Will FDA Regulations Preempt Personal Injury Suits?
By Elizabeth C. Moran, JD
Digest, Winter, 1996
In January 1996, the U.S. Supreme Court agreed to decide whether FDA regulation of medical devices precludes patients from bringing strict liability, negligence, and other common law claims for injuries caused by improper design, manufacture, or labeling of medical devices.
In Lohr v. Medtronics, Inc., the plaintiff claimed she was injured by an unsafe pacemaker, a Class III device which had been marketed under the abbreviated Section 510(k) procedure as “substantially equivalent” to previous pacemakers.
Applying the Medical Device Amendments of the Food, Drug and Cosmetic Act, which prohibit states from imposing regulations on medical devices that are “different from or in addition to” federal regulations, the U.S. Court of Appeals for the Eleventh Circuit determined that because the FDA imposed specific regulations on the manufacture and labeling of the device, injured patients cannot sue the manufacturers for manufacturing defects or inadequate warnings. The Court held, however, that claims relating to improper design of the pacemaker still could be pursued because the FDA had not imposed any specific requirements governing design.
Over the past several years, the courts have issued widely divergent and conflicting decisions in this area. For example, the Ninth Circuit recently held, in Kennedy v. Collagen Corp., that the Medical Device Amendments do not preclude personal injury suits at all but are intended to prevent states from enacting statutes and regulations that apply specifically to medical devices.
Some courts have held that certain kinds of injury claims are preempted for Class III devices that have gone through full Pre-Market Approval, but not for devices, such as Class II devices, that are subject to lesser regulation. Other courts have held that there is no preemption unless the FDA has enacted regulations specific to a particular device, such as the specific requirements for warnings on tampons and hearing aids. Still others have applied the doctrine of preemption broadly, concluding that the FDA’s general requirements for manufacturing procedures and labeling, which apply to all medical devices regardless of classification, preclude most, if not all, common law injuries.
The Supreme Court’s decision will have a profound effect upon the scope of litigation involving medical devices.
If the Court applies preemption broadly, as many lower courts have done, device manufacturers will be largely insulated from liability. However, the physician who uses the device remains a potential defendant — perhaps the only “deep pocket” — under theories of medical negligence and lack of informed consent.
Criticism Aimed at Colleagues Can Prompt Malpractice Litigation
By William D. Noonan, MD, JD
Argus, January, 1996
One of the legal dangers in a managed care environment is that eye patients are sometimes given inadequate or inappropriate eye treatment by primary care physicians and nurses before they are referred to ophthalmologists for definitive care. As a result, eye specialists are more likely to see advanced cases or inadequately treated patients who are at greater risk for an unfavorable outcome that could result in malpractice litigation.
The specialist’s initial reaction may be smug satisfaction that primary care physicians and nurses will have to bear the legal consequences of providing specialized eye care without specialized training. This satisfaction evaporates, however, when the ophthalmologist is also named as a defendant in a lawsuit even though his or her only role may have been to improve the situation as best as possible. When lawsuits are filed, almost every professional person who participated in the care of the patient may be named as a defendant. Hence, it can be an act of self-preservation to resist the urge to share with any patient your opinion that a previous treating physician provided substandard care.
This is illustrated by the case of a 39-year-old woman who was hammering a nail into a bookcase when the nail flipped back against her left eye. A primary care physician evaluated her that same day in an emergency room. The physician instilled fluorescein in her eye and diagnosed a corneal abrasion. Visual acuity was not determined. She was treated with gentamicin ointment, a cycloplegic and a narcotic analgesic, and told to consult an ophthalmologist if the eye was unimproved the following day.
The next afternoon she was seen in an ophthalmology clinic, complaining of unremitting left eye pain and visual loss. Visual acuity in that eye was count fingers at one foot, and she had marked periorbital edema, chemosis and conjunctival injection. On slit lamp exam, there was a corneal laceration and a clear defect in the iris at 5 o’clock. The lens was completely opaque, intumescent appearing, and 5mm thick by ultrasonographic examination. The corneal wound was Seidel positive, and there was 1+ cell and flare in the anterior chamber. Intraocular pressure in that eye was 28. The patient underwent cataract extraction with repair of the corneal laceration. Her postoperative recovery was uneventful with eventual visual acuity of 20/25.
The primary care physician had incorrectly diagnosed the patient’s ruptured globe as a corneal abrasion, in spite of an obvious hole in the iris. This oversight delayed primary closure of the wound and exposed the patient to an increased risk of endophthalmitis. Although the patient was fortunate to have a favorable visual outcome, there was a risk of unnecessary blindness. At first it would seem that the ophthalmologist could best be insulated from liability by informing the patient that her injury had been misdiagnosed, but that everything possible would now be done to save the vision in her eye.
That kind of candor, however, only tends to promote malpractice litigation. Many patients who would not otherwise consider litigation are prompted to sue when a physician criticizes the care previously provided by a colleague. Once litigation is initiated, even the “blameless” specialist who fixed the problem may be named as a defendant.
Hence, the safest course for reducing one’s risk of litigation and legal liability is to carefully document the patient’s condition on presentation, provide high quality care with a realistic assessment of probable outcomes, and accurately present the facts of the situation to the patient while refraining from criticizing a medical colleague. Not all diagnostic errors are ipso facto negligence; therefore, it is always best to limit discussions with the patient to findings supported by objective data and to avoid speculation. If the patient questions the care of another health care provider, encourage the patient to talk directly with that provider.
It is naive to believe that less criticism of colleagues will eliminate or even substantially reduce medical malpractice litigation. A patient with postoperative endophthalmitis who undergoes enucleation knows something went wrong and will not need prompting to consider legal action.
But a variety of other conditions (such as missing an early diagnosis of glaucoma or overcorrecting a radial keratotomy) are within the realm of competent, but less than optimal, ophthalmic care. Patients may be dissatisfied with such an outcome but reluctant to consider litigation until given “permission” by a critical subsequent ophthalmologist. Under these circumstances, it is important to refrain from criticizing a colleague and to help maintain civility in medicine even as the profession is increasingly turned into a business by health care companies.
Emergency Room Protocol for On-Call Ophthalmologists
By Kenneth C. Chern, MD
Argus, August, 1996
Many emergency room physicians receive little or no formal training in ophthalmology, yet they commonly see and treat acute ophthalmic injuries. As a consulting ophthalmologist, you may find yourself relying on an ER physician’s description of a patient’s condition and recommending treatment by phone without ever seeing the patient. Follow-up may not occur until days later, by which time the patient’s condition may have advanced beyond the window for optimal treatment. These factors increase the risk of ER-related claims.
The following is a typical scenario:
It is 10:00 on a Saturday night. A 35-year-old man comes to the ER with a red, painful right eye. The ER physician calls you at home:
“Hello, this is Dr. Jones, ophthalmology, on call.”
“This is Dr. Smith in the ER. I have a young man here for whom I want a sideline opinion. You don’t have to come in.”
“OK, what happened?”
“Mark wears extended wear contact lenses. He hasn’t worn them for the past 48 hours or so because of discomfort, although he regularly wears them continuously for up to two weeks. I think he may have scratched his cornea putting his lenses in since a small area of the cornea lights up with fluorescein. He says he has scratched his cornea several times before. What do you do for these corneal abrasions?
“Usually they heal with an antibiotic ointment and an overnight patch.”
“I’ll patch him up and have him see you on Monday morning.”
“That will be fine. Good night.”
On Monday morning, when the patient comes in, you find a dense stromal infiltrate and purulent material under the patch. The “scratched cornea” was the start of an infective corneal ulcer. With appropriate antibiotics, the cornea heals, leaving a residual scar and decreased vision.
With emergency rooms and urgent care centers fast becoming the first gateways for acute ophthalmic emergencies, a methodical and regimented routine is essential to ensure that the patient receives prompt and appropriate initial treatment.
It is not always necessary for the ophthalmologist to see the patient in the ER. Phone consultation may be sufficient and expedite care and treatment. However, when providing telephone consultation, a thorough history, vision test, and full physical exam are necessary to elicit other causes of the symptoms that the ER physician may not have considered. If you have any doubt about what has been described, there is no substitute for examining the patient yourself. Mentally run through a differential and treat the patient as if you were treating the most serious possibility. A corneal abrasion will heal even if it is treated as a bona fide infection with topical antibiotics.
Follow all emergencies closely until they are resolved. Referral follow-ups from the ER especially need to be re-evaluated in a timely fashion by an experienced ophthalmologist even if this means seeing the patient on a weekend or a holiday. This is part of appropriate patient management for an on-call physician.
Education is the best prevention against scenarios like the one described. Educate the ER physician and staff to recognize signs of serious ophthalmic problems, to express uncertainty, and to contact the on-call ophthalmologist immediately in complex cases. Encourage them to ask more probing questions when history and examination findings do not fit the diagnosis. When you are on call, report back to the ER physician about patient outcomes. This may be the only feedback and instruction they receive on ophthalmic emergencies. Their education is your best defense if a claim arises from care in the ER.
Ancillary Personnel Should Know Their Limits When Screening Patients
By Richard H. Birdsong, MD
Argus, Nov.-Dec., 1996
Increasingly, ophthalmologists are relying on ancillary personnel to screen patients, but as the following case history illustrates, ancillary personnel need to understand their clinical limitations. When faced with serious eye problems beyond their training and experience, they should know when to refer patients to an ophthalmologist.
A 15-year-old male was struck in the left eye with a dart-like projectile. After removing the projectile, the boy noted “tearing” and sought medical attention. He presented to the emergency room of a community hospital, where he was referred to the ophthalmology clinic within the same hospital. The patient initially was seen by a technician who, following the clinic’s protocol, took a brief history, obtained a visual acuity, and performed a non-contact tonometry (NCT). The patient noted that the “tearing” from the injured eye ceased after the NCT.
After these screening steps, one of the clinic’s ophthalmologists evaluated the patient, noting a central full thickness corneal laceration, air in the anterior chamber and lens damage. The patient was immediately referred to the nearby supporting medical center for emergent evaluation and repair.
At the medical center, the examination revealed VA of count fingers two and one-half feet OS. In addition to the corneal laceration, there was lens cortex and capsule to the wound. The patient underwent emergent repair of the corneal laceration, lensectomy and sulcus fixated posterior chamber intraocular (IOL) placement. Intravitreal hemorrhage was noted nasal to the disc, consistent with an exit wound. Systemic and subconjunctival antibiotics and subconjunctival steroids were given.
Two days later, the patient developed endophthalmitis and returned to surgery, at which time the IOL was removed, a core vitrectomy was performed, and intravitreal antibiotics were given. Cultures revealed gram positive cocci in chains and pairs, gram negative rods and gram positive rods.
Four days after the initial injury, the patient again returned to surgery for repeat intravitreal antibiotics and cultures, which revealed persistent gram positive cocci. The endophthalmitis resolved, but four weeks later there was a corneal wound melt, which was treated with cyanoacrylate glue. Two weeks later, further cortical vitrectomy was performed for a traction retinal detachment and nonclearing vitreal debris. Presently, the patient has VA of CF at three feet with +12 correction and a cloudy central cornea. VA by Potential Acuity Meter is 20/160, and a penetrating keratoplasty is planned for the future.
In this case, the proper use of screening procedures by ancillary clinic staff prior to patient evaluation by the ophthalmologist was called into question. While the dart was the likely source of bacterial contamination, introducing air into the anterior chamber during NCT was almost certainly a contributing factor. This could have been avoided if the technician had recognized the significance of the patient’s history and presenting complaints as well as the urgent need to consult the ophthalmologist before proceeding further.
Screening protocols are clearly an efficient time-saving tool since most patients present with common clinical problems that can be handled well by a division of labor between the ophthalmologist and the clinical staff. However, these protocols can contribute to adverse outcomes if they don’t include eye trauma and selected eye emergencies, particularly when clinic staff who are inadequately trained or unfamiliar with potentially serious eye conditions perform screening tests. In this case, the technician was unable to determine that the patient’s history indicated a very strong possibility of an open globe, which contraindicated NCT.
Screening procedures should allow for some flexibility, and technicians should be encouraged to ask the ophthalmologist to initially examine patients who present with non-routine problems.
Eyes, Lies and Videotape
By Jean Hausheer Ellis, MD, FACS
Argus, May 1997
For quite some time, ophthalmologists and other specialists have been videotaping surgical procedures, sometimes for educational purposes and sometimes to help keep operating personnel aware of the progress of a surgical procedure. Some ophthalmologists offer their patients a copy of the video to enhance patient education and strengthen the patient/physician relationship as well as to market a given surgical method or technique to a targeted audience. Considering, however, that about 70% of medical misadventures for all specialties occur in the operating room, a videotape can act as a shield and help diminish the chance of a paid claim or as a sword and increase exposure to a claim.
The Physicians Insurance Association of America (PIAA), an association of about 50 doctor-owned professional liability insurance companies, surveyed member companies and found that only 18% of respondents thought a videotape of the procedure would be helpful in making the decision to defend or settle a case. Some respondents felt the risks of using a videotape far outweighed the benefits. One member company reported that it had to make a settlement for $700,000 more than it thought a case was actually worth because the wrong instructions had been given to the surgeon and were recorded on the audio portion of the videotape.
PIAA also surveyed defense attorneys and found that 73% opposed videotaping surgical procedures. Some commented that videos present an inflammatory scene to an untrained eye in the jury box, and an appropriate procedure could appear otherwise to a layman, resulting in a frivolous or nuisance lawsuit. Another concern was that since fewer than 40% of iatrogenic injuries ever come to the attention of the patient, why send the patient home with a tape that might clearly show the surgeon making a mistake?
If an ophthalmologist does decide to videotape surgery, it is important to have policies and procedures in place. In most states, the videotape of a surgical procedure will likely be considered part of the patient’s medical record. As such, if a malpractice suit is filed, videotapes will be discoverable by the plaintiff and admissible at trial. Therefore, videotapes should be identified with the patient’s name, identification number and date of procedure. As with all medical records, videotapes should be properly stored to prevent loss, misfiling or damage. Videotapes should be stored under the proper conditions (i.e., humidity, temperature and darkness) to preserve their quality.
Obtain Separate Informed Consent Before Videotaping
Before videotaping a surgical procedure, obtain a separate informed consent which includes the reasons for taping the surgery, permission to tape the procedure in question, and the fee, if any, to be charged for taping the procedure. It also should include permission to use the videotape for educational or other purposes, and acknowledgment that the surgeon has the right to retain ownership and possession of the original tape. The form should include an explanation of the patient’s right to obtain a copy of the tape and the involved charges, if any, as well as a description of the physician’s policy regarding the length of time the tape will be preserved. It is recommended that the form include the scheduled date for destruction of the tape with an explanation that the patient should request a copy prior to that date if desired.
It is important to be consistent when videotaping. For example, some videotapes purposely contain only part of a procedure (especially if a problem arises during surgery). Generally, it is advisable to tape the entire procedure including difficult problems. If it becomes necessary to discontinue videotaping a surgical procedure, or if there is unintentional alteration or erasure of a videotape, the reason and a description of the discontinuance, alteration or erasure should be documented in the patient’s medical record. Intentional alteration, editing or erasure of a videotape without prior written consent of the patient is as improper as altering the written medical record. If there is any intention to edit, erase or destroy a tape (prior to the scheduled date of destruction on the informed consent), the ophthalmologist should advise the patient of this intention prior to doing so, and obtain the patient’s written consent. A dictated transcription of the designated videotape to be destroyed can be done prior to its destruction.
In conclusion, if the ophthalmologist has a specific protocol in place for videotaping surgery (informed consent and consistency when taping) and handling the videotape (storage and ultimate disposition), the possible legal risks of videotaping a surgical procedure can be minimized.
