Opinion
No. X04 MMX CV04 4003261 S
September 19, 2006
MEMORANDUM OF DECISION
The defendant CryoLife, Inc., has moved for summary judgment in its favor. The plaintiffs, the administrator of the estate of Leonard J. Klein and his widow, have alleged that the decedent's death was caused by a fungal infection arising from a contaminated implanted heart valve which was supplied by CryoLife. The plaintiffs have included in the action negligence claims against other defendants, not relevant here, and a wrongful death claim against CryoLife, which this court ordered stricken in a ruling dated December 22, 2005. Some of the underlying pleadings and contentions of the parties are recited in that memorandum and need not be repeated at length here. The subject of the motion under consideration is a products liability claim brought by the plaintiffs against Cryolife.
In the tenth count, the plaintiff Barbara Miller, the administrator, alleges that Cryolife at relevant times was in the business of obtaining tissues from human cadavers, processing and preserving them, and distributing them for implantation. The key allegation, for the purpose of this motion, is that the culled, preserved and distributed valves are "products" and CryoLife is a "product seller" for the purpose of Connecticut's Products liability Act, General Statutes § 52-572m et seq. The count further alleges that the valve in issue was defective and unreasonably dangerous, that warranties were violated and that CryoLife was negligent. Count Eleven alleges a loss of consortium on behalf of Ms. Klein. The twelfth count reasserts the products liability claim and alleges recklessness. All of the remaining counts against CryoLife, then, are dependent on the valve's status as a "product" and CryoLife's status as a "product seller." CryoLife's motion for summary judgment urges that the valve is human tissue rather than a "product" and it is thus not liable.
In its ruling dated December 22, 2005, this court discussed the issue and some of the relevant case law in the context of CryoLife's motion to strike. While recognizing some validity to CryoLife's position, this court decided that the matter was more appropriately determined in the context of a motion for summary judgment. CryoLife urges that there is no genuine issue of material fact and that judgment should be granted for several reasons. It argues that General Statutes § 19a-280 excludes human tissue, including the valve in question, from the ambit of products liability and that no court has held that human transplant tissue is a "product." The plaintiff suggests that the federal Food and Drug Administration has included such valves as products for some purposes and that, in any event, more factual investigation is appropriate to determine whether there is a genuine issue of fact.
Summary judgment "shall be rendered forthwith if the pleadings, affidavits and any other proof submitted 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." LaFlamme v. Dallessio, 261 Conn. 247, 250 (2002); Practice Book § 17-49. The party moving for summary judgment bears the burden of proving the absence of a genuine dispute as to any material fact; and the party opposing such a motion must provide an evidentiary foundation to demonstrate the existence of a genuine issue of material fact. "Equally well settled is that the trial court does not sit as the trier of fact when ruling on a motion for summary judgment . . . [T]he trial court's function is not to decide issues of material fact, but rather to determine whether any such issues exist." (Citations omitted; internal quotation marks omitted.) Field v. Kearns, 43 Conn.App. 265, 269-70, cert. denied, 239 Conn. 942 (1996). "To satisfy his burden the movant must make a showing that it is quite clear what the truth is, and that excludes any real doubt as to the existence of any genuine issue of material fact." Witt v. St Vincent's Medical Center, 252 Conn. 363, 373 n. 7 (2000); D.H.R. Construction Company v. Donnelly, 180 Conn. 430, 434 (1980). In deciding a motion for summary judgment, the trial court must view the evidence in the light most favorable to the nonmoving party. The test is whether a party would be entitled to a directed verdict on the same facts. Sherwood v. Danbury Hospital, 252 Conn. 193, 201 (2001); Serrano v. Burns, 248 Conn. 419, 424 (1999); Forte v. Citicorp Mortgage, Inc., 66 Conn.App. 475 (2000). In Connecticut, "[a] trial court should direct a verdict for a defendant if, viewing the evidence in the light most favorable to the plaintiff, [the trier of fact] could not reasonably and legally reach any other conclusion than that the defendant is entitled to prevail." (Internal quotation marks omitted.) Colombo v. Stop Shop Supermarket Co., 67 Conn.App. 62, 64 (2001), cert. denied, 259 Conn. 912 (2002).
There are no genuine issues as to the following facts. The plaintiffs themselves allege that CryoLife is in the business of purchasing, processing and distributing human heart valves. They are human tissue, most compellingly and obviously at the beginning of the process. The affidavit of David Fronk, a vice president of CryoLife, avers as well that CryoLife is a tissue bank that processes, preserves, stores and distributes human tissue for use in medical procedures, including heart valve allografts. The organization receives valves from cadavers from a national network of organ procurement organizations. Fronk describes the processing as "inspection, dissection, disinfection in an antimicrobial cocktail, packaging and cryopreservation." After the processing, which takes two days, the preserved tissues are stored in sub-zero freezers and then distributed to medical providers for implantation and transplantation for a fee. Since 1984 CryoLife has distributed about 49,000 allograft heart valves and maintains an inventory of about 750 valves. Fronk indicates that 146 days, presumably a mean or an average, elapse between procurement and distribution.
The plaintiffs argue that the processing has the effect of transforming the tissue into something other than human tissue, and that the something other is a product for the purpose of the products liability act.
1. Is the action barred by General Statutes § 19a-280?
General Statutes § 19a-280 provides that human tissue is not to be considered a product for the purpose of products liability. It reads:
The implied warranties of merchantability and fitness shall not be applicable to a contract for the sale of human blood, blood plasma, or other human tissue or organs from a blood bank or reservoir of such other tissues or organs. Such blood, blood plasma, and the components, derivatives or fractions thereof, or tissue or organs shall not be considered commodities subject to sale or barter, but shall be considered as medical services.
In Zichichi v. Middlesex Memorial Hospital, 204 Conn. 399 (1987), our Supreme Court held that the statute barred all products liability actions against such providers rather than only breach of warranty actions. The language of the statute is quite broad: "[s]uch . . . tissue . . . shall not be considered commodities subject to sale or barter, but shall be considered as medical services." Similarly, the Second Circuit, applying Connecticut law, held that the reach of the statute extends to for-profit enterprises, as well as to non-profits such as the Red Cross, in Coffee v. Cutter Biological, 809 F.2d 191 (2d Cit. 1987).
It seems clear that the product comes to medical providers from a "reservoir of such other tissues." Though the plaintiffs seem to seek more detail, the general idea that CryoLife maintains a network of suppliers, receives tissues, processes them and stores them in deep freeze is incontrovertible. The term "reservoir", it is agreed, has no legal meaning and is not a term of art; it is to be given its plain meaning. See General Statutes § 1-2z. Webster's Third New International Dictionary defines "reservoir" as "a place where something is kept in store." (First meaning.) There can be no question but that the facility providing the tissue fits the definition.
A California Court of Appeals panel held, in a thorough opinion, that a human tendon allograft provided by CryoLife and apparently processed analogously was human tissue from a "tissue bank" and was therefore not a product under the relevant California statute. CryoLife, Inc. v. Superior Court of Santa Cruz County, 110 Cal.App. 4th 1145 (2003).
The plaintiff further seems to suggest that because of the perhaps significant processing, the valves lose their character as human tissue. This suggestion, though imaginative, is implausible. Although CryoLife has objected to some of the discovery requests regarding its processes, because it deems them confidential and irrelevant to the present dispute, there is nonetheless no question but that human tissue forms the basis for the allograft. As such, the valve is subject to the statute. See, e.g., Coffee, supra (Koate, a processed blood product, subject to the statute); CryoLife, Inc. v. Superior Court, supra; Roe v. Miles Laboratories, Inc., 740 F.Sup. 740 (D.Alaska 1989) (processed antihemophilic clotting factor). It would probably not be seriously argued that processed blood "products", such as red blood cells or fresh frozen plasma, are not human tissue because they have been manipulated or derived from whole blood. The same principle applies here, and, probably significantly, no case law to the contrary has been presented. The action is bared by the plain language of General Statutes § 19a-480.
2. Does the common law recognize a cause of action in products liability for human tissue?
The Restatement (Third) of Torts, Products Liability (1997), § 19(c), recognizes that "[h]uman blood and human tissue, even when provided commercially, are not subject to the rules of this section." Cases collected in Comment c suggest that, either for policy reasons or by statute, no court has held that human tissue is subject to various products liability actions. See, e.g., Kirkendall v. Harbor Insurance Co., 887 F.2d 857 (8th Cir. 1989); Condos v. Musculoskeletal Transplant Foundation, 208 F.Sup.2d 1226, 1229-30 (D. Utah 2002) (processed bone tissue). Even in the absence of statute, then, there is no cause of action for defective allograft heart valves under the products liability act.
3. Does a regulation of the Food and Drug Administration compel a contrary result?
The plaintiffs suggest that a regulation of the federal Food and Drug Administration requires a holding that the CryoLife allograft heart valve is a product. The reliance is misplaced.
The materials submitted by the plaintiffs support the proposition that for reporting purposes the FDA has included allograft valves in the category of "medical devices"; CryoLife suggests that as of May 2005, the FDA modified its rule such that human valves may be considered tissue rather than medical devices. Either way, the FDA itself has stated that such categorization for its purposes is not intended to have any effect on products liability actions. It has stated, at 66 Fed. Reg. 5447, 5455 (Jan. 19, 2001), that although it had categorized eyes in eye banks and blood in blood banks as "products", that categorization had no effect on tort actions, and the agency expected a similar lack of impact here.
The FDA action, in short, has no value in deciding the issue at hand.
4. Conclusion.
For policy reasons, stated both by our legislature and by courts around the country, human tissue is not considered a product for products liability purposes. Although the subject tissue is processed in a sophisticated manner, it is still "tissue" for this purpose. The precise process involved does not change the result. Further discovery would only delay the inevitable and cause the expense and inconvenience that the summary judgment process is designed to avoid.
The action has already been pending for over two years and the death occurred four and a half years ago. Significant discovery has occurred.
Summary judgment shall enter in favor of the defendant CryoLife, Inc.