No Injury Lawsuits and Constitutional Standing to Sue in Federal Courts.By Mary T Yelenick & Phoebe A Wilkinson Originally published June 2005 Introduction Product manufacturers increasingly face the phenomenon of 'no-injury' lawsuits: lawsuits commenced by plaintiffs who have suffered neither a personal injury nor property damage as a claimed result of their use of a manufacturer's product. Such plaintiffs sue because they, or their attorneys, believe that some or all of the products may contain an as-of-yet unmanifested safety defect.1 Yet US federal courts are "courts of limited jurisdiction". They derive authority to act from Article III of the US Constitution, which requires that there be a "case or controversy" between parties in order to litigate actions in federal court.2 Inherent to the 'case or controversy' requirement is that plaintiffs must establish constitutional standing to pursue their claims.3 The US Supreme Court has articulated the Article III standard by which the "irreducible irreducible /ir·re·duc·i·ble/ (ir?i-doo´si-b'l) not susceptible to reduction, as a fracture, hernia, or chemical substance. ir·re·duc·i·ble adj. 1. constitutional minimum of standing" is established. It requires three elements: injury in fact; causation; and redressibility.4 Failure to establish any one of the three elements deprives a federal court of jurisdiction to hear the proposed suit.5 Therefore, one of the threshold inquiries regarding whether a litigant litigant n. any party to a lawsuit. This means plaintiff, defendant, petitioner, respondent, cross-complainant, and cross-defendant, but not a witness or attorney. LITIGANT. One engaged in a suit; one fond of litigation. can avail of the federal court system is whether he or she has suffered an injury in fact.6 This update (i) discusses the 'injury in fact' requirement of the constitutional standing doctrine in the context of no-injury product liability lawsuits, and (ii) explores some of the different circumstances in which federal courts have addressed whether no-injury product liability plaintiffs have properly established Article III standing in such cases. Federal Court Jurisdiction Federal courts are courts of limited jurisdiction. They can preside over only those cases that fall within the judicial power entrusted to them by the US Constitution. Hence the presumption is that a federal court lacks subject-matter jurisdiction In civil procedure, the subject-matter jurisdiction of a court determines the kinds of claims or disputes over which it has jurisdiction, or the power to render a decision. to preside over a particular lawsuit unless and until it has been demonstrated that proper jurisdiction over the subject matter exists.7 The constitutional standing doctrine The constitutional standing doctrine is a jurisdictional prerequisite based upon Article III, without which federal courts lack power to entertain proceedings. If a plaintiff lacks standing to maintain the lawsuit, the federal court in which the suit is pending lacks judicial power to adjudicate adjudicate ( v its resolution.8 The law is well settled that the party invoking federal jurisdiction - generally the plaintiff - has the burden of establishing the constitutional standing elements.9 Nevertheless, federal courts also have the power to raise the issue on their own, and are urged to do so, because litigants cannot confer jurisdiction on a federal court, either by waiver, express consent or other conduct.10 As noted above, the party seeking to litigate in federal court must establish the three elements set forth in the Article III standing test: injury in fact, causation and redressibility. These requirements are "not merely pleading exercises; Article III's standing requirements assure that 'the dispute...will be presented in an adversary context and in a form historically viewed as capable of judicial resolution'."11 Courts "should not be deciding legal questions in the abstract, but based on a fully developed factual record".12 What Constitutes an Article III Injury in Fact? An Article III injury in fact is an "invasion of a legally protected interest" which must be: (i) "concrete and particularized par·tic·u·lar·ize v. par·tic·u·lar·ized, par·tic·u·lar·iz·ing, par·tic·u·lar·iz·es v.tr. 1. To mention, describe, or treat individually; itemize or specify. 2. ", and (ii) "actual or imminent, not conjectural con·jec·tur·al adj. 1. Based on or involving conjecture. See Synonyms at supposed. 2. Tending to conjecture. con·jec or hypothetical".13 How then do federal courts apply this test in the context of plaintiffs who bring no-injury product liability lawsuits? The answer to this question can depend on a number of circumstances, including the manner in which plaintiffs characterize the gravamen The basis or essence of a grievance; the issue upon which a particular controversy turns. The gravamen of a criminal charge or complaint is the material part of the charge. of the lawsuits, and the juncture at which courts address the inquiry. In many instances application of the 'injury in fact' test is affected by plaintiffs' (and their counsel's) efforts to prosecute no-injury product liability lawsuits as class actions.14 In such circumstances the context in which the federal court conducts the injury in fact analysis can depend on the status of the lead plaintiff and the breadth of the proposed class definition. Claimed enhanced risk of harm One theory litigants advance is the 'enhanced risk of harm' theory. In such cases no-injury plaintiffs file lawsuits claiming they have an enhanced risk of future harm because they used, ingested in·gest tr.v. in·gest·ed, in·gest·ing, in·gests 1. To take into the body by the mouth for digestion or absorption. See Synonyms at eat. 2. or otherwise came into contact with a product which they allege may cause a presently unmanifested safety defect to arise in the future. There are differing views as to whether this claimed risk constitutes an Article III injury in fact. A Tennessee federal court recently addressed the issue and dismissed a case on the ground that it was not.15 In that lawsuit, Sutton v St Jude Medical Inc, the plaintiff had an aortic aortic pertaining to or emanating from the aorta. See also aortic arch. aortic aneurysm occurs most often in dogs, where it is caused by Spirocerca lupi larvae, turkeys and primates, causing dyspnea, cyanosis and coughing. connector device implanted in his body during cardiac bypass surgery Bypass surgery A surgical procedure that grafts blood vessels onto arteries to reroute the blood flow around blockages in the arteries (arteriosclerosis). .16 Although the plaintiff alleged having the aortic connector implanted, he did not allege that he personally suffered any physical injury as a result. Instead, he claimed the device had led to severe and disabling medical conditions See carpal tunnel syndrome, computer vision syndrome, dry eyes and deep vein thrombosis. in other patients, and that some of those patients had been harmed, needed to have their connectors removed, or needed special periodic medical monitoring to look out for potentially problematic signs or symptoms of injury.17 As a result of the claimed experiences of those other patients, the Sutton plaintiff maintained he suffered an increased risk of medical complications,18 and he sought to prosecute the lawsuit as a class action seeking redress for himself and other connector implantees. The defendants moved to dismiss Sutton on the grounds that the plaintiff had not suffered any physical injury and thus lacked standing to litigate in a federal court because he could not meet the Article III injury in fact requirement.19 The court agreed. The Sutton court Sutton Court, Stowey also known as Stowey Court, is a large house built on the site of a fourteenth century castle, with sections built in the fifteenth and sixteenth century. distilled the inquiry as follows: is an "increased risk of harm from an implanted medical device...sufficient injury in fact to confer standing"?20 The court determined it was not, noting that the plaintiff had "not provided the court with any information from which to assess his allegedly increased risk of harm from implantation of the aortic connector", and that the plaintiff had done nothing more than allege that use of the aortic connector had led to "severe and disabling medical conditions" in others and that a "high rate of adverse event reports" was associated with use of the device.21 Hence, the court found that any injury with regard to the plaintiff himself was "purely hypothetical", and could not satisfy the injury in fact standing test which expressly mandates that a qualifying injury can not be conjectural or hypothetical: "With merely a hypothetical injury, [the] plaintiff is unable to demonstrate standing. Absent standing in the named plaintiff A named plaintiff is one of the small group of individual plaintiffs in a class action who are identified by name and who stand in for and represent the interests of the larger group of people who comprise the plaintiff class. , there is also no standing in the proposed class and no subject-matter jurisdiction in this court."22 Conversely, a Louisiana federal court addressed a similar question but came to a different conclusion. Like Sutton, the plaintiff in In re Propulsid Products Liability Litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. did not claim to have suffered a physical injury as a result of her use of the prescription medication Propulsid.23 However, she sought to represent a putative class of all persons in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. who had taken Propulsid, had not suffered any physical injury, but sought relief in the form of medical monitoring to determine whether there were claimed lasting effects of Propulsid after discontinuing use. The plaintiff in Propulsid filed a motion seeking class certification. Prior to considering whether it was proper to grant the class motion, the court first addressed whether the plaintiff had established Article III standing. The plaintiff argued that "her prior consumption of Propulsid had increased her risk of sustaining heart disease and/or related cardio-dysfunctions", and claimed this was sufficient to establish the Article III injury in fact requirement.24 The court acknowledged there was considerable disagreement between the plaintiff and the defendants as to whether use of Propulsid had a permanent or long-term hazardous effect on the heart after discontinuation dis·con·tin·u·a·tion n. A cessation; a discontinuance. Noun 1. discontinuation - the act of discontinuing or breaking off; an interruption (temporary or permanent) discontinuance of use, but nevertheless found that the allegation of increased risk of harm of possible cardiac complication in the future - without more - was sufficient for Article III purposes.25 Potential economic harm Plaintiffs have also advanced a different theory of harm when pursuing no-injury product liability lawsuits: economic harm. Their theory is that they did not receive what they paid for, or they have a diminished ability to re-sell the subject product should they decide to do so in the future. Courts have not responded to this theory in a uniform fashion. In some instances, courts have applied the Article III injury in fact test and disposed of the lawsuit at the outset. In others, courts have addressed the merits of whether such theories sufficiently claim or establish damages, but they do so by discussing the same shortcomings A shortcoming is a character flaw. Shortcomings may also be:
For example, in Rivera v Wyeth-Ayerst Labs a federal appellate court A court having jurisdiction to review decisions of a trial-level or other lower court. An unsuccessful party in a lawsuit must file an appeal with an appellate court in order to have the decision reviewed. dismissed a no-injury, economic-theory lawsuit because the plaintiff had failed to establish an Article III injury in fact.26 The lead plaintiff - who had openly disavowed any physical or emotional injury - proposed to represent a nationwide class of patients who had ingested the prescription pain medication Duract.27 The lower court certified the class and the defendants appealed. On appeal, the Fifth Circuit suggested that the Rule 23 class certification decision was significantly flawed, but premised its dismissal - and focused all of its analysis - on the findings that the suit did "not even present a justiciable Capable of being decided by a court. Not all cases brought before courts are accepted for their review. The U.S. Constitution limits the federal courts to hearing nine classes of cases or controversies, and, in the twentieth century, the Supreme Court has added further case or controversy under Article III",28 and the "district court [had] erred by not demanding...a showing" establishing the three elements of the injury in fact test before it certified the class.29 The Rivera court specifically rejected the plaintiffs' argument that they had been denied "the benefit of the bargain", and denounced "[the] plaintiffs' attempt to recast their product liability claim in the language of contract law. The wrongs they allege - failure to warn and sale of a defective product - are product liability claims. Yet, the damages they assert - benefit of the bargain, out-of-pocket expenditures - are contract law damages. The plaintiffs apparently believe that if they keep oscillating os·cil·late intr.v. os·cil·lat·ed, os·cil·lat·ing, os·cil·lates 1. To swing back and forth with a steady, uninterrupted rhythm. 2. between tort and contract law claims, they can obscure the fact that they have asserted no concrete injury. Such artful art·ful adj. 1. Exhibiting art or skill: "The furniture is an artful blend of antiques and reproductions" Michael W. Robbins. 2. pleading, however, is not enough to create an injury in fact."30 Unlike Rivera, not all courts have conducted a threshold Article III injury in fact inquiry when reviewing no-injury, economic-theory suits. Instead they have focused on the damages element of the subject causes of action when ruling on defence motions, such as motions to dismiss for failure to state a claim Within a judicial forum, the failure to present sufficient facts which, if taken as true, would indicate that any violation of law occurred or that the claimant is entitled to a legal remedy. Failure to state a claim is frequently raised as a defense in civil litigation. and motions for summary judgment. In both circumstances federal courts inherently assume - even though they do not necessarily so state - that Article III jurisdiction exists.31 Defendants who have pursued these motions have enjoyed a good measure of success. A close look at why, however, reveals that courts often grant such motions on the basis of finding the same deficiencies that might have caused the court to dismiss the action for lack of Article III injury in fact standing, had it considered the issue at the outset. Briehl v General Motors Corp is an example.32 In Briehl, the plaintiffs filed an action seeking to represent a purported class of General Motors (GM) car, truck and sport utility vehicle owners. They sued GM and the company which made the vehicles' anti-lock braking systems An anti-lock braking system (ABS) (translated from German, Antiblockiersystem) is a system on motor vehicles which prevents the wheels from locking while braking. The purpose of this is to allow the driver to maintain steering control under heavy braking and, in some (ABS), alleging that defendants "jointly designed a dangerously defective ABS system, knew that the brakes were defective, concealed the information from the public, and promoted the ABS as a highly effective safety device."33 The plaintiffs sought to represent a class of all persons residing in the United States who owned or leased certain GM vehicles equipped with the particular ABS system. Their theory was that when the brakes were applied in an emergency (causing a driver to press down on the brakes suddenly), the brake pedal fell "rapidly and without warning to the floor of the vehicle". The plaintiffs argued that this was "counter-intuitive to how an average driver is conditioned to respond when a hard braking manoeuvre is attempted" and that drivers would assume the brakes had failed in such a situation.34 The plaintiffs did not claim the brakes did not stop the vehicles, nor did they claim the ABS had violated any national safety standards Safety standards are standards designed to ensure the safety of products, activities or processes, etc. They may be advisory or compulsory and are normally laid down by an advisory or regulatory body that may be either voluntary or statutory. . Instead they claimed "the 'pedal-to-the-floor' phenomenon constituted a defect because the performance of the brakes causes drivers to react a certain way". The plaintiffs alleged that GM and the ABS manufacturer had failed to inform vehicle owners of the allegedly unsafe defect, causing damage to plaintiffs and members of the proposed class.35 The plaintiffs "explicitly disclaimed any intent to seek recovery for personal injuries or property damage suffered", arguing instead that their vehicles "experienced decreased resale value and were worth less than the plaintiffs had paid" because of the allegedly defective ABS.36 The plaintiffs claimed damages "solely for (1) lost resale value, and (2) overpayment o·ver·pay v. o·ver·paid , o·ver·pay·ing, o·ver·pays v.tr. 1. To pay (a party) too much. 2. To pay an amount in excess of (a sum due). v.intr. To pay too much. for the vehicles at the time of purchase".37 GM and the ABS manufacturer moved to dismiss pursuant to Federal Rule of Civil Procedure 12(b)(6), on the grounds that the plaintiffs had failed to allege manifestation of a defect and had failed adequately to allege damages. The district court agreed and granted the motion. The plaintiffs appealed.38 The appellate court affirmed, in an opinion containing reasoning very similar to Article III injury in fact considerations. The court found that because the plaintiffs had "failed to allege any manifest defect and their vehicles perform in a satisfactory manner, the [lower] court was correct when it dismissed" the plaintiffs' lawsuit.39 It noted that "courts have been particularly vigilant in requiring allegations of injury or damages in product liability cases" before allowing such cases to go forward.40 It specifically rejected the plaintiffs' claims that they had suffered economic harm in the form of lost resale value: "[The] plaintiffs do not allege...that any member of the purported class has actually sold a vehicle at a reduced value... The plaintiffs' conclusory con·clu·so·ry adj. 1. Conclusive. 2. Law Convincing, but not so much so that contradiction is impossible; not justified or supported by all the facts: assertions that they, as a class, have experienced damages (and the method the plaintiffs use to calculate the damages) are simply too speculative to allow this case to go forward."41 When the plaintiffs tried to remedy the pleading defect by re-pleading that some proposed class members had actually suffered an accident or had traded in their vehicles at a loss, the court rebuffed the theory, noting: "An overwhelming majority of courts have dismissed these unmanifested defect claims and rejected the idea that the plaintiffs can sue manufacturers for speculative damage."42 In re General Motors Type III Type III may stand for:
"none of the plaintiffs' cases deals with the special circumstances special circumstances n. in criminal cases, particularly homicides, actions of the accused or the situation under which the crime was committed for which state statutes allow or require imposition of a more severe punishment. at issue in this case, in which alleged defects that have not manifested themselves are said to have caused injury... [The] plaintiffs still have not produced a single case in which a 'difference in value' injury is sufficient to withstand a motion for summary judgment motion for summary judgment n. a written request for a judgment in the moving party's favor before a lawsuit goes to trial and based on recorded (testimony outside court) affidavits (or declarations under penalty of perjury), depositions, admissions of fact, answers in the absence of any manifested defect, physical or economic injury."46 In language echoing Article III injury in fact concepts, the Door Hatch Litigation court concluded: "Again, I reiterate that I am not advocating a blanket rule which says that only a plaintiff with a product which has malfunctioned can ever be said to have sustained a legal injury. But if no palpable injury has occurred, there must at least be some showing that either: (1) the injury is imminent or at least quite likely to occur; (2) there is evidence of diminished value; or (3) there has been a specific misrepresentation misrepresentation In law, any false or misleading expression of fact, usually with the intent to deceive or defraud. It most commonly occurs in insurance and real-estate contracts. False advertising may also constitute misrepresentation. about the value or quality of the product. Here, the link between the alleged defect and the purported injury is just too tenuous to survive a motion for summary judgment."47 Hence, the court reached the same result - the litigation was dismissed because the claimed injury was not imminent and was too tenuous - but only after engaging in two years of discovery and presumably pre·sum·a·ble adj. That can be presumed or taken for granted; reasonable as a supposition: presumable causes of the disaster. substantial motion practice. Had the court addressed the same deficiencies at the outset of the litigation it might have determined that the plaintiffs never had Article III injury in fact standing to begin with. Putative Class Actions Finally, Article III injury in fact inquiries also arise in putative class action lawsuits class action lawsuit A lawsuit in which one party or a limited number of parties sue on behalf of a larger group to which the parties belong. For example, investors may bring a class action lawsuit against a brokerage firm that has actively promoted a tax where the lead plaintiff claims to have suffered an injury but seeks to use the class action device to prosecute the action on behalf of both injured putative class members and no-injury putative class members. In that instance, the lead plaintiff's individual ability to sue in a federal court is not challenged under the Article III injury in fact test (because he or she has alleged an injury - unlike the Sutton, Propulsid and Rivera plaintiffs). Instead, Article III standing issues arise when the court proceeds to the question of whether the lead plaintiff can satisfy the predicates necessary to prosecute the lawsuit as a class action.48 Martin v American Medical Systems, Inc is an example.49 There, the plaintiff, a user of a penile implant Noun 1. penile implant - an implant that creates an artificial erection implant - a prosthesis placed permanently in tissue , filed a putative class action seeking to represent all persons who had surgically placed within their bodies certain models of penile implants over the course of a defined period of time.50 Although the proposed class did not differentiate between putative members who had or had not suffered any injury, the lead plaintiff himself claimed he had.51 The plaintiff moved for class certification. The court denied the motion on a number of grounds, including (i) the injured lead plaintiff could not adequately represent the interests of the proposed class members who had not experienced any problems with their implants, and (ii) the injured lead plaintiff's claims were not typical of those of no-injury implant patients.52 With respect to the latter, the court stated: "It is not clear that satisfied recipients of...implants even could bring suit to obtain relief. Any plaintiff bringing his own suit would need to allege injury for proper standing to bring suit. Such an injury would have to be 'concrete and particularized' and 'actual and imminent, not conjectural or hypothetical'."53 Comment Litigants should be mindful of the Article III injury in fact standing requirement when faced with litigating no-injury product liability lawsuits. Depending on the product in question and the plaintiff's theory of harm, there is considerable precedent to which litigants and courts can look for guidance to determine whether such lawsuits are properly before federal courts. As the sample of cases discussed in this update demonstrates, federal courts are generally reluctant to allow no-injury product liability lawsuits to proceed, even if there is some inconsistency as to how and when they arrive at that conclusion. At the heart of the reluctance is an overriding concern that no-injury product liability actions are too speculative and too hypothetical to warrant adjudication The legal process of resolving a dispute. The formal giving or pronouncing of a judgment or decree in a court proceeding; also the judgment or decision given. The entry of a decree by a court in respect to the parties in a case. in the courts. Those same principles form the bedrock of the Article III injury in fact standing doctrine. Hence, litigants should consider availing themselves of the doctrine as an early means to challenge no-injury product liability suits.54 Endnotes (1) An as-of-yet unmanifested safety defect is sometimes also referred to as a 'latent' defect. (2) Article III of the US Constitution. (3) "Standing requirements have drawn from two sources, constitutional and prudential." Charles Alan Wright Charles Alan Wright (1927 - 2000), was a prominent authority in the United States on constitutional law and federal procedure, and was the author of the treatise, Federal Practice and Procedure. & Arthur R Miller, Federal Prac and Proc Section 3531 (2d ed 1984). See, for example, Young v Klutznick, 652 F 2d 617, 623 (6th Cir 1981) ("In addition to the minimum requirements imposed by Article III, courts have developed rules [of standing] to limit their exercise of jurisdiction in particular cases when prudential considerations militate against mil´i`tate a`gainst´ v. t. 1. To argue against; to cast doubt on; - used in reference to facts which tend to disprove a hypothesis; as, the absence of a correlation of budget deficits with inflation militates against any causal relation invocation invocation, n a prayer requesting and inviting the presence of God. of the judicial process"). This update does not discuss prudential considerations. (4) Lujan v Defenders of Wildlife Defenders of Wildlife is non-profit 501(c)(3) organization founded in 1947 out of concern for perceived cruelties of the use of steel-jawed leghold traps for trapping fur-bearing animals. , 504 US 555, 560-61, 112 S Ct 2130, 2136 (1992). (5) In re Propulsid Prods Liab Litig, 208 FRD FRD Ford (street type) FRD Federal Research Division FRD Free Radical Design (game developer) FRD Formerly Restricted Data FRD Foundation for Research Development FRD Functional Requirements Document 133, 139 (ED La 2002), citing Lujan, 504 US at 560, 112 S Ct at 2130. (6) "The requirement that jurisdiction be established as a threshold matter 'spring[s] from the nature and limits of the judicial power of the United States' and is 'inflexible and without exception'." Steel Co v Citizens for a Better Env't, 523 US 83, 94-95, 118 S Ct 1003, 1012 (1998) (quoting Mansfield, C & LMR LMR Land Mobile Radio LMR Labor-Management Relations LMR Last Minute Resistance LMR Living Marine Resources LMR Longmoor Military Railway (UK) LMR Liquid-Metal Reactor LMR Laser Magnetic Resonance Co v Swan, 111 US 379, 382, 4 S Ct 510, 511 (1884)). (7) Turner v Bank of N Am, 4 US 8, 10, 1 L Ed 718 (1799) (8) Valley Forge Valley Forge, on the Schuylkill River, SE Pa., NW of Philadelphia. There, during the American Revolution, the main camp of the Continental Army was established (Dec., 1777–June, 1778) under the command of Gen. George Washington. Christian Coll v Americans United for Separation of Church and State Americans United for Separation of Church and State (Americans United or AU for short) is a religious freedom advocacy group in the United States which promotes the separation of church and state, a legal doctrine seen by the AU as being enshrined in the Establishment , Inc, 454 US 464, 475-76, 102 S Ct 752, 760 (1982). (9) Lujan, 504 US at 561, 112 S Ct 2130 at 2136. (10) United States v Hays, 515 US 737, 742, 115 S Ct 2431, 2435 (1995). (11) Rivera v Wyeth-Ayerst Labs, 283 F 3d 315, 321 (5th Cir 2002), quoting Sierra Club Sierra Club, national organization in the United States dedicated to the preservation and expansion of the world's parks, wildlife, and wilderness areas. Founded (1892) in California by a group led by the Scottish-American conservationist John Muir, the Sierra Club v Morton, 405 US 727, 732, 92 S Ct 1361 (1972) (internal quotations omitted). (12) Id; see also Simon v Eastern Kentucky Welfare Rights Org, 426 US 26, 39, 96 S Ct 1917, 1925 (1976) (a federal court cannot ignore the standing requirement "without overstepping its assigned role in our system of adjudicating only actual cases and controversies"). (13) Lujan, 504 US at 560, 112 S Ct 2136 (quotation marks quotation marks Noun, pl the punctuation marks used to begin and end a quotation, either `` and '' or ` and ' quotation marks npl → comillas fpl and citation omitted). (14) See Fed R Civ P 23. (15) Sutton v St Jude Medical, Inc, 03-2576 DV, 2003 WL 22801176, at *3 (WD Tenn, November 25 2003). (16) Id at *1. (17) Id at *1-2. (18) The Sutton plaintiff claimed he suffered from an enhanced risk of "aortic bypass stenosis stenosis /ste·no·sis/ (ste-no´sis) pl. steno´ses [Gr.] stricture; an abnormal narrowing or contraction of a duct or canal. or occlusion occlusion /oc·clu·sion/ (o-kloo´zhun) 1. obstruction. 2. the trapping of a liquid or gas within cavities in a solid or on its surface. 3. and its resulting physical injuries". Id at *1. (19) The defendants also moved to dismiss on alternative grounds (including failure to state a claim for relief under Tennessee law, because a tort claim requires the plaintiff to have suffered an injury, and Tennessee did not recognize medical monitoring relief), but once the court determined that the plaintiff was without standing to sue - and hence the court was without jurisdiction to hear the case - it did not address the defendants' additional arguments. Id at *2-3. (20) Id at *2. (21) Id at *3. (22) Id. (23) Propulsid was initially approved by the US Federal Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for use in treating the symptoms of nocturnal heartburn heartburn, burning sensation beneath the breastbone, also called pyrosis. Heartburn does not indicate heart malfunction but results from nervous tension or overindulgence in food or drink. due to gastroesophageal reflux disease gastroesophageal reflux disease (GERD) Disorder characterized by frequent passage of gastric contents from the stomach back into the esophagus. Symptoms of GERD may include heartburn, coughing, frequent clearing of the throat, and difficulty in swallowing. . The plaintiff alleged that dangerous heartbeat irregularities developed when Propulsid was consumed in certain instances by some individuals. Seven years after the medication was approved by the FDA, the manufacturer decided to end general distribution of the medication. The manufacturer stated it had decided to do so because, despite warnings regarding Propulsid's adverse effects when combined with contraindicated medicines and risk factors, the drug was being prescribed inappropriately by physicians. In re Propulsid, 208 FRD at 135. (24) Id at 139. (25) Id. The Propulsid court stated courts have "long recognized" this principle and cited three cases in support. None of the cases, however, addressed the injury in fact question in connection with the ingestion ingestion /in·ges·tion/ (-chun) the taking of food, drugs, etc., into the body by mouth. in·ges·tion n. 1. The act of taking food and drink into the body by the mouth. 2. of an FDA-approved prescription medication. Instead, one case concerned monitoring children for brain damage after being in an aircraft whose doors fell off, causing an explosive decompression Explosive decompression (ED) refers to a sudden marked drop in the pressure of a system that occurs in less than 0.1 seconds, associated with explosive violence. Generally it results from some sort of material fatigue or engineering failure, causing a contained system to and loss of oxygen, and then crashed (see Friends For All Children, Inc v Lockheed Aircraft This is a list of aircraft produced or proposed by the Lockheed Aircraft Corporation from its founding as the Lockheed Aircraft Company in 1926 to its merging with Martin Marietta to form the Lockheed Martin Corporation in 1995. Corp, 746 F 2d 816 (DC Cir 1984)); the second concerned monitoring in connection with exposure to polychlorinated biphenyls polychlorinated biphenyls, (pol´ēklôr´ PCB in full polychlorinated biphenyl Any of a class of highly stable organic compounds prepared by the reaction of chlorine with biphenyl, a two-ring compound. Litig, 916 F 2d 829 (3d Cir 1990)); and the last concerned plaintiffs suing the FDA itself for deciding not to evaluate the safety and effectiveness of pedicle pedicle /ped·i·cle/ (ped´i-k'l) a footlike, stemlike, or narrow basal part or structure. ped·i·cle n. 1. A constricted portion or stalk. 2. screw devices before allowing the manufacturers of those devices to market them to the public (In re Orthopedic Bone Screw Prods Liab Litig, CIV A 98-4643, MDL MDL - (Originally "Muddle"). C. Reeve, Carl Hewitt and Gerald Sussman, Dynamic Modeling Group, MIT ca. 1971. Intended as a successor to Lisp, and a possible base for Planner-70. Basically LISP 1.5 with data types and arrays. 1014, 1999 WL 455667 (ED Pa July 2 1999)). (26) Rivera, 283 F3d at 318. (27) Id. (28) Id. (29) Id at 319. (30) Id at 320-21. (31) Justice Scalia has criticized the practice where federal courts "find it proper to proceed immediately to the merits question, despite jurisdictional objections, at least where (1) the merits question is more readily resolved, and (2) the prevailing party The litigant who successfully brings or defends an action and, as a result, receives a favorable judgment or verdict. prevailing party n. the winner in a lawsuit. on the merits on the merits adj. referring to a judgment, decision or ruling of a court based upon the facts presented in evidence and the law applied to that evidence. A judge decides a case "on the merits" when he/she bases the decision on the fundamental issues and considers would be the same as the prevailing party were jurisdiction denied". Steel Co, 523 US at 93, 118 S Ct at 1012. (32) Briehl v General Motors Corp, 172 F 3d 623 (8th Cir 1999). (33) Id at 626. (34) Id. (35) Id. (36) Id. (37) Id. (38) After the district court dismissed the complaint, the plaintiffs filed a motion seeking leave to amend the complaint, and, as required, submitted the proposed amended complaint amended complaint n. what results when the party suing (plaintiff or petitioner) changes the complaint he/she has filed. It must be in writing, and can be done before the complaint is served on any defendant, by agreement between the parties (usually their lawyers), . The district court reviewed the proposed amended complaint and denied the motion because it found that granting leave to amend would have been futile where the proposed amended complaint failed to cure the subject deficiencies. Id at 626-27. (39) Id at 628. (40) Id at 627. (41) Id at 628-29. (42) Id at 630. (43) In re General Motors Type III Door Latch Litig, 98 C 5836, 99 C 2566, MDL 1266, 2001 WL 548755 (ND Ill May 21 2001). (44) Id at *1. (45) Id. (46) Id. (47) Id at *2. (48) This is consistent with the Supreme Court's statement that the constitutional standing inquiry is logically antecedent ANTECEDENT. Something that goes before. In the construction of laws, agreements, and the like, reference is always to be made to the last antecedent; ad proximun antecedens fiat relatio. to the statutory Rule 23 analysis. See Ortiz v Fibreboard fibreboard Noun a building material made of compressed wood Noun 1. fibreboard - wallboard composed of wood chips or shavings bonded together with resin and compressed into rigid sheets fiberboard, particle board Corp, 527 US 815, 831, 119 S Ct 2295, 2307 (1999) ("class certification issues are...'logically antecedent' to Article III concerns, and themselves pertain to pertain to verb relate to, concern, refer to, regard, be part of, belong to, apply to, bear on, befit, be relevant to, be appropriate to, appertain to statutory standing, which may properly be treated before Article III standing. Thus the issue about Rule 23 certification should be treated first") (internal citations omitted); Amchem Prods Inc v Windsor, 521 US 591, 612, 117 S Ct 2231, 2244 (1997). (49) Martin v Am Med Sys Inc, IP 94-2067-C-H/G, 1995 WL 680630, at *1-2 (SD Ind October 25 1995). (50) Id. (51) The plaintiff asserted a number of legal theories, including that the device suffered from a design and/or manufacturing flaw. He also alleged that the manufacturer "engaged in deliberate fraud or at least negligence by marketing allegedly defective penile implants and by failing to fully inform prospective patients about the risks and hazards associated with penile implants". His wife asserted related claims for loss of consortium. Id at *2. (52) The court further noted that even if the proposed class were narrowed to include only implant recipients who had experienced difficulties, the plaintiff could still not establish the additional requirements that common issues predominate over individual issues, and that a class action is superior to other methods for resolving such claims. Id at *7-10. (53) Id at *6 (internal citations omitted). See also McElhaney v Eli Lilly Eli Lilly can refer to:
(54) Generally, the outcome would not be any different in instances where the suits were filed in state courts. The vast majority of state courts which have considered similar no-injury product liability lawsuits have found such claims too speculative "to constitute a legally cognizable The adjective "cognizable" has two distinct (and unrelated) applications within the field of law. A cognizable claim or controversy is one that meets the basic criteria of viability for being tried or adjudicated before a particular tribunal. tort injury". Ziegelmann v DaimlerChysler Corp, 649 NW 2d 556, 558 (ND 2002) (North Dakota Supreme Court The North Dakota Supreme Court is the highest court of law in the state of North Dakota. The Court rules on questions of law in appeals from the state's district courts. affirmed dismissal of action for failure to state a claim upon which relief could be granted where plaintiff had filed suit alleging DaimlerChrysler was negligent in the manufacture, inspection, testing and distribution of vehicles that did not contain a brake-shift interlock A device that prohibits an action from taking place. but also "expressly disclaim[ed] any intent to seek...any recovery for personal injuries or property damages that have been suffered or that may be suffered...by the absence of the brake-shift interlock device"). See also Pfizer, Inc v Farsian, 682 So 2d 405, 406-07 (Ala 1996) ("a heart valve implantee [does not] have a valid cause of action for fraud under Alabama law if he asserts that the valve's manufacturer fraudulently induced him to have the valve implanted when the damages that he asserts do not include an injury-producing malfunction of the product because the valve has been and is working properly"; "Farsian's fear that his valve could fail in the future is not, without more, a legal injury sufficient to support his claim"); Verb v Motorola, Inc, 284 Ill App 3d 460, 672 NE 2d 1287, 1295 (1996) (affirming dismissal on the pleadings of the plaintiffs' class action claiming breach of express and implied warranties, negligence, strict liability, consumer fraud and deceptive trade practices based on their purchases of cellular phones allegedly emitting potentially harmful radio waves Radio waves Electromagnetic energy of the frequency range corresponding to that used in radio communications, usually 10,000 cycles per second to 300 billion cycles per second. and seeking damages for reduction in value of the phones and for increased risk of personal injury, because no proper allegations of present personal injury or damages was included in the complaint; "plaintiffs' future 'personal injury and damages' claims constitute conjecture and speculation"); Frank v DaimlerChrysler Corp, 292 AD 2d 118, 128, 741 NYS 1. Is not. See Nis. 2d 9, 17 (NY AD 2002) (affirming dismissal on the pleadings of putative class action for negligence, strict liability, breach of implied warranty, negligent concealment and mispresentation, fraud, unfair and deceptive trade practices and civil conspiracy based upon allegedly defective front-seat backrests of certain vehicles and seeking damages for alternate transportation or expense in correcting the defect, because plaintiffs "fail[ed] to plead any actual injury"). The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances. Chadbourne & Parke 30 Rockefeller Plaza New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of NY 10112 UNITED STATES Tel: 2124085100 Fax: 2125415369 URL URL in full Uniform Resource Locator Address of a resource on the Internet. The resource can be any type of file stored on a server, such as a Web page, a text file, a graphics file, or an application program. : www.chadbourne.com Click Here for related articles (c) Mondaq Ltd, 2005 - Tel. +44 (0)20 8544 8300 - http://www.mondaq.com |
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