On February 20, 2013, department stores  J.C. Penney Inc. and Macy’s Inc. faced off in a new arena – a New YorkState courtroom.  The two retailers are going to trial over Martha Stewart.  Macy’s suit accuses J.C. Penney of attempting to convince Martha Stewart to break her company’s exclusive merchandise contract with the department store chain – a contract Macy’s says gives them the exclusive rights to sell certain Martha Stewart products until 2018.  Part of Macy’s lawsuit reads: “J.C. Penney want[s] to rob Macy’s of market share and destroy the competitive advantage that it enjoys as a result of its existing exclusive agreement with (Martha Stewart Living).”

J.C. Penney argues that Macy’s rights to the Martha Stewart merchandise are not nearly as broad as Macy’s claims.  According to J.C. Penney: “Macy’s should stop competing in the courtroom and start competing in the marketplace.”

The move to market the Martha Stewart line is one of several initiatives by J.C. Penney to revive its struggling business.  As part of its new plan, J.C. Penney acquired a 16.6% stake in Martha Stewart’s company in December of 2011, subsequently announcing its plan to open up Martha Stewart ‘mini shops’ in most of its stores.  In response, Macy’s immediately sued J.C. Penney and was granted a preliminary injunction prevent the sale of the Martha Stewart goods at J.C. Penney while the trial played out.

A central issue of the case is whether or not the court agrees that the mini-shops fall under the exclusivity clause of the Macy’s/Stewart agreement.

Macy’s, J.C. Penney go to court over Martha Stewart

As originally posted on February 22 at sportslawinsider.com

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This is a toxic tort case wherein Plaintiff’s experts were excluded under Daubert principles and Defendant’s summary judgment motions for general and specific causation were granted.  The opinion by Hon. Justin Quackenbush (Senior Judge) is an extremely thorough and scholarly analysis that contributes significantly to the body of Daubert case law.

The plaintiff, a tanker truck driver, sued ConocoPhillips and others, claiming that his occupational exposure to gasoline caused a form of cancer, acute myelogenous leukemia (AML).  While the medical and scientific evidence supports the proposition that AML can be caused by exposure to the chemical benzene, the science is more equivocal when it comes to gasoline, which contains benzene as a minor component.  Defendant attacked the scientific methodology employed by plaintiffs’ experts, arguing that the case was a gasoline and not a benzene case, despite the presence of benzene in gasoline.

This case represents a significant victory for the gasoline refining and marketing industry, involving its number one product.  An adverse result would have sent shock waves, and potentially opened the door to a new mass tort wave.  The potential number of persons exposed to gasoline vapors in the workplace and at the pump is huge.  Discouraging those who would seek to connect such exposure to cancer is of major importance to the industry.

Introduction

Plaintiff Neil Henricksen was employed as a tanker truck driver.  His job duties required him to load and unload cargo (typically gasoline and diesel fuel) several times per day over a period of many years.  Defendant operated a petroleum product terminal in Spokane, Washington where Plaintiff loaded his truck.  Plaintiff’s alleged exposure to benzene in gasoline was the basis for his lawsuit against Defendant.  Plaintiff alleged that his acute myelogenous leukemia (AML) was caused by exposure to benzene while loading gasoline at Defendant’s terminal.

Daubert Challenges

To support his case, Plaintiff designated experts from the fields of industrial hygiene, warnings, hematology, epidemiology, and toxicology.  Plaintiff’s causation experts included hematologists (John Caton, Frank Gardner), a toxicologist (William Sawyer), and an epidemiologist (Peter Infante).  Plaintiff’s dose calculation experts included a professional engineer (Marco Kaltofen) and a toxicologist (William Sawyer).  Defendant successfully challenged the methodologies of Plaintiff’s expert witnesses and all five were excluded by the Court.  Henricksen v. ConocoPhillips Co., 605 F.Supp2d 1142 (E.D. Wash., February 11, 2009).

Frank Gardner, MD

The causation opinion of Plaintiff’s expert in hematology (“Gardner”) was excluded for three methodological reasons.  First, Gardner’s general causation opinion (gasoline exposure causes AML) was excluded because he could not “point to any source which reliably supports his conclusion.”  Id. at 1161.  As the Court noted, this methodological flaw “renders his opinion merely [a] personal opinion.”  Id.

Second, Gardner’s specific causation opinion was excluded because he neither attempted to calculate his own dose assessment for Plaintiff nor relied on the dose assessment of any other expert.  Id. at 1162.  In short, while agreeing that benzene-induced AML is a dose-dependent phenomenon, Gardner opined on specific causation without a dose.  Id.  As the Court explained, “this renders his opinion on specific causation inherently unreliable.”  Id.

Finally, Gardner’s specific causation opinion was excluded because he did not “reliably rule out reasonable alternative causes of [the alleged harm] or idiopathic causes.”  Id. (citing Soldo v. Sandoz Pharmaceuticals Corp., 244 F.Supp.2d 434, 567 (W.D. Pa. 2003)).  As the Court made clear, “the presence of a known risk factor is not a sufficient basis for ruling out idiopathic origin in a particular case, particularly where most cases of the disease have no known cause.”  Id.  The Court paid careful attention to the presentation of Plaintiff’s disease and described ways in which Plaintiff’s presentation could have been compared to individuals with and without benzene-induced AML.  Id. at 1162-63.  Garder performed no such analysis.

John Caton, MD

John Caton, one of Plaintiff’s treating physicians, opined that Plaintiff’s occupational exposure to gasoline caused his AML.  Although the Court struck Caton on procedural grounds, it noted that Caton’s opinions would have not have withstood Daubert scrutiny.  Id. at 1160.  Caton’s main methodological flaw was that he failed to consult the relevant literature before offering an opinion on causation.  Id.

William Sawyer, PhD

Dr. William Sawyer provided both causation opinions and a retrospective dose calculation for Plaintiff.  Neither opinion survived Daubert scrutiny because, as the Court noted, “At each step of his analysis, Sawyer bases his analysis upon speculation and/or erroneous data, and without adequate explanation, these steps render his methodology unreliable and misleading, and his opinions are therefore inadmissible.”  Id. at 1163.

Dr. Saywer’s causation opinion was rejected for one principal reason: he embraced the “no safe level” model for carcinogenicity.  Citing to numerous district court and appellate court opinions, as well as to the Federal Judicial Center Reference Manual on Scientific Evidence (2d ed. 2000), the Court recognized that the “no safe level” theory is: (1) a hypothesis that cannot be tested, verified, or falsified, (2) has been rejected by a majority of the scientific community, and (3) has no known potential rate of error.  Id. at 1166.  About Sawyer’s theory, the Court wrote:

“Sawyer's theory that any amount of exposure more than negligible should be considered substantial risk factor for AML flies in the face of the scientific literature reviewed and other expert testimony in this case that there is a threshold or dose below which you do not see a statistically significant risk of developing AML. Even though benzene has been shown to cause AML, it is too difficult a leap to allow testimony that says any amount of exposure (above the short term exposure limits) to this toxin can cause AML and caused AML in Henricksen.

Because Sawyer's dose calculation is unreliable and his belief that low-dose exposure to benzene as a component of gasoline is capable of causing AML a hypothesis rather than science sufficiently reliable for causation purposes, it is fails the Daubert factors.”

Id. at 1166.

Sawyer’s dose calculation did not survive for three reasons: (1) he cherry-picked a non-representative study from which to base his overall calculation, (2) he cherry-picked an exposure value (and the less reliable value) from within that study, and (3) his calculation was full of factual errors.  Id. at 1164-65.

If Dr. Sawyer had relied on published industrial hygiene data describing the exposure of U.S. tanker-truck drivers (like Plaintiff), the remainder of his errors may have gone unreported.  Instead, Sawyer relied on a small and obscure Japanese study with an unknown work environment, and without explaining the scientific reason for doing so.  Id. at 1164.  As the Court noted: “While Rule 702 does not require an expert to find a study linking the exact facts, it does require the expert [to] demonstrate a scientifically valid basis for projecting the findings of a study to the proffered casual theory. Sawyer has not provided an adequate basis for reliably linking the values derived from the circumstances of [the Japanese study] to the circumstances of Henricksen's case.”  Id. at 1164-65

Marco Kaltofen, PE

Marco Kaltofen also attempted to perform a retrospective benzene dose calculation.  Had Mr. Kaltofen relied on the reported data describing exposure among U.S. tanker truck drivers, his methodology may have survived.  Instead, Kaltofen relied on a Swedish study, made an assumption from that study which the authors never reported, and then applied his assumption to Plaintiff’s work environment without any support in the literature for doing so.  Id. at 1167.  The Court noted that Kaltofen’s assumption (“the five times multiplier”) had never been tested, recognized by an expert in the field, or reported in the literature.  Id.  Other factors weighing against admissibility were that Kaltofen’s methodology was crafted for purposes of rendering an opinion in this case, and that it was subject to a wide rate of error.  Id. at 1168.  The Court concluded:

“Kaltofen's methodology in arriving at the multiplier of 5 shows a lack of scientific rigor in that he expands the application of [the Swedish study] beyond good science, drawing conclusions the authors of the study did not make from limited data. It is this kind of scientifically unsupported “leap of faith” which is condemned by Daubert.”

Id. at 1168.

Peter Infante, PhD

Dr. Infante’s general causation opinion (gasoline exposure causes AML in humans) and specific causation opinion (low-dose benzene exposure from gasoline caused Plaintiff’s AML) were excluded because the studies advanced for those propositions did not support them.  In both instances the Court noted that there was simply “too great an analytical gap between the data and the opinion proferred.”  Id. at 1168, 1170.  Infante’s specific causation opinion was also struck because he relied on Marco Kaltofen’s unreliable dose assessment.  Id. at 1176.

Summary Judgment

Defendant moved for summary judgment on the grounds of general causation and specific causation.  Having excluded Plaintiff’s causation experts because the literature they relied upon did not support their opinions, Plaintiff could not meet his summary judgment burden:

None of the studies relied upon have concluded that gasoline has the same toxic effect as benzene, and none have concluded that the benzene component of gasoline is capable of causing AML. The studies relied upon by Plaintiffs make clear that the connection between gasoline or the benzene component of gasoline and AML is at this point in time only a hypothesis in need of further investigation. Based upon the court's review of these studies Plaintiffs' experts can only reliably attest to gasoline exposure as a theoretical or possible cause, not a probable cause of Henricksen's AML

Id. at 1176.

Without reliable evidence of general causation, Plaintiffs' experts can not analyze specific causation while comporting with the scientific method. However, even if the court were to admit the testimony that gasoline is generally capable of causing AML, these studies do not support the conclusion that exposure at 8 ppm-years is capable of causing AML.

Id. at 1176.

Conclusion

Henricksen v. ConocoPhillips Co. is an important opinion for two reasons.  First, it is a landmark opinion concerning the non-carcinogenicity of gasoline.  The scientific “evidence” put forward by Plaintiff to support his claim, and the experts hired to advocate for Plaintiff’s position, were scientifically and legally inadequate to survive a summary judgment challenge.  Second, the opinion provides practitioners with thorough and well-reasoned application of Daubert principles to a variety of expert methodologies.

July 2009

Brett J. Young
Senior Associate
Fulbright & Jaworski L.L.P.
1301 McKinney Suite 5100
Houston, Texas 77010-3095
(713) 651-5200 direct
(713) 651-5246 facsimile
byoung@fulbright.com

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Categories: Daubert | Expert Witnessess | Toxic Tort

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This summer the Corporate Counsel Committee will celebrate its one-year anniversary. In the first year, the committee expanded from 17 die-hard founding members to over 80 members strong—and those numbers will continue to grow.

The Corporate Counsel Committee provides in-house counsel a forum within DRI to address the unique needs of corporate legal departments. Membership is limited to in-house counsel and focuses on topics that are distinctive to the in-house practice. “In-house to in-house” is the committee’s core principle.

For 2009, one of our main goals is to continue to get the word out about our new committee and to increase our membership. To achieve this goal we have a number of membership initiatives planned and we are reaching out to all DRI members for help.

Initiative #1—DRI Corporate Counsel Recruitment

DRI has close to 400 in-house counsel members who we will personally reach out to and encourage to join the committee. Being a Corporate Counsel Committee member means being able enjoy a number of benefits, including in-house-only programming at select seminars and the DRI Annual Meeting; access to a restricted section of the committee webpage, including a list serve for corporate counsel committee members to share questions and ideas; roundtable conference calls about topics unique to in-house counsel; networking opportunities with other in-house counsel in a protected environment; and the opportunity to hold counsel me tings (formerly known as panel counsel meetings) at DRI seminars and meetings. The committee also provides in-house counsel with professional development opportunities, including committee leadership positions; publishing opportunities; and speaking opportunities at DRI programs.

For in-house counsel who are DRI members and would like to become a member of the Corporate Counsel Committee, you can sign up through DRI’s website or you can contact Lynn Conneen, DRI Director of Committees,at lconneen@dri.org.

Initiative #2—Non-DRI Corporate Counsel Recruitment

Our committee’s second membership initiative is to reach out and recruit corporate counsel who are not DRI members. The membership committee will take the first step in this initiative and contact all the in-house counsel who have participated in DRI seminars and meetings in the past, and inform them of all the benefits that membership has to offer. The next step is to reach beyond those who know about DRI. This is where we could use the help of all DRI members. If you have in-house clients or contacts, we encourage you to reach out to them. This is the perfect excuse for you to reconnect with your clients or in-house contacts and to tell them about all the great benefits that DRI and, more specifically, the Corporate Counsel Committee have to offer.

A great selling point is the two-tiered corporate counsel membership. In-house counsel can join for only $225 a year or they can take advantage of the group rate and receive up to four individual memberships for only $500. Each additional corporate individual membership is only $150. And all first-time corporate members listed on the initial membership application will receive a free certificate to attend a DRI seminar.

To help with your efforts, DRI developed a corporate counsel membership brochure that explains how to join, the rates and the benefits of membership. DRI can either send you the brochures to send out to your clients and contacts, or the Corporate Counsel Membership Subcommittee can reach out to them for you if you provide us their contact information. If you would like us to reach out, please contact Lynn Conneen at DRI (lconneen@dri.org) and she will coordinate that effort.

Initiative #3—Seminar/Committee Outreach

The Corporate Counsel Membership subcommittee will be contacting all program and committee chairs prior to each seminar to let them know about the committee and to ask them to make, or to allow one of our committee members in attendance to make, an announcement about the committee at the seminar and at their committee meetings.

The key with all these initiatives is to get the word out about this new and exciting committee. We appreciate all your help and look forward to a long and successful partnership with DRI and all its committees.

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Categories: Corporate Counsel | Daubert

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How experts misuse scientific literature:

A critical element of Daubert, specifically stated, is that scientific literature used by experts to support their opinions must be relevant (or, fit) the situation extant in the case. Frequently, experts provide such “support” with long bibliographic lists or stacks of authoritative-seeming articles from scientific journals. This sheer mass of material ostensibly supports your opponent’s opinion. The list may be impressive and daunting. When we do relevance checks, however, we commonly find that many of those citations are irrelevant because they fail to support either general or specific causation in the case at hand. Some of the reasons they fail include:

• Conclusions drawn from animal, not human, studies;
• The quantitative doses or exposure levels in the literature are not comparable to the levels in the case;
• The literature cites the wrong disease;
• The published regulatory data are not applicable to a specific individual;
• The latency period in the literature is inconsistent with the matter;
• The clinical course of treatment in the matter is different; and
• There are many other possibilities as well.

Here’s a simple, non-scientific, example. Assume a man died after being hit by a truck. The operator of the truck was accused of contributing to the death. Plenty of research could be produced to support the proposition that trucks can kill. But wait! This was a child playing with a toy Tonka truck. Clearly, his toy truck could not have been responsible. Thus, all of the vast evidence that trucks can kill is irrelevant in this case. It is often equally irrelevant in cases involving allegations of chemically-induced injuries. However, in these latter cases, the lack of relevance is less apparent to the non-scientist.

Don’t be intimidated by a long reference list or a box of literature.

In a case currently pending before a State Supreme Court, the claimant’s attorney, attempting to salvage her disqualified expert, argued that her expert used a “ weight of evidence approach”. In that matter, she intended “weight” to mean “fully considered” What it actually meant was numbers of pounds. The hundreds of articles weighed a great deal, but they were, in totality or individually, inadequate to support the claim. Most were irrelevant.

On almost any medical or scientific subject, it is possible for an expert to produce dozens, if not hundreds, of articles which are offered to support his/her position. Some may be right on point. Often, many are extraneous or irrelevant, even when they have the name of the chemical, or of the disease, in the title itself. They are simply provided to bolster a poorly-supported position. Attorneys may do the same thing when they compare the facts of their case to a prior precedent, but there are differences. First, the number of legal citations offered is generally less. Second, because they are being used by lawyers to bolster legal arguments against other lawyers’ positions, a critical analysis and response is anticipated. Thus, while the citations may not be directly on point, they either come close, or are readily disputed by opposing counsel. By contrast, attorneys and the Court are in no position, without help, to dissect the hundreds of impressive scientific papers when assessing their relevance. Because of these circumstances, medical and scientific experts are better positioned to mislead.

Case Example

Under Daubert, supporting literature must be “relevant” or “fit” the circumstances at issue, but there are many reasons why imposing stacks of articles may fail the relevancy test. For example:

In certain situations the chemical is known to cause the disease at issue as is the case with Benzene and Leukemia.

Certain relatively high levels of occupational exposures to benzene are clearly connected to a specific form of leukemia: AML (acute myelogenous leukemia). AML is not a terribly rare disease and can arise with no known cause. In fact, most do. It is common for patients who develop leukemia to be asked about “chemical exposures” Some may have worked with or around some chemicals that contain either benzene or other chemicals that contain the name “benzene.” This finding alone may then generate either a workers’ compensation claim, or a liability claim alleging that “benzene” in the workplace caused the leukemia.

A voluminous stack of articles dealing with all aspects of benzene and leukemia accompanied by MSDS’s (the manufacturer’s material safety data sheets--the product information sheets) of chemicals at the workplace containing the word “benzene” will be put forth to support the claim. A closer look at those information sheets, a relevance check, commonly finds them to be irrelevant. Why? Many chemicals which are not benzene contain the name benzene, for example, ethyl benzene, methyl benzene, dichlorobenzene, and many others. These do not cause leukemia. Also, all chemicals derived from petroleum, including paints, paint thinners, and even furniture polish, contain low levels of residual benzene (0.1 % or less). Certain levels, albeit very low, require them to have “benzene” on the label. Exposures to these products containing small amounts of benzene are not connected to leukemias. Again, these MSDS’s may appear persuasive, but they are irrelevant.

Performing a relevancy check

When your experts perform a relevancy check of opposing experts’ literature, they must examine a number of critical questions:

1. Are the studies sufficiently robust and replicated to support a general causation argument?
2. Do the studies establish the potential for the types of clinical effects alleged in the claim? Or, for example, do they investigate subtle biochemical changes which, at present, have no direct clinical applicability?
3. How much effect do the studies show? For example, if a risk is increased by 5%, it is rarely possible to use such studies to allege specific causation in an individual.
4. Were the studies performed in human beings under circumstances similar to those at issue in the case? Agents injected into a mouse’s abdomen are not the same as lower-level materials inhaled by people.
5. What doses were used or observed in those studies? Occupational exposures to a chemical are rarely equivalent or directly applicable to low-level consumer product exposures.

These are just a few of the numerous types of relevancy issues with which we deal daily in our causation analyses. The simple take away message is that daunting lists or piles of scientific and medical articles may be worrisome to attorneys, but they are meaningless to a claim, if they are irrelevant to the specific facts of the case.

Ronald E. Gots, M.D., Ph.D.
International Center for Toxinology and Medicine
Member of the NMAS group
www.ictm.com

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Categories: Daubert | Expert Witnessess

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Beware of the Expert Too Willing To Please

Posted on January 16, 2009 10:33 by Patrick J. Kenny

Everyone hopes to have some ability to influence their expert witnesses.  Some attorneys try to control their experts by engaging in the risky approach of only providing them limited information. Others exert  more subtle influence through their assistance in the preparation of their expert’s report.  Of course, most expert witnesses are professionals in their own right and are not subject to a great deal of influence. That is just as well given the very real possibility that any influence exerted by counsel over an expert will be discovered by and put to effective use by the other side.  Where counsel loses sight of those risks, and an expert is too willing to please, disaster can ensue – as plaintiffs’ counsel learned in Manez v. Bridgestone Firestone North American Tire, LLC, 533 F.3d 578 (7th Cir. 2008).

The plaintiffs in Manez were the family of a Mexican citizen who was killed in Veracruz, Mexico after a tire installed on his Ford Explorer exploded.  Id. at 582.  Originally the district court had granted a motion to dismiss under the doctrine of forum non conveniens on the ground that a forum in Mexico would be available and more appropriate for the litigation.  The plaintiffs appealed that ruling.  On appeal the plaintiffs submitted documents indicating that they had filed suit in a Mexican court and that the case had been dismissed on the grounds that the court “did not have jurisdiction over the case.”  Id.  They argued to the United States Circuit Court for the Seventh Circuit that the dismissal of the lawsuit in Mexico demonstrated conclusively that the courts in Mexico were not available to hear the case and thus the dismissal for forum non conveniens was improper.  The defendants, however, raised serious questions regarding the documents related to the lawsuit in Mexico.  The appellate court therefore remanded the case to the district court for further consideration. 
Upon remand the district court held an evidentiary hearing.  Ultimately that court concluded that the dismissal in Mexico “had indeed been procured in bad faith and thus was not subject to recognition.”  Id. at 582.  It therefore reaffirmed its earlier dismissal on the ground of forum non conveniens.  The defendants then moved for sanctions against the plaintiffs’ U.S. and Mexican lawyers.

As it turns out, the plaintiffs originally had hired a Mexican attorney, Dr. Pereznieto, to serve as an expert witness with respect to questions of Mexican law in the case.  After the district court in the United States had dismissed the plaintiffs’ case the first time based on forum non conveniens, and while that dismissal was on appeal, the plaintiffs also hired Dr. Pereznieto in a second capacity – to file the Mexican lawsuit and “insure that the judge would ‘throw out the suit according to what we planned.’”  Id. at 584-85.  Dr. Pereznieto accomplished that task.  Id. at 584.  Meanwhile, Dr. Pereznieto submitted an “expert affidavit” to the Seventh Circuit in support of the plaintiffs’ arguments seeking to overturn the first forum non conveniens ruling.  That affidavit did not reveal that Dr. Pereznieto was representing the plaintiffs in their Mexican lawsuit, much less that he had been hired with the goal of making sure the Mexican lawsuit was thrown out. 

After the Seventh Circuit remanded the case to the district court for further consideration of the first forum non conveniens ruling, approximately a year of discovery ensued during which the above facts were revealed.  Unsurprisingly, once it became aware of the above facts, the district court was very receptive to the defendants’ motion for sanctions. 

The district court sanctioned the plaintiffs’ U.S. attorneys $50,000 and ordered that those funds be divided among the defendants in any way that they thought was appropriate.  Id. at 582. 

In addition, the district court sanctioned Dr. Pereznieto personally in the amount of $100,000, half of which was payable to the defendants and the other half which was payable to the clerk of the court.  The district court also barred Dr. Pereznieto from providing any testimony against any defendant in the case in any U.S. court until the monetary sanction was paid in full.  The court also held that for purposes of resolving any “remaining cases in this multidistrict litigation, any and all sworn assertions reflecting the views or opinions of Leonel Pereznieto, whether made by him directly or indirectly, shall be stricken and we shall not consider as authority cases where his testimony whether oral or written was relied upon as justification for the court’s opinion.”  Id. at 583. 
 
In the end, the appellate court reversed the sanction against Dr. Pereznieto (albeit without prejudice), due in part to deficiencies with respect to the notice he had been given before the sanctions were imposed.  Nevertheless, after reading the sordid facts that led to the sanctions one wonders if the plaintiffs’ U.S. attorneys would not have preferred an expert who was a little more difficult to work with.  Indeed, although Dr. Pereznieto eventually might be able to avoid some of the sanctions imposed on him personally, the plaintiffs’ U.S. attorneys had no such luck – and did not appeal from the $50,000 sanction imposed on them. 

As always, if you have any thoughts, questions, comments or suggestions on this topic or for making this a more useful resource, please feel free to contact me directly.
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