New Jersey Injury Lawyer & Attorney : Law Offices of Scott D. Grossman : Serving Monmouth County, Bergen County

Madison, New Jersey based Quest Diagnostics, the largest medical diagnostic facility in the country has admitted that it sent out a large number of erroneous Vitamin D test results to doctors and patients in 2008. The company launched an investigation into the matter in June when doctors from around the country began questioning the validity of some of the test results that they had received.   The announcement comes after a probe confirmed that errors had indeed been made with an unspecified number of Vitamin D blood tests that the company had conducted last year.

The company hasn't confirmed how many patients may have been affected by the inaccurate test results nor has it admitted the number of laboratories that were involved in these messed up results. According to industry watchers however, the number is possibly in the thousands. The company has faced problems with Vitamin D analysis testing of the blood before, and had changed its test design from an earlier FDA approved one to a new design. However, the new test design has problems of its own, especially when used to test large volumes.

And volumes of Vitamin D tests have increased dramatically Quest. Recent studies have now linked Vitamin D to the prevention of a number of diseases including cancer, diseases of the auto immune system, and heart disease, although these findings have been debated by medical experts. Besides, Vitamin D has for decades been recognized for its bone strengthening abilities.

The inaccuracy of the results could have led to two kinds of prescription errors, experts say - either the test results may be erroneously too low, in which case a patient who doesn't really need any additional supplements may end up developing an over dosage reaction to Vitamin D, or the results could show a higher reading that ensures that patients don’t receive the strength of dosage they require. At least one doctor in New York City has confirmed that one of his patients developed a toxic level of Vitamin D in the blood as the result of an overdose. 

Toxicity of Vitamin Dcan be seen in minor symptoms, like nausea, vomiting and constipation, but its major effects can be seen in the form of increased levels of calcium in the blood, disorientation and abnormal heart rhythm. Excess calcium can be deposited in the kidneys, increasing the risk of kidney stones.

The question doctors and Monmouth County medical malpractice lawyers are asking is why the company took so long to admit that there had been inaccuracies in its results, when these slip-ups had first been brought to its attention in 2007.

 

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USA Today has an interesting report on how pharmacy boards across many states have a majority of their board members made up of employees of major chain pharmacies, ensuring that any oversight of pharmacies or reduction of filling errors is limited at best.

The concept of having pharmacy chain employees on state pharmacy boards supposedly ensures that these boards have the expertise of seasoned professionals to draw from. While that may be true, it also ensures that the boards are staffed with a number of members who act to protect the interests of the pharmacies they work for. It reduces the concept of an "independent" state board regulating and overseeing the functioning of thousands of pharmacies in a state, to a farce.

For instance, in Illinois, the chairman of the Pharmacy Board has a day job as the national director of pharmacy affairs at Walgreen. Similarly, Pennsylvania's Board is chaired by the vice president of pharmacy services at Rite Aid. There are more such examples at Arkansas, Massachusetts and Minnesota where pharmacy chain employees occupy important positions on the board.

Nobody should be too surprised when these board members who have vested interests proceed to veto decisions that are detrimental to the interests of the chain they work for. A perfect example to illustrate the conflict of interest here is the case of Tonya Pearson, a pharmacist at a Jacksonville Walgreen outlet, whose failure to catch a prescription error led to the death of Terry Paul Smith, a construction worker. When the employee came up for disciplinary hearings, a board member who was also a pharmacist at Walgreen, vetoed a fine of $10,000 on the erring Pearson. She got away with a $1,000 fine, and an "education program" to help catch errors – something Walgreen should have put her through before it allowed her to fill prescriptions at their outlet.

Such conflict of interest has riled advocates of better separation between the regulator and the regulated. But, the status quo continues merrily, and the only sufferers are victims of prescription errors like Terry Paul Smith. It's injustices like these that inspire pharmacy misfill lawyers who often turn out to be the only line of defense against well connected, big name chain pharmacies and their widespread sphere of influence. 

 

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Earlier this year, I had discussed a bill introduced in the New Jersey legislature, called innocuously enough “The Pharmacy Quality Improvement and Error Prevention Act." On the surface of it, the Bill, which was passed unanimously in the Assembly in March 2006, addressed common concerns about the increasing instances of pharmacy errors, and the need for more measures to prevent these errors, and hold pharmacies accountable for the results of any prescription mistakes on their watch. The Bill also included immunity for pharmacists from any civil liability that may arise from prescription mistakes they made. In all the brouhaha over the Bill, its sponsors conveniently failed to highlight this significant point.

Now, an identical bill “The Pharmacy Quality Improvement and Error Prevention Act A-1803" has been introduced in the Assembly by Assemblywoman Valerie Huttle. She has been busy promoting her legislation, hailing it as an effective measure to prevent the number of injuries that occur because of prescription mistakes in New Jersey.  

What she does not mention anywhere in her promotion hype, is a small line tucked away in Page 9 Sec C of the bill which says:

A registered pharmacist, who reports information to the board relating to a medication-related error, as required pursuant to subsection a. of this section, shall be immune from liability in a civil action for any injury or damages in connection with that medication-related error.

If the bill becomes law, what it will mean for New Jerseyans, is that in the event that they are injured because of a prescription error, the pharmacist who was responsible for filling the prescription will not be held liable for any injuries that were caused by his mistake. All that's required for the pharmacist is essentially to report his error to the New Jersey State Board of Pharmacy, to get away with a slap on the wrist, and not much more.

As a pharmacy error lawyer, I am all for legislation to prevent errors, and the establishment of an oversight committee that will act as a watchdog to prevent innocent consumers from having to suffer the often dangerous effects of prescription mistakes. What I cannot understand however, is the establishment of a Task Force that has just two members out of its 17 public members, representing the needs of health care consumers. The remainder of the members is made up heavily of chain pharmacies, pharmaceutical companies, and other allied interests.

Throughout the country, we're seeing big name pharmaceutical interests taking increasing precedence over the protection of the consumer. Whether it’s the eagerly awaited outcome of the currently ongoing Wyeth-Levine lawsuit that threatens to take away an individual's right to sue a company for injuries sustained by an FDA-approved drug, or this bill that jeopardizes the rights of New Jersey residents to claim liability when they have been injured because of pharmacy error, increasing legislative interference with the rights of citizens is a dangerous and continuing trend that must be curbed.  

 

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Earlier this week a story on ksl.com, a Utah television station, reported that an eighteen-year-old honor student received a potentially lethal dose of oxycodone for strep throat and has been in a coma since April 30. The teen, Jessie Scott of Draper, Utah, was given a teaspoon of concentrated oxycodone hydrochloride for pain due to strep throat, when the actual prescription called for a five-milligram dose. The Wal-Mart pharmacy that filled the prescription, was supposed to dilute the concentrated medication before dispensing it to Jessie, but it failed to do so. Jessie received 20 times’ the prescribed dosage due to Wal-Mart’s negligence. As of a result of the pharmacy’s horrific error, a few hours after taking the lethal dose, Jessie Smith’s organs began to fail, he was placed on a ventilator, and one of his lungs collapsed.

Our thoughts and prayers are with Jessie Scott and his family.

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Pharmacy error, mistake, negligence… whatever you want to call it, is becoming a national epidemic. How many more babies and young people have to get injured or die before something is done to address it? Last week, yet another report filed in Texas of newborns receiving an adult dosage of Heparin, the blood thinning medication, leading to terrible tragedy, only this time, the babies did not survive. Unlike the overdose that occurred involving actor Dennis Quaid’s newborn twins, the Texas overdose was not due to a labeling error, rather, it was apparently due to a mixing error by a hospital’s pharmacy. That hospital was Christus Spohn Hospital South in Corpus Christi, Texas. According to a recent AP article, on July 4, 2008, 17 newborns received 100 times the appropriate dosage of the drug. Of the 17, two died, three were released, and the remaining 12 are in the hospital’s NICU.

Kiii.com, a television station in Texas, further reported that the premature twins, a boy and a girl born to Eric and Erica Garcia, were transferred to Christus Spohn after birth  and allegedly died from the Heparin overdose. While the hospital is not admitting responsibility for the twins’ death since they were born four weeks early, they are investigating the matter. It is of note that two of the staff pharmacy employees have taken temporary leave.

Our hearts go out to the Garcia family during this difficult time.

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A large chain pharmacy commits another mistake by mislabeling a three month old's prescription with the wrong dosage.  I used the word mistake here because it is a well known way to describe pharmacy errors but the truth is that the words "pharmacy mistake" sound way too innocuous for these situations. 

This time, in a  recent article on FoxNews.com, the victim was a baby with a sinus infection. The parents filled a doctor's prescription for Histacol DM syrup at a Palm Coast, Florida Walgreen's store. The dosage of the medication was to be a quarter of a milliliter. The prescription was erroneously filled by a Walgreen's pharmacy, who wrote the  dosage at a quarter teaspoon, six times the prescribed amount of medication.  Upon taking the first dosage, the baby became unresponsive and was rushed to the hospital, where doctors were able to stabilize the child. In a typical move,  Walgreen's offered $2,000 to make this bad story disappear, which the family refused.

My experience with clients who have fallen victim of "pharmacy error" or "pharmacy mistake" at the hands of the large drugstore chains has taught me that Walgreen's would have made any settlement conditional upon the family signing a strictly enforced confidentiality agreement. This is of course done to shield pharmacy's from bad publicity and to prevent the public from knowing the truth about the frequency at which these mistakes occur.  Good for the Ruddell family who decided to go public with their story in order to inform others about what happened and to try to help save others from the same mistake.  

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I’m sure everyone is aware of the horror that actor Dennis Quaid and his wife Kimberly Buffington have suffered through in recent months. The couple welcomed twins in late November who were accidentally given 10,000 units of heparin instead of the usual 10 units of heparin while in the hospital (Cedar-Sinai Medical Center, Los Angeles). The babies, thankfully are recovering, but the Quaids have filed a lawsuit against the maker of the drug. The lawsuit centers around Baxter Healthcare Corporation’s failure to clearly label its 10 unit and 10,000 unit vials of heparin and failing to recall the product after three other babies died due to such a mistake. Apparently, both the small and large doses of the drug have similarly colored labels.

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Citizens of New Jersey, would it shock you to learn that in response to concerns about a dangerous increase in pharmacy-related prescription errors, your state legislature has introduced a bill, which if enacted into law, would preclude all forms of recourse should your pharmacist’s mistake cause you or your loved ones to suffer serious physical injuries. Well it’s hard to believe, but amazingly true: pharmacists would receive total immunity from civil liability for any errors committed resulting in serious harm as long as the error was reported to the New Jersey Board of Pharmacy. Even more astonishing is the likely effect the legislation will have on the large national and regional pharmacy chains- complete insulation from liability for the negligent acts of their pharmacist employees. In 2003, Auburn University conducted a study of retail community pharmacies and dispensing errors. The study revealed the error rate was nearly one error per 55 prescriptions filled (1.72%). The researchers concluded that, for more than three billion prescriptions dispensed nationwide, 51.5 million pharmacy errors occur annually. Just so we are all on the same page, I will define a pharmacy-related error. A pharmacy -related error occurs when a pharmacist:

• dispenses the incorrect medication;
• dispenses the incorrect dosage of the correct medication;
• dispenses the correct medication with incorrect instructions;
• dispenses the incorrect drug quantity and strength; or
• fails to take into account known drug allergies or dangerous drug interactions with other medications being taken by a patient.

“The Pharmacy Quality Improvement and Error Prevention Act”(A-1025) was passed in the New Jersey Assembly by an astonishing 76 to 0 vote in March 2006. As of this writing, the measure has been referred to the State Senate Commerce Committee for further consideration.

The bill was originally introduced to the New Jersey Assembly by Assemblyman Jeff Van Drew (District 1). Van Drew, a dentist, sponsored the bill in response to a series of articles printed in The Press of Atlantic City during 2002 that chronicled how patients were harmed by faulty prescriptions caused by improper labeling or dosage, increased pharmacists’ workloads and other mistakes.

"To err is human, but pharmaceutical mistakes pose serious, life-threatening consequences. Pharmaceutical errors should not be shrugged off as trivial, rare occurrences, particularly when dealing with drugs that can stop a heart, trigger allergic reactions, or lead to a patient's death," said Assemblyman Van Drew.   See press release dated September 14, 2006.  It is important to note that all press releases from NJ Legislators failed to mention any information about the fact that the bill also contains language that would totally limit the rights of all seriously injured victims of pharmacy errors to seek compensation through our civil justice system.   Here’s an overview of A-1025(I encourage everyone to link to the bill and read it in its entirety): The bill begins with a discussion of a study that revealed that every year, more than 7,000 Americans die from medication errors and further, that the number of complaints filed with the New Jersey Board of Pharmacy concerning prescription errors has more than doubled in the past eight years. The bill calls for immediate action to reduce the possibility of prescription errors as they may seriously harm New Jersey citizens. I agree whole-heartedly that intervening action is desperately needed in order to reduce pharmacy-related medication errors. With the increase in large retail pharmacy chains charged with generating large corporate profits, overworked pharmacy staffs are at risk of making life-threatening errors in increasing numbers. But my analysis of this bill suggests that public safety is not the driving force behind this legislation that the bill’s sponsors would like us to believe it is. It would seem that surrounding the pharmacy industry in a cloak of secrecy and immunity is the way some legislators believe that the public good will be best served. The bill establishes a 24-member task force called the “New Jersey Task Force on Medication Error Prevention.” Out of the 24 members of this task force, 17 are considered “public members” and the remaining seven members are heads of state agencies, representatives of state medical boards, and the Dean of School of Pharmacy at Rutgers. Eleven of the 17 public members are appointed by the recommendations of representatives of organizations of pharmacies, chain drug stores, pharmaceutical manufacturers, mail service pharmacies and health insurance carriers. The stated purpose of the task force is to provide guidelines to assist the New Jersey Board of Pharmacy in medication error prevention, pharmacy quality improvement, and in the development of consumer education programs. These guidelines also set forth the types of situations in which registered pharmacists would be required to report to the Board when they believe a medication-related error may have occurred.
Under the bill, where a patient has suffered “serious” or “significant harm,” a pharmacist would be required to report the error to the Pharmacy Board. The task force is also charged with considering what constitutes “serious” or “significant harm” and further, what information is required in such report.
The bill also requires pharmacies to establish what is called a “quality improvement program” designed to document, review and assess the medication related-errors for the purpose of minimizing the incidents. This information is potentially valuable for analyzing why, where and how pharmacy errors occur so that measures to prevent if not eliminate errors can be developed in response. But here’s the rub: any and all of the information gathered by a pharmacy’s “quality improvement program” concerning medication-related errors is to be considered privileged and confidential and per the terms of this bill, cannot be released to the public for any purposes. It is only allowed to be reviewed internally. I cannot really think of many other professions where the negligent acts of its brethren can be kept hidden from the public via government sanction. The public is prevented from obtaining knowledge as to whether the pharmacist who regularly fills their prescriptions has a history of committing dispensing errors, because that information is privileged. The State believes this is good for the public; the theory is that it will encourage pharmacy professionals to come forward and admit mistakes, hopefully learn from them and not repeat them. In effect, under the guise of public safety, it is the pharmacist who gets the protection after committing an error, and it is the public who is left out in the cold. And I wonder how we would ever know whether this plan works in reducing dispensing errors if we are not able to gather the data surrounding dispensing errors? If the confidentiality provision of the bill didn’t grab your attention, maybe the total immunity concept will. Check this out: Section 9, subsection c of the bill provides in relevant part that registered pharmacists who reports information to the Board relating to a medication-related error, shall be immune from liability in a civil action for any injury or damages in connection with that medication–related error. My fellow New Jerseyans, it is time to wake up and realize what is going on here. This legislation is designed to create a protected class of people who are immune from liability and who are also allowed to self regulate bad behavior in secret under the guise of protecting the public at large. How would the public ever know if this legislation actually achieves its stated purpose when all of the data is completely sealed off from the public? Regardless of how egregious the medication error or how serious the harm, the victim will be left with absolutely no remedy. He or she is supposed to be content with the fact that the Board shall police itself. Your right to protect yourself from injury by the negligent acts of pharmacies has been stripped away, all in the name of reducing pharmacy error. If the State Legislature were serious about reducing the number of medication related errors it would start by adopting laws that impose restrictions on the number of hours a pharmacist can work during any shift. The demands on the chain pharmacies to maximize corporate profits through an assembly line production outfit ultimately leads to more mistakes and patient harm. “In some retail locations, pharmacists are being asked to work 12 hour shifts, sometimes back to back. Pharmacists are asked to handle 30 prescriptions an hour. That’s two minutes to fill a prescription, counsel a patient, and check for potential drug interactions. Pharmacists are under incredible pressure to crank out prescriptions. It’s no wonder mistakes are being made.” Says Phillip Grauss, a senior pharmacist at Kaiser Pernmanente. See Caremark article.
Some states have taken a meaningful approach to reducing the rate of dispensing errors. In North Carolina, for instance, drugstores are now legally responsible when an overworked pharmacist makes a mistake while filling out more than 150 prescriptions per day. If this bill is made into law, then in New Jersey, chain pharmacies would never be held accountable for the negligence of its pharmacist employee, and this is supposed to be in the interest of protecting the consumers of New Jersey. I wonder how it came to be that this bill sailed through the State Assembly without any public outrage. What corporate interests were really behind the crafting of this legislation? Am I the lone voice of outrage here? [1] Elizabeth Allan Flynn et al, National Observational Study of Prescription Dispensing Accuracy and Safety in 50 Pharmacies, 43(2) J.AM. PHARM. ASSOC. 191-200 (2003). Copyright © 2007 by Law Offices of Scott D. Grossman, LLC. Scott D. Grossman is a New Jersey licensed attorney with a Master’s degree in political science from Rutgers University and a passion for protecting patient and consumer rights.

Tags: Improper Prescriptions, Medical Malpractice, New Jersey pharmacist mistake, Patients' Rights, Personal Injury Law, Pharmacy Error, The Pharmacy Quality Improvement and Error Prevention Act, medication error, pharmacy mistakes, wrong prescription

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