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IN THE SUPERIOR COURT OF PENNSYLVANIA
MARY SMITH, Executrix of the Estate of Anne Doe, Deceased, JANUARY PHARMACEUTICA, INC., FEBRUARY CORPORATION, MARCH & MARCH, and APRIL E.P.S. PHARMACY, MAY HEALTH, INC., BRIEF OF APPELLANT
Appeal from the Order of January XX, 20XX entered in the Court of Common Pleas of Washington County at docket number XXXX-XXXX Patrick P. Lawyer, Esquire XXX Forest Avenue Attorney No. XXXXX Attorney for Appellant TABLE OF CONTENTS
TABLE OF CITATIONS …………………………….…….…. STATEMENT OF JURISDICTION …………………….….… STATEMENT OF THE SCOPE OF REVIEW AND STANDARD OF REVIEW …………………….……. ORDER IN QUESTION …………………………….….….… STATEMENT OF THE QUESTION INVOLVED ……….…. STATEMENT OF THE CASE ……………………….…… SUMMARY OF THE ARGUMENT ……….……….….……. ARGUMENT …………………………………….…….……… CONCLUSION …………………………………………….…. OPINION OF THE TRIAL COURT …………………… STATEMENT OF MATTERS COMPLAINED OF ON APPEAL …………………………….…… CERTIFICATE OF SERVICE ……………………….…. TABLE OF CITATIONS
Brandon v. Ryder Truck Rental, Inc., 34 A3d 104 (Pa. Super. 2011) …………………………… Chepkevich v. Hidden Valley Resort, L.P., 607 Pa. 1, 2 A3d 1174 (2010) ……………………….…. Coker v. S.M. Flickinger Company, Inc., 533 Pa. 441, 625 A2d 1181 (1993) ……………………… Donoughe v. Lincoln Electric Co., 936 A2d 52 (Pa. Super. 2007) …………………………… Grossman v. Barke, 868 A2d 561 (Pa. Super. 2005) …………………….……. Lewis v. Coffing Hoist Division, Duff-Norton Co., Inc., 515 Pa. 334, 528 A2d 590 (1987) …………………….… Morrison v. Commonwealth, Department of Public Welfare, 538 Pa. 122, 646 A2d 565 (1994) Toy v. Metropolitan Life Insurance Company, 593 Pa. 20, 928 A2d 186 (2007) …………………….….
Webb v. Zern,
422 Pa. 424, 220 A2d 853 (1966) ……………………….
Wiggins v. Synthes (USA),
29 A3d 9 (Pa. Super. 2011) ………………………………
Statutes / Court Rules

42 Pa.C.S. § 742 ………………………………………….……
Pennsylvania Rule of Appellate Procedure 341(b) ……………. Pennsylvania Rule of Civil Procedure 1035.2 ………………….
Treatises
Restatement (Second) of Torts, §402A ………………….…….
STATEMENT OF JURISDICTION
This appeal is from an Order that granted summary judgment in favor of the Appellees. It disposed of all remaining claims and all remaining parties and, as such, was a "final order". Pa.R.App.P. 341(b). In light of this, the Superior Court has jurisdiction pursuant to 42 Pa.C.S. § 742, which The Superior Court shall have exclusive appellate jurisdiction of all appeals from final orders of the courts of common pleas, regardless of the nature of the controversy or the amount involved, except such classes of appeals as are by any provision of this chapter within the exclusive jurisdiction of the Supreme Court or the Commonwealth Court. 42 Pa.C.S. § 742. STATEMENT OF THE
SCOPE OF REVIEW AND STANDARD OF REVIEW
Scope of Review
As stated in Morrison v. Commonwealth, Department of Public Welfare, 538 Pa. 122, 646 A2d 565 (1994): ‘Scope of Review' refers to ‘the confines within which an appellate court must conduct its examination.' In other words, it refers to the matters (or ‘what') the appellate court is permitted to examine. Id at 131, 646 A2d at 570 (emphasis in original) quoting Coker v. S.M. Flickinger Company, Inc., 533 Pa. 441, 450, 625 A2d 1181, 1186 (1993) (citation omitted). Where, as in the present case, the Superior Court is asked to resolve a question of law, its review is plenary. See Chepkevich v. Hidden Valley Resort, L.P., 607 Pa. 1, 2 A3d 1174 (2010). Standard of Review
The "Standard of Review" relates to the manner in which an Appellate Court is to examine the record and sets the degree of scrutiny to be applied to the Lower Court's Decision. Morrison v. Commonwealth, Department of Public Welfare, supra. An Appellate Court may reverse an order granting summary judgment if there has been an abuse of discretion or an error of law. Toy v. Metropolitan Life Insurance Company, 593 Pa. 20, 928 A2d 186 (2007). ORDER IN QUESTION
This appeal is taken from the Order of January XX, 20XX entered by the Honorable Pauline Public. It stated – MEMORANDUM ORDER
AND NOW, this XXX day of January, 20XX, upon consideration of Plaintiff Mary Smith, Executrix of the Estate of Anne Doe's Motion to Vacate and Reconsider Order Granting Summary Judgment, and after briefs and argument thereon, it is hereby ORDERED, ADJUDGED, AND DECREED that said Motion is DENIED. On September 10, 2012 this Court entered an Order granting summary judgment in favor of Defendants January Pharmaceutica, Inc., February Corporation, and March & March and dismissing the case. On October 9, 2012, Plaintiff filed a Motion to Vacate and Reconsider that Order and set this case for trial. The Court heard argument on Plaintiff's Motion on October 25, 2012. The Court, after reviewing the record, briefs, and applicable case law can find no reason to disturb its prior Order. A court has the inherent power to reconsider its own rulings. Moore v. Moore, 634 A2d 163, 167 (Pa. 1993); Hutchison v. Luddy, 611 A2d 1280, 1288 (Pa. Super. 1992). See also 42 Pa.C.S.A. §5505 (trial court may reconsider its own order within thirty days of entering the order). However, motions for reconsideration are generally discouraged unless law or facts not previously brought to the attention of the Court are raised. They serve to cure a clear error of law or an abuse of discretion rather than as a "second bite at the apple". Here, Plaintiff argues that the Court erred in granting Defendants' Motions for Summary Judgment because a genuine issue of material fact exists as to whether there was a defect in the Duragesic patch worn by the decedent, Anne Doe. In support of her contentions Plaintiff relies upon the July 27, 2009 and April 4, 2012 reports of Frederick Roe, Ph.D. and the April 6, 2012 report of Dr. Cyril Boe. Additionally, Plaintiff contends that the Court improperly relied on MA Laboratory's toxicology testing to conclude that Ms. Doe had a therapeutic level of fentanyl in her blood at the time of her death. Plaintiff asserts that Dr. Roe's July 27, 2009 report casts such doubt on the reliability of MA's analysis that it should be excluded. Importantly, Plaintiff presents no evidence or law that was not before the Court at the time of its disposition of Defendants' Motions for Summary Judgment. Rather she merely disagrees with the Court's conclusion and argues that issues of fact remain for a jury to consider. The Court notes that it specifically considered and rejected Dr. Roe's April 4, 2012 report as creating a material issue of fact. (See Omnibus Opinion and Order at 18-19). Indeed, the Court incorporates by reference all of its' analysis and conclusions contained in its Omnibus Opinion and Order as if fully set forth herein. Additionally, the Court did consider Dr. Boe's report of April 6, 2012, but did not specifically cite to it in its Opinion as his conclusions were similarly insufficient to create a genuine issue of material fact as to a defect in the fentanyl patch. At best, both experts opine that the alleged area of edema on Doe's shoulder is indicative of a fentanyl welt which is then circumstantial evidence that the patch was defective and delivered an overdose of fentanyl. (See April 4, 2012 report of Dr. Roe at 4 and April 6, 2012 report of Dr. Boe at 2-3). However, Plaintiff ignores the fact that she has never had an expert examine the patch, despite having access to it. Dr. Coe, the only expert to examine the patch found that it had a complete seal and was free from defects. Plaintiff's expert, Dr. Kris Green, who only observed screen captures of Dr. Coe's inspection admitted that she did not "have any absolute hard facts that there was a breach [in the seal of the patch]." (Green Deposition at 53:12-15). She also opined that examining the patch in-person using a light microscope "would be a necessary means to determine the patch's integrity." (Green Depo at 39:23-41:5). Ultimately, Dr. Green does not offer an opinion to a reasonable degree of scientific certainty that the patch was defective in her deposition or expert report. It is axiomatic that to establish a prima facie case of strict product liability, the threshold inquiry is whether there is a defect in the product. Donoughe v. Lincoln Electric Co., 936 A2d 52, 61 (Pa. Super. 2007). Here, where the product is extant and readily available, the Plaintiff had to establish by expert testimony the existence of a defect in the patch. However, despite the long and contentious discovery process, Plaintiff never had an expert inspect the patch. Rather, she relies upon the alleged fentanyl welt, which can manifest at therapeutic levels, to infer the possibility of a genuine issue of material fact as to defect. This is simply not enough to survive summary judgment when all of the available objective evidence demonstrates that the patch was free of defects and that the decedent had a therapeutic level of fentanyl in her blood. As to the admissibility of MA Laboratory's post-mortem toxicology results, there is no dispute that Ms. Doe's blood specimen was lost between 2006 and 2008 and is no longer available for retesting. The only available GC/MS test result established that Ms. Doe had a therapeutic level of fentanyl (1.1 ng./mL) in her blood at the time of her death. (MA Laboratory Report, attached as Exhibit X of Defendant January Pharmaceutica's Motion for Summary Judgment). Plaintiff asserts again, as she did at the time of summary judgment, that this result should be excluded because MA Laboratory was unable to produce the "validation package" which typically accompanies such testing. (July 27, 2009 Report of Dr. Roe at 3-4). Plaintiff claims she is prejudiced by her inability to retest the blood sample. However, Plaintiff does not seem to be contesting this Court's finding that Defendants and MA Laboratory did not conspire to fabricate the fentanyl test result or destroy Doe's blood sample. After once again reviewing the transcript from the spoliation hearing as well as the expert report of Dr. Roe, the Court finds that Dr. Roe's criticism of MA Laboratory's methodology and reliability go more to the weight rather than to the admissibility of the fentanyl test result. Defendants and MA Laboratory have given a reasonable explanation for how the validation package was lost. Additionally, this Court found that MA Laboratory is a fully accredited laboratory and did not engage in a conspiracy to fabricate the test result. The Court also found that Plaintiff failed to fulfill her duty to secure the blood sample and test it when this litigation commenced. Therefore, Defendants are no less prejudiced than Plaintiff in this regard as they have had to respond to Plaintiff's claims of spoliation and are unable to retest the blood to definitively rebut Plaintiff's scandalous accusations. A finder of fact could reasonably weigh the fentanyl immunoassay result with Dr. Roe's report, as well as the other evidence. Therefore, Plaintiff's Motion to Exclude MA Laboratory's Post Mortem Toxicology Results is once again DENIED. PAULINE PUBLIC, JUDGE (RR at 410a-414a). STATEMENT OF THE QUESTION INVOLVED
Whether the Lower Court erred when it granted summary judgment in favor of Appellees January Pharmaceutica, Inc., February Corporation and March & March where a substantial question of material fact exists as to whether the Duragesic fentanyl patch in question was defective in that it leaked an excessive amount of fentanyl onto the decedent causing her to overdose on the drug? (Answered in the negative by the Court below) STATEMENT OF THE CASE
Anne Doe was a 49 year old woman who suffered from a number of physical problems, including chronic low-back pain, as a result of a fall. Over the years, she took an array of medications to relieve her intense pain and assist her in sleeping. These included Elavil, Neurontin, MS Contin and even morphine. (RR at 106a, 110a). In June of 2002, she was also prescribed fentanyl, which is a synthetic opioid approximately 80 times more potent than morphine, its natural counterpart. (RR at 312a). This drug was administered to her by way of a "Duragesic" transdermal patch designed and manufactured by February Corporation, and distributed by January Pharmaceutica, Inc. and March & March. The structure of the patch was described in its literature – DURAGESIC is a rectangular transparent unit comprising a protective liner and four functional layers. Proceeding from the outer surface toward the surface adhering to skin, these layers are: 1) a backing of polyester film; 2) a drug reservoir or fentanyl and alcohol USP gellied with hydroxyethyl cellulose; 3) an ethylene-vinyl acetate copolymer membrane that controls the rate of fentanyl delivery to the skin surface; and 4) a fentanyl containing silicone adhesive. Before use, a protective liner covering the adhesive layer is removed and discarded. (RR at 61a). The following diagram of the system was also provided in the (RR at 61a). Essentially, the "protective liner" is pulled off and the "adhesive" layer is attached to the patient's skin. The patch contains highly concentrated fentanyl gel which can cause a fatal overdose if it comes into direct contact with unprotected skin. (RR at 312a-313a). This manifests itself with respiratory depression that progresses to complete respiratory suppression and death. (RR at 312a). The victim essentially dies of suffocation. (RR at 312a). Ms. Doe was initially administered patches that released 50 µg/hr 1 of the drug but her dosage was increased on February 9, 2004 to 75 µg/hr. (RR at 106a- 107a). April E.P.S. Pharmacy delivered the first 75 µg/hr patches to her on February 10, 2004. 1 The designation "µg/hr" denotes micrograms released per hour. Just one month later, on March 11, 2004, a friend found her dead in An autopsy was performed and the coroner's report noted that a 75 µg/hr Duragesic fentanyl patch was present on her shoulder. (RR at 150a). Samples of her blood and urine were taken for toxicological examination and the coroner concluded that she died "as a result of combined drug toxicity: morphine and fentanyl". (RR at 146a). On March 9, 2006, Mary Smith, the Executrix of Ms. Doe's estate, commenced the present wrongful death and survival action and asserted claims of strict product liability and negligence against February Corporation, January Pharmaceutica, Inc., March & March, and April E.P.S. Pharmacy. The latter defendant then added May Health, Inc. as an additional defendant 2. Ms. Smith averred that the patch worn by the decedent was defective and had leaked a fatal amount of fentanyl into her system. On March 9, 2012, April E.P.S. Pharmacy filed a motion for summary judgment, which was later granted by the Lower Court. That Order is not at issue in this appeal. 2 On April 26, 2012, the case against May Health, Inc. was discontinued and "dismissed with prejudice". None of the parties to this appeal have contested that dismissal. The remaining defendants filed a joint motion for summary judgment and argued that no issue of material fact existed as to whether the patch was defective. They asserted that (1) the medical examiner who retrieved the patch from Ms. Doe's shoulder visually inspected it and did not note any damage to it; (2) the toxicology report detected a toxic level of morphine in her system and the post-mortem fentanyl level was within the therapeutic range; and (3) a purported expert in material sciences, Dr. Maureen Coe, had inspected the patch and concluded that its "seal was ‘fully intact and functional'". (RR at 27a-30a). In her response to the joint motion, Ms. Smith argued that her experts believed, with a reasonable degree of scientific certainty, that the patch was defective and leaked a fatal dose of fentanyl onto Ms. Doe. In an Order dated September 10, 2012, however, the Lower Court granted the joint motion for summary judgment and dismissed the cases against those defendants "with prejudice". In its view, Ms. Smith "failed to demonstrate any issues of material fact as to whether there was a defect in the patch worn by Ms. Doe at the time of her death". (RR at 330a). Ms. Smith filed a motion to reconsider and vacate that Order and, on October 9, 2012, the Lower Court vacated it "pending reconsideration". On January 18, 2013, however, it denied the motion for reconsideration. (RR at 410a-414a). A timely appeal was then taken by Ms. Smith and, at the direction of the Lower Court, she submitted a Statement of Matters Complained of on Appeal that included the argument discussed in this brief. That Court's Opinion has now been filed and the case is ready for appellate review. SUMMARY OF THE ARGUMENT
Summary judgment can only be entered where there are no genuine issues as to any material fact and the right to it is clear and free from doubt after viewing the record in the light most favorable to the non-moving party. In the present case, the Lower Court granted the joint motion for summary judgment of February Corporation, January Pharmaceutica, Inc. and March & March, and dismissed the cases against them with prejudice. Its Decision was based on the belief that Ms. Smith "failed to demonstrate any issues of material fact as to whether there was a defect in the patch worn by Ms. Doe at the time of her death". This was error since, when the correct standard is applied and the record is viewed in the light most favorable to Ms. Smith, it is clear that issues of fact remain as to whether the patch was defective and leaked a fatal dose of fentanyl onto the decedent. Thus, summary judgment should not have been entered. ARGUMENT
The Lower Court erred when it granted summary judgment in favor of Appellees January Pharmaceutica, Inc., February Corporation and March & March since a substantial question of material fact exists as to whether the Duragesic fentanyl patch in question was defective in that it leaked an excessive amount of fentanyl onto the decedent causing her to overdose on the drug. This case involves an Order granting summary judgment to the Appellees in accordance with Pennsylvania Rule of Civil Procedure 1035.2. In general, summary judgment can only be entered where there are no genuine issues as to any material fact and the right to it is clear and free from doubt after viewing the record in the light most favorable to the non-moving party. Toy v. Metropolitan Life Insurance Company, 593 Pa. 20, 928 A2d On appeal, an Order granting summary judgment is reviewed to determine whether an abuse of discretion or an error of law has occurred. The term, "discretion", is one of art and refers to "the exercise of judgment, wisdom and skill so as to reach a dispassionate conclusion". Coker v. S.M. Flickinger Company, Inc., 533 Pa. 441, 625 A.2d 1181, 1184 (1993) (citation omitted). As noted by the Supreme Court – "discretionary power can only exist within the framework of the law, and is not exercised for the purpose of giving effect to the will of the judge". Id. It must be "exercised on the foundation of reason, as opposed to prejudice, personal motivations, caprice or arbitrary actions". Id. Applying these principles, the Coker Court formulated a standard for determining when an "abuse of discretion" occurs – Discretion is abused when the course pursued represents not merely an error of judgment, but where the judgment is manifestly unreasonable or where the law is not applied or where the record shows that the action is a result of partiality, prejudice, bias or ill will. Id. In short, "an inquiry into an abuse of discretion is operationally equivalent as one into the merits of the trial court's decision". Id. As will be explained below, when the Court reviews the merits of the Order at issue herein, it will be clear that summary judgment was erroneously entered. This case involves products liability and negligence claims relating to a defective Duragesic fentanyl patch that leaked an excessive and fatal amount of fentanyl onto the decedent. With regard to the products liability claim, Pennsylvania has adopted Section 402A of the Restatement (Second) of Torts which provides, in pertinent part – (1) One who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer, or to his property, if (a) the seller is engaged in the business of selling such a product, and (b) it is expected to and does reach the user or consumer without substantial change in the condition in which it is sold. Restatement (Second) of Torts, §402A(1). See also Webb v. Zern, 422 Pa. 424, 220 A2d 853 (1966). To prevail on this theory, therefore, an injured plaintiff must establish just two elements – "(1) the existence of a defect in the product that was present at the time the product left the control of the manufacturer; and (2) that the defect caused the plaintiff's injuries". Donoughe v. Lincoln Electric Co., 936 A2d 52, 61 (Pa. Super. 2007). See also Wiggins v. Synthes (USA), 29 A3d 9 (Pa. Super. 2011) (A plaintiff presents a prima facie case of strict liability by establishing that the product was defective and that the product caused his injury). A negligence claim is distinct from one based on products liability. In a negligence action, the liability of the defendant is measured by his behavior while, in a products liability case, it is measured solely by the characteristics of the product at issue. Lewis v. Coffing Hoist Division, Duff-Norton Co., Inc., 515 Pa. 334, 528 A2d 590 (1987). In general, a negligence claim is established by proof of four elements: "(1) a duty or obligation recognized by law; (2) a breach of that duty; (3) a causal connection between the conduct and the resulting injury; and (4) actual damages". Grossman v. Barke, 868 A2d 561, 566 (Pa. Super. Ct. 2005) (citation omitted). Applying this to a products liability case, a plaintiff must prove that his injury was "proximately caused by a specific defect in design or construction" of the product at issue. Brandon v. Ryder Truck Rental, Inc., 34 A3d 104, 110 (Pa. Super. 2011) (citation In the present case, the Lower Court determined that no genuine issue of material fact existed as to whether the patch in question leaked a fatal dose of fentanyl onto the decedent and concluded from this that no defect That, however, was error. In their motion for summary judgment, the Appellees asserted that (1) the medical examiner who retrieved the patch from Ms. Doe's shoulder visually inspected it and did not note any damage to it; (2) the toxicology report detected a toxic level of morphine in her system and the post-mortem fentanyl level was within the therapeutic range; and (3) a purported expert in material sciences, Dr. Maureen Coe, inspected the patch and concluded that its "seal was ‘fully intact and functional'". (RR at 27a-30a). In her response to that motion, Ms. Smith asserted that her experts believed, with a reasonable degree of scientific certainty, that the patch was defective and leaked a fatal dose of fentanyl onto Ms. Doe. She attached the experts' reports for the Court's consideration. The first was Dr. Kris Noel Green, an assistant professor at Carnegie Mellon University in its Departments of Biomedical Engineering and Chemical Engineering. She was highly critical of the inspection method used by the defense expert, Dr. Coe. After noting that she watched the video of Dr. Coe's inspection, read her report and attended her deposition, Dr. Green stated – After first viewing the videotape, I was surprised at the imprecise nature used to inspect the patch. Defects, including micro-defects, can not all be observed by the naked eye, in my scientific opinion and experience. (RR at 299a). She further noted that, in the past, Dr. Coe had also concluded that naked eye inspection is not sufficient for this purpose. (RR at 299a- 300a). Dr. Green then concluded – It is my opinion that microscopic observation, using a light microscope, which is least destructive, could be a necessary means to determine the patch's integrity. (RR at 300a). She characterized this as "absolutely necessary". (RR at Another expert, Dr. Frederick W. Roe noted that "when fentanyl is delivered at greater than label doses, erythematous skin hypersensitivity occurs". (RR at 307a). In other words, "the result of greater than label fentanyl doses is a fentanyl wheal or flair [welt]". (RR at 307a). Such a welt was found post-mortem on Ms. Doe's shoulder where the patch was removed. (RR at 307a). It had "a pattern of deep fissures" that corresponded to certain "black lines on the membrane" of the patch in question. (RR at 307a). There were also brown spots on the patch that, in the doctor's view, were "probably cellular fluids from the cellular necrosis, blood, serum or all three". (RR at 307a-308a). As explained by Dr. Roe - "the fissures in the fentanyl welt are evidence that fentanyl was in overdose in the vasculature underlying the fentanyl welt" and that there was a "fatal fentanyl overdose". (RR at 307a). He also noted that the black lines found on the patch post-mortem were either "fentanyl aggregations that accumulated from a defect in the patch and caused the cellular necrosis that caused the fissures in the welt or fentanyl crusts with a high fentanyl concentration". (RR at 307a). From all this he concluded – Based upon the available data, at this point in time, it is my opinion, that the fissures in the fentanyl welt on Ms. Doe's shoulder and the black lines and brown spots on the transfer membrane of the 75 microgram per hour Duragesic Transdermal System removed from Ms. Doe post mortem is evidence that the patch removed from Ms. Doe post mortem had a defect that delivered a fatal fentanyl overdose. A third expert retained by Ms. Smith was a forensic pathologist, Dr. Cyril H. Boe. He agreed with Dr. Roe on the significance of the fentanyl welt on Ms. Doe's shoulder. (RR at 312a-313a). To quote his report – The presence of the fentanyl welt on the area of skin below the site on Ms. Doe's shoulder where Dr. Jones removed the Duragesic Patch during autopsy is pathological evidence that highly concentrated fentanyl gel came in contact with Ms. Doe's skin. The size and severity of the irritated area of skin is forensic evidence that the fentanyl gel contacted most, if not all, of the skin under the patch, and was in high enough concentration to raise the welt under the complete area of the patch. That amount of fentanyl gel provided forensic evidence that Ms. Doe received a fatal fentanyl overdose from a defect in the patch that allowed the highly concentrated fentanyl gel to leak from the drug reservoir on the patch, and then come into contact with Ms. Doe's skin. (RR at 313a) (emphasis supplied). Dr. Boe also pointed out that her corpse was found lying on its side, the same position she was in when last seen alive in her bed. (RR at 313a). He surmised from this that, when she rolled over on her side, she "released the fentanyl gel … in one massive overdose". (RR at 313a). All three experts rendered their opinions with a reasonable degree of scientific or medical certainty. Despite this evidence, the Lower Court granted summary judgment. Although the Judge purported to view the evidence in the light most favorable to Ms. Smith, that clearly did not happen. This is reflected in the following statement from her Omnibus Opinion and Order of September 10, Dr. Green admitted that she lacked ‘hard facts' of a defect in the patch. She failed to offer an opinion to a reasonable degree of scientific certainty that the patch was defective in either her deposition or her expert report. Nor did she ever actually inspect the patch with a light microscope, which in her opinion ‘would be a necessary means to determine the patch's integrity'. Additionally, even if Ms. Doe had a fentanyl welt as Dr. Roe opines, the evidence establishes that she had a therapeutic level of fentanyl in her blood. Therefore, if the welt did exist, it is not evidence of a fentanyl overdose. (RR at 332a-333a) (references to the record omitted). The Judge then issued a second Order on January 18, 2013 in which she adopted the above statement. She further noted that Dr. Coe had not seen a broken seal on the patch and reiterated her belief that the fentanyl level in Ms. Doe's blood was at "therapeutic levels". (RR at 412a). She also made the curious and unsupported statement that a fentanyl welt "can manifest at therapeutic levels". (RR at 412a). It is clear from all this that the Judge failed to view the record in the light most favorable to Ms. Smith. Instead, she weighed the evidence and then accepted as true Dr. Coe's opinion and the toxicology report that allegedly reflected a "therapeutic level" of fentanyl in the decedent's blood. It was for the jury to determine, after cross-examination of both Dr. Coe and the proponent of the toxicology report, whether to accept their findings as true or whether to accept the opinions of Ms. Smith's experts that the welt on Ms. Doe's body indicated a fentanyl overdose. In general, therefore, when the record is viewed in the light most favorable to Ms. Smith and all doubts as to the existence of an issue of fact are resolved in her favor, it is clear that questions of fact remain as to whether the patch in question was defective and leaked a fatal amount of fentanyl onto Ms. Doe. Thus, summary judgment should not have been granted in favor of January Pharmaceutica, Inc., February Corporation and CONCLUSION
Based upon the arguments raised herein, the Order granting summary judgment to Appellees January Pharmaceutica, Inc., February Corporation and March & March should be reversed and the case remanded for trial. Respectfully submitted, Patrick P. Lawyer, Esquire Attorney for Appellant CERTIFICATE OF SERVICE
I, Patrick P. Lawyer, do hereby certify that, on the _ day of August, 2013, I did serve six copies of the foregoing document upon the following person by first class mail. This manner of service is in conformance with the Pennsylvania Rules of Appellate Procedure. John H. Attorney, Esquire 123 West Third Street Pittsburgh, PA 15222 Patrick P. Lawyer, Esquire

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