Opinion
Index No. 800129/10
07-02-2014
PATRICIA WISNIEWSKI McGRATH and KIERAN McGRATH, Plaintiffs, v. ALLISON V. DOWNER, M.D., DUANE READE INC., DUANE READE #204, "JOHN" VARGH, R. Ph., and "JOHN" MASI, R.Ph., Defendants.
Decision, Order, and
Judgment
JOAN B. LOBIS, J.S.C.:
In this medical malpractice and pharmaceutical negligence action, Plaintiffs Patricia Wisniewski McGrath and Kieran McGrath allege that Ms. McGrath received improper medical and psychiatric care from Defendant Allison V. Downer, M.D., and negligent pharmaceutical services from Defendants Duane Reade Inc., Duane Reade #204, Varghese John, R. Ph., and Joseph Masi, R. Ph., (collectively "Duane Reade"). Defendants move for summary judgment in motion sequences #2 and #3, which are consolidated for the disposition of this decision and order. For the reasons stated below, Dr. Downer's motion is denied, except as to Plaintiffs' causes of action for res ipsa loquitur, respondeat superior, and vicarious liability, and Duane Reade's motion is denied in full.
Incorrectly named as "John" Vargh, R.Ph.
Incorrectly named as "John" Masi, R. Ph.
Ms. McGrath first began treating with Dr. Downer on July 18, 2008. Ms. McGrath had suffered from anxiety since age five, and, as an adult, was treated with several different anti- anxiety medications. Dr. Downer diagnosed her with obsessive compulsive disorder and prescribed Xanax, Paroxetine, and Klonopin. Between July 18, 2008, and November 24, 2008, Dr. Downer changed the Paroxetine for Fluoxetine, and increased the dosages of the various prescriptions due to the ineffectiveness of lower doses.
Generic for Paxil.
Generic for Prozac.
Dr. Downer would telephone prescriptions to Ms. McGrath's pharmacy, Duane Reade #204. Upon receiving a telephone prescription, the pharmacist transcribes the prescription into a form, including the name of the drug, quantity, instructions, and refills. This form goes into the prescription file and is entered into the computer. The pharmacist then checks the suggested maximum dosage. If the suggested maximum dosage exceeds the prescription, it is customary to discuss the prescription with the prescribing physician. Following the discussion, if necessary, the pharmacist notes on the back of the prescription why the physician said the higher dosage was necessary.
Ms. McGrath and Dr. Downer had a telephone call to discuss the prescriptions on November 24, 2008. By prescription dated November 25, 2008, Dr. Downer prescribed 25 milligrams of Clomipramine, a tricyclic anti-depressant, at bedtime for one week, after which the dosage would increase to 50 mg at bedtime. On December 29, 2008, Dr. Downer increased the dosage, instructing the patient to take 50 mg for two weeks and then 100 mg for two weeks.
On January 18, 2009, Dr. Downer and Ms. McGrath had another telephone conversation. Dr. Downer claims that she telephoned the prescription, and intended to increase the Clomipramine dosage to 150 mg, or three 50 mg pills per day. The Duane Reade records, however, indicate that the prescription was for "50 mg 3 BID." The short BID means twice a day. The parties do not contest that the "50 mg 3 BID" is a prescription for three 50 mg pills twice a day. 300 mg exceeds the 250 mg suggested daily maximum for Clomipramine. Dr. Downer denies prescribing 300 mg per day, and Duane Reade denies transcribing the prescription incorrectly. Joseph Masi, R. Ph., a registered pharmacist and employee of Duane Reade, filled the January 18, 2009, prescription. In this instance, he does not specifically recall speaking with Dr. Downer regarding the prescription.
Dr. Downer had a telephone conversation for thirty minutes with Ms. McGrath on February 13, 2009. Dr. Downer noted that Ms. McGrath felt fearful and anxious, and sounded regressed. The following day Dr. Downer made another call-in prescription. The prescription for Clomipramine states 50 mg 4 tabs BID, or four 50 mg pills twice a day for a total of 400 mg. Dr. Downer denies prescribing 400 mg.
Varghese John, R. Ph., a registered pharmacist and employee of Duane Reade, took Dr. Downer's telephone prescription on February 13, 2009. Though Mr. John does not recall his conversation with Dr. Downer, the notes on the prescription indicate that he spoke with her. He noted that Dr. Downer was aware that the dosage increase exceeds the maximum for Clomipramine. Duane Reade claims that they accurately transcribed Dr. Downer's prescription.
On February 19, 2009, Ms. McGrath suffered a seizure or seizure-like event. She lost consciousness and woke up with vomit on her. Neither Ms. McGrath nor her husband Kieran McGrath recall if she soiled herself. Mr. McGrath explained that he saw a liquid coming from her mouth. Ms. McGrath was taken to Lawrence Hospital Center in Bronxville, NY. Her neurologist Dr. Ronald Silverman, M.D., diagnosed her with a grand mal seizure. Dr. Allison Pack, M.D., a neurologist at The Neurological Institute of New York, Columbia University Medical Center, diagnosed her with a singularized seizure caused by an overdose of Clomipramine.
Plaintiffs now bring this medical malpractice and pharmaceutical negligence action. Plaintiffs' first cause of action alleges that Defendants violated their standards of medical and professional practice by prescribing or administering Clomipramine above the suggested maximum dosage to Ms. McGrath. Plaintiffs' second cause of action alleges that Mr. McGrath suffered, among other things, loss of services and economic contribution. They allege that as a result, Plaintiffs sustained serious, permanent personal injuries and disability.
Dr. Downer moves for summary judgment. She argues that the Plaintiffs' cause of action for medical malpractice must be dismissed because there is no evidence of causation. Dr. Downer claims that the prescription of Clomipramine did not cause any permanent injuries and did not cause Ms. McGrath's grand mal seizure. In support, Dr. Downer attaches the expert affirmation of Philip R. Muskin, M.D., a board certified psychiatrist and neurologist.
Dr. Muskin asserts that Clomipramine cannot cause permanent damage. He maintains that once it leaves the body, it no longer has any effects on the body. He contends that even if Dr. Downer prescribed Clomipramine at 300 mg or 400 mg dosages, the dosages are not inherently toxic. He argues that the FDA guidelines for the maximum dosage of 250 mg per day are merely guidelines, and that it is accepted medical practice for a physician to use her own medical judgment to prescribe a dosage greater than 250 mg per day. Dr. Muskin claims that because the drug has a half-life of thirty-two hours, once an individual stops taking Clomipramine, the amount of the drug in the body is reduced by half every thirty-two hours, and the effects of the medication diminish over time.
He contests that Ms. McGrath had a seizure. He argues that Ms. McGrath was not incontinent during the event, and that, therefore, she was missing a key sign of a seizure. Dr. Muskin opines that Ms. McGrath experienced a loss of consciousness due to orthostatic hypotension, a common side-effect of tricyclic anti-depressants, and not a seizure. He explains that when someone suffers from orthostatic hypotension, her blood pressure drops very quickly when she gets up, and, as a result, the person faints.
Dr. Downer argues that the Plaintiffs' cause of action for lacked of informed consent in the bill of particulars should be dismissed as it was not raised in the complaint. She argues that any claims for lack of informed consent should be dismissed because Clomipramine did not cause the seizure or the alleged permanent injuries. Dr. Downer also contends that any cause of action against her for respondeat superior or vicarious liability that is raised in the complaint must be dismissed as Plaintiffs' bill of particulars states that there is no claim for vicarious liability. Lastly, she argues that any cause of action for res ipsa loquitur must be dismissed because Clomipramine was not in the exclusive control of Dr. Downer.
In its motion for summary judgment, Duane Reade argues that its pharmacists did not violate their professional standard. It claims that the documentary evidence substantiates that the Mr. Masi and Mr. Varghese called Dr. Downer to confirm her directive for higher doses of Clomipramine. It maintains that is it not the duty of the pharmacists to countermand the directives of a treating physician. It asserts that there are causation issues as to whether the Clomipramine caused a seizure or pseudo-seizure and adopts Dr. Downer's proximate cause arguments.
In support of its motion, Duane Reade attaches the affirmation of Richard S. Blum, M.D., a physician specializing in pharmacology. Dr. Blum argues that a seizure disorder is an adverse reaction that can occur with any antidepressant medication. He claims that prescribing over the upper limit dosage is still good medical practice. He maintains that it is the responsibility of the pharmacist to make the physician aware that the prescription is outside of the labeled dosage range only. He asserts that since Duane Reade informed Dr. Downer that dosage of Clomipramine exceeded 250 mg, that it met the standard of care.
In opposition to the motions for summary judgment, Plaintiffs argue that both Dr. Downer and Duane Reade failed to show there are no triable issues of fact. Plaintiffs argue that it is a triable issue of fact whether Dr. Downer prescribed Clomipramine in dosages that exceeded the maximum daily dosage. In particular, they point to the discrepancy between Dr. Downer's claims and Duane Reade's claims regarding the prescriptions. They allege that Dr. Downer's decision to prescribe Clomipramine and increasing the dosage was not based upon professional medical determinations resulting from a careful examination.
Plaintiffs further contend that there are triable issues of fact as to whether Duane Reade pharmacists accurately transcribed Dr. Downer's telephone prescriptions. They assert that Duane Reade's expert assumes that the pharmacists filled the prescriptions properly. Plaintiffs claim that there is a discrepancy between Dr. Downer's deposition testimony and Duane Reade records and depositions as to the amount of Clomipramine that Dr. Downer ordered. They maintain that either Dr. Downer mistakenly prescribed the wrong dosage on January 18, 2009, or Mr. Masi transcribed it incorrectly. Plaintiffs also argue that Mr. Masi and Mr. Varghese should have refused to fill the Clomipramine prescriptions that exceeded the suggested maximum dosage. They claim that the pharmacists should have counseled Ms. McGrath but did not.
They also contend that issues of fact remain as to proximate cause. Plaintiffs maintain that Dr. Muskin's affidavit is insufficient as he ignores the seizure diagnosis by other doctors and Mr. McGrath's testimony of what happened during the seizure or seizure-like event. They assert that incontinence is a sign of a seizure but does not necessarily always accompany a seizure. Plaintiffs claim that Dr. Muskin offers no medical or scientific basis for his opinion that 400 mg of Clomipramine would not be any more likely to cause a seizure than a lower dosage. They assert that in formulating his opinion, Dr. Muskin ignored the medical records, which state that Ms. McGrath did suffer from a seizure.
In support of the opposition to the motions for summary judgment, the Plaintiffs provide the expert affidavit of Theodore Schecter, R.Ph., a New York licensed pharmacist. Plaintiffs also attach the expert affidavit of a New York licensed physician who is a board certified psychiatrist. The expert psychiatrist's name has been redacted.
Mr. Schecter explains that a seizure or seizure-like event is a risk of Clomipramine, and that the risk increases as the dosage increases. He states that the maximum recommended daily dosage is 250 mg. He opines that prescriptions for 300 and 400 mg are grossly excessive and put the patient at significant risk. He asserts that it was incumbent on the pharmacist to decline to fill a prescription that exceeded the daily maximum dosage by such a significant amount. Mr. Schecter argues that registered pharmacists are required to exercise their independent judgment. He opines that either the pharmacists did not properly transcribe Dr. Downer's prescriptions or they filled a prescription that they should not have filled. He contends that both actions would be a departure from the standards of pharmaceutical practice required of licensed, registered pharmacists.
Plaintiffs' medical expert claims that Dr. Downer deviated from the standard of care and treatment. The expert opines that before increasing a prescription dosage, Dr. Downer should have ordered blood testing to determine Clomipramine levels. Furthermore, the expert argues that it is a deviation from the standard of care to increase a prescription dosage without first seeing the patient, which Dr. Downer did not do. The expert contends that the increase in Clomipramine dosage would increase the risk of seizure activity or seizure like activity. The expert opines within a reasonable degree of medical certainty that the medication in this case would cause the seizure activity or seizure-like incident.
In reply, Dr. Downer argues that there were no issues of material fact presented in the Plaintiffs' opposition to the motion for summary judgment. Dr. Downer contends that Plaintiffs concede that Clomipramine did not cause Ms. McGrath's permanent injuries. Dr. Downer asserts that Plaintiffs' expert does not provide evidence from the record to support the conclusion that there was a grand mal seizure. She claims that the Plaintiffs' expert does not dispute that there is only a de minimus increase in the risk of seizure when increasing the dosage of Clomipramine. She maintains that the "seizure like activity" constitutes a new claim, as is any claim that Dr. Downer failed to monitor Ms. McGrath's blood levels. Dr. Downer asserts that any claim that combining Clomipramine with other medications caused the seizure is a new claim that is highly prejudicial. Lastly, Dr. Downer claims that Plaintiffs concede that there are no claims as to res ipsa loquitur, respondeat superior, vicarious liability, or informed consent.
In replying to Plaintiffs' opposition, Duane Reade argues that it made out a prima facie case for dismissal that has not been rebutted. It argues that Clomipramine in any dosage did not cause Plaintiffs' long-term injuries. Lastly, it claims that the pharmacists spoke with Dr. Downer and noted these conversations on the prescriptions so there is no triable issue of fact as to whether Mr. Masi and Mr. Varghese communicated with the doctor.
In considering a motion for summary judgment, this Court reviews the record in the light most favorable to the non-moving party. E.g., Dallas-Stephenson v. Waisman, 39 A.D.3d 303, 308 (1st Dep't 2007). The movant must support the motion by affidavit, a copy of the pleadings, and other available proof, including depositions and admissions. C.P.L.R. Rule 3212(b). The affidavit must recite all material facts and show, where defendant is the movant, that the cause of action has no merit. Id. This Court may grant the motion if, upon all the papers and proof submitted, it is established that the Court is warranted as a matter of law in directing judgment. Id. It must be denied where facts are shown "sufficient to require a trial of any issue of fact." Id. This Court does not weigh disputed issues of material facts. See, e.g., Matter of Dwyer's Estate, 93 A.D.2d 355 (1st Dep't 1983). It is well-established that summary judgment proceedings are for issue spotting, not issue determination. See, e.g., Suffolk County Dep't of Soc. Servs, v. James M., 83 N.Y.2d 178, 182 (1994).
In a medical malpractice case, to establish entitlement to summary judgment, a movant must demonstrate that it did not depart from accepted standards of practice or that, even if it did, the departure did not proximately cause injury to the patient. Rogues v. Noble, 73 A.D.3d 204, 206 (1st Dep't 2010). In claiming treatment did not depart from accepted standards, the movant must provide an expert opinion that is detailed, specific and factual in nature. E.g., Joyner-Pack v. Sykes, 54 A.D.3d 727, 729 (2d Dep't 2008). Expert opinion must be based on the facts in the record or those personally known to the expert. Rogues, 73 A.D.3d at 195. The expert cannot make conclusions by assuming material facts not supported by record evidence. Id. Defense expert opinion should specify "in what way" a patient's treatment was proper and "elucidate the standard of care." Ocasio-Garv v. Lawrence Hosp., 69 A.D.3d 403, 404 (1st Dep't 2010). A defendant's expert opinion must "explain 'what defendant did and why.'" Id. (quoting Wasserman v. Carella, 307 A.D.2d 225, 226 (1st Dep't 2003)). Conclusory affirmations fail to establish prima facie entitlement to summary judgment. 73 A.D.3d at 195. Expert opinion that fails to address a plaintiff's essential factual allegations fails to establish prima facie entitlement to summary judgment as a matter of law. Id. If a defendant establishes a prima facie case, only then must a plaintiff rebut that showing by submitting an affidavit from a doctor attesting that the defendant departed from accepted medical practice and that the departure proximately caused the alleged injuries. Id. at 207.
In cases involving claims of negligence by pharmacists, the cause of action generally must include an allegation that "pharmacy defendants failed to fill the prescriptions precisely as they were directed by the manufacturers and physicians . . . ." Elliott v. A.H. Robins Co., Inc.. et al., 262 A.D.2d 132, 132 (1st Dep't 1999); see Bichler v. Willing, 58 A.D.2d 331 (1st Dep't 1977). Alternatively, there may be liability if a plaintiff "had a condition of which the pharmacists were aware rendering prescription of the drugs at issue contraindicated [.]" Elliot, 262 A.D.2d at 133. Liability, however, can also be found when there is "active negligence on the part of the pharmacist." Brumaghim v. Eckel, 94 A.D.3d 1391, 1391 (3d Dep't 2012).
The Court finds that Dr. Downer has not established a prima facie case for summary judgment. Dr. Downer does not concede that there was a departure but her argument relies only on proximate cause. Though Dr. Downer's expert, Dr. Muskin, claims that no seizure or permanent damages were caused by the Clomipramine, the medical record and deposition testimony show triable issues of fact remain on these points. In a deposition, Dr. Downer herself states that there is an increased chance for seizure from the dosage that Ms. McGrath received. The medical records indicate that multiple treating physicians have diagnosed Ms. McGrath with a seizure. In addition, Dr. Muskin does not address whether Dr. Downer's actions departed from the standard of care. Accordingly, the Court must deny this portion of Dr. Downer's motion for summary judgment.
Next the course addresses the issues of lack of informed consent, respondeat superior, vicarious liability, and res ipsa loquitur. Lack of informed consent was not raised in the complaint, and there is not a cause of action. In the Bill of Particulars, Plaintiffs deny making any claims for vicarious liability. They do not oppose Dr. Downer's current motion as to vicarious liability or respondeat superior. Dr. Downer establishes a prima facie case for the cause of action for res ipsa loquitur, which Plaintiffs also do not oppose. Accordingly, Dr. Downer's motion is granted only as to res ipsa loquitur, respondeat superior, and vicarious liability.
Turning to Duane Reade's motion, the Court finds that Duane Reade has not established a prima facie case for summary judgment. Based on Duane Reade's pharmaceutical records, Dr. Downer's medical records, and the depositions, a triable issue of fact remains as to whether Duane Reade's pharmacists, Mr. Masi and Mr. Varghese, filled Dr. Downer's prescriptions precisely as they were directed. See Elliot, 262 A.D.2d at 132. There is conflicting evidence whether the pharmacists made an error in transcribing and entering the prescription or if Dr. Downer prescribed too high a dosage of Clomipramine. Furthermore, there is conflicting evidence whether the prescription of Clomipramine was contraindicated. See Elliot, 262 A.D.2d at 133. Duane Reade adopted Dr. Downer's proximate cause argument, but, as discussed above, triable issues of fact remain on this issue. Accordingly, it is
ADJUDGED that Dr. Downer's motion for summary judgment is granted only as to res ipsa loquitur, respondeat superior, vicarious liability, and denied in all other respects; it is further
ORDERED that Duane Reade's motion for summary judgment is denied; and it is
ORDERED that the parties appear for a pre-trial conference in Room 345, 60 Centre Street, on July 29, 2014, at 9:30 am.
ENTER:
__________
JOAN B. LOBIS, J.S.C.