This is one of many cases involving phenylpropanolamine ("PPA"), an ingredient that a number of over the counter allergy, cold and appetite suppressant (weight loss) drugs contained and that in the late 1990's was associated with strokes in a small number of instances. All of the PPA cases filed in the courts of the State of New York have been assigned to me for pre-trial management, and all but a few have been fully resolved.

In this motion, defendant Bristol-Meyers Squibb, the manufacturer of Comtrex, a cold remedy that contained PPA, joined in by defendants Price Chopper # 166 and Golub Corporation, seek summary judgment dismissing the within action contending that there is no scientific evidence that Frank W. Duffy's stroke could be related to PPA. They base this on the fact that Mr. Duffy sustained an ischemic (clotting or blocking) stroke rather than a hemorrhagic (bleeding) stroke after allegedly ingesting Comtrex to ameliorate the symptoms of a cold and fever. They contend that the specific type of ischemic stroke that Frank Duffy sustained is caused by a vertebral arterial dissection for which there is no association, no biologically plausible mechanism and no epidemiology linking PPA to vertebral-basilar arterial dissections.

The facts of this case are as follows. Plaintiff Frank Duffy, aged 49, sustained a severe brain stem stroke in his home in Malone, New York, on February 13, 2000 which has left him seriously impaired. He was first taken to a local Hospital, Alice Hyde Hospital (three houses from his home) and later that night transported to Fletcher Allen Medical Center in Burlington, Vermont. In response to questions about medications that he was taking, Lillian Anderson-Duffy, Frank Duffy's wife, told the medical personnel at Alice Hyde Hospital that he was taking Theraflu, an over the counter drug that does not contain PPA. On November 7, 2000, nine months later, Mrs. Duffy's sister telephoned her to report that her daughter Allison heard on television that certain cold medicines may cause strokes. Mrs. Duffy then read that certain medicines were removed from the market because they contained PPA. When she read a list of such medicines to Frank, he communicated to her that he had been taking Comtrex before his stroke. He also let her know that there were some pills remaining in the medicine cabinet. She asserts that she found a box of Comtrex Deep Chest Cold & Congestion Relief medicine in her medicine cabinet and found that there were ten liquid gel pills remaining in a 24 pill box. [*2]

It is undisputed that Frank Duffy sustained an ischemic stroke on February 13, 2000 which is by far the more common type of stroke (80% of strokes are ischemic). Dr. John Stirling Meyer, an 82 year old Board certified neurologist-psychiatrist licensed to practice in Texas, who has testified for plaintiffs in numerous cases and who reviewed Frank Duffy's medical records, contends in an extensive deposition in this case that plaintiff sustained an ischemic stroke initially but that it converted several days later to a partial hemorrhagic stroke. Dr. Meyer, based on his review of Frank Duffy's records, insists that he sees "beading" in the vertebral dissecting artery on the MRA angiogram (magnetic resonance arteriogram) which he believes indicates within a reasonable degree of medical certainty that Mr. Duffy's stroke was caused by his ingestion of PPA in the days and hours preceding his stroke. Dr. Meyer avers that phenylpropanolamine (PPA), which he opines is a vaso-constrictor, raised Mr. Duffy's blood pressure and promoted clotting of the vertebral arteries and thrombosis of his basilar artery which in turn caused the stroke. He asserts that the PPA causes the arteries to constrict in rings of muscle giving a bead-like appearance to the blood vessels. He states that the constriction also damages the blood vessel walls promoting thrombosis and dissection (separation of the arterial walls) which can cause and here caused clot formation. The constriction, Dr. Meyer claims, can also weaken the vessel wall so that there can be hemorrhaging as a result of the dissection. Dr. Meyer insists that Mr. Duffy's MRA shows both "beading" and arteritis or arterial inflammation. He cites various studies concerning the activity and impact of other sympathomimetics, a class of drugs that includes PPA containing medicines, for his conclusion that PPA caused Mr. Duffy's ischemic stroke.

However, the test records at Fletcher-Allen state that Mr. Duffy suffered a brainstem infarction secondary to a vertebral basilar artery dissection. The physicians' notes indicate that the dissection may have resulted from a coughing fit and mention that Mr. Duffy , a charter airplane pilot, had suffered a head trauma when he hit his head in a plane two weeks earlier. (Mr. Duffy characterizes that incident as a minor bump.) The records also noted that Mr. Duffy weighed about 296 pounds at the time he suffered the stroke and had a history of mild to moderate untreated hypertension. In addition, Mr. Duffy suffered from cervical spondylosis, a known risk factor for ischemic stroke. None of the physicians who cared for Mr. Duffy at Fletcher-Allen, including the neurologists and stroke neurology experts, several of whom have been quoted, believes that the stroke was caused by or related to PPA.

Defendants proffer the opinions of Caren Jahre, M.D., a board certified neuro-radiologist who is currently Chief of Neuroradiology at Lenox Hill Hospital and an Assistant Professor of Radiology at New York University School of Medicine, and of George Newman, M.D.-Ph.D., a Board certified neurologist who is Chairman of Neurosensory Sciences at Albert Einstein Medical Center in Philadelphia and professor of Neurology and Radiology, formerly at the University of Wisconsin and the State University of New York at Stony Brook. Dr. Newman was also Director of the University of Wisconsin Stroke Health Program.

Dr. Jahre avers that her review of the films makes clear that the images in which Dr. Meyer claims to see "beading" are artifacts resulting from imperfect MRA technology. Beading, she states, "is a phenomenon produced by alternating segments of dilation and constriction of blood vessels." She states that the ostensibly "beaded" posterior cerebral artery was not implicated in Mr. Duffy's stroke, and was in any event perfectly healthy. Moreover, Dr. Jahre [*3]contends that there is no medical or scientific literature that identifies the actual radiologic pattern of beading as diagnostic of a sympathomimetic induced ischemic stroke.

Dr. Newman avers that arterial dissection is increasingly recognized as a cause of stroke among stoke patients under 50 years old. Clots may form where the tear occurs and be dislodged causing arterial emboli or the tear can become larger and itself occlude the blood vessel. Minor trauma, coughing, genetic disorders and infections are all causes of dissections. Dr. Newman opines that there is no plausible role for PPA in a stroke due to arterial dissection. He states that there are neither epidemiological studies or even individual case reports purporting to link PPA to dissection of an artery, which all of the records indicate Mr. Duffy experienced..

In evaluating the potential relationship between PPA and ischemic strokes, this court is aided by the decisions of other judges who have confronted such issues.Hon. Barbara Rothstein has been assigned by the Judicial Panel on Multi-district Litigation as the MDL Judge to manage all cases filed in federal courts, under the rubric of MDL #1407. Judge Rothstein held extensive hearings to which she invited state court judges' who manage PPA cases within their states to participate. After days of hearings, she made findings pursuant to the reliability and relevance standards set forth in Daubert v. Merrell Dow Pharmacies., Inc., 509 U.S. 579 (1993). She has shared both transcripts and findings with the state court judges who either participated in the hearings or evinced an interest in having them. Her findings support an association of PPA with both hemorrhagic and ischemic strokes. Judge Rothstein concludes that there is sufficient evidence to allow cases of both types of strokes following ingestion of PPA containing drugs to go to trial, although she finds the evidence correlating hemorrhagic strokes with PPA far more reliable and scientifically based. See In re: PHEYLPROPANOLAMINE (PPA) PRODUCTS LIABILITY LITIGATION, 289 F. Supp.2d 1230 (W.D. Washington 2003).

Although New York adopts the more restrictive standard for evaluating expert evidence that is set forth in Frye v. United States, 293 F. 1013 (D.C. Cir. 1923) and holds that the expert's opinion must be generally accepted in the scientific community (see Heckstall v. Pincus et al., 19 AD3d 203 (1st Dept. 2005)), Judge Rothstein's opinion and analysis using the Daubert standard of relevance and reliability is instructive. First, Judge Rothstein acknowledges the generally accepted proposition that only twenty per cent of strokes are hemorrhagic and eighty per cent are ischemic. Thus, the hemorrhagic strokes usually associated with PPA and other sympathomimetic substances are the rarer kind stroke.^[FN1] Second, Judge Rothstein bases her conclusions that find an association between PPA and hemorrhagic strokes, particularly in women between the ages of 18 and 49, on a study conducted at Yale University known as the Hemorrhagic Stroke Project (HSP). That study, conducted between 1994 and 2000 issued a final report that has suggested that PPA increases the risk of hemorrhagic stroke, particularly for women using PPA-containing appetite suppressants. After the HSP report, the FDA requested voluntary removal of PPA-containing products from the market and issued a public health advisory (November 2000). The New England Journal of Medicine published an article about the HSP results in December of 2000. See Walter N. Kernan et al., Phenylpropanolamine and [*4]the Risk of Hemorrhagic Stroike, 343 New En. J. Med. 1826 (2000).

Defendants aver that there is no study linking ischemic strokes to PPA and that, pursuant to the Frye standard, the Court cannot credit the unsubstantiated if not incredible conclusions of Dr. Meyer. This might be persuasive might it not be for Judge Rothstein's conclusions allowing PPA cases involving ischemic strokes to go forward. Judge Rothstein credits the testimony of Dr. Steven Levine, a board certified neurologist and Professor Neurology at Mount Sinai School of Medicine and Medical Center in New York with a background in stroke investigation who opined that on rare occasions and in some people, PPA can trigger an ischemic stroke. In her decision, Judge Rothstein states, "Dr. Levine's opinion rests on case and adverse drug reports, biological plausibility, comparison to other sympathomimetics and naturally occurring conditions with altered sympathetic tone PPA blood pressure studies, textbook and other references, and both his own and others' clinical experience." Dr. Levine also relies upon the vasoconstricting qualities of PPA and other sympathomimetics to reach his opinion. While it is clear that no epidemiological study confirms Dr. Levine's opinion, that alone may not be sufficient to exclude evidence of causation. Judge Rothstein also cites a medical treatise that associates arteritis or inflammation of the arteries with PPA among other substances. (Michael A. Sloan, Toxicity/Substance Abuse," Primer on Cerebrovascular Diseases, K.M.S. Welsh et al. eds. 1997). Judge Rothstein evaluates each of the above factors, including Dr. Levine's comparison to other sympathomimetics like cocaine and ephedrine and finds sufficient reliability to establish general causation.

Judge Rothstein's decision is consistent with that of the Honorable Norman Ackerman, Coordinating Judge of the Complex Litigation Center of the Court of Common Pleas in Philadelphia County, Pennsylvania. After a hearing, in which he relied upon the Frye standard of general acceptance in the relevant scientific community, Judge Ackerman credits Dr. Levine's testimony sufficiently to admit expert testimony "that PPA increase[s] the risk of ischemic stroke in any segment of our society because there is general acceptance of the methodology of extrapolation utilized....and supported by the lines of evidence, materials, textbooks and case reports......supported by a strong logical inference, to wit: that drugs of the same class.....may be compared as to effect.." In re: Phenylpropanolamine ("PPA") Litigation, 2001 WL 34153359 (Pa. Common Pleas 2001). In the latter decision, Judge Ackerman also refers to the "beading" phenomenon associated with other sympathomimetics that plaintiffs' experts claim has been seen in PPA cases, and which plaintiffs contend is evidence of stroke potential.

Based on the foregoing, it appears that there is evidence sufficient to meet the Frye standard of general causation, at least to the extent that some ischemic strokes may be caused by PPA. Thus, a Frye hearing to establish general causation is appropriate. The evidence of specific causation, that is that Frank Duffy suffered a PPA related stroke is still problematic. Whether the type of vertebral arterial dissection that caused his stroke can be related to PPA is unclear, particularly in view of the evidence submitted by defendants, including statements of Frank Duffy's treating physicians. However, to reject Dr. Meyer's testimony without a Frye hearing to determine whether it has any scientific validity might be precipitous. Thus, the hearing will deal with both general and specific causation. Since it appears that there are available physicians in the New York area like Doctors Jahre, Newman and Levine, obtaining witnesses for such a hearing should not be onerous. It will not be necessary for plaintiff, who is seriously impaired, to [*5]be present at such a hearing.

Counsel are directed to call the courtroom to set up a Frye hearing date. (646)386-3275.

Dated: May 16, 2006Enter:

_________________________

Helen E. Freedman, J.S.C.

Appearances of counsel