Summary
holding that a plaintiff must submit expert testimony to prove that a prescription drug is unreasonably dangerous
Summary of this case from Oiler v. Biomet Orthopedics, Inc.Opinion
CIVIL ACTION NO: 02-2581, SECTION: "D" (1)
December 8, 2003
MINUTE ENTRY
Before the court is the " Motion for Summary Judgment" filed by Defendant Merck Co., Inc. (Merck). Plaintiff, Jimmie Ray Sheridan, filed a memorandum in opposition. The motion, set for hearing on Wednesday, November 26, 2003, is before the court on briefs, without oral argument. Nov;, having reviewed the memoranda of counsel and the applicable law, the court finds that there is no genuine-issue of material fact and Merck is entitled to judgment as a matter of law.
I. Background
Plaintiff alleges that he took the lipid lowering drug simvastatin marketed by Merck under the brand name "Zocor", for the treatment of high cholesterol, and as a result, he suffered severe and debilitating injuries. (Complaint at ¶¶ 1, 12). Some of these alleged injuries are "[r]habdomyolysis, kidney and other organ failure, severe and debilitating muscle pain, tubular necrosis, fluid loss, weakness, malaise, fatigue, joint pain, fever, seizures, dark urine, nausea and vomiting." (Complaint at ¶ 30).
Plaintiff describes "rhabdomyolysis" as "a condition that causes . . . the cell breakdown and release of muscle cells into the bloodstream Symptoms of rhabdomyolysis include . . . severe and debilitating muscle pain, tubular necrosis, fluid loss, weakness, malaise, fatigue, joint pain, fever, seizures, dark urine, nausea and vomiting. In some persons, rhabdomyolysis may be so severe that it causes kidney and other organ failure, which can be fatal." (Complaint at ¶ 11).
Plaintiff sues Merck alleging that Merck failed to warn of, misrepresented, and concealed the risks associated with the use of the cholesterol-lowering medication, Zocor. Plaintiff claims that Zocor is defective and it is an "unreasonably dangerous product" as defined by the Louisiana Products Liability Act, as well as an "absolute vice" under Louisiana redhibition law. (Complaint at ¶¶ 21, 22, 25). Plaintiff further claims adulteration and/or misbranding under state and federal Food, Drug and Cosmetic Acts. (Complaint at ¶ 24).
Under the court's standing scheduling order, Plaintiff had until September 18, 2003 to tender his expert reports. (Minute Entry, Doc. No. 10). On September 18, 2003, Plaintiff filed a last minute Motion to Extend this deadline, and the Magistrate Judge extended the deadline to October 22, 2003. However, the Magistrate Judge instructed Plaintiff that he would only be allowed to submit reports of experts who were identified in his discovery response of September 11, 2002, plus an economic expert. (Doc. No. 21).
The only reports that Plaintiff tendered were the narrative reports of Dr. Roig and Dr. Shamsnia. ( See Dr. Roig's September 24, 2003, report attached to Defendant's Motion as Exhibit C, and Dr. Shamsnia's September 17, 2003, report attached to Defendant's Motion as Exhibit D).
In its Motion for Summary Judgment, Merck argues that Plaintiff cannot show a "defect" in Zocor, which Merck contends is an essential element of Plaintiff's case. Plaintiff attempted to have the hearing of this motion continued until Plaintiff took the depositions of Drs. Roig and Shamsnia, so that these doctors could "elaborate on their experience in pharmacology, pharmokenitics and biochemistry . . . and what they believe the defect in the drug Zocor to be in detail." ( See Plaintiff's Memo., Doc. No. 52, p. 3).
However, the court denied Plaintiff's motion for a continuance finding that:
the deadline for producing [Plaintiff's] expert reports has come and gone. While Plaintiff timely produced reports of Drs. Shamsnia and Roig, the Plaintiff cannot now use depositions of his experts to bootstrap into his expert reports the testimony he should have gathered over the last 14 months and which should have been included in his expert reports.
Merck relied upon the Plaintiff's expert reports in preparing its defense. To allow Plaintiff to now garner from his experts testimony addressing for the first time, an alleged drug defect would unfairly prejudice Merck and its defense. Further, to allow an expert to state an opinion for the first time in his deposition, after his expert report has been produced, would render meaningless the expert report deadline.
( See Minute Entry, Doc. No. 46).
"When a party is not given a full and fair opportunity to discover information essential to its opposition to summary judgment, the limitation on discovery is reversible error." Access Telecom, Inc. v. MCI Telecommunications Corp., 197 F.3d 694, 720 (5th Cir. 1999). Here, however, in seeking a continuance of Defendant's Motion for Summary Judgment, Plaintiff was not seeking additional discovery, but rather he was clearly trying to do an impermissible end run around his expert report deadline by untimely supplementing his expert reports with depositions of his own experts.
In Plaintiff's opposition memorandum, Plaintiff elaborates on her failure to warn claim, alleging for the first time that Merck failed to warn of the risk of "the concomitant use of Zocor with the IV dye used in his angiogram procedure." (Plaintiff's Opp. at 1). However, as discussed below, the court finds that Plaintiff has offered no summary judgment evidence supporting this allegation (or any other allegation previously made in his Complaint).
II. Legal Analysis
The Louisiana Products Liability Act (LPLA), LSA-R.S. 9:2800.51 et seq., establishes the "exclusive theories of liability fo1r manufacturers for damage caused by their products. A claimant may not recover from a manufacturer for damage caused by a product on the basis of any theory of liability that is not set forth in the Chapter." See LPLA, 9:2800.52, and Brown v. R.J. Reynolds Tobacco Co., 52 F.3d 524, 526 (5th Cir. 1995). Thus, the court concludes at the outset that the Louisiana Products Liability Act (LPLA, LSA-R.S. 9:2800.51 et seq.) controls this matter and all of Plaintiff's claims must be examined in that context.
Under the LPLA, the "manufacturer of a product shall be liable to a claimant for damage proximately caused by a characteristic of the product that renders the product unreasonably dangerous when such damage arose from a reasonably anticipated use of the product by the claimant or another person or entity." LSA-R.S. 9:2800.54(A).
A product is unreasonably dangerous if and only if:
(1) the product is unreasonably dangerous in construction or composition;
(2) the product is unreasonably dangerous in design;
(3) the product is unreasonably dangerous because an adequate warning about the product has not been provided; or
(4) the product is unreasonably dangerous because it does not conform to an express warranty of the manufacturer about the product.
LSA-R.S. 9:2800.54(B) (1-4).
To prove that Zocor was "unreasonably dangerous" within the meaning of the LPLA, Plaintiff must submit expert testimony because the composition, design, testing, and product characteristics of Zocor require sophisticated knowledge on topics such as biochemistry, pharmacology, and pharmacodynamics, which are outside the average person's common understanding. However, Plaintiff has no expert testimony to support his claim that Zocor is unreasonably dangerous.
In opposition to Merck's motion, Plaintiff submits for the first time that Plaintiff has the condition "rhabdomyolysis" due to the "concomitant use of Zocor with the IV dye used in his angiogram procedure." (Plaintiff's Opp. at 1). Plaintiff then argues that:
Zocor provides a warning label regarding several potential problems, including rhabdomyolysis, occurring rarely; however, Zocor does not provide any warnings for concomitant use with IV dye. This specific risk is known to the defendant as this HMG CoA reductase is both liver and kidney metabolized. Merck should have had a clinical warning to warn against the use of IV dye when administering Zocor. Merck's failure to warn of this particular risk is a violation of the Louisiana Products Liability Act.
(Plaintiff's Opp. at 2).
However, the "mere allegation of inadequacy" is insufficient for Plaintiff to survive summary judgment on a failure-to-warn claim. Stahl v. Novartis Pharmaceuticals Corp., 283 F.3d 254, 264 (5th Cir. 2002), citing Anderson v. McNeilab, Inc., 831 F.2d 92, 93 (5th Cir. 1987). Instead, Plaintiff must "go beyond the pleadings and designate specific facts in the record showing a genuine issue of material fact for trial" to defeat summary judgment. Stahl, 283 F.3d at 264-65, citing Wallace v. Texas Tech. Univ., 80 F.3d 1042, 1047 (5th Cir. 1996).
Louisiana applies the "learned intermediary doctrine" to product liability claims involving prescription drugs. Stahl, 283 F.3d at 265. Under this doctrine, there is a two-prong test governing inadequate-warning claims under the LPLA when the learned intermediary doctrine is applicable:
First, the plaintiff must show that the defendant failed to warn (or inadequately warned) the physician of a risk associated with the product not otherwise known to the physician.
Second, the plaintiff must show that this failure to warn the physician was both a cause in fact and the proximate cause of the plaintiff's injury.Id. at 265-66.
Here, Plaintiff has failed to raise a genuine issue of material fact on both prongs. While Plaintiff contends that Drs. Roig and Shamsnia "provide the necessary expertise to testify as to the failure to warn as to the risk of concomitant use of IV dye and Zocor," neither of these doctors offer in their narratives, expert opinion on the interaction of some unidentified "IV dye" and Zocor. Further, neither of these doctors prescribed Zocor to the Plaintiff or performed the alleged angiogram using the IV dye, and neither offer any opinion on what the prescribing/treating physician knew or should have known from reading the Zocor label.
In her opposition memorandum, Plaintiff abandons all other claims that could be brought under the LPLA. As with her "failure to warn claim", Plaintiff has no evidence to show a genuine issue of material fact as to Plaintiff's other claims alleged in her Complaint. In their narrative reports, neither Dr. Roig nor Dr. Shamsnia opine about an "unreasonable construction or composition" that caused Plaintiff's injuries, and neither doctor opines about an "express warranty" associated with Zocor that caused Plaintiff's injuries. In short, Plaintiff has offered no evidence to show that there is a genuine issue of material fact regarding an unreasonably dangerous defect in Zocor.
Without any expert testimony establishing that Zocor is defective or "unreasonably dangerous" within the meaning of the LPLA, the court finds that there are no genuine issues of material fact and Defendant Merck is entitled to judgment as a matter of law. Accordingly;
Even if the LPLA did not establish the exclusive theories of liability for manufacturers for damage caused by their products, the court finds that Plaintiff's claim for redhibition under Louisiana Civil Code Article 2520 would also not survive summary judgment because Plaintiff has failed to show proof of a defect, rendering the product absolutely useless for its intended purpose. Finally, as a matter of law, Plaintiff has no private cause of action under either the state or federal Food, Drug and Cosmetic Acts.
IT IS ORDERED that Defendant Merck's " Motion for Summary Judgment" be and is hereby GRANTED.