CLOSE X
RSS Feed LinkedIn Instagram Twitter Facebook
Search:
FMG Law Blog Line

Archive for the ‘Medical & Health Care’ Category

Georgia Prescription Drug Monitoring Program – The Last Deadline Approaches

Posted on: June 27th, 2018

By: Shaun Daugherty

For those of you that have not been residing off planet these last few years, you know that there is a lot of coverage of the opioid “crisis” across the United States.  Many states have taken steps to try and help monitor and control the controlled substances that are moving from prescription pad to pharmacy to patient.  Georgia is no different.

Several years ago, the Georgia legislature passed the bill that established the Georgia Prescription Monitoring Program (PDMP).  It is an electronic database that is used to track the prescribing and dispensing of controlled substances per patient.  In 2017, the Legislature tweaked some of the requirements and added some deadlines for the same.

As of July 1, 2017, all Georgia retail pharmacies and dispensing prescribers were required to update the PDMP at least every 24 hours.  At the time there was no requirement on the pharmacy or prescriber to obtain any information from the database or the patients who were receiving the medications, they were just required to update the information about the medications being put into circulation.

On January 1, 2018, each Georgia prescriber with a DEA number was required to be registered with the PDMP.  If you have not done so, please do so immediately at https://georgia.pmpaware.net/login.  Any new Georgia prescriber that obtains a DEA number must register with the PDMP within 30 days of obtaining said number.  Between January 1 and May 31 of 2018, random testing of the PDMP occurred to assure that it was accessible 99.5% of the time.  Data from this random testing has not yet been published.

Now the upcoming deadline:

Effective July 1, 2018, any person initially prescribing a schedule II opioid or any benzodiazepine shall seek a review of the patient’s PDMP information at the time of the initial prescription and then at least once every 90 days thereafter.  However, this requirement does not apply if the: 1) prescription is for no more than 3 days/26 pills; 2) the patient is an inpatient in a hospital, LTCF, hospice, personal care home, etc. and uses the medicine on premises; 3) patient had out-patient surgery and the prescription is for no more than 10 days/40 pills; 4) patient is terminally ill and in an outpatient hospice; or 5) if the patient is being treated for cancer.

If you are not exempt, then the check of the PDMP must be documented in the patient’s records.  There is not a requirement that the information be printed from the database and placed in the patient’s records, but that would seem to be easy proof if anyone came to ensure that the requirements were being met.  All prescribers of opioids are required to provide patients information about the risks of using opioids and their proper disposal as well.  A handout given to each patient with this required information would be easy to create, distribute and post in the office for patient education and to fulfil this requirement.

Any prescriber found violating these requirements will be held administratively liable to their professional licensing board.  That is the same licensing board that has the power to sanction, limit, suspend or revoke your professional license.

If you have any questions or would like more information, please contact Shaun Daugherty at [email protected].

Ordinarily, Is It Professional Negligence? Georgia Supreme Court Thinks So In $22 Million Reversal

Posted on: April 17th, 2018

By: Shaun Daugherty

The Georgia appellate courts have addressed the issues between claims of ordinary and professional negligence in medical malpractice cases for a number of years.  The standards for liability are distinctly different, but in certain factual scenarios there may be a fine line drawn between the two.  The Georgia Supreme Court made a clear distinction on the issue last month in reversing a $22 million dollar compensatory verdict awarded in Southeastern Pain Specialists v. Brown.  This was after the same verdict had been affirmed by the Court of Appeals that found no error in the trial court charging the jury on both ordinary and professional negligence.

The Georgia Supreme Court had some clear leanings regarding the quality of care that was provided in the underlying lawsuit according to the evidence presented at trial.  The case involved an epidural steroid injection procedure where a pulse oximeter and blood pressure cuff were placed on the patient for monitoring while she was administered anesthesia face down.  During the procedure, the evidence was that the pulse oximeter read 0% and the blood pressure cuff registered no reading for a significant amount of time.  The evidence was that the defendant doctor, with knowledge of the readings, continued the procedure insisting that everything was fine.  After the 18-minute procedure, the patient was repositioned on her back and did not recover as expected.  She was taken to the local ER for further care and the defendant doctor indicated to the medical personnel that the patient was having complications from the anesthesia.  He failed to provide any information regarding the intra-procedure pulse oximeter or blood pressure readings. The patient was found to have suffered brain damage and ultimately died from the same.

At trial, the court charged the jury on both ordinary negligence, over objection by the defense, and professional negligence.  The plaintiff argued that the ordinary negligence charge was warranted due to the obvious obligation to save someone if they are not breathing and the misrepresentations made by the defendant doctor to the other healthcare providers.  The court provided no guidance as to which facts and circumstances in the case may apply to which theory of negligence. Further, the plaintiff appears to have argued in closing that the ordinary negligence standard was to be applicable generally to the defendants.

The Georgia Supreme Court made it clear that even “a very strong case of medical malpractice does not become a case of ordinary negligence simply due to the egregiousness of the medical malpractice.”  It was recognized that medical providers could be held to the ordinary negligence standard under the right circumstances, but primarily only in those cases where there was no need to exercise medical judgment.  Multiple times in the Court’s reversing opinion, it was highlighted that the facts of the case involved medical data provided by medical equipment during a medical procedure and the proper response to the same.  It was found that this required the exercise of medical judgment.

In cases involving claims of medical malpractice, the defendant is provided a presumption of due care which must be overcome by expert testimony by the plaintiff.  In cases involving ordinary negligence, no such presumption is given.  The Court found that the Court of Appeals erred in finding that a lay person would not need expert testimony to understand the meaning of the data provided from the medical machines and the proper method of response during the medical procedure.  The “trust” of the plaintiff’s argument was that the defendant doctor failed to properly respond to the data that was being provided by the machines.  This was information that required expert judgment and decision making which was outside the scope of ordinary negligence.

The Court determined that providing the jury with an ordinary negligence instruction, without clarification as to which facts and claims it may apply, invited them to decide the medical liability outside the boundaries for claims of professional negligence.  Primarily the need for expert testimony to overcome the presumption of due care.  This was compounded by the plaintiff’s counsel’s arguments in closing which made no distinction and appeared to encourage the ordinary negligence standard to all claims.  The jury verdict in favor of the plaintiff was a general form and did not allow the Court to determine whether the verdict was based on the application of the appropriate standard.  Because it was error to provide the ordinary negligence charge without further clarification or instruction, the Court reversed and remanded the matter to the Court of Appeals with a direction to send it back to the trial court for a full retrial as to the appealing parties, including the issue of punitive damages to which the plaintiff had previously been awarded $0.

So what does this opinion tell us?  It tells us that ordinary and professional negligence claims can live in the same case, but it is essential that they be clearly defined for the jury.  The trial court’s vague instruction, coupled with the plaintiff’s counsel’s closing argument, invited the reversal in this instance.  As the Court indicated many times, medical data from medical machines during a medical procedure require the exercise of expert medical judgment in determining the proper response.  The failure of the trial court and attorney to set this apart from any ordinary duty of care in defendant’s communications to other medical providers was harmful error which required the retrial.

If you have any questions or would like more information, please contact Shaun Daugherty at [email protected].

Arbitration Clauses Are Only As Good As the Signatory’s Power to Bind, Obviously

Posted on: November 29th, 2017

By: Shaun Daugherty

A name is just a name when it was found on the signature line of an arbitration agreement between a Tift County Georgia nursing home and one of its residents. A U.S. District Judge in the Middle District of Georgia rejected the nursing home’s request to enforce the agreement and move the litigation to arbitration under the Federal Arbitration Act (“FAA”).  Why?  Because the daughter that signed the agreement did not have the power to do so on her mother’s behalf.

A negligence suit1 against the nursing home was filed in state court following the death of the plaintiff’s mother at the facility. The case was removed to federal court and the defendant moved to have the case dismissed and to compel arbitration pursuant to the arbitration agreement that was signed at the time of the admission of the decedent.  The defendant claimed that the FAA applied and preempted state laws that may say otherwise.

The court agreed that the agreement would have been enforceable under the FAA, that is, if it had been a valid agreement. However, in order to determine the validity of the agreement, the court looked to state law first.  Upon the admission of the mother to the nursing home, the daughter signed the admission paperwork that included the arbitration agreement.  Unfortunately for the nursing home, the daughter did not have power of attorney at the time.  In addition, there was no evidence that the mother had given implied authority to the agreement as she was apparently not aware of its existence and was not present when it was signed by the daughter.  These facts led the federal judge to determine that there was no valid or binding agreement between the mother and the facility and the pending litigation remains pending for a potential jury trial.

This could be a costly lesson for this particular facility and should be a valuable example for other long-term care facilities that have implemented arbitration agreements for this very purpose. It seems basic, but it bears repeating, make sure that a person signing an agreement, if not the resident, has the actual power to bind the resident.  Contract law dictates that an enforceable arbitration clause must be valid between the facility and the resident.  If the resident is not the signatory, put a copy of the power of attorney, or other rights-transferring legal document, in the resident’s file.  If there is no such document, get as much evidence of implied authority as possible and follow up often until you get something official in the file.  It could be the evidence that keeps your company out of a courtroom and in front of an arbitrator.

Plaintiffs would prefer to have the case before a jury where sympathy and emotion can be inflamed with strategic evidence presentation, including graphic photographs of the decedent. Indeed, the attorney for the plaintiff in this particular case is quoted as indicating that litigation often leads to fairer outcomes for his clients compared to arbitration.  Reading between the lines, that generally equates to larger jury verdicts versus arbitration awards.  He also indicated that state court allows for more “robust” discovery.  As those of us that have dealt with these cases know, that typically means extensive, expensive discovery requests by the plaintiffs’ counsel in hopes of obtaining some discovery sanction from the court for alleged failure to respond.  Arbitration can be much more focused and streamline the process.  Bottom line, attorneys for injured parties prefer a jury.

The moral of the story is if you want a valid agreement, you must get the right binding signature.

If you have any questions or would like more information, please contact Shaun Daugherty at [email protected].

 

1. [Davis v. GGNSC Administrative Services LLC, case number 7:17-cv-00107, in the U.S. District Court for the Middle District of Georgia.]

 

Medical Expert Witness Reports in California: When to Produce Them…and When Not To

Posted on: September 20th, 2017

By: Jon H. Tisdale

We are all familiar with the mandate that a defense medical examination report, the so-called “IME”, must be produced upon written request by the patient’s attorney. California law requires production 30 days after the demand (or 30 days after the examination, if demanded prior thereto). Basically, as soon as your expert doctor in any discipline of medicine lays a hand on the plaintiff, he or she must author a report of the examination within 30 days and you must produce if demanded (and they always demand it; it is in every form response to a demand for IME used by the entire plaintiff’s bar). You and your expert must also produce any previous reports created by or provided to the examining expert for review.

What is far less clear is whether you must produce reports containing that expert’s assessment and opinions that are separate and apart from the actual IME report. The custom and practice in California that has evolved over many decades is that medical experts prepare two reports: (1) a report of the examination itself (the IME Report) which contains the current complaints of the plaintiff, the examiner’s findings, results of tests conducted, diagnoses, prognoses and “conclusions” of the examiner, and (2) a report of the examiner’s review of all pertinent medical records, films, images and test results by plaintiff’s treating physicians, together with the examiner’s opinions and anticipated trial testimony regarding what injuries or conditions are accident-related versus those that may not be. It is this writer’s opinion that you may never be required to produce the latter report.

Once you have designated a retained expert, you are now obligated to produce him for an expert witness deposition at the request of the plaintiff’s attorney. Typically, the notice for such a deposition includes a demand to produce records at the deposition. Bear in mind that your obligation to produce the examination report is separate and distinct, and may not wait until your expert’s deposition is noticed. Further, prior to a formal demand for production of documents contained in the expert witness deposition notice, there is nothing in California case law or statute that requires you to produce anything else. More specifically, there is nothing in California law that requires you to produce a Medical Record Review.

At the time of the designation of experts before trial, California law allows plaintiff’s counsel to make a demand for simultaneous exchange of all discoverable reports and writings. When the expert’s deposition is noticed, California law requires production of all materials no later than three business days before the deposition. By implication, this also means discoverable materials, as the statute is clearly not intended to invade privilege or work product. So, the key question that lurks within the statute but is not squarely addressed is this: What constitutes a “discoverable” report, versus a non-discoverable report? The statutory framework is silent, so we must examine case law.

National Steel Products Co. v. Superior Court (1985) 164 Cal.App.3d 476 holds generally that not all work by an expert witness is properly the subject of discovery. The court found that the product of the expert’s services rendered in an advisory capacity was not removed from the protection of the attorney work product doctrine merely because the expert was retained.

Scotsman Mfg. Co. v. Superior Court (1966) 242 Cal.App.2d 527 took the work product protection a step further, stating: “ . . . the mere fact that the expert may have the dual status of a prospective witness and of advisor to the attorney, does not remove the product of his services rendered exclusively in an advisory capacity . . . from the work product limitation upon discovery”. The court goes on to state: “We hold that an expert’s report rendered in an advisory capacity is one designed to assist the attorney in such matters as . . . the manner of presentation of proof, and cross-examination of opposing expert witnesses; matters that are often reflective of the mental processes of the attorney under whose direction the expert works.”

To be sure, there is nothing that prevents opposing counsel from asking the expert in deposition what his opinions are and upon what facts and records the opinions are based. However, when a retained expert assists the attorney is assessing causation, apportionment to preexisting conditions or subsequent events at the specific request of the attorney who hired him, arguably the report which explains these tactical considerations at trial remains work product. Certainly, where an expert’s report reflects the attorney’s analysis of trial issues that must be addressed, it can properly be cloaked with work product protection. The worst case scenario is an in camera inspection of the report and redaction of protected portions. Rarely will it get that far. For example, Medical Record Reviews are not intended as trial exhibits. In 37 years of practice, I have introduced such a report into evidence exactly ZERO times. Why on earth would I want jurors behind closed doors reading that voluminous gibberish and speculating why something is in the report that was not testified to or why something isn’t in the report that was testified to? (That’s a rhetorical question . . . there is no reason to introduce the report and subject your expert to cross-examination on what is in or not in the report.)

In the case of non-examining doctors (i.e., neuroradiologists) and non-medical experts (i.e., biomechanical experts, accident reconstructionists, and engineers) the solution is much simpler. Advise them when you retain them that you do not want a report. All you really need is to know what their trial testimony will be.

Are you 100% protected if the other side learns of a Medical Record Review and you decline to produce it? No, it’s just not that clear. However, I think the best practice is to not share the report or even acknowledge that such a report exists. If the other side finds out that there was a written Medical Record Review, make them seek a court order that it is not work product. On the other hand, if the Medical Record Review only hurts the plaintiff’s case and only helps your defense, you can consider sharing it to gain advantage in negotiations at a Mediation. The only downside to sharing it is that if the case does not resolve, your expert will be cross-examined on the review and his expert opinions at trial may be limited to what is contained therein.

If you have any questions or would like more information, please contact Jon Tisdale at [email protected].

Informed Consent! What Is It Good For? Absolutely Nothing. Say It Again.

Posted on: August 4th, 2017

By: Shaun Daugherty

 

Ok. That may be a bit extreme. After all, it is in the American Medical Association’s Code of Medical Ethics and the concept is addressed in most medical professional organizations guidelines in one form or another. And let’s not forget that it is mandated by statute and common law in most states. So the bottom line is that it is seen universally as a good idea for a medical provider to obtain informed consent from a patient prior to providing therapy, care, or treatment. While the precise legal requirements differ from state to state, the gist is that a medical provider should provide sufficient information for a patient to make an informed decision as to whether to accept the treatment. Generally speaking, the patient should be informed of the diagnosis, the alternative treatment options, the likelihood of success, the major risk/complications associated, and the consequences of just doing nothing.   Fantastic. You have obtained informed consent from your patient. I ask again, what is it good for?

In the legal context, in most situations, if you do not obtain informed consent, a patient has a cause of action to sue a medical provider for lack of informed consent. The theory being that the patient was not given sufficient information to make an educated decision about their care, and if they had been told “X,” they never would have agreed to the procedure. The “X” is usually one of the risks/complications of the procedure that the patient experienced, unfortunately.

On the defense side of a malpractice action, the informed consent has very limited value unless there is actually a claim of lack of informed consent made by the patient. In that scenario, informed consent is a relevant and target point of contention with the written informed consent form front and center for the jury. Without the specific claim being alleged, many courts are ruling that the informed consent forms that are signed by the patients are inadmissible pieces of evidence and are redacted from the records. They are also ruling that informed consent cannot be discussed in any form or fashion unless for the purpose of impeachment. That is, if the patient denies knowing that a particular risk was possible.

The typical scenario is that a patient suffers one of the known risks or complications of a procedure, let’s say a nerve injury during parathyroid surgery, and then sues the provider for the injury that they suffered. The provider says that it is a known risk of the procedure and it was not caused by negligence. The informed consent form will typically have the specific risk listed as one of the possible complications of the procedure and the defense would like to show the form to the jury to say, “see, we told them this was a risk of the procedure.” The claimant wants to keep the issue of informed consent out of evidence because, as the courts have reasoned, they are afraid that the jury could be misled to believe that the patient consented to the injury itself instead of focusing on whether there was a deviation in the standard of care.

One of the practical problems from a defense standpoint is the juries’ expectations with regard to their own common experiences. That is, the average juror of a medical negligence case will be very familiar with informed consent forms and will often look for them in the records during deliberations to either confirm or refute whether something is or is not a known risk/complication. If it is absent from the records, this could become a problem for the defense as the juror may believe that informed consent was not obtained and become a reason to find fault, even though it was not an issue in the case. An otherwise non-existent burden of proof has been created for the defense to disprove an issue that was never part of the case. Defending a medical negligence case can be difficult enough without having to chase phantoms.

We will keep looking for the legal trends and implications to govern ourselves accordingly while medical providers need to keep getting written informed consent as often as possible. After all, informed consent is ultimately good for something, perhaps the most important thing, patient information and decision making.

If you have any questions or would like more information, please contact Shaun Daugherty at [email protected].