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United States v. St. Louis University, a Corporation
336 F.3d 294
4th Cir.
2003
Check Treatment
Docket

*1 294 denial, the defendant en- Austin, Following this Assis- Amy Leigh

ARGUED: which Richmond, plea agreement under Defender, tered into Public Federal tant im- eighteen months he was James sentenced Appellant. Michael for Virginia, prisonment. Attorney, States Elston, United Assistant Alexandria, Appellee. ON Virginia, for asked us defendant has appeal, the On Jr., Dunham, Federal BRIEF: Frank W. Johnson in in opinion our to reconsider Richmond, Defender, Virginia, for Public Supreme Court deci- of the recent light McNulty, United Paul J. Appellant. Morrison, v. 529 United States sions Flannery, Assis- E. Attorney, Sara States 1740, 598, 658 146 L.Ed.2d 120 S.Ct. U.S. Alexandria, Attorney, tant United States, v. United (2000), 529 Jones and Appellee. Virginia, 1904, 848, L.Ed.2d 902 U.S. S.Ct. Mor- (2000). Because we do construe WILKINS, Judge, Chief Before in the or Jones to establish change rison BEEZER, WIDENER, Judge, Circuit previ- to overrule requires law that us of the United States Judge Circuit Senior court, panel of another ous decision of the United States Court Court our decision we decline reconsider Circuit, sitting by Appeals for the Ninth Najjar, v. United States Johnson. See designation. Cir.2002). F.3d 486 n. 8 by published per curiam Affirmed district Accordingly, opinion. court is AFFIRMED.

OPINION PER CURIAM: was in- Ralph Howard Rich

Defendant Virginia in the Eastern District

dicted failing pay unlawfully willfully and support for more than child

court-ordered than in an amount years greater

two $10,000 Support in violation of Child America, STATES UNITED Act, § as amend- Recovery 18 U.S.C. Plaintiff-Appellant, Punishment Parents ed Deadbeat 228(a)(3) Act, (Supp.1999). § 18 U.S.C. v. the indict- moved to dismiss defendant UNIVERSITY, a ST. LOUIS § ground ment on U.S.C. corporation, Defendant- of Con- unconstitutional exercise was an Appellee. dis- power. The gress’s Commerce Clause No. 02-1351. motion, reasoning trict court denied by the Fourth Circuit that it was bound Appeals, United States Court Johnson, decision of United States Fourth Circuit. (4th Cir.1997), which this F.3d Support Recov- court held that Child Argued: Jan. 2003. Congress’s exercise of ery proper Act is a July 2003. Decided: a state power because Commerce Clause “thing in interstate support order is child parent and obligated when

commerce” states. child reside different

dependent *2 Mary Leach, McElroy

ARGUED: Sen- Trial, ior Department United States Of Justice, D.C., Washington, Appellant. for Moller, Marc Simon Kreindler & Krein- dler, York, York, New Appellee. New McCallum, Jr., ON BRIEF: Robert D. General, Attorney Assistant Thomas M. DiBiagio, Attorney, Jeffrey United States Axelrad, Director, Branch, Torts Di- Civil vision, United Department Of Jus- tice, D.C.; Washington, Troy, Daniel E. Chief, Blumberg, Eric M. Deputy Chief for Litigation, Druckman, Michael N. Associ- ate Chief for Biologies, Drug U.S. Food & Administration, Rockville, Maryland; Alex against SLU.1 judgment entered General, Department Of II, Azar, M. Services, and remand. Washington, reverse Human And Health Dunn, R. Her- Mark D.C., Appellant. L.L.P., Louis, McGhee, St. &

zog, Crebs I. BACKGROUND Kops, Cynwyd, Bala Missouri; P. Stanley *3 Korein, Carr, Carr, A. The Vaccine Rex Pennsylvania; Glass, St. Kunin, Montroy & East Tillery, poliomyelitis; types of There are three Missouri, Louis, Appellee. a only from contracted “Type I can be II virus, only Type from a I II Type Type LUTTIG, NIEMEYER, and Before Type a III only III from Type and virus TRAXLER, Judges. Circuit Polio Vaccine In re Oral virus.” by published and remanded Reversed F.Supp. 412 Litig., Liab. Prods. wrote the Judge TRAXLER opinion. 1950s, (D.Md.1990). an oral polio In the Judge in which opinion, majority (“OPV”) a developed that used vaccine Judge joined. LUTTIG NIEMEYER polio vi- or weakened live but attenuated dissenting opinion. a wrote cultivated from live all rus. “Like vaccines viruses, immunity induc- OPV creates OPINION recipient.” in the mild infection ing a TRAXLER, Judge: Circuit Co., 158 Cyanamid v. Stuart American (“SLU”) paid a University $16 Louis St. Cir.1998). (2d However, 622, 625 F.3d to Missouri state-court million a a with it risk that also OPV carries boy paralyzed became family of a who (or in close contact with recipient someone Orimune, polio an oral vac receiving after contract the disease recipient) will from sought contribution SLU cine. through vaccine. company parent Cyanamid, American wild virus produced by passing OPV is manufacturer, and United the vaccine to an animal host type through each ap tested and government, which of attenuated virus. develop a “strain” district court the vaccine. The proved uses the strain The vaccine manufacturer summary judgment favor of granted virus, type of each grow a “seed” government, concluding and the Cyanamid monopools of produce are used seeds claims were SLU’s contribution virus, “lots” of that virus type of each estoppel. of collateral by principles barred monopools. from the type are derived St. and remanded. reversed are type of virus then Lots from each States, Fed.Appx. v. Univ. United Louis single pool, into a “trivalent” combined (4th 2001); Cyanamid Cir. American pro- can be vaccine from which trivalent (4th Univ., Fed.Appx. 131 St. Louis types all three protect against duced to 2001). remand, After on motions and Cir. States, 486 v. United polio. See Berkovitz judgment, summary cross-motions 100 L.Ed.2d S.Ct. U.S. govern court concluded district (1988). ment, Cyanamid, was liable in but not approved ap The United States The to SLU. contribution adopted regula- in 1961 in 1960 and OPV court’s conclusion the district peals manufacture governing tions to the state- required to contribute can be claim asserted rejection of its contribution Cyanamid Co. v. St. Louis Uni In American 1. appeal in Cyanamid. We address that versity, 2003 WL 21660347 336 F.3d 2003), separate opinion. appeals the district court's Cir. SLU regulations The required vaccine. OPV to B. The State Court Action certain “neurovirulence” tests. satisfy The judgment paid by state-court SLU is the in- capacity Neurovirulence an arose from SLU’s actions in treating 3- agent produce pathologic fectious ef- Danny month old Approximate- Callahan. system. on the central fects nervous ly one receiving month after a dose of context, it refers to vaccine’s Orimune, Danny developed a fever ability paralytic poliomyelitis. to cause perirectal abscess. He was treated at product neurovirulence of a vaccine Cardinal Hospital by Glennon hospital and injecting product tested into SLU employees. Although the abscess monkeys. product meets neu- improved, Danny’s legs and left arm were only specified rovirulence criterion if a permanently paralyzed. Type III vi- *4 number of the animals survive and a rus in stool, was isolated Danny’s and doc- comparative analysis demonstrates that tors ultimately Danny concluded that suf- the neurovirulence of prod- the vaccine fered from polio. vaccine-associated uct does not exceed the neurovirulence plaintiffs’ The theory of the case was product reference previously a select- that improperly SLU Danny’s treated ab- by agency. ed by scess giving him wrong kind of Berkovitz, 486 U.S. at 545 n. 108 S.Ct. antibiotic. improper The treatment al- (internal omitted). quotation marks endotoxins, lowed the release of sup- which original Under the OPV regulations, giv- a pressed Danny’s system immune a during en monopool produce could be used to polio time when the virus from the vaccine if only vaccine its neurovirulence did not was still replicating Danny’s in gastroin- exceed that of the reference vaccine and testinal tract. Danny’s Because immune the monopool was one of consecutively five system compromised, was the attenuated monopools made that all satisfied the mon- polio virus in the vaccine was able to repli- key neurovirulence test. cate fast enough to sup- overcome his pressed system, immune government resulting polio- in amended substantially myelitis. plaintiffs’ monkey experts regulations neurovirulence in testified that if in had part immediately because abscess studies been did show incised and drained required by correlation between as higher neurovir- care, standard Danny and if monkeys ulence scores had the inci been and antibiotic, treated with an appropriate dence of polio vaccine-associated in hu mans. See endotoxins not have Additional would been Standards Viral released Vaccines, system his immune would Fed.Reg. not have (May 8, 1991) (“No suppressed. Thus, expert been single vaccine lot has been wit- Danny nesses testified that associated with an had increased incidence of been properly, treated he would not poliomyelitis. The lots that have been been paralyzed by polio jury’s identified as associated vaccine. The para with a case million lytic poliomyelitis verdict favor of the $16 have had typically low was by the Supreme when tested FDA affirmed Missouri scores and the manu Court. v. facturer for See Cardinal neurovirulence in Callahan Glennon monkeys.”). (1993) (en banc). Hosp., 863 repealed In FDA S.W.2d number of regulations, including polio the oral vaccine C. In re Sabin regulations. See Revocation Certain Regulations, 61 Fed.Reg. While Callahan Cardinal Glennon 1, 1996). (August Hospital was proceeding through the Mis- IV”). vaccine received The Orimune bin courts, Orimune multi-district state souri derived from one Danny was gov- by Callahan the United cases filed the district court Tort Claims of the vaccine seeds the Federal under ernment improp were District of cases concluded to the Sabin transferred Act were erly approved by of the common the government. Maryland for resolution In re factual legal questions. THE ACTION II. CONTRIBUTION Prods. Liab. Polio Vaccine Sabin Oral (D.Md.1990); re F.Supp. 410 Litig., 743 af- Supreme Court After the Missouri Liab. Prods. Polio Vaccine Sabin Oral verdict, filed SLU firmed the Callahan (D.Md.1991); In re F.Supp. 811 Litig., 763 Maryland against action contribution Liab. Prods. Polio Vaccine Sabin Oral States, Danny alleging the United (D.Md.1991) (“Sa- F.Supp. 952 Litig., 774 polio Callahan’s III”). plaintiffs contract- The Sabin bin in the failings mental identified vac- receiving the Orimune ed after partial moved for cases. The with a into contact coming after cine or judgment, arguing SLU was summary They sued recipient vaccine. estoppel from relit- by collateral barred alia, that the inter alleging, government, jury’s conclusion that igating the Callahan for re- negligently approved Danny’s polio. malpractice caused SLU’s *5 the which contained the vaccine lots lease concluding that agreed, The district court though to the even given plaintiffs, doses relitigating from the prohibited was SLU were which the lots the vaccine seeds from the Callahan facts that the court believed the neurovirulence derived did not meet in order to reach its jury necessarily found regu- governing the set forth in standards (1) that breach- against SLU: SLU verdict lations. of care when applicable ed the standard (2) abscess; Danny’s that treating Danny’s ultimately concluded district court The sup- been system not have immune would could be held liable government that the inadequate treat- pressed but for SLU’s did not approving vaccine lots that (3) abscess; that, but the ment of regulatory requirements comply with the Danny’s sys- immune state of suppressed the “Good Applying for neurovirulence. tem, contained polio the five virus the Restatement principles of Samaritan” vaccine, repli- (Second) Torts, would not have been able court deter- the district (4) polio; and enough cate fast by violating government, mined that, negligence, Danny but for approv- SLU’s regulatory its own standards The paralyzed. not be district derived from seeds would ing for release vaccine estoppel prevented court’s collateral order stan- that exceeded the neurovirulence negli- it not dards, arguing from that was of harm for SLU had the risk increased on vaccine, any negligence at all or that its proxi- gent receiving the which those Danny’s polio, part did not contribute to plaintiffs’ injuries. Sa- mately caused the proceed on III, ruling allowed SLU at 958. This court but F.Supp. bin theory with the Callahan any consistent court’s causation affirmed the district Thus, estoppel after the collateral In re Sabin verdict. liability determination. order, prevail could could SLU still Litig., Liab. Oral Polio Vaccine Prods. curiam) (“Sa- (4th Cir.1993) immunosuppressed an child establish that (per F.2d cases re Sabin cases. judge presiding over the 2. The district currently presided over the In before us also polio remand, would not have contracted from a After SLU offered no new evi- complied vaccine that with all regulatory dence, deposed witnesses, no new and of- requirements. fered no theory new Instead, causation. it relied almost exclusively on the fact that estoppel ruling,

After the collateral cases, in the Sabin the court determined parties engaged eighteen months of dis- that the government’s regulatory violations covery. then moved for caused injuries at issue. argued SLU summary judgment on ground that Danny Callahan’s vaccine came prove govern- SLU could not from one of the seeds that the district ment’s negligence Danny’s polio. caused Sabin had concluded The district court reviewed the evidence ment negligently approved in violation of submitted SLU and concluded that it its regulatory own standards. insufficient, Since the given the Callahan find- court had Sabin concluded that gov- ings, to establish a causal connection be- failings ernment’s proximately caused the government’s tween the negligence and injuries of the plaintiffs, Sabin sug- SLU Danny’s injuries. The district court there- gested that those regulatory same viola- granted summary fore to the tions must also be held to proximate- on SLU’s contribution claim. ly Danny’s injuries. caused remanded, We reversed and concluding that the district court improperly applied agreed district court with Ap- SLU. Missouri law when it held that the Calla- plying analysis the same the court had jury han verdict had collateral estoppel III, used the district court con- effect on SLU’s contribution action cluded negligence in government. explained that Mis- approving vaccine that did satisfy souri law did not limit SLU to causation neurovirulence standards Danny’s *6 predicated theories on the Callahan jury’s polio. The district court granted therefore implicit conclusion that Danny would not partial summary SLU, to con- have contracted negli- but for SLU’s cluding government that the was liable in gence suppression which resulted in the of SLU, contribution to but for la- reserving However, his system. immune the district ter the determination of the extent of the court had during limited SLU discovery to government’s liability to SLU.3 causation theories consistent with rul- its ing as to the estoppel collateral effect of III. ANALYSIS the judgment, Callahan and the district government’s liability The premised court in contribu- its order granting sum- tion, course, dependent of mary judgment on SLU’s pres- on SLU’s failure to ability to establish that government ent evidence the of causation consistent with can be its collateral held hable on the tort claim in estoppel ruling. the Because of underlying action. the district court’s error with See United v. regard to the Co., issue, 543, estoppel 546-50, collateral Yellow Cab we 340 U.S. 71 reversed the (1951) grant district court’s S.Ct. 95 L.Ed. summary judg- (concluding ment to opportunity allow SLU an to de- of sovereign immunity waiver un- velop appropriate other theories of causa- der the Federal Tort Claims Act encom- tion. passes claims for contribution the law 3. ap- bring The district court interlocutory certified the order as appeal. See 28 review, propriate immediate 1292(b) (West 1993). and this § U.S.C.A. granted government permission the to the cases as appears that the court viewed private hold state would the relevant on the binding precedent in the establishing contribution liable for

individual circumstances); v. Corp. proximate cause. See St. question Gramex same Inc., States, S.W.3d Supply, v. United Green Louis Univ. banc) (“To (en ac- (Mo.2002) (“I maintain an (D.Md.2002) am 500 5 F.Supp.2d n. contribution, party seek- both tion for of collateral relying upon not doctrine defendant ing contribution may not be invocable estoppel, which sought must contribution is whom against simply fol- government. I am tortfeasors, liable to the originally be III that lowing my reasoning Sabin (alterations and party.” plaintiff-injured (citation omitted)). appeal.” affirmed on omitted)). The marks quotation internal then, III is whether Sabin question, The presented that SLU contends government serve as and our in Sabin IV decision showing that no evidence think precedent in this case. We binding vac- original polio ment’s violations is no. question the answer to that caused the proximately regulations cine Ac- by Danny Callahan. injuries suffered Tort Claims the Federal Under the district cording government, law, Act, serves as not federal state amounts to the case approach court’s liability.” “the source substantive liability for the imposition of absolute 471, 478, 114 Meyer, v. 510 U.S. FDIC inconsistent with which is government, (1994). 127 L.Ed.2d 308 S.Ct. Tort of the Federal requirements liability to requires Act meet the causa- Act and Claims does “in with the law determined be accordance Missouri law. Given tion requirements of act or omission place where the any admissible the absence of (West 1346(b)(1) § occurred.” U.S.C.A. evidence, contends Supreme Court has con Supp.2003). must have reached that the district court place” the “law of the refers cluded that estoppel collateral by giving its decision law,” choice-of-law including the “whole III, but that to its decision effect negligent principles of the state where applied cannot be estoppel collateral See Richards act or omission occurred. in this case. against the States, 1, 11, 82 S.Ct. United U.S. (1962). 7 L.Ed.2d 492 A. *7 with government’s the actions Because ar- the consider We first in polio place took regard to the vaccine decisions in the as to whether the

guments III, F.Supp. 774 at Maryland, see Sabin controlling given ef- cases must Sabin be 953-54, law, Maryland including its choice- outset, At we litigation. in the fect this case, just as principles, governs of-law government’s claim dispense can with the Under Ma- governed it the Sabin cases. improperly gave col- that the district court the law to principles, ryland’s choice-of-law the deci- estoppel Sabin lateral effect the law of the applied in tort cases is be sions, might well have an action which suffered, not injury where the was state v. Mendo- been error. See United negligent the act occurred. 568, where za, 162, 104 S.Ct. U.S. Co., 785 F.2d Foods (1984) Johnson Oroweat (rejecting the use of L.Ed.2d 379 Cir.1986). Danny Callahan estoppel offensive nonmutual collateral Missouri, Missouri law injured so was The district government). the against the applies to SLU’s claim the expressly give Sabin did Instead, plaintiffs in the Sabin ment. But the effect. estoppel cases collateral Maryland cases were residents The district court concluded that SLU injuries Florida and suffered their in those sufficiently had established that gov- Thus, proximate states. cause deter- ernment’s regulatory violations caused by ap- mination in III was injuries. reached Callahan’s The court explained law, plying Maryland III, and Florida while that in Sabin proximate cause determination in this I held that cause was estab- by applying-Missouri case must be made by lished the mere fact that if seeds 45 law. Accordingly, notwithstanding the fac- B 85 B use, and 45 165 had not been in cases, tual overlap analyses of the giving vaccine injuries rise to the simply Sabin III and Sabin IV do not would not have been manufactured. govern this case.4 The evidence clearly establishes that but

for the United States’s negligence, the- B. seeds would not have been used. I went reject on to an ancillary contention made plaintiff Under Missouri by seeking to hold a defendant liable in tort dispelled by specif- the fact that the must duty establish the existence of a on ic lots involved in the two cases under part protect defendant to consideration had met the regulatory plaintiff, a duty, breach of that and dam criteria, neurovirulence I concluded See, ages by e.g., caused the breach. that the causal connection between the ex L.A.C. rel. D.C. v. Ward Parkway Shop regulatory plaintiffs’ inju- violations and Co., (Mo.2002) ping Ctr. 75 S.W.3d logical, ries are sensible and direct. The (en banc). (and In this case the Sabin Fourth Circuit affirmed this holding on eases), the district court concluded that the appeal. government’s duty arose under the “Good doctrine, through

Samaritan” which My liabili reasoning Sabin III equally is ty may imposed be negligent applicable exe here. easily This can be most voluntarily cution of by undertaken duties. hypothesizing seen that SLU is cor- Dairy, See Hoover’s Inc. v. Mid-America rect in contending that the immunosup- (Mo. Dairymen, pression S.W.2d 432-33 allegedly by its mal- 1985) (en banc) (following practice Good Samaritan played absolutely no role in (Sec standards set forth in making Restatement susceptible Callahan to contract- ond) (1965)). §§ Torts 324A ing polio true, For from If that OPV. purposes litigation, of this exactly po- Callahan stands in the same agreed has to be bound findings sition as did the in other Sabin the Sabin cases duty that it breached its cases because that event the sole violating regulations. OPV See St. cause of his was the vaccine. Like- Univ., Thus, F.Supp.2d wise, Louis at 498. immunosuppression even the did *8 only issue before the district court play some role in process, the disease whether Danny SLU could establish that exposure Callahan’s to the oral vaccine injuries Callahan’s were had to contributing be a cause to his government’s duty. breach of paralysis. Type po- The isolation of III Instead, assuming 4. Even Maryland that SLU is correct in its and Florida law. we will Maryland contention that the tort laws of and go directly to the source and consult Missouri similar, Missouri are it makes little sense for cases to determine whether SLU has satisfied apply by way this court to Missouri law of requirements of Missouri law. IV, applied Sabin HI and Sabin cases that have occurred but for injuries would not stool demon- in Callahan’s lio virus no one cause is not polio, and that conduct. Proximate he contracted strates fact, immunosuppression is a limitation the causation but suggests caused the disease. upon right to recover imposes alone could law III, I held in Sabin Cal- Accordingly, as negligent of a act. consequences for the to the as a exposed virus proximate lahan was proving of requirement - government’s viola- consequence of the it those actors whom cause absolves gov- If the regulations. tion of OPV punish unfair to because of the would be wrongfully approved had not ernment relation which their conduct attenuated which the vaccine was seed from plaintiffs injury. bears to the derived, have been Callahan would never (citations Robinson, at 77 and S.W.3d of and a dose Orimune administered omitted). quotation marks internal polio have contracted even would never Danny district court’s conclusion Cal- immunosuppressed. This had he been lahan not have contracted “but would relationship meets the stan- “but for” goes action thus for” Missouri of cause under proximate dard causation-in-fact, only question to the law of just it does under the law as cause, proximate because it does not applicable in Sa- Maryland and Florida partic- of whether the question answer bin III. ular result that occurred was a reasonable Univ., F.Supp.2d at 499-500 Louis St. probable consequence and of the (footnotes, alterations, quota- and internal Callahan, ment’s conduct. See 863 S.W.2d omitted). tion marks (Missouri generally at 865 courts “have assume, course, that Sabin injury must be a said reasonable Mary properly applied III and Sabin IV act probable consequence and of the or Nonetheless, it is Florida law.5 land and defendant.”). omission approach in the Sabin clear that the taken explanation The district court’s requirements with the cases is inconsistent why required different results were as governs this case. of Missouri which the claims law, plaintiff must estab Under Missouri manufacturer, Cyanamid, sug the vaccine lish both causation-in-fact gests that the court believed the causation Callahan, 863 S.W.2d at cause. See standard is different cases where 865; Highway State Robinson v. Missouri duty arises under the Good Samaritan doc (Mo. Com’n, Transp. & S.W.3d trine. The court stated: curiam). (per Ct.App.2000) Cyanamid I find that cannot be held

A defendant’s conduct is the cause injuries where the hable for contribution to SLU and that fact of a States, (4th Cir.1991) points out that when this ed 923 F.2d 5. The ("Our interpretation Maryland TV affirmed the in Sabin law in Waf- III, analysis we in Sabin relied on question we is called into because were Waf fen Department v. Health & United interpreting Maryland espoused law as in He fen Services, Cir.1986), Human 799 F.2d 911 Weimer, v. was later trick which reversed requirements considered causation un which (footnote Maryland Appeals.” Court of Maryland der law in the context of claim for Hartman, omitted)); Cooper 311 Md. Subsequent cases loss of chance of survival. (1987) (placing 533 A.2d 1297 & n. Maryland from this state courts court and among group of decisions that im Waffen *9 accurately have indicated that did not Waffen regarding properly "relaxed the standards proxi Maryland's articulate the contours of causation”). Hurley requirements. mate cause v. Unit- (“[T]his banc) to summary judg- is therefore entitled Court has recognized that recognize (Second) I that this hold- ment. While section [of the Restatement may asymmetrical, paradoxi- ing seem duty ] Torts creates a of In care. creat- of cal, perverse or in light my even of ing duty, this section of the Restate- finding government is hable for type ment defines a negligent of behavior contribution, in the difference result but does not alter the rules of causation.” flows from the difference in the nature (citation omitted)). Thus, SLU’s claim respective by duties owed the against government requires evidence Cyanamid United States and to those proximate cause in addition to evidence exposed who were to the live virus con- of but-for causation. in tained OPV. proximate cause, As to we note that all above, As indicated in III I OPV, including regu- OPV satisfied all ruled that the Good Samaritan doctrine latory requirements, carried the risk that parallel provision, and its Restatement recipient actually polio. would contract (Second) § imposed Torts upon Therefore, to Danny’s polio show that duty approve not to regulatory vi- in

vaccine seeds violation of the OPV olations, we conclude that SLU was re- regulations. Cyanamid no was under quired to Danny likely establish that would duty. responsibili- such Its duties and (or not have contacted would have public, partic- ties to the members of the polio) contracted less severe case of from ularly recipients to their OPV fami- a vaccine that satisfied the government’s nes, products liability [are] defined neurovirulence requirements. Any lesser In considering law. against claims standard would in result Cyanamid, the focus must therefore be being strictly held regulatory liable for its on safety product, of its not the violations, which would be inconsistent regulatory process govern- for which the with Missouri law. See Sill v. Burlington Likewise, responsibility. ment bore in R.R., No. (Mo.Ct.App. S.W.3d analyzing the element of 2002) (explaining that the violation of a cause in against Cyanamid, claims can, circumstances, statute under certain focus must on plaintiff be whether the support claim, a negligence per se but that prove can it was a defect plaintiff prove must that the statutory OPV resulted in his injury, not sim- “violation was the cause of the ply- a case —as evidence, injury.”). course, And this exposed ment —whether he had been to expert must be the form of testimony. OPV derived from a seed that had been See, Barr, e.g., Wright v. 62 S.W.3d improperly approved in violation of the (“If (Mo.Ct.App.2001) there is a so regulatory process. Under Missouri law phisticated injury, requires one that surgi this element of required causation is cal intervention or other highly scientific plaintiff whether a sues for strict liabili- techniques diagnosis, expert medical ty, negligence, or warranty. breach of causation.”). testimony required prove Univ., St. Louis F.Supp.2d at 500. law, however, Missouri There is no such quite makes it evidence this record. best, clear that At experts the Good Samaritan SLU’s assumed that in- doctrine is relevant question creased neurovirulence in- duty only; it led increased no effect general has on the polio, rules of causa- cidence vaccine-associated but tion. See Wollen v. DePaul experts opinion. Health Cen- SLU’s did not offer that ter, (Mo.1992) (en fact, 828 S.W.2d experts none of SLU’s were even

304 it entitled to contri- to show that is opinion.6 The failed such an render

qualified to there- government. from the bution this absence of recognized district of Univ., grant court’s fore reverse the district evidence, Louis St. see in favor of SLU (“Whether summary judgment partial oral or not an F.Supp.2d at 502 judgment entry for the and we remand the OPV complied with that polio vaccine Monahan government. of the in favor caused Callahan regulations would Va., F.3d Chesterfield, County cases in the other Sabin and the Cir.1996) that (explaining ultimately unknowable is contract summary judg- SLU, cross-motions where as does SLU. unprovable.”), filed, appellate court have been to ment however, required it is not insists that favor entry can direct the proximate cause. present evidence of appellant). of the SLU, es- regulations According to AND REMANDED. REVERSED standards tablishing the neurovirulence presumption” “unrebuttable created an LUTTIG, Judge, dissenting: Circuit exceeding the standards any that vaccine recipi- unacceptable judg- risk affirm the district court’s posed an I would Appel- polio. binding prece- Brief of ent would contract ment in this case under the Thus, contends that once In In re 21. SLU of the circuit. Sabin Oral lee at dent Liability Litiga- in the Sabin cases it was established Polio Vaccine Products (4th Cir.1993) (“Sabin regulations tion, violated its F.2d 124 IV”), caused proximately that under a tort and that the violations we determined respects was automati- injuries, regime, identical all relevant injuries here, injury, for the suffered an identical cally liable the one at issue here, derived proximately received a vaccine at anyone who to the one issue at seeds issue conduct identical to that from one of the vaccine tortious above, such an As noted the basis of the reason- alleged the Sabin cases. here. On case, with Mis- in that I must approach utterly ing adopted inconsistent which we (“If Sill, at a application 87 S.W.3d that our here of Mis- souri law. See conclude negli- under a yields case is made law the conclusion submissible souri state action, plaintiff a gence per appellee proffered se cause SLU sufficient evidence that a jury necessary could recover if a concluded causation legally to establish the violation was prevail. statute was violated and the injury.”); proximate cause con- majority opposite reaches the Corp., Tire Friend v. Yokohama It reasons that “our decision clusion. (“One (Mo.Ct.App.1995) 5.W.2d binding pre- serve as [does not] Sabin IV action negligence per of a se elements case,” in this ante at because cedent was the is that the violation of statute determination in Sa- “the cause injury.”). proximate cause of by applying Maryland bin III was reached while the and Florida is no evidence Because there in this case must be made proxi- determination government’s regulatory violations at by applying Missouri law.” Ante 300. Danny’s injury, SLU has mately caused Moreover, pursue appeal. the district appeal, noted that it on 6. first this court expert provided who neurovi- court concluded that there was some evidence that more testimony qualified to render an this was not Danny to have more rulent vaccine caused causation, however, SLU, opinion on and SLU does not chal- polio. did not severe case of appeal. lenge on pursue theory does not that determination after remand and *11 reasoning would if compelling This be abide it until this court en banc or the proposed apply that we Supreme SLU the state law Court holds otherwise. holdings of Sabin IV to the facts of the Having rejected mistakenly the authori- But, today. majority case before us is TV, ty of Sabin majority asserts that SLU, wrong suggest by implica- that or the district court erred here because it tion, I, that argue binding Sabin IV is as a in engaged proximate no cause determina- matter of Missouri state All law. that tion whatsoever. But Sabin quite TV asks, I appro- SLU and all that contend is clearly shows majority to be error priate, judgment by is we reach our There, point. on this we concluded that an applying binding reasoning of Sabin identical causation theory, in the unique IV. circumstance where the tortfeasor’s func- tion is that of a product-approver, suffices While our decision in Sabin IV resulted to establish cause. rea- law holdings, produced state it also rea- soned as follows: soning, by which we reached those state point The final appeal concerns the law holdings. This is reasoning uniquely district court’s determination that [the court, and, the creature of this as it is government’s] approval of the lots was us, binding upon apply we must it in other cause of plaintiffs] [the involving predicate cases the same facts injuries. The probable test of [sic] (ie., functionally underlying identical tort cause is one of “reasonable probability facts, theories). regime, and causation or certainty.” reasonable In other manner, Sabin TV binds us as a mat- words, plaintiff “the has the burden of ter of open federal delimiting the field introducing evidence which affords a that we would otherwise face formulat- reasonable basis for the conclusion that ing our reasoning. question Because the it is likely more than not that the con- simply before us is how we will reason to duct of the defendant awas substantial application our regime, Missouri’s tort in bringing factor about the result.” which regime is functionally identical in The district court concluded: regards the relevant to those from which Regardless acceptability of the of the IV, we reasoned in Sabin our conclusion as specific lots from which were derived the to how to application reason to this vaccine ... government] [the had governed by Sabin IV. properly applied C.F.R. credit, majority, to its does at- 73.114(b)(l)(iii) § ... the seed would not tempt deny point the crucial in this have been used. This is so because case, namely, Sabin IV we rea- manufacturer would have been unable to soned from two state tort regimes, law satisfy consistency requirement injuries, from and from asserted causation 73.116(c). § in 42 found C.F.R Like- theories, functionally were wise, indistin- regardless acceptability of the guishable from those before us today. the lots from which the vaccine adminis- But, denial, such absent it has no basis derived, plaintiff] tered to [the were on which to reach the conclusion it reaches lots would produced never have been today other than disagrees that it with the approval released but for the reasoning adopted Thus, we in Sabin TV.While I [the] seed.... the causal connec- am sympathetic somewhat critique to the regulatory tions between the violations the majority implicitly plaintiffs’ injuries levels at that rea- logical, are sensi- soning, I, majority, as am is bound to ble and direct. already it, that we quite for it is clear argument analysis, court’s the district concluded that was not regulation amend the

failure parties’ the two distinguishing between 'proximate *12 effects, And this proper. de- was causal the injuries misconstrues us, of wheth- regardless termination binds opinion. court’s and the district claims why it is so is prior reasoning as our er liability arose out of government’s] [The persuasive. reg- the violation of vaccine in releasing the ulations, failure to amend not in its score, on this majority’s The concern regulations. however, fully borne out. That is not even government’s con- causal effect of IV, add (emphasis F.2d at that of understood than omitted). differently ed) (citations duct the result of fact the manufacturer is clearly concluded passage, we By this role as tortfeasor government’s reasoning the district court’s —what product- as a from its actions springs here merely but-for here terms a majority manufacturer, a opposed to approver. As proper a analysis causation —constituted product, range a presumably who sells respect to a analysis cause with defect, a without with and some some as a unilateral who functions tortfeasor only role is to deter- product-approver’s binding this Under product-approver. product goes to particular a mine whether required to conclude we are precedent, role, failure, unique market at all. this reasoning court’s identical that the district care, duty a does not and breach of cause proper proximate likewise here is comparison any easy between result analysis. had the happened would have defec- what majority’s underlying dissatisfaction because, defective, “product” not been tive on the be- analysis based with this seems tortfeasor, “prod- the defective for such analysis “would result an lief that such completely the failure to withhold uct” is strictly held liable being from distribution. the distributed item violations, which would regulatory its Thus, “product” government’s had the law.” Ante with Missouri be inconsistent defect, offending of the free of none been matter, liability initial strict As an at 803. distributed at all. would have been vaccine (e.g., negli- culpability effects standards of a the case manufac- This contrasts with etc.), recklessness, causation not gence, who, product been turer had its defect every viola- regulatory That standards. free, free have defect would distributed where the tion in the circumstance injury by one’s product. causation proxi- is the product-approver is a ment quite different from “defective” action is injuries by the use mate cause of sustained other, “defect-free” since one’s action simply defectively approved product of the market keeps product all from the while liability since under does not create strict distributes defect-free the other instead proven it be Missouri law still must law, Maryland Since product. Florida negligence was result of the violation plaintiffs to require just like Missouri or recklessness. demonstrating prove defect-free, And, sympathetic that, I product while am somewhat had the been occurred, and since majority’s apparent concern— not injury to the would other product differently defect-free is treated complete withholding regards to the been the than the with would have manufacturer vaccine, great of a not too effect of its action Callahan’s of causal stretch, wholly persuasive, even our on injury may not base —we alleged us to conclude Sabin IV that the proximately alleged COMPANY,

conduct caused the in- AMERICAN CYANAMID jury- Plaintiff-Appellee, The district court’s notation that its cau- analysis sation took into account that the government acted under a Good Samari- UNIVERSITY, ST. LOUIS duty aspect

tan articulates this Defendant-Appellant. majority case. That instead thinks No. 02-1235. signals notation that the lower court *13 mistakenly “believed the causation stan- United States Appeals, Court of dard is different cases where duty Fourth Circuit. arises under the Good Samaritan doc- trine[,]” added), (emphasis ante at 302 il- Argued: Jan. 2003. panel’s lustrates the appreciate failure to how a manufacturer’s defect injury causes July Decided: 2003. way, in one product ap- while defective proval injury causes in another. That dif-

ferent relationships causal exist between categories

different of conduct in- and the

jury they bespeaks nothing as to

what legal applies standard to those causal

relationships in a tort action.

But any even there were merit to the

majority’s prior concerns that our analysis

effectively creates a liability culpabil- strict

ity standard or a but-for causation stan-

dard and treats the differently manufacturer,

from the those issues have

already fought been over and decided— by today’s opinion.

and not de- IV provides

cided the matter and so binding which,

reasoning, if we were to apply

today, would result affirmance of the Indeed,

district judgment. court’s the rule us,

we only face not binds every but also

district court within our circuit every panel court,

future of our and the dissent’s

judgment only evades that reality tempo-

rarily. Maryland, See Booth v. 327 F.3d Cir.2003) 382-83 (explaining that

it is error to follow the more recent of two

contradicting panels). reasons,

For these I respectfully dissent.

Case Details

Case Name: United States v. St. Louis University, a Corporation
Court Name: Court of Appeals for the Fourth Circuit
Date Published: Jul 16, 2003
Citation: 336 F.3d 294
Docket Number: 02-1351
Court Abbreviation: 4th Cir.
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