July/August 2009

Ever-changing nurse practice acts, and scope

© 2009 The Medical-Legal News

By Frances W. Sills, RN, MSN, ARNP

As nurses and professional healthcare providers, we are subject to the laws and regulations established by the board of nursing and nurse practice act in the state or province in which we work. more…

Intubation: Immobilized and helpless — patient suffering an aspect of damages

© 2009 The Medical-Legal News

By Patricia Iyer, MSN, RN, LNCC

ESSAY

Critically ill patients are frequently intubated and attached to ventilators. Intubation is a lesson in helplessness, and constitutes an element of damages in personal injury and medical malpractice cases. more…

Verdicts & Settlements

Compiled from www.verdictslaska.com; Comments by Rose Clifford, RN, LNCC, editor

DRUGS

• Defense verdict. The plaintiff had a long history of mental illness, including panic attacks, suicide attempts and depression. In January 2000 the plaintiff was prescribed Adderall, which is made by the defendant. More…

Court: A nurse doing code comparisons in a billing fraud case passes Daubert

By Rose Clifford, editor

© 2009 The Medical-Legal News

• The Gist: As coding and billing fraud cases become more common, attorneys and consultants must remember that their methodologies may have to pass Daubert or other state rules about admitting witnesses. Here, the comparison of treatments to codes was not a medical judgment issue between nurses and doctors. And because coding methodology was reliable, it was admissible.
— RC

In a Medicare billing fraud case, the defendant billing company tried to disqualify an experienced nurse and nurse consultant, Edith M. Sposato, who was offered as a coding expert and who would be testifying that the defendants’ codes would not match the medical treatments paid for by the government. More…

Medicaid Integrity Program efforts are coming on stronger: More audits likely

By Rose Clifford, editor

© 2009 The Medical-Legal News

Medicaid Program Integrity (MPI) efforts and audits have not received as much attention as other Centers for Medicare and Medicaid Services (CMS) program integrity initiatives such as the Recovery Audit Contractor reviews (RACs), Medicare Administrative Contractors conversions, the new quality related contracts or revised scope of work statements, or the “One PI” initiative.
Enacted as part of the Deficit Reduction Act of 2005 (DRA) and currently in the third of an initial five-year project time frame, the MIP, the multiple components of the Medicaid Integrity Group (MIG), Medicaid Integrity Institute and the associated Medicaid Integrity Contractors (Thomson Reuters, AdvanceMed, Booz Allen Hamilton and HMS) and their reviews are starting to increase momentum and have an impact in multiple states.
The DRA requires CMS to hire contractors to conduct the following activities to counter fraud and abuse:
1) Review Medicaid providers’ actions to determine if fraud or abuse has occurred;
2) Audit claims for services;
3) Identify overpayments; and
4) Educate providers, beneficiaries and others with respect to payment integrity and quality of care issues.
Audit issues that have already been identified for review include, but are not limited to, services after date of death, duplicate claims, code definitions and short day admissions.
Physicians, pharmacies and providers will be most burdened in their efforts to research and defend themselves against the alleged potential overpayments within the defined time frame.
All Medicaid providers should be aware of the audit contractor reviewing their state.
Attorneys and clients will benefit and quickly glean important insight from professionals who are intimate with the program and have been following the MIG initiative for the last several years. •

Nurses on causation in bed sore cases: Another court opens the possibility

By Rose Clifford, editor

© 2009 The Medical-Legal News

• The Gist: This newspaper has reported on nurse causation testimony in bed sore cases before, most notably in Gaines v. Comanche County from Oklahoma.
On a more clinical level, note that this case follows the golden rule that “if it was not documented, it was not done” with respect to whether the nurses turned the plaintiff every two hours as required.
— RC

Another bed sore case has found some favor in the permitting of nurses to testify to causation for pressure ulcers. More…

Should records review go offshore?

By Rose Clifford, RN, LNCC, editor

© 2009 The Medical-Legal News

OPINION

Something of a scuttlebutt has arisen in the medical records review community about sending work to other countries. As with many other professional services, from telemarketing to medical tourism, the possibility of getting cheap medical record reviews from foreign countries looms large. One records review firm contacted us, and, as a test, we sent some closed-case records to be put in chronological order.
The work was well done, and cheap.
But, after some careful review, we have decided not to engage the use of foreign, in this case Indian, records reviewers.
Why?
First, our biggest concern is with identity theft. (And for our experiment, we redacted all social security numbers, birth dates and addresses from the records.) The foreign company we used claims to have great security, firewall protection, and such. But we are skeptical that identity theft will occur only by hackers or a “corporate” entity. What about the foreign rank-and-file workers who do data entry and see the records? Anyone could remember at least one birth date, name and social security number each day and walk out of the office armed with marketable info for the black market. This is to say nothing of cell phones, cameras and other devices. And if a breach occurs, who’s liable? Even a U.S.-based company may be simply a marketing company, with layers of corporate and international protection all the way back to the ground level employee in a foreign land.
Second, will these firms go the next step and do merit reviews? Do they have nurses or doctors who know American clinical standards? Knowing how to be a great consultant is more than textbook learning, as it is based on real world experience and networking.
Third, will these firms provide nurses or attorneys who know the law, and who can ferret out breaches in standards? Will they know how to determine which records are missing, or other avenues of liability or defense to explore?
Also, will courts accept affidavits from these reviewers, and if so, would an attorney then have to ask an American consultant to step into the shoes, as a fact or expert witness, and grab the baton from the foreign consultant? This would seem insulting, I would think.
And what of ongoing professional relationships? Hopefully this means something.
Would there be a backlash against foreign reviewers, not unlike the griping that U.S. customers sometimes have against foreign-based technical support or sales calls?
Many questions are unanswered here.
Even if foreign reviewers are much cheaper, the savings don’t seem worth the risks, on balance, to high-dollar cases or to the identity risks of the patients. •

The legal electronic health record and e-discovery: a gray area not easily traversed

By Rose Clifford, editor

© 2009 The Medical-Legal News

The Issue
Defining the legal health record used to be straightforward: Medical records were legal business records that varied based upon practice setting and were maintained according to legal principles defined in federal and state laws, regulations such as the Medicare conditions of participation, accreditation standards, payer requirements and various applicable professional practice standards. More…

Hot topics in the legal arena: Borrowing meds from one patient to give to another

By Rolando Morales, RPh

© 2009 The Medical-Legal News

What are the legal ramifications in borrowing patient medications for another patient’s use?
This practice is not an acceptable standard of care in any setting, and bypasses the checks and balances provided by the pharmacy.
Use for another patient constitutes fraud, as the medications have been charged to the patient for which it was prescribed and must be credited back to that same patient.
Governing bodies such as the Joint Commission set standards prohibiting such practice, and facilities tolerating such behavior risk losing their license, and fines.
Never engage in such practice. Follow your facility’s policies on medication administration.

Sound-alikes
A recent medication error headline involved a verbal order for ephedrine that was mistakenly heard as epinephrine. It involved a 57-year-old woman who became hypotensive and nauseated following excision of a neuroma on her foot.
Not only do the medications sound alike, both are vasoconstrictors and vasopressors that are stored in alphabetical proximity in similarly sized vials.
To help differentiate between these two medications, “tall-man” letters should be used to label the storage containers. (ePHEDrine and EPINEPHrine).
Verbal orders should not be taken unless it is an emergency, and an order should be concurrently written in the patient’s chart and always read back and verified with the prescriber, spelling the medication name.

PCA pump math
Although it is crucial to program PCA pumps accurately, setting a PCA pump at a higher concentration than the actual drug does not necessarily result in an overdose, and setting it at a lower concentration than the actual drug does not result in an underdose.
The concentration of PCA medication and volume are inversely proportional, so a more concentrated drug requires a smaller volume to be delivered than a lesser concentrated drug. For example, to get 1mg of morphine from a standard premixed 1mg/ml syringe requires 1ml of solution.
If it were prepared in a lower concentration, such as 0.1mg/ml, it would require 10ml of solution to deliver 1mg.
When programming the actual dose, care should be taken to correctly enter the drug concentration so the pump can accurately calculate the exact volume needed to safely and effectively relieve the patient’s pain. •

Rolando Morales, RPh, is a pharmacist consultant with DisceRNment, LLC. He and his wife, a legal nurse consultant, are based in Ellijay, Ga.; (706) 636 5276, www.DisceRNment.Biz.

Pennsylvania Supreme Court says yes to nurse experts on causation in bed sore cases, but statute says no

© 2009 The Medical-Legal News

• The nurses-testifying-to-medical-causation debate took a turn in Pennsylvania recently, with nurses winning in court in a Freed case, but they are probably shut out via a more recent state law aimed directly at keeping them from testifying.
The case was reported by The Legal Intelligencer on June 17.
According to the article, the Pennsylvania Supreme Court in 1994’s Miller v. Brass Rail Tavern case took a “liberal” approach to permitting non-doctors as expert medical witnesses. The case concerned a medical examiner and a patient’s time of death. The court in Miller said that a person need only “possess greater expertise than is within the ordinary range of training, knowledge, intelligence or experience” to qualify as an expert witness.
In 1997’s Flanagan v. Labe, the court tightened its liberal stance and said that the state’s Professional Nursing Law forbade nurses from testifying.
According to the article, in the most recent Freed v. Geisinger Medical Center and Healthsouth Corp. case from June, the court said the PNL only applied to “the practice of nursing,” not activities outside of nursing, such as testifying.
Thus, the supreme court went from being liberal, to tough and back to liberal with regard to permitting nurses to testify as medical expert witnesses.
The Freed court reasoned that if a completely non-medical person, or even an unlicensed nurse, could be admitted as an expert under Pennsylvania’s Rule 702, then to not allow a registered nurse would be “incongruous.” The Freed case was about bedsores, and the high court said nurses could testify to both procedures and causation.
However, Pennsylvania’s new MCARE Act from 2002 specifically bars anyone but a doctor from testifying against a doctor in liability cases, so Freed is a short-lived victory for nurses testifying in doctor-based negligence, according to the story. Ironically though, the act does not appear to prevent nurses from testifying in other professional liability suits, such as actions against non-doctor healthcare providers or criminal cases. •

Editor’s note: In the last issue I wrote a column that discussed the problems that can occur when a state seeks to statutorily be the “gatekeeper” for expert witnesses. The column basically concluded that the nuances of expert witness admission are complex and hard to codify. The column is on our web site. — R.C.

Obama issues memo on preemption regulations 

© 2009 The Medical-Legal News

WASHINGTON, May 20 (UPI) — Federal departments and agencies announcing regulations that preempt state laws will not do so without a sufficient legal basis, U.S. President Barack Obama has said.
Obama has thus reversed many of the policies of former President Bush in the area of preemption.
In a memorandum distributed to the heads of executive departments and agencies in mid-May, Obama said, “(The) general policy of my administration (is) that preemption of state law by executive departments and agencies should be undertaken only with full consideration of the legitimate prerogatives of the states and with a sufficient legal basis for preemption.”
Obama said federal officials need to remember that state residents have distinctive circumstances and values and that it is appropriate, in many instances, for states to apply rules and principles that reflect the circumstances and values.
During recent years, however, executive departments and agencies have sometimes announced that their regulations preempt state law, including state common law, without explicit permission for preemption by Congress or an otherwise sufficient basis under applicable legal principles.
The Supreme Court’s recent Wyeth v. Levine case was of a similar anti-preemption tenor to the Obama policy reversal.
Among other things, Obama said heads of departments and agencies should not include in regulatory preambles any statement that the department or agency intends to preempt state law or regulations, except where preemption provisions are included in the codified laws.
According to The Boston Globe, during the Bush administration, more than 50 federal regulations were proposed or adopted that included language to limit state lawsuits.
The Globe also reported that Les Weisbrod, president of the American Association for Justice, a national trial lawyers group, said that the Obama administration has “overturned actions taken by Bush administration bureaucrats who were influenced by powerful, well-connected corporations.”
The paper also noted that consumer groups were happy with the recent preemption reversals. •

Uncle Sam gets tough on billing and coding fraud

© 2009 The Medical-Legal News

In mid-May President Obama signed the Fraud Enforcement and Recovery Act, which beefs up the False Claims Act that permits whistleblower suits, according to Modern Healthcare of May 25. FERA will greatly expand who can be charged with fraud, thus overturning the Allison Engine case, and fix statute of limitations problems.
A new task force has been created to “focus on tracking and sharing… data to more efficiently identify fraudulant billing….,” according to the article.
The Obama administration is boosting, by 50%, the amount of money dedicated to Medicare and Medicaid integity efforts, or $311 million. The article said this money will recoup $2.7 billion in provider overpayments over the next five years.
In short, the U.S. is making fraudulent claims a priority, and healthcare organizations could see more FCA suits, which will impact attorneys and consultants. •

Suits: Pediatric psychiatric drugs are “chemical restraints,” or overused

© 2009 The Medical-Legal News

A woman is claiming a South Florida doctor and now-closed group home overmedicated her autistic son and caused his death with chemical restraints, according to The Miami Herald of May 20.
An autopsy showed the son died of serotonin syndrome, a condition where the brain makes too much serotonin as a result of medications.
Martha Quesada, the mother of 12-year-old Denis Maltez, filed a wrongful death suit and a medical malpractice lawsuit against psychiatrist Steven L. Kaplan and the Rainbow Ranch group home.
The suit alleges the “drug cocktail” at issue was composed of Seroquel and Zyprexa (anti-psychotics), Depakote, an anti-seizure and mood drug, and Clonazepam, a tranquilizer.
In a similar case also reported in The Herald on June 4, a Tamarac, Fla., woman, Norma Tringali, has sued Fort Lauderdale Hospital and a psychiatrist, Dr. Sohail Punjwani, who worked there, claiming both overmedicated her 16-year-old son with a cocktail of mental health drugs, some of which have not been approved for the treatment of children.
The son, Emilio Villamar, was diagnosed with bipolar disorder by Punjwani in 2002.
According to the article, the teen was given 16 different drugs, some of which he was still being given when he died from a heart attack.
Ringali is represented by Michael S. Freedland.
The child was under the care of the Florida Department of Children and Families. DCF is investigating and says 3,068 children in the DCF’s care (about 13% of the total) were taking mind-altering drugs.
According to The Herald, experts point out that parents often give informed consent regarding the care given a child when a child is removed from a home, but that parents are largely unaware of what they have signed. •

Ashcroft v. Iqbal may heighten pleading requirements in civil suits

© 2009 The Medical-Legal News

Defense attorneys are likely aglow after the U.S. Supreme Court’s recent ruling in the Ashcroft v. Iqbal case. The case could have ramifications for how pleadings are drafted in all civil suits, according to a law.com article of May 20.
According to the article, Iqbal has expanded on the Court’s heightened factual requirements for a plaintiff which were first put forth in Bell Atlantic v. Twombly (2007). There, the bar was raised on the amount of detail needed under Rule 8 to draft a complaint that can survive the defense side’s motion to dismiss.
Some experts see the Court’s move as further chipping away at the liberal, plaintiff-friendly approach to pleadings that has prevailed for decades, according to the article.
Rule 8, which governs pleadings drafting, was for a long time interpreted under 1957’s Conley v. Gibson case, which said that “fair notice” of what the plaintiff’s claim is and the grounds upon which it rests is enough, according to Chase Law School professor Davida Isaacs.
Conley said of sufficiency: “A complaint should not be dismissed unless it appears beyond doubt that the plaintiff can prove no set of facts in support of his claims which would entitle him to relief.”
Later, a shift: The Supreme Court’s Twombly antitrust case ruling of 2007 resulted in the creation of more pre-trial work for the plaintiff side. The case required that a plaintiff must allege facts “plausibly” suggesting the existence of an action. Pros and cons to Twombly are argued. Presumably, more facts must be known pre-trial, which could be hard to discern without the power of discovery that occurs once a suit is underway. Conversely, a greater factual burden on the plaintiff arguably would reduce fishing expeditions and onerous discovery burdens on a defendant.
According to Isaacs, under Twombly, a complaint had to contain facts to support the elements of the claim — simply alleging the elements of the claim, without facts to support it, was no longer enough.
Shortly after Twombly, the Court was more lenient with a pro se (represents oneself) prisoner plaintiff in Erickson v. Pardus, so it was unclear if Twombly applied outside of business litigation.
Now, in Iqbal, Twombly has clearly expanded outside of business litigation, according to the law.com article. In Iqbal, the plaintiff said in his pleading that Ashcroft was the “principal architect” of the policies at issue. Justice Kennedy said this statement was “conclusory and not assumed to be true.” •

Court: Caution advised if billing paralegal work as nurse consultant work; Here, nurse consultants $150; paralegals $85; lawyers $340

By Rose Clifford, editor

© 2009 The Medical-Legal News

• The Gist: This case gives an interesting peek into what courts consider reasonable fees, and the importance of accurate billing.
— RC

Be careful how you bill, and document. A nurse consultant doing “paralegal” work may come up short.
In a court-cost recovery case, where a mother was seeking reimbursement from the government for her costs associated with a claim under the National Childhood Vaccine Injury Act, the court took issue with a nurse consultant doing too much work (and thus billing more money) that otherwise was paralegal in nature. More…

Writing articles for publicity

By Pat Bemis

© 2009 The Medical-Legal News

Most legal nurse consultants (LNCs) know that writing and publishing articles in trade magazines will bring attention to their firm.
However, they don’t think they can write. They wish they could write. They want to be published, but they don’t believe they can. I believe each LNC has at least one story inside him or herself. Most can tell the story to another nurse. If you write in conversation style, you can also write your story. More…

Home health providers indicted for kickbacks from alleged marketing scheme

By Elizabeth E. Hogue, Esq.

• The Gist: President Obama recently signed the Fraud Enforcement and Recovery Act, which beefed up the False Claims Act that permits whistleblower suits. Subcontractors can more easily be hit with suits, even when no false claim was directly submitted to the government.
— RC

In December 2008 a federal grand jury indicted owners and employees of eight home health agencies in the metro-Detroit area on charges that they took part in a plan to solicit and pay kickbacks in exchange for Medicare patient referrals.More…

Homeopathic remedies under fire

© 2009 The Medical-Legal News

The FDA has ordered Matrixx Initiatives, which makes 19 Zicam homeopathic products, to subject three of its cold remedies to new testing, according to the Fort Lauderdale Sun-Sentinel of June 22.
Plaintiffs are coming forward with suits, claiming loss of the sense of smell (anosmia), possibly caused by the ingredient zinc gluconate.
Unregulated homeopathic drugs generally contain trace amounts of natural ingredients, but the drugs are mostly unregulated, according to the Associated Press. The AP says 800 homeopathic ingredients were potentially implicated in problems in 2008, and that $830 million is spent per year on such remedies by 4 million Americans. •

Acne drug Accutane to be discontinued

© 2009 The Medical-Legal News

Accutane is being pulled off the market, according to Bloomberg.com of June 26.
Roche Holding AG, maker of the drug, said the move is the result of competition from generic versions of Accutane. Accutane’s patent expired in 2002.
Roche also noted that it has been “faced with high costs from personal-injury lawsuits that the company continues to defend vigorously.”
According to the story, juries have awarded about $33 million in suits involving bowel disease, an alleged side effect of taking the acne medicine.
Roche faces about 5,000 lawsuits concerning the drug, with many suits focusing on a failure to warn of side effects such as inflammatory bowel disease, birth defects and depression, according to Bloomberg.
John Mullarkey, a 20-year-old Pennsylvania man, claims Accutane-induced depression led him to kill his cheerleader girlfriend. •

$2M paid in negligent credentialing case

© 2009 The Medical-Legal News

Weirton Medical Center of West Virginia offered a $2 million settlement to a surviving family to end a negligent credentialing and lack-of-informed consent lawsuit, according to The State Journal of May 12.
The plaintiff family alleged that an inexperienced urologist and his assistant perforated the decedent’s stomach in a procedure to remove a kidney mass. The stomach festered for five days before it was discovered and a resulting infection killed the decedent, according to the story. Ironically, the procedure was unnecessary as decedent was cancer-free. The family also allegedly had not been told that an assistant would be used.
The hospital agreed to pay the plaintiffs’ trial expenses, according to the story. The urologist, Dr. Hardev Parihar, and his assistant settled before trial.
Bordas & Bordas was the firm for the plaintiffs. •

$1.88M for cancer

© 2009 The Medical-Legal News

A jury awarded a widow $1.88 million in a failure-to-diagnose case where the husband’s cancer was missed, according to the Scranton Times-Tribune of June 3.
Christine Golden sued urologist Milan J. Smolko, pathologist Lillian Longendorfer and Wayne Memorial Hospital.
The story reported that Terrence E. Golden, the late husband, saw Smolko numerous times in a 16-month period complaining of urinary problems, but Smolko did not sufficiently investigate.
Another doctor diagnosed Golden’s bladder cancer about a year later, but Golden died. •

Amputee allowed to re-sue after loss by jury

© 2009 The Medical-Legal News

In a rare move, a judge in Florida is allowing a woman to sue, for a second time, the doctors who allegedly breached her care.
According to the Associated Press of May 30, plaintiff Lisa Strong initially sued doctors for a failure to diagnose kidney stones, which led to a downward spiral in Strong’s health and subsequent septic shock, which resulted in the death of tissue in her hands and feet. She is now a quadruple amputee.
According to the story, Strong alleged that miscommunication between doctors was largely to blame for the failure to properly treat her. Even though Strong had told nurses that she had a history of kidney stones, and was sure that the pain that brought her to the ER was related to kidney stones, she was diagnosed by doctors with acute cholecystitis, a gallbladder condition.
According to the AP, Broward County (Fla.) Circuit Judge Charles M. Greene reversed the jury’s defense verdict and said the verdict was “contrary to the law and the manifest weight of the evidence.”
Such a reversal only occurs in less than one-half of 1% of civil cases, according to the AP story. The story said that, according to the National Center for State Courts, judges set aside jury verdicts in a mere 78 of 18,306 civil trials in 2005.
The doctors at issue were Laurentina Kocik and Jason Strong (not related). 

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