Source: https://de.scribd.com/document/129530265/PAUL-DECKER-V-GEHC-IN-RE-GADOLINIUM-BASED-CONTRASTING-AGENTS-PRODUCTS-LIABILITY-LITIGATION
Timestamp: 2019-04-22 09:11:41+00:00

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MEMORANDA OF OPINION AND ORDER Signed by Judge Dan A. Polster February 13, 2013 In short, a punitive-damages claim for an FDA-approved drug is allowed under Ohio law only if the FDA has made a finding of either fraud or misrepresentation. There is no such finding here. WHERE IS THE FDA? WHY HAVEN'T THEY INVESTIGATED? WHY IS THIS PRODUCT STILL ON THE MARKET?
Case: 1:12-gd-50004-DAP Doc #: 162 Filed: 02/13/13 1 of 31.
correspond to the sections below. Because sur-replies are unnecessary in the Court’s analysis of the pending motions, the Court DENIES the motions for leave to file them. (Doc ##: 137, 142.) I. On January 11, 2013, GEHC filed a Motion to Preserve and Clarify the Record on Appeal. (Doc #: 106.) GEHC asks the Court for an order “expressly confirming the Court’s prior decision that all items on the main MDL docket and on the dockets of the four bellwethers (Knase, Bullock, Marino, and Kono) is part of the record in Decker.” (Id. at 1.) GEHC also asks the Court to direct the parties “to file any materials relevant to Decker, solely for purposes of the record on appeal, no later than 14 days following entry of judgment after trial.” (Id.) Although GEHC seeks to formally preserve all of its prior objections, “this motion does not seek to challenge these rulings.” (Id. at 1-2 (emphasis in original).) Rather, its purpose is purely procedural, i.e., “to ensure that the record in this case is clear and preserved for any appeal in an efficient manner.” (Id. at 2.) Plaintiffs consent to this Motion. Accordingly, the Motion to Preserve and Clarify the Record on Appeal is hereby GRANTED.
of course. (See Decker Case. who has examined the plaintiff and reached a conclusion on that plaintiff’s NSF diagnosis. such as diabetes. 2013. the Court excluded those opinions. Doc #: 96. give the basis for his conclusion. seeks to broaden the Court’s previous rulings. the differential diagnosis. If there is no challenge to a given plaintiff’s NSF diagnosis. In that case.9 [AN 9] A case specific expert (such as Dr.) The Court denied GEHC’s letter request. Gaspari) who opines that a particular plaintiff does not have NSF could. the Court will quote those rulings wholesale. complicating factors in diagnosing NSF. and is nonsensical. arguing that the Motion is premature. the generic expert’s testimony would be superfluous. Gaspari’s generic expert report discusses the history of NSF.”). Br. Gaspari offered two basic opinions – that NSF is difficult to diagnose and that four Adverse Event Reports (AERs) sent to GEHC prior to 2006 were not “clinically” diagnostic of NSF. and an analysis of four Adverse Event Reports received by GEHC. (Id. GEHC filed an opposition brief. (See id.Case: 1:12-gd-50004-DAP Doc #: 162 Filed: 02/13/13 4 of 31. lacks merit. In the 2009 Report. “Opp. generic expert testimony about various NSF diagnostic issues is not relevant. asking the Court to strike the pending Motion. In Daubert I. how it is diagnosed. 2013. A generic expert testifying at length about how NSF is diagnosed and how other conditions. and directed GEHC to file a brief in opposition to the Motion no later than January 16. Dr. Dr.) To save the Court time paraphrasing its prior Daubert rulings regarding Dr. at 1. To the extent that GEHC disputes that any of the plaintiffs in the four bellwether trials has NSF. it will need to offer a case-specific expert. which could include an explanation of -4- .. The testimony concerning NSF diagnosis shall not be permitted because it is irrelevant and does not assist the trier of fact. Doc #: 118 (hereafter. Gaspari. PageID #: 6775 submitted a letter to the Court. and in the spirit of preserving and bringing clarity to those rulings.) On January 16. complicates NSF diagnosis is not relevant unless the particular plaintiff has diabetes and a case-specific expert testifies that the plaintiff does not have NSF.
Sec.” (Doc #: 736-5. or any other relevant data GEHC had at its disposal. See Adverse Event Reports Discussion. Gaspari only examined four Adverse Event Reports and was not provided any preclinical or animal studies conducted by GEHC.Case: 1:12-gd-50004-DAP Doc #: 162 Filed: 02/13/13 5 of 31. III (B). Moreover. the primary purpose of which was to review the four AERs and “determine whether there was any consistency in [these] reports to suggest that exposures to gadolinium based contrast agents (GBCA) resulted in NFD/NSF. Dr. In Daubert I. Dr. Waikar).) As observed by Plaintiffs. At deposition. which the Court did in detail. at 55 (Dr. supra. Accordingly. PageID #: 6776 the difficulty in diagnosing NSF and how other conditions that plaintiff suffers from has complicated the diagnosis. the Court also precluded Drs. along with the Wahba and Collidge studies that the Court found similarly flawed. the Court affirmed its earlier ruling excluding those opinions: The record shows that Dr.) In short. This information formed the basis for his conclusion that the AERs did not support a clinical diagnosis of NSF. at 5. Dr. Gaspari may not draw conclusions from the four Adverse Event Reports received by GEHC that GEHC was unaware of Omniscan’s potential risks. Gaspari’s pharmacovigilance opinions. With regard to Dr. Gaspari’s conclusions are based on incomplete information and therefore do not satisfy the Federal Rule of Civil Evidence 702 requirement that expert testimony be based on sufficient facts or data. consistent clinical history to alert GE Healthcare to the presence of any association between Omniscan and NFD/NSF. any medical literature. Gaspari had co-authored. Newton). Gaspari examines four Adverse Event Reports received by GEHC between April 2002 and July 2005 and concludes that the data did not support a diagnosis of NSF in any of these cases and therefore that they did not offer “a compelling. Dr. (See Daubert I at 51 (Dr. at 18.) GE subsequently asked the Court to reconsider its rulings. Gaspari made clear that the purpose for this conclusion was to -5- .” (Doc #: 736-5. Adverse Event Reports examined in a vacuum have significant limitations and are therefore only useful when assessed in the context of other available date. (Daubert I at 53-54. Gaspari submitted an expert report. Newton and Waikar from opining that NSF occurs in the absence of gadolinium exposure based on two Deng studies which Dr. In his generic expert report. Gaspari’s pharmacovigilance opinions. the Court excluded Dr. Dr.) The report included preliminary information about the history of NSF and the difficulties associated with diagnosing it.
at 51. Newton relied for the same proposition.) Furthermore. at 130-132. GE’s in vivo.2 Hence.) He repeatedly testified that his sole assignment was to review. e.Case: 1:12-gd-50004-DAP Doc #: 162 Filed: 02/13/13 6 of 31. Gaspari’s deposition testimony makes clear that he is not an expert in pharmacovigilance. (See. 93. 145). Gaspari Dep. 77. Waikar’s expert report and finds that.) The Court properly excluded this testimony. at 81-87. his report and deposition answers showed that he arrived at his “safety signal” conclusion without reviewing all the information GEHC had available to it at the time. Gaspari admitted that the patients in the four AERs all had advanced renal insufficiency. he looked only at the information in the AERs and limited followup information given to him by GEHC in opining whether the AERs constituted a safety signal. 80. PageID #: 6777 show that the four AERs did not give rise to a “safety signal of NSF. and the Omniscan label for safety information (id. 52. at 79-80). Waikar from testifying that NSF has occurred in the absence of GBCA exposure. at 111-115). The question of whether these AERs constituted a safety signal requires someone with expertise in pharmacovigilance. at 51-52). [AN 2] Dr. the AERs gave rise to a safety signal alerting GEHC to the risks associated with administering Omniscan. and whether they supported a clinical diagnosis of NSF..” (Id. in -6- . e.. Rather. The Court also affirmed its ruling precluding Drs.g. including epidemiological studies (id. given all the information available to GEHC at the time.) Dr. Newton and Gaspari from testifying that NSF occurs in the absence of GBCA exposure: GEHC challenges the Court’s ruling precluding Dr. id. in vitro and human studies reflecting GEHC’s knowledge regarding gadolinium toxicity (id. relevant GEHC internal documents (id. at 134. e. at 93-94. whether the four AERs supported a clinical diagnosis of NSF is irrelevant to the question of whether the AERs constituted a safety signal. the four AERs and the followup information that was given to him by GE. as a dermatologist. particularly to the renally impaired.. Waikar..g. Gaspari Dep.. Doc #: 737-12. 155-163). and to determine whether there were any consistencies or inconsistencies between those AERs. at 110. The Court properly excluded this testimony because it was based on the Wahba and Collidge studies – the same ones upon which Dr. clinical and preclinical data (id. Doc #: 737-12. The expert must determine whether. (Daubert II at 12-13) (emphasis added). (See. The Court has again reviewed Dr.g. (See. 94.
Localized Nephrogenic fibrosing dermopathy: Aberrant dermal -7- .) The Court notes that. The second study upon which Dr.3 Yet. et al. one of whom is Dr. PATHOL. Doc #: 737-12.) This is the same 2009 Deng study the Court previously precluded Dr. 2. at 2 (prohibiting Dr. A. at 57.. Waikar from relying on the Deng study for the same proposition. including the case that my group has published in the clinical dermatology literature (1.) Interestingly. at 55). 2009. Gaspari. there is only an association of GBCA exposure.. at 18 (some emphasis added). the Court precludes Dr. 25-35). based now upon fourteen different studies. for the first time in his summary: Even in 2009. Gaspari relies for this opinion is the 2009 Deng study which he co-authored and which the Court earlier precluded him from relying on to support that particular proposition. (Doc #: 736-5.. Gaspari made clear that he was not going to opine on the mechanistic cause of NSF or whether it has been demonstrated that gadolinium causes NSF (Gaspari Dep. stated that possible gadolinium exposure in other hospitals could not be ruled out). Dr.) For the same reasons the Court precluded Dr.” (Deng. In reviewing Dr. Nephrogenic Systemic Fibrosis with a Spectrum of Clinical and Histopathological Presentation: A Disorder of Aberrant Dermal Remodeling. Gaspari states. the first study upon which Dr. Gaspari relies is another article he co-authored that reviews the case of a single NSF patient for whom he was unable to find GBCA exposure – while simultaneously noting that the patient was “lost to clinical followup. et al. 18. Gaspari from relying on to support the identical proposition. Dr.Case: 1:12-gd-50004-DAP Doc #: 162 Filed: 02/13/13 7 of 31. A. and the development of NFD/NSF in patients with chronic renal failure.. he reports that NSF occurs in the absence of GBCA exposure. J CUTAN. in his deposition testimony. There is no clear cause and effect. (See Doc #: 677-9. Waikar cites as an additional basis for this opinion the Deng study.. [AN 3] Dr. the Court observed that Dr. PageID #: 6778 addition to the Wahba and Collidge studies. Gaspari’s generic report a second time. Mar 31. at 37) (citing Deng. Gaspari from opining that NSF occurs in the absence of GBCA exposure based on the Deng article because the authors. (See Doc #: 642. (Id. Gaspari also testified that he was not going to be addressing the history or evolution of NSF. Newton from relying on the Wahba and Collidge studies for the proposition that NSF occurs in the absence of GBCA exposure. It is noteworthy that there are a number of cases of NFD/NSF occurring in patients with renal failure in the absence of GBCA exposure.
Gaspari testified that the tissue for this particular patient still exists and has not been tested for the presence of gadolinium. Weisbord from testifying that NSF may occur in the absence of gadolinium exposure: [T]he Court will not exclude those opinions in the Supplemental Report derived from review of the Lemy study. (Case No. the Court affirmed its ruling precluding Drs. and Waikar from offering expert testimony on that issue. (Daubert II at 15-17 (emphasis added). however.) For a more detailed explanation of why the Court precluded GEHC’s generic experts from opining that NSF occurs in the absence of gadolinium exposure. Gaspari relies for the proposition that NSF occurs in the absence of GBCA exposure and finds that these articles have the same deficiencies as the Collidge. based upon local practice. 2010 that dealt with the plaintiffs’ motion to strike the supplemental report of case-specific expert Steven Weisbord. PageID #: 6779 repairing? JAAD 2008. the Lemy authors attempted to determine whether the patient who reportedly developed NSF without exposure to a GBCA may have been administered gadolinium at another facility. (Doc #: 1632 at 9. 2011. Newton). Wahba and Deng studies. see Daubert II at 5-8 (Dr. the transplantation hospital would have to give permission to conduct an imaging scan (with or without a GBCA) on the patient. 1:08 GD 50026. 1 -8- .)1 Accordingly.) Additionally. At deposition. “Knase”). Newton.) In Knase.Case: 1:12-gd-50004-DAP Doc #: 162 Filed: 02/13/13 8 of 31. The Lemy study does not suffer from the same methodological deficiencies as the Collidge and Wahba studies. Unlike the Collidge study. Dr. Gaspari. The Court has also reviewed the remaining twelve articles upon which Dr.) Of relevance here. the Court issued a Memorandum of Opinion and Order on December 6.D. (See Knase v. M. Case No. is the Court’s ruling denying the motion to exclude Dr. in contrast to the Wahba study. General Electric Co. 1:08 GD 50026 (hereafter. Doc #: 257. (Id.. 58: 336-9). the Lemy study conducted a blind test on the tissue of the patient in question using mass spectrometry to confirm the lack of gadolinium in the patients’ tissue. The authors of the study noted that. The Knase case is a bellwether case that was scheduled for trial on January 24. the records indicated that no such permission was granted.
which does not appear to contain the methodological flaws of previous studies. Weisbord to opine on the Lemy study. These articles. Gaspari ignore the Court’s previous rulings. at 4. the Court will permit Dr. Lemy and his co-authors are correct in their description of [patient 5] as a Gdnaive NSF/NFD patient. (Supp.Case: 1:12-gd-50004-DAP Doc #: 162 Filed: 02/13/13 9 of 31. This information combined with previouslypublished articles in the peer-reviewed literature. Gaspari states: As discussed in my previous report. because it is based on research published after August 2010. (Id. Rpt.) GE has now submitted the Supplemental Report of Dr.3 Indeed. as well as my own clinical experience. Not only does Dr.) -9- .) 3 Dr. (3-15). Gaspari states: But. PageID #: 6780 Thus.2 he does so with defiance. at 6. (Id. of the 19 studies he cites in support of the proposition that NSF occurs in 2 Dr. there have been similar findings of patients with NSF/NFD who have lacked exposure to GBCAs reported elsewhere in the medical literature. shows that it would be generally unacceptable and contrary to the scientific method to ignore prior articles reporting NSF/NFD in “Gd-naive” patients. and that description passed peer-review in a highly respected dermatology journal. at 8 (emphasis added). Gaspari expounds on his earlier proposition that NSF occurs in the absence of exposure to gadolinium. These reports support the conclusion that there are factors other than GBCA exposure that play a role in the pathophysiology of NSF/NFD. Gaspari. The Court will also grant Plaintiffs leave to supplement expert reports based on the Lemy study. citing in support of that proposition 19 articles – 14 of which the Court previously found flawed to support that discrete proposition. and identified him as a generic expert who is expected to provide testimony at the Decker trial that is consistent with his initial and supplemental reports. Dr. call into question whether exposure to a GBCA is a necessary co-factor in the development of NSF/NFD. In the Supplemental Report.
With respect to Dr. Accordingly. Gaspari has flagrantly disregarded my previous rulings on this issue. and because the additional articles he cites are similarly flawed to support the proposition that NSF has occurred in the absence of GBCA exposure. But the Court previously ruled. he is barred from opining on pharmacovigilance matters. GE contends that Dr. an expert on pharmacovigilance. the only study that could conceivably support this proposition is the Lemy study. his testimony is barred. all of this data was available and accessible to Dr. however. Of course. with regard to Dr. However.e. -10- . post Daubert I and II. Gaspari at the time he submitted his Initial Report. Gaspari’s reports disclose.. legal documents. Because Dr. i. GEHC has expressly designated Dr. Gaspari as a generic expert. Gaspari considered what the Court concluded any pharmacovigilance expert should have considered before rendering an opinion. extensive preclinical data. and is not now. clinical trial data. the history of NSF – a subject they argue may become relevant at trial. Dr. among other things. More to the point. additional AERs. that only a case-specific expert who opines that a plaintiff does not have NSF could give the basis for the conclusion. not a case-specific expert. because he cites to and adopts his prior report including every article the Court specifically and unambiguously excluded as unreliable. Gaspari. Gaspari was not then. PageID #: 6781 the absence of GBCA exposure. this argument fails.Case: 1:12-gd-50004-DAP Doc #: 162 Filed: 02/13/13 10 of 31. Dr. etc.” the Supplemental Report shows that. Gaspari’s pharmacovigilance opinion regarding “safety signals. Accordingly. which could include an explanation of the difficulty diagnosing NSF and how other conditions that plaintiff suffers from has complicated that diagnosis.
Dr.) The whole purpose of Daubert proceedings.. and Richard Cohan.D. Gaspari’s generic expert testimony should not be made “before a single witness takes the stand” – and that prematurely ruling on Dr. M.D. III. Ph.. Accordingly. Nor can supplementing his report turn him into a pharmacovigilance expert when the Court found he was not. PageID #: 6782 GE also argues that the Court’s decisions on Dr. (Doc #: 87).D. however. (Doc #: 92. Gaspari cannot cure the many deficiencies in his Initial Report by filing a Supplemental Report citing evidence he should have reviewed before rendering his opinions in the first place. (Doc #: 114. Alan Watson. Plaintiffs maintain that neither party can ignore the Court’s Daubert rulings.) Plaintiffs contend that these experts have submitted supplemental reports that explicitly violate the Court’s order restricting such reports to emerging new science or to new studies supplementing old science. Br. Opp. prior to trial. 3. Gaspari’s opinions or expertise today would constitute “an impermissible advisory opinion. at 4. Ph. whether a challenged expert is qualified to render his opinions and whether he applied the appropriate methodology to support those opinions.D.D. Steven Weisbord.” (Opp. and relying extensively on the very same studies that the Court previously rejected.) As an -11- . Br. GE acknowledges that the Court has ruled on multiple occasions that the generic experts could supplement their 2009 opinions with new science. Plaintiffs ask the Court to exclude certain testimony from GEHC experts Benjamin Newton. the Court GRANTS Plaintiffs’ Motion to Strike the Supplemental Expert Report of Defense Generic Expert Anthony Gaspari.Case: 1:12-gd-50004-DAP Doc #: 162 Filed: 02/13/13 11 of 31.. at 2. M. or attempt to retroactively cure deficiencies in their 2009 reports with previously available literature or evidence that they failed to consider in the first place.. M. is to determine.
to opine on flaws with the free gadolinium theory of NSF causation. Ben B. The Court made clear that what it had formally ruled was admissible – and what it had ruled was not admissible – would still apply with one proviso. Benjamin B. Jimenez.D. and because the study did not suffer the same methodological flaws the Court found in the Deng. If there was emerging new science that somehow modified the generic experts’ earlier opinions. Newton. those experts would be permitted to file supplemental reports.) Apparently. Weisbord from opining that NSF had occurred in the absence of GBCA exposure.) 4 -12- . Newton. denying those plaintiffs’ request to exclude Dr. A. the Daubert rulings the Court had previously made. Wahba. PageID #: 6783 example. Ph. The Court has never wavered from that representation. With this in mind. The Court has ruled from the get-go that it was not going to allow the parties to relitigate. in Decker. GEHC points to the Court’s ruling in December 2010 in Knase. GEHC believes that if the supplemental reports were filed before the deadline for filing them in this case.4 (Id. the Main Case. a GEHC employee. Doc #: 945. Plaintiffs have no basis to challenge those reports or testimony. based on the Lemy study. Collidge studies. Nor did the Court expect supplemental reports the sole purpose of which was to cure deficiencies the Court previously found in the initial reports. Doc #: 257. What the Court never intended was the filing of supplemental reports that re-asserted opinions the Court earlier concluded certain experts were not qualified to make. Mechanism of NSF: New The Court allowed the testimony because the study was published after the deadline for submitting supplemental expert reports. the Court allowed Dr. at 5-6. None of that is new science.Case: 1:12-gd-50004-DAP Doc #: 162 Filed: 02/13/13 12 of 31. and the Plaintiffs deposed those experts. with particular respect to the findings published in an article he co-authored. the Court is prepared to issue its rulings. In Daubert I. Newton & Sergio A. (See the Knase Case.
with regard to Dr. Newton’s background does not include the focused study of chemistry necessary to be considered an expert on the stability of chemical compounds. Gadolinium Is Not The Only Trigger For Nephrogenic Systemic Fibrosis: Insights From Two Cases And Review Of The Recent Literature. White K. monocytes and macrophages. [a]long with challenging the free gadolinium theory. 1277. Dr. such as dermal induration. Mark PB. The Collidge study did not examine whether the one NSF patient who had not received a GBCA while -13- . His degree in pharmacology and background as a translational scientist and cellular biologist. This article sets forth an alternative hypothesis of NSF causation.) Finally.MAGNETIC RESONANCE IMAGING. (Daubert I. However.Case: 1:12-gd-50004-DAP Doc #: 162 Filed: 02/13/13 13 of 31. Additionally. cells that are present in the early stages of NSF. Simpson EL. however. Thomson PC. Newton to testify that NSF has occurred in the absence of GBCA exposure. Newton’s opinion that NSF occurs in the absence of gadolinium exposure. 7 AM. 1280-81 (2009).Wahba IM. Dr. 245 RADIOLOGY 168-175 (2007) – are fundamentally flawed. Dr. to render a reliable expert opinion on this topic. Newton may not testify about the relationship between in vitro and in vivo chemical stability of Omniscan. It is clear from Dr. at 51-52. the Court concluded: The Court. pathology or histology makes his testimony challenging the similarity of rat lesions to the symptoms of NSF unreliable. provide him with the necessary expertise to offer a reliable opinion. Newton’s lack of significant training or experience in dermatology. 30 J. Newton’s deposition that he lacks the requisite level of comfort with basic dermatohistology or dermatologic clinical manifestations. Newton may also provide limited expert testimony on whether it was foreseeable that GBCA exposure would lead to the injuries encountered by renally compromised NSF patients. Newton in support of this proposition . will not permit Dr. which is the basis for his foreseeability opinions. Gadolinium-Enhanced MR Imaging And Nephrogenic Systemic Fibrosis: Retrospective Study of a Renal Replacement Therapy Cohort. et al. 1-8 (2007) and Collidge TA. Dr. The Court also determined that. J OF TRANS. the primary point being that chelated gadolinium is not as inert as once believed – and that it is chelated gadolinium that stimulates the proliferation of fibroblasts. The Court agrees with Plaintiffs that the two studies cited by Dr. PageID #: 6784 Evidence Challenging the Prevailing Theory.
(Doc #: 129-11. raising further questions about the role of retained gadolinium in the aetiology of NSF. at 11. he cites recent data and development in the field which “bolster[s] the hypothesis that the persistent pathology underlying NSF is triggered by a single high GBCA dose in susceptible patients and that gadolinium found in tissues. role in the development of this condition. which concluded that two patients developed NSF without exposure to a GBCA. Newton is precluded from opining that NSF may occur in the absence of GBCA exposure based on any study or article but the Lemy study. at 12. with the sole exception of the Lemy study.” (Id. Newton opining that NSF occurs in the absence of GBCA exposure based on these particular studies.) Further. at 53.” (Id. Newton’s supplemental report. at 2. Dr.g. “NSF has been diagnosed in more and more patients who have no history of GBCA administration suggesting that other factors trigger the pathology of NSF. among other things.) In short. The Court has reviewed Dr. “[t]here is a growing number of reports of NSF in patients not exposed to GBCA. that “patients with no history of GBCA administration have developed NSF.” (Id.) He supports this proposition with articles the Court previously found unreliable to do so. may play a very limited. the Court closed the door on Dr.) Therein. Newton is unable to opine without discussing the studies the Court has found unreliable to support that proposition. As before. The Wahba study. e.Case: 1:12-gd-50004-DAP Doc #: 162 Filed: 02/13/13 14 of 31.) And. Newton opines that the hypothesis that retained gadolinium causes NSF has become “untenable” because recent studies show. he may not testify about it at all. Dr. did not confirm its findings by testing these patients’ tissue for the presence of gadolinium. -14- . at 20. Newton’s opinions on this issue with one important exception. bone and skin. if any.) The Court sees no reason to exclude Dr. And if Dr. (Id. PageID #: 6785 undergoing an MRI had undergone any non-MRI procedures in which a GBCA was used.” (Id.
Watson holds a B. his responsibilities appear to have been more on the business side than on the science side. a Ph. In Daubert I. (8) The Early History of Salutar. Watson’s expert report contains the following substantive subject headings: (1) The Need for GBCAs. or foreseeability of gadolinium poisoning. the study of how inorganic elements function in living organisms. and (12) Commonality of All the Current Commercially Available GBCAs.D.) Upon GEHC’s request for reconsideration. his assessment of Omniscan or GBCA toxicology or toxicology studies. the Court dealt with the challenge to Dr. Watson’s generic expert report and testimony as follows: The Court will not permit defense expert Dr.B. Plaintiffs seek to exclude certain testimony by GEHC expert Alan C. in 1988. (11) Foreseeability. Watson’s responsibilities have been primarily on the business side at least since 1999 and perhaps since 1988. Watson is qualified to speak generally about bioinorganic chemistry. Dr. Given that Dr.B. Dr. Because of his background. Ph. the Court affirmed its prior ruling: -15- . in Coordination and Bioinorganic Chemistry and an M. (7) Skin Lesions During Preclinical Testing. (2) GBCA Design and Stability. (9) Salutar and Nycomed Publications. (6) The Issue of Gadolinium Retention. he is not qualified to provide expert testimony on most of the subjects discussed in his expert report. Ph. (5) Toxicity Studies of GBCAs. Watson does not have the requisite expertise to opine on the other issues within his report. Watson. Dr. PageID #: 6786 B. Alan C. Dr. Since receiving his M. The topics which may correspond to his knowledge of bioinorganic chemistry are: The Need for GBCAs. (4) Macrocyclic Chelate Complexes as GBCAs.Sc. (Daubert I at 52-53. Dr. Macrocyclic Chelate Complexes as GBCAs and The Issue of Gadolinium Retention.Case: 1:12-gd-50004-DAP Doc #: 162 Filed: 02/13/13 15 of 31. degree in Chemistry.D. (3) Thermodynamic and Kinetic Stability Factors. GBCA Design and Stability.A. (10) Nycomed’s Own Internal Documents.A. In particular. Thermodynamic and Kinetic Stability Factors. Watson. analysis of relevant publications on GBCAs. Watson may not provide an opinion on the FDA’s review of Omniscan.D. Alan Watson to testify on matters outside the field of bioinorganic chemistry. any preclinical or clinical studies of Omniscan (including those done by Salutar and Nycomed).
they cannot properly be compared. at 3. He has particular and extensive experience diagnosing. Watson. Because Dr. on the other hand. However. Fine and Parisian. Watson’s background and experience are significantly different than the that of Drs. Watson from analyzing similar. . Parisian and Fine to analyze clinical trials and relevant publications because they have the experience necessary to understand and opine on them. Fine is a board-certified nephrologist and an Associate Professor of Medicine. the date he submitted his initial report. The Court allowed Drs. not a medical doctor.) Plaintiffs ask the Court to strike documents and related testimony from Dr. Dr. 2009. Rpt. .) -16- . However. (Daubert II at 17-18.Case: 1:12-gd-50004-DAP Doc #: 162 Filed: 02/13/13 16 of 31. He has little to no experience analyzing clinical data. Dr. Watson’s supplemental report which are based upon documents available to him prior to August 31. Jerrold Abraham’s free gadolinium studies – both issues upon which the Court found Dr.’” (Suppl. Rather. Plaintiffs contend that Dr. they contend that he is simply re-addressing Dr. Watson from testifying about matters outside his field of bioinorganic chemistry. Watson lacks the requisite expertise to provide a legitimate analysis of documents outside the field of biochemistry. the Court properly precluded Dr. Parisian. GE argues that Dr. Karen Saebo’s relaxometry study and Dr. She has particular experience reviewing and evaluating clinical trials through her work at the FDA. PageID #: 6787 GEHC objects to the fact that the Court allowed Drs. “these studies . Dr. and has published numerous articles on this topic since 2003. Dr. or in some cases identical. publications and clinical trials. Watson has not supplemented his initial report with new science. Watson’s expertise is significantly different than Plaintiffs’ two experts. and little experience in any other field outside of biochemistry. is a board-certified anatomic and clinical pathologist with a Masters Degree in Biology.) According to Dr. Watson unqualified to opine. Dr. Watson is a biochemist. while precluding Dr. As such. Parisian and Fine to interpret outside publications and testify regarding the significance of clinical trials. at 3. clearly establish the extent to which protein binding is the correct explanation for the relaxometry results obtain by Muller and Saebo. researching and treating NSF.” (Id. and he has not worked directly on the scientific side of the pharmaceutical industry for at least twenty years. As explained supra. Watson discusses “new studies that ‘provide a clear and convincing alternative explanation for the interpretation of Muller and Saebo’s data.
M. Doc #: 933-3. 2010. (Id.. and pharmacology... Abraham. FASN On August 31. (See the Knase case. Doc #: 933. Watson may only opine on the fields to which he was limited in 2010 and. and on Dr.) The Court has reviewed Dr. Weisbord. PageID #: 6788 According to GE. at 1.) On November 8. the Knase plaintiffs filed a motion to exclude or limit the case-specific testimony of Dr. (Id. Abraham is a response to Dr.Sc. 2010.) On September 8. he is again precluded from opining about areas outside of bioinorganic chemistry – including toxicology. Cramer and Dr. clinical studies. Abraham’s EXAFS studies. the Plaintiffs’ Steering Committee filed a motion to exclude the supplemental generic expert reports of Drs. the Knase plaintiffs filed a motion to strike Dr.. 2009. his discussion of Dr. Doc #: 736-1.. (Id. Dr. (See the Main case. 1) at 57. C. M.) Meanwhile. Doc #: 163.) -17- . 2010.) Moreover. (Doc #: 115-1. Dr. Doc #: 136-1. Dr. 2012. Saebo and Muller between 1988 and 1993. Steven Weisbord prepared an expert report on generic issues common to all MDL cases on behalf of GEHC – which report GEHC filed on March 15.Case: 1:12-gd-50004-DAP Doc #: 162 Filed: 02/13/13 17 of 31. Rpt.D. 2010. (Id. Watson’s Supplemental Report. Weisbord prepared a Supplemental Report. (Ex. Doc #: 136.) Suffice it to say that Dr.. Dr. Tr. Weisbord and Waikar. on July 8. Weisbord’s supplemental generic report.) And on October 11. Weisbord. (Knase Final Pretrial Hrg. Cramer’s deposition and the new studies carried out by Dr. 59-60. Therein. Watson offers precisely the kind of supplemental opinions this Court expected and permitted in Knase. Weisbord prepared an expert report on issues related specifically to the Knase plaintiffs. he expounds at length on the studies conducted by Drs. 2010. Steven D. (Supp. based on his own admissions at his 2008 deposition.) On September 28.
however.Case: 1:12-gd-50004-DAP Doc #: 162 Filed: 02/13/13 18 of 31. 2009. at 5-6. Doc #: 945. Exhibit A to the Supplemental Report contains a comprehensive list of additional documents reviewed by Dr. (Id.) The Court explained therein that it held a telephonic hearing with counsel on September 15. the Main Case. Weisbord prior to his August 31. the Court will not permit Dr. Carl Einar Sjogren. The Court noted. if Dr. during which the Court denied GEHC’s motion. those parts of Dr. he may not testify about it at all. the Court will not consider untimely those aspects of the Supplemental Report addressing new science not available to Dr. (Knase.) With regard to other generic issues. PageID #: 6789 On December 6. the Court issued opinions in the Knase and Main cases regarding the Supplemental Report. Weisbord’s Supplemental Report that are derived from review of the Lemy study. that if GEHC’s experts believed that the science had changed. Doc #: 257. GEHC could propose a supplemental expert report based upon that new science. (Doc #: 945. (Id. and Per Trygve Normann. Weisbord may not testify based upon this information. because those declarations are not based on new science or research published since August 31. 2009. Similarly. 2009 are stricken and Dr. at 3. Weisbord to render any opinions in the Supplemental Report based upon the declarations of GEHC employees Aud Moxnes. (citing Hrg. 2010. Therefore. Most of these documents were available to Dr. at 2 (citing Doc #: 891).) Now. 2010. Weisbord is unable to opine that NSF may have occurred in the absence of GBCA exposure without discussing the studies the Court has already found flawed. Weisbord. Tr. as then. Weisbord prior to August 31. Weisbord’s Supplemental Report derived from his review of documents available prior to August 31. 2009 Expert Report. the Court held: Accordingly. -18- . the Court noted that GEHC had moved yet another time for reconsideration of that part of Daubert I related to case studies of NSF victims with no antecedent GBCA administration. the Court will not exclude those opinions in Dr. However.) As a preliminary matter.
IV. Cohan’s initial generic expert report or a ruling excluding any of his opinions in that report.). or when he should have known through the exercise of reasonable diligence that his NSF is related to GBCA exposure. “[t]he fact that GE failed to supply its own internal documents to its own expert prior to the deadline for generic expert reports in this MDL is not a valid reason for allowing such a supplementation. Obviously. Richard Cohan. Dr. Plaintiffs have filed a motion for summary judgment. Otherwise. See Id. (Doc #: 92-1. This case was filed on February 2. at (B)(1).C.10(A). there is no dispute: Decker was informed by competent medical authority in August 2010 – well within the two-year limitations period—that he had -19- . With respect to the first date. 2012. See O. Plaintiffs point out that Dr. the Motion (Doc #: 92) is DENIED as to Dr. Richard Cohan has submitted a supplemental report to his generic expert report that includes a list of 49 references—32 of which cannot possibly be considered new science because they date back as far as 1989. Cohan may not opine that NSF has occurred in the absence of GBCA exposure based on any of the studies this Court has found deficient. at 10. The parties agree that the applicable statuteof-limitations period is two years.Case: 1:12-gd-50004-DAP Doc #: 162 Filed: 02/13/13 19 of 31. M.D. Decker’s claims are not time barred. § 2305. the Court has been unable to find either Dr. The parties also agree that the twoyear clock did not start running until the earlier of the following dates: when Paul Decker was informed by competent medical authority that his NSF is related to exposure to GBCA.” (Id. asking the Court to rule that Mr.R. 1991 and 2006. Cohan.) According to Plaintiffs. PageID #: 6790 D. (Doc #: 84). Despite its best efforts.
is the earliest date on which Decker could have known he had NSF because it was on that date he received the NSF diagnosis. the nephrologist replied. His nephrologist wrote in his office notes: “Differential diagnosis would be systemic sclerosis [scleroderma] versus nephrogenic systemic sclerosis [NSF].” (Doc. contending that Decker’s “treating physicians may have informed him as early as August 2009 – outside the applicable two-year limitations period – that he had NSF associated with his MR procedure with contrast in 2005. “I would conjecture that I probably did. When asked at his deposition if he mentioned NSF to Decker. his doctors believed he had – and formally gave him a diagnosis of – scleroderma.” (Doc. Even though Decker was not formally diagnosed with NSF until 2010. During the appointment. 2010. Decker complained of skin tightening. 2009. the doctor considered NSF as a possible cause of Decker’s symptoms. Decker was seen by a different nephrologist. Both of these nephrologists asked Decker whether he had received an administration of GBCA with his MR procedure. Defendant disagrees. Plaintiffs argue that August 25. before then. As to the second date. PageID #: 6791 NSF as a result of his exposure to gadolinium. the nephrologist responded.” (Doc. #: 126-5 at 3). In August and September of 2009. One of his regular nephrology appointments took place on July 31. During these visits. #: 126-10 at 5). there is a dispute.” (Doc. #: 126 at 9). Given that Decker was told by two nephrologists during a span of two months that NSF was a possible diagnosis. “I most likely did discuss it. These facts give rise to a genuine dispute—at least when viewed in the light most favorable to Defendant. #: 84-14). that those doctors gave him reason to think his 2005 -20- . the onset of his NSF symptoms began as early as 2006.Case: 1:12-gd-50004-DAP Doc #: 162 Filed: 02/13/13 20 of 31. When asked at his deposition whether he had discussed the potential NSF diagnosis with Decker.
80. should. § 2307. In the second part of its motion. and the fact that Decker declined his nephrologist’s invitation in early 2009 to seek treatment for his skin hardening (specifically. which the parties are to file by February 14. The remedy. fraud.R. GEHC is correct. track the elements of the Ohio Products Liability Act.R. this motion (Doc #: 84) is DENIED. with the exercise of reasonable diligence. Accordingly. and Plaintiffs concede the point. a rational juror could conclude that. he should have figured out in 2009—outside the applicable limitations period—that his disease is related to his gadolinium exposure. GEHC argues that the Deckers are barred from recovering punitive damages. the parties acknowledge. See O.C.C. which they must do promptly. the widespread availability of information—both in the medical community and online—about NSF. 5 -21- .Case: 1:12-gd-50004-DAP Doc #: 162 Filed: 02/13/13 21 of 31. breach of express warranty. That statute allows for the recovery of punitive damages where the manufacturer “manifested a They are: manufacturing defect. breach of implied warranty. the issue is for the jury to decide. § 2307. and loss of consortium. The jury instructions. # 88). GEHC has filed a two-part motion for partial summary judgment on certain causes of action (Doc. Summary judgment is therefore not appropriate. he declined to have his legs tested). is to allow Plaintiffs to amend the complaint. V. misrepresentation. defect due to nonconformance with representations. that he had NSF symptoms as early as 2006. of course. design defect. In the first part. GEHC observes that all ten of the Deckers’ common-law product-liability claims5 have been abrogated by the Ohio Products Liability Act.71(B) (declaring that the Act is “intended to abrogate all common law product liability claims or causes of action”). negligence. The resolution of this issue turns mainly on O. PageID #: 6792 GBCA administration was medically relevant to his condition. defect due to inadequate warning.
But there is another obstacle: only the FDA gets to determine whether the manufacturer committed fraud or misrepresentation.80(A). at 966 (original emphasis). 693 F..Case: 1:12-gd-50004-DAP Doc #: 162 Filed: 02/13/13 22 of 31. The question before the Court was whether the statute is preempted by federal law. Litig. Genentech. Liab. The Court gave a clear. Marsh v.” Id. O. Wyeth-Ayerst Labs. In re Aredia & Zometa Prods. at § 2307. 551 (6th Cir. But the statute has a special rule applicable to claims involving drugs that have received FDA approval. 352 F.3d 546. The Sixth Court. App. but conditional.C. To allow otherwise – to permit a court to make an independent finding of fraud – would lead to “inter-branch-meddling. 994 (6th Cir.R.. The rule is that a manufacturer of an FDA-approved drug is not liable for punitive damages unless the manufacturer fraudulently withheld from the FDA material and relevant information or the manufacturer misrepresented such information to the FDA. § 2307.” Id. In Garcia v. for the proposition that the rule in Garcia applies to “claims that the manufacturer misrepresented or withheld information about a drug from the FDA after the FDA -22- . Inc. in a published opinion. answer. The same goes for the second exception to the general punitive-damages bar – misrepresentation of material and relevant information to the FDA.. PageID #: 6793 flagrant disregard of the safety of persons who might be harmed by the product in question.3d 961 (6th Cir.” Id. 2012). 2009). the Sixth Circuit considered a Michigan statute that authorized a fraud-on-the-FDA tort claim. The Court explained that “state tort remedies requiring proof of fraud committed against the FDA” are preempted unless “the FDA itself determines that a fraud has been committed on the agency during the regulatory-approval process. 2004). cited with approval a recent unpublished opinion. 385 F.80(C)(1)(a).
but a claim for punitive damages. of course. which was an opinion in the Knase case. 385 F. A few sentences later. the Court spoke in terms of a “cause of action for fraud on the FDA. the Court ruled that the plaintiffs were not precluded on preemption grounds from presenting evidence that GEHC withheld key scientific and safety information from the FDA in support of causes of action other than fraud on the FDA.” and “tort remedies” interchangeably..” In short. Plaintiffs offer a twofold response. such as a failure-to-warn claim. Not so. because the Court. But the distinction matters little here. This case is different. not a claim for fraud.” Id.3d at 966 (emphasis added).Case: 1:12-gd-50004-DAP Doc #: 162 Filed: 02/13/13 23 of 31. There is no such finding here. they are a remedy for certain causes of action. used the phrases “cause of action. PageID #: 6794 had approved it. they can’t do absent an FDA finding of fraud or misrepresentation. (Id. as the Ohio statutory scheme makes clear.” Garcia. (emphasis added). whereas in this case Plaintiffs have brought. In the relevant opinion. in articulating the relevant holding in Garcia. Here. They argue that this Court already decided in their favor. Plaintiffs must prove fraud on the FDA or misrepresentation to the FDA in order to recover punitive damages – which. a punitive-damages claim for an FDA-approved drug is allowed under Ohio law only if the FDA has made a finding of either fraud or misrepresentation. punitive damages are not a stand-alone cause of action.) Indeed. To clarify. Plaintiffs’ second angle of attack is to distinguish the Sixth Circuit cases mentioned above. Doc. the plaintiffs in that case were asserting neither a fraud-on-the-FDA claim nor any claim that requires proof of fraud. -23- . In one sentence the Court used the phrase “a state common law fraud-on-the-FDA tort claim. They argue that in those cases the plaintiffs brought claims for fraud on the FDA. # 263.” “claim.
in his deposition testimony. GEHC has filed a motion for partial summary judgment on Plaintiffs’ design-defect claim. Shaffer. Decker. GEHC bases its argument on the opinions of two radiologists: Mr. Dr. 2002). Since punitive damages are no longer part of this case.C. Richard Semelka. (Doc. Dr. the FDA. feasible alternative design that would have prevented the harm. 510 (6th Cir. the Court. GEHC contends that Plaintiffs cannot successfully make out a designdefect claim because they are unable to prove an element: a practical. Phillip Shaffer. no safe alternative to Omniscan exists. GEHC argues that.R. § 2307. #: 89). in stating its conclusion. Dr. The point is clear. VI. Richard Semelka. 506. (emphasis added). Decker’s treating radiologist. wrote that “state tort remedies requiring proof of fraud committed against the FDA” are preempted absent an FDA finding. VII. because no GBCA is safe for renally impaired patients like Mr. Dr. See O. and Plaintiffs’ radiology expert. PageID #: 6795 And at the end of the same paragraph. -24- . punitive damages are unavailable to Plaintiffs.Case: 1:12-gd-50004-DAP Doc #: 162 Filed: 02/13/13 24 of 31. 26 Fed. said he no longer uses GBCAs in his practice on renally impaired patients because the risks outweigh the benefits. or misrepresentation to. who opines that the decision to forego GBCAs altogether in renally impaired patients is consistent with the current standard of care. Appx. the Garcia rule applies to every legal theory – whether the theory is part of a claim or remedy – that requires proof of fraud on. McGrath v. Defendant’s motion to bifurcate punitive damages from liability at trial (Doc#: 105) is DENIED AS MOOT. GMC.75(F). For these reasons. GEHC also quotes the testimony of Plaintiffs’ radiology expert.
Plaintiffs claim. # 121-10). convened a task force to review the safety of Omniscan and other GBCAs. Decker. it is feared. GEHC’s predecessor company. even if there are alternative designs. The task force concluded that macrocyclic GBCAs are both more effective and safer than linear GBCAs. which is significantly less likely to release “free” gadolinium in a patient’s body. Omniscan is an example of a linear contrast agent. is that the manufacturing costs were an order of magnitude higher than the costs associated with Omniscan. are of the macrocyclic variety. In 1989. Prohance and Dotarem. which are used by the healthcare company Bracco. Nycomed. as the relevant Ohio statute requires. renally impaired patients). releasing. none of these designs would have prevented Mr. (See Doc. Because they are less stable. But it is perfectly logical to infer that a macrocyclic GBCA.e. Nycomed even developed and tested – with positive results – a macrocyclic GBCA. would have prevented – or at least slowed the development of – NSF in Mr. Such an inference is premised on Plaintiffs’ free- -25- . The company considered two types of GBCAs that are differentiated on the basis of their molecular structure: linear. linear GBCAs more easily become untethered to the binding agent. or ring-like. “free” gadolinium that can remain in the body of individuals whose kidneys have trouble filtering it out (i. GBCAs and macrocylcic.Case: 1:12-gd-50004-DAP Doc #: 162 Filed: 02/13/13 25 of 31. The task force recognized that macrocyclic structures are safer than linear structures because linear structures are less stable than macrocyclic structures.. Other scientists have likewise concluded that a linear structure is more toxic than a macrocyclic structure. PageID #: 6796 But Plaintiffs have ample evidence that there is now – and was well before Mr. GBCAs. Decker’s NSF. or single-chain. The reason it never made it to market. GEHC responds to this evidence by arguing that. Decker received his MRI scan – safe alternatives to Omniscan.
Drs. Plaintiffs have filed a motion for partial summary judgment on the issues of NSF diagnosis and causation. They contend that Mr. his case-specific experts have opined that he has NSF. 2012 C. is a valid. 1. Decker has NSF and that his Omniscan-enhanced MRI caused it. in which case they recommend a macrocyclic. not a linear.” (See Motion. VIII. he would have been less likely to develop NSF. the Motion (Doc #: 89) is DENIED.” in which the authors acknowledge that GBCAs may be appropriate in some renally impaired patients. GEHC’s case-specific experts. which. Decker’s NSF diagnosis or its cause through either of its two case-specific experts. Drs. 13). More to the point. Ex. Philip Calabrese. relevant theory of what caused Mr. Both experts have explicitly stated that they accept the NSF diagnosis and will not dispute the role of the -26- . GEHC has not sought to contradict either Mr. his physicians have uniformly testified that he has NSF. (Doc # 122-5 at 9.) Furthermore. (Doc #: 75. rather than Omniscan. Decker’s medical records uniformly show that he has NSF. Sica and Weisbord. # 90-2 at 18). one of the radiologists that GEHC cites to support its position undermines it with his statement that if Mr. as we shall see. Decker had received Magnevist. GBCA be used. PageID #: 6797 gadolinium theory. Tisi Letter to J. Decker’s NSF diagnosis. Weisbord and Sica. there is no dispute that Mr.Case: 1:12-gd-50004-DAP Doc #: 162 Filed: 02/13/13 26 of 31. December 3.) According to Plaintiffs. and counsel for GEHC has represented that GEHC “will not call a witness to dispute Mr. will neither dispute that he has NSF nor that the September 2005 Omniscan administration caused his NSF. Decker’s NSF. The issue is clearly one for the jury. GEHC's argument is also called into question by the article “Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy in Advanced Renal Failure. (See Doc. Moreover. Consequently.
“the jury may find that Mr. leading the pathologist to question whether Mr. In its trial brief.) And.” (Id.) It is clear that Plaintiffs have the burden of proving. Decker has NSF – and if that issue is disputed. by a preponderance of the evidence. PageID #: 6798 September 2. based on the Lemy study. it must produce a case-specific expert who has examined the plaintiff and reached the conclusion that the plaintiff does not have NSF. unless GEHC -27- .” (Opp. it is also Plaintiffs’ burden to show that the single dose of Omniscan caused Mr. If GEHC does not present this type of evidence. (emphasis added).) Moreover. With respect to causation.” (Doc #: 149. at 4. GEHC expressly states that it does “not dispute that NSF has created some limitations on Mr. And. Decker’s ability to perform his normal activities of daily living. GE argues that Plaintiffs’ motion on Mr. Decker has some other condition instead of or in addition to NSF. was associated with his development of NSF.” (Doc #: 149. Decker’s NSF diagnosis must be denied because evidence about his diagnosis is relevant to several important issues at trial “and would permit a jury to find that Mr. in its trial brief. Decker does not have NSF. at 4 (emphasis added). Decker has another condition. Decker’s NSF. Decker has ‘a deeper sclerosing process’ that is not NSF. at 4. that Mr. for example. it will not allow GEHC to refute causation. Decker’s September 2005 Omniscan-enhanced MRI.) Nonetheless. 2005 Omniscan exposure had in causing it. at 3 (emphasis added).” (Id. Decker’s clinical presentation does not correlate well with a diagnosis of NSF. Br. “along with other co-factors. GEHC does not dispute that Mr. In other words. the Court has previously ruled that if GEHC disputes a plaintiff’s NSF diagnosis. the Court cannot grant summary judgment on it. “Mr.) While the Court will not grant summary judgment on specific causation.Case: 1:12-gd-50004-DAP Doc #: 162 Filed: 02/13/13 27 of 31. the Court will not allow it to argue that Mr. However.
) According to GE. As noted above. There is no independent disease called “idiopathic NSF” or “gadolinium-naive NSF. because Mr. Decker and Patient 5 in the Lemy study and based upon this analysis and comparison concludes that Mr. The Lemy study is a retrospective study of six kidney transplant recipients at a single institution during an 8-year period who were diagnosed with NSF. GEHC asks the Court to exclude expert testimony that “free” gadolinium caused Paul Decker’s NSF. Decker has chosen not to have his tissue tested for the presence of gadolinium.” There is one disease. X. Decker’s NSF was not caused by his 2005 Omniscan. IX. The Court has reviewed the motion and the related briefs and concludes as follows. Nor should Plaintiffs’ -28- . in him – or that free gadolinium caused his NSF. PageID #: 6799 has an expert who has analyzed Mr. he cannot legitimately say that he has gadolinium. One of the six (Patient 5) seems to have contracted NSF without a known GBCA exposure.Case: 1:12-gd-50004-DAP Doc #: 162 Filed: 02/13/13 28 of 31. It is undisputed that at the very least there is a causal connection between GBCAs and NSF. and it is NSF. Decker’s NSF was not caused by his 2005 Omniscan. (Doc #: 91. Plaintiffs ask the Court to exclude opinions relating to idiopathic or socalled gadolinium-naive NSF (Doc #: 81). On a related note. this fact is not relevant in the Decker trial unless GEHC has an expert who has analyzed both Mr. Five of the patients contracted NSF after exposure to a GBCA. free or otherwise. Decker and Patient 5 in the Lemy study and has determined that the conditions of the two of them are so similar that it is probable that Mr.
or free. and the research of Plaintiffs’ experts relates not only to their review of the literature but to matters growing -29- . in vitro studies. Plaintiffs and their experts can only speculate that free gadolinium is a specific or general cause of Mr. In other words. for denying GEHC’s motion to exclude Plaintiffs’ generic experts from opining that de-chelated. at best. Plaintiffs contend that GEHC’s motion is a thinly-veiled attempt to exclude expert testimony that this Court has already found admissible concerning Omniscan’s propensity to release and deposit gadolinium – the virtually universally acknowledged mechanism by which Omniscan causes NSF – and a concern of which GEHC was aware as far back as the 1980's. the theory has been generally accepted in the relevant scientific and medical community. FED. Decker’s NSF was a result of the release of gadolinium from the unstable Omniscan module. Decker’s NSF. GEHC seeks to strike any evidence that the likely cause of Mr. the theory has been subjected to publication and peer review. The free gadolinium theory passes reliability muster under Daubert because it is based on research conducted by scientists and doctors performing animal studies.) In 2009. EVID. gadolinium causes NSF. Because the epidemiologic evidence does not identify an association between free gadolinium (as opposed to GBCAs) and NSF. Plaintiffs and their experts must rely on general epidemiological evidence that. best articulated in Daubert I. R. In response. Absent evidence that Mr. in vivo studies. the Court summarized why Plaintiffs’ free gadolinium theory passes Daubert and Rule 702 muster: The free gadolinium theory passes the relevancy test because it has a tendency to make the existence of any fact that is of consequence to the determination of the action more probable or less probable than it would be without that evidence. suggests an association between GBCAs and NSF. (See Daubert I at 5-16. 401. This Court need not repeat its detailed reasoning. PageID #: 6800 experts be allowed to testify that free gadolinium is a general cause of NSF on the facts of this case.Case: 1:12-gd-50004-DAP Doc #: 162 Filed: 02/13/13 29 of 31. the Plaintiffs’ experts have adequately accounted for obvious alternative explanations. human clinical studies and retrospective case studies along with review of the relevant published scientific and medical studies. Decker has gadolinium in his body.
transmetalation. as GBCAs are chelated gadolinium.e. at 593-94. at 11. the 2012 American College of Radiology Manual states that “it is now generally accepted that GBCA exposure is a necessary factor in the development of NSF. “[i]f the prevailing hypothesis is true – that the development of NSF is related to the release of gadolinium from the chelates that constitute GBCAs – the differences in number of reported cases may.” (Doc #: 111-7. the fibrotic process leading to NSF. The Court questions how this theory helps GEHC.. R. which goes to weight of the evidence. who opines that chelated gadolinium (i.) Given the relevance and reliability of this theory. GBCA) is less stable than previously thought.S. Among other things. (Daubert I.. and it is more likely that chelated (versus free) gadolinium triggers.”6 (Id. 702 Advisory Committee’s Notes (2000 Amends.) It appears that the passage of time since the Court issued Daubert I has not diminished that theory. EVID. at a cellular level. 6 -30- .) Furthermore. (emphasis added)) The only competing causation theory of which this Court is aware is that of GEHC’s expert and employee. in part. at 66 (emphasis added).Case: 1:12-gd-50004-DAP Doc #: 162 Filed: 02/13/13 30 of 31. But in any event. FED. Dr. Newton. stimulation of microphages and macrophages leading to fibrotic cells present in NSF). there are a few reasonable theories related to characteristics of the gadolinium ion that are commonly considered to cause NSF (e. GEHC’s challenge to that theory. 509 U. is more properly made during cross-examination at trial rather than as a Daubert challenge to admissibility.g. See Daubert. PageID #: 6801 naturally or necessarily out of research they have conducted independent of this litigation. but strengthened it. be explained by differences in chemical properties of different GBCAs. GEHC is entitled to While the precise mechanism is unknown.
PageID #: 6802 present its chelated gadolinium theory/defense. as Plaintiffs are entitled to present their free gadolinium theory. /s/ Dan A. For these reasons. Polster February 13. IT IS SO ORDERED. 2013 Dan Aaron Polster United States District Judge -31- . the Court DENIES GEHC’s motion (Doc #: 91).Case: 1:12-gd-50004-DAP Doc #: 162 Filed: 02/13/13 31 of 31.

References: v. 
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