Friday, January 18, 2013

Weeks Reasoning – No Sweet Home In Alabama For Research Pharma

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 pharmaceutical companies 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 Supreme Court is following:  Thou Shalt (if you’re an Alabamian) Recover From An Out-Of-State Drug Company.
While the Alabama Supreme Court certainly has the power to abandon the notion of manufacturer liability for defects in its products (unlike a federal court sitting in diversity), having the power to do something doesn’t make it right.  And if there’s one thing that’s not right, it’s having the liability of a defendant non-manufacturer turn on what its competitors did (or didn’t do).  And if there’s another thing that’s not right, it’s imposing liability on a product manufacturer that didn’t make a cent (and probably was driven out of the market by) from the product that actually 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 which products bear similar warnings.  Sometimes, as with prescription drugs, such similarity is mandated by the government (cars, for example, or chemicals); sometimes similarity is simply a function of similar products having similar risks, and thus requiring similar warnings.  One such example could be asbestos.  There were lots of different asbestos products, and the same kinds of asbestos products do (or, at least, plaintiffs allege they do) have similar risks.  We have to think that asbestos plaintiffs are going to have a field day with Weeks – more, perhaps, than even generic plaintiffs, since the learned intermediary rule still applies to prescription drug cases.
Anyway, we could go through each of these policy considerations at length, but we’re not going to.  We already did that in connection with the original decision in Conte v. Wyeth, 168 Cal. App. 4th 89 (Cal. Ct. App. 2008).  So we’ll rely on our discussions there:
First, this kind of liability is contrary to the fundamental legal tenet that manufacturers’ are supposed to be liable because they made money putting the injurious product on the market:
Well, [branded liability] is an end run around the heart of modern product liability, which was created . . . some fifty years ago.  [Courts] recognized a core principle of social responsibility that justified what was then a new form of liability:  The purpose of this [product] liability is to ensure that the costs of injuries resulting from defective products are borne by the manufacturers that put such products on the market.  In other words, because manufacturers profit from the sale of their products, it is appropriate for them to answer for injuries caused by defects in those products.  Time after time, . . . liability for injuries caused by allegedly defective products has been justified by reference to this paramount policy.
DDLaw, Closing The Arguments On Conte (1/22/2009) (citations and quotation marks omitted).
Second, divorcing liability from manufacture creates open-ended and unpredictable liability that uniquely penalizes innovative drug manufacturers, and raises the price of all drugs, not just the one involved in litigation:
Under Hatch-Waxman, a manufacturer of a pioneer drug has only the seventeen-year life of its patent to recoup its re­search expenses for that 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, the pioneer manufacturer must also factor in the inevitable expense of product liability.  But [with branded liability], a pioneer manufacturer’s exposure to product liability may not decrease as its market share evaporates under generic competition.  Rather, that exposure stays the same – or even increases. . . .  [Such liability], in the case of pioneer drugs, has an inevitable effect of penalizing precisely the research and innovation that [the law] sought to foster. Companies inventing new drugs incur more liability, while non-innovative generic manufac­turers have less responsibility for their own products. . . .  This sort of liability cannot be anything but a profound disincentive to innovation and research. . . .  Pioneer manufacturers that have long since ceased making or selling a product end up saddled with liability that can only be recouped by raising the prices of other, unrelated pioneer products.  Such disincentive is the necessary byproduct of divorcing product liability from product manufacturing.
Id. (citations omitted).
Third, the economic incentives are all wrong, as non-manufacturer liability rewards questionable practices by generic manufacturers 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 case series.  Careful takes a look at its data and 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 a clinical trial. Rival manufacturer, Flybynight, upon reading the published article, immediately promotes its competing drug, “Almost X,” off label for curing high blood pressure, and gets a huge market share because Almost X is much cheaper.  Careful’s expensive clinical 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 would draw the analogy between the two closely related products (especially since that’s precisely what Flybynight’s reps were saying)?  And to that, we can add that the relevant warnings for X and Almost X were identical because they were in same class. And isn’t it foreseeable that doctors would rely more on Careful, given its much better 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 the sloppiness/illegal actions of a competitor (Flybynight). There’s nothing it can do about it, since it has no control over the competitor – short of closing its eyes 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 recognized that “patients . . . are safer taking brand-name drugs.”  So under Weeks, the “safer” branded product is being penalized (and made more expensive) for injuries suffered because people took a less safe generic product.
Fourth, there’s nothing special about “misrepresentation” that excuses it from the same limitations that affect any other claim arising from a product-related injury:
The black letter of the Third Restatement of Torts likewise considers product-related misrepresentation to be a subset of product liability.  For product-related physical harm, the Restatement recognizes the liability of “[o]ne engaged in the business of selling or otherwise distributing products” for a misrepresentation made “in connection 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 §9 suggests that there could be actionable product-related misrepresentations on the 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 expansive liability that would raise their price or restrict their availability is to be avoided:
Such a strained view of foreseeability is especially inappropriate in the case of pioneer drugs, given the extraordinarily burdensome nature of the proposed duty and its social cost. . . .  Dramatic expansion of liability for product defects, in and of itself, implicates basic issues of social policy and the divide between judicial and legislative functions . . . .  [Courts have] repeatedly recognized the overriding policy considerations that attach to prescription drugs, given their unique life-saving attributes and their dependence upon extensive scientific research and continual innovation. . . .  Public policy favors the development and marketing of beneficial new drugs even though some risks, perhaps serious ones, might accompany their introduction, because drugs can save lives and reduce pain and suffering.  It is contrary to the public interest, to deter prescription drug manufacturers from undertaking research into the development of new drugs because of the fear of large adverse monetary judgments.  Even when not deterred altogether from developing innovative products, prescription drug manufacturers could be forced by the “cost of insurance and defending against lawsuits” to reduce drug availability and increase drug prices.
Id.  (1/22/2009) (citation and quotation marks omitted).
Sixth, it gives certain plaintiffs an unwarranted extra shot at liability:
But because it was a generic drug, the plaintiff made a claim that users of pioneer drugs can’t bring. She also sued a non-manufacturer – . . . which made pioneer version of the drug that plaintiff never took at all. Incorporating all of the standard product liability allegations about 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 relied upon any warnings that might have come with the generic drug.  That testimony killed the plaintiff’s standard product liability case, because under [established state] law, a plaintiff cannot establish causation in an inadequate warning case where the prescribing physician did not rely upon the allegedly defective warning.  Under these facts, if [the case] were an ordinary prescription drug product liability case, plaintiff would have been out of court and out of luck. . . .  But because federal law requires that generic manufacturers use verbatim the labeling initially prepared by the inventor of the drug . . . plaintiff got a second bite at the apple against [the branded manufacturer], even though she indisputably never used [that] drug, and [the branded manufacturer] no longer even manufactured it. . . .  [T]here is no reason that a plaintiff claiming injury from a generic drug should be better off – with an extra cause of action against a non-manufacturing pharmaceutical company – than an identical plaintiff who took a pioneer drug.
Id. (1/22/2009) (citations omitted).
Seventh, non-manufacturer liability under a misrepresentation 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 drive New Baby around.  To replace it, he buys a hybrid made by Minigas, Inc. to drive to work. Wife puts New Baby’s carseat in the front seat, and plows into a telephone pole (or something else, it really doesn't matter).  The airbag kills New Baby.  Gasguzzlers ‘R Us didn’t get its federal bailout and goes bankrupt. But since both of the family cars had identical government-mandated (allegedly) inadequate warnings about not putting an infant car seat next to an airbag, who gets sued, Minigas – even though its car had nothing to do with the accident. . . .  Isn’t it foreseeable that New Mom and Dad would have relied on the warnings in the brand new owner’s manual they just saw when 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 manual at all)?. . . .  So the hybrid maker ends up paying for injuries caused by an accident involving a different – and bankrupt – manufacturer’s SUV.
We’ve seen plaintiffs come up with lots of creative theories when the usual suspect is broke.  Think “asbestos.” We have no doubt they’d try something like this, and try it 100,000 times over.  So let’s try an asbestos hypothetical.  We’ll keep it simple:  Landowner hires contractors, who hire subcontractors, who hire subs of their own, to install or remove asbestos products from Blackacre.  The owner doesn’t tell anybody any more about asbestos risks than did the manufacturers, which is to say nothing.  Half a century later, all the asbestos manufacturers are bankrupt, so the employees of all the various entities sue Landowner.  Why bother with all the ins and outs of premises liability?  Just call the tort “negligent/intentional misrepresentation,” and . . . all privity-related limitations upon premises liability evaporate.  If Landowner 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 of these arguments (and more) were raised in Weeks, either by the defendant or by defense amici.  Let’s see what the Alabama Supreme Court had to say.
First Weeks distinguishes Alabama product liability claims (the so-called “Alabama Extended Manufacturer’s Liability Doctrine,” or “AEMLD”) from misrepresentation claims.  “[T]he AEMLD did not subsume a common-law negligence or wantonness claim.”  2013 WL 135753, at *3.  “We have also recognized that fraudulent suppression is a claim separate from an AEMLD claim.”  Id.  Therefore, “we will not treat the [plaintiffs’] claims as AEMLD claims governed by the principles of the AEMLD.”  Id.  That’s always step one – get the claim away from all those inconvenient product liability cases that predicate liability (or in Alabama, “extended” liability) on the defendant having made the product.
But why aren’t AEMLD principles relevant?
Weeks doesn’t say.
Continuing, Weeks discusses the relationship between branded and generic drugs under the FDCA.  Id. at *4-5.  The court points out that adverse event reporting is a shared responsibility of both branded and generic manufacturers, id. at *5, but holds that while a branded manufacturer “is responsible for the accuracy and adequacy of its label,” a generic manufacturer is only “responsible for 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 federal regulations, branded drugs are “safer” than generics.  So what is it that justifies saddling the safer 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 Mensing for several pages.  2013 WL 135753, at *7-9.
The court distinguishes all the prior Alabama cases on 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 “other jurisdictions . . . conclud[ing] that a brand-name manufacturer does not owe a duty to warn users of the generic version of the prescription drug of the 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 from the same flaw:  Foster was issued before the Supreme Court decided [Mensing]. . . .  The Foster court’s finding that manufacturers of generic drugs are responsible for the representations they make 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 law generally – 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) (applying Louisiana 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); Lashley v. Pfizer, Inc., 877 F. Supp.2d 466, 471-73 (S.D. Miss. 2012); Guarino v. Wyeth LLC, 2012 WL 1138631, at *1-2 (M.D. Fla. April 3, 2012); In re Darvocet, Darvon & Propoxyphene Products Liability Litigation, 856 F. Supp.2d 904, 910-13 (E.D. Ky. 2012) (applying Georgia, Indiana, Louisiana, Minnesota, Mississippi, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, 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 West Virginia law); Del Valle v. Pliva, Inc., 2012 WL 4747259, at *5-8 (S.D. Tex. Sept. 12, 2012); In re Darvocet, Darvon & Propoxyphene Products Liability 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 & Propoxyphene Products 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); Condouris v. Wyeth, 2012 WL 2401776 (N.J. Super. Law Div. June 26, 2012).
Umm….  Those cases present inconvenient facts.  Weeks only 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 liability based solely on “foreseeability”:
[T]he Supreme Court concluded in [Mensing] that the labeling for a generic drug is required by federal regulations to be the same as the labeling for the brand-name drug.  Therefore, an omission or defect in the labeling for the brand-name drug would necessarily be repeated in the generic labeling, foreseeably causing harm to a patient who ingested the generic product.  A brand-name manufacturer is well aware of the expiration of its patent and well aware that a generic version of the drug will be made when the patent expires.  It is recognized that generic substitutions are allowed in all 50 states.  A brand-name manufacturer could reasonably foresee that a physician prescribing a brand-name drug (or a generic drug) to a patient would rely on the warning drafted by the brand-name manufacturer even if the patient ultimately consumed the generic version of the drug.
2013 WL 135753, at *15.  So Weeks elected to view the claims as simply a type of “fraud claim based on misrepresentations made not to a plaintiff 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 defendant was 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,” a prescription drug “may be necessary to alleviate pain and suffering or to sustain life.”  Brown v. Superior Court of San Francisco, 44 Cal.3d 1049, 1063, 245 Cal.Rptr. 412, 751 P.2d 740, 749 (1988).  Prescription medication is heavily regulated by the FDA. It can be obtained only through a health-care provider who can make a determination as to the benefits and risks of a drug for a particular patient.
Weeks, 2013 WL 135753, at *17.
Wow!  Talk about standing precedent on its head.  In Brown, the California Supreme Court discussed the special nature and FDA oversight of prescription drugs as reasons why even traditional forms of product liability were inappropriate.  Heck, our fifth block-quote proposition stated above (about the extraordinarily beneficial nature of prescription drugs) was mostly a bunch of quotes taken from Brown.  Uniquely, Weeks concludes that – because drugs are both extremely valuable and heavily regulated – they should be subjected to more, not less, liability.
Because – Mensing.  “Moreover, the brand-name manufacturer is under a continuing duty to supply the FDA with postmarketing reports of serious injury and can strengthen its warnings on its own accord. In contrast, a generic manufacturer's label must be the same as the brand-name manufacturer's label, and the generic manufacturer cannot unilaterally change its warning label.”  Weeks, 2013 WL 135753, at *17.
So we guess we can say that Weeks did consider at least our fifth policy ground – and decided to do exactly the opposite.  The more valuable the product is to society, and the more heavily it is regulated by the government, the more liability the manufacturer is able to shoulder.  Weeks doesn’t discuss it in these terms, but it reads like an application of the principle of charging whatever the traffic will bear.
Weeks nowhere even alludes to any of the other practical reasons that counsel against non-manufacturer liability – unless one might say that, by its focus on the unique nature of prescription drugs, the opinion means, sub silentio, to preclude the automobile and asbestos examples in our seventh policy ground.  Instead, the only “fairness” that the court considers is that Alabama plaintiffs should have somebody to sue despite Mensing preemption:
The Supreme Court in [Mensing] held that it would have been impossible for the generic-drug manufacturers to change their warning labels without violating the federal requirement that the warning on a generic drug must match the warning on the brand-name version, preempting failure-to-warn claims against generic manufacturers.  In the context of inadequate warnings by the brand-name manufacturer placed on a prescription drug manufactured by a generic-drug manufacturer, it is not fundamentally unfair to hold the brand-name manufacturer liable for warnings on a product it did not produce because the manufacturing process is irrelevant to misrepresentation theories based, not on manufacturing defects in the product itself, but on information and warning deficiencies, when those alleged misrepresentations were drafted by the 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 ever heard (or spoke) it.
Well, in its own way, Weeks is a ringing re-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 Court learned intermediary rule precedent expressly limited liability to “users” of the defendant's product.  See Springhill Hospitals, Inc. v. Larrimore, 5 So.3d 513 (Ala. 2008) (“the duty at issue was a drug manufacturer's or a drug dispenser’s duty to warn customers”) (emphasis added); Walls v. Alpharma USPD, Inc., 887 So.2d 881, 883 (Ala. 2004) (“a manufacturer’s duty to warn is limited to an obligation to advise the prescribing physician of any potential dangers that may result from the 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 [its product]”) (emphasis added); Stone v. Smith, Kline & French Laboratories, 447 So.2d 1301, 1304 (Ala. 1984) (“the manufacturer’s duty to warn is limited to an obligation to advise the prescribing physician of any potential dangers that may result from the drug’s use”) (emphasis added).  So we could say that that the rule, as well, has been upended – becoming an excuse for more, not less, liability – but we’re looking for something, anything that’s a silver lining here.
The only other thing we can say on the plus side is that, much more than Conte, Weeks makes clear that causation can cut off branded misrepresentation claims.  Conte would allow liability on vague testimony about what a prescriber might have read decades earlier.  Weeks seems more tightly drawn on the causation side:
Once that duty [to warn prescribers] is fulfilled, the manufacturer has no further duty to warn the patient directly.  However, if the warning to the learned intermediary is inadequate or misrepresents the risk, the manufacturer remains liable for the injuries sustained by the patient. The patient must show that the manufacturer failed to warn the physician of a risk not otherwise known to the physician and that the failure to warn was the actual and proximate cause of the patient’s injury.  In short, the patient must show that, but for the false representation made in the warning, the prescribing physician would not have prescribed the medication to his patient.
Weeks, 2013 WL 135753, at *19 (emphasis added).  From this quote, we take away:  (1) proof of warning causation is the plaintiff’s burden – there’s no heeding presumption; (2) prior prescriber knowledge defeats this new misrepresentation theory just as it would a product liability theory;and  (3) causation requires evidence that there would have been no prescription, not some lesser change in the prescriber’s informed consent or monitoring procedures.
Yeah that’s pretty weak.  We know it.  But that’s Weeks for you.
The quickest fix would be for the Alabama legislature to enact a product liability bill (similar to New Jersey and several other states) – to replace the “judicial legislation” of the AMELD, Weeks, 2013 WL 135753, at *3 − that broadly encompasses "all" liability theories and requires manufacture of 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.


Max Kennerly said...

Didn't the Supreme Court recently rule that generic drug manufacturers were required to use exactly the same label that the brand name put forward? Weren't you folks overjoyed with that?

Well, here's the natural result. If the label is wholly up to the brand name, then the brand name is responsible for it. Can't have your cake and eat it, too.

Bexis said...

Overjoyed? No. Supportive? Yes. Basically because we appreciate the liability pressure (let them sue somebody, anybody) that this puts on courts to produce counterproductive decisions such as Weeks.

We don't see any basis why a constitutional, non-mreits related decision such as Mensing should change the long-standing economic basis (you made it, you're responsible) for product liabilty. The economic incentives created by this type of liability are just all wrong. Even ATLA views brandeds as safer, so why should they be liable for someone else's screw up (assuming anybody screwed up)?