What do the Kansas City pharmacist Robert Courtney, Doc's Pharmacy in Walnut Creek, Calif., and Vioxx (rofecoxib, Merck) have
in common? All involve pharmaceuticals, pharmacies, claims of harm to patients—and lawsuits against pharmacists.
Courtney was hit with a $2.2 billion civil judgment and a 30-year prison term in 2002 after admitting he had diluted cancer
chemotherapy products since at least 1992. Injections of betamethasone compounded at Doc's Pharmacy killed three patients
in 2001. Vioxx was taken off the market last September amidst charges that Merck systematically ignored safety data linking
the drug to increased risk of cardiac events.
Plaintiffs' attorneys are taking all three cases—and thousands more—all the way to the bank. When it comes to product liability
and malpractice cases, pharmacists are no longer innocent bystanders even when they do nothing wrong.
"We are not suggesting that Walgreen's or individual pharmacists [who dispensed Vioxx] engaged in malpractice, fraud, or misrepresentation,"
said Madison McClellan, a Stuart, Fla., attorney representing 49-year-old Mark Tomlin, who suffered heart failure while taking
Vioxx for neck pain. Tomlin filed suit against Walgreen's and Merck in early December. "The issue here is with the manufacturer,"
McClellan said. "But under Florida product liability law, the distributor has a duty to ensure that every product is not unreasonably
dangerous. The distributor bears a burden here."
Walgreen's does not comment on pending litigation, but Wayne State University pharmacy practice professor Jesse Vivian is
not surprised by the Florida suit. Lawsuits are filed as much for tactical reasons as for cause. In product liability cases,
he explained, it is common for attorneys to file cases against distributors in state court. The goal is to have the case heard
at the state level, which is seen as more sympathetic to individuals than the federal courts.
There is also what Vivian calls the shotgun effect. "The plaintiff shotguns everybody in sight. All it takes is hitting one
defendant with deep pockets, so you sue the drugmaker, the pharmacist, the pharmacy, the wholesaler, the physician—anybody
and everybody you can imagine might have the slightest connection. All it takes is one of them paying to make it worthwhile."
Increasingly, that anybody includes pharmacists. It is not that pharmacists' stature or public image is eroding, Vivian said. It is more a change in
the way pharmacy and law are practiced. Pharmacists used to be drug distributors. As such, their liability was limited to
mechanical errors, dispensing the wrong drug, the wrong dose, or the wrong label. But as pharmacists expand their scope of
practice to include counseling, utilization review, prescribing protocols, immunizations, and other services, they are also
expanding their liability exposure.
"If you look to intellectual issues such as allergies, interactions, or how to use drugs, more and more of these cases are
coming up each year," Vivian said. "The trend is increasing scope of practice and increasing scope of liability. The number
of cases is growing."
Pharmacy insurers see the same trends. Liability claims are increasing faster than the number of pharmacy liability policies.
Loss ratios, the ratio of claims insurance companies are called upon to pay compared with the size of the population that
they insure, are increasing. The cost of liability coverage for pharmacists is nowhere near the levels paid by specialty physicians
(see sidebar), but pharmacy rates are likely to rise over the next few years.
"We are seeing more claims, even taking into account our own growth," said Kenneth Baker, senior VP and general counsel of
Pharmacists Mutual Insurance Co., the only insurance firm in the nation that specializes in covering pharmacists and pharmacies.
"Claims are of higher dollar value," he said. "The margin between what is being paid and what is being collected is shrinking.
We are looking at ways to control losses."
Translation: Insurers can lower their risk by introducing tougher standards and covering fewer pharmacists, by reducing coverage,
or by raising rates.
Marsh & McLennan, the nation's No. 2 pharmacy insurer, is also seeing claims rise. "With more automation and more technicians
in pharmacies, you would expect to see claims decrease," said Gary Bull, head of retail practice at Marsh. "The numbers are
actually up even though pharmacy retailers [drug chains plus grocery chains and mass-merchandisers with pharmacy operations]
tend to cover their own losses."
Why claims are filed against pharmacists
|
Translation: Insuring pharmacies is a riskier business than it used to be. Pharmacists are not falling down on the job. Rather,
courts are holding them to a higher standard of practice.
"Looking at reported case reviews, there are new legal angles that we haven't seen before," said Susan Winckler, VP of policy
and advocacy for the American Pharmacists Association. "The new theories tend to build around a pharmacist's duty to warn.
Every new activity in pharmacy brings with it a new liability."
Careful what you ask for The biggest change is to what is known in legal circles as the learned intermediary doctrine. The basic concept, explained attorney Roger Morris, partner and head of the healthcare practice group at Quarles & Brady
LLP in Phoenix, is that responsibility and liability lie with the most knowledgeable party.
That used to be the physician, who knew medicine, knew the patient, and knew pharmaceuticals. The physician was the learned
intermediary between the manufacturer, who did not know the patient or the practice of medicine, and the patient, who knew
nothing about drugs or medical practice.
The pharmacist's only role was to dispense. As long as the prescription was filled as written, the pharmacist was off the
liability hook. Following orders led to decisions that seem peculiar to current sensibilities.
In the early 1960s, according to San Francisco-area pharmacy owner Paul Lofholm, a local teenager died of aplastic anemia
after taking Chloromycetin (chloramphenicol, Parke-Davis) prescribed by multiple physicians. All of the Rxs were filled at
the same pharmacy, but neither pharmacy nor R.Ph. was liable because the Rxs had been filled as written. California courts
held that it was not the pharmacist's duty to second-guess physicians. The prescribing physicians were held responsible even
though none knew of the other Rxs that contributed to overdose and death.
"We, as a profession, have fought that edict," Lofholm said. "One pharmacist had access to all those scripts and failed to
recognize that the patient was getting the same drug from three different physicians. It's an ethical issue regardless of
the legalities involved. Now the legal outlook is changing."
The learned intermediary doctrine was created by drug manufacturers to shift liability to physicians, explained attorney Edward
Krill, partner in the Washington, D.C., firm of Carr Maloney, which represents drug chains. The drugmaker's duty was to inform
physicians as to indications and possible adverse reactions. Protecting the patient from adverse effects was the physician's
role. "It was all up to the physician," he said. "All the pharmacist was supposed to do was fill the script without comment."
Changing technology and changing pharmacy roles are eroding the learned intermediary doctrine. Increasingly, Krill said, courts
are holding that the pharmacist has a duty to warn patients and intervene on their behalf.
How much insurance is enough?
|
Krill points to the development of computerized drug utilization review as key. Not only do today's pharmacists have specialized
training that exceeds the drug knowledge available to most physicians, DUR and on-line drug profiles give pharmacists more
complete patient information.
Pharmacists and pharmacies have emphasized that special knowledge and pushed for additional responsibility, Krill said. By
and large, they have succeeded. "Pharmacists have been advertising the fact that they have access to all the scripts a patient
is filling, at least within the chain or the health plan," he said. "Pharmacists are touting their ability to check for interactions
that no one else has the information to uncover. We now expect pharmacists to make the best professional judgment possible.
They can no longer walk away claiming it is the physician's responsibility."
Plaintiff attorneys have seen the same increase in pharmacist responsibility. In 1991, Pharmacists Mutual had no claims involving
drug utilization review. In 1999, drug review claims accounted for 9% of all pharmacist liability claims. A 2002 claims study
found the drug review claims were continuing the straight-line increase. There are no indications that the increase has leveled
off as R.Ph.s continue to expand their scope of practice.
Collaborative practice agreements with physicians offer more opportunities for pharmacists to use their expertise. So do practice
specialties such as diabetes care or drug regimen reviews and new services such as immunization and lab tests.
The Medicare Rx drug benefit that debuts in 2006 offers the prospect of medication therapy management for millions of patients.
Pharmacists are lining up for expanded professional roles, but they may not realize that expanded responsibilities bring expanded
liabilities. "You can't absorb the full professional role without accepting full professional liability," said John Rector,
senior VP of government affairs for the National Community Pharmacists Association. "As soon as you begin to think in terms
of acting as a learned intermediary, you take on that additional liability. You can't have the expression and the exercise
of professional judgment without the corollary of professional liability. You absolutely need malpractice insurance. That
is a sea change for pharmacists."
Are you protected? It is not just community pharmacists who are affected. Professional associations say that every pharmacist, regardless of
practice site, needs his or her own professional liability insurance. "People think that they are covered by the hospital,"
explained David Witmer, director of professional practice and scientific affairs for ASHP. "They are covered, but the pharmacist's
interests and the hospital's are not always the same. When it comes to liability, business is business. You need to protect
your own assets and interests."
Some pharmacists may need protection more than others. Compounding R.Ph.s represented 1% of Pharmacists Mutual claims in a
recent year but 16% to 17% of monies paid out, Baker said. One year does not make a trend, he conceded, but the firm is looking
at ways to reduce its risk. One possibility is to put compounders in a separate risk pool, or category, and charge higher
premiums to cover the higher payouts. Another possibility is to lessen the risk by requiring special training and certification
for compounders. Better training means fewer errors, and fewer errors means fewer claims.
Pharmacists Mutual is backing the Pharmaceutical Compounding Accreditation Board (PCAB), which is being created by several
pharmacy associations and will be overseen by the National Association of Boards of Pharmacy. Insurers may require PCAB accreditation,
Baker said.
"We are seeing the beginnings of a litigation wave," said NAPB executive director Carmen Catizone. "The learned intermediary
doctrine that protected pharmacists is starting to be questioned. People see that best practices, reasonable practices, need
to be codified and followed."
How to keep an error from becoming a lawsuit
|
The biggest problem is that no one can predict where the next liability claim will come from. Pharmacies that filled Vioxx
scripts are prime targets for plaintiff attorneys. Pharmacy outlets that dispensed other COX-2 inhibitors or Rx/OTC products
containing naproxen could be next.
"We clearly have a situation in transition," said pharmacist/attorney Richard Abood, professor of pharmacy practice at Thomas
J. Long School of Pharmacy and Health Sciences, University of the Pacific. "A few years ago, if a person had a drug-related
claim, it was the physician who got sued. Now pharmacists are very much on the radar screen. The tendency is to sue everybody
and hope somebody pays."
Even pharmacists who do not make errors are targets for liability by association. Drug chains, wholesalers, and manufacturers
have been sued over counterfeit products, Morris noted. So why not sue the pharmacist who unwittingly dispensed and counseled
on a counterfeit so realistic that neither the manufacturer, the wholesaler, nor the drug buyer could detect the fake?
Drug imports are another problem area. It is only a matter of time, he predicted, before a patient is harmed by an imported
product and sues the most convenient target, a domestic pharmacist.
Over-the-counter products and herbals are another potential problem. Pharmacists routinely ask whether patients are taking
non-Rx products, but cannot counsel properly if the patient chooses not to answer truthfully. "It is the patient who chooses
not to tell the pharmacist everything, but it is the pharmacist who will get sued for that lapse," Morris warned. Liability
insurance has become as essential as a pharmacy license, he added.
"It is not fun to win a lawsuit," Morris said. "It costs just as much to win a case as to lose; it takes just as much effort
and time. And when you come out the other side, no one is going to pat you on the back and say, 'Congratulations, you didn't
kill that patient after all.' "
