The Saga of Preempting Prescription Drug Design Defect Claims

            Not so long ago in a Circuit not such far away, the issue of whether design imperfection claims against branded prescription drug manufacturers are preempted was joined.  Much like the origins of the Jedi or the major end-of-year holidays as we discern them, one would expect a clearer published chronicle of how this came to have existence.  There can be a disposition to read back from recent actual presentation and imbue our past selves by more knowledge or foresight that we in fact had.  For preemption of design desert claims against branded prescription drug manufacturers, we discern we have been arguing for it with regard to years and we are not quite sure why it took so long for a Circuit Court to adopt it.  As we distinguished a few weeks ago, Yates v. Ortho-McNeil-Janssen Pharms., Inc., No. 15-3104, 2015 U.S. App. LEXIS 21428 (6th Cir. Dec. 11, 2015), did furnish preemption, and did it pretty definitively.  So definitively that it took our sully as top decision of 2015.  Along the distance, the court declined to follow a precursory decision of the same court, Wimbush v. Wyeth, 619 F.3d 632 (6th Cir. 2010), that itself reversed decisions of the sorrow court in Longs v. Wyeth, 536 F. Supp. 2d 843 (N.D. Ohio 2008) (granting laconic judgment), and Longs v. Wyeth, 621 F. Supp. 2d 504 (N.D. Ohio 2009) (denying suggestion to alter judgment), each of what one. included the holding that pre-approval design default and negligence claims were preempted.  It is with the Longs/Wimbush decisions where our invention starts, subject to some back invention and with a healthy dose of links to ended posts.

            We pristine note, however, that it has ~-spun been our view, expressed in multitude posts and elsewhere, that design abandon allegiance does not make much sense considered in the state of a theory of liability for a usage drug.  In most cases, the sort of the plaintiff alleges made the drug excessively risky and thus defectively designed cannot it may be be changed without making it a sundry drug.  One of the principles of pharmacology is that changes to the chemical compromise will typically affect both the desired and undesired movables in the body–or as the Supreme Court observed in Bartlett, “since of [a drug’s] simple compromise, [it] is chemically incapable of existence redesigned.”  133 S. Ct. 2466, 2475.  Rarely, a well change to the “design” of the spirited. compound can be identified—maybe slice off this ethyl group or vary it from a racemic mixture to a stereoisomer—that force of ~ plausibly reduce the pertinent risk, at the same time that maintaining benefits and avoiding new risks.  Even at which place that kind of proposed design vary exists, the change would make the mix with ~s a different product, not a less ill version of the same product, what one. is what design defect is supposed to have existence about.  There may be some cases where a plaintiff claims that a distinct balance of a combined drug’s ingredients, or every inactive ingredient, or the delivery order should be changed to reduce the jeopard without making it a different physic.  Even those cases, though, look better suited to warnings-based claims.

            We be durable to maintain that prescription drug cases should exist about the adequacy of the advice provided through professional labeling, which is correspondent with the focus of the regulatory intrigue.  Because all drugs have risks, and individualized physician decisions to prescribe drugs weigh the risks and benefits of numerous options (including not prescribing any put ~s into) in light of the likely impact of patient counseling, it makes a great deal of more sense to impose liability based ~ward inadequate disclosure of the risks than up~ the presence of the risks.  As assortment out in our comment k examine, a bunch of jurisdictions agree by us, including where they have adopted a statutory system that makes warnings an issue in design failing cases.  When there is a intellect to look at the design itself, careless design is arguably a better skeleton for evaluating liability than strict liability design defect, as the former puts the point of convergence on the defendant’s knowledge and bearing whereas the latter puts it in successi~ the product itself.  With the whole of due respect to mechanical engineers and through some interest in shortening our passing from many to one detour, prescription drugs are not lawnmowers.

            So, wherefore did all that matter for preemption?  As we wish said when questioning the reasoning of a equal in ~ of decisions, it will typically have existence appropriate to ask whether an asserted produce of action has been recognized by state law and whether the plaintiff can make out a prima facie situation for it before looking at whether the claim is preempted.  Even in which place a plaintiff did assert a scrupulous liability design defect claim against a prescript drug manufacturer, one would have expected these issues to gain sorted out on motions for synoptical judgment rather than on motions to dismiss, at smallest until the law became fairly well quiet.  That means that there were a compute of reasons why a prescription mix with ~s case would not have produced a prevalent on whether a design defect claim with a view to a prescription drug is preempted, obstruction alone one that got published.  We can add to that the traditional focus on the larger issue of whether warnings claims—like we before-mentioned, logically and historically, the main abstract principles of liability for prescription drug cases—would subsist preempted.  In drug preemption’s inflectional period, there was not much litigation against generic drug manufacturers (and innovator accountability was practically unheard of).  In branded direction drug cases, manufacturers were hesitant to arouse preemption broadly, particularly while Levine was without ceasing its way up to the Supreme Court.  That started to make different with Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), and the year behind Buckman saw the first published resolution using Buckman to exclude evidence that intelligence was withheld from FDA.  See Bouchard v. American Home Products Corp., 213 F. Supp.2d 802 (N.D. Ohio 2002) (Katz, J.).

            Even in litigations to which place warnings-based claims are the plaintiffs’ force theory, there will be cases to what the prescribing physician gives clear manifestation that she knew the relevant peril and a different warning would not receive changed the prescription decision, or that she not read the manufacturer’s warnings at every one of.  Rather than simply accede to compend judgment on warnings-based claims—feed in mind that manufacturing defect claims with prescription drugs are almost always a dead end—more plaintiffs began to proceed solely steady a claim that the drug should not bear been available for any physician to direct it to any patient, arguably workmanship the prescriber’s knowledge and scantiness of proximate cause for failure to warn not bearing upon the point in question to the manufacturer’s liability.  While this “preclude selling” or “never sell” hypothesis has been labeled in various ways (including “stratagem on the FDA”) to meet the plaintiff’s single needs, it seems to us like a re-framing of design lack, albeit without pesky requirements like a practicable alternative design, no liability with suitable (or without inadequate) warnings, or proximate cause.

            We sententious precept three such prescription diet drug cases in fairly brief order, each of which shifted gears behind the collapse of the warnings claim that other plaintiffs had featured.  (Why everything three involved residents of northern Ohio is something of a mystery, like why Rey has a British accentuate.)  The first one was resolved judgment comprehensive rulings.  The second single in kind was Lance, where the trial court granted curt judgment based on Pennsylvania law not recognizing a enterprise of action for “you should not get sold it” under strict liability or disregard, without getting to whether such a hypothetical claim would be under the necessity been preempted.  Two appellate courts expanded the state’s carelessness law to accommodate the new speculation with the latter dancing around the striking of the intervening decisions in Mensing and Bartlett.  The third part case—this time asserting Ohio claims and having them heard in every Ohio federal court—was called Buchanan v. Wyeth.  When the plaintiff died, the case became known in the manner that Longs after the representative of the possessions.  On appeal, the case became Wimbush in the pattern of the initial representative died and was replaced.  Like in Lance, that the plaintiff’s decedent was alleged to be obliged died from the condition that the prescribing healer testified was a known and pleasing risk in prescribing the drug to the plaintiff might have garnered some extra concert from the court.  The role of sympathies which time the plaintiff’s lawyers abandon the diet-and-butter claim (warnings) and in the room argue for a novel reading of the state Product Liability Act is harder to presage.

            This is basically in what plight it went down in Longs v. Wyeth, 536 F. Supp. 2d 843 (N.D. Ohio 2008), be it so we are not mimicking the decision’s series.  After defendant moved for without fault summary judgment on lack of next cause and partial summary judgment without ceasing preemption, the plaintiff withdrew her warnings claim in approve of her previously asserted statutory design imperfection and common law negligence claim.  (We force of ~ ignore the punitive damages aspect of the state.)  In opposing summary judgment put ~ her remaining claims, plaintiff elected to rest particularly on legal arguments rather than proposal evidence.  At argument, she maintained that the unsalable article never should have been sold based up~ the evidence of its risks serviceable by the time it was approved and launched.  Under the Ohio statutory design fall away from duty provision, modeled on comment k, there is no design defect if the manufacturer “provides one adequate warning . . . concerning that unavoidably hazardous aspect.”  Based on the manifest in the record, the defendant admitted summary judgment because the Redux warnings towards primary pulmonary hypertension were adequate as a matter of law and prosecutor did not carry her burden of proving that they were disproportionate.  Id. at 854.  That left the threadbare law negligence claims, assuming they were not abrogated ~ means of enactment of the Ohio Product Liability Act.  The court held that the OPLA (as antidote to the time when the plaintiff’s account of action arose) abrogated “ill-defined negligence” claims but left “negligent design” claims.  Id. at 855.

          But had plaintiff asserted the same negligent design claim that Ohio courts had recognized judgment the OPLA?   (The analytics of abrogation really should have looked at whether usual law had recognized the duty that accuser sought to impose liability on the defendant during breaching.  A good preemption algebra should ask similar question about category law.)  Well, “Plaintiff had not clearly stated the nature of her negligence claim.”  Id. at 854.  She had alleged a bunch of things about the drug and the defendant, on the other hand they all flowed into “Defendants breached their what one is bound by . . . putting Redux on the emporium in 1996” or “they not at any time should have marketed Redux.”  Id.  And she had offered ~t any evidence supporting any breach:  “Plaintiff has not put forth any evidence that Defendants did not take appropriate steps in providing adequate warnings about Redux, that Defendants should be in actual possession of taken Redux off the market sooner, or that Defendants’ alleged failure to take Redux on the farther side the market sooner proximately caused Buchanan’s harm and/or death.”  Id. at 856.  She in like manner offered nothing on the drug’s design—other than it had risks—or for what cause to lessen them—other than to in no degree sell it.  So, plaintiff destroyed summary judgment on the merits in the same proportion that to whatever it was her inadvertency claim was supposed to assert, object she had no claims left.  But the court not at all actually determined that she was asserting a heedless design claim, as Ohio law had recognized it, at the same time that opposed to something that would regard imposed a previously unrecognized duty in c~tinuance a manufacturer.

            This led to a more or less confused decision on preemption, which conspicuous between pre-approval and post-approval claims.  We declaration “led,” but the sentiment discussed preemption first, before it had determined that plaintiff had no viable claims.  The conflict analysis for preemption of whatever pre-approval claims accuser was trying to make was fairly outspoken:

In other words, the FDA is amenable for regulating which drugs are on the market and the warnings in the same state drugs must provide. As such, Plaintiffs limited liability and negligence claims that Redux was one “unreasonably dangerous” drug for what one. no warning would have been commensurate directly conflicts with the FDA’s warrant to determine which drugs are sufficiently protected and effective to be, marketed.  Although Plaintiff asserts that she alleges solely that Defendants should not have marketed Redux, and that she does not plead that the FDA did anything improper, the court finds that her claim that Redux should in no degree have been placed on the mart interferes with the FDA’s objectives.  Consequently, every part of claims relating to pre-FDA approval are preempted ~ dint of. the FDA. In addition, to the stretch that Plaintiff alleges fraud-on-the-FDA or that Defendants concealed or misrepresented complaint to the FDA, these claims are preempted, in the manner that well.

Id. at 847 (emphasis added).  Perhaps because plaintiffs’ purported post-approval claims were so poorly described, the analysis of why they were not preempted was not in addition probing:

In In re Diet Drugs Prods. Liab. Litig. (“Mingus v. Wyeth,” or “Mingus”), No. 04-23744, 2006 WL 1071545, at *3 (E.D. Pa. Apr. 21, 2006), the court held that the plaintiff’s claims that “Wyeth designed a faulty product and was negligent in not seizing Redux off the market sooner tha[n] it did. . . . [i]n essence, . . . that Wyeth failed in its letter-carrier-approval duties” were not preempted.  Furthermore, Defendants have cited nothing in the FDCA, FDA regulations, or ~-ending law that suggests that the FDA intended to restrain all design defect claims.  Therefore, the court finds that Plaintiffs column-FDA approval design defect claims, less than strict liability and negligence, are not preempted.

Id. at 848.  Mingus was the highest diet drug case that we mentioned more than.  Without going into the distinct parts, it was not a final or published conclusion and preemption was hardly its point of convergence.  The larger issue with finding that some sort of post-approval design claim was not preempted was that prosecutor never articulated such a claim or the kind of evidence would support it distinct from the testimony that would have supported a (preempted) pre-approval design abandon allegiance claim.  This was not like Levine at which place the drug was marketed for decades before the prosecutor took it.  Rather, although accuser had no prescription or pharmacy records—even-handed to make things more complicated—she claimed to be favored with used the drug shortly after it collision the market.  In other bickering, this was not a case in what place the evidence of “you should take stopped selling it” was different than the testimony of “you never should be favored with sold it,” so a distinction of pre-approval and post-approval claims did not be of advantage much sense.

            A not many weeks after summary judgment, plaintiff filed motions to Vacate Order and Judgment and to Alter Judgment Pursuant to Federal Rule of Civil Procedure 59(e).  On preemption, she argued that Reigel and Kent in some way undercut the finding of preemption with a view to pre-approval claims.  The court waited to the time when Levine was decided and addressed it overmuch:

The instant case is distinguishable from Wyeth since this case does not involve a failure to warn claim, which served as the basis for the Supreme Court’s persistence. Furthermore, the court, in holding that a failure to warn claim is not preempted, focused put ~ the fact that the claim arises away of the actions of the manufacturer disgrace-FDA approval. The Court found that hinder the FDA approves a product conducive to the market, manufacturers maintain a duty to update warning labels because of their prevalent knowledge of new risks concerning their products. See id. This office-FDA approval duty is distinguishable from a manufacturer’s duty prior to approval by the FDA, a incidental that the Court does not explicitly petition. While Wyeth may stand for the tender that post-FDA approval claims are preempted, it does not tenor to hold that the same is real for pre-FDA approval claims. Thus, Plaintiff fails to prove that this court erred in its holding that Plaintiffs pre-FDA approval claims are preempted.

621 F. Supp. 2d at 509.  Having won adhering all claims—the plaintiff’s other arguments in spite of undoing summary judgment were rejected of the same kind with well—the defendant had no mind to try to expand the preemption ruling to cover the unsupported post-approval claims. 

            On seek reference of the case, of course, everything was up beneficial to grabs again.  While the Sixth Circuit affirmed up~ the body the OPLA design defect claim and the fix-approval negligence claims, it reversed the pre-approval inadvertency claims with a preemption analysis that netted the enclose the honor of being our get the better of decision of 2010.  To be~ there, the court had to procure past abrogation and the one-sided chronicle evidence below.  The abrogation analytics did not look at whether the omission theory plaintiff espoused had ever been adopted in the same proportion that part of the pre-OPLA often met with law, just whether all negligence claims had been abrogated.  619 F.3d at 639.  On the merits, the appellate court started with a curious narrowing of what the circuit court had held.  In its compendium judgment decision, the district court plant that the walkover on evidence suitably in the record precluded plaintiff from material out a prima facie case with respect to any negligence claim.  536 F. Supp. 2d at 855-56.  This was emphasized in the negation of the motions to vacate:  “Plaintiff’s failure to bring forward evidence regarding proximate cause was pernicious to any claim of negligence.”  621 F. Supp. 2d at 512-13 (weight added).  While appellate court agreed that the register evidence below meant that the defendant should regard won summary judgment on any asserted advertise-approval negligence claim, it wrongly limited the circuit court’s holding to “Buchanan failed to instant evidence demonstrating proximate cause between Wyeth’s alleged thoughtlessness after the FDA approved Redux and Buchanan’s wrong or death sufficient to survive a mental act for summary judgment.”  619 F.3d at 641 (stress added).  So, instead of evaluating whether plaintiff made out a prima facie on account of any negligence claim to which preemption force apply, the court jumped to preemption in the outline.  See id. at 645-46 (“For these reasons, we gripe that the district court erred in granting syllabus judgment to Wyeth on preemption dregs on Buchanan’s pre-approval customary law negligence claims.  In in such a manner holding, however, we do not let go upon whether there may be other bases for adjudicating these claims direct of trial. Neither the parties nor the quarter court have asserted any such alternative, so the issue is not prior to us.”).  It did not so much as evaluate whether Ohio law imposed the what one ought to do that could have created the conflict with federal law, as essential work of a proper conflict preemption decomposition:  “This discussion assumes the viability of of that kind a claim under the Ohio universal law. We do not address whether so a claim actually exists; instead, we entreaty only whether FDA approval would preempt of that kind a claim if it does subsist.”  Id. at 641 n.6.

            Given this way, it is not surprising that the preemption algebra went as it did, relying heavily without interrupti~ Levine’s presumption against preemption.  Id. at 642-43.  Our exemplar post on Wimbush lays out detailed criticisms of the ratiocination, which we will not repeat in the present life.  The crux on lack of clash was this:

In this case, being of the cl~s who a general proposition, we can see no physical impossibility between complying by a state law duty to appliance reasonable care in the process chief up to placing a drug adhering the market and complying with the founded on government’s process for approving drugs.  This is not to tell that such a physical impossibility could not at all exist, for instance if a public duty required that the manufacturer bestow something that the FDA forbade or defect versa. But such a situation would, we design, be the exception to the lordship. Thus, we are not persuaded that it is everlastingly impossible to comply with both predicament law duties and FDA regulations in the measure leading up to FDA approval.

Id. at 643 (force of utterance added).  Of course, the “position law duty to exercise reasonable care” is a unsettled characterization of the duty at the center of a claim that the manufacturer should not wish sold the drug because of its risks—risks that FDA had considered welcome in light of its benefits.  There was too the lingering issue of whether drugs that be delivered of been recalled, as Redux was not above eighteen months of its approval, generate a different set of rules whereas it comes to preemption.

            By difference to the complicated history that led to the tortured Wimbush settlement, Yates presented a much more show preemption challenge to design defect claims.  Yates was concern of the Ortho Evra MDL, overseen ~ dint of. the same Judge Katz who issued the Bouchard resolution mentioned above.  We have placed previously on a number of rapid judgment decisions from the litigation centered round the lack of viable warnings claims by means of any state’s law.  Like in this place and here.  These decisions made discernment because the risks at issue in these cases had been the subject of detailed warnings on the side of Ortho Evra and other estrogen-based contraceptives for a long time and physicians are well conscious of them.  Along the high~, various other claims fell, including design fall away from duty based on lack of affirmative testimony and on preemption.  Yates was at the close of the line of these decisions and knocked ~right all claims in two separate short judgment decisions.  It ended up considered in the state of first to be decided on appeal and presents a nice study of a clean defense win in a fundamentally equivocal case brought over a risk the prescriber understood, discussed with the plaintiff, and shared by the other drugs that were considered notwithstanding the plaintiff.  We will point of convergence on the preemption of the purported New York law design defect claim given the same court’s prior decision in Wimbush.

            It would have ~ing easy to say that the description for the difference between the product in Wimbush and Yates was the interjacent decision in Bartlett, particular its often-cited statement that “Once a drug—whether generic or brand-name—is approved, the manufacturer is prohibited from fabrication any major changes to the ‘qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications provided in the approved indication.’”  2015 U.S. App. LEXIS 21428, *27 (quoting Bartlett, 133 S. Ct. 2466, 2471 (2013)).  Yates considered this to subsist dicta and found Bartlett “did not extend to the sweeping conclusion that all design lack claims regarding a generic drug and clarified that preemption cannot have ~ing avoided if the only way a manufacturer be able to comply with both federal and express law is to exit the emporium.”  Id.  Nor did it be studious in books Bartlett as limited to generic drugs.  Instead, the court applied each impossibility (conflict) preemption analysis based steady Levine, Mensing and Bartlett–including Levine’s “visible evidence” standard (not repeated in Mensing or Bartlett) further not any presumption against preemption.  The spring of the analysis, as we be obliged been saying all along, is to induce what duties are actually imposed ~ the agency of the state law upon which plaintiff seeks to impose liability.  New York statute follows the same standard for design deficiency claims, whether labeled as negligent design or tense liability, requiring plaintiffs to prove a practicable alternative design and (consistent with make notes k) not imposing liability on manufacturers of prescript drugs that establish the warnings were sufficing.  Continuing the approach from foregoing cases, Yates analyzed preemption for pre-approval and column-approval claims separately, starting with the latter.

            It was not a agree call.  “Yates’s disgrace-approval design defect claim is clearly preempted ~ means of federal law.”  Id. at *32.  Unlike most purported design defect cases, including the diet remedy cases that first articulated a recent “stop selling” theory, the plaintiff in Yates actually came up by a proposed change to the design of the medicine:  reduce the estrogen dosage ~ means of 20%.  She probably had thing of no importance more than speculation to say that this vary would have avoided plaintiff’s attack or would not have reduced the drug’s potency, both of which she would gain been required to prove.  For impracticability preemption, however, the question is whether the manufacturer could wish changed the dosage on its acknowledge after approval.  Based on a straight read of the regulations, “We fancy it clear that changing the dosage of the same height of the active of Ortho Evra constitutes a ‘major change,’ such that prior FDA approval is necessary.”  Id. at **33-34.  Thus, some post-approval liability based on failure to cut short the estrogen dosage was preempted.

            Pre-approval was a narrow harder, even without Wimbush, because of the approachable appeal of the argument that “no federal law [] restricts a brand-connection drug manufacturer from designing a with reason safe product prior to FDA approval.”  Id. at *35.  But the Yates court looked back at what plaintiff would need to prove to enjoin liability and found no duty that could be reconciled with federal law.

But Yates’s subject regarding defendants’ pre-approval duty is likewise attenuated. To imagine such a pre-approval what one ought to do exists, we would have to ponder that had defendants designed Ortho Evra differently, the FDA would get approved the alternate design. Next, we would hold to assume that Yates would be delivered of selected this method of birth direct.  Further yet, we would esteem to suppose that this alternate design would not be delivered of caused Yates to suffer a knock. This is several steps too farther.  Even if New York ordinance requires defendants to produce and market a different design, the ultimate availability to Yates is fortuitous upon whether the FDA would approve the alternate design in the rudimentary place.

Id. at **35-36.  This walked right into the Mensing exemption from arbitrary control principle.  “Defendants could not be in actual possession of complied with whatever pre-approval what one is bound might exist without ultimately seeking the FDA’s approval precedent to marketing Ortho Evra, and certainly anterior to Yates’s use of the medicine.”  Id. at *37.

            Wimbush did not ordain a different result.  Whereas Wimbush held it was not unceasingly impossible to comply simultaneously with FDA order and with “a state legal science duty to exercise reasonable care in the train leading up to placing a remedy on the market”—ignoring that the prosecutor had never articulated what the defendant should wish done besides not try to memorize the drug approved—the vagueness of the claim in Yates worked close up to her.  “However, Yates  has not explained precisely that which a pre-approval claim would mien like in her case.  And we are incapable to conceive of any coherent pre-approval duty that defendants would have owed to Yates whenever it was developing Ortho Evra.”  Id. at **37-38.  Wimbush was likewise distinguishable because Redux was withdrawn and Ortho Evra is ~atory fairly widely prescribed.  To us, we produce not see a basis for a ecumenical rule for preempting design defect claims during drugs that are marketed at the time the instance is pending but not for those that be delivered of been withdrawn or discontinued for some reason.

            The Yates court in like manner noted that Bartlett’s rejection of the “intermit selling” rationale as a way to engender around conflict preemption also supports its finding of preemption for pre-approval design revolt claims.  “In contending that defendants’ pre-approval what one is bound would have resulted in a coming into life control patch with a different formulation, Yates essentially argues that defendants should none have sold the FDA-approved formulation of Ortho Evra in the in the ~ place place. We reject this never-come into existence suddenly selling rationale for the same reasons the Supreme Court in Bartlett rejected the come to a stand-selling rationale of the First Circuit.”  Id. at *39.  This is surely correct, but it suggests that Wimbush’s preemption decision should not be “good law” anymore.  Id. at *38.  Recall, the accuser in Longs/Wimbush withdrew her warnings claims to go solely on the theory—however labeled—that the deaden with narcotics never should have been sold.  Wimbush did not “apprehend that an actor seeking to fill both his federal- and state-body of rules obligations is not required to desist acting altogether in order to have nothing to do with liability,” as Bartlett requires.  It accepted the over against premise.  Going forward, we object of trust and expect that the preemption of design blemish claims for branded prescription drugs faculty of volition expand as the conflict of meagre reasoning like in Wimbush and Lance cannot be reconciled with the principles outlined in Mensing and Bartlett.

            Do we wish some tie back to the Star Wars trilogy of trilogies?  Do we acquire some prediction about which circuit last ~ and testament be first to follow Yates?  Do we hold some final imbedded joke to relax the readers (or ourselves)?  No, nay and no.  We do, however, have a wish for a Happy New Year to whoever made it the whole of the way through this post.

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