Disturbing but interesting pharmacy legal cases

[evilolive]

One of my friends is a law student, and came up with some interesting thoughts when reading about pharmacy. Here are some of the thoughts that she shared with me.

Concerning the "duty to warn" concept with liability for "product defects" currently in the field, there are a couple cases about pharmaceutical companies' duty to warn on drug labels: in MacDonald v. Ortho Pharmaceuticals Co., the court found that a warning may be legally insufficient despite its satisfaction of FDA requirements. These warnings should be comprehensible to the average user and convey a fair indication of the nature and extent of the danger to the mind of a reasonably prudent persona the adequacy of such warnings is measured not only by what is stated, but also by the manner in which it is stated. A warning may be found unreasonable in that it was lacking a sense of urgency in tone.

In Mc.Kee v. American Home Products Corp., it was decided that pharmacists have no duty to warn that is normally imposed on prescribing physicians. "It is apparent that a pharmacist would not be qualified to make such a judgment as to materiality. Requiring the pharmacist to warn of potential risks associated with a drug would interject the pharmacist into the physician-patient relationship and interfere with ongoing treatment. We believe that duty, and any liability therefrom, is best left with the physician."

I'm shocked that the legal system views pharmacy in this manner, especially with our goal of implementing Medication Therapy Management. Why would the court rule with this decision? This means that pharmacists aren't necessaily responsible for these drug problems despite them being the authority on the medications? Do the courts believe it is because pharmacists lack the diagnosing capacity and proper background to fully grasp a physician's decision? What do you all think?

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[Old Timer]

Here is a link from NACDS. You can see most courts have haled we don not have the duty to warn. But you have to look at each case and the devil is always in the details.

In Florida, there is a duty to warn.

 

[genesis09]

In Illinois, pharmacists have historically be viewed as not healthcare providers. So many court cases reflect that. They believe the learned intermediary is the MD not the pharmacist. However, the most recent court case, it still hasn't reached the state Supreme Court, is Happel v Wal-Mart. The appellate ruling says when a pharmacist has knowledge that an injury could happen, a pharmacist does have a duty to contact and warn the MD (prescriber) and/or patient. If this remains the final ruling, Illinois will have duty to warn.
Chief Justice Earl Warren stated, "A pharmacist no more renders a true professional service than does a clerk who sells law books."

 

[evilolive]

Here is a link from NACDS. You can see most courts have haled we don not have the duty to warn. But you have to look at each case and the devil is always in the details.

In Florida, there is a duty to warn.

How do you deal with this Old Timer? Have you ever heard of this stipulation put into practice? Do you believe that pharmacists should be responsible? I thought that as pharmacists we would be the experts on the drugs and yet we are shielded from this liability.

 

[Old Timer]

How do you deal with this Old Timer? Have you ever heard of this stipulation put into practice? Do you believe that pharmacists should be responsible? I thought that as pharmacists we would be the experts on the drugs and yet we are shielded from this liability.

This is one of those on the one hand and then on the other hand.

First there is the legal obligation to warn and the moral obligation to warn:

Legal: The way I read most of these cases is the pharmacist is shielded or not treated as the learned intermediary in those cases where he may not be privy to all of the information and that is why the doctor gets the blame. Most of the cases where the pharmacist is on the hook pertain to cases where he had all of the information. New they were allergic to X and dispensed it anyway. Kept refilling narcotic rxs early until the patient OD'd, etc

Moral: You know by now that I am a religious person. Regardless of my legal obligation, I have a moral obligation to the patients I serve to provide them with the best care possible and sometimes that means not filling a prescription (see this thread). Sometimes it means verifying the dosage, quantity, drug or duration of therapy. It does not matter what the law says, I wouldn't sleep well at night if I contributed to harming a patient when I could have prevented it even if there are no legal issues.


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On the other hand who wants to get sued. You are going to practice the way you want regardless of how the "legal" system treats you.

 

[evilolive]

I definitely agree with the underlying duty laid out by moral ethics, as that's what most of us (hopefully) are going into the profession for, although some people sadly tell me they know people in it solely for the money. That's a fascinating story you had in your previous thread, and it definitely has me wondering how it's possible for physicians to even be expected to know every single contraindication. I guess the profession is slow to advance its image compared to its ideals. I can only speculate, though, as to how huffy puffy some doctors can get when they feel that their recommendations are being trampled on by pharmacists.

 

[ButlerPharm.D.]

It is quite saddening to read such garbage, "Chief Justice Earl Warren stated, "A pharmacist no more renders a true professional service than does a clerk who sells law books." Unfortunately such decisions are based on lack of information or knowledge regarding the services many pharmacies and pharmacists offer. Would the judge have made the same sort of uninformed comments if the case involved a hospital pharmacy? It is unfortunate that many people in today's society are unaware of the importance pharmacists have in medical care regardless of practice setting.

In Illinois, pharmacists have historically be viewed as not healthcare providers. So many court cases reflect that. They believe the learned intermediary is the MD not the pharmacist. However, the most recent court case, it still hasn't reached the state Supreme Court, is Happel v Wal-Mart. The appellate ruling says when a pharmacist has knowledge that an injury could happen, a pharmacist does have a duty to contact and warn the MD (prescriber) and/or patient. If this remains the final ruling, Illinois will have duty to warn.
Chief Justice Earl Warren stated, "A pharmacist no more renders a true professional service than does a clerk who sells law books."

 

[bananaface]

Do you realize how old that quote is? Earl Warren was Chief Justice from 1953-1969. At the time his assessment was correct. http://www.theannals.com/pdf/1264.pdf

 

[BMBiology]

Thousands of patients suffered serious and fatal drug reactions per year. Do you really want the court to hold pharmacists responsible for medications that their physicians prescribed?

I do it because of professional and moral obligation, not because of legal obligations, and I can tell you many people don't understand or appreciate it.

 

[PharmaSynergy]

I can only speculate, though, as to how huffy puffy some doctors can get when they feel that their recommendations are being trampled on by pharmacists.

Interesting thought. It reminds me of a recent case about a health food store pharmacist-owner who was fined $1 million by the Tennessee Medical Board for 'practicing medicine without a license'. The RPh is challenging the fine in court. Unfortunately the article didn't detail the types of consultations and/or actions the pharmacist did to be construed by the Medical Board as 'practicing medicine'. My guess is, being a health food store, perhaps he recommended or otherwise gave advice on alternative therapies, dietary supplements, etc. I can see how the director of the TN Pharmacists Association takes the position that "the fact that he is a pharmacist is incidental." I mean, what if it were a holistic health counselor (HHC) giving the same recommendations? In that case I think it would be less likely that the Medical Board would be fining the HHC for 'practicing medicine'. What do you all think?

A Tennessee pharmacist is challenging in court a $1 million fine and the decision of the state Board of Medical Examiners that he practiced medicine without a license. In May, the board ruled that Larry Rawdon, R.Ph., owner of Osa's Garden, a health food store in Hohenwald, Tenn., had improperly provided care to more than 10,000 patients since 1995. While some pharmacists have worried the ruling would have a chilling effect on pharmacy consultations, Baeteena M. Black, D.Ph., executive director of the Tennessee Pharmacists Association, cautioned that the case is very unique. "The fact that he is a pharmacist is incidental," she insisted. "His store was very different from most pharmacies in Tennessee."
(Source: Drug Topics Oct. 2007 Latebreakers: Tenn. medical board fines R.Ph. $1 million - Drug Topics)