Silverman, et al v. Watson Pharmaceuticals, Inc., et al
Filing
116
MEMORANDUM OPINION AND ORDER DENYING 70 MOTION to Exclude Opinions of Plaintiffs' Experts on General and Specific Causation and MOTION for Summary Judgment.(Signed by Judge Gray H. Miller) Parties notified.(rkonieczny)
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF TEXAS
HOUSTON DIVISION
BAILEY SILVERMAN , et al.,
Plaintiffs,
v.
WATSON PHARMACEUTICALS, INC., et al.,
Defendants.
§
§
§
§
§
§
§
§
§
CIVIL ACTION H-10-1952
M EMORANDUM O PINION & O RDER
Pending before the court is defendant Capsugel, Inc.’s motion to exclude the opinions of
plaintiffs’ experts on general and specific causation and for summary judgment. Dkt. 70. Upon
consideration of the motion, the response, the reply, oral argument presented by counsel, and the
applicable law, the motion is DENIED.
BACKGROUND
In September 2008 Bailey Silverman switched her blood pressure medication to the generic
version, called Taztia XT, manufactured by defendants Watson Pharmaceuticals, Inc. and Watson
Pharma, Inc. (collectively the “Watson defendants”) using hard gelatin capsules made by defendant
Capsulgel. Dkt. 70. She began to suffer symptoms such as difficulty walking, fatigue, muscle
weakness, and a metallic taste in her mouth. Dkt. 93. Her symptoms worsened and in December
2008 she went to the emergency room. Id. She was treated by Dr. Fleming, a neurologist. Dkt. 70.
He could not determine the cause of her problems but thought she might be having a stroke, or Bell’s
Palsy. Id. However, tests showed elevated levels of arsenic in her urine. Id. Dr. Fleming performed
other tests and determined that she was suffering distal polyneuropathy. Dkt. 93. Dr. Fleming
treated her with steroids with no success. Id. Mrs. Silverman’s husband, Dr. Louis Silverman, a
thoracic surgeon, began to suspect that the elevated arsenic in her urine might be the cause. Id. So,
when her symptoms worsened again, he spoke with Dr. Joseph Varon—a neurologist well versed
in the area of arsenic poisoning. Id.
Upon Dr. Varon’s advice, Mrs. Silverman was hospitalized in January 2009. Dr. Varon
suspected she was suffering from arsenic poisoning. Dkt. 70, Ex. A-1. He brought in Dr. Vincent
Virgadamo to assist in treating Mrs. Silverman. Id. Dr. Varon ran tests that ruled out other possible
causes of her symptoms. Id. Believing that her condition was life-threatening, Dr. Varon began
treating her with chelation therapy. Id. Chelation therapy is itself life threatening but is the only
known cure for arsenic poisoning. Id. She survived the painful two-week course and the levels of
arsenic in her system dropped to normal. Dkt. 93, Ex. F. However, she continues to suffer after
effects of the poisoning. Id. She has peripheral neuropathy, joint pain, numbness, fatigue, and
difficulty performing tasks requiring fine motor skills. Id.
At the same time that Mrs. Silverman began treatment with Dr. Varon, she discontinued
taking the Taztia XT. Id. Dr. Silverman filed a complaint with the FDA reporting that Mrs.
Silverman had suffered degeneration of her body from taking one of her medications. Dkt. 70, Ex.
A-3. The FDA collected samples from the Walgreen’s pharmacy the Silvermans used but could not
determine the specific drug lot used by Mrs. Silverman. Id. at A-8. Dr. Silverman sent 44 Taztia
XT capsules to the FDA for testing. Id. Additionally, Dr. Silverman sent samples of the Taztia XT
to Kappa Laboratories, Inc. for testing. Dkt. 93. Kappa sent the pills to an affiliate, Advanced
Environmental Laboraties (“AEL”).
Id.
Plaintiffs retained Dr. Ernest Lykissa—a forensic
toxicologist—to testify regarding the results of the lab test results and Mrs. Silverman’s condition.
Dkt. 70, Ex A-10.
2
Capsugel now moves the court to exclude the expert testimony of Dr. Varon and Dr. Lykissa
and to grant summary judgment for defendants because plaintiffs fail to present an issue of fact
regarding causation.
I.
Motion to Exclude
Capsugel moves to exclude the causation testimony of plaintiffs’ experts—Dr. Joseph Varon,
and Dr. Ernest Lykissa. As a threshold matter, Capsugel asks the court to conflate federal procedural
law governing the admissibility of expert testimony with Texas substantive law regarding the levels
of proof required to demonstrate causation in a toxic tort case. And perhaps the legal sufficiency
question could be considered part of the relevance prong of Daubert. However, while there is dicta
from the Fifth Circuit suggesting that the Daubert inquiry and scientific sufficiency under Texas law
are coterminous, no consensus exists. Wells v. SmithKline Beecham Corp., 601 F.3d 375, 381 (5th
Cir. 2010). Therefore, the court will address Capsugel’s legal sufficiency arguments through the
vehicle of the motion for summary judgment rather than on a motion to exclude. And, since all of
Capsugel’s arguments under this heading go to the subject of legal sufficiency, the motion to exclude
is denied.
II.
Motion for Summary Judgment
Capsugel moves for summary judgment arguing that plaintiffs have failed to meet the
standards under Texas law for general and specific causation.
A.
Legal Standard
A motion for summary judgment shall be granted “if the movant shows that there is no
genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.”
FED . R. CIV . P. 56(a); see also Carrizales v. State Farm Lloyds, 518 F.3d 343, 345 (5th Cir. 2008).
A fact issue is “material” if its resolution could affect the outcome of the action. Burrell v. Dr.
3
Pepper/Seven Up Bottling Group, Inc., 482 F.3d 408, 411 (5th Cir. 2007). “[A]nd a fact is genuinely
in dispute only if a reasonable jury could return a verdict for the [nonmovant].” Fordoche, Inc. v.
Texaco, Inc., 463 F.3d 388, 392 (5th Cir. 2006). Ultimately, “[w]here the record taken as a whole
could not lead a rational trier of fact to find for the [nonmovant], there is no ‘genuine issue for trial.’”
Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587, 106 S. Ct. 1348 (1986).
When the movant bears the burden of proof on an issue, he must establish beyond
peradventure all of the essential elements of the claims or defenses to warrant judgment in his favor.
Fontenot v. Upjohn Co., 780 F.2d 1190, 1194 (5th Cir. 1986) (emphasis in original). But when the
movant does not bear the burden of proof on a claim or affirmative defense, he bears the initial
burden of production to show an absence of evidence to support the non-movant’s claim. TIG Ins.
Co. v. Sedgwick James, 276 F.3d 754, 759 (5th Cir. 2002). If the movant makes this showing, the
ultimate burden to avoid summary judgment shifts to the non-movant who “must go beyond the
pleadings and come forward with specific facts indicating a genuine issue for trial.” Davis-Lynch,
Inc., v. Moreno, 667 F.3d 539, 550 (5th 2012). Conclusory allegations and denials, speculation,
improbable inferences, unsubstantiated assertions, and legalistic argumentation are no substitute for
specific facts showing a genuine dispute for trial. TIG Ins. Co., 276 F.3d at 759.
B.
Analysis
1.
Toxic Tort Causation
Capsugel argues that in order to survive summary judgment, the plaintiffs must meet their
burden to show causation pursuant to Texas laws regarding toxic torts. Under Texas law, “causation
in toxic tort cases is discussed in terms of general and specific causation.” Merrell Dow Pharms.,
Inc. v. Havner, 953 S.W.2d 706, 714 (Tex. 1997). “General causation is whether a substance is
4
capable of causing a particular injury or condition in the general population, while specific causation
is whether a substance caused a particular individual's injury.” Id.
Capsugel argues that plaintiffs cannot show general causation because the Texas Supreme
Court has held that for an epidemiological study to support general causation, it must show a
doubling of the risk. Dkt. 70 (citing Havner, 953 S.W. 2d at 720–21). Plaintiffs do not directly
address Capsugel’s general causation argument, arguing instead that it is almost axiomatic that
exposure to arsenic would cause arsenic poisoning.
Capsugel next argues that plaintiffs cannot show specific causation because their experts do
not model the dose of arsenic that Mrs. Silverman received. Capsugel argued at the hearing before
the court that Borg-Warner Corporation v. Flores, 232 S.W.3d 765 (Tex. 2007) controls in this
matter. In that case, Flores—a brake mechanic, who repaired brakes for 35 years brought suit against
Borg-Warner, among others, for his alleged asbestosis. Id. at 766. Flores was able to demonstrate
that grinding brakes created dust that he inhaled. Id. He also could show that in certain instances
inhaling asbestos can cause asbestosis. Id. at 766–67. Additionally, there was no argument that the
brakes manufactured by Borg-Warner contained asbestos. Id. at 766. Flores knew approximately
how many brake pads he ground that were manufactured by Borg-Warner during the time period in
question. Id. And, he knew the range of asbestos contained in each pad. Id. The Texas Supreme
Court reversed the trial and appellate courts, saying:
This record, however, reveals nothing about how much asbestos Flores might have
inhaled. He performed about fifteen to twenty brake jobs a week for over thirty years,
and was therefore exposed to “some asbestos” on a fairly regular basis for an
extended period of time. Nevertheless, absent any evidence of dose, the jury could
not evaluate the quantity of respirable asbestos to which Flores might have been
exposed or whether those amounts were sufficient to cause asbestosis. Nor did Flores
introduce evidence regarding what percentage of that indeterminate amount may have
originated in Borg–Warner products. We do not know the asbestos content of other
brands of brake pads or how much of Flores's exposure came from grinding new pads
5
as opposed to blowing out old ones. There were no epidemiological studies showing
that brake mechanics face at least a doubled risk of asbestosis. . . . Thus, while some
respirable fibers may be released upon grinding some brake pads, the sparse record
here contains no evidence of the approximate quantum of Borg–Warner fibers to
which Flores was exposed, and whether this sufficiently contributed to the aggregate
dose of asbestos Flores inhaled, such that it could be considered a substantial factor
in causing his asbestosis.
Id. at 771–72 (internal citations omitted). Although the Court recognized the difficulties in proving
asbestos claims and stated that causation “need not be reduced to mathematical precision,” it still
required a plaintiff to show “the approximate dose to which the plaintiff was exposed, coupled with
evidence that the dose was a substantial factor in causing the asbestos-related disease.” Id. at 773.
Capsugel concludes that based on Borg-Warner all toxic tort cases in Texas must show dosage
calculations to support causation.
Plaintiffs counter that Borg-Warner clearly sets the standard for asbestos causation, but not
causation for all product liability cases. Additionally, they argue that because their expert testimony
is based on a differential diagnosis,1 they do not need dose models. For this proposition, they rely
heavily on Johnson v. Arkema, Inc., 685 F.3d 452 (5th Cir. 2012) (interpreting Texas law). In
Johnson the plaintiff was exposed in two separate incidents to Monobutylin Trichloride (MBTC) and
Hydrochloric acid (HCl) when defendant’s specialized hood designed to vacuum up fumes
malfunctioned. Id. at 457. After the second incident, he was taken to the emergency room and
diagnosed with chemical pneumonitis. Id. Much later he was diagnosed with restrictive lung disease
and pulmonary fibrosis, which he alleged were also attributable to his exposure to MBTC and HCl..
1
“‘A reliable differential diagnosis typically, though not invariably, is performed after physical examinations,
the taking of medical histories, and the review of clinical tests, including laboratory tests, and generally is accomplished
by determining the possible causes for the patient's symptoms and then eliminating each of these potential causes until
reaching one that cannot be ruled out or determining which of those that cannot be excluded is the most likely.’” Johnson
v. Arkema, Inc., 685 F.3d 452, 468 (5th Cir. 2012) (quoting Westberry v. Gislaved Gummi AB, 178 F.3d 257, 262 (4th
Cir.1999)) (internal quotation marks omitted).
6
Id. The district court excluded the plaintiff’s two experts on causation. The first expert opined that
MBTC and HCl can cause restrictive lung disease and pulmonary fibrosis because the chemicals
were part of a class of chemicals that are respiratory irritants. Id. at 460. And since other members
of the class are known to cause lung injury, the expert inferred that MBTC and HCl also cause lung
injury. Id. The Fifth Circuit found that the district court had not abused its discretion when it
excluded the first expert because
save for highlighting their shared classifications as irritants, [the expert] did not
attempt to explain any direct correlation or “fit” between [MBTC and HCl] and the
known scientific data concerning exposure to, for example, chlorine, ammonia, or
nitric acid vapor. Accordingly, given the diverse chemical structures and toxicities
of irritants, . . . we hold that the district court did not abuse its discretion in
concluding that [the expert]'s “class of chemicals” theory presented “too great an
analytical gap between the data and the opinion proffered.”
Id. at 462 (citing Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146, 118 S. Ct. 512 (1997)).
The Fifth Circuit treated the second expert differently, noting that the expert had conducted
a differential diagnosis. Id. at 467–68. The Court went on to explain that a properly supported
differential diagnosis could, in some circumstances, constitute evidence of specific causation. Id.
at 468. However, in Johnson, the Court found that because the plaintiff’s first expert had failed to
prove general causation, the second expert’s opinion must also fail. Id. at 469 ( “Thus, before courts
can admit an expert’s differential diagnosis, which, by its nature, only addresses the issue of specific
causation, the expert must first demonstrate that the chemical at issue is actually capable of harming
individuals in the general population, thereby satisfying the general causation standard.”). Plaintiffs
contend that because the Court did not require a dosage calculation in Johnson, the Borg-Warner
case is not the blanket rule on causation that defendants urge.
The problem with the parties’ arguments on this issue is their characterization of the case as
a toxic tort case. The plaintiffs did not plead a toxic tort case. They pled a strict liability
7
manufacturing defect case. The court does not dispute that courts will sometimes conflate the two,
however, as is highlighted in this case, the distinction can be an important one.
A toxic tort is defined as “[a] civil wrong arising from exposure to a toxic substance, such
as asbestos, radiation, or hazardous waste.” BLACK’S LAW DICTIONARY 1627 (9th ed. 2009). In
Borg-Warner and other asbestos exposure cases, there is no allegation that the brake pads were
anything other than what the manufacturer intended. The alleged asbestos exposure and resulting
injuries are unintended consequences of the product. Some pharmaceuticals arguably fall into this
profile if the suit revolves around unintended side-effects of an FDA approved and properly
manufactured drug. See Merck & Co. v. Ernst, 296 S.W.3d 81 (Tex.App.–Houston [14th Dist.]
2009, pet. denied. And, in these cases, dosage models are reasonably easy to perform since the
product specifications are known. But in this case, the product allegedly did not comport with the
manufacturer’s standards. For the reasons described below, that puts it in the ambit of Texas law
on manufacturing defects, not toxic torts.
2.
Manufacturing Defect Causation
In a manufacturing defect case, the product at issue “deviates, in its construction or quality,
from the specifications or planned output in a manner that renders it unreasonably dangerous.” Ford
Motor Co. v. Ridgway, 135 S.W.3d 598, 600 (Tex. 2004). In order to meet its burden in a
manufacturing defect case, “[a] plaintiff must prove that the product was defective when it left the
hands of the manufacturer and that the defect was a producing cause of the plaintiff's injuries.” Id.
A specific defect “must be identified by competent evidence and other possible causes ruled out.”
Ford Motor Co. v. Ledesma, 242 S.W.3d 32, 42 (Tex. 2007). The Texas Supreme Court defines
“producing cause as being a substantial factor in bringing about an injury, and without which the
injury would not have occurred.” Id. at 46.
8
“Both direct and circumstantial evidence may be used to establish any material fact.”
Ridgway, 135 S.W.3d at 601. Circumstantial proof of a defect is often the only evidence available
to a plaintiff. Turner v. Gen. Motors Corp., 584 S.W.2d 844, 848 (Tex. 1979). However, “[t]he
inference of defect may not be drawn . . . from the mere fact of a product-related accident.”
Ridgway, 135 S.W.3d at 602. Instead, “[f]or circumstantial evidence to support an inference that the
product was defective, it must provide a reasonable basis for concluding the injury would not
ordinarily have occurred absent a defect.” Shaun T. Mian Corp. v. Hewlett-Packard Co., 237
S.W.3d 851, 862–63 (Tex.App.–Dallas, 2007, pet. denied) (emphasis added) (citing Ridgway, 135
S.W.3d at 604 (Hecht, J., concurring)).
The court recognizes that this case looks, at first blush, like it might fall into the toxic tort
paradigm. Arsenic is a poison, like many of the substances involved in toxic tort cases. And, like
some pharmaceutical cases, Mrs. Silverman took a prescription drug prescribed for one condition
and experienced an adverse reaction. However, unlike those cases, the product here allegedly
deviated from the manufacturer’s specifications. And, since Mrs. Silverman did not save pills from
each and every lot of pills she ingested, there is no way for her—or anyone else—to show how much
arsenic, if any, was in each lot. The previous lots could have had no arsenic or they could have had
hundreds of times the level of arsenic found in pills she did save. That is why, in this case, the
distinction between Texas law governing toxic tort cases and Texas law governing manufacturing
defect cases is critical. And based on the record before the court, the plaintiffs have carried their
burden to demonstrate that genuine issues of material fact exist regarding causation. For that reason,
summary judgment is not appropriate.
9
CONCLUSION
Pending before the court is defendant Capsugel’s motion to exclude and for summary
judgment. Dkt. 70. Upon consideration of the motion, the response, the reply, the summary
judgment record, the argument of counsel at oral hearing, and the applicable law, the motion is
DENIED.
It is so ORDERED.
Signed at Houston, Texas on April 16, 2013.
___________________________________
Gray H. Miller
United States District Judge
10
Disclaimer: Justia Dockets & Filings provides public litigation records from the federal appellate and district courts. These filings and docket sheets should not be considered findings of fact or liability, nor do they necessarily reflect the view of Justia.
Why Is My Information Online?