Opinion
CIVIL ACTION NO. 00-1449 SECTION B(4)
May 22, 2001
ORDER AND REASONS
This matter was set for oral argument on April 25, 2001 in consideration of Defendant Biornatrix's Inc.'s ("Biomatrix") Motion in Limine (Rec. Doc. No. 60) and reurged Motion for Summary Judgment (Rec. Doc. No. 56). Due to a conflict on the Court's schedule, the matter was continued to April 26, 2001. The following counsel were present at the April 26th hearing: L. Kevin Coleman representing the plaintiffs and Stanton E. Shuler and Karen M. Dicke representing the defendant, Biomatrix. Background and Facts
Defendant Wyeth-Ayerst Laboratories, Division of American Home Products Corporation, was voluntarily dismissed without prejudice on March 21, 2001. (Rec. Doc. No. 39.).
Plaintiff Thomas Pipitone ("Pipitone") was injected with Synvisc® at the office of his orthopedist, Dr. Chad Millet ("Dr. Millet") on January 25, 2000. It is undisputed that Dr. Millet injected the contents of the Synvisc® tube manufactured by Biomatrix into Pipitone's knee using a needle from his own supply and not from the defendant. Ex. A, Larsen Declaration, Attachment 2, Directions for Use Section of Package Insert. The plaintiffs allege that soon after the injection, Pipitone developed pain and swelling in his knee.
Synvisc®, a product of chicken combs, is indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesic, e.g., acetaminophen. Ex. 1. Plaintiff's Mem. in Opp. to Def.'s Reurged Mot.
On January 27, 2000, fluid was extracted from his knee, which contained salmonella infection. The plaintiffs concluded that the Synvisc® was contaminated, subjecting Biomatrix to liability for the resulting damage. Plaintiffs filed a state court suit alleging violations of the Louisiana Products Liability Act ("LPLA"), redhibition, and adulteration. The defendants removed the state court action to this Court on May 17, 2000. Defendant brought its original summary judgment motion on March 2, 2001. The defendant moved this Court to grant summary judgment on the grounds that: (1) the plaintiffs' LPLA, redhibition and adulteration claims are preempted by the Medical Device Amendments ("MDA") to the Food, Drug and Cosmetics Act ("FDCA") and (2) even if the plaintiffs' claims are not preempted there is no proof that Synvisc® is unreasonably dangerous under the LPLA.
On March 21, 2001, this Court denied the defendant's motion for summary judgment as to the redhibition claims without prejudice to reurge. The Court further ordered that supplemental memoranda as to those claims should be filed by the parties no later than April 18, 2001. In addition, in view of plaintiffs' proposed voluntary dismissal of the LPLA claims, Biomatrix's motion for summary judgment on the LPLA claims was dismissed as moot without prejudice to reurge if plaintiffs failed to file the motion for dismissal by March 26, 2001.
The plaintiffs filed a voluntary dismissal without prejudice to reurge the claims brought under La. R.S. 40:616 of the Louisiana Food, Drug and Cosmetic Act, and the LPLA claims for defective design, inadequate warning and nonconformity to express warranty but maintained its LPLA. claim of defective construction or composition. The defendant opposed dismissal of the case without prejudice and this Court denied plaintiffs' motion. Subsequently, the parties filed supplemental memoranda.
In the instant supplemental motion for summary judgment, the defendant moves this Court to grant summary judgment on the grounds that (1) the plaintiffs' redhibition claim is preempted, (2) the plaintiffs' claims in redhibition are limited to economic loss despite plaintiffs' contention that the reenactment of the Civil Code did not repeal the LPLA and (3) even if plaintiffs' redhibition claims are not preempted, they cannot maintain an action in redhibition.
The defendant further contends that the testimony of Dr. Jeffrey Coco, and the affidavit and testimony of Dr. Chad Millet, should be excluded from the plaintiffs' opposition to summary judgment and trial should the plaintiffs survive summary judgment insofar as the affidavit and testimony concern beliefs that Synvisc® may have had some causal effect in Pipitone's knee infection. The plaintiffs argue that the issues raised by the Motions in Limine should be addressed to a trier of fact on the merits, not a motion in limine or motion for summary judgment.
Motion in Limine
The trial court has broad discretion to rule on the admissibility of the expert's evidence offered in the summary judgment context. Christophersen v. Allied-Signal Co., 939 F.2d 1106, 1109 (5th Cir. 1991) (en banc). The affidavit submitted at the summary judgment stage must be based upon personal knowledge. See Boyd v. State Farm Ins. Cos., 158 F.3d 326, 331 (5th Cir. 1998).
The defendant contends that Dr. Millet has no specialized knowledge in the area of disease causation and therefore his testimony as to such should be excluded. Further, his opinion is unreliable and contrary to the scientific evidence in the case. In addition, the defendant points out that Dr. Millet has a personal stake in the outcome of this litigation. In response, the plaintiffs contend that Dr. Millet is eminently qualified in his field and has extensive experience.
Plaintiffs' have recently concluded that it was necessary to join Dr. Chad Millet ("Millet") as a party defendant in these proceedings.Plaintiff's Mot. to Continue (Rec. Doc. No. 32). p. 1. Millet, however, is not a party to the present suit because the plaintiffs cannot, under Louisiana law, join Millet prior to review by the medical review panel.
This Court does not question the qualifications of Dr. Millet in the field of orthopaedic surgery. This Court, however, agrees with the defendant in that Dr. Millet's qualifications in orthopaedic surgery, standing alone, do not qualify him to testify in the area of epidemiology or disease causation. Dr. Millet has testified that he had no direct evidence that the salmonella came from the Synvisc®. Ex. A., Defendant's Motion in Limine. Dep. of Dr. Millet at p. 110. He further conceded that his opinion was not based on a reasonable degree of certainty and was not scientifically grounded. Thus, Millet's deposition testimony and affidavit are excluded to the extent they discuss causation as it relates to the salmonella infection of Mr. Pipitone.
Dr. Coco, on the other hand, is employed in the area of hospital epidemiology by three local hospitals. He has a broad understanding of epidemiological procedures as they relate to infections, infection control practices, prevention of infectious diseases and limiting the spread of infections. Dr. Coco was not charged, however, with the responsibility of performing an epidemiological survey in the present case and admittedly did not utilize any of the epidemiological techniques mentioned to determine whether the salmonella in the instant case came from the Synvisc® injection. Dr. Coco's Deposition at 69.
Dr. Jeffrey Coco stated that his primary concern was possible contamination of other people.
He instead conducted a literature search. As a result of the search, he was not able to find any other reported case of salmonella being a contaminant in any injectable knee material. Thus, Coco has no support for his hypothesis and his testimony is therefore not reliable.
Considering Dr. Coco's theory in this matter, his conclusions are too speculative. According to Dr. Coco, "[i]t's highly unusual for salmonella to be in any type of material that one would inject in the knee. In fact, [he] actually did a literature search, found no other reported cases of salmonella being a contaminant in . . . injectable material in knees." Id. Further, Dr. Coco specifically stated that he excluded Synvisc® from his literature search. Moreover, he stated, "it [is] such an unusual event to have salmonella in a knee that somebody could get from an injection, one would have to question anything about this. This is equivalent to winning the $70,000,000 lottery." Id. at 72. Despite this testimony, Dr. Coco speculated that the most likely source was a contaminated Synvisc® infection by concluding, without foundational support, that the probability was extremely high, 99.9 percent. Id. at 76-78.
In opposition to the limine motion, plaintiffs direct us to the case of Precht v. Case Corp., 99-1296 (La.App. 3 Cir. 2/16/00), 756 So.2d 488) for the proposition that they are allowed to rely on the doctrine of res ipsa loquitur. In Precht, plaintiffs filed a products liability action against a tractor manufacturer for injuries sustained from a fire that had engulfed the tractor. The defendant argued that it was error for, the trial court to rely upon circumstantial evidence in a products liability case. Id. at 497. The Louisiana Court of Appeal found no such error. Id. at 497. The court found that circumstantial evidence is sufficient. Id. Specifically, the court stated that "[p]roof that excludes other reasonable hypothesis of cause with a fair amount of certainty so that it is more probable than not that the fire was caused in a particular manner or scenario is enough to establish liability." The court further determined that the evidentiary doctrine of res ipsa loquitor applies to products liability cases. Id. In that case, however, the court found that no other potential source of the fire was identified. Id. (Emphasis added.).
In contrast, there have been many viable alternative sources identified in the present case by the plaintiffs' own expert, Dr. through the gastrointestinal tract or the salmonella could infect a specific organ or joint when they become bacteremic from salmonella they have already carried on their body. Dr. Coco did no thorough investigation which would allow him to reliably rule out these scenarios and pronounce his 99.9 percent conclusion. He simply based his opinion on the timeliness of the infection, the source of the Synvisc®, and the type of organism that infected Pipitone. The ultimate opinions of Dr. Millet and Dr. Coco offer nothing more than unsupported conclusions. Thus, defendant's Motion in Limine is GRANTED excluding Millet and Coco's ultimate conclusions on causation.
Motion for Summary Judgment
Summary judgment is proper if the pleadings, depositions, interrogatory answers and admissions, together with any affidavits, show that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law. Fed.R.Civ.P. 56(c); see also Celotex Corp. v. Catrett, 477 U.S. 317, 327, 106 S.Ct. 2548, 2554-55 (1986). A genuine issue exists if the evidence would allow a reasonable jury to return a verdict for the nonmovant. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 2510 (1986). Although the Court must consider the evidence with all reasonable inferences in the light most favorable to the non-moving party, the nonmovant must produce specific facts to demonstrate that a genuine issue exists for trial. Webb v. Cardiothoracic Surgery Associates off North Texas, 139 F.3d 532, 536 (5th Cir. 1998). The nonmovant must go beyond the pleadings and use affidavits, depositions, interrogatory responses, admissions, or other evidence to establish a genuine issue. Id. Accordingly, conclusory rebuttals of the pleadings are insufficient to avoid summary judgment. Travelers Ins. Co. v. Liljeberg Enter., Inc. 7 F.3d 1203, 1207 (5th Cir. 1993).
Medical Device Amendments
Under the MDA, state law claims are preempted from establishing, "any requirement" that is "different from, in addition to," the FDCA. 21 U.S.C. 360(k)(a)(1). The act classifies medical devices in three categories based on the risk that they pose to the public. Devices that present no unreasonable risk of illness or injury are designated Class I and are subject only to minimal regulation by "general controls." 21 U.S.C. § 360c(a)(1)(A). Devices that are potentially more harmful are designated Class II; although they may be marketed without advance approval, manufacturers of such devices must comply with federal performance regulations known as "special controls." § 360c(a)(1)(B). Finally, devices that either "presen[t] a potential unreasonable risk of illness or injury," or which are "purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health," are designated Class III. § 360c(a)(1)(C). There is no dispute that Synvisc® is a Class III device. See 21 C.F.R. § 870.3610 (1995); See also Defendant's Mot. for Summ. Judg. Memo. at 4.
Before a new Class III device may be introduced to the market, the manufacturer must provide the Food and Drug Administration ("FDA") with a "reasonable assurance" that the device is both safe and effective. See 21 U.S.C. § 360e(d)(2). Despite its relatively innocuous phrasing, the process of establishing this "reasonable assurance," which is known as the "premarket approval," or "PMA" process, is a rigorous one. Medtronic v. Lohr, 518 U.S. 470, 476 (1996). Manufacturers must submit detailed information regarding the safety and efficacy of their devices, which the FDA then reviews, spending an average of 1,200 hours on each submission. Hearings before the Subcommittee on Health and the Environment of the House Committee on Energy Commerce, 100th Cong., 1st Sess. (Ser. No. 100-34), p. 384 (1987) (hereinafter 1987 Hearings); see generally Kahan, Premarket Approval Versus Premarket Notification: Different Routes to the Same Market, 39 Food Drug Cosm. L.J. 510, 512-514 (1984).
Preemption
The defendant contends that assuming, arguendo, plaintiffs can prove that the Synvisc® contained a defect in the form of salmonella, the plaintiffs' claims are preempted. The defendant contends that the pre-market approval process applicable to Class III devices such as Synvisc® constitutes a specific requirement applicable to a particular device.
The defendant argues that plaintiffs' lawsuit, which is based on state law claims, will result in device-specific state requirements that are in addition to or different from the MDA requirements and is therefore preempted.
The plaintiffs cite Medtronic v. Lohr for the contention that their claims are not completely preempted. In Medtronic, the United States Supreme Court granted certiorari to rule on the preemptive scope of the MDA. In that case, plaintiff filed a complaint against the defendant in state court, alleging state law claims of negligence and strict liability, based on the alleged failure of her pacemaker to function properly. Specifically, plaintiff alleged claims for defective design, manufacturing, and labeling, as well as a claim based on the violation of FDA regulations. After removing the case to federal district court, defendant moved for, and the district court granted, summary judgment on the grounds that the MDA preempted all of plaintiff's state law claims. The Eleventh Circuit Court of Appeals affirmed the dismissal of plaintiff's negligent manufacturing and failure to warn claims, but the appellate court concluded that plaintiff's negligent design claims were not preempted.
The Supreme Court — in a plurality decision with three opinions — found that the MDA did not preempt any of plaintiff's common law claims, and the case was remanded for further proceedings. A majority of the Court recognized that the language used in the MDA expressly preempts state law. Medtronic, 518 U.S. at 2250. The Court was strongly divided, however, as to the extent to which state law was preempted. See Reeves v. AcroMed Corp., 103 F.3d 442, 446 (5th Cir. 1997) (explaining that "the Court concluded that the domain expressly preempted by that language must be identified").
It appears that in light of the Medtronic decision, the federal circuits are left with unanswered questions as to when preemption might apply. Julian Safko, Note, Massachusetts Sets Precedent for the First Circuit: The Premarket Approval Process of the Medical Device Amendment Preempts State Common Law Causes of Action, 34 New Eng. L. Rev. 739 (Spr. 2000). The two issues that were not addressed by the Supreme Court are: (1) Does the premarket approval (PMA) process of the MDA impose a specific requirement, thus having a preemptory effect? and (2) Do state common law causes of action create requirements "different from, or in addition to," the requirements imposed by the PMA. process? Id.
In this case, it is undisputed that the Synvisc® was subject to the PMA approval process. The Fifth Circuit has held that the PMA process constitutes a specific requirement applicable to a particular device under the MDA. Stamps v. Collagen Corp., 984 F.2d 1416, 1422 n. 3, 1424 n. 8 (5th Cir. 1993)
Not all, nor even most, Class III devices on the market today have received pre-market approval ("PMA") because of two exceptions. First, Congress realized that existing medical devices could not be withdrawn from the market while the Food and Drug Administration ("FDA") completed its PMA analysis for those devices. The statute therefore includes a "grandfathering" provision which allows pre-1976 devices to remain on the market without FDA approval until such time as the FDA initiates and completes the requisite PMA. See 21 U.S.C. § 360e(b)(1)(A); 21 C.F.R. § 814.1 (c)(1) (1995). Medironic v. Lohr, 518 U.s. 476 (1996). Second, to prevent manufacturers ofgrandfathered devices from monopolizing the market while new devices clear the PMA hurdle, and to ensure that improvements to existing devices can be rapidly introduced into the market, the Act also permits devices that are "substantially equivalent" to pre-existing devices to avoid the PMA process. See 21 U.S.C. § 360e(b)(1)(B). Id.
Since Medtronic, the courts that have addressed this issue have distinguished devices that are subject to the rigorous PMA process from those subject to the more lement "substantial equivalent" process. In the latter group of cases, the courts rely almost exclusively on Medtronic and conclude that the state common law claims are not preempted because the device at issue was never reviewed under the MDA for safety or efficacy, and the FDA never required the device to take any particular form. See, e.g., Reeves v. AcroMed Corp., 103 F.3d 442, 447-48 (5th Cir. 1997); Duvall v. Bristol-Myers-Squibb Co., 103 F.3d 324, 330 (4th Cir.1996). In cases in which the device was subject to the PMA process, however, the holding from Medtronic is not directly transferable.
Although the FDA's requirements are general in the sense that the "Conditions for Approval" are imposed upon each device subject to the PMA process, the FDA's affirmative approval of the device and its subsequent modifications constitute device-specific requirements. Mitchell v. Collagen Corp., 126 F.3d 902, 911 (7th Cir. 1997). The defendants argue that the plaintiffs' claims place an additional requirement that all possibilities of contamination be eliminated. The issue before this Court, therefore, is whether the requirements under the law of the LPLA, adulteration and redhibition are different from or in addition to FDA requirements.
The PMA. is a very in depth process. The PMA process requires the manufacturers to provide the FDA with samples of the device, an outline of the device's components and properties, a description of the manufacturing process, copies of the proposed labels, various other data and information, and any other information the FDA requests. 21 C.F.R. § 814.20; Easterling, 986 F. Supp. 366, 373 (E.D. La. 1997). Synvisc® has been scrutinized since 1997. For the past number of years Biomatrix has submitted a series of PMA supplements to the FDA. Each supplement was approved by the FDA subject to the conditions described in the "Conditions of Approval." Further, Biomatrix must submit any changes to the Center for Devices and Radiological Health including, but not limited to:
(1) new indications for use;
(2) labeling changes;
(3) changes in existing manufacturing facilities, methods, or quality control procedures;
(4) the use of a different facility or establishment to manufacture, process, or package the device;
(5) changes in sterilization procedures;
(6) changes in packaging;
(7) changes in the performance of design specifications, circuits, parts, components, accessories, ingredients, or physical layout of the device; and
(8) extension of the expiration date of the device based on data obtained under a new or revised testing protocol that has not been approved by the CDRH.
The PMA process reflects the government's careful consideration of the risks and benefits of the device, and the FDA's approval of a device constitutes a set of federal requirements that are imposed upon the specific device in order to render the device safe and effective. As the Seventh Circuit stated in Mitchell, FDA approval "constitutes approval of the product's design, testing, intended use, manufacturing methods, performance standards and labeling." Mitchell, 126 F.3d at 912.
Louisiana Products Liability Act
As stated earlier, the defendant in its original motion for summary judgment, contends that the plaintiffs' LPLA claims are preempted by the MDA. The defendant argues that under the plain language of the statute, the LPLA addresses the same issues of safety and effectiveness that the FDA reviewed in the Class III PMA process for Synvisc®. Consequently, the MDA preempts the LPLA in this case.
In Easterling v. Cardiac Pacemakers, 986 F. Supp. 366 (E.D. La. 1997) (Vance, J.), plaintiff brought LPLA claims against a manufacturer. The court held that the MDA preempted the plaintiffs' LPLA claims in a case involving a Class III device reviewed under the PMA process. Id. at 369, 374. The court noted that approval pursuant to the PMA process required the FDA to determine that the device is safe and effective based on its thorough evaluation of all aspects of the device's construction, composition, design, manufacturing process, and labels. Id. at 373. The court reasoned that LPLA claims assert that the manufacturer is negligent or strictly liable despite its adherence to the standards set forth by the FDA in the PMA concerning the device's design, testing, use, manufacturing methods, performance standards and labeling. Such claims, if allowed, would necessarily conflict with the determination by the FDA that its requirements rendered the product safe and effective. Id. at 374-375.
The court further concluded, as does this Court, that the only claims that may survive preemption were the plaintiffs' construction and composition claims which are based on an alleged failure to manufacture the product in accordance with the manufacturer's specifications and standards approved by the PMA process. Id. at 376. In other words, the plaintiffs must prove that the Synvisc® he received deviated in a material way from the manufacturing specifications and standards approved by the FDA in the PMA process. Thus, this Court holds that the plaintiffs' claims for design defect, inadequate warning, and nonconformity with express warning under the LPLA are preempted by the MDA.
Under the LPLA, a product is unreasonably dangerous in construction or composition if, at the time the product left the manufacturer's control, it deviated in a material way from the manufacturer's specifications, or from otherwise identical products manufactured by the same manufacturer La. R.S. § 9:2800.55. To avoid summary judgment on a claim of defective construction or composition, the plaintiffs must present competent evidence that would enable a trier of fact to conclude that the product deviated in a material way from the manufacturer's specifications or from otherwise identical products manufactured by the same company at the time the product left the manufacturer's hands. Morgan v. Gaylord Container Corp., 30 F.3d 586, 590 (5th Cir. 1994).
Under Louisiana law, a fact-finder is not allowed to presume a product defect based solely on the fact that an accident or injury occurred. Spott v. Otis Elevator, Co., 601 So.2d 1355, 1364 (La. 1992). Therefore, the plaintiffs must present specific facts and expert testimony to support their claims. Id.
Here, the plaintiffs have submitted no expert reports or any other evidence indicating that the Synvisc® deviated in any material way from Biomatrix's specifications or the PMA standards. Drs. Millet and Coco did not offer any opinion, reliable or otherwise, to show a deviation from FDA approved manufacturing specifications and standards. In addition, the plaintiffs have failed to produce or identify any tests, other reports or documents that would support that the Synviac® Pipitone received deviated in a material way from other Synvisc® when it left Biomatrix's control.
To the contrary, the defendant has submitted evidence that shows that the organism that caused Pipitone's infection could not survive the chemicals in the manufacturing process of Synvisc®. Ex. A to Defendant's Mot. for Summary Judg., Larsen Declaration. In addition, Lot V9905 of the Synvisc® batches, which was the lot from which the syringe used by Pipitone was removed, was tested before packaging and distribution and revealed no presence of salmonella bacteria. Id. Further, both Biomatrix and Metrolab tested samples of the lot and kit used by Mr. Pipitone after he reported his infection. The test revealed no presence of salmonella bacteria. Id. Therefore there are no disputed issues of material facts and the defendant is entitled to judgment as a matter of law.
LPLA and Redhibition
The LPLA is the exclusive form of recovery against a manufacturer only for those damages as defined by the Act; the Act does not preclude recovery from a manufacturer for damages for economic loss due in a redhibition claim. Draten v. Winn Dixie of Louisiana, Inc., 94 0767 (La.App. 1st Cir. 3/3/95), 652 So.2d 675, 678; Monk v. Scott Truck Tractor, 619 So.2d 890, 893 (La.App. 3d Cir. 1993). The LPLA defines "damage" as follows:
"Damage" means all damage caused by a product, including survival and wrongful death damages, for which Civil Code Articles 2315, 2315.1 and 2315.2 allow recovery. "Damage" includes damage to the product itself and economic loss arising from a deficiency in or loss of use of the product only to the extent that Section 3 of Chapter 6 of Title VII of Book III of the Civil Code, entitled "Of the Vices of the Thing Sold," does not allow recovery for such damage or economic loss. Attorneys' fees are not recoverable under this Chapter.
Redhibition is the avoidance of a sale on account of some defect in the product that would render an item useless or so inconvement to use that it would be presumed that a buyer would not have bought the thing had he known of the defect. LA. CIV. CODE ANN. art. 3492 (West 1999). The exclusivity provisions of the LPIJA have been held not to be a bar to redhibition actions. "The LPLA was never intended to eliminate redhibition as a means of recovery against a manufacturer. . . The right to sue in redhibition for economic loss still exists." Grenier v. Medical Engineering Corp., 243 F.3d 200 n. 5 (5th Cir. 2001) citing Monk v. Scott Truck Tractor, 619 So.2d 890, 893 (La.App. 3 Cir. 1993) (emphasis added). Thus, although "redhibition is not available as a theory of recovery for personal injury," it is "still viable against the manufacturer to recover pecuniary loss." Jefferson v. Lead Indus. Ass'n, Inc., 106 F.3d 1245, 1251 (5th Cir. 1997); Borskey v. Medtronics, 1998 WL 122602, *4 (E.D. La. Mar 18, 1998); Morris v. United Services Automobile Association, 32, 528 (La.App. 2 Cir. 2/18/00), 756 So.2d 549, 562.
The legislative branch is presumed to intend to achieve a consistent body of law. State v. Piazza, 596 So.2d 817, 819 (La. 1992); 1AN. Singer, Sutherland Statutory Construction § 23.09 (Sands 4th ed. 1986). When a legislature enacts a statute without mention of existing statutes on the same subject matter, the later act may, by necessary implication, effect the repeal of the preexisting law. Id. However, there is a presumption against implied repeal, based on the theory that the legislature envisions the whole body of law when it enacts new legislation. Id. ( Emphasis added). The plaintiffs have failed to overcome this presumption.
Despite the clear precedent of the Fifth Circuit and Louisiana state courts that a claim in redhibition is not available as a theory of recovery for personal injury but is limited to recovery of pecuniary loss, the plaintiffs still argue that the LPLA applies only to the extent that it is not in conflict with the articles on redhibition. The plaintiffs do not argue, nor could they, that the law on redhibition expressly repealed the LPLA. Neither has the plaintiff provided the court with any authority, and this court has found none, which implies that the laws on redhibition repeal the LPLA. Thus, the plaintiffs have failed to overcome the presumption against implied repeals and if indeed plaintiffs' redhibition claims survive preemption such claim would be limited to economic loss.
Under the law of redhibition, a seller is in bad faith when he has actual knowledge that the thing he sells is affected by a hidden defect and fails to disclose that circumstance to the buyer. Saul Litvinoff, Sale and Lease in the Louisiana Jurisprudence pg. 467 (1997). In the case of a manufacturer, the law presumes his knowledge of defects in the things he makes. Id. Because Synvisc® is a Class III device, the issue of whether or not there exists a defect must be answered in light of the requirements placed on the defendants by the MDA. As stated earlier, the plaintiffs offer no evidence which shows that Biomatrix did not comply with the requirements of the MDA and this Court cannot place any requirements on the manufacturing of the Synvisc® that is different from or in addition to those placed by the MDA. Thus, plaintiffs' redhibition claim fails as a matter of law.
Adulteration
The State Food, Drug, and Cosmetic Law provides, "[t]he authority to promulgate regulations for the efficient enforcement of this Part is vested in the secretary of the Department of Health and Hospitals." La. R.S. 40:604 (West Supp. 2001). Hearings authorized or required by this Part shall be conducted by the department or the officer or employee designated by it for the purpose. La. R.S. 40:605 (West 1992). Under Louisiana law, a court may review the regulations and administrative actions of the department. La. R.S. 40:606 (West 1992). Even under such circumstances the plaintiff must show that the regulation or administrative action is unreasonable, arbitrary or capricious, or not in accordance with the facts or law and that petitioner may suffer substantial damage thereby. The plaintiff has not provided this Court with any disputed regulation for which we are to review. Thus, the defendant is entitled to judgment as a matter of law. Accordingly,
IT IS ORDERED that Defendant's Motion for Summary Judgment hereby is GRANTED.