Florida Injury Lawyers Blog

About two dozen states, including Florida, have enacted tort reform laws for the purpose of limiting non-economic damages awards by juries in medical malpractice lawsuits. Non-economic damages generally pertain to monetary compensation for pain and suffering. Proponents of tort reform laws argue that these laws are necessary to retain qualified doctors by protecting them from the financial onslaught of high medical malpractice insurance premiums and exorbitant jury judgments against them. Of course a “problem” with this logic is that theoretically, truly qualified, knowledgeable, and careful doctors and other medical providers should never face the prospect of exorbitant jury judgments against them. So just exactly who is being protected by tort reform laws? Maybe it’s the bad apples within the medical profession who are also contributing to the high insurance premiums, not just “outlandish” jury verdicts influenced by trial lawyers as insurance lobbyists would have us all believe. In other words, physician don’t just heal thyself, but monitor thyself and thy colleagues.

Perhaps not surprisingly, caps on non-economic damages are facing opposition in state courts. In March, a unanimous Supreme Court of Georgia struck down limits on jury awards in medical malpractice cases by finding that they violated the right to a jury trial as guaranteed under the Georgia Constitution. In February, the Illinois Supreme Court also declared its state’s caps on non-economic damages as unconstitutional. Florida courts have not yet declared the Florida’s cap on non-economic damages as unconstitutional. This issue will most likely be eventually decided by the Florida Supreme Court. In the meantime, Florida courts have instead been asked to determine whether the retroactive application of the “caps" statute was constitutionally permissible.

In Weingrad v. Miles and Haynes, 29 So. 3d 406 (Fla. 3d 2010), Florida’s Third District Court of Appeals recently held that, under the facts of the case, the retroactive application of the statute did not violate the plaintiff’s constitutional rights. Whether or not one agrees that the caps in and of themselves are unconstitutional, the Weingrad court’s opinion serves a primer on the tests that Florida courts will consider in determining whether any statute can be applied retroactively. The Weingrad Court relied on three previous Florida Supreme Court cases which had articulated the following standards for evaluating when a statute can be applied retroactively:
1. Is the statute procedural or substantive?
2. Was there an unambiguous legislative intent for retroactive application?
3. Would the retroactive application impair a vested right?

The Weingrad Court began its analysis by stating that the “general rule is that procedural or remedial statutes may operate retrospectively but substantive statutes may not unless the Legislature has indicated a clear intent to the contrary.” It found that the “statutory cap on noneconomic damages affects an individual’s right to a certain amount of damages” and was therefore substantive in nature.”

The Weingrad Court next reviewed the statute’s language and legislative history to determine if the Legislature had evidenced an unambiguous intent for the “caps” statute to apply retroactively. The Court noted that the statute’s enabling clause, included as a footnote to section 766.118, indicated an unambiguous intent that the statute was to apply retroactively by stating that the statute “shall apply to any medical incident for which a notice of intent to initiate litigation is mailed on or after medical incident for which a notice of intent to initiate litigation” was mailed on or after September 15, 2003.”

Having found that the statute met the first two standards for passing the “retroactive” test, the Weingrad Court then focused on whether the application of the “caps” statute would impair a vested right. Under Florida law, no statute can be applied retroactively if “it impairs vested rights, creates new obligations, or imposes new penalties.” Weingrad Court citing State Farm Mut. Auto. Ins. v. Laforet, 658 So. 2d 55, 61 (Fla. 1995). This analysis required a determination as to whether or not the appellee-plaintiff’s right at issue, namely a right to sue, was a vested right.

Continue reading "Constitutional or Not? Florida's Law which Places Caps on Non-Economic Damages in Medical Malpractice Cases" »

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Posted In: medical malpractice

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As a Florida law firm involved in nursing home negligence and abuse litigation, we are well-acquainted with the acts and omissions on the part of nursing homes which often result in serious harm to vulnerable nursing home residents. Once in a while we, however, can still be astounded by the actions of nursing home administrators and staff members, including doctors, which are so egregious in nature that they rise to the level of criminal conduct.

Take, for example, the recent matter involving nursing home residents at the Kern Valley Nursing Home in California. Various residents had supposedly complained to the nursing home director about certain matters. As reprisal, she chemically restrained them with powerful anti-psychotic drugs, there being no showing that these residents were psychotic. The drugs’ effects were so severe that three (3) of the residents died. The director, an administrator, and staff physician have been charged with criminal violations by the State of California.

Certainly the care of nursing home residents is demanding because the residents are more likely than not suffering from some stage of Alzheimer’s and/or dementia and often physical problems as well. In understanding just why the "Kern's" trio's conduct was criminal in nature, one needs to understand that FDA has approved certain drugs for treating Alzheimer’s, but has never approved any drugs whatsoever specifically for the treatment of dementia, generally associated with confusion and anxiety. Therefore, the prescribers of these anti-psychotic drugs for dementia are knowingly administering these drugs under a practice known as “off label” usage.

Furthermore, the FDA issued warnings in June 2008 to medical providers that anti-psychotic drugs used to treat dementia in the elderly are associated with a high risk of death. Therefore those healthcare providers who violate the warnings of the FDA and use anti-psychotic drugs on the elderly cannot claim ignorance as to the potentially dangerous consequences of their actions.

One of the anti-psychotic drugs on the FDA's June 2008 "dangerous drug" warning list is Seroquel, a drug manufactured and marketed by AstraZeneca. Seroquel has recently received considerable negative press because of AstraZenaca's suspect marketing activities. Seroquel has been approved by the FDA only for the treatment of short term bipolar disorder and schizophrenia. Despite that “limited” approval, AstraZeneca had engaged in a calculated effort to “expand” the deliverance of this drug to the elderly despite the known, potentially life-threatening risk factors. To accomplish this suspect objective, the drug was marketed to geriatric physicians and primary care physicians who treat elderly patients, not psychiatrists. Psychiatrists are the doctors who generally diagnose and treat schizophenia and bipolar disorder, not primary care physicians.

Interestingly, a 2005 British Medical Journal report showed that Seroquel actually made cognitive functioning worse in elderly patients with dementia! So not only was the drug ineffective, but it also can cause harm to the patient! Not surprisingly, class action civil lawsuits have been filed against AstraZeneca on behalf of the victims harmed of the company’s questionable marketing practices

Why would drug manufacturers such as AstraZeneca “push” the usage of drugs to unsuspecting elderly patients through cooperative physicians? Think about it. Seroquel and other antipsychotic drugs have a relatively small market compared to the burgeoning “elder” market. Indeed a member of our law firm had personal experience with a situation where a physician prescribed Seroquel to an elderly family member, who was not in a nursing home at time, and after the FDA’s warning to healthcare providers in 2008. The elderly family member began experiencing excessive thirst and other “new” symptoms associated with diabetes, one of Seroquel’s well-known risk factors. The elderly person had none of the risk factors associated with diabetes and in fact had hever had a "bad" glucose test reading in her life. After several conversations with the doctor, the elderly person’s caregiver gradually “weaned” the patient off of Seroquel and changed doctors. Her entire medication schedule has been changed, and considering her age, she is doing remarkably well.

And who pays for the prescriptions for the elderly? Medicare and Medicaid. Indeed the U.S. Department of Justice filed an action against AstraZeneca for among other things, Medicare and Medicaid fraud in 2009. On April 27, 2010, AstraZeneca agreed to settle the case for $ 520 million.

Continue reading "Chemical Restraints as an Easily Hidden Form of Egregious Nursing Home Abuse: A Problem that Is Further Magnified by the Unethical Marketing Practices of Anti-Psychotic Drug Manufacturers Such as Astra Zeneca. " »

Posted by Troy & Schwartz | Permalink | Email This Post

Posted In: Assisted Living Facilities - ALFs , Florida Nursing Home Bill of Rights , Nursing Home Abuse , Nursing Home Negligence , chemical restraints

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We previously wrote a blog concerning what has become a common practice of nursing home owners: the inclusion of arbitration provisions in nursing home admission documents. Except in very limited circumstances, Florida courts have routinely found that such arbitration provisions are legally valid. See Manocare Health Service, Inc. v. Stiehl, 22 So. 3d 96, 104, n.7 (Fla. 2d 2009). This current blog on such arbitration agreements is divided into two parts. Part I provides a discussion of the validity of nursing home arbitration agreements signed by individuals acting under a durable power of attorney. Part II discusses the legislative efforts which are being made to make nursing home arbitration agreements illegal.

Part I. The Validity of Nursing Home Arbitration Agreements Signed Under the Authority of a Durable Power of Attorney

Many times nursing home admission documents are signed by a family member acting as the resident’s durable power of attorney and not by the actual resident. The grant of powers under a durable power of attorney is known as an advanced directive. To be valid, a grant of durable power of attorney requires the execution of a formal document which specifies the powers being granted in accordance with the formalities specified by Florida Statute 709.06. A durable power of attorney is one which remains effective should the grantor become incapacitated in the future.

The following issue has arisen in nursing home negligence and abuse cases: whether nursing home admission documents requiring that claims arising under the admissions agreement be arbitrated are valid when the admissions agreement was signed by a person acting under a durable power of attorney. That is, does an individual acting under a durable power of attorney (DPOA) have the authority to consent to arbitrate claims arising from the resident’s nursing home care?

According to Florida courts, the answer depends upon the scope of the authority granted under the durable power of attorney document. In the Estate of Smith v. Southland Suites of Ormond Beach, LLC, et al., So. 3d (Fla. 5th DCA 2010), the decedent’s nursing home admission contract had been signed by her daughter acting under a durable power of attorney. The mother died while a resident at the nursing home, and her estate sued the nursing home for wrongful death. The estate argued that the daughter’s durable power of attorney did not authorize her to consent to arbitrate claims arising from her mother’s nursing home care. Hence, the action for wrongful death could be brought in a court of law.

The Smith Court noted that the DPOA did not specifically state that the daughter was being granted the right to enter into arbitration agreements on behalf of her mother. Nevertheless the Smith Court went on to state that the DPOA at issue did provide the daughter with broad authority to effectuate her mother’s legal rights and that “[t]he language of the DPOA is clearly broad enough to encompass arbitration and to authorize [the mother’s] daughter to enter a binding agreement on her mother’s behalf.” The Smith Court based its opinion on the following provision in the DPOA signed by the daughter:

“generally to do and perform all matters and things, transact all business, execute, and acknowledge all contracts, whether involving real property or not, orders, deeds, writings, assurances, and instruments, which may be requisite or proper to effectuate any matter or thing appertaining to or belonging to me, and generally to act for me in all matters affecting my business or property . . .”

In reaching its conclusion that the DPOA authorized the daughter to enter into a binding arbitration agreement, even though the DPOA did not specifically “allow” such an agreement, the Smith Court cited Florida Statute 709.08(6) which provides that “[u]less otherwise stated in the durable power of attorney, the durable power of attorney applies to any interest in property owned by the principal, including . . . all other contractual or statutory rights or elections.” The Smith Court basically concluded that the DPOA granted the daughter the right to enter into all contracts on behalf of her mother without limitation as to the nature and type of contract and/or the provisions within the contract.

Other Florida appeals courts have reached the same conclusion when the DPOA at issue granted broad powers. See, for example, Jaylene, Inc. v. Steur ex rel. Paradise, 22 So. 3d 711 (Fla. 2d DCA 2009) and Five Points Healthcare, Ltd. v. Mallory, 998 So. 2d 1180 (Fla. 1st DCA 2008). But see our previous blog on arbitration agreements for examples of arbitration agreements which were deemed void by Florida courts.

The premise underlying the Smith Court’s holding is that a nursing home admission agreement, as a contract, constitutes an interest in property. As consideration for the acceptance into the nursing home, the resident or his/her DPOA, whichever the case may be, is agreeing to both: (a) pay for the resident’s care; and (b) also give up the right to pursue legal action in a court of law for injuries sustained as the result of nursing home negligence and abuse at the facility which is being paid to provide proper care. Seems a little one-sided, doesn’t it, especially when one considers why nursing home arbitration agreements are so popular these days: because awards of damages in arbitration proceedings for nursing home negligence will generally be substantially less relative to awards of damages by juries.

Continue reading "Current Topics in Nursing Home Arbitration Agreements" »

Posted by Troy & Schwartz | Permalink | Email This Post

Posted In: Bedsores , Nursing Home Abuse , Nursing Home Negligence

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As is well known, Florida has a large population of individuals over the age of sixty-five (65). Many of these individuals are, or will eventually become, residents of a nursing home or an assisted living facility (ALF). Moreover, the number of individuals in nursing homes/ALFs throughout the country is projected to increase dramatically over the next two to three decades due to the aging baby boomer population. Although most individuals adamantly state that they never “want to live in a nursing home facility,” the fact remains that many elderly individuals will, at some point in their lives, be admitted to a nursing home facility. Such an admission may be for short term stay, for example, where the individual is admitted for rehabilitation purposes after a hip replacement surgery. Other stays will be for the long term, and many an elderly person may in fact live out his/her life at a nursing home facility. Florida nursing homes are governed by the Statute entitled Nursing Homes and Related Healthcare Facilities (Florida Statute 400).

Assisted Living Facilities (ALFs) are an alternative to nursing homes and in many cases may be a suitable alternative to nursing home confinement where the resident is not in need of skilled nursing care. As in the case of Florida nursing homes, Florida ALFs must go through a licensing process and be approved by the State of Florida. It must be emphasized that ALFs, in contrast to nursing home facilities, do not provide on-site nursing care. ALFs are generally allowed only to administer doctor-prescribed medications to the resident, which are ideally dispensed by the pharmacy in unit dose packs. Moreover, ALFs must not accept or keep as residents any individual who has physical or mental health issues which require skilled medical treatment or which would pose either a danger to the individual or other residents of the nursing home facility. Assisted Living Facilities are governed by Florida Statute 429.

Elderly individuals confined to a nursing home are ripe candidates for negligent care and abuse due to their vulnerability, whether physical (e.g., frailness); mental (e.g., dementia or Alzheimer’s), or a combination of the two. The Florida legislature has made it very clear that such residents are entitled to certain rights and privileges through a law commonly known as the Nursing Home Resident Bill of Rights (Florida Statute Chapter 400 s.022). Every Florida nursing home resident resident or his /her legal representative should be provided with a copy of the “Bill of Rights” at the time of admission. In brief, residents’ rights, under Florida Statute 400.022, include the following:

1. The right to civil and religious freedom.
2. The right to private and uncensored communication.
3. The right to have reasonable access to the resident by an entity or individual that provides health, social, legal or other services to residents of nursing homes.
4. The right of a resident to present grievances, i.e., providing a forum where grievances can be presented.
5. The right to organize and participate in resident groups.
6. The right to participate in social, religious, and community activities.
7. The right to examine the results of the most recent federal or state inspection of the facility.
8. The right to manage his or her own financial affairs.
9. The right to be fully informed at the time of admission and throughout of services available in the facility and the related charges for such services.
10. The right to be adequately informed of his or her medical condition and proposed treatment, including the right to refuse medication and treatment.
11. The right to refuse medication or treatment and to be informed of the consequences.
12. The right to receive, in a nursing home, adequate and appropriate healthcare and protective and support services, including social, mental, recreational, therapeutic and rehabilitative services consistent with the resident’s care plan and with established and recognized practice standards.
13. The right to privacy and treatment and in caring for the resident’s personal needs, including the right to confidentiality of their medical records.
14. The right to be treated courteously, fairly, and with the fullest measure of dignity.
15. The right to be free from mental and physical abuse, corporal punishment, extended but involuntary seclusion and to be free from physical and chemical restraints, except those restraints authorized by a physician for a specified and limited period of time or as necessitated by emergency.
16. The right to be transferred or discharged only for medical reasons or for the welfare of other residents.
17. The right to freedom of choice in selecting a personal physician.
18. The right to retain and use personal clothing and possessions.
19. The right to have copies of the facility’s rules and regulations.
20. The right to receive notice before a resident’s room is changed.
21. The right to be informed of the bed reservation policy for hospitalization.
22. For recipients of Medicaid or Medicare, the right to challenge the decision by the facility to discharge or transfer.

Continue reading "Florida’s Nursing Home Residents’ Bill of Rights and the Right to Sue " »

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Posted In: Assisted Living Facilities - ALFs , Bedsores , Nursing Home Abuse , Nursing Home Negligence

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We have written numerous blogs concerning the development of decubitis ulcers, commonly known as bedsores, due to the negligent treatment of the nursing home resident or hospital patient by staff members. One blog suggested using a quality-control approach to reducing the possibility of pressure ulcers. In this blog, we will revisit the concept of objective quality care approaches as a valid means of reducing: 1) the incidence of bedsores in the first place and/or 2) reducing the possibility of developing particularly serious Stage III (associated with open sores) and Stage IV (associated with craters or holes) bedsores.

This blog is intended to emphasize that: 1) the causes of bedsore development are known; 2) the risk factors for developing bedsores are known; and 3) steps/procedures which will help reduce the development of bedsores or at the very lease allow for early “treatment” intervention are well known. The above prevention tactics are nothing more than common-sense procedures that every nursing home and hospital can implement via specific quality care programs which are actually followed. That this blog contains references to Dr. Deming is due to the fact that one of the authors, prior to attending law school, was involved in product development in the medical device industry for an international medical device manufacturing company where product development was carried out through product development teams consisting of members ranging from R&D to regulatory affairs. The teams’ responsibilities included the establishment of objective quality assurance indicators. As discussed below, the authors believe that Dr. Deming’s principles are applicable to hospital and nursing home settings for reducing the development of bedsores.

As the name suggests, pressure sores result when the weight of the person’s body presses against a firm surface such as a bed mattress or a chair. Or put another way, the bed sores develop due to the pressure exerted by the bed or chair on the person’s body. In understanding just how such pressure cause bedsores, remember that the skin contains hundreds of blood vessels. Bedsore occur when the pressure cuts off the skin’s blood supply to the "pressure-contact" area. This area of damaged skin will become more susceptible to pressure-induced damage if steps are not taken to relieve/reduce pressure on the now-compromised skin. (Reference #2)

It should not be surprising that the elderly, who are often frail due to poor bone and skin integrity, are particularly susceptible to pressure sores because of their lower tissue tolerance for pressure. Old age is thus a “no brainer” risk factor for developing bedsores. Yet, many other well-known risk factors are associated with the development of pressure sores. Obviously the greater the number of risk factors specific to the person, the greater the likelihood that the person will develop bedsores. Besides old age, the following factors are known to increase the risk for developing pressure sores:

• Being bedridden
• Spending considerable time in a wheelchair
• Diabetes or vascular disease that prevents areas of the body from receiving proper blood flow
• Spinal cord injury (paralysis), brain injury, or other physical condition which prevents the person from moving parts of his/her body without assistance.
• Malnourishment
• Mental disability such as Alzheimer’s disease or dementia which may prevent the patient from moving parts of his/her body without assistance not necessarily because they are unable to do so, but because they are not aware that then need to do so
• Urinary incontinence or bowel incontinence (Reference #1).

Many of the listed risk factors are typically associated with old age; therefore most elderly persons have multiple risk factors ranging from confinement to bed and wheelchairs to incontinence, mental disability, and/or malnutrition. Upon their admission to a nursing home or hospital, elderly persons should thus undergo a formal risk factor assessment to determine their risk of developing bedsores. They should then be monitored carefully for the onset of bedsores so that treatment can be timely rendered while the bedsore is still at a readily treatable stage.

Unfortunately, failure of nursing home staff members and administrators to actively take measures to minimize the onset of bedsores and/or initiate prompt medical intervention can result in dire consequences for the “bedsore” patient, especially where Stage III and Stage IV bedsores are at issue. Obviously, nursing home patients confined to their beds should be turned frequently to “spread out” the pressure from the hard surface across a large area of the person’s body. The medical literature suggests that turning should occur every two hours. Nor should residents be allowed to sit for hours on end in a wheel chair without pillows or other means to reduce pressure points between their skin and the chair itself.

Pressure sores may also result if the bed-ridden elderly person is dragged or slid across bed sheets, thereby creating potentially harmful frictional forces between the person’s skin and the bed sheet. (Reference 2). It is also conceivable that “dragging” an elderly frail person may result in injuries to muscles or bones quite apart from bedsores. Such treatment may also constitute abuse. Nursing home patients are entitled to respectful, gentle treatment to prevent injuries, and it is up to the administrators to ensure that the residents are treated appropriately.

Another known risk factor involves incontinence. Failure to frequently change the underwear of individuals who are incontinent may increase the risk of developing bedsores; the resultant wetness from bodily waste can make the skin too soft and more likely to be injured by pressure.

Diabetes and hyperglycemia are two other well known risk factors for bedsores. One would hope that any nursing home resident or hospital patient who is known to be diabetic or hyperglycemic would receive a “heightened scrutiny” type of monitoring for bedsores from the onset of his or her hospitalization or residence at a nursing home.

Bedsores are generally associated with nursing homes. It must be emphasized, however, that bedsores do not only originate in nursing homes. Elderly people who are hospitalized also have a high risk of developing bedsores due to the various risk factors which make them susceptible to bedsores. Patients transferred from hospitals to nursing home rehabilitation centers or being returned to their previous nursing home residences, are particularly vulnerable to bedsores according to the statistics. It has been estimated that at least 10% and upwards of 35% of individuals transferred from hospitals to nursing home rehabilitation centers or the nursing home where they had previously resided prior to hospitalization already have bedsores at the time of admission. (Reference #4). Nursing homes should thus make every effort to carefully check any patient being transferred to the nursing home for bedsores at the time of admission. Without proper medical care, even minor bedsores originating at the hospital may “turn into” serious Stage III and Stage IV bedsores.

We further emphasize that pressure sores are not merely a condition of the elderly. Individuals suffering from conditions which prevent movement such as paralysis, severe arthritis and/or multiple sclerosis, are susceptible to bedsores because of their inability to move without assistance. Recently, Eric Trainor, a 30-year-old New York State resident, was awarded $2.2 million by a jury for the pain and suffering caused by horrific bedsores. As a consequence of a motor vehicle accident in which he had been a passenger, the Mr. Trainor had been hospitalized at Westchester Medical Center. His injuries had caused him to become a quadriplegic. Because of the hospital’s failure to turn the injured patient every two hours during his 6 week stay, the patient developed Stage IV bedsores which had to be surgically closed. Furthermore, as a consequence of the bedsores, the injured man had to refrain from participating in physical rehabilitation so much so that he lost the chance to build up his upper body strength.

Continue reading "A Lawyer's Perspective: Quality Care Programs Based on Objective Quality Indicators for the Strategic Purpose of Reducing Bedsores in Nursing Home Residents and Hospital Patients " »

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Posted In: Bedsores , Bedsores - Hospitals , Nursing Home Abuse , Nursing Home Negligence , medical malpractice

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At first blush, Florida’s statute of limitations for bringing a medical malpractice suit appears to be quite straight forward. The Florida Statute which governs medical malpractice claims states the following:

“An action for medical malpractice shall be commenced within 2 years from the time the incident giving rise to the action occurred or within 2 years from the time the incident is discovered, or should have been discovered with the exercise of due diligence.” Section 95.11(4)(b), Florida Statutes.

This particular time frame imposed by the Florida Legislature is considerably shorter than the statute of limitations for bringing actions for personal injuries caused, for example, by motor vehicle accidents, dog bites, and slip and fall accidents. For these "non-med mal" negligence cases, the statute of limitations under Florida law is four (4) years.

The medical malpractice statute of limitations is not as cut and dry as it may seem. For example, in the case of motor vehicle accident, the date and time of the event which caused the the plaintiff’s injuries is documented, generally through an accident report form prepared by police officer called to the scene of the accident. Also, in many cases, the injured plaintiff will have been transported by an ambulance to a hospital.

In medical malpractice cases, the start date from which the statute of limitations is calculated may well be open to interpretation. In the case of a malpractice matter, the negligence may not be discovered for a considerable time after the negligence which gave rise to the malpractice occurred. For example, the ramifications of a missed cancer diagnosis may not be known for years. Also, pain is often the result of surgery. When should a patient be required to know that certain pain manifestations following surgery were a possible cause of medical malpractice? The bottom line is that for medical malpractice cases, the start date for assessing the statute of limitations is not always as easy to pin down as it may seem.

The most recent Florida case to deal with the issue of the medical malpractice statute of limitations is Cohen v. Cooper, a case decided by the Fourth District Court of Appeal on October 28, 2009. No. 4D07-4056. In Cohen, the Plaintiff appealed the lower court judge’s ruling that her medical malpractice claim for “eye” complications resulting from cosmetic surgery was barred by the statute of limitations for medical malpractice lawsuits and that the defendant was therefore entitled to final summary judgment as a matter or law. The plaintiff appealed..

In arriving at a decision favorable to the plaintiff, the Cohen court discussed the numerous Florida cases which have held inter alia that the “determination of timeliness under the statute of limitations is fact specific and within the province of the jury, not the trial judge.” For example, in Tanner v. Hartog, 618 S0. 2d 177, 181 (Fla. 1993), the Florida Supreme Court held that “the knowledge of the injury as referred to in the rule as triggering the statute of limitations means not only knowledge of the injury but also knowledge that there is a reasonable possibility that the injury was caused by medical practice.” The Tanner court was concerned over situations where the injured party became aware of a detrimental medical result after treatment by a medical practitioner, but did not have enough information available to ascertain that there was a reasonable possibility that the injury was caused by medical malpractice.

In Cunningham v. Lowery, 724 So. 2d 176, 178 (Fla. 5th DCA 1999), the court held that the plaintiff’s awareness of a medical condition “is not the same thing as knowledge that there was a reasonable possibility” that the plaintiff was injured through the malpractice of a doctor. The Cunningham court further opined that the statute’s requirement of “due diligence” does not require that courts hold a plaintiff struggling with the fact of a crippling or horrifying illness to undertake sophisticated medical analysis. Furthermore, the defendant-doctor in Cunningham continued to treat the plaintiff for a bacterial infection which was diagnosed following spinal surgery performed by that same doctor. The Cunningham court found this fact troublesome, and held that the continued treatment of the injured plaintiff by the defendant “embodies an estoppel concept; Medical providers or their agents who convince patients than untoward medical event was ‘natural’ and non-negligent will rarely be permitted to deny that same representation is correct for purposes of the statute of limitations.” Cohen citing Cunningham, 724 So. 2d at 180.

In 2008, the Florida Third District Court of Appeal held that “pain after a medical procedure, standing alone, does not trigger the statute of limitations and creates a question of fact on the issue of notice [of intent to initiate medical malpractice litigation]." Cohen citing Gonzalez v. Tracy, 994 So. 2d 402, 405 (Fla. 3d 2008).

Continue reading "The Reasonableness Standard for Triggering the Statute of Limitations for Medical Malpractice Suits in the State of Florida" »

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Posted In: medical malpractice , statute of limitations

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The Sun Sentinel recently provided an outstanding public service to the citizens of Florida by exposing serious loopholes in Florida law which have allowed individuals of questionable background to obtain employment in day-care-centers, assisted-living facilities (ALFs), and nursing homes, sometimes even before the results of their criminal background check were obtained. Even if the background checks raised red flags, many felons were able to continue working as caregivers with children or the elderly by “establishing” that they were reformed felons to the satisfaction of the Department of Children & Families or the Agency for Healthcare Administration.

Both nursing homes and ALFs are regulated by the Agency for Healthcare Adminstration. ALF's are also known as adult congregate living centers and are governed by Chapter 429, Florida Statutes. ALFs may range from large residential facilities to private homes. Generally, ALFs which have been granted a stadard license by the State of Florida are required to provide only the "basics" of day-to-day living and limited personal services. A special license is required to provide nursing services through licensed nurses.

Nursing homes often involve large institutions which provide skilled nursing care and are governed by Chapter 420 of the Florida Statutes. Nursing home residents may include long-term residents or residents who are released to the nursing home for a period of rehabilitation following a hospital stay. The latter situation typically occurs when the elderly person is released to a nursing home directly from the hospital, say, for example, after a hip replacement surgery, for an interim stay at a nursing home.

Individuals who work at nursing homes or ALFs and will be performing personal services on behalf of the elderly residents are supposed to pass a background check pursuant to Florida Statute 435.03, otherwise known as "Level I" screening. Interestingly, the Level I screening requirement does not require a nationwide background check for criminal "activities" through the Federal Bureau of Investigation (FBI). The "loose" Level I screening requirements mean that theoretically a former felon from another state could move to Florida, begin working at a nursing home or day-care center or ALF and pass a Florida background check!

As the Sun Sentinel Article pointed out, a more stringent background check (Level II) involving a nationwide criminal background check is required for individuals whose jobs involve handling financial assets pursuant to Florida Statute 435.04.

Furthermore, the law allows individuals who have a suspect criminal background record to apply for an exemption through Florida Statute 435.07. Perhaps it is this loophole in the law that is most disturbing. According to the Sun Sentinal report, the "exemption" system has cleared nearly 9000 individuals with a criminal past to work as caregivers with children and the elderly. The report has prompted state officials to investigate over 850 individuals who were cleared to work as caregivers and then re-arrested for new crimes!

As a consequence of the Sun Sentinel's investigation, legislation is now being proposed to close this loophole where nationwide background checks for children and elder caregivers would be required before such caregivers are even hired. Also, Florida's Attorney General, Bill McCollum, has ordered a review of Florida's questionable employee screening system which has allowed convicted felons to work in nursing homes, day-care centers, and assisted living facilities (ALFs). Bravo!

It is difficult to understand just why Florida has such loosy goosy standards in place. Perhaps the underlying intention was to give reformed felons a “second chance” in life. Unfortunately this program has resulted in serious ramifications for unsuspecting elderly adults and their families as the Sun Sentinel investigative series discussed. For example, a jury has just convicted Andrew Gosciminski, a supposedly “reformed” felon, for the robbery and murder of the daughter of a resident at the Fort Pierce ALF where he was actually the marketing director! The jury recommended the death sentence.

The Sun Sentinel also reported a case where an "exempt" former felon stole $36,000.00 from the patients at the nursing home where she was employed and pedophiles have been employed in jobs where they have routine contact with children! Moreover, the high recidivism rate of felons is well known. Who knows if certain former felons who seek employment at facilities serving our vulnerable citizens are simply looking to commit crimes of opportunity? Or perhaps, the crime of opportunity, which happens to present itself, is just too good to pass up.

Thanks to the Sun Sentinel's investigation, Florida state senators and representatives are promising to take swift action to remedy these pitfalls in Florida law. As nursing home negligence and abuse attorneys, we have posted numerous blogs on nursing home negligence and abuse, including one blog which touched on implementing common sense procedures designed to better protect the elderly from injuries related to negligence and/or abuse. Requiring stringent screening standards for those who work with the elderly and children is surely a common sense approach for protecting our vulnerable citizens from exploitation by “unsavory” characters which can result in both physical harm and financial harm. Afterall, what better a victim than an elderly person suffering from frailty, dementia, and/or Alzheimer's?

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Posted In: Nursing Home Abuse , Nursing Home Negligence

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In the recent case of Probkevitz v. Velda Farms, LLC. and Joseph Anthony Dixon, Florida’s Third District Court of Appeal (Third DCA) reversed the trial court’s denial of the plaintiff’s motion for a new trial because the trial court had “impermissibly allowed introduction of evidence of negligence [on the part of the minor decedent’s mother] and allowed the jury to consider such evidence.” No. 3D07-1052, Opinion filed September 9, 2009. The Third DCA further held that the trial court had: 1) abused its discretion by forbidding the presentation of the plaintiff’s rebuttal evidence; and 2) committed prejudicial error by allowing the traffic homicide officer who investigated the accident to render an opinion over the cause of the accident.

The opinion is instructive because it involves a situation where the trial court “impermissably allowed the introduction of evidence of negligence and allowed the jury to consider such evidence” in contradiction of the standard established by the Florida Supreme Court in D’Amario v. Ford Motor Co., 806 So. 2d 424, 436 (Fla. 2001), for determining when the introduction of evidence of the plaintiff’s or a third party’s negligence should be allowed at trial and considered by the jury. Moreover, the Probkevitz opinion reiterates well-settled areas of law concerning the admission of evidence and expert testimony. As plaintiffs' attorneys, we believe that the Third DCA’s decision is clearly correct because in this particular case, the Plaintiff was prejudiced by not one but several questionable rulings.

The Prokevitz case was a wrongful death action brought by the personal representative (the minor decedent’s mother) of the minor decedent’s estate. The decedent died as the result of an automobile accident in which she had been driving a vehicle owned by her mother. The decedent had a learner’s permit at the time of the accident which had been signed for by her mother.

Under Florida law, adults who sign for a minor learner’s permit are representing that they will not allow the minor to drive unless accompanied by a licensed Florida driver. On the night of the accident, the decedent had evidently taken the mother’s car without the mother’s permission or knowledge after the mother had gone to bed. Dixon (the defendant driver) had asserted as an affirmative defense that the personal representative’s action was barred, or that his percentage of fault should be reduced because of the mother’s negligence. Dixon later moved for leave to file a third-party complaint against the mother-personal representative in her capacity as a survivor, for vicarious liability, negligent supervision, and negligent entrustment. The trial court denied the counts related to negligent supervision and negligent entrustment.

The trial court then went on to make several conflicting rulings during the trial as to whether or not the jury would be allowed to consider the mother’s vicarious negligence and/or evidence pertaining to the mother’s own negligence as the proximate legal cause of the unfortunate accident. Eventually on the last day of trial, the trial court reversed its previous ruling which had disallowed the mother’s negligence as a legal proximate cause of the accident to be considered. Or put another way, the trial court reversed its previous ruling which had only allowed the vicarious negligence of the mother to be considered by the jury.

For those who may not be familiar with the various negligence theories, suffice it to say that vicarious liability means the owner of a vehicle may be financially liable for the injuries caused by the driver of the vehicle even though the owner's actions were not the legal proximate cause of the accident. The issue of vicariously liability often arises in the context of employment-employer relationships where the employer, in the performance of his work duties, causes an injury to another, e.g., as the result of an automobile accident. Vicarious liability provides a means to obtain compensation for the injuries caused by, e.g., the employee while performing duties in the scope of his employment. In fact, the plaintiff in Probkevitz was presumably suing Defendant Velda Farms as Dixon’s employer under the legal theory of vicarious liability.

We will briefly note here that vicarious liability has become a less likely means of securing recovery for injuries in certain situations. Readers should also keep in mind that many companies which rely on drivers are often now hiring independent contractors in lieu of having actual company employees as drivers. One “legal” benefit to such companies is that they will generally not be found as being vicariously liable for injuries caused by the negligent driving of an independent contractor. It would seem, however, from a public policy perspective, that companies do at least only hire independent contractors which carry adequate motor vehicle liability insurance and have safe driving records.

The Defendants in Probkevitz understandably wanted to issue of the mother’s own negligence included on the verdict form. Why? Because this jury instruction would have required the jury to consider the issue of the mother’s negligence separate and apart from the negligence of the minor decedent and the Defendant driver. Any resultant award of damages to the decedent’s estate would have been reduced according to the assignment of “fault” to both the mother and the decedent, thereby most likely effectively reducing the amount of damages subsequently paid to the estate. The following examples illustrates this point.

Continue reading "Negligence or Not? Florida’s “Remote Condition Standard for Establishing Proximate Cause in Motor Vehicle Accidents.”" »

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Most drivers who have the misfortune of being injured through the negligence of the driver of a rental car company may not be aware of relatively recent changes to the law which make it virtually impossible to “win” a claim of vicarious liability against a rental car company where the at-fault driver was driving a rental car at the time of the accident. The latest Florida case on the vicarious liability of rental car companies reiterates this point. Blanks v. Enterprise Leasing Co., et al. (Fla. 3d DCA, Sept. 2, 2009).

The Blanks Court held in favor of the defendant rental car company by simply citing two previous opinions on the same issue, Kumarsingh et al., v. PV Holding Corp. and Avis Rent A Car System, Inc., 983 So. 2d 599 (Fla. 3d DCA 2008); and Vargas v. Enter. Leasing Co., 993 So. 2d 614 (Fla. 4th DCA 2008). The purpose of this blog is to provide background on “Graves Amendment” jurisprudence which clearly establishes that car rental companies are off the hook for vicarious liability claims.

In Kumarsingh, the plaintiffs had been seriously injured in an automobile accident caused by the driver of a rental car. The rental car driver had a valid Mexican driver but was uninsured. The plaintiffs filed a lawsuit against the rental car company “alleging vicarious liability as the owners/lessors of the car and negligent entrustment.” See Kumarsingh at 599.

The defendants argued that a federal law, 49 U.S.C. s. 30106, commonly known as the Graves Amendment, pre-empted or “trumped” Florida’s statute imposing vicarious liability of auto lessors up to the limits set forth in section 324.021(9)(b)(2)., Florida Statutes). Section 324.021(9)(b)(2)., Florida Statutes is part of Chapter 324, Florida Statutes entitled “Financial Responsibility.” The purpose of the Chapter 324 is to:

Recognize the existing privilege to own or operate a motor vehicle in the public streets and highways of this state when such vehicles are used with due consideration for others and their property, and to promote safety and provide financial security requirements and provide financial security requirements for such owners or operators whose responsibility it is to recompense others for injury to person or property caused by the operation of a vehicle. Garcia, et al., v. Vanguard Car Rental USA, Inc., 510 F. Supp. 2d 821, 828 (Fla. M.D. 2007) citing Fla. Stat. s. 324.011 (The Kumarsingh opinion cited Garcia.)

As the Garcia Court pointed out, in return for the privilege of operating a motor vehicle in Florida, Chapter 324 requires the operators of motor vehicles in Florida to establish their financial responsibility by “proof of ability to respond in damages for liability on account of crashes arising out of the use of a motor vehicle in the amount of $10,000.00 per person, $20,000.00 per accident for bodily injury and $10,000.00 for property damage per accident.” Fla. Stat. s. 324.021(7).

Section 324.021(9)(b)(2) of Florida’s Financial Responsibility Chapter pertains specifically to the liability of owners/lessors of cars where the motor vehicle lease was for a short term lease (less than 1 year). Under the statute, short term lessors were vicariously liable up to “$100,000 per person and up to $300,000 total for bodily injury and up to $50,000. The short term lessor could also be held liability for up to an additional $500,000 in economic damages if the lessee or the operator of the vehicle was uninsured or had insurance with limits less than $500,000.
See also Garcia at 829.

The Graves Amendment, which became effective on August 10, 2005, has effectively abrogated Florida’s Financial Liability laws as they applied to car rental companies under Section 324.021(9)(b) by providing that “a lessor of a motor vehicle shall not be liable under the law of any state by any reason of being the owner, for harm that arises out of the use of the vehicle during the lease period if the owner is engaged in the trade of renting vehicles and there is no owner negligence or criminal wrong-doing on the owner’s part.”

Continue reading "Rental Car Companies: Off the Hook for Vicarious Liability Under the Federal Graves Amendment " »

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Posted In: Automobile Accidents , Injuries Automobile Accident , motor vehicle accidents , motor vehicle insurance

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On November 2, 2004, eighty percent of Florida’s voters voted to pass Amendment 7, known as the “Patients’ Right to Know” Amendment. Amendment 7, now a part of Florida’s Constitution under Article X, Section 25, provides that “any records made or received in the course of business by a health care facility or provider relating to any adverse medical incident are subject to discovery.” “Adverse Medical Incident” is defined as:

“[M]edical negligence, intentional misconduct, and any other act, neglect, or default of a health care facility or health care provider that caused or could have caused injury to or death of a patient, incuding, but not limited to, those incidents that are required by state or federal law to be reported to any government agency or body, and incidents that are reported to or reviewed by any health care facility peer review, risk management, quality assurance, credentials, or similar committee of representative of any such committees. See Article X, Section 25(c), Fla. Const.

Perhaps not surprisingly, requests for the release of medical incident reports pursuant to the requirements of Amendment have been met with resistance. Medical providers have engaged in lengthy and costly litigation over the scope and applicability of the amendment to no avail. See e.g., Florida Eye Clinic, P.A. v. Gmach, (5th DCA, May 29, 2009); and Florida Hospital Waterman, Inc. v. Buster, 984 So. 2d 478 (Fla. 2008). Arguments used by the defendants in such cases have ranged from “protected attorney work product” arguments to “federal law preemption” arguments.

Recently even the constitutionality of Amendment 7 was challenged in Columbia Hospital Corporation of S. Broward v. Fain, (Fla. 4th DCA, August 19, 2009). In Fain, William Fain, while a patient at a hospital operated by Columbia, died as the result of a fall from his hospital bed. His estate sued Columbia for medical negligence. As part of its discovery request, the estate had requested incident reports for Fain’s fall and all adverse medical incident reports involving falls of patients under “fall precautions” within the past five years. Columbia objected to the request on a number of grounds based on Florida’s Amendment 7, including an argument that incident reports such as the ones requested were protected work product. Columbia appealed the trial court’s order overruling many of Columbia’s objections, and Columbia appealed.

Columbia’s first argument against providing the requested incident report was based on its assertion the information was protected work product under the Florida Rules of Civil Procedure and therefore not discoverable under Amendment 7. As stated above, such arguments have been used in other Florida cases. The Fain Court noted that, “[p]rior to the passage of Amendment 7, a hospital’s incident reports have generally been considered protected as a fact work product and discoverable only upon a showing of need and undue hardship.”

The Fain Court declined to decide on the work product issue on “lack of ripeness grounds”, but did state that “[a] distinction may need to be made between fact work product and opinion work product” to provide clarity on the records discoverable under Amendment 7. The Fain Court did opine that “[i]t is not clear that a provider or healthcare facility may, after the amendment, continue to refuse to provide an adverse medical incident report based on a fact work product.”

Columbia further argued that the “estate’s discovery requests are irrelevant, overbroad, and unduly burdensome.” The Fain Court noted that other decisions of Florida’s courts have held that the Amendment’s scope is very broad. For example, in Morton Plant Hospital Ass’n v. Shahbas ex rel. , 960 So. 2d 820, 825 (Fla. 2d DCA 2007) the Court held that “burdensome is not a relevant consideration under Amendment 7.” The Shabas Court further stated held that “Amendment 7 contains no requirement that information sought by a patient be relevant to any pending medical malpractice action or medical care decision.” Fain Court citing Shahbas at 825.

Also in 2008, the Florida Supreme Court found that Amendment 7 applied retroactively to materials prepared before its passage and that attempts by the Florida legislature to limit requests under Amendment 7 to facilities or providers where the party seeking the information was physically a “patient” receiving treatment were unconstitutional. Fain, citing Florida Hospital Waterman, Inc. v. Buster, 984 So. 2d 478, 493 (Fla. 2008).

As the Fain Court noted, “[t]he purpose of Amendment 7 was to lift the shroud of secrecy from records of adverse medical incidents and to make them widely available." In finding that the estate’s discovery request was not irrelevant, overbroad, and burdensome, the court went on to state:

A request for Amendment 7 materials is not an ordinary discovery request which can be subjected to overbreadth, irrelevance, or burdensome objections. Pursuant to the amendment, a “patient” has the absolute right to discover records relating to an adverse medical incident and that right is not conditioned on the discovery being relevant to a pending claim. A litigant in a medical malpractice case clearly qualifies as a “patient” under the amendment and is entitled to discover the information. It is illogical to conclude that the estate could discover information regarding adverse medical incidents out the context of this litigation but cannot discover the same information as part of its discovery in this case.

Columbia also argued that the estate’s request should be limited to those incidents which must be reported by law under Florida Statute 395.0197. The Fain Court again recognized the broadness of Amendment 7 by stating that “[t]he amendment provides that it is “not limited to” incidents that already must reported under law.” Fain Court citing Article X, section 25(c)(3).

Continue reading "Your Right to Know: Medical Malpractice Litigation, Discovery, and Florida’s Amendment 7" »

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In Diaz-Hernandez v. State Farm Fire and Casualty Company (Fla. Law Weekly D1046; May 27, 2009), the Third District Court of Appeals of the State of Florida recently held that a provision in State Farm’s policy for uninsured motorist’s coverage was against the public policy of the Florida Uninsured Motorists (UM) Statute, section 627.727. The policy provision at issue required that State Farm’s insured file any lawsuit against both the uninsured motorist and State Farm.

In Diaz-Hernandez, the Insured filed a lawsuit against State Farm, seeking to recover UM benefits for injuries sustained in an automobile collision with an uninsured motorist. The complaint did not name the uninsured motorist as the second defendant. State Farm attempted to “get out” of the law suit by arguing that the lawsuit should be dismissed because Diaz failed to name both State Farm and the uninsured motorist as joint defendants. The trial court granted State Farm’s motion to dismiss with prejudice and Diaz-Hernandez appealed, arguing that the provision in the UM policy, which required him to join the uninsured motorist in his claim against State Farm, is against the public policy of Florida’s Uninsured Motorists (UM) statute.

The Diaz-Hernandez Appellate Court noted that State Farm’s policy added “an additional burden upon the Insured by requiring the Insured to join the uninsured motorist in the Insured’s contractual action against State Farm for UM coverage.” In reaching its decision, the Diaz-Hernandez Court relied on the Florida Supreme Court’s holding in Mullis v. State Farm Mutual Automobile Insurance Co., 252 So. 2d 229, 233-34, 238 (Fla. 1971) which stated in part:

The public policy of the uninsured motorist statute . . . is to provide uniform and specific insurance benefits to members of the public to cover damages for bodily injury caused by the negligence of insolvent or uninsured motorists and such statutorily fixed and prescribed protection is not reducible by insurers’ policy exclusions and exceptions. . . .
. . . .

[The uninsured motorist statute] was enacted to provide relief to innocent persons who are injured through the negligence of an uninsured motorist; it is not to be “whittled away” by exclusions and exceptions.

The Diaz-Hernandez Court agreed with the Insured and stated that the “additional burden [Statefarm’s policy provision] places upon the Insured violates the clear policy articulated in Armstrong v. Allstate Ins. Co., 712 So. 2d 788 (Fla. 2d DCA 1998), that the purpose of the UM coverage is to protect the injured motorist, not to benefit the UM carrier or the uninsured motorist.” The policy provision at issue was found to be void because it violated public policy.

Continue reading "Chalk One Up for the Uninsured/Underinsured Motorist Insurance Policy Owner in Florida" »

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Posted In: Automobile Accidents , Injuries Automobile Accident , motor vehicle accidents , motor vehicle insurance

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Although it originated as a personal injury lawsuit in Vermont state court, the Wyeth v. Levine case quickly assumed the “mantel” of a constitutional law case because it involved constitutional law principles involving the doctrine of pre-emption. Under the pre-emption doctrine, federal law, including federal statutes, treaties, administrative rules, and common law “trumps” state law that is inconsistent with the specific terms of overall objectives of the federal law.

In Wyeth v. Levine, 555 U.S. (2009) (complete citation not available as of the date of this post; citations are for Slip Opinion), the Plaintiff, a professional musician, lost her hand to gangrene when she was administered Phenergan, an FDA-approved drug manufactured by Wyeth Pharmaceuticals for treating the nausea which often accompanies severe migraine headaches. During her first visit to the clinic, Phenergan was administered by an intra-muscular injection. The Plaintiff returned later in the day, but this time the drug was administered by an “IV-push” intravenous injection by the attending physician’s assistant. Unfortunately for the Plaintiff, the “second” injection procedure caused the drug to come into contact with arterial blood, resulting in the onset of gangrene and eventually the amputation of her hand and forearm.

The Plaintiff sued Wyeth in Vermont State Court on grounds of negligence for failure to provide an adequate warning concerning the potential danger of an “IV-push” procedure for administering the drug and product liability. A Vermont jury agreed and found Wyeth liable on grounds of negligence and product liability, and awarded Ms. Levine over $6,000,000.00 in damages.

Wyeth appealed the verdict to Vermont’s Supreme Court arguing that the drug’s label, which had been approved by the FDA, was in compliance with federal laws and regulations which govern drug safety and labeling requirements. Hence, the FDA’s regulatory requirements for prescription drug labels should pre-empt Vermont’s tort law which were in conflict with the FDA’s requirements. The Vermont Supreme Court affirmed the verdict and rejected Wyeth’s position. Wyeth appealed the decision to the U.S. Supreme Court.

The issue before the U.S. Supreme Court was whether Phenergan’s FDA- approved warning label "preempt state law product liability claims premised on the theory that different labeling judgments were neessary to make drugs reasonably safe for use." Slip Op. at 6. According to the U.S. Supreme Court, the answer is no. The Court, in a 6 to 3 decision, to the surprise of many observers, has affirmed the Vermont Supreme Court by holding that Vermont’s tort law was not pre-empted by the FDA’s labeling requirements for Phenergan.

Justice Stevens delivered the opinion of the Court, with Justice Kennedy and Justice Thomas concurring in separate opinions.

To better understand the US Supreme Court’s “pre-emption discussion,” some background on the pre-emption doctrine may be helpful. Generally pre-emption can be broken down into three distinct types: Conflict Pre-emption, Field Pre-emption, and Implied Pre-emption. The Wyeth decision focused on Conflict Pre-emption. Under case law developed for Conflict Preemption, federal law generally will trump state law under the following two circumstances:

1. A conflict between federal and state law makes it physically impossible to comply with both federal and state standards. Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142-143 (1963).
2. A state law may conflict with federal law by creating an “obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” Hines v. Davidowitz, 312 U.S. 52, 67 (1941).

Wyeth argued that FDA labeling requirements preempted or “trumped” Vermont’s tort laws on the basis of both types of Conflict Preemption as follows:

1. It is impossible for Wyeth to comply with both the state-law duties and federal-labeling regulations, since the latter forbids it from changing its label without FDA approval. See Fidelity Fed. Sav. & Loan Assn. v. De la Cuesta, 458 U. S. 141, 153 (1982). Slip Op. at 6.
2. Permitting states to require stronger warnings creates an unacceptable “obstacle to the accomplishment and execution of the full purposes and objectives of Congress,” Hines v. Davidowitz, 312 U. S. 52, 67 (1941), because it substitutes a lay jury’s decision about drug labeling for the expert judgment that Congress sought to entrust with drug labeling decisions when it created the FDA. Slip Op. at 6-7.

The majority’s analysis of the pre-emption issue begins by stating that “[o]ur answer to that question must be guided by two cornerstones of our pre-emption jurisprudence. “ ‘First, the purpose of Congress is the ultimate touchstone in every pre-emption case.’ ” Slip Op. at 8. citing Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (1996) (internal quotation marks omitted).

" Second, “ ‘[i]n all pre-emption cases, and particularly in those in which Congress has "legislated. . .in a field which the States have traditionally occupied, . . . we ‘start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.’ " Lohr, 518 U.S., at 485 (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218 230 (1947)" Slip Op. at 8.

In reaching its conclusion that Wyeth’s two-pronged preemption argument must fail, the High Court first reviewed the history behind Congress’ establishment of the Food and Drug Administration in 1906 to the gradual expansion of the FDA’s power to ensure the safety and efficacy of prescription drugs in 1962. Since 1962, any prescription drug sold in the US must be pre-approved by the FDA before it can actually be sold in this country. Pre-market approval involves the submission of considerable safety and efficacy data to the FDA for evaluation. Clinical trials, performed according to defined clinical trial protocols are required and the results become part of the FDA “new drug” evaluation package. Slip Op. at 9-10.

Regarding Wyeth’s first pre-emption argument, the majority emphasized that re-labeling the drug to conform to Vermont law would not necessarily have violated federal labeling regulations.
Although a manufacturer generally needs FDA approval before changing a drug label, the agency's “changes being effected” (CBE) regulation permits certain unilateral labeling changes that improve drug safety without waiting for FDA approval. Such changes may include warnings that “add or strength an instruction about dosage and administration that is intended to increase the safe use of the drug product.” Slip Op. at 11 quoting the CBE regulation §§ 314.70(c)(6)(iii)(A), (C). Any such “CBE” changes must be accompanied by a supplemental application to the FDA which retains its authority to review all supplemental applications. Slip Op. at 11.

Continue reading "Wyeth v. Levine: The Intersection of FDA Drug Labeling Requirements, State Tort Laws, and Drug Manufacturer Responsibility According to the U.S. Supreme Court" »

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Posted In: Prescription Drug Product Liability

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