmacists and other interested persons to stay abreast of those legal issues that cross my path  (though were my entrancing, educational and entertaining posts a catalyst to you hiring me, that is fine).

So, the posts that follow will contain the following: descriptions of current pharmacy related legal cases; my own experiences with clients (who permit me to tell their stories); trends in the law; Board opinions, decisions, etc.; and my editorial opinion on all the above.

And I have already been asked: “Can we ask questions?”  Yes, I answer questions from pharmacists every day.  You can use this site or e-mail me at ppclaw@insightbb.com.  “Do you charge for answering questions?”  Most often, I do not.  But if it requires time and effort, I probably will state a fee.

This is a site still under construction, and a big part of that will be your feedback on the posts.  I welcome thoughts, comments, stories, and constructive criticism (and I do mean “constructive.”  Please do not be like the person on Goodreads who took my review of “HRC” and responded with a derogatory political diatribe.).

How often will I post?  When I did PLN, I averaged 8-12 posts a year.  I hope to do better than that but we’ll have to see.

Vineet, thanks for your help in setting this up.  Everyone else, Vineet did a lot to get this going.  That I am starting with the site still under construction (design wise) is a reflection on me, not him.