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Defense Verdict Obtained In Philadelphia Birth Defect Case Alleging Negligence Against Pharmacy/Pharmacist
12/26/06
Contact
Jack Snyder or Brett Wolfson
(215) 575-4220
DEFENSE VERDICT OBTAINED IN PHILADELPHIA BIRTH DEFECT CASE ALLEGING NEGLIGENCE AGAINST PHARMACY/PHARMACIST
On December 14, 2006, a Philadelphia jury returned a defense verdict in favor of a pharmacist and pharmacy in a negligence case in which it was alleged that prescription drugs caused severe birth defects in a little boy, currently age four. The damages placed on the board for future medical expenses and lost earnings ranged between $37 million to $92 million.
The defense was headed by Jack Snyder, Brett Wolfson, and Jack’s team of diligent attorneys, paralegals and assistants. Having only received this voluminous file one month before trial, preparation required the help of Jack’s entire team who worked countless hours towards the successful outcome. Stepping in as trial counsel on short notice for cases with damages of catastrophic proportions is a specialty for which Jack’s practice has been known for many years.
The drug alleged to have caused the defects is Arthrotec, an anti-inflammatory (Diclofenac) combined with a component for coating the stomach (Misoprostol). The FDA has placed Arthrotec and Misoprostol within a class of drugs known as “Category X” which indicates a contraindication with pregnancy. Misoprostol is a known abortofacient – it causes spontaneous abortions in pregnant women. In the late 1980s and through the 1990s Misoprostol was sold over the counter in several countries in South America where abortion is illegal. Misoprostol gained widespread use during that time in women attempting to self-induce abortions. The history showed, however, that it was not a very reliable means for causing abortions. Birth defects were found in several of the babies born with exposure to Misoprostol following failed abortion attempts. One aspect of the defense focused on the fact that many misoprostol exposed babies in utero have been born with no birth defects.
Prior to April 2002, plaintiff-mother was attempting to become pregnant after two miscarriages. She had been seeing a fertility specialist and had been taking fertility medication, including Clomid. Clomid is a well known fertility medication taken by women for stimulating egg development. Also prior to April 2002, plaintiff-mother developed a problem known as pericarditis. Pericarditis is an inflammation of the pericardial wall that surrounds the heart, causing discomfort or pain. For this she was prescribed Colchicine, an anti-inflammatory. For several months plaintiff-mother had been taking both medications for fertility and for the pericarditis.
On April 17, 2002, plaintiff-mother’s cardiologist changed her prescription for the pericarditis medication to the Arthrotec. Based upon his medical records, the cardiologist was aware plaintiff-mother had been trying to become pregnant. The cardiologist testified at his deposition that he knew prior to prescribing the Arthrotec that it could cause a miscarriage but he was not aware until later that it had been “associated” with birth defects. He testified also that given what he knows today, that he still would have prescribed the Arthrotec due to the fact that he claimed plaintiff-mother advised him that she was not pregnant at the time he prescribed the Arthrotec.
The cardiologist and his practice group settled for $4 million prior to trial, leaving the pharmacy and pharmacist as the only remaining defendants at trial. One hurdle throughout the case was the decision by the Court to enter summary judgment in favor of the cardiologist and the decision prior to the evidence to exclude the cardiologist from the verdict form for purposes of apportioning damages.
One month prior to filling the April 17th prescription for Arthrotec, the pharmacy had filled plaintiff-mother’s prescription for Clomid. The argument set forth by plaintiffs was that the pharmacy should have known that the mother was trying to become pregnant given the prescription for Clomid the previous month. Furthermore, had the pharmacist performed a competent drug utilization review, she would have seen the past medications of Clomid in the patient profile. Therefore, she would have known that the Clomid and the Category X drug, Arthrotec, were antagonistic to each other.
Another theory against the pharmacy/pharmacist was alleged negligent failure to “counsel” the plaintiff-mother when she had the prescription for Arthrotec filled. The plaintiffs asserted that the pharmacist should have been more proactive in orally speaking to the plaintiff-mother about issues such as her efforts to become pregnant, her pregnancy status, her need for use of birth control – based upon the Clomid prescription. Plaintiffs also alleged that perhaps the plaintiff-mother should not have been permitted to leave with the prescription – claiming that the pharmacist was the “last line of defense.”
The ability to deduce pregnancy from the fact of a prior prescription of Clomid is a much more complex principle than may appear. The greater concept is whether the pharmacy had any duty beyond what it in fact did: included a written warning on the prescription vial not to take if pregnant, included a prescription information sheet with the prescription warning not to take if pregnant and orally asking that customer/patient “do you have any questions for the pharmacist.”
The practice of pharmacy in Pennsylvania is governed by a statute, 49 Pa. Code. §27.19, State Board of Pharmacy Standards – this statute requires, among other things, an “offer to counsel.” The plaintiffs argued that more should have been asked of plaintiff-mother than whether she had any questions. The plaintiffs’ experts testified that the pharmacist should have asked the mother whether she was pregnant or trying to become pregnant, whether she had a negative pregnancy test and whether she was using effective means of birth control.
The position of the pharmacy is that beyond written warnings and offering to answer any questions, it is the physician’s role to make inquires into such personal matters. While the pharmacist is privy to all available drug and drug interaction information, the pharmacist is not a physician and therefore is not privy to the medical history and personal relationship that customers share with their physicians.
With respect to the written warning sheet that plaintiff-mother received with the prescription, she admitted that she never read them. She did, however, save it in her home for several years and thus it was available for production in this case. It was surprising that a woman trying to become pregnant with a history of two miscarriages and who eventually became pregnant did not read the prescription insert. More surprising was plaintiff-mother’s lack of concern or action upon her OB/GYN advising her to discontinue taking the Arthrotec after she became pregnant.
A number of physicians with whom plaintiff-mother had been seeing during the relevant time period came to know she was taking Arthrotec while trying to become pregnant and eventually became pregnant – two cardiologists, two OB/GYNs and her family physician. Within one to two weeks after starting the Arthrotec, plaintiff-mother received a positive pregnancy test. She saw her OB/GYN within a few days thereafter who advised her to speak to the cardiologist to change to a different prescription. Plaintiff-mother continued to take the Arthrotec and scheduled an appointment to see the cardiologist, but not for another two weeks.
Probably the most dramatic moment at trial came when, on cross-examination of the mother-plaintiff, the jury learned that the family continues to use to this very day, the same pharmacy named as defendant in this trial. It was stated in plaintiffs’ opening, as well as during direct examination of plaintiff-mother: the pharmacy breached her trust; she trusted they would not allow her to take a medication that could cause harm to her or her unborn child.
During her direct examination, a day-in-the-life video was played of the four year old child demonstrating his severe birth defects and disabilities. During this recently recorded film it was observed that of the many medications displayed during the video, they bore the store-name label of the defendant-pharmacy. The defense was already aware of prescriptions filled at its pharmacy as recently as one week prior to trial. The video, however, was spliced for the jury to view the son’s prescriptions during cross-examination of the mother. This seriously weakened the mother’s credibility.
Given the evidence of the several physicians involved, and given the failure of the plaintiff-mother to act on her own behalf, the jury found that neither the pharmacy nor the pharmacist were negligent – and this despite the tremendous sympathy that could hardly be overcome from an innocent young four year old with severe deformities and disabilities.
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