Florida Federal Court holds Patient Safety Act preempts Amendment 7 and protects Patient Safety Work Product

In Florida Health Sciences Center, Inc. d/b/a Tampa General Hospital v. Alex Azar, Secretary of the United States Department of Health and Human Service, case number 8:18-cv-238, Judge Moody of the United States District Court, Middle District of Florida, Tampa Division, recently held: (1) that 241 documents at issue in a state court action were protected by the patient safety work product; (2) the federal Patient Safety and Quality Improvement Act preempts Article X, section 25 of the Florida Constitution with respect to these 241 documents; and (3) the Secretary of the United States Department of Health and Human Services was enjoined from enforcing the Patient Safety Act in the state court action, which included enjoining the Secretary from imposing the mandatory penalty against the hospital. 

This case was filed in federal court in Tampa, Florida when Tampa General Hospital filed a declaratory judgment to enjoin the Secretary of the United States Department of Health and Human Services from imposing mandatory penalties pursuant to the federal Patient Safety and Quality Improvement Act of 2005, also known as the “Patient Safety Act.” 

For those who are not familiar with The Patient Safety Act, it was enacted to create a system wherein health care providers could voluntarily collect and report medical errors in an attempt to educate themselves on preventable medical errors.  The purpose was to improve the quality of medical care and patient safety. However, to encourage participating it was found it would be necessary that a legal protection of confidentiality was established to promote the free exchange of this information without fear of liability or legal retribution because this information would be shared across state lines. 

Or, as stated by the Department of Health and Human Services, “By establishing strong protections, providers may engage in more detailed discussions about the causes of adverse events without fear of liability from information and analyses generated from those discussions. Greater participation by health care providers will ultimately result in more opportunities to identify and address the causes of adverse events, thereby improving patient safety overall.” HHS, Agency for Healthcare Research and Quality Patient Safety Organization Program Frequently Asked Questions, https://pso.ahrq.gov/faq, accessed September 4, 2019.   

The Department of Health and Human Services also recognized there were potential burdens of maintaining duplicates systems for the federal government and the state governments.  In an effort to resolve this issue, it was decided that healthcare providers would collect all information in one Patient Safety Evaluation System (“PSES”) where the information would remain protected unless and until the healthcare provider determines it must be removed from the PSES for state reporting. As part of the Patient Safety Act, there shall be a civil monetary penalty of not more than $10,000 when a person discloses identifiable patient safety work product in a knowing and reckless violation of this Act.   

This federal case derived from a pending state court medical malpractice action between Lawrence Brawley, the plaintiff, and Tampa General Hospital, the defendant, wherein the plaintiff sought records though a request for production pursuant Amendment 7 seeking record related to “any adverse medical incident” concerning the plaintiff and other patients. Tampa General is a member of a Patient Safety Organization under the Patient Safety Act and there were 241 documents potentially responsive to the request for production.  Tampa General Hospital moved for a protective order, so it did not have to produce any documents in response to this request for production.  The state court judge denied the motion.  Accordingly, the Hospital appealed the state court's denial of its protective order and requested the state court judge stay the case and its ruling pending the state court appeal and the federal court case.  The state court judge denied this request and held Tampa General Hospital would be fined $100 per day until it produced the 241 documents responsive to the plaintiff's request for production.

It is important to understand that in Florida, Amendment 7 to the Florida Constitution provides “a right to have access to any record made or received in the course of business by a health care facility or provider relating to any adverse medical incident.”  Amendment 7 gives patients access to any adverse medical incident for any patient.  This contradicts the language of the Patient Safety Act.  This became a significant issue to the Hospital in the state court case because the Patient Safety provides for a civil monetary fine if identifiable patient safety work product documents and information are knowingly or recklessly disclosed.  The fine is not more than $10,000 for each act constituting a violation.  Arguably, disclosure of 241 documents protected by the patient safety work product would amount to 241 separate acts equating to a possible fine of $2.41 million.

This case is significant because Judge Moody held “there is no dispute in this action about whether The Patient Safety Act expressly preempts Amendment 7” when the documents are submitted to a patient safety organization.  It would appear, based on this ruling, that Tampa General Hospital should have the state court's denial of its motion for protective order reversed and remanded with instructions to enter an order granting it.  However, this is a federal court's interpretation and application of the Patient Safety Act, and the appeal on the motion for protective order is pending before the Florida Second District Court of Appeal.  Hence, the argument is the federal court ruling is only persuasive authority and not binding.

If the Florida Second District Court of Appeal makes the same finding as the federal court did, then this will provide a beneficial protection to hospitals who are members of patient safety organizations and are submitting documents to them.  It will be imperative for any practitioner representing hospitals in Florida to keep an eye on the state court developments in this case.  The attorneys at Andrews, Crabtree, Knox & Longfellow are keeping an eye on cases like this one, so it can continue to protect the interests and rights of its clients.

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Requirements for Physicians to Order Cannabis for Patients in Florida

The ever-changing regulatory landscape in the world of medical marijuana treatment makes it difficult to navigate.  Most patients, providers, and lawyers don't quite get it.  Misunderstanding the law can result in patient and provider arrest, revocation of professional license, and civil litigation.  This author prosecuted the first case of its kind in Florida, resulting in permanent revocation of a Florida physician's license for violating Florida cannabis laws.  Understanding the state of the law is critical.  A brief history follows.

Since the enactment of The Controlled Substance Act of 1970, cannabis has been illegal in the United States.  Under Federal law, cannabis is classified as a schedule I controlled substance, which means it has no accepted medical use and has a high potential for abuse. Many states have made cannabis readily available, but that doesn't change the status of the Federal laws. Today, cannabis remains illegal under Federal law, which means though cannabis is available in Florida, it is still illegal to cultivate, possess, distribute, or consume in any of the United States.

In a landmark decision in 1991 in Florida First District Court of Appeal, a Florida court first recognized “medical necessity” as an affirmative defense to marijuana cultivation charges.  SeeJenks v. State, 582 So. 2d 676 (Fla.1stDCA 1991). Contrary to the understanding of many lawyers and doctors, this decision did not authorize a patient to cultivate, possess, distribute, or consume cannabis out of medical necessity.  Rather, a person would be arrested for these offenses but could later raise medical necessity as an affirmative defense to the crime.

In 2014, the Florida legislature acknowledged medical value in low-THC cannabis by passing the Compassionate Medical Cannabis Act.  This Act authorized qualified physicians to order low-tetrahyrdocannabinol (“THC”) cannabis for qualified patients.  THC is the psychoactive chemical component in cannabis. The legislature instructed the Florida Department of Health to create the Office of Compassionate Use to regulate the cultivation, distribution, and consumption of low-THC cannabis.

Just two years later, in a 2016 constitutional amendment, Florida voters made clear their desire for full-potency cannabis in the medical industry. The constitutional amendment passed with a popular vote of 71%.  In response, the legislature enacted § 381.986, Florida Statutes, directing the Department of Health to promulgate rules governing cultivation, possession, distribution, and consumption of cannabis.

In addition to registering as an ordering physician with the Department of Health, § 381.986, Florida Statutes, requires a physician to conduct an in-person physical examination of the patient.  This means a physician cannot order cannabis for a patient after merely examining a patient via telemedicine.  Additionally, the statute requires physicians to:

Initially, regulators prohibited cannabis in traditional smokable forms, but in recent litigation, this prohibition was deemed unconstitutional. Consequently, now a physician may order smokable cannabis for a patient, but only if the physician notifies the board of a list of other routes of administration tried by the patient, the length of time tried, and an assessment of the effectiveness of those routes of administration.  The physician must then submit research to the applicable board; document the effectiveness of smoking as a route of administration to treat similarly situated patients with the same condition, and provide a statement that in the physician's opinions, the benefits of smokable cannabis outweigh the risks.  A patient must also be over the age of 18 for a physician to order smokable cannabis, unless the patient is terminally ill. In that case, additional legal requirements apply to physicians.

This is not intended to be legal advice, or an exhaustive list of regulations placed on ordering physicians in Florida, but rather, a summary of the change in the laws and some of the current requirements placed on ordering physicians.  The attorneys at Andrews, Crabtree, Knox & Longfellow are prepared to advise physicians on compliance and enforcement matters related to ordering cannabis for their patients in Florida.

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Why doesn't this Joint PFS state the amount and terms attributable to each party?

Proposals for settlement are quagmires muddled with landmines all over.  If used properly, a proposal of settlement can be another strategic tool in your litigation tool belt to effectively resolve a difficult case or posture a case for settlement when it otherwise would not settle.  If you are recommending or preparing a proposal of settlement or “PFS”, you should always review Rule 1.442, Florida Rules of Civil Procedure, and § 768.79, Florida Statutes, prior drafting it as well as check out either Westlaw or LexisNexis for the latest case law discussing this issue. 

Paragraph (c) of Rule 1.442, Florida Rules of Civil Procedure, and paragraph (2) of § 768.79, Florida Statutes, provide the form and content for a proposal for settlement.  It is imperative your proposal follows these rules and guidelines.  Otherwise, you are likely not going to have an effective or valid proposal for settlement, and your opposing counsel and party will not be concerned about the attorney's fee and costs provisions being enforced—i.e., this means you just lost an opportunity to use one of your litigation tools. 

Rule 1.442(c)(3), Florida Rules of Civil Procedure, states “A proposal may be made by or to any party or parties and by or to any combination of parties properly identified in the proposal.  A joint proposal shall state the amount and terms attributable to each party.”  However, the next paragraph in this Rule changes the requirements for joint proposals “when a party is alleged to be solely vicariously, constructively, derivatively, or technically liable.”

Rule 1.442(c)(4), Florida Rules of Civil Procedure, reads “Notwithstanding subdivision (c)(3), when a party is alleged to be solely vicariously, constructively, derivatively, or technically liable, whether by operation of law or by contract, a joint proposal made by or served on such a party need not state the apportionment or contribution as to that party.  Acceptance by any party shall be without prejudice to rights of contribution or indemnity.” 

Hence, a joint PFS in an automobile case by a defendant, on behalf of both defendants where one of the defendants is just vicariously liable due to ownership or title to the vehicle, does not need to apportion out the amount being offered to the plaintiff by each defendant. Instead, it can just state one amount and include a requirement that if accepted, then both defendants must be dismissed with prejudice. 

This is just one of the many quagmires found within the rules governing proposals for settlement.  There are many others depending on the facts of the case, the case strategy, and the ever changing law in this area.  It is important to speak to someone who understands these issues and is in a position to advise you through the potential landmines.  Again, a proper proposal for settlement can be an effective tool in resolving your case and posturing it for resolution that could save you thousands of dollars, if not more, in attorney's fees, costs and settlement amounts.  The attorneys at Andrews, Crabtree, Knox & Longfellow are prepared and willing and able to assist you in this area.  FRCP 1.442(c)(4).

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Joe Longfellow argues before the Eleventh Circuit Court of Appeal in Montgomery, Alabama

On August 20, 2019, Joe Longfellow went before a panel of 3 judges of the Eleventh Circuit Court of Appeal to argue in favor of affirming the district court's holding that an officer was entitled to qualified immunity and summary judgment on a false arrest claim brought pursuant to 42 U.S.C. § 1983.  

Joe Longfellow argued to the panel there was no constitutional violation with the officer arresting the Appellant and entering the home to effectuate the arrest based on exigent circumstances.  He further argued the law was not clearly established as to whether exigent circumstances were even needed based on the language of Fla. Stat. § 901.15.  Accordingly, it would be reasonable for an officer to believe he had a right to enter a home without a warrant as long as the suspect committed either a felony or misdemeanor in the officer's presence and either immediately or in fresh pursuit went to arrest the suspect.  

This appeal derives from a claim wherein excessive force was also claimed, tried and resulted in a defense verdict.  

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Is a government agency considered a “Person” under 42 U.S.C. §1983?

Contrary to the outcome of most legal research assignments, a few minutes digging provided a bright-line answer to the topic for discussion.  However, the answer is perplexing even amongst practitioners wholly devoted to practicing employment law.

The short answer is the state, its agencies, and its actors in their official capacity are not a “Person” under 42 U.S.C. § 1983, while municipalities and their actors in any capacity and state actors in their individual capacity are considered a “Person.” 

Most employment attorneys will balk at this contention; I know I did.  We've all read articles and cases about a Plaintiff pursuing cases and recovering against law enforcement agencies and individual officers on excessive force theories brought under 42 U.S.C. § 1983.  A logical question follows: If sheriff and police departments and their deputies and officers are an arm of the government who can be sued under 42 U.S.C. § 1983 claims, then why can't the state, its agencies and its actors such as law enforcement officers be sued?  It would seem that if the local sheriff's office is a “Person” under 42 U.S.C. 1983, then the state agency should also be considered a “Person.”  The Supreme Court cleared this addressed this issue back in the late seventies and eighties.

In order to state a prima facie claim for deprivation of civil rights under 42 U.S.C. § 1983, a Plaintiff must show: (1) he/she was deprived of a right secured by the Constitution and laws of the United States, and (2) the persondepriving the plaintiff of that right acted “under color of state law.” See42 U.S.C. § 1983.

In Monell v. Department of Social Services, 436 U.S. 658 (1978), the United States Supreme Court held “a local government is a ‘person' that can be sued under [42 U.S.C. § 1983].”  However, a decade later, the Court made it clear states are not “persons” who can be sued under § 1983. See Will v. Michigan Dep't of State Police, 491 U.S. 58, 58 (1989).

How do we rectify the Court's holdings between these two cases?  Why is a local government subject to suit under 42 U.S.C. § 1983, but a state government isn't?  There must be a logical reason to explain the Court's holding.  Could it be based on sovereign immunity under the 11thAmendment of the United States Constitution? 

The 11thAmendment provides a state enjoys sovereign immunity from lawsuits in federal court.  The 11thAmendment does not extend to municipalities.  Thus, it seems to logically follow a state can't be sued under 42 U.S.C. § 1983, but a municipality can because states enjoy sovereign immunity whereas municipalities do not.  However, this was not the Court's reasoning for its decision in Will

It's easy to get distracted by 11th Amendment sovereign immunity here.  To be clear, sovereign immunity under the 11thAmendment means states can't be sued in federal court without their consent.  Sovereign immunity does not mean states can't be sued in state court under federal causes of action without their consent.  So then why can't a state be sued in state court under 42 U.S.C. § 1983? 

The Court's distinction in Willis not drawn solely because states enjoy sovereign immunity under the 11thAmendment, but rather because a state is not a “person.”  It is true the Court considered sovereign immunity as the dominant factor in its analysis of whether the state is a person.  However, the Court in Willfocused on the plain language and legislative history behind 42 U.S.C. § 1983 in determining congress simply did not intend to abrogate the states' sovereign immunity in its enactment of 42 U.S.C. § 1983 or it would have expressly said so.  Accordingly, the word person in 42 U.S.C. § 1983 does not include states.

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Increases to Jurisdictional Amounts Coming to Florida Courts January 1, 2020

 

During the Florida 2019 legislative session, changes were made to the jurisdictional amounts for matters in controversy applicable to both county and circuit courts in Florida state courts.  On May 27, 2019, Governor DeSantis signed H.B./S.B. 337 into law but its effects won't be felt until January 1, 2020.   

Currently, the county court has exclusive jurisdiction of all actions at law, except those within the exclusive jurisdiction of the circuit courts, in which the matter in controversy does not exceed the sum of $15,000.00.  Effective January 1, 2020 the sum will be increased to $30,000.00 for county court on all matters filed on or after January 1, 2020. However, this is not the end of the jurisdictional amounts in controversy changing.  On January 1, 2023, the sum will increase again to $50,000.00. 

So, what does this mean?  Simply put, as of January 1, 2020, unless the circuit court has exclusive jurisdiction of a matter, the damages alleged in Complaints or admitted to in discovery will have to be more than $30,000.00 for the circuit courts in Florida to have jurisdiction.  If not, then the county court will have jurisdiction.  Similarly, on January 1, 2023, the damages alleged in Complaints or admitted to in discovery will have to be more than $50,000.00 for the circuit courts in Florida to have jurisdiction.  This will require your attorney to appreciate the effect of these changes and understand the importance in defending your case in both the pleading and discovery phases of your case. 

These details will ultimately determine which court has jurisdiction and who your judge will be in your case.  Equally important, it could be a basis to move to dismiss or event limit the damages before the case even begins to move forward. 

The hiring of an attorney is an important decision.  You need an attorney who is up to date on the current laws and rules of the courts and paying attention to these types of details when representing you in the state courts of Florida.  The attorneys at Andrews, Crabtree, Knox & Longfellow, LLP are prepared to represent you in your case.

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Know the Process--Getting a Notice from DOH

Health professions and their respective licenses are regulated under Chapter 456, Florida Statutes, individual practice acts, and rules promulgated by the Florida Department of Health (“Department”) and its regulatory boards.  The web of laws and rules that governs healthcare practitioners and the way they interact is complex and changes frequently in response to medical industry advances.

If you find your license under investigation by the Department, it's imperative that you hire an attorney at your earliest opportunity who understands the law and the disciplinary process and is respected amongst decision makers who will review the allegations against you and determine the fate of your license.

First, you will receive a notification letter informing you that you are being investigated and requesting a response within 20 days (45 days for medical doctors).  An investigator will then contact you and request an interview. 

Unfortunately, interviews are often performed by investigators who lack healthcare backgrounds and may not fully appreciate the complex medical issues or explanation you have given.  The investigator then attempts to summarize your interview for the prosecutor's review.  In the interview summary, the investigator controls how much of what you had to say and the tone of your explanation.  Mischaracterizations and misunderstandings are common and frequently passed on to the prosecutor's as direct quotes from you.  For these reasons, rarely, if ever, do we advise our clients to submit to an interview. 

However, getting your version of the events to the prosecutor is critical to avoiding disciplinary action.  It is often best to control the narrative the prosecutor's will review by offering your explanation in writing through an attorney who has reviewed hundreds of practitioner explanations and knows what the decision makers value and what they don't.

 A writing through an attorney that is well thought out with supporting facts, medical literature, and/or expert opinion for consideration can be of great assistance in presenting your side early and persuasively to convince the Department that no formal action should be taken against your license.  

After the investigation is complete, your case is sent to the Department's Prosecution Services Unit in Tallahassee and a prosecutor makes a recommendation to a probable cause panel of the Board or Department to dismiss or prosecute the case.  The probable cause panel members are a group of your peers who will only be permitted to review written documents in the file to determine whether your license should be disciplined.  This is a confidential proceeding and you are not permitted to attend or otherwise provide your version of the events.

If the prosecutor makes a recommendation to file formal charges against your license, you have a statutory right to review the Department's entire investigative file prior to consideration by the probable cause panel. This includes medical opinions from the Department's experts which may incorrectly opine that you have committed malpractice or other wrongdoing, all confidential patient records the Department has gathered during the investigation, as well as the investigator's summaries and any other evidence the Department intends to use against you. Getting your hands on these documents to review their accuracy and submit a response is vital to protecting your license.

If formal charges are filed, you will be served with an Administrative Complaint and you will have 21 days to respond with an Election of Rights.  Failure to timely respond results in a waiver of your rights to challenge the allegations. Your peers will accept the allegations as true and will impose discipline based on the Department's allegations and file.

If you respond timely, you are permitted to challenge the Department's allegations before an Administrative Law Judge (a neutral third party) who will make a decision and recommend dismissal or punishment.  The judge's decision will be sent back to the Board or Department for final approval.

Once the Board or Department makes a final decision, you can appeal that decision to the First District Court of Appeal in Tallahassee.

Protect yourself and the license you worked hard to obtain by hiring Andrews, Crabtree, Knox & Longfellow to represent you immediately. Our team of attorneys have nearly four decades of experience defending healthcare licensees.  We have even recently added a former Department prosecuting attorney to our team. We are respected amongst the decision makers who routinely review these cases and we are located in Tallahassee, where the Department's prosecutor's offices are located, allowing us to spare our clients time and expense and putting our firm in an excellent position to represent you.

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Andrews, Crabtree, Knox & Longfellow, LLP welcome Ross Vickers to the Firm

Ross Vickers joins the firm after serving several years as Assistant General Counsel with the Florida Department of Health and the Florida Department of Business and Professional Regulations.  He is an associate practicing in the areas of employment, commercial and tort litigation, insurance defense, education law, and administrative law.  His practice focuses on defending claims brought under Title VII, the ADA, ADEA and FMLA, Florida Civil Rights Act, Florida's Public Whistleblower Act, and various contract, general liability and other tort matters.  Ross has represented and advised corporations and employers on a variety of employment law related matters.  Ross also advises public post-secondary institutions on a wide range of matters unique to the college education setting.  Ross is experienced in appearing before administrative judges and boards throughout Florida.  He has handled numerous matters before various licensing boards in the state of Florida, and is well equipped to address a variety of licensure issues that may arise.

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