author: ACKERMAN, J.,

text:
    In re Phenylpropanolamine (PPA) Litigation

      Sol Weis, Martin Rubenstein, Lee Balefsky and Michael Weinkowitz, for plaintiffs.

      Albert Bixler and Andy Trevelise, for defendants.

      September 2, 2003
   ACKERMAN, J.,

INTRODUCTION

A. Trach As the Legal Guide to the Use of Extrapolation As a Generally Accepted Methodology To Satisfy Frye

This court is guided by the opinion of the Superior Court of Pennsylvania en banc by the Honorable Judge Ford Elliott in the case of Trach v. Thrift Drug Inc., 817 A.2d 1102 (Pa. Super. 2003).

The Trach case involved a negligence action brought by a customer against a pharmacist arising from cognitive and vision problems the customer developed, allegedly resulting from taking medication that was erroneously dispensed to him by the pharmacist. The majority of the Trach court held that the Frye test governing the admissibility of expert testimony only applies to determine if the relevant scientific community has generally accepted principles and methodology that the scientist employs and not conclusions the scientist reaches before the court may allow an expert to testify.

In the Trach case, the customer’s expert witness used the methodology of extrapolation to deduce that the customer’s chronic symptoms, including glaucoma, were the result of a massive overdose of Doxepin. The Trach court held that the methodology of extrapolation, in the context of the case before it, was generally accepted in the scientific community and thus the testimony in question was admissible.

The Trach court emphasized that “Frye is an exclusionary rule of evidence” and that “as such, it must be construed narrowly so as not to impede admissibility of evidence that will aid the trier of fact in the search for truth.” See PaJR.E. 702,42 Pa.C.S., but “noting that Rule 702 does not alter Pennsylvania’s adoption of the Frye standard.” (At 1102.)

In the Track case, it was noted that Doxepin when taken in the recommended dosage may result in blurred vision, confusion, disorientation and hallucinations, (emphasized by the court) (At 1104.) In Track, there had been no proposed studies to determine the effect of a massive dose of Doxepin, such as the dose Track took.

Dr. Shane was Track’s expert witness who relied upon clinical trials prior to the approval of the drug by the FDA and also from clinical experience since the drug had been on the market, as well as from the side effects and contraindications for a therapeutic dose as noted in the PDR. Dr. Shane also testified as to the mechanism that leads to glaucoma.

The Track court reviewed a dissent by Justice Castille in the case of Blum v. Merrell Dow Phamaceuticals Inc., 564 Pa. 3, 764 A.2d 1 (2000) at 7-8, and notes that the testimony in the Blum case “demonstrates how ‘scientific consensus’ can be created through purchased research and the manipulation of a ‘scientific’ literature funded as part of litigation defense, and choreographed by counsel” rather than from the required objective evidence.

The Track court held that Dr. Shane employed the generally accepted principle of the “ ‘dose-response,’ a principle ‘as old as the pyramids.’ ”

Finally, Track held that “extrapolation is one of the methodologies Dr. Shane used to conclude that a massive overdose of Doxepin could result in permanent and/or exacerbated adverse effects documented at the recommended dose, is not science: in fact, it is a logical method used to ‘estimate the value of a variable outside its tabulated or observed range’ or ‘to infer (that which is not known) from that which is known,’ Webster’s 505. The question then becomes whether extrapolation, although not science, is a methodology generally accepted and used by scientists within the relevant scientific community.” (At 1114.)

Track cited the case of Donaldson v. Central Illinois Public Service Co., 199 Ill. 2d 63, 262 Ill. Dec. 854, 767 N.E.2d 314 (2002), as persuasive authority while not binding precedent as follows: “As the Donaldson court observed, ‘extrapolation is commonly used by scientists in certain limited instances . ..’; for example, when the medical inquiry is new or the opportunities to examine a specific cause and effect relationship are limited; when the number of cases limits study of the disease, or, as noted supra, when ethical considerations prevent exposing individuals to a toxic substance for research purposes. Id. at 85, 87, 262 Ill. Dec. 854, 767 N.E.2d at 328, 330. According to the Donaldson court, when an expert relies upon scientific literature discussing similar, but not identical, cause and effect relationships, the fact that the expert must extrapolate affects the weight of the testimony rather than its admissibility. Id. at 85, 262 Ill. Dec. 854, 767 N.E.2d at 328. (citation omitted)” (At 1115.)

Track further cites Donaldson, which stated that “the method of extrapolation does not concern a technique new to science that may instill a sense of ‘false confidence’ or carry a misleading sense of scientific ‘infallibility.’ Id. at 86, 262 Ill. Dec. 854, 767 N.E.2d at 329. (citation omitted) As the Donaldson court continued, ‘[Extrapolation by nature admits its fallibility — the lack of specific support to establish the existence of a known cause and effect relationship.’ Id. at 87, 292 Ill. Dec. 854, 767 N.E.2d at 329. (citation omitted)” (At 1115-16.)

The court also cited the case of Ferebee v. Chevron Chemical Co., 736 F.2d 1529 (D.C. Cir. 1984), cert. denied, 469 U.S. 1062, 105 S.Ct. 545, 83 L.Ed.2d 432 (1984), as follows: “As long as the basic methodology employed to reach such a conclusion is sound, such as use of tissue samples, standard tests, and patient examination, products liability law does not preclude recovery until a ‘statistically significant’ number of people have been injured or until science has had the time and resources to complete sophisticated laboratory studies of the chemical.” (At 1116.)

The Track court, after reviewing Donaldson, supra, and Ferebee, supra, stated as follows: “We find the facts of this case even more compelling than the facts of Ferebee, supra, or Donaldson, supra, based on the even stronger logical inference that a substance known to cause adverse side effects in its recommended dose is likely to cause a heightened level of the same or similar adverse effects when taken in a massive overdose.” (emphasis supplied) (At 1116.)

Accordingly, if there is a strong logical inference to support extrapolation, which is a generally accepted methodology, then Frye will be satisfied.

B. HSP Report Relevant Conclusions

We next will examine Phenylpropanolamine & Risk Of Hemorrhagic Stroke: Final Report Of The Hemorrhagic Stroke Project as it affects the gender-related issue to be discussed infra.

In the Discussion section of that report which contains the conclusions derived from all of the results of the Statistical Analysis section, the final conclusion as to the applicability of the study of men is set forth as follows: “Because so few men were exposed to PPA in the HSP (n=19), we were unable to determine if their risk for hemorrhagic stroke (with use of PPA) is different from that of women.” (At p. 22, final report.)

The above conclusion was reached notwithstanding the following statement contained under the section entitled Sample Size as follows: “Because our research interest extended to men and to exposures other than PPA, we doubled our sample size to include 350 men and 350 women for a total of 700 case subjects and 1,400 controls.” (At p. 12, final report.)

I. PPA Increases the Risk of Hemorragic Stroke in the Female Population Over the Age of 49 Years

All parties agree that “There were no data or findings reported in the HSP applicable to ... women ... greater than 49 years old.” (See affidavit of Ralph L. Sacco M.D., M.S., paragraph 57.)

Dr. Sacco argues that “HSP findings cannot be extrapolated to ages not studied in the HSP . . . Subarachnoid Hemorrhagic Stroke (S AH) represents a greater proportion of all strokes in younger people than in older people.” (Sacco affidavit, paragraph 58.)

Dr. Sacco further states (paragraph 58) that “Moreover many, if not all, of the modifiable risk factors for... S AH are known to create increasing health consequences over time, i.e., cigarette smoking, alcohol abuse, diabetes, chronic hypertension, etc.” Accordingly, the defendants primarily argue and point to the fact that the risk of stroke increases as age increases. However, there is a strong logical inference that as a woman ages, she becomes more susceptible not only to stroke but to PPA which has already been shown to increase the risk of stroke in younger women.

This court does not see any reason either to reject the strong logical inference to utilize extrapolation from the HSP study of females under the age of 49 years (already accepted by the court), or to conclude that the increasing risk of stroke would render the HSP unreliable as applied to this age group.

The FDA found no reason to believe the risks posed by PPA were limited to individuals within the age range studied in the HSP.

Thus, this court finds testimony by plaintiffs’ experts that PPA increases the risk of hemorrhagic stroke in the female population over the age of 49 years to be admissible under Frye in that the methodology of extrapolation here based upon the aforesaid strong logical inference is generally accepted in the scientific community and, therefore, Frye is satisfied.

II. PPA Increases the Risk of Hemorrhagic Stroke in the Male Population 18 Years of Age and Older

All parties agree that “There were no data or findings reported in the HSP applicable to men.” (See affidavit of Ralph L. Sacco M.D., M.S., paragraph 57.)

It is true that plaintiffs rely on a smaller number of case reports directly related to men, but Donaldson, supra, and approved by Track, approves of extrapolation in this regard.

Defendants also highlight differences between men and women. It is true that the incidence rate of stroke, type of stroke and some of the risk factors for stroke vary between these groups.

Plaintiffs’ experts concede the aforesaid differences but maintain that these subpopulations share far more similarities than differences.

At the outset, it must be noted that the FDA did not differentiate between men and women.

Plaintiffs’ experts attest to the commonplace practice of extrapolation between the genders based upon, in significant part, the historical exclusion of women from scientific studies. (See Track and reasons for extrapolation, supra.)

Defendants’ expert, Dr. Hopkins, notes current studies accounting for the differences between men and women, but does not suggest that this very recent shift has yet effectuated a change in the practice of extrapolation.

Plaintiffs’ experts stress that in either gender strokes are an “uncommon adverse reaction” (Dr. Feldman) and that only the “outliers” in the population are at risk.

Dr. Feldman was a co-investigator of the HSP. Dr. Feldman’s testimony is based upon his own clinical research, experience, education, the HSP, medical literature and case reports.

Plaintiffs’ experts maintain the need for extrapolation given the unsurprisingly smaller amount of evidence directly relating to the male outliers. Dr. Feldman, plaintiffs’ expert, testified that extrapolating is done frequently from men to women and women to men.

Dr. Feldman, one of plaintiffs’ experts, testified that he never saw any textbook or peer-reviewed article which stated that men were not at risk for stroke but women are. (Preservation deposition, TR 552,553.) Dr. Feldman categorically testified that PPA is capable of causing hemorrhagic stroke in men based upon his clinical practice, in research and in writing. Dr. Feldman testified that decongestant action constricting the blood vessels which relates to hemorrhage is not limited to women. Toxicity is not limited to men and not women. There are tremendous and overwhelming similarities between men and women and effects of PPA usage and stroke as follows:

Increases in blood pressures, one could not distinguish between arteriorogram of men and women to distinguish diseases stated Dr. Feldman and “as a general rule there is no exclusivity by gender and by and large no differences except exposure and anatomical differences.” In reference to drugs, Feldman testified that as a general rule there is the same effect in men and women. Absolute and exclusive differences are not the rule. Effect on women and on men is a difference only in degree. Hemorrhagic stroke is not seen in one sex and not in another.

Women are at greater risk to hemorrhagic stroke than men, Feldman concedes, but states that clinical, human physiology and animal studies of men and women disclose both sexes at risk from surge in blood pressure, constricture of blood vessels, constricture of arteries and that PPA was seen in both sexes both before and after bleeding. Both men and women experience vasospasm and bleeding, both present where hemorrhagic strokes occur, even though the bleeding occurs in some places in women and different places in men.

Dr. Feldman, under cross-examination (Preservation deposition, TR 224), discussing one of his case reports concerning a male 21 years old and obese, testified that he concluded from this case report that “PPA is an independent risk factor for brain bleeding as was alcohol abuse by this male.... this is not a patient who had one risk factor for brain bleeding. This patient had several risk factors for brain bleeding and multiple risk factors don’t protect you from brain bleeding. They just increase the risk even further and they’re additive.” (Preservation deposition, TR 224, 547, 548.) This was the one case which had control. (Preservation deposition, TR 225.) There were five other cases in all in a five-year study, and the total of six also had other independent risk factors for brain bleeding. (Preservation deposition, TR 227, 228.)

Dr. Feldman testified on redirect that “the FDA looked at the multiple risk factor cases and were very satisfied with the adjustments we made” (for those multiple factors). (Preservation deposition, TR 549.)

“Hormones may explain some of the difference in risk that we observe between men and women.'’'’ (Preservation deposition, TR 232.) (emphasis supplied)

Thus, the differences between men and women are differences mainly in degree, and this court finds that extrapolation from the HSP study from women to men is a generally accepted methodology based upon the strong, logical inference supported by both reason and academic literature and case reports. Accordingly, there is an objective basis here for extrapolation.

Accordingly, Frye is satisfied and plaintiffs’ expert may testify that PPA increases the risk of hemorrhagic stroke in the male population 18 years of age and older.

III. PPA Increases the Risk of Ischemic Stroke in Any Segment of Our Society

Unlike the discussion about sub-population groups based upon age and gender, we now examine the applicability of a form of extrapolation from data and scientific knowledge as they relate to a type of stroke different from the hemorrhagic stroke covered in the HSP report, to wit: ischemic stroke.

All parties agree that the comparison approach utilized by plaintiffs in which they compare PPA, a drug known as sympathomimetic, with other drugs in that group, is a form of extrapolation.

Dr. Feldman frankly testified that he has not yet arrived at a final opinion as to whether PPA can cause ischemic stroke. (TR 39, line 24.) However, that is the conclusion about which some plaintiffs’ experts wish to testify and Track, supra, directs us not to consider the general acceptance of conclusions but only methodology and principles.

Ischemic stroke accounts for 75-80 percent of all strokes (Dr. Levine). Many people who experience ischemic stroke suffer from other health problems or conditions, such as high blood pressure or hypertension and heart disease. Other factors that increase a person’s risk of ischemic stroke are gender, race and age. Sometimes the deposits of cholesterol narrow the arteries so much that blood cells may collect and form clots. Ischemic strokes can be caused when these blood clots block an artery. If the blockage occurs in an artery or occludes a blood vessel leading to the brain, a thrombotic stroke or cerebral infarction can occur. Sometimes a blood clot is formed within an artery outside the brain. If this blood clot dislodges, travels within the bloodstream, and becomes trapped in an artery closer to the brain, an embolic stroke can occur.

A hemorrhagic stroke occurs when there is release of blood by the sudden rupture of an artery within or surrounding the brain. There are two types of hemorrhagic stroke: intracerebral and subarachnoid. Intracerebral hemorrhage occurs when an artery within the brain bursts, allowing blood to leak within the brain. The release of blood in the brain increases pressure within the brain and can damage the brain cells surrounding the released blood. The most common cause of intracerebral hemorrhage is hypertension. Subarachnoid hemorrhage occurs when an artery near the brain ruptures and fills the area surrounding the brain with blood. The release of blood, as in an intracerebral hemorrhage, creates an increase in pressure and can damage the brain cells surrounded by the blood.

PPA is a sympathomimetic amine, which means that it stimulates the sympathetic nervous system by mimicking the effects of molecules that regulate the system. The sympathetic nervous system is one part of the autonomic nervous system; the parasympathetic nervous system is the other part. The autonomic nervous system is automatic, i.e., it cannot be controlled by the mind. These systems work in balance with each other and directly or indirectly affect the body. The sympathetic nervous system has an active pushing system; the parasympathetic has a relaxing function.

Both plaintiffs’ and defendants’ experts discussed the pharmacology of PPA. Specifically, sympathomimetic amines are similar in structure to norepinephrine, which is found in the brain and is the primary neurotransmitter in the sympathetic nervous system. Norepinephrine controls “fight or flight” reactions. Sympathomimetic amines are also similar in structure to epinephrine, which is a brain neurotransmitter and a major hormone in the body. Both norepinephrine and epinephrine are both catecholamines produced by the body to regulate the nervous system.

Amphetamine, ephedrine, cocaine and PPA are examples of sympathomimetic amines. Sympathomimetic amines have similar chemical structures. For example, PPA’s structure is nearly identical to amphetamine; but PPA has a particular carbon hydroxl group that amphetamine lacks. However, sympathomimetic amines are not identical and, consequently, may produce different effects or may be more or less potent. For example, PPA is far less potent than amphetamine.

Common effects of the “fight or flight” response are increases in heart rate, increases in blood pressure, dilation of the trachea and bronchi, pupil dilation and increases in blood flow to the brain, heart and skeletal muscles, and decreases in blood flow to the skin and internal organs.

Defendants argue that the effects of PPA are not identical to those of other sympathomimetic drugs. “Relatively minor modifications in the molecule may result in major changes in pharmacological properties.” (Louis S. Goodman et al., The Pharmacological Basis of Therapeutics 32 (10th ed. 2001)).

Defendants maintain that PPA’s properties differ from those of other sympathomimetic drugs that are generally accepted risk factors for stroke. One significant reason for this difference, according to the defendants, is that PPA is substantially less potent than other sympathomimetic drugs. Defendants suggest that the differences between PPA and other sympathomimetic drugs do not permit extrapolation under Frye and Track.

Next the defendants highlight that acute increases in systemic blood pressure is a well-accepted means of preventing ischemic stroke following a hemorrhagic stroke. Defendants also note that blood pressure increases equal or greater than those reported in studies cited by plaintiffs occur during normal daily activity. The autoregulatory system, according to the defendants, is equipped to handle these routine blood pressure increases. Defendants proffer that the autoregulatory system must also be capable of handling blood pressure increases following ingestion of PPA.

Plaintiffs’ experts rely upon the similarities of PPA’s structure to that of other sympathomimetics including amphetamine and cocaine. Toxicologists and pharmacologists routinely consider an observed effect of similar drugs to infer that other similar drugs may also cause the same effect because scientists, recognize that similar chemicals may have similar properties, according to the plaintiffs.

In this case, plaintiffs claim that PPA and other sympathomimetic drugs cause similar side effects, including elevation in blood pressure, headache, stroke, seizure, psychic disturbances, and death. Defendants concede that PPA is a sympathomimetic that can cause elevations of blood pressure at particular levels but argue that although PPA may have some properties of other sympathomimetics, it also has subtantial differences. Plaintiffs agree with the defendants that all sympathomimetic drugs do not produce all of the same side effects. However, plaintiffs in opposition state that it is accepted that these drugs constrict blood vessels and cause strokes. In particular, plaintiffs explain that PPA and other sympathomimetic drugs can cause transient and diffuse constrictions or isolated rings of contraction in blood vessels. When viewed on a cerebral angiogram with radio-opaque dye, these constrictions can look like a string of beads — hence the term “beading.” Beading has been observed with many sympathomimetic drugs, including PPA. These observations have been published in peer-reviewed literature. See e.g., Carlos S. Kase et al., Intracerebral Hemorrhage, in Neurology in Clinical Practice: The Neurological Disorders, 1032-47 (2d ed. 1996).

Moreover, plaintiffs point out that analogizing one drag to other similar drags is routinely performed in certain scientific disciplines, e.g., toxicology and pharmacology. The plaintiffs conclude by offering that their experts’ use of this technique is appropriate in this case.

Plaintiffs’ experts also rely on human clinical trials; e.g., Paul R. Pentel, Toxicity of Over-the-Counter Stimulants, 252 JAMA 1898 (1948); J.D. Horowitz et al., Hypertensive Responses Induced by Phenylpropanolamine in Anorectic and Decongestant Preparations, 8159 The Lancet 60, 61 (1980); Steven C. Dilsaver et al., Complications of Phenylpropanolamine, 39(4) Am. Farm Physician, 201, 201-206 (1989). The most common adverse effect of PPA in these clinical trials was a sudden rise in blood pressure.

Physicians, according to plaintiffs, routinely use differential diagnosis as a method of opining on causation of a disease. Differential diagnosis is a process by which different possible causes or risk factors for a disease are systematically considered, tested for and ruled in or ruled out. Plaintiffs suggest that differential diagnosis is an appropriate methodology when opining on causation of a disease regardless of whether the opinion is reached for expert testimony or patient treatment.

Today 10 causality factors are often used to assess causality: consistency, congruence, strength of association, sensitivity, specificity, temporality, dose-response, plausibility, experiments and research, and analogy. Plaintiffs argue that their contention that PPA causes stroke can be supported by several of these factors.

Plaintiffs assert that it is biologically plausible that PPA causes stroke through vasoconstriction. The plaintiffs claim that the evidence suggests coherence. Plaintiffs assert that PPA is structurally and biologically analogous to other sympathomimetics that are generally accepted to cause stroke.

Plaintiffs present Dr. Steven Levine as an expert. Dr. Levine is a highly qualified neurologist who specializes in stroke. His education, experience and training focus on stroke. There is no dispute that Dr. Levine is qualified as an expert in the field of neurology.

Dr. Levine is a board certified neurologist and is a professor of Neurology and Director of Cerebrovascular Education at the Mount Sinai School of Medicine and Medical Center in New York City. He was previously the Detroit area principal investigator for the National Institute of Health and served as a co-chair of both the Michigan Stroke Initiative and the America Stroke Association Operation Stroke Detroit. Dr. Levine has also treated numerous patients who have had strokes during his medical career.

Dr. Levine has published his opinions that sympathomimetic drugs, including PPA, can cause strokes. Dr. Levine’s first published opinion about sympathomimetics, including PPA, was published in the early 1990s.

Dr. Levine, in reaching his conclusions regarding PPA relied upon the kinds of facts and data that stroke neurologists rely on in the course of their academic and clinical work. Dr. Levine highlighted the evidence that he relied upon in reaching his opinion. Dr. Levine explained,

“So there are about 10 kinds of evidence that sort of, if you will, all converge or point to one direction with regard to supporting ... my opinion that PPA in select individuals can cause an infarct. These lines of evidence are case reports that are published that are peer reviewed in the medical literature. Short series, two cases that are included in that, adverse events, adverse drug reports that were reported to the FDA. Animal studies with sympathomimetics. Clinical structure, function, and pharmacological class that are similar with PPA to amphetamines and ephedrine. And there’s some analogy as well to naturally occurring conditions that altered sympathetic tone, where there’s a disruption of the sympathetic nervous system. . . . There’s literature on similar drugs of the same class that have the same mechanisms of action. Similar mechanisms of action. There’s biological plausibility based on a class of drug. The fact that PPA has a narrow therapeutic index. Human blood pressure experiments. Multiple textbooks. And in fact not just my personal experience, but also other stroke neurologists around the country’s personal experience as well.”

This scientific literature and scientific evidence, as Dr. Levine testified, is the same evidence that stroke neurologists rely upon everyday.

Dr. Levine concluded that, “given that sympathomimetics are known to be a vasoconstrictor and affect cerebral vessels, then I think there is biological plausibility in the tenet that PPA can cause ischemic stroke, fits well and nicely within biological plausibility.” Dr. Levine also testified that, “If you look at the reports and personal experience, and textbooks, at the epidemiological studies, there is a temporal association with the medication, or the drug, and the effect. And also dose response, where higher doses are more likely to cause adverse events in question.” In reaching this conclusion, Dr. Levine focused on PPA’s ability to constrict the vessels and reduce blood flow.

Dr. Levine also recognized that sympathomimetic drugs vary in some significant ways, in particular, potency:

“Q. And you would agree, of course, doctor, that the effects of PPA are not identical to the effects of cocaine?

“A. I think that they’re not the same drug, but they have similar effects in terms of some of their pharmacology. They both can raise blood pressure. They both can vasoconstrict. Cocaine is much more [central nervous system] active than PPA is. So, yes, they’re different drugs. Cocaine is on a potency level much more potent than PPA is, but they do share similar pharmacological effects, because they have similar sympathomimetic action.”

Dr. Levine refers to Koch’s Postulates:

“(1) Biological plausibility/known drug effects;
“(2) Temporal association to stroke;
“(3) Dose response — higher doses more likely to cause strokes.”

Dr. Levine’s references to top neurologists specializing in stroke shows wide acceptance but not necessarily general acceptance of his conclusions.

Dr. Levine testified that if you take an angiogram soon enough, and if the ischemic stroke is bad enough, you will see clot obstruction in 85 percent of ischemic stroke cases.

Dr. Levine’s level of proof is a Grade D in concluding that PPA causes ischemic stroke.

Dr. Levine cites the following textbooks and other materials in support of his methodology:

“(1) Caplan’s Stroke, A Clinical Approach (supporting clinical decision-making based on anecdotal experiences and intuition — reviewed favorably by Gregory W. Albers M.D. et al.).
“(2) Rosen’s Emergency Medicine Concepts and Clinical Practice Fifth edition — Chapter 95 Stroke
“Recreational drugs such as cocaine, phenylpropanolamine and amphetamines are potent vasoconstrictors associated with both ischemic and hemorrhagic stroke.
“(3) Ischemic Cerebrovascular Disease by Adams M.D., Hachinski M.D. and Norris M.D.
“Among persons abusing drugs, stroke can be secondary ... to drug-induced vasoconstriction of the cerebral vessels, a vasculitis, or marked by elevated blood pressure.
“Ischemic stroke is most commonly described with the abuse of cocaine and amphetamines.
“Stroke is a potential complication of other medications that have vasoconstrictive properties. Among the medications that have been implicated are phenylpropanolamine and ephedrine ... The former agent is a component of medications that are used to suppress appetite or to rhinitis (decongestant), whereas ephedrine is available as a prescribed stimulant. Young patients should be asked about recent use of these medications.
“(4) Vasculitis by Gene V. Ball et al.
“Drugs, particularly those with sympathomimetic properties, have been associated with a myriad of neurologic problems including cerebral infarcts, intracerebral bleeding and subarachnoid hemorrhage. The most commonly implicated drugs are oral intravenous amphetamines, cocaine, heroin, ephedrine and phenylpropanolamine.
“(5) Experimental and Clinical Neurotoxicology by. .. Herbert H. Schaumburg M.D. et al.
“Abuse or overtreatment with agents with vasopressor/constrictor side effects (ergotamine, amphetamine, phenylpropamine, cocaine) can precipitate cerebral vasospasm or hemorrhage.
“(6) Stroke and Substance Abuse by John C.M. Brust
“Amphetamine-like psychostimulants include dextroamphetamine, methamphetamine, methylphenidate (Ritalin), ephedrine, pseudoephedrine, phenylpropanolamine, and a large number of other agents marketed as decongestants or appetite suppressants. Ischemic or hemorrhagic stroke is a well-recognized complication of these drugs.
“Amphetamine-induced cerebral vasculitis has also caused ischemic stroke.”

Dr. Gregory William Albers, defendants’ expert, agrees that there are sources linking PPA to ischemic stroke but disagrees with them. He agrees that leading textbooks state as medical knowledge that PPA can cause ischemic stroke.

Dr. Thomas Michel, a defense expert in adrenergic pharmacology, a practicing cardiologist and board certified in internal medicine and cardiology, testified that PPA is a weak vasoconstrictor and a very, very weak alpha-1 adrenergic agonist, but states that he “is not sure that there is a very substantive signal there” that if PPA were to work in conjunction by releasing more norepinephrine, then PPA itself becomes a better stimulator. (TR pp. 99, 100.)

Dr. Michel also testified “that the definitive identification of a reproducable drug effect of a large change in blood pressure was not documented.” (TR p. 105.) (emphasis supplied) Thus, it appears that the effect of PPA is not disputed but only the degree of the effect.

Finally, Michel admits on cross-examination that it is “common knowledge” that cocaine is one drug that he acknowledges causes both heart attack or myocardial infarction and stroke. (TRp. 110.)

Dr. Gregory William Albers, who testified live as a defense expert, was asked whether he agrees that some people who take PPA could get extreme elevations in blood pressure (TR p. 88), and Dr. Albers answered as follows (TR pp. 88-92, both inclusive):

“A. It’s a very interesting question, because my thinking on this changed a bit when I went back to the Lake article. When I wrote my original report, where I had a sentence like that, it was based on my reading of an article by Lake, where he indicated a number of patients had malignant hypertension associated with PPA. Then I went back later after I had written the article, and I pulled every reference that was — where Lake said malignant hypertension had occurred in a PPA case, and I was quite amazed to find that not one of those patients had malignant hypertension, and that most of those patients, the blood pressure was either normally or minimally elevated.
“So, my opinion would have changed a bit after I reviewed more detail, the original sources.
“Q. Let’s take a look at your report, put up report of Dr. Albers, paragraph 38. This is the original report you wrote in the MBL litigation that you’re referring to?
“A. This is what I am just talking about right now. Correct.
“Q. And take a look at that paragraph, paragraph 38 on page 13 of your report—
“A. Correct.
“Q. —where you stated, abrupt severe elevation in blood pressure has also been suggested as potential cause of brain hemorrhages following consumption of PPA?
“A. Correct.
“Q. And you say, rare individuals develop stream (extreme) elevations in blood pressure following administration of PPA?
“A. Correct.
“Q. So, you’re now changing that opinion?
“A. Well, what I am saying is that part of that opinion was based quite heavily on the review article by Lake, and that the Lake article reported a number of patients that took PPA and developed what’s called hypertensive encephalopathy, which is a very extreme elevation in blood pressure. So, I was relying, to a great extent, on that article being correct. And then subsequently, having more time to go back and really examine these cases in detail, I pulled all the individuals cases from Lake where hypertensive encephalopathy was reported, and was failure (fairly) astonished to find that in many of those case reports, the blood pressure was absolutely normal, there was not even an elevation in blood pressure.
“So, I certainly would write that sentence different today now that I have had more opportunity to review more detailed literature.
“Q. After you went back and you reviewed Dr. Lake’s report, and changed your opinion, did you write a supplemental report, notify counsel for the defendant that you had changed your opinion on this issue?
“A. Well, I certainly discussed it with the attorneys, and then this issue came up again in Seattle at the Dolbert (Daubert) hearings.
“Q. Well, in Seattle you didn’t indicate that you had changed your opinion on this issue, did you?
“A. I wasn’t, I think, asked specifically. I think this is a part in the transcript where I indicated that I had rereviewed Lake, and found that the severe degrees of blood pressure elevation that I thought had been reported, based on reading his article, actually did not occur.
“Q. Let’s take a look at the last sentence of that article. Furthermore, patient who ingests overdose of PPA can have extreme elevation in blood pressure. Again, you said it again.
“A. Again, this was before reviewing Lake, where it was lot of the cases who reportedly had the hypertensive encephalopathy had major overdoses.
“Q. Don’t you think it would be important for purposes have (of) this litigation for you to write a supplemental report, saying that paragraph 38 of my original report is now wrong?
“A. I wasn’t asked to write a supplemental report. Iff was asked to write a new report, I would structure this paragraph a bit different.
“Q. Whether you were asked to or not, this is a significant change in your opinion, is it not?
“A. Maybe I am not as familiar with the legal proceeding as you are. I was under no impression that everytime I learned something new, I needed to addend to my report.
“Q. If you write a medical article, yourself, and you later learn that something you wrote in that article is not correct, you’re going to write an article or a supplement to that, saying that I was wrong?
“A. Well, if the opportunity comes up to address the topic again, certainly. Every time people update book chapters, they update things. They don’t put out some alert every time they realize that there’s been some change in their thinking on the topic. I mean, medicine evolves over time as more data comes to light.”

Dr. Albers agrees that high blood pressure is a risk factor that is common for both hemorrhage and ischemic strokes. (TR pp. 87-88.)

This court is concerned about the change in the testimony of Dr. Albers from his written report without having submitted a supplemental report providing the change in testimony and the reasons for such change.

This court finds that the methodology utilized by the plaintiffs’ experts on this issue is the same as used in hospitals across the country, taught at medical schools and described in medical textbooks.

This court finds that the plaintiffs have carried their burden of proof at this Frye hearing and that the weight of the evidence establishes that the plaintiffs’ experts may testify that PPA increases the risk of ischemic stroke in any segment of our society because there is general acceptance of the methodology of extrapolation utilized by those experts and supported by the lines of evidence, materials, textbooks and case reports, so that there is objective evidence supporting the methodology. In addition, the methodology of extrapolation by comparison, here utilized, is supported by a strong logical inference, to wit: that drugs of that same class, which to some extent bring about effects which in turn contribute to ischemic stroke, may be compared as to effect.

Plaintiffs’ experts, like any other expert witnesses, may be cross-examined during trial to distinguish the evidence that they rely upon in applying their opinion from the scientific literature to the facts in a given trial. Defendants’ own experts may also offer opinions that challenge plaintiffs’ experts’ conclusions, thus creating questions for the jury to weigh and ultimately resolve.

ORDER

And now, September 2, 2003, after review of defendants’ motion pursuant to Pa.R.C.P. 207.1 to exclude testimony of plaintiffs’ generic experts, defendants’ brief in support of said motion and defendants’ exhibits, plaintiffs’ responses and exhibits and attachments thereto, defendants’ reply brief and exhibit volumes 1-3, plaintiffs’ sur-reply to defendants’ reply brief and supplement thereto, the studies, reports and literature submitted by all parties to this court pursuant to this court’s order dated May 30, 2003, and after a Frye evidentiary hearing and argument, the following findings and order are set forth below and in the accompanying opinion as to the issues remaining pursuant to the order of this court dated May 30, 2003:

(1) Plaintiffs’ generic experts are permitted to testify and render opinions that PPA increases the risk of hemorrhagic stroke in the male population 18 years of age and older because the methodology and principles producing such proposition, to wit, extrapolation, are generally accepted by the relevant scientific community; and, thus, Frye is satisfied in this regard.

(2) Plaintiffs’ generic experts are permitted to testify and render opinions that PPA increases the risk of hemorrhagic stroke in the female population over the age of 49 years because the methodology and principles producing such proposition, to wit, extrapolation, are generally accepted by the relevant scientific community; and, thus, Frye is satisfied in this regard.

(3) Plaintiffs’ generic experts are permitted to testify and render opinions that PPA increases the risk of ischemic stroke in any segment of our society because the methodology and principles producing such proposition are generally accepted by the relevant scientific community; and, thus, Frye is satisfied in this regard.


source: Caselaw Access Project

author: McGINLEY, J.,

license: Public Domain

text:
    Rothrock Motor Sales Inc. v. Northern Insurance Co. of New York

      C.P. of Lehigh County,
    no. 93-E-0059.

      Wallace B. Eldridge, for plaintiff.

      Richard Bruce Morrison and Christine L. Davis, for defendant Northern Insurance Co. of New York.

      Daniel Morgan, for defendants Bowers Schumann & Welch Insurance Agency and Witbeck.

      Clyde Bartel, for defendants Rothrock.

      June 5, 2003
   McGINLEY, J.,

— The issue before us is the interpretation of a policy of insurance with regard to indemnification for a wrongful discharge of an employer.

The relevant facts are as follows. On July 16, 1992, Rothrock Motor Sales Inc. through its principal, Bruce Rothrock Sr. discharged Ted Rothrock, father and supervisor of Douglas Rothrock. The jury found that the discharge was in retaliation because Douglas had filed a workers’ compensation claim and awarded Ted Rothrock $192,000 in compensatory damages. The matter was appealed to the Superior Court on a question of first impression, and the verdict was affirmed by decision of the Superior Court on September 25,2002. Petition for reargument was denied on December 4,2002. These events were litigated at 1993-C-211 (2638 EDA2001, Superior Court).

Concomitantly, Rothrock Motor Sales Inc. sued Northern Insurance in equity in the instant matter to compel a defense and indemnification pursuant to certain policies of insurance that were in effect at the time of the occurrence. On June 12,2000, the Honorable William E. Ford, chancellor, found that Northern Insurance was obligated to defend the wrongful discharge action. He deferred the question of indemnification pending resolution of the wrongful discharge litigation.

The wrongful discharge litigation has now concluded, with a final judgment against Rothrock for the wrongful discharge of Ted Rothrock. The plaintiff and the defendant filed cross-motions for summary judgment to determine whether the plaintiff is owed indemnity from the defendant.

We summarize the relevant findings as follows: For the years 1991 and 1992 when this cause of action arose, Northern carried two policies for Rothrock. Under one of these policies, called the “garage liability” policy, there was coverage for employment practices.

Northern did not attach an exclusion to the policy for “employment-related practices.” Furthermore, the agent, Mr. Witbeclc, wrote “not on policy” on the exclusions, to demonstrate that there was in fact, employment-related practices coverage.

The agent advised Rothrock that Rothrock had coverage for wrongful termination and sexual harassment. Ms. Toth, a senior employee at the insurance agency, noted in writing that “wrongful dischargment” would be covered. Ms. Toth had discussed these matters with a representative of Northern Insurance. A further written memorandum from Mr. Witbeck noted “all covered, except plagiarism as it is an intentional act with prior knowledge. If not intentional, even this is covered.”

A jury verdict having been rendered in favor of Ted Rothrock and against Rothrock, Rothrock now seeks indemnification from Northern. Northern claims that since the jury found that the wrongful discharge was in retaliation for Ted’s refusal to fire his son, that it is an intentional act not covered by the policy.

DISCUSSION

An order that Northern defend the litigation is not dis-positive of the duty to indemnify.

An insurer’s duty to defend is a distinct obligation, different from and broader than its duty to indemnify Aetna Casualty and Surety Co. v. Roe, 437 Pa. Super, 414, 650 A.2d 94 (1994).

Northern claims that the following language in the policy relieves it from the obligation to indemnify.

“This insurance does not apply to any of the following: Expected Or Intended Injury. ‘Bodily injury’ or ‘property damage’ expected or intended from the standpoint of the insured ....”

First, we find this exclusion has no applicability at all in this case. The prior decree found, and appropriately so, that any coverage is afforded to Rothrock is due to the “personal injury” coverage, rather than the bodily injury coverage. Personal injury is a broader concept and it is under this coverage that the employment practices coverage was extended. The “bodily injury” exclusion would apply only to the bodily injury coverage.

The jury having now found that the insured is liable for wrongful discharge, but having rejected an award for punitive damages, the insured is clearly entitled to indemnification pursuant to the policy coverage for “wrongful dischargement.”

Although we hold here that the “expected or intended” clause is inapplicable, we would otherwise decline to extend the “inferred intent” line of cases to the tort of wrongful discharge. As shocking as one might find this situation, it does not compare to selling heroin, Minnesota Fire and Casualty v. Greenfield, 805 A.2d 622 (Pa. Super. 2002); sexual molestation of a child, Erie Insurance Exchange v. Claypoole, 449 Pa. Super. 142, 673 A.2d 348 (1996);180 Ed. Law Rep. 302 (1996) or intentional physical assault, Erie Insurance Exchange v. Fidler, 808 A.2d 587 (Pa. Super 2002).

DECREE NISI

And now, June 5,2003, after consideration of the cross-motions for summary judgment of the plaintiff, Rothrock Motor Sales Inc. and the defendant Northern Insurance Co. of New York, the briefs, and after argument, and for the reasons set forth in the accompanying adjudication, it is hereby ordered and decreed that the motion of the plaintiff Rothrock Motor Sales Inc. is granted, and the defendant Northern Insurance Co. of New York shall indemnify Rothrock Motor Sales Inc. in the sums due and owing pursuant to the verdict against Rothrock Motor Sales Inc. in Theodore Rothrock and Douglas Rothrock v. Rothrock Motor Sales, Lehigh County no. 1993-C-211.

It is further ordered and decreed that the motion for summary judgment of Northern Insurance Co. of New York is denied.

This shall become a final decree of court upon praecipe of either party, if no exceptions or objections are filed within 10 days of the date of this decree.

      . The decision of the Superior Court denying reargument was unavailable to this court at the time of the argument of these motions on December 17, 2002. Although we entered an order in this case that counsel should notify us in writing upon the receipt of a final decision from the Superior Court in that case, all counsel have failed to do so.

      . It should also be noted that the jury declined to award punitive damages.


author: NEALON, J.,

text:
    White v. Behlke

      C.P. of Lackawanna County,
    no. 03 CV 2663.

      Robert T. Szostak, for plaintiffs.

      Chris J. Carling, for defendants Behlke, Rabin and OB/GYN Consultants Ltd.

      Bruce L. Coyer, for defendant CMC.
    November 23, 2004
   NEALON, J.,

— The parties’ submissions in this malpractice action concern the appropriate procedure for seeking the dismissal of a professional negligence claim for failure to file a timely certificate of merit pursuant to Pa.R.C.P. 1042.3. For the reasons set forth below, a corporate liability claim against a hospital must be supported by an independent certificate of merit under Rule 1042.3(a)(1), since a corporate liability claim requires expert testimony and is not based solely on allegations of vicarious liability for the conduct of other health care professionals. Moreover, since Rule 1042.6 identifies a judgment of non pros as the sole means for challenging the absence of a certificate of merit, a health care provider may not use preliminary objections or a motion for judgment on the pleadings to secure the dismissal of a malpractice claim for failure to file a timely certificate of merit under Rule 1042.3. Finally, inasmuch as a judgment of non pros under Pa.R.C.P. 1042.6 is not an adjudication on the merits for res judicata purposes, the judgment of non pros entered in favor of one defendant in this case does not bar the minor plaintiff from filing another malpractice action against that defendant in accordance with the Minor Tolling Statute.

I. FACTUAL BACKGROUND

Plaintiffs commenced this obstetrical malpractice suit by the filing of a writ of summons on June 26, 2003, naming, inter alia, Richard Behlke M.D., Marc Rabin M.D., OB/GYN Consultants Ltd., and Community Medical Center Health Care Systems as defendants. (Dkt. entry no. 1.) In response to rules to file a complaint, plaintiffs filed their original complaint on September 11,2003. (Id, nos. 5,7,11.) Count I of the complaint charged Dr. Rabin with specified negligence and Counts III, IV, and V addressed the conduct of Community Medical Center (CMC). Specifically, Count III set forth a corporate liability cause of action whereas Count IV asserted a vicarious liability claim based upon the actions of CMC’s actual or ostensible agents. Count V sought to recover punitive damages from CMC based upon the same conduct alleged in Counts III and IV. (Id., no. 11, pp. 5-8, 10-16.)

In any civil action filed after January 27,2003, in which the plaintiff alleges “that a licensed professional deviated from an acceptable professional standard,” the plaintiff must file a certificate of merit within 60 days of the filing of the complaint. Pa.R.C.P. 1042.3(a) requires the certificate of merit to confirm that either: “(1) an appropriate licensed professional has supplied a written statement that there exists a reasonable probability that the care, skill or knowledge exercised or exhibited in the treatment, practice or work that is the subject of the complaint, fell outside acceptable professional standards and that such conduct was a cause in bringing about the harm, or (2) the claim that the defendant deviated from an acceptable professional standard is based solely on allegations that other licensed professionals for whom this defendant is responsible deviated from an acceptable professional standard, or (3) expert testimony of an appropriated licensed professional is unnecessary for prosecution of the claim.” Pa.R.C.P. 1042.3(a)(l)-(3). The official note accompanying Rule 1042.3(a)(1) states that the “appropriate licensed professional” who provides the written statement must possess sufficient qualifications to testify as an expert under the new expert witness criteria set forth in section 512 of the MCare Act, 40 P.S. §1303 .512. See Herbert v. Parkview Hospital, 854 A.2d 1285, 1291-94 (Pa. Super. 2004) (discussing expert witness standard under 40 P.S. §1303.512); Gartland v. Rosenthal, 850 A.2d 671, 675-76 (Pa. Super. 2004) (same); Wexler v. Hecht, 847 A.2d 95, 102-105 (Pa. Super. 2004) (same).

Rule 1042.3(d) allows the court, “upon good cause shown,” to extend the time for filing a certificate of merit for a period not to exceed 60 days, provided that the motion to extend is presented on or before the original deadline for the filing of the certificate of merit under Rule 1042.3(a). Although the plaintiffs’ certificate of merit should have been filed in this case by November 10,2003, the parties voluntarily extended that deadline while the defense produced relevant records. Due to a dispute regarding CMC’s production of certain medical records and diagnostic testing materials, the plaintiffs filed a “Motion to extend time for filing of certificate of merit” on January 20, 2004. Dr. Behlke, Dr. Rabin, OB/GYN Consultants and CMC also filed preliminary objections challenging certain averments contained in the complaint on the grounds that they lacked the requisite specificity under Pa.R.C.P. 1019(a). In addition, CMC presented a demurrer to the plaintiffs’ claim for punitive damages based upon section 505 of the MCare Act, 40 P.S. §1303.505. (Dkt. entry nos. 20-23, 26-27.)

The official note to Rule 1042.3(d) states that “[tjhere is a basis for granting an extension of time within which to file the certificate of merit... if, despite diligent efforts by counsel, records necessary to review the validity of the claim are not available.” Based upon the plaintiffs’ representation that the merits of their malpractice claims could not be evaluated by an appropriate expert until CMC produced the maternal fetal ultrasound studies, chord blood study specimen and chest x-ray films that the special discovery master had ordered CMC to produce, we granted the plaintiffs’ motion for an extension on February 6, 2004, and directed the plaintiffs to file their certificates of merit within 60 days of the production of those designated items which were necessary “to review the validity of the proffered malpractice claims against the defendants.” (Id., no. 46.) As to the defendants’ preliminary objections challenging the factual specificity of the plaintiffs’ allegations, we directed the plaintiffs to file an amended complaint curing those factual inadequacies. (Id, no. 47.) We deferred any ruling on CMC’s demurrer to the punitive damages claim “pending the plaintiffs’ production of a certificate of merit pursuant to Pa.R.C.P. 1042.3 within the next 60 days certifying that an appropriate licensed professional has supplied a written statement that the defendants are chargeable with willful or wanton conduct or reckless indifference to the rights of others.” (Id, ¶2.)

On April 5,2004, the plaintiffs filed an amended complaint against Dr. Behlke, OB/GYN Consultants and CMC. Count II alleges a corporate liability claim against CMC while Count III asserts vicarious liability on the part of CMC. (Diet, entry no. 55, pp. 7-11.) The amended complaint does not name Dr. Rabin as a defendant, nor does it contain any malpractice allegations against him. Additionally, the amended complaint does not include a claim for punitive damages against CMC or Dr. Behlke, presumably due to the plaintiffs’ inability to secure a supporting certificate of merit for that claim as per ¶2 of our order dated February 6, 2004.

Plaintiffs filed a certificate of merit as to Dr. Behlke on April 5, 2004, certifying pursuant to Rule 1042.3(a) (1) that an appropriate licensed professional had supplied a written statement regarding Dr. Behlke’s deviation from the standard of care. (Id., no. 54.) With respect to OB/ GYN Consultants and CMC, the plaintiffs submitted a certificate of merit under Rule 1042.3(a)(2) stating that their professional negligence claims against those defendants were based solely on allegations that they are vicariously liable for the negligence of other licensed professionals. (Id., nos. 52-53.) However, the plaintiffs did not produce a certificate of merit under Rule 1042.3(a)(1) with regard to their corporate liability claim against CMC.

On April 7, 2004, CMC filed preliminary objections to the plaintiffs’ amended complaint seeking to strike the corporate liability claim (Count II) for failure to file a supporting certificate of merit in accordance with Pa.R.C.P. 1042.3(a)(1). (Id., no. 57.) In response, the plaintiffs belatedly filed a certificate of merit relative to their corporate liability claim on April 12,2004, setting forth the required statement pursuant to Rule 1042.3(a)(1). (Id, no. 60.) On April 14,2004, CMC filed a motion to strike the certificate of merit dated April 12, 2004, on the grounds that it was filed untimely under Rule 1042.3(a). (Id, nos. 61-63.)

On July 6, 2004, Dr. Rabin filed a motion for judgment on the pleadings asserting that he should be dismissed with prejudice due to the absence of a supporting certificate of merit against him. (Id, no. 67.) On August 2, 2004, the plaintiffs filed an answer to Dr. Rabin’s motion and included a “Counter-petition to discontinue action without prejudice nunc pro tunc pursuant to Pa.R.C.P. 229 as to defendant, Marc Rabin M.D.” {Id., no. 71.) On October 25,2004, Dr. Behlke filed a praecipe for entry of judgment of non pros under Pa.R.C.P. 1042.6, and on that date, the clerk of judicial records entered a judgment of non pros in favor of Dr. Rabin. (Id., nos. 73-74.) On November 8, 2004, the plaintiffs then filed a “Petition to strike praecipe of non-party, Marc Rabin M.D., for entry of judgment of non pros pursuant to Rule 1042.6.” (Id, no. 76.)

Plaintiffs contend that their original certificate of merit with respect to CMC is sufficient under Rule 1042.3(a) since their corporate liability claim is allegedly predicated upon the actions of other licensed professionals for whom CMC is responsible. Plaintiffs further aver that assuming arguendo that a separate, corporate liability certificate of merit was required under Rule 1042.3(a)(1), they did in fact file such a certificate before CMC secured any judgment of non pros pursuant to Rule 1042.6. CMC counters that inasmuch as it is merely seeking to strike Count II of the amended complaint rather than requesting judgment in its favor on all claims, preliminary objections are the appropriate vehicle by which to challenge a single theory of liability which is unsupported by a certificate of merit.

In his motion for judgment on the pleadings, Dr. Rabin seeks to dismiss all malpractice claims with prejudice since plaintiffs have not submitted a supporting certificate of merit with regard to him. Plaintiffs request leave of court nunc pro tunc to voluntarily discontinue their claims against Dr. Rabin without prejudice to the minor plaintiff’s right to refile a malpractice action against Dr. Rabin in the future in accordance with the Minor Tolling Statute, 42 Pa.C.S. §5533. In an apparent effort to preserve the minor plaintiff’s malpractice claim under the Minor Tolling Statute, the plaintiffs also seek to strike Dr. Rabin’s judgment of non pros which he obtained pursuant to Rule 1042.6. Encumbered by this involved procedural background, we will address the parties’ certificate of merit arguments.

II. DISCUSSION

(A) Corporate Liability Claim Against CMC

Pa.R.C.P. 1042.3(a) requires a certificate of merit to be filed in any civil action in which the plaintiff alleges that a “licensed professional” deviated from an acceptable professional standard. Cf. Thompson v. Janetta, 152 Pitts. L.J. 162, 163 (Allegheny Cty. 2004) (since a lack of informed consent claim is not based on an allegation that the physician deviated from an accepted professional standard, Rule 1042.3 does not require the filing of a certificate of merit in an informed consent case); Herrmann v. Pristine Pines of Franklin Park Inc., 64 D.&C.4th 14, 20 (Allegheny Cty. 2003) (where a complaint does not allege a professional liability claim against a licensed professional, the plaintiff is not required to file a certificate of merit). As stated above, a “health care provider” under section 503 of the MCare Act is considered to be a “licensed professional” for purposes of Rule 1042.3, and 40 PS. §1303.503 defines a “health care provider” as including a hospital. (See n.1, supra.) Thus, by definition, Rule 1042.3(a) and40 P.S. §1303.503 require a certificate of merit to be filed if a plaintiff alleges that a hospital deviated from the accepted standard of care. However, plaintiffs contend that since a hospital can only act through its agent or employees, a corporate liability claim need only be supported by a vicarious liability certificate of merit under Pa.R.C.P. 1042.3(a)(2).

In the seminal case of Thompson v. Nason Hospital, 527 Pa. 330, 591 A.2d 703 (1991), the Supreme Court of Pennsylvania recognized the doctrine of corporate liability based upon a hospital’s duties “to use reasonable care in the maintenance of safe and adequate facilities and equipment,” “to select and retain only competent physicians,” “to oversee all persons who practice medicine within its walls as to patient care,” and “to formulate, adopt and enforce adequate rules and policies to ensure quality care for the patients . .. .” Id. at 339-40, 591 A.2d at 707. Unlike vicarious liability which is predicated upon the negligence of an actual or ostensible agent, a cause of action for corporate negligence is not dependent upon the negligence of a third party such as a physician or nurse. Welsh v. Bulger, 548 Pa. 504, 513, 698 A.2d 581, 585 (1997); Oven v. Pascucci, 46 D.&C.4th 506, 513 (Lacka. Cty. 2000). Instead, corporate liability is based on the negligent acts of the institution. Moser v. Heistand, 545 Pa. 554, 561, 681 A.2d 1322, 1326 (1996). A cause of action for corporate negligence arises from the policies, actions or inaction of the institution itself rather than the specific acts of individual hospital agents. Welsh, supra; Moser, 545 Pa. at 560, 681 A.2d at 1326; Gurevitz v. Piczon, 42 D.&C.4th 308, 317-18 (Lacka. Cty. 1999) (corporate liability is premised “upon the systemic or institutional negligence of the hospital itself rather than the acts of individual hospital employees.”). Therefore, under the theory of corporate liability, “a corporation is held directly liable, as opposed to vicariously liable, for its own negligent acts.” Welsh, supra, 548 Pa. at 513, 698 A.2d at 585; Rauch v. Mike-Mayer, 783 A.2d 815, 827 (Pa. Super. 2001), app. denied, 568 Pa. 634, 793 A.2d 909 (2002).

Notwithstanding the plaintiff’s argument to the contrary, it is apparent that corporate negligence is distinct from vicarious liability and is not contingent upon “allegations that other licensed professionals for whom [the] defendant is responsible deviated from an acceptable professional standard” as per Rule 1042.3(a)(2). Furthermore, unless a hospital’s corporate negligence is obvious, “a plaintiff must produce expert testimony to establish that the hospital deviated from an accepted standard of care and that the deviation was a substantial factor in causing the harm to the plaintiff.” Welsh, 548 Pa. at 514, 698 A.2d at 585. Accord, Rauch, supra; Whittington v. Episcopal Hospital, 768 A.2d 1144, 1149-50 (Pa. Super. 2001). Accordingly, since a corporate liability claim is not based solely on respondeat superior principles and, except in cases of obvious negligence, must be supported by expert testimony establishing a deviation from the accepted standard of care, a certificate of merit under Rule 1042.3(a)(1) is required for a corporate negligence claim. But, see Olshan v. Tenet Health System City Av enue, 849 A.2d 1214, 1218 (Pa. Super. 2004) (remarking in obiter dictum that “no such certificate [of merit] is required for allegations made against the hospital or other corporate entity.”).

CMC submits that it may seek to dismiss the plaintiffs’ corporate liability claim by presenting preliminary objections in the nature of a motion to strike Count II of the amended complaint. Pa.R.C.P. 1042.1-1042.8 set forth specific procedures governing certificates of merit, including the model form of the certificate of merit, the sanctions which may be imposed upon a lawyer for improperly certifying that a supporting written opinion exists, and limitations on discovery prior to the filing of a certificate of merit. See Pa.R.C.P. 1042.5, 1042.7 and 1042.8. Rule 1042.6 prescribes the procedure to be followed by a defendant to obtain relief based upon the plaintiff’s failure to file a timely certificate of merit, and states that “[t]he prothonotary, on praecipe of the defendant, shall enter a judgment of non pros against the plaintiff for failure to file a certificate of merit within the required time provided that there is no pending timely filed motion seeking to extend the time to file the certificate.” Pa.R.C.P. 1042.6(a). Rule 1042.6(b) even provides the form for the “Praecipe for entry of judgment of non pros pursuant to Rule 1042.6” to be used by defendants. However, the Rules of Procedure governing certificates of merit do not authorize the use of any other pleading, motion or filing to challenge the absence of a certificate of merit under Rule 1042.3.

According to the plain language of Rule 1042.6, if a plaintiff neglects to file a timely certificate of merit, the defendant’s sole recourse is to praecipe for the entry of judgment of non pros. Although CMC argues that preliminary objections should also be regarded as a proper procedure for a certificate of merit challenge, Pa.R.C.R 127 directs that when the words of a rule are clear, the letter of the rule may not be disregarded under the pretext of pursuing its spirit. Sahutsky v. H.H. Knoebel Sons, 566 Pa. 593, 596, 782 A.2d 996, 998 (2001). If the Supreme Court had intended for preliminary objections to be employed to dismiss malpractice claims which are not properly supported by certificates of merit, that procedural option would have been identified in Pa.R.C.P. 1042.6. It is not our prerogative to insert language into a rule which was not included by the drafters of the rule. Cf. Olsofsky v. Progressive Insurance Co., 52 D.&C.4th 449, 477 (Lacka. Cty. 2001) (“The judiciary should not attempt to assume the role of the legislature by inserting language into a statute which the General Assembly has seen fit to exclude.”).

Even assuming for the sake of argument that Rule 1042.6 was not so explicit in identifying the proper procedure to be followed, we would note that our interpretation of Rule 1042.6 achieves the goal sought to be attained by the certificate of merit rules. See Pa.R.C.P. 127(c) (when the words of a rule are not explicit, the intention of the Supreme Court may be ascertained by considering, inter alia, the occasion and necessity for the rule, the mischief sought to be remedied, and the object to be attained). The purpose of Pa.R.C.P. 1042.1-1042.8 is to weed out non-meritorious malpractice claims at an early stage of the litigation by compelling the plaintiff to certify that [s]he has obtained an appropriate expert opinion in support of the plaintiff’s claims before requiring the defendant health care provider to incur the burden and expense of discovery, depositions and pretrial preparation. See e.g., Supervalu Inc. v. Construction Engineering Consultants Inc., 65 D.&C.4th 449, 453 (Allegheny Cty. 2004) (“The purpose of Pa.R.C.P. 1042.1 et seq. is to protect licensed professionals from expending resources to defend professional liability claims that may never be substantiated by expert testimony . . . .”); Speicher v. Toshok, 63 D.&C.4th 435, 443 (Allegheny Cty. 2003) (“The purpose of these rules is to minimize the costs of defense and the time that a licensed professional must devote to the litigation until the plaintiff has been able to secure a certificate of merit.”). An expert in hospital practices and policies has reportedly furnished the plaintiffs’ counsel with a written statement opining that CMC deviated from the acceptable standard of care and that such corporate negligence was a cause in bringing about the minor plaintiff’s harm. Therefore, the plaintiffs in this case have provided CMC with the requisite certificate of merit under Rule 1042.3(a)(1) so as to allow their corporate liability claim to proceed beyond the pleadings phase of this suit and to justify requiring CMC to incur further expense in the defense of that claim.

In short, the plaintiffs have won the race to the courthouse discussed in n.3, supra. Since the unambiguous language of Rule 1042.6 required CMC to challenge the absence of a certificate of merit via a praecipe for judgment of non pros, see Thompson, 152 Pitts. L.J. at 163 (affirming entry of judgment of non pros as to two of three counts of the complaint), and the plaintiffs belatedly filed their supporting certificate of merit before the entry of any judgment of non pros with regard to the corporate liability claim, CMC’s preliminary objections will be overruled and its motion to strike the corporate liability certificate of merit will be denied. See Boyd v. Cheltenham York Road Nursing and Rehabilitation Center Inc., no. 1243 April term 2003, Bernstein, J., at p. 2 (Phila. Cty. Oct. 14,2003) (“No rule permits and no policy reason exists for striking a certificate of merit attesting to the validity of the claim of professional negligence where the defense itself has refrained from exercising its [judgment of non pros] rights under Rule 1042.6(a).”).

(B) Malpractice Claims Against Dr. Rabin

As a result of the plaintiffs’ failure to file a certificate of merit addressing Dr. Rabin’s care and treatment, Dr. Rabin originally filed a motion for judgment on the pleadings and later filed a praecipe for entry of judgment of non pros pursuant to Rule 1042.6. In reply, the plaintiffs have presented a petition to discontinue this malpractice action against Dr. Rabin without prejudice and a separate petition seeking to strike Dr. Rabin’s praecipe for entry of judgment of non pros.

Plaintiffs contend that Dr. Rabin’s motion for judgment on the pleadings and praecipe for entry of judgment of non pros are fatally flawed since they identify Dr. Rabin as a named defendant in their captions. Plaintiffs posit that subsequent to the filing of the amended complaint, Dr. Rabin lacks standing to file any motion or petition inasmuch as he is no longer a party to this action. However, as evidenced by the plaintiffs’ own petition to “Discontinue action without prejudice nunc pro tunc pursuant to Pa.R.C.P. 229 as to defendant, Marc Rabin M.D.,” the claims against Dr. Rabin may be discontinued by the plaintiffs only by leave of court. Rule 229(b) provides that “[a] discontinuance may not be entered as to less than all defendants except upon the written consent of all parties or leave of court after notice to all parties,” and Rule 2039(a) states that “[n]o action to which a minor is a party shall be... discontinued except after approval by the court....” Absent court action or order, the plaintiffs’ amended complaint did not necessarily operate to discontinue this matter as to Dr. Rabin. In fact, even after the filing of the amended complaint, the plaintiffs themselves continued to file motions, briefs and other papers which identify Dr. Rabin as a defendant.

With respect to the merits of Dr. Rabin’s filings, as we have noted in section II (A) above, the certificate of merit rules designate a judgment of non pros as the sole means for seeking the dismissal of a malpractice claim due to the lack of a supporting certificate of merit. Since a motion for judgment on the pleadings is not identified in Rule 1042.6 as a device for challenging the absence of a certificate of merit, Dr. Rabin’s motion for judgment on the pleadings will be denied on that basis. See Harris v. Sangodeyi, no. 11339 of 2003, Kunselman, RJ., at p. 4 (Beaver Cty. Sept. 3, 2004) (“a certificate of merit required by Pa.R.C.P. 1042.3 is not part of the pleadings and so the failure to timely file a certificate of merit cannot be the basis upon which to enter judgment on the pleadings.”). Dr. Rabin, nevertheless, did proceed correctly by filing a praecipe under Rule 1042.6 and securing a judgment of non pros.

Plaintiffs seek to strike. Dr. Rabin’s judgment of non pros and submit that their petition to discontinue without prejudice should be granted in order to preserve the minor plaintiff’s ability to file a malpractice claim against Dr. Rabin in the future. An injury to a minor gives rise to two separate causes of action: one being the parents’ claim for medical expenses and loss of the minor’s services during minority, and the other being the minor’s claim for economic losses (medical expenses and loss of earnings) after minority and for pain and suffering both during minority and after reaching the age of majority. Schmidt v. Kratzer, 402 Pa. 630, 635, 168 A.2d 585, 587 (1961); Brower by Brower v. City of Philadelphia, 124 Pa. Commw. 586, 590, 557 A.2d 48, 50 (1989), app. denied, 525 Pa. 604, 575 A.2d 569 (1990); Shumek v. Scranton Counseling Center, 100 Lacka. Jur. 173, 175 (1999). Although the minor’s claims are governed by the Minor Tolling Statute which tolls the commencement of the applicable statute of limitations until the minor reaches the age of majority, the parents’ nonderivative claims for economic losses during the child’s minority are subject to the customary limitations period. See Hathi v. Krewstown Park Apartments, 385 Pa. Super. 613, 616, 561 A.2d 1261, 1262 (1989); Santiago v. St. Luke’s Hospital, 26 D.&C.4th 385, 387 (Northampton Cty. 1996). Hence, a minor may be permitted to discontinue an action without prejudice, particularly at an early stage of the litigation and before the defense has incurred considerable expense in pretrial preparation. See Fancsali v. University Health Center of Pittsburgh, 563 Pa. 439, 450-51, 761 A.2d 1159, 1165 (2000); Conway v. Yavorek, 101 Lacka. Jur. 205, 210-11 (1999), aff’d, 564 Pa. 248, 766 A.2d 854 (2001). Compare Truesdale by Truesdale v. Albert Einstein Medical Center, 767 A.2d 1060, 1064-65 (Pa. Super. 2001) (trial court’s discontinuance of incompetent’s action without prejudice until she regained competence was an abuse of discretion since it extended the limitations period indefinitely and the defendant had already “expended substantial effort and expense in the process of litigation ....”).

It is unnecessary for the plaintiffs to strike Dr. Rabin’s judgment of non pros in order to protect the minor plaintiff’s right to file a malpractice action against Dr. Rabin. An entry of judgment of non pros for failure to file a complaint or prosecute an action diligently is not considered to be an adjudication on the merits so as to have any res judicata or collateral estoppel effect. See Municipality of Monroeville v. Liberatore, 736 A.2d 31, 33 (Pa. Commw. 1999) (judgment of non pros, with prejudice, for failure to prosecute is not a determination on the merits and has no res judicata effect), app. denied, 561 Pa. 704, 751 A.2d 195 (2000); Gutman v. Giordano, 384 Pa. Super. 78, 81, 557 A.2d 782, 783 (1989) (non pros judgment for failure to answer a trial listing is not an adjudication on the merits and may not form the basis for application of res judicata); Brower v. Berio Vending Co., 254 Pa. Super. 402, 406, 386 A.2d 11, 13 (1978) (citations omitted) (“An order of non pros adjudicates nothing, so it cannot be res judicata . . . [n]or may an order of non pros support a plea of collateral estoppel, since (to name only one defect) it does not involve a ‘final judgment on the merits.’ ”). For that reason, where a plaintiff has suffered a judgment of non pros, [s]he may later commence a new action involving the same parties and alleging the same cause of action “so long as the second action is commenced within the applicable statute of limitations.” Hatchigian v. Koch, 381 Pa. Super. 377, 381, 553 A.2d 1018, 1020 (1989). Consistent with this reasoning, if a judgment of non pros is entered against a plaintiff pursuant to Pa.R.C.P. 1042.6, the plaintiff may nonetheless commence a second action against the same health care provider(s) provided that the applicable statute of limitations has not yet expired. Helfrick v. UPMC Shadyside Hospital, 65 D.&C.4th 420, 427-28, 439 (Allegheny Cty. 2003). In the event that the plaintiff is a minor, [s]he may refile such a second suit at any time prior to reaching the age of 20. See42Pa.C.S. §5533(b).

As a result, Dr. Rabin’s judgment of nonpros does not foreclose Cody White from filing a second malpractice action against Dr. Rabin prior to the minor plaintiff’s 20th birthday. Plaintiffs have not articulated any legitimate reason for striking Dr. Rabin’s judgment of non pros which was properly entered pursuant to Rule 1042.6. Furthermore, the relief requested by the plaintiffs’ nunc pro tunc petition is unwarranted in that the validly entered judgment of non pros does not affect the minor plaintiff’s right to file another malpractice claim against Dr. Rabin. Accordingly, the plaintiffs’ motion to strike Dr. Rabin’s judgment of non pros will be denied and their petition to discontinue without prejudice nunc pro tunc will be dismissed as moot. An appropriate order follows.

ORDER

And now, November 23,2004, upon consideration of the preliminary objections, motion for judgment on the pleadings, motions to strike, and counterpetition to discontinue without prejudice nunc pro tunc filed by the parties, the memoranda of law and oral argument presented by counsel, and based upon the reasoning set forth in the foregoing memorandum, it is hereby ordered and decreed that:

(1) The preliminary objections of defendant Community Medical Center Health Care Systems are overruled and dismissed;

(2) The motion of defendant Community Medical Center Health Care Systems to strike the plaintiffs’ certificate of merit dated April 12, 2004, is denied;

(3) The motion of defendant Marc Rabin M.D. for judgment on the pleadings is denied;

(4) Plaintiffs’ petition to strike the praecipe of defendant Marc Rabin M.D. for entry of judgment of non pros is denied; and

(5) The clerk of judicial records is directed to remove Marc Rabin M.D. as a named party in this suit; and

(6) Since the judgment of non pros entered in favor of Marc Rabin M.D. does not preclude the minor plaintiff from refiling a malpractice action against defendant Marc Rabin M.D., in accordance with the Minor Tolling Statute, 42 Pa.C.S. §5533, the plaintiffs’ counterpetition to discontinue this action with prejudice nunc pro tunc pursuant to Pa.R.C.P. 229 as to defendant Marc Rabin M.D., is dismissed as moot.

      . Pa.R.C.P. 1042.1(b)(l)(i) states that a “licensed professional” includes a “health care provider as defined by section 503 of the Medical Care Availability and Reduction of Error (MCare) Act, 40 P.S. §1303.503.” Section 503 of the MCare Act defines a “health care provider” as “[a] primary health care center, a personal care home ..., or a person, including a corporation, university or other, educational institution licensed or approved by the Commonwealth to provide health care or professional medical services as a physician, a certified nurse midwife, a podiatrist, hospital, nursing home, birth center, and an officer, employee or agent of any of them acting in the course and scope of employment.” 40 P.S. §1303.503.

      . As a general rale, a medical malpractice plaintiff must present medical expert testimony to establish that the defendant health care provider “deviated from good and acceptable medical standards, and that such deviation was a substantial factor in causing the harm suffered.” Sutherland v. Monongahela Valley Hospital, 856 A.2d 55, 60 (Pa. Super. 2004). “A very narrow exception to the requirement of expert testimony in medical malpractice actions applies ‘where the matter is so simple or the lack of skill or care so obvious as to be within the range of experience and comprehension of even non-professional persons,’ [citation omitted], also conceptualized as the doctrine of res ipsa loquitur.” Toogood v. Owen J. Rogal D.D.S. P.C., 573 Pa. 245, 255, 824 A.2d 1140, 1145 (2003); Colacicco v. Karumbaya, 65 D.&C.4th 555, 559-60 (Lacka. Cty. 2004). Rule 1042.3(a)(3) addresses res ipsa loquitur and obvious instances of negligence and allows for the filing of a certificate of merit verifying that “expert testimony of an appropriate licensed professional is unnecessary for prosecution of the claim.”

      . The official note to Rule 1042.6(a) states that the 10-day notice provision in “Rule 237.1 does not apply to a judgment of non pros entered under this rule.” See also, Parkway Corp. v. Edelstein, 861 A.2d 264, 268 (Pa. Super. 2004) (“There is especially no necessity for notice to be given of intent to file a praecipe for non pros, as the note to Rule 1042.6 specifically states that Rule 237.1 ‘does not apply to a judgment of non pros entered under this rule.’ ”). The lack of any notice requirement has resulted in the proverbial race to the courthouse on the 60th day following the filing of the complaint, with plaintiff’s counsel attempting to file a certificate of merit under Rule 1042.3(a) or a motion for an extension pursuant to Rule 1042.3(d) before defense counsel files a praecipe for entry of judgment of non pros under Rule 1042.6. See e.g., Moore v. John A. Luchsinger P.C., 862 A.2d 631, 632 (Pa. Super. 2004) (holding that a judgment of non pros may not be entered “in a professional malpractice case after a certificate of merit has already been filed, whether or not the certificate was filed late” and remanding for a hearing to determine when the praecipe for entry of judgment of non pros should be deemed filed); Kerry v. Butler Memorial Hospital, 66 D.&C.4th 569, 576 (Butler Cty. 2004) (petition to open judgment of non pros denied where defendant filed a praecipe to enter judgment of non pros on January 13,2004 and plaintiff filed certificates of merit on January 14, 2004); Helfrick v. UPMC Shadyside Hospital (Helfrick l), 64 D.&C.4th 129, 132-36 (Allegheny Cty. 2003) (petition to open judgment of non pros granted where plaintiff filed a certificate of merit at 8:30 a.m. on the 64th day after the complaint was filed and defense counsel filed a praecipe for entry of judgment of non pros at 2:38 p.m. on the same date). Delinquent plaintiffs who lose the race to the courthouse and thereafter seek to set aside a judgment of non pros must satisfy the tripartite test contained in Pa.R.C.P. 3051, including a reasonable explanation for failing to seek an extension within the 60-day time period pursuant to Rule 1042.3(d). See Hoover v. Davila, 862 A.2d 591, 595 and n.3 (Pa. Super. 2004); Koken v. Lederman, 840 A.2d 446, 448-49 (Pa. Commw. 2003). Compare Velazquez v. UPMC Bedford Memorial Hospital, 328 F. Supp.2d 549, 560 (W.D. Pa. 2004) (finding Pa.R.C.P. 3051 inapplicable and holding that courts have no discretion to open ajudgment of non pros entered pursuant to Rule 1042.6 even if reasonable explanation or legitimate excuse for inactivity or delay is provided).

      . If CMC is ultimately dismissed from this case through voluntary dismissal, verdict or order of court, Rule 1042.7(a) entitles it to demand that the plaintiffs provide CMC “with the written statement obtained from the licensed professional upon which the certificate of merit as to that defendant was based.” Rule 1042.7(b) further provides that if the court determines that an attorney has violated Rule 1042.3 (a)( 1) by improperly certifying that the required written opinion exists, the court may impose appropriate sanctions, including those identified in Pa.R.C.P. 1023.4.

      . For example, the plaintiffs’ response to CMC’s preliminary objections, their brief in opposition to CMC’s preliminary objections, their response to CMC’s motion to strike, their brief in opposition to CMC’s motion to strike, and their amended stipulation dated September 27, 2004, all identify Dr. Rabin as a named defendant. (Dkt. entry nos. 68-70, 72.)