Weeks Reasoning – No Sweet Home In Alabama For Research Pharma

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This post is by the Reed Smith part of the blog only.  The Decherts are too involved in this litigation to comment publicly.

There aren’t many research-oriented pharmaceuticalcompanies based in Alabama, and after last week’s execrable decision in Wyeth,Inc. v. Weeks, ___ So.3d___, 2013 WL 135753, slip op. (Ala. Jan. 11, 2013), that’s not likely to change any time soon.  We don’t know why that started; Huntsville, at least, has a distinguished scientific background (and there's a statue of a Vulcan in Birmingham – wait a minute, the ears don't match Spock's), but it’s certainly true now. Unfortunately it appears that, instead of (or perhaps in addition to, given the recent election results) the Ten Commandments, there’s another commandment that the Alabama SupremeCourt is following:  Thou Shalt (if you’re anAlabamian) Recover From An Out-Of-State Drug Company.
While the Alabama Supreme Court certainly has thepower to abandon the notion of manufacturer liability for defects in itsproducts (unlike a federal court sitting in diversity), having the power to dosomething doesn’t make it right.  And ifthere’s one thing that’s not right, it’s having the liability of a defendantnon-manufacturer turn on what its competitors did (or didn’t do).  And if there’s another thing that’s notright, it’s imposing liability on a product manufacturer that didn’t make acent (and probably was driven out of the market by) from the product thatactually caused the injury in question.

Nor is it very likely that this novel theory of“fraud/misrepresentation” liability can be limited to prescription drugs, whatever its intended scope.  There are lots of situations in whichproducts bear similar warnings. Sometimes, as with prescription drugs, such similarity is mandated bythe government (cars, for example, or chemicals); sometimes similarity is simplya function of similar products having similar risks, and thus requiringsimilar warnings.  One such example couldbe asbestos.  There were lots ofdifferent asbestos products, and the same kinds of asbestos products do (or, atleast, plaintiffs allege they do) have similar risks.  We have to think that asbestos plaintiffs aregoing to have a field day with Weeks – more, perhaps, than even genericplaintiffs, since the learned intermediary rule still applies to prescriptiondrug cases.Anyway, we could go through each of these policyconsiderations at length, but we’re not going to.  We already did that in connection with theoriginal decision in Conte v. Wyeth, 168 Cal. App. 4th 89 (Cal. Ct. App.2008).  So we’ll rely on our discussionsthere:First, this kind of liability is contrary to the fundamental legal tenetthat manufacturers’ are supposed to be liable because they made money puttingthe injurious product on the market:Well, [branded liability] is an end run around the heartof modern product liability, which was created . . . some fifty yearsago.  [Courts] recognized a coreprinciple of social responsibility that justified what was then a new form ofliability:  The purpose of this [product]liability is to ensure that the costs of injuries resulting from defectiveproducts are borne by the manufacturers that put such products on themarket.  In other words, becausemanufacturers profit from the sale of their products, it is appropriate forthem to answer for injuries caused by defects in those products.  Time after time, . . . liabilityfor injuries caused by allegedly defective products has been justified byreference to this paramount policy.
 DDLaw, Closing The Arguments On Conte(1/22/2009) (citations and quotation marks omitted).Second, divorcing liability from manufacturecreates open-ended and unpredictable liability that uniquely penalizesinnovative drug manufacturers, and raises the price of all drugs, not just theone involved in litigation:Under Hatch-Waxman, a manufacturer of a pioneer drug hasonly the seventeen-year life of its patent to recoup its re­search expenses forthat drug, and to make a profit, before low-priced generic competition –unburdened by significant research or development costs of its own –effectively drives the pioneer drug off the market. . . .  Out of this finite revenue stream, thepioneer manufacturer must also factor in the inevitable expense of productliability.  But [with branded liability],a pioneer manufacturer’s exposure to product liability may not decrease as itsmarket share evaporates under generic competition.  Rather, that exposure stays the same – oreven increases. . . . [Such liability], in the case of pioneer drugs, has an inevitable effectof penalizing precisely the research and innovation that [the law] sought tofoster. Companies inventing new drugs incur more liability, whilenon-innovative generic manufac­turers have less responsibility for their ownproducts. . . .  This sortof liability cannot be anything but a profound disincentive to innovation andresearch. . . .  Pioneermanufacturers that have long since ceased making or selling a product end upsaddled with liability that can only be recouped by raising the prices ofother, unrelated pioneer products.  Suchdisincentive is the necessary byproduct of divorcing product liability fromproduct manufacturing.
 Id. (citations omitted).Third, the economic incentives are allwrong, as non-manufacturer liability rewards questionable practices by genericmanufacturers and penalizes more careful competitors:Careful Drug Co. gets word from the field that its drug,“X”, might cure high blood pressure when a doctor comes to it with a caseseries.  Careful takes a look at its dataand concludes that the doctor might just be right.  It encourages the doctor to publish the data,and, because this would otherwise be an off-label use, immediately begins aclinical trial. Rival manufacturer, Flybynight, upon reading the publishedarticle, immediately promotes its competing drug, “Almost X,” off label forcuring high blood pressure, and gets a huge market share because Almost X ismuch cheaper.  Careful’s expensiveclinical trial reveals that, when X is used long term it causes cancer.Everybody sues Almost X, and it declares bankruptcy/settles cheap/whatever.Everybody then sues Careful. . . .  Isn’t it foreseeable that the doctors woulddraw the analogy between the two closely related products (especially sincethat’s precisely what Flybynight’s reps were saying)?  And to that, we can add that the relevantwarnings for X and Almost X were identical because they were in same class. Andisn’t it foreseeable that doctors would rely more on Careful, given its muchbetter reputation, than Flybynight? How about if preliminary, short-term,results of Careful’s clinical trial were favorable and were published?  Because prescriber reliance is “foreseeable,”the responsible manufacturer (Careful) gets hit with liability for thesloppiness/illegal actions of a competitor (Flybynight). There’s nothing it cando about it, since it has no control over the competitor – short of closing itseyes to a potentially breakthrough new use for its product.DDLaw, More Thoughts On Conte v. Wyeth(11/13/2008).  Even the plaintiffs’ bar(through ATLA) has recognizedthat “patients . . . are safer taking brand-name drugs.”  So under Weeks, the “safer” brandedproduct is being penalized (and made more expensive) for injuries sufferedbecause people took a less safe generic product.Fourth, there’s nothing special about“misrepresentation” that excuses it from the same limitations that affect anyother claim arising from a product-related injury:Theblack letter of the Third Restatement of Torts likewise considersproduct-related misrepresentation to be a subset of product liability.  For product-related physical harm, theRestatement recognizes the liability of “[o]ne engaged in the business ofselling or otherwise distributing products” for a misrepresentation made “inconnection with the sale of a product.”  Restate­ment(Third) of Torts, Products Liability) §9 (1998); accord id. at comment a(§9 “appl[ies] to commercial product sellers”). Nothing in Restatement §9suggests that there could be actionable product-related misrepresentations onthe part of a non-manufacturer or seller.DDLaw, Closing The Arguments On Conte(1/22/2009).Fifth, prescription drugs – especially new,branded drugs − are extraordinarily beneficial to society, and expansiveliability that would raise their price or restrict their availability is to beavoided:Such a strained view of foreseeability is especiallyinappropriate in the case of pioneer drugs, given the extraordinarilyburdensome nature of the proposed duty and its socialcost. . . .  Dramaticexpansion of liability for product defects, in and of itself, implicates basicissues of social policy and the divide between judicial and legislativefunctions . . . .  [Courtshave] repeatedly recognized the overriding policy considerations that attach toprescription drugs, given their unique life-saving attributes and theirdependence upon extensive scientific research and continual innovation. . . .  Public policy favors the development andmarketing of beneficial new drugs even though some risks, perhaps serious ones,might accompany their introduction, because drugs can save lives and reducepain and suffering.  It is contrary tothe public interest, to deter prescription drug manufacturers from undertakingresearch into the development of new drugs because of the fear of large adversemonetary judgments.  Even when notdeterred altogether from developing innovative products, prescription drugmanufacturers could be forced by the “cost of insurance and defending againstlawsuits” to reduce drug availability and increase drug prices.Id. (1/22/2009) (citation and quotation marks omitted).Sixth, it gives certain plaintiffs anunwarranted extra shot at liability:But because it was a generic drug, the plaintiff made aclaim that users of pioneer drugs can’t bring. She also sued a non-manufacturer– . . . which made pioneer version of the drug that plaintiff nevertook at all. Incorporating all of the standard product liability allegationsabout the allegedly inadequate label, she changed the name of the claim to“misrepresentation”. . . . More stuff happened. The prescribing physician was deposed.  He testified that he neither read nor reliedupon any warnings that might have come with the generic drug.  That testimony killed the plaintiff’s standardproduct liability case, because under [established state] law, a plaintiffcannot establish causation in an inadequate warning case where the prescribingphysician did not rely upon the allegedly defective warning.  Under these facts, if [the case] were anordinary prescription drug product liability case, plaintiff would have beenout of court and out of luck. . . .  But because federal law requires that genericmanufacturers use verbatim the labeling initially prepared by the inventor ofthe drug . . . plaintiff got a second bite at the apple against [thebranded manufacturer], even though she indisputably never used [that] drug, and[the branded manufacturer] no longer even manufacturedit. . . .  [T]here is noreason that a plaintiff claiming injury from a generic drug should be betteroff – with an extra cause of action against a non-manufacturing pharmaceuticalcompany – than an identical plaintiff who took a pioneer drug.Id. (1/22/2009) (citations omitted).Seventh, non-manufacturer liability under amisrepresentation theory cannot logically be limited to prescription drugs:Plaintiff New Dad gives plaintiff New Mom his old SUV,manufactured by Gasguzzlers ‘R Us, so she has something big and safe to driveNew Baby around.  To replace it, he buysa hybrid made by Minigas, Inc. to drive to work. Wife puts New Baby’s carseatin the front seat, and plows into a telephone pole (or something else, it reallydoesn't matter).  The airbag kills NewBaby.  Gasguzzlers ‘R Us didn’t get itsfederal bailout and goes bankrupt. But since both of the family cars hadidentical government-mandated (allegedly) inadequate warnings about not puttingan infant car seat next to an airbag, who gets sued, Minigas – even though itscar had nothing to do with the accident. . . .  Isn’t it foreseeable that New Mom and Dadwould have relied on the warnings in the brand new owner’s manual they just sawwhen buying their brand new hybrid, instead of the older manual in the SUV,which they haven’t looked at in years (assuming they still have the old manualat all)?. . . .  So thehybrid maker ends up paying for injuries caused by an accident involving adifferent – and bankrupt – manufacturer’s SUV.We’ve seen plaintiffs come up with lots of creativetheories when the usual suspect is broke. Think “asbestos.” We have no doubt they’d try something like this, andtry it 100,000 times over.  So let’s tryan asbestos hypothetical.  We’ll keep itsimple:  Landowner hires contractors, whohire subcontractors, who hire subs of their own, to install or remove asbestosproducts from Blackacre.  The ownerdoesn’t tell anybody any more about asbestos risks than did the manufacturers,which is to say nothing.  Half a centurylater, all the asbestos manufacturers are bankrupt, so the employees of all thevarious entities sue Landowner.  Whybother with all the ins and outs of premises liability?  Just call the tort “negligent/intentionalmisrepresentation,” and . . . all privity-related limitations uponpremises liability evaporate.  IfLandowner could have known, everything else is “foreseeable.”DDLaw, More Thoughts On Conte v. Wyeth(11/13/2008).Anyway, we’re not uniquely, or even particularly,brilliant.  We have no doubt that all ofthese arguments (and more) were raised in Weeks, either by the defendantor by defense amici.  Let’s see what the Alabama Supreme Court hadto say.First Weeks distinguishes Alabama productliability claims (the so-called “Alabama Extended Manufacturer’s LiabilityDoctrine,” or “AEMLD”) from misrepresentation claims. “[T]he AEMLD did not subsume a common-law negligence or wantonnessclaim.”  2013 WL 135753, at*3.  “We have also recognized thatfraudulent suppression is a claim separate from an AEMLD claim.”  Id. Therefore, “we will not treat the [plaintiffs’] claims as AEMLD claimsgoverned by the principles of the AEMLD.” Id.  That’s always step one– get the claim away from all those inconvenient product liability cases thatpredicate liability (or in Alabama, “extended” liability) on the defendanthaving made the product.
 But why aren’t AEMLD principles relevant?
 Weeks doesn’t say.
 Continuing, Weeks discusses the relationshipbetween branded and generic drugs under the FDCA.  Id. at *4-5.  The court points out that adverse eventreporting is a shared responsibility of both branded and generic manufacturers,id. at *5, but holds that while a branded manufacturer “is responsiblefor the accuracy and adequacy of its label,” a generic manufacturer is only “responsiblefor ensuring that its warning label is the same as the brand name's.”  Id.; see also id. at *8(repeating the same quote from Mensing). That sounds a lot like the ATLA position that, under federalregulations, branded drugs are “safer” than generics.  So what is it that justifies saddling thesafer product with liability for injuries caused (if at all) by ingestion of the less safe product?The answer – in a word – Mensing.  Weeks goes on to discuss Mensingfor several pages.  2013 WL 135753, at*7-9.The court distinguishes all the prior Alabama caseson branded liability in generic cases as being decided prior to Mensing. 

• Mosley v. Wyeth, 719 F. Supp.2d 1340 (S.D. Ala. 2010) − “[W]e note that Mosley was issued before the United States Supreme Court in [Mensing], supra . . . Reliance upon the reasoning in Mosley that a generic manufacturer is responsible for its own warning labels and revisions of those labels is unsound”).  Weeks, 2013 WL 135753, at *9.
• Overton v. Wyeth, Inc., 2011 WL 1343392 (Mag. S.D. Ala. March 15, 2011), adopted, 2011 WL 1343391 (S.D. Ala. April 7, 2011) – “Overton was issued before the Supreme Court decided [Mensing]. Accordingly, the federal court's conclusion in Overton that a generic manufacturer becomes responsible for its own warning label after the ANDA process is incorrect.” Weeks, 2013 WL 135753, at *10.
• Simpson v. Wyeth, Inc., 2010 WL 5485812 (N.D. Ala. Dec. 9, 2010) − Simpson was issued before [Mensing] was decided, and the federal court's conclusion in Simpson − that generic manufacturers have their own duty to correctly advise a physician of risks associated with the generic drug regardless of the fact that a generic label is required to be the same as the brand-name label − is questionable. Weeks, 2013 WL 135753, at *11.

Weeks similarly swept aside the law in “otherjurisdictions . . . conclud[ing] that a brand-name manufacturer doesnot owe a duty to warn users of the generic version of the prescription drug ofthe dangers associated with the drug.”  Id.at 11.  The seminal case, Foster v.American Home Products Corp., 29 F.3d 165 (4th Cir. 1994), suffered fromthe same flaw:  “Foster was issuedbefore the Supreme Court decided [Mensing]. . . .  The Foster court’s finding thatmanufacturers of generic drugs are responsible for the representations theymake in their labeling regarding their products is flawed based on the “’ameness’requirement discussed in [Mensing]."  Weeks,2013 WL 135753, at *15.
What about all those courts that, post-Mensing,have declared that Foster – and traditional product liability lawgenerally – remains unchanged under the laws of Arizona, Arkansas, Connecticut, Florida,Georgia, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota,Mississippi, Nevada, New Jersey, New York, North Carolina, Ohio, Oklahoma,Pennsylvania, South Carolina, Tennesssee, Texas, Washington, and West Virginia?  See Demahy v. Schwarz Pharma, Inc.,___ F.3d ___, 2012 WL 6698692, at *3-4 (5th Cir. Oct. 25, 2012) (applyingLouisiana law); Smith v. Wyeth, Inc., 657 F.3d. 420, 423-24 (6th Cir.2011) (applying Kentucky law); Hogue v. Pfizer, Inc., ___ F. Supp.2d___, 2012 WL 4466609, at *2-5 (S.D. Ohio Sept. 27, 2012); Baymiller v.Ranbaxy Pharmaceuticals Inc., ___ F. Supp.2d ___, 2012 WL 3929768, at *3-8(D. Nev. Sept. 6, 2012); Phares v. Actavis-Elizabeth LLC, ___ F. Supp.2d___, 2012 WL 3779227, at *10-11 (S.D. Tex., Aug. 30, 2012); Eckhardt v.Qualitest Pharmaceuticals, Inc., ___ F. Supp.2d ___, 2012 WL 3600194, at*2-6 (S.D. Tex. Aug. 9, 2012); Strayhorn v. Wyeth Pharmaceuticals, Inc.,___ F. Supp.2d ___, 2012 WL 3217672, at *5-8 (W.D. Tenn. Aug. 8, 2012); Lashleyv. Pfizer, Inc., 877 F. Supp.2d 466, 471-73 (S.D. Miss. 2012); Guarinov. Wyeth LLC, 2012 WL 1138631, at *1-2 (M.D. Fla. April 3, 2012); In reDarvocet, Darvon & Propoxyphene Products Liability Litigation, 856 F. Supp.2d904, 910-13 (E.D. Ky. 2012) (applying Georgia, Indiana, Louisiana, Minnesota,Mississippi, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, SouthCarolina, Tennessee, and Texas law); Moore v. Mylan, Inc., 840 F.Supp.2d 1337, 1344 (N.D. Ga. Jan. 5, 2012); In re Darvocet, Darvon &Propoxyphene Products Liability Litigation, 2012 WL 4831632, at *2-3 (E.D.Ky. Oct. 10, 2012) (applying Arizona, Florida, Kentucky, Louisiana,Massachusetts, Michigan, Mississippi, New Jersey, New York, North Carolina,Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, and WestVirginia law); Del Valle v. Pliva, Inc., 2012 WL 4747259, at *5-8 (S.D.Tex. Sept. 12, 2012); In re Darvocet, Darvon & Propoxyphene ProductsLiability Litigation, 2012 WL 3610237, at *3-4 (E.D. Ky. Aug. 21, 2012)(applying Arkansas, Connecticut, Georgia, Kentucky, Louisiana, Massachusetts,Oklahoma, and West Virginia law); In re Darvocet, Darvon & PropoxypheneProducts Liability Litigation, 2012 WL 767595, at *2-9 (E.D. Ky. March 7,2012) (law not stated); Metz v. Wyeth, Inc., 830 F. Supp.2d 1291, 1294(M.D. Fla. Nov. 18, 2011); Morris v. Wyeth, Inc., 2011 WL 4975317, at*3-4 (W.D. La. Oct. 19, 2011); Madden v. Teva Pharmaceuticals, USA, Inc.,2012 WL 4757253 (Pa. C.P. Oct. 1, 2012) (applying Washington law); Condourisv. Wyeth, 2012 WL 2401776 (N.J. Super. Law Div. June 26, 2012).Umm….  Thosecases present inconvenient facts.  Weeksonly cites one of them (Baymiller),  and doesn't mention that it's post-Mensing.  Besides,they only account for 24 states (albeit every other state in the old Confederacy except Virginia) – less than half the country.

Or almost half the country  − just sayin'.Weeks was determined to go its own way,following Conte at least part way down the slippery slope of liabilitybased solely on “foreseeability”:[T]he Supreme Court concluded in [Mensing] that thelabeling for a generic drug is required by federal regulations to be the sameas the labeling for the brand-name drug.  Therefore, an omission or defect in thelabeling for the brand-name drug would necessarily be repeated in the genericlabeling, foreseeably causing harm to a patient who ingested the genericproduct.  A brand-name manufacturer iswell aware of the expiration of its patent and well aware that a genericversion of the drug will be made when the patent expires.  It is recognized that generic substitutionsare allowed in all 50 states.  Abrand-name manufacturer could reasonably foresee that a physician prescribing abrand-name drug (or a generic drug) to a patient would rely on the warningdrafted by the brand-name manufacturer even if the patient ultimately consumedthe generic version of the drug.2013 WL 135753, at *15.  So Weeks elected to view the claims assimply a type of “fraud claim based on misrepresentations made not to aplaintiff but to a third party.”  Id.at *16.  That, without Mensing, the case would be a routine AEMLD case, went without saying.Alabama law had never permitted this sort of theory that where the defendantwas not a manufacturer of the product that had injured the plaintiff,however.  Id. at *17.  Why change the rules now?  Well, because … it’s a prescription drug:Unlike “construction machinery,” “lawnmowers,” or“perfume,” which are “used to make life easier or to provide pleasure,” aprescription drug “may be necessary to alleviate pain and suffering or tosustain life.”  Brown v. SuperiorCourt of San Francisco, 44 Cal.3d 1049, 1063, 245 Cal.Rptr. 412, 751 P.2d740, 749 (1988).  Prescription medicationis heavily regulated by the FDA. It can be obtained only through a health-careprovider who can make a determination as to the benefits and risks of a drugfor a particular patient.Weeks, 2013 WL 135753, at *17.Wow!  Talkabout standing precedent on its head.  InBrown, the California Supreme Court discussed the special nature and FDAoversight of prescription drugs as reasons why even traditional forms ofproduct liability were inappropriate. Heck, our fifth block-quote proposition stated above (about theextraordinarily beneficial nature of prescription drugs) was mostly a bunch ofquotes taken from Brown. Uniquely, Weeks concludes that – because drugs are both extremelyvaluable and heavily regulated – they should be subjected to more, not less,liability.Why?Because – Mensing.  “Moreover, the brand-name manufacturer isunder a continuing duty to supply the FDA with postmarketing reports of seriousinjury and can strengthen its warnings on its own accord. In contrast, ageneric manufacturer's label must be the same as the brand-name manufacturer'slabel, and the generic manufacturer cannot unilaterally change its warninglabel.”  Weeks, 2013 WL 135753, at*17.So we guess we can say that Weeks didconsider at least our fifth policy ground – and decided to do exactly theopposite.  The more valuable the productis to society, and the more heavily it is regulated by the government, the moreliability the manufacturer is able to shoulder.  Weeks doesn’t discuss it in theseterms, but it reads like an application of the principle of charging whatever the traffic will bear.Weeks nowhere even alludes to any of theother practical reasons that counsel against non-manufacturer liability –unless one might say that, by its focus on the unique nature of prescriptiondrugs, the opinion means, sub silentio,to preclude the automobile and asbestos examples in our seventh policyground.  Instead, the only “fairness”that the court considers is that Alabama plaintiffs should have somebody to suedespite Mensing preemption:The Supreme Court in [Mensing] held that it wouldhave been impossible for the generic-drug manufacturers to change their warninglabels without violating the federal requirement that the warning on a genericdrug must match the warning on the brand-name version, preemptingfailure-to-warn claims against generic manufacturers.  In the context of inadequate warnings by thebrand-name manufacturer placed on a prescription drug manufactured by ageneric-drug manufacturer, it is not fundamentally unfair to hold thebrand-name manufacturer liable for warnings on a product it did not producebecause the manufacturing process is irrelevant to misrepresentation theoriesbased, not on manufacturing defects in the product itself, but on informationand warning deficiencies, when those alleged misrepresentations were drafted bythe brand-name manufacturer and merely repeated by the generic manufacturer.2013 WL 135753, at *19.  Well, perhaps free health insurance through tort law could be a substitute for Obamacare in more places than just Philadelphia.
 There are lots of reasons why the injury-causing party might not be subject to suit, such as a statute of repose, or lack of personal jurisdiction, or bankruptcy. What is it about preemption that supposedly warrants making a pretzel out of established law?  We've said repeatedly that strange things happen when courts encounter preemption in tort cases.  Weeks is now at the top of that strange heap.Is there anything good in Weeks?It’s not as bad as Conte.Now there’s damning with faint praise if we everheard (or spoke) it.Well, in its own way, Weeks is a ringingre-endorsement of the learned intermediary rule.  Id. at *18 (characterizing the rule as“an absolute defense for ‘failure to warn’ cases”).  Of course, all prior Alabama Supreme Courtlearned intermediary rule precedent expressly limited liability to “users” ofthe defendant's product.  See SpringhillHospitals, Inc. v. Larrimore, 5 So.3d 513 (Ala. 2008) (“the duty at issuewas a drug manufacturer's or a drug dispenser’s duty to warn customers”) (emphasis added); Walls v. AlpharmaUSPD, Inc., 887 So.2d 881, 883 (Ala. 2004) (“a manufacturer’s duty to warnis limited to an obligation to advise the prescribing physician of anypotential dangers that may result fromthe use of its product”) (emphasis added); Morguson v. 3M Co.,857 So.2d 796, 802 (Ala. 2003) (“[defendant’s] duty was to warn the physicians. . . who used [itsproduct]”) (emphasis added); Stone v. Smith, Kline & French Laboratories,447 So.2d 1301, 1304 (Ala. 1984) (“the manufacturer’s duty to warn is limitedto an obligation to advise the prescribing physician of any potential dangersthat may result from the drug’s use”)(emphasis added).  So we could say thatthat the rule, as well, has been upended – becoming an excuse for more, notless, liability – but we’re looking for something, anything that’s a silverlining here.The only other thing we can say on the plus side isthat, much more than Conte, Weeks makes clear that causation cancut off branded misrepresentation claims. Conte would allow liability on vague testimony about what aprescriber might have read decades earlier. Weeks seems more tightly drawn on the causation side:Once that duty [to warn prescribers] is fulfilled, themanufacturer has no further duty to warn the patient directly.  However, if the warning to the learnedintermediary is inadequate or misrepresents the risk, the manufacturer remainsliable for the injuries sustained by the patient. The patient must show that the manufacturer failed to warn thephysician of a risk not otherwiseknown to the physician and that the failure to warn was the actual and proximate causeof the patient’s injury.  In short, thepatient must show that, but for thefalse representation made in the warning, the prescribing physician would nothave prescribed the medication to his patient.Weeks, 2013 WL 135753, at *19 (emphasisadded).  From this quote, we takeaway:  (1) proof of warning causation isthe plaintiff’s burden – there’s no heeding presumption; (2) prior prescriberknowledge defeats this new misrepresentation theory just as it would a productliability theory;and  (3) causation requires evidence that there would have been noprescription, not some lesser change in the prescriber’s informed consent ormonitoring procedures.Yeah that’s pretty weak.  We know it. But that’s Weeks for you.The quickest fix would be for the Alabamalegislature to enact a product liability bill (similar to New Jersey andseveral other states) – to replace the “judicial legislation” of the AMELD, Weeks,2013 WL 135753, at *3 − that broadly encompasses "all" liability theories and requires manufactureof the product as an essential element. But is that in the cards, with research pharma’s aforesaid negligible presence in Alabama?

We're not holding our breath.