A Couple Of Interesting New Cases Forwarded By Our Readers

We like it when our readers contact us, even when it’s only to tell us that we made a mistake.  At least they’re paying attention.  But we like it most when our readers send us new opinions of interest − especially good ones.  The rapid exchange of information helpful to the defense of prescription drug and medical device product liability litigation is what the DDLaw blog is all about.

But once we receive good new cases, it becomes our responsibility to get the word out, and that’s what we’re doing today, even if we feel we’ve been a mite slow about it.

Eckhardt v. Qualitest

Two readers (Quinton Urquhart of Irwin, Fritchie, and Rachel Passaretti-Wu of Skadden) both sent us, in response to our “Conte Rejected Again” post, Eckhardt v. Qualitest Pharmaceuticals, Inc., C.A. No. M-11-235, slip op. (S.D. Tex. Aug. 9, 2012).  Eckhardt − guess what? − also rejected the notorious Conte theory that brand-name manufacturers could be liable for allegedly inadequate warnings accompanying competing generic drug products that they never sold.

Eckhardt is the latest of a number of cases to reject brand-name liability under Texas law.  As indicated in our Branded/Generic liability scorecard, Eckhardt builds on Finnicum v. Wyeth, Inc., 708 F. Supp.2d 616, 620-22 (E.D. Tex. 2010); Cousins v. Wyeth Pharmaceutical, Inc., 2009 WL 648703, at *2 (N.D. Tex. March 10, 2009); Hardy v. Wyeth, Inc., 2010 WL 1049588, at *2-5 (Mag. E.D. Tex. March 8, 2010), adopted, 2010 WL 1222183 (E.D. Tex. Mar. 29, 2010); Burke v. Wyeth, Inc., 2009 WL 3698480, at *2-3 (S.D. Tex. Oct. 29, 2009); Pustejovsky v. Wyeth, Inc., 2008 WL 1314902, at *2 (N.D. Tex. April 3, 2008), aff’d on other grounds, 623 F.3d 271 (5th Cir. 2010); Block v. Wyeth, Inc., 2003 WL 203067, at *2 (N.D. Tex. Jan. 28, 2003) and Negron v. Teva Pharmaceuticals USA, Inc., 2010 WL 8357563, slip op. at 1-2 (Tex. Dist. Dallas Co. May 7, 2010), in hewing to the traditional product liability axiom that manufacturers are the only ones that can be liable for their products.

We make that point because we were somewhat disturbed to read the Eckhardt court expressing “disappointment” with the quality of the briefing on both sides.  Slip op. at 2-3.  While we expect the other side to do things like throw in “two several-hundred-page depositions” without page citations, id., we’re not accustomed to seeing our side criticized for citing “cases that have no nexus with” relevant law.  Id.

That’s precisely what we try to avoid with our branded/generic scorecard.  If as is the case in Eckhardt, the jurisdiction in question has a statutory product liability scheme (like Texas, or Tennessee, Kentucky, and New Jersey to name a few), we try to note in our case summary.  That way we try to make it easy for defense counsel everywhere to cite to the most relevant cases, whether inside or outside any particular jurisdiction.

Anyway, the rest of Eckhardt is good.  It’s a “one-two punch” case − by that we mean (as is apparent from our Generic Preemption scorecard) that the generic defendants have also been dismissed on preemption grounds.  Eckhardt v. Qualitest Pharmaceuticals, Inc., ___ F. Supp.2d ___, 2012 WL 1511817 (S.D. Tex. April 30, 2012).  Thus, the one-two punch of preemption and product identification has effectively ended the case.

Eckhardt makes the following holdings that might be useful in future cases:

• The tenuous relationship of branded products to generic labeling was not sufficient to justify liability under any Texas product liability theory.  Slip op. at 4-5.
• Fraud and similar claims satisfy the statutory definition of “products liability” claims.  Id. at 6-7.
• Breach of warranty and consumer protection claims fail where the defendant did not make the product.  Id. at 8-9.
• Negligence and negligent misrepresentation fail because a non-manufacturer owes no recognized duty to persons using competing products.  Id. at 10-11.

Baker v. APP Pharmaceuticals

We thank old colleague Will Sachse of Dechert for sending along Baker v. APP Pharmaceuticals LLP, C.A. No. 09-05725 (JAP), slip op. (D.N.J. Aug. 21, 2012).  Baker contains an excellent description of the New Jersey presumption of adequacy of FDA-approved warnings:

In failure to warn cases involving prescription drugs, “[i]f the warning or instruction given in connection with a drug . . . has been approved or prescribed by the federal Food and Drug Administration under the ‘Federal Food, Drug, and Cosmetic Act,’” there is a rebuttable presumption that the warning is adequate.  This is no ordinary rebuttable presumption.  “Compliance with FDA regulations” gives rise to “what can be denominated as a super-presumption[.]”  “[C]ompliance with FDA standards should be virtually dispositive of such claims.”  Indeed, the PLA’s presumption that an FDA-approved prescription drug label is adequate “is stronger and of greater evidentiary weight than the customary presumption referenced in [New Jersey Rule of Evidence] 301.”

 
Baker, slip op. at 12-13 (citations, but not quotation marks, omitted).

The New Jersey presumption suffers from ill-advised, judicially-created exceptions to the broad legislative mandate, but Baker held that neither of those applied.  There can’t be “deliberate concealment” of information that’s “publicly available in published scientific and medical literature.”  Slip op. at 9-10.  Moreover, the plaintiffs weren’t being honest with the court.  The information in question was, in fact, disclosed to the FDA.  Id. at 10-11.  (The concealment claim was also a preempted fraud on the FDA claim, but the court didn’t have to discuss that.)  Also, for case-specific reasons (after-the-fact timing, and the information involving a different drug), the court found no manipulation, “intentional” or otherwise, of FDA post-marketing regulatory processes.  Id. at 12-14.  Thus the FDA-approved warning was as a matter of law.

Of equal interest, the court in Baker held that, even if the warning had been inadequate, it couldn’t have caused any injury.  This is important, because there hasn’t been all that much New Jersey law on warning causation.  There’s Strumph v. Schering Corp., 606 A.2d 1140, 1148-49 (N.J. Super. App. Div. 1993) (dissenting opinion), rev’d, 626 A.2d 1090 (N.J. 1993) (adopting dissenting opinion below), which establishes the warning causation principle in New Jersey.  There’s also Appleby v. Glaxo Wellcome, Inc., 2005 WL 3440440, at *5-6 (D.N.J. Dec. 13, 2005).  These are both cases where the prescribing physician already knew the information and didn’t read the warning.  Two favorable opinions for a jurisdiction with as much learned intermediary rule litigation as New Jersey strikes us as a little thin.

Baker’s now a third case in that category.  First of all the court took out the lamentable “heeding presumption.”  “The heeding presumption is rebutted, however, if the plaintiff’s physician was aware of the risks of the drug that he prescribed, and having conducted a risk-benefit analysis, nonetheless determined its use to be warranted.”  Slip op. at 14-15 (citation and quotation marks omitted):

Moreover, a manufacturer who fails to warn the medical community of a particular risk may nonetheless be relieved of liability under the learned intermediary doctrine if the prescribing physician either did not read the warning at all, or if the physician was aware of the risk from other sources and considered the risk in prescribing the product.  In that case, the physician’s conduct is the superseding or intervening cause that breaks the chain of liability between the manufacturer and the plaintiff.

 
Id. at 15 (citations, quotation marks, and footnote omitted).  That happened in Baker.  Not only did the prescriber know of the alleged heparin-related risk, but he “stood by his decision to administer heparin” under the facts of the case.  Id. at 15-16.  Further blocking any causal inference was the physician’s failure to read labels for “frequently” prescribed drugs with which he was familiar:

[The prescriber] testified in his deposition that he does not read the label of drugs he prescribes often, which includes heparin.  Moreover, Plaintiffs concede that [the prescriber] never testified that he would have consulted a black box warning or “Dear Doctor” letter, or that he ever reviewed the Physician’s Desk Reference when prescribing heparin.  Therefore, a different warning would not have made a difference in [plaintiff’s] treatment or outcome because [the prescriber] would not have reviewed it.

 
Baker, slip op. at 16 (citation omitted).

There was also a case-specific superseding cause − the “fail[ure]” of the nursing staff “to follow its own heparin treatment protocol” and monitor the drug level in the plaintiff’s blood.  Id. at 16-17.

Therefore, Plaintiffs have failed to raise a genuine issue of material fact that it was the heparin labeling, as opposed to the failure of the hospital to follow its treatment protocol, that was a substantial factor in causing or exacerbating [plaintiff’s] injuries.

 
Baker, slip op. at 17.

Thus, Baker is a nice causation triple play (prior knowledge, failure to read, and third-party superseding cause) in a jurisdiction where such precedent is most welcome.

Thanks to everyone who sends us cases − and keep them coming.

More breaking news - NJ Ortho-Evra

Thanks to Susan Sharko of Drinker for forwarding today's win in Hayes-Jones v. Ortho-McNeil Pharmaceutical, No. MID-L-3416-10, slip op. (N.J. Super. L.D. Aug. 3, 2012).  It's late on a Friday afternoon, and we're trying to get out for vacation, but we liked it, so we think you will too.

Hayes-Jones is a failure to warn case under Virginia law.  The facts are fairly complex because the decedent was a member of the military and several military prescribers were involved.  Also plaintiff was on and off the product at various times over the years.

Basically, the defense swept the board on summary judgment.  The warnings (dating from 2008) were adequate as a matter of law with respect to blood clots/pulmonary embolism, the alleged risk, because the risk was identified and and warned about in detail.  Slip op. at 11-14.  The prescribers who were deposed understood that risk very well.  Id. at 14-18.

Since the plaintiff couldn't win on the facts, she launched a frontal assault on Virginia's learned intermediary rule.  That assault failed in every aspect.  The court rejected an exception for drugs where the FDA mandates direct to patient warnings.  Slip op. at 19.  That "exception" hasn't been adopted by any court in decades.  The court also rejected a direct to consumer exception.  Id. at 20.  The court also held that there's no heeding presumption in Virginia.  Id. at 21.  Finally, the learned intermediary rule applies to subsequent as well as original prescribers.  Id. at 21-22.

That's two good learned intermediary/warning causation decisions we learned about today.  That takes some of the sting out of the loss in Schilf v. Eli Lilly & Co., No. 11-2082, slip op. (8th Cir. Aug. 3, 2012), which was more about how to read a particular physician's testimony than anything else.

Fifth Circuit Affirms Summary Judgment In Mesh Case

Thanks and congratulations to Christy Jones and Anita Modak-Truran of Butler Snow for letting us know about - and more importantly winning - today's decision in Smith v. Johnson & Johnson, No. 11-60624, slip op. (5th Cir. Aug. 2, 2012), affirming summary judgment in a vaginal mesh case.

Smith has two aspects, procedural and substantive.  Since the opinion deals puts procedure first, so will we.  Basically plaintiff tried to litigate on the cheap with respect to expert witnesses, and it backfired badly.

There are two types of causation in a warning case.  There's medical causation, meaning that the product must cause the injury.  Then there's warning causation, sometimes also going under the rubric of "legal" or "proximate" cause, meaning that the claimed defect in the warning must have affected the recipient's (here, the physician under the learned intermediary rule) conduct in some way that caused injuy.

In Smith, only the latter - warning causation - was seriously in dispute.  But plaintiff, as the deadline for designating experts passed, designated only experts who addressed medical causation.  Smith, slip op. at 3.  Aggravating plaintiff's failure was the complete inadequacy of the designations.  Id.  Then, after the defendant moved for summary judgment on warning causation, and long after the expert deadline had passed, the plaintiff responded with a conclusory affidavit from another purported expert who had never been designated at all.  Id.

The judge, quite understandably, threw out the untimely affidavit.  Id. at 5.

On appeal the Fifth Circuit held that the judge acted well within his discretion in refusing to countenance the plaintiffs' playing fast and loose with expert designation procedures:

[T[he documents upon which [the belatedly designated expert] relied were available prior to the original September deadline for designation of experts. . . .  [E]very one of [his] opinions could be elicited from their other expert witnesses. . . .  [D]efendants [were] prejudiced by the months of delay in expert designations, and a continuance would not have cured that prejudice due to the long history of delays in the case.  Denying the plaintiffs’ motion to designate . . . [the] expert was not an abuse of discretion.

Slip op. at 6.  That's good - plaintiffs get away with this kind of hide-the-expert game all too often.

The substantive part of Smith was even better.  It's a familiar story, but one that doesn't lose its cogency with retelling.  Under Mississippi's learned intermediary rule - which the court specifically held applies to both medical devices and drugs, slip op. at 7 - there simply isn't warning causation as a matter of law where the prescribing physician already knew everything the plaintiff alleges should have been disclosed.  Specifically, in this case the prescriber knew about the consequences of tearing of the mesh:

[The prescribing surgeon] testified that he was aware of the risks inherent in using [the mesh], and stated that he was personally aware of the possibility of adverse events including extrusion and erosion.  [He] had performed a number of surgeries using [the] mesh, and some of those patients had reported to him with erosions and tears.  [The surgeon] also testified that he read the “Contraindications” section of the [mesh] package insert, which advised that . . . mesh “in contaminated wounds should be used with the understanding that subsequent infection may require removal of the material.”  [He] saw infection as a very serious potential issue and took that possibility into account in deciding whether surgery with [the] mesh was the best option for [plaintiff].

Smith, slip op. at 8-9.  When the defense hits a home run like that with the prescriber's testimony, it should be, and was in Smith, all over.

Breaking News - Another Aredia Win

Another remanded Aredia/Zometa case has apparently bitten the dust.  See Ingram v. Novartis Pharmaceuticals Corp., No Civ-05-913-L, slip op. (W.D. Okla. July 18, 2012).  Ingram threw out all of the plaintiff's on warning causation grounds, a strong defense in this litigation, which involves a drug used to treat cancer.  A basic problem that plaintiffs face in such situations is that, when the alternative is likely death by cancer, most prescribing oncologists aren't going to be swayed by the possibility of a much lesser injury (with bisphosphonates, osteonecrosis of the jaw).  So an allegedly defective warning about the lesser injury won't deter anything.

The law, in Oklahoma as elsewhere, requires warning causation - some material change in prescriber conduct:
Slip op. at 6.

Even if the plaintiff establishes a duty to warn and a breach of that duty, she must further establish proximate causation by showing that had defendant issued a proper warning to the learned intermediary, he would have altered his behavior and the injury would have been avoided.

Slip op. at 4. Oklahoma is one of those unfortunate jurisdictions that applies a heeding presumption even in pharmaceutical cases, but for the reasons we discussed above, it was easily rebutted in Ingram.

[The prescriber] testified that had he known of [the drug's] potential complication of osteonecrosis of the jaw, he would have prescribed it for [plaintiff's decedent] anyway.  This testimony establishes that although the prescribing physician . . . would have read and heeded the warnings regarding [the drug] and ONJ, this would not have changed [the prescriber's] decision to prescribe it to [the decedent].

As is also common in these cases, plaintiff tried to salvage the case with lesser causation evidence - that the prescriber, while still using the drug, now gives various advice about dental issues.  Slip op. at 6-7.  That didn't work in Ingram because even the plaintiff's own expert (a Dr. Marx - is that Harpo, Groucho, Chico, or Zeppo?) admitted that the decedent already had ONJ. Slip op. at 8:

When this finding [pre-existing ONJ] is kept in mind, it is clear that plaintiff’s arguments regarding [the prescriber's] changed prescribing practices are insufficient to discharge her burden of proof on proximate causation.  As demonstrated above, [the prescriber] has unequivocally testified that had he known in January of 1999 that [the drug] had the potential complication of ONJ, he would have prescribed it for [the decedent] anyway.

Slip op. at 8.

The court also throws out plaintiff’s wrongful death claim, because it wasn't supported by any expert testimony.  We've commented previously about the weakness of many of the cases we're seeing after remand from the A/Z MDL, and judging by the expert testimony here, Ingram looks like another.

In any event put another one in the "W" column for the Hollingsworth Aredia team.

News Flash: Texas Adopts Learned Intermediary Rule; Rejects DTC Exception

In his role as amicus curiae for the Product Liability Advisory Council ("PLAC") Bexis is now two for two since moving to Reed Smith - of course that also means that somebody else is doing the really heavy lifting, in this case Randy Roach of Roach & Newton and Gene Williams and Manuel Lopez of Shook Hardy.  Today the Texas Supreme Court, in a landmark (there goes Bexis breaking his arm patting himself on the back again) 55-page unanimous decision, the Texas Supreme Court held the following:

(1) the learned intermediary doctrine generally applies within the context of the physician-patient relationship, and a prescription drug manufacturer fulfills its duty to warn its product’s end users by providing an adequate warning to the prescribing physician; (2) the [lower court] erred by adopting a DTC advertising exception to the doctrine; (3) the learned intermediary doctrine is not a common-law affirmative defense, but a common-law rule and its applicability was not waived by [defendant]; (4) [a] non-prescribing, treating physician, owed no duty to warn [plaintiffs] of the risks associated with [the drug] beyond the risks directly attributable to the infusion process; (5) because all of [plaintiff's] claims are premised on [defendant's] alleged failure to warn, the learned intermediary doctrine applies to all of their claims; and (6) [plaintiffs] failed to introduce any evidence that the allegedly inadequate warning was the producing cause of [plaintiffs'] purported injuries.

Centocor, Inc. v. Hamilton, No. 10-0223, slip op. at 55 (Tex. June 8, 2012).

Texas was the largest state (by far) lacking state supreme court precedent adopting the learned intermediary rule in prescription medical products (although several lower courts had done so).  Plaintiffs made it a pitched battle, and Bexis pitched in on the defense side through PLAC.  We rated the decision that the Texas Supreme Court just reversed, Centocor, Inc. v. Hamilton, 310 S.W.3d 476 (Tex. App. 2010), as the #4 worst decision of 2010.

So its Texas-sized party time here on the Drug and Device Law Blog.

First, the Texas Supreme Court ringingly endorsed the learned intermediary rule in Centocor:

Our decision to apply the learned intermediary doctrine in the context of prescription drugs, prescribed through a physician-patient relationship, not only comports with our prior references to the doctrine and many years of Texas case law, but it places us alongside the vast majority of other jurisdictions that have considered the issue.  Our sister states have overwhelmingly adopted the learned intermediary doctrine in this context. . . .  The underlying rationale for the validity of the learned intermediary doctrine remains just as viable today as stated by Judge Wisdom in 1974 [citations, inclulding block quote from Reyes v. Wyeth Labs., 498 F.2d 1264, 1276 (5th Cir. 1974) omitted].  Because patients can obtain prescription drugs only through their prescribing physician or another authorized intermediary and because the “learned intermediary” is best suited to weigh the patient’s individual needs in conjunction with the risks and benefits of the prescription drug, we are in agreement with the overwhelming majority of other courts that have considered the learned intermediary doctrine and hold that, within the physician-patient relationship, the learned intermediary doctrine applies and generally limits the drug manufacturer’s duty to warn to the prescribing physician.

 
Slip op. at 29-30 (footnote omitted) (emphasis added).  The footnote that we've omitted was pulled together from the list compiled in Bexis' PLAC brief - because we recognize all of the citations (particularly the Nevada Allison case).  Texas becomes the sixth state in which Bexis has participated in high court briefing that has resulted in adoption/reaffirmance of the learned intermediary rule (Pennsylvania, Coyle; New Jersey, Niemiera; Ohio, White; Kentucky, Larkin (for PLAC); and Connecticut, Vitanza (for PLAC)).  See also Id. at 42 n. 27 (rejecting as "unpersuasive" an argument "that we should not adopt the learned intermediary doctrine because the fundamental basis for the doctrine has changed with the evolving dynamics of contemporary society and the developing system of healthcare in the United States").
 
Second, and as importantly, Hamilton reverses the lower court's adoption of a direct-to-consumer exception to the learned intermediary rule - leaving New Jersey as the only state to adopt that exception (although as Hamilton observes, West Virginia used DTC as an excuse for rejecting the rule altogether).  Slip op. at 33-34.  While the Court did not rule out a DTC exception in extreme cases, id. at 35, it found no need for such an exception generally:

On this record, the rationale for adopting a DTC advertising exception to the learned intermediary doctrine is simply non-existent.  Even so, we must believe that patients who seek prescription drugs based solely on DTC advertising will obtain them only when the prescribing physician has evaluated the potential risks and benefits for the particular patient.  To safeguard the public from harmful products and misleading advertising, both the federal government and Texas law regulate the design, marketing, and distribution of prescription drugs.  Drug manufacturers that fail to comply with FDA regulations can face criminal fines and imprisonment as well as civil penalties.  Although pharmaceutical companies have increased DTC advertising since courts first adopted the learned intermediary doctrine, the fundamental rationale for the doctrine remains the same:  prescriptions drugs require a doctor’s prescription and, therefore, doctors are best suited to communicate the risks and benefits of prescription medications for particular patients through their face-to-face interactions with those patients.

Slip op. at 37-38 (various citations omitted) (emphasis added).
 
Third, the learned intermediary rule is a legal doctrine, not an affirmative defense.  Plaintiffs can't use application of the rule to avoid having to prove their cases:

While the learned intermediary doctrine shifts the manufacturer’s duty to warn the end user to the intermediary, it does not shift the plaintiff’s basic burden of proof.  Doing so would create an anomalous situation where, once the defendant prescription-drug manufacturer invokes the learned intermediary doctrine, the plaintiff would be relieved of proving a key burden in any product warning case—that the product warning was inadequate.

Slip op. at 41.

Fourth, the learned intermediary rule flows through prescribing - but not non-prescribing physicians.  Just because a non-prescriber used a manufacturer's patient education materials, the non-prescriber did not become obligated to provide full warnings to the patient:

Despite the intricate web of modern healthcare providers and treatments, the bedrock of our healthcare system is the physician-patient relationship, and the ultimate decision for any treatment rests with the prescribing physician and the patient.  As a matter of both necessity and practicality, the duty to warn the patient of the potential risks and possible alternatives to any prescribed course of action rests with the prescribing physician.

Slip op. at 43 (emphasis added).  To impose such a duty on a non-prescriber would only "undermine" the physician/patient relationship by requiring second-guessing by non-prescribers, and "thwart the efforts of prescription drug manufacturers to provide valuable educational information about available treatments."  Id. at 43.

While #4 wasn't an issue that PLAC briefed, we note that it's been raised recently in organophosphate-related litigation. 

Fifth, the learned intermediary rule can't be avoided through claims of fraud.  Rather it applies to any claim that is based upon the information that flows through a learned intermediary to the end user of the product:

Texas appellate courts have applied the learned intermediary doctrine to a variety of causes of action predicated on the alleged inadequacy of a prescription drug manufacturer’s product warning.   We find the [this] application of Texas law persuasive. . . .   [W]hen a patient alleges . . . omissions about a prescription drug’s potential side effects, (1) the patient cannot plead around the basic requirements of a failure-to-warn claim, and (2) the learned intermediary doctrine applies.  Therefore, the learned intermediary doctrine applies to all of [plaintiffs’] claims.

Slip op. at 46-47 (footnote omitted).

Sixth, and finally (in another non-PLAC issue), the court applied what we call "learned intermediary causation" to hold, as a matter of law, that plaintiffs could not prove that any inadequacy in the defendants' warnings caused them injury.

[W]hen the prescribing physician is aware of the product’s risks and decides to use it anyway, any inadequacy of the product’s warning, as a matter of law, is not the producing cause of the patient’s injuries. . . .  It is undisputed that all of [plaintiffs'] medical providers were aware [of the risk at issue] as a side effect of [the drug].  [Plaintiffs] presented no evidence that [the] prescribing physicians or [plaintiffs] would have acted differently had [defendant] provided a different warning that included [the information plaintiffs advocated].

Slip op. at 49-50 (lots of citations omitted).  Thus a multi-million dollar verdict became a judgment n.o.v.:

Because [plaintiffs'] prescribing physicians were aware of the potential risk . . . but chose to prescribe [the drug] in spite of those risks, and because the [plaintiffs] failed to present any evidence that including additional [information] in the warning would have caused [the prescribing] physicians to change their prescription, [plaintiffs] failed to meet their burden of proof.

 
Slip op. at 54.
 
Thus a really bad Texas intermediate appellate decision has been replaced by a really good Texas Supreme Court opinion.  As an extra added benefit another really bad (we described it previously as "ugly") decision purporting to apply Texas law should also fall as a result of that decision's undue haste in following the now reversed intermediate decision in Hamilton v. Centocor.  See Murthy v. Abbott Laboratories, ___ F. Supp. 2d ___, 2012 WL 734149 (S.D. Tex. Mar. 6, 2012) (cited twice, and not favorably, by the Texas Supreme Court, slip op. at 33, 35 n.22).  Since Murthy made #8 on our bottom ten decisions last year, we won't be sad to see it go.

Just What The Doctor Ordered

Ringing in the New Year’s been a might slow.  Not too much shaking loose in the Drug/Device law area it seems.  There were some pretty hideous Daubert rulings in Yazmin/Yaz, but not all that much reasoning to support them.  It seems to be a judicial settlement pressure tactic - aimed at defendants - since we read this morning that, immediately after issuing all these bad rulings, the court cancelled the bellwether trial that had prompted the motions in the first place, and required mediation instead.  Anyway, we noted the worst of the bunch in our bottom ten post a week ago, so we’ll leave them at that.


One new case we’ve seen is Roberts v. Albertson’s LLC, ___ Fed. Appx. ___, 2011 WL 6807608 (9th Cir. Dec. 28, 2011) (non-precedential), where the combination of a corner-cutting lawyer and his not-so-bright client resulted in a nice defense win. Roberts involved a medical device, a blood pressure monitor. The plaintiff claimed it didn’t work right and gave deceptively low readings. Allegedly that caused, or was a substantial factor in, the plaintiff having a stroke.

We say allegedly because – well, we’re defense lawyers – but more because plaintiff didn’t have any expert to explain why that was. Usually that kind of thing happens where: (1) causation is pretty darn obvious, or (2) the plaintiff has lost the product and has no other choice. That doesn’t seem to be the case in Roberts. How a mere monitoring device can cause a stroke is anything but obvious, and there’s no mention of a lost product in the case, so we chalk the absence of any plaintiff experts up to the other side not willing to invest anything in the case.

So much the better for us.

So to the client. Plaintiff was prescribed blood pressure medication after the one time he had his blood pressure tested by a doctor, it was elevated. He also bought the home BP monitor that was at issue in the case. It gave him consistently normal readings – plaintiff claims improperly. Supposedly, due to those readings, the plaintiff decided, contrary to doctor’s orders to stop taking his medication and to use a “homeopathic” regimen of his own concoction (fish oil and something called “Co-Q 10”) instead. After abandoning real drugs for that garbage, he had a stroke.

And he didn’t have any experts.

The district court granted summary judgment, and now the Ninth Circuit affirmed, albeit on somewhat different grounds, those being:

• Although there was a discrepancy between the home readings and the one doctor’s reading, “that single discrepancy does not establish that the monitor gave inaccurately low readings.” 2011 WL 6807608, at *2. The directions warned that readings could vary, and any comparison to a single in-office reading wasn’t valid without some kind of expert proof.

• There was no “substantial factor” causation because nothing in the monitor’s directions made it any more, or less, likely – in the absence of any affirmative evidence – that the plaintiff would have stopped taking his prescribed drugs, contrary to doctor’s orders. Id.

• There was no proximate cause. Plaintiff had no evidence that it was “foreseeable” that a malfunction in a home monitor would cause a reasonable man to stop taking prescribed drugs, contrary to doctor’s orders, and go homeopathic. Id. at *2-3

The court didn’t say it in quite this fashion, but we will – product liability is not free insurance against a plaintiff’s own stupid behavior involving drugs or medical devices. A would-be plaintiff who simply stops taking his/her prescribed drugs on his/her own volition has only him/herself to blame.

A Tale Of Two – No, Three – Drugs

It was the best of times, it was … no, check that, it was the best of times.  In the recent decision, Wendell v. Johnson & Johnson, 2011 WL 6291792 (N.D. Cal. Dec. 15, 2011), the moving defendants all received summary judgment, so it was just the best of times.

 

Wendell itself is something of a three ringed circus, insofar as the facts involve three drugs – mercaptopurine (also known, for reasons unknown to us, as "6-MP," which has the advantage of being shorter), Remicaid, and Humira – and the interaction between their respective warnings.  The only simple thing about the facts is there is only one prescribing physician.

 

Here goes.

 

In 1998, the plaintiff’s decedent was diagnosed with inflammatory bowl disease (“IBD”), a nasty autoimmune condition.  Prescriber, who didn’t ordinarily review drug labeling – but did just enough to preclude summary judgment on that basis – began drug treatment.  Initially, the treatment featured Prednisone.  Unfortunately Prednisone is well-know among those who prescribe and use it (such as Bexis’ daughter, for a while) for causing adverse reactions approximately 100% of the time.

 

The decedent didn’t like the reactions, and Prednisone isn’t a very good long-term treatment for a chronic condition anyway.  Thus, by 1999, the prescriber went with 6-MP to try to get the decedent off Prednisone.   6-MP isn’t without its own risks, either.  “At the time [the prescriber] prescribed 6–MP he was aware of a paper reporting the occurrence of lymphoma [that’s a kind of cancer] in adults taking the drug.”  The prescriber warned the decedent about this, although he might have said “malignancy” rather than the precise type.

 

Apparently, the attempted substitution didn’t work all that well, because almost three years later the poor man is still taking both Prednisone and 6-MP. All this (and a lot of what follows) is from the “Background” section of Wendell, 2011 WL 6291792, at *1-5, by the way.

 

Still trying to get the decedent off Prednisone, the prescriber, now in mid-2002, discusses adding Remicade to the mix.  Remicade is an “anti-tumor necrosis factor” drug – an “TNF inhibitor.”  The tumor necrosis factor in the body causes inflammation, and inflammation is a major problem in a whole host of autoimmune conditions, including IBD.  Unfortunately, “tumor necrosis” means exactly what it sounds like – tumor death.  Tumor necrosis factor also kills tumors. Inhibit TNF, as this type of drug does, and one of the body’s defenses against cancer goes away.

 

Thus, Remicade (and probably all TNF inhibitors) is also associated with increased risks of malignancies.  It’s a trade-off:  almost a certainty of less inflammation for an increased risk of possible cancer.

 

The prescriber knew this, too. And “virtually always” informed his patients of an increased risk of tumors and malignancies.

 

In 2005 and 2006, more information became available about a possible synergistic effect between 6-MP and Remicade, involving a particularly dangerous form of lymphoma.  This development culminated in 2006 with an FDA black box warning about using these drugs in combination.

 

The prescriber was contemporaneously aware of all of this.  Fortunately, the stuff also worked.  By mid 2006, the decedent’s IBD was in remission.  He was taken off Remicade.

 

One problem with autoimmune conditions is that once they’re beat, they don’t always stay beat.  Half a year later, in November, the decedent had a relapse.  Instead of Remicade and 6-MP, the prescriber prescribed Humira and 6-MP. When asked why he had switched from one TNF inhibitor to another, the prescriber stated:

 

So in November ′06, we had been aware for some time of complication of hepatosplenic T-cell lymphoma, so that would have been part of my discussion with the family.  Ease of therapy is always a discussion with Humira versus Remicade.

Wendell, 2011 WL 6291792, at *4.

 

However, it was also true that, at that time Remicade bore the aforementioned black box warning about cancer risk, while Humira did not.  The prescriber said, essentially, that the black box didn't make much difference to him, since he already was aware of the risk and discussed it with his patients.  In addition to being easier to administer, Humir, also had (the prescriber said, we have no independent idea) a "superior" safety profile for other reasons, primarily being 100% human (as opposed to being produced from genetically modified mice) in its origin.

 

Wendell is a product liability suit, so necessarily the worst happened.  After using this second TNF inhibiter for seven months, the decedent got the nasty lymphoma warned about in the Remicade black box and died.

 

On this record the makers of Humira and 6-MP moved for summary judgment under the learned intermediary rule.  The maker of Remicade did not (also for reasons unknown to us).

 

The court granted the motions.

 

Here’s why.

 

The prescriber knew full well about the risks involved when he prescribed those drugs.  It didn’t matter that the black box warning was only on Remicade, because he saw it on that drug before prescribing the other one.

 

California law is quite good, going back even before Motus v. Pfizer, Inc., 358 F.3d 659 (9th Cir. 2004), on there being no duty – or no causation – where plaintiffs demand that physicians be warned about things they already know:

 

[The prescriber] knew of the risk of malignancies associated with 6–MP and Humira, but still prescribed the medication.  Thus, there is insufficient evidence to create a material dispute of fact as to whether the warnings that Plaintiffs contend should have been given would have changed [the decedent’s] treatment.

Wendell, 2011 WL 6291792, at *6.  Indeed, the prescriber had known about the risk of 6-MP since day one – and probably warned the plaintiff about it way back then.  Id.

 

Then it gets really interesting.  Plaintiffs love to claim than any post-injury change in prescribing habits means that the same change could have been induced earlier had only there been adequate warnings.  But rarely is there any real proof of this.  In Wendell the court required some supporting evidence, and when none was forthcoming, pitched the claim:

 

Nor is there evidence that a warning specific to pediatric patients or specific to treatments combining 6-MP with TNF-blockers would have led [the prescriber] to stop prescribing 6-MP alone or in combination. . . . Contrary to [plaintiffs’] contention, evidence that [he] ceased prescribing TNF-blockers in combination with 6–MP after [the decedent’s injury] does not prove that he would have changed his prescription practices based on the warning they suggest. A warning about rare occurrences . . . associated with therapy combining 6-MP and Remicade is bound to have less persuasive power than an instance of the disease affecting a doctor's own patient follow[ing] that therapy.

Id. at *7 (emphasis added).  In the end, the issue (at least as to 6-MP) boiled down to prescription despite prior knowledge, “[T]he undisputed fact is that [the prescriber] was already aware of the risk of lymphomas associated with 6-MP, but still chose to prescribe the drug.”  Id.

 

Touché.

As to Humira, given the timing of the first prescription, the causation fight was won for these reasons:

 

• As with 6-MP, a mere subsequent change in prescribing habits, with no additional affirmative evidence, did not mean that it would have happened earlier had there been different warnings.  Id.
• The “better safety profile” wasn’t linked to black box warnings, or to cancer risk at all, but to a 100% human origin product having fewer allergenic risks – a major concern with an autoimmune patient.  Id. at *8.
• With the prescriber already knowing about the risk, there’s no evidence that the different state of warnings (black box versus no black box) played any part in the prescription decisions.  Id.
• Since the prescriber had prescribed other drugs with cancer risks, whether or not the prescriber believed that Humira had that risk was not by itself causal.  Id.
• The plaintiff parents’ self-serving statements that they would never have allowed the treatment had they been warned, was immaterial, since the decedent was an adult and made his own treatment decisions.  Id.

 

In states like California, where the basic law concerning learned intermediary causation is well established, collecting analogous fact patterns where causation is defeated as a matter of law is the name of the game.  Wendell has some good ones.

 

A To Z Revisited

A reader contacted us the other day, a little miffed because we hadn’t updated one of our “scorecards.” That surprised us, because we do try to keep our scorecards, and our cheat sheets, up to date as new cases are decided.  So we replied, interested to find out what we had apparently been missing.

It turns out that what we hadn't updated wasn’t anything we considered a scorecard at all.  Rather, it was a comparison we had run between two mass torts, Aredia/Zometa and Zyprexa.  He was right, we hadn’t updated that, but also wrong in that it wasn't something we intended to keep updated.

But we can’t expect our readers to know that if we don’t tell them.  So first, the explanation.  Our “scorecards” involve issues where the defense clearly has the upper hand.  In the scorecards, we keep track of every decision we know on a subject, good or bad.  However, most of the decisions will be good.  After all, we’ve said on numerous occasions, that because we’re an unabashedly defense blog, we don’t do the other side’s research for them.

Our “cheat sheets” are a little different.  Cheat sheets cover important issues where the law isn’t overwhelmingly favorable to our side.  It can be said (and we’ve said it) that, because those issues are more evenly divided, that it’s even more critical to get the word out about the caselaw that's favorable to our position.  Our cheat sheets try to do precisely that. But, since we don’t care to do the other side’s research, we only include the favorable cases.

Everything else is just a post.

Our Aredia (and Zometa) versus Zyprexa post was simply that. We were interested in those two litigations because they had gotten to the stage where the defense wasn’t killing off the entire mass tort at one fell swoop (something that only preemption is really capable of doing – see Sprint Fidelis), nor was it killing off entire categories of injury at a stroke (which is what successful Daubert motions do (see Seroquel)).  Rather Aredia and Zyprexa are both like our old Bone Screw lititgation – a mass tort being litigated, case by case, on (usually) learned intermediary rule issues.

But maybe it is time to check in again.  After all, our comparative post is now over two years old – my,  how time flies when we’re having fun.

But we were pushed over the edge the other day when we received from Robert Johnston, at Hollingsworth a copy of Eberhart v. Novartis Pharmaceuticals Corp., No. 1:08-cv-2542-WSD, slip op. (N.D. Ga. Oct. 31, 2011), making it a Happy Halloween indeed.  Eberhart is as good a place to start as any.  It demonstrates what good defense counsel have to do in difficult learned intermediary situations – keep pushing and keep asking questions.

In Eberhart, the plaintiff (as in all the A-Z cases) had some form of metastatic cancer. She took Zometa, a bisphosphonate (so is Aredia). That medication probably saved her life.  Slip op. at 3 (“[a]fter starting the Zometa treatment, Plaintiff’s hypercalcemia immediately improved and she remains alive”).  Nonetheless, the plaintiff got a bad (but not fatal) adverse reaction – osteonecrosis of the jaw (“ONJ”), basically parts of the jawbone start dying.  While it might seem like blaming Louis Pasteur because rabies vaccine has some nasty side effects, ingratitude isn’t a defense to a tort claim, so the plaintiff sued.

In the A/Z litigation, there’s at least enough of a causal basis for a link between bisphosphonate and ONJ that the defendant hasn’t succeeded with Daubert motions.  That's not today's topic, so on to the learned intermediary rule and warning causation.

The theory in these cases is that patients on these drugs shouldn't have tooth extractions because that procedure can touch off ONJ.  Allegedly, without such a warning in the drug label, the plaintiff in Eberhart did just that.  So the question becomes would a better warning have made any difference?  We start with the oncologist who prescribed Zometa against breast cancer.  She testified that, no, she wouldn’t have changed either her prescription or her treatment of the plaintiff.  Eberhart, slip op. at 14.  Point to defendant.

However, the plaintiff fought back.  The treating oncologist did change one thing after learning about the ONJ risk – she prepared some new handouts and discussed dental issues in more depth with patients who are prescribed these drugs. Id. at 13.  As always happens in a “changed warning” claim, the plaintiff claimed that, had she too been warned, she would have have sought dental treatments short of extraction.  Id. at 14.  Point to plaintiff.

There appear to be two problems with that testimony:  (1) it’s probably not true, since plaintiff had testified at least twice that “she did not want to have a root canal done and preferred to have the tooth extracted.”  Eberhart, slip op. at 9; see also id. at 9 (“she did not want a root canal or to even talk with [the specialist] about it, so she wanted [the tooth] removed”).  (2) The kind of dental work the plaintiff claimed she would have had simply wasn’t available.  The dental specialist on the case testified that he “would not have performed any endodontic treatment on [Plaintiff’s] teeth.”  Id. at 14.  Point back to defendant.

The first of the plaintiff’s problems, perhaps unfortunately, can only be decided at trial.  It’s not the job of a court to find testimony incredible, however blatantly self-interested and contradictory a party’s story might be.  The second problem, however, was a legitimate basis for summary judgment.  If the alternative medical treatment that the plaintiff claims a different warning would have prompted was not, in fact, available from the only specialist the plaintiff was seeing – there’s no causation, because there wasn’t really any alternative:

[O]n the record here that Plaintiff has not shown that [defendant’s] failure to warn was a cause of her alleged injury and has not shown that there is an issue of fact on causation.  Based on the evidence in the record as presented by the parties, the Court concludes that there are no facts to support that endodontic treatment was available to avoid the extraction of [the tooth in question], which was the site of Plaintiff’s claimed ONJ.  Accordingly, the Court finds there is no disputed fact regarding causation and the motion for summary judgment is required to be granted.

Eberhart, slip op. at 32.  We omitted a lot of pages dealing with the plaintiff’s technical objections to the doctor’s testimony (including an interesting flip flop from the A/Z plaintiffs' usual position on treater expert testimony), because we don’t think they matter in this context.  The plaintiff has the burden of proof, so even if there’s nothing negative, there’s still nothing positive on this causation point, and the defendant should win.

Anyway, the point of Eberhart to us is that defense counsel have to keep probing.  A smart plaintiff’s lawyer will try to find a way around a prescriber’s testimony that defeats warning causation, be it “I already knew,” “I wouldn’t do anything differently,” or “I didn’t read it at all.”  Sometimes the other side will be successful in breaching the first wall of causation.  At that point, the defense has to pursue secondary avenues of cutting off causation, as in Eberhart.

But Eberhart’s only one case.  How have other Aredia/Zometa cases fared in the two years since our earlier post?

Not so hot, actually.  We don't sense any problem in discussing them, because the other side already knows all about these.

We’ve already discussed the recent Winter case here, and it’s bad.  The prescriber decided that he couldn’t be bothered with warnings – any warnings.  The opinion's rather mushy analysis held that there was a fact issue whether the defendant should have tried in some other way (sales reps? Dear Doctor letters?) to warn the willfully ignorant doctor.  2011 WL 5008008, at *3.

There’s also Stevens v. Novartis Pharmaceuticals Corp., 247 P.3d 244 (Mont. 2010).  The opinion didn't spend much time on warning causation (as opposed to experts and other legal issues), but did state this: “The testimony also showed that [the dental specialist] would not have undertaken the tooth extraction if he had known of the risks of ONJ in Zometa patients such as [plaintiff].” Id. at 267.  So Stevens appears to have involved the kind of causation evidence missing in Eberhart.

We also found In re Aredia & Zometa Products Liability Litigation, 2010 WL 5136142 (M.D. Tenn. Dec. 7, 2010) (McDaniel).  Again the defendant attempted a causation defense, but it was a tough case.  The prescriber’s notes indicated he was considering restarting the plaintiff on Aredia even after an ONJ diagnosis, but that might not have happened had the warnings been different:

[T]here are genuine issues of material fact as to whether, given different warnings, [plaintiff] would have agreed to any suggestion that she continue or restart Aredia.  Her Aredia was, in fact, discontinued.  There are genuine issues of material fact as to whether different warnings would have changed the behavior of [plaintiff] or her health care providers.

Id. at *3.  In addition there was a heeding presumption under Arkansas law, although we’re not sure how relevant it was in this particular instance.

We also took a look at In re Aredia & Zometa Products Liability Litigation, 2010 WL 5072022 (M.D. Tenn. Dec. 7, 2010) (Brown).  This was in some ways similar to Eberhart, except that the plaintiff was effectively rewarded for being even less credible.  Like the prescriber in Eberhart, the prescriber in Brown now gives different warnings, even though he would still have prescribed (we’re dealing with an effective treatment for metastatic cancer, remember).  The plaintiff in Brown – ignoring the life-saving effect of A/Z – simply testified that “he would not have taken the drugs.”  Id. at *2. Taking that testimony at face value, the court denied summary judgment on warning causation grounds.  Id.  That plaintiff would rather be dead, it seems - at least now that there's money to be had.

There’s also In re Aredia & Zometa Products Liability Litigation, 2010 WL 5092784 (M.D. Tenn. Dec. 7, 2010) (Talley), where the prescriber reduced the plaintiff’s Zometa dosage after learning of the risk.  The plaintiff avoided summary judgment by claiming that “she would have reduced her dosage earlier and would have insisted on greater vigilance and dental monitoring to protect her jaw.”  Id. at *2.  Not a great summary judgment case, either.

The only other A/Z learned intermediary rule causation decisions our search pulled up were duplicates.  In re Aredia and Zometa Products Liability Litigation, 2010 WL 5136148 (M.D. Tenn. Dec. 7, 2010), is an earlier decision in the Eberhart case, with a less complete record, so it really shouldn’t count separately.  Ditto for Fussman v. Novartis Pharmaceuticals Corp., 2010 WL 4104707 (M.D.N.C. Oct. 18, 2010), which duplicates a case discussed in our prior post.

So, adding together these new A/Z opinions, we calculate the defendant’s score on warning causation (these are tougher than usual cases because there are two independent sets of treaters – oncology and dentistry) to stand at 5-11.  Not good, although we hasten to add that a significant number of the cases mentioned in the earlier post wound up getting thrown out on other grounds.  See Thomas v. Novartis Pharmaceuticals Corp., 2011 WL 3701816 (6th Cir. Aug. 23, 2011) (affirming summary judgment in Thomas, Melau, and Anderson on medical causation grounds); Emerson v. Novartis Pharmaceuticals Corp., 2011 WL 3701835 (6th Cir. Aug. 23, 2011) (affirming summary judgment in Emerson on Florida-specific FDA compliance grounds).

In the Zyprexa litigation, by contrast, the beat goes on - most of the time:

• In re Zyprexa Products Liability Litigation, 2011 WL 4962349 (E.D.N.Y. Oct. 18, 2011) (McClamrock) (prescriber already knew of relevant risk) (applying North Carolina law).
• In re Zyprexa Products Liability Litigation, 2011 WL 4963048 (E.D.N.Y. Oct. 18,2011) (Waheed) (prescriber already knew of relevant risk) (applying Arkansas law).
• In re Zyprexa Products Liability Litigation, 2011 WL 2516333 (E.D.N.Y. June 23, 2011) (Shepherd) (prescriber already knew of relevant risk) (applying Oklahoma law).
• In re Zyprexa Products Liability Litigation, 2011 WL 182489 (E.D.N.Y. Jan. 20, 2011) (Modley) (prescriber already knew of diabetes risk) (applying Mississippi law).
• In re Zyprexa Products Liability Litigation, 2011 WL 4052913 (E.D.N.Y. Oct. 14, 2010) (Gaskins) (prescriber already knew of relevant risk; case not within “mass immunization” exception) (applying North Carolina law).
• In re Zyprexa Products Liability Litigation, 2011 WL 348276 (E.D.N.Y. Jan. 22, 2010) (Trimble) (prescriber already knew of relevant risk; prescriber not “biased” despite receiving speaker’s fees from various drug companies) (applying Illinois law).
• In re Zyprexa Products Liability Litigation, 2009 WL 5216930 (E.D.N.Y. Dec. 21, 2009) (Treuchel) (prescriber already knew of relevant risk; prescriber did not read or otherwise rely upon defendant’s information) (applying Minnesota law).
• In re Zyprexa Products Liability Litigation, 2009 WL 5062109 (E.D.N.Y. Dec. 10, 2009) (Chavez) (prescriber already knew enough of the relevant risks and would have prescribed anyway) (applying Arizona law).
• In re Zyprexa Products Liability Litigation, 2009 WL 5062114 (E.D.N.Y. Dec. 10, 2009) (Guillen) (prescriber already knew of relevant risk and would have prescribed anyway) (applying California law).
• In re Zyprexa Products Liability Litigation, 2009 WL 3596982 (E.D.N.Y. Oct. 20, 2009) (Blume) (no evidence from prescribers; plaintiff personally already knew of relevant risk) (applying California law).
• In re Zyprexa Products Liability Litigation, 2009 WL 3596526 (E.D.N.Y. Oct. 16, 2009) (Folse) (prescriber would have prescribed anyway) (applying Louisiana law).
• In re Zyprexa Products Liability Litigation, 2009 WL 3597194 (E.D.N.Y. Oct. 16, 2009) (Quirarte) (prescriber already knew of relevant risk) (applying Illinois law).
• In re Zyprexa Products Liability Litigation, 2009 WL 3597447 (E.D.N.Y. Oct. 16, 2009) (Belcher) (prescriber already knew of relevant risk and would have prescribed anyway) (applying California law).

There have been three adverse Zyprexa rulings since our previous look see.  In In re Zyprexa Products Liability Litigation, 2010 WL 3257712 (E.D.N.Y. Aug. 16, 2010) (Harvard), where the plaintiff was able to muddy an informational timeline that “favor[ed the defendant’s] position” with testimony about a sales representative – “[the prescriber’s] testimony, however, raises questions about the extent to which she was influenced by information supplied by [defendant’s] sales representative.  Id. at *7 (applying New Jersey law).

In In re Zyprexa Products Liability Litigation, 2009 WL 5125636 (E.D.N.Y. Dec. 29, 2009) (Gurovitsch), the prescribers were less than specific about whether their knowledge of the drug’s effects occurred before or after treating the plaintiff, and one of them subsequently changed his procedures.  The court found a jury issue under Minnesota law. Id. at *13-14.

Finally, there’s little any defendant could do about the adverse prescriber testimony in a case decided the day after our original post:  In re Zyprexa Products Liability Litigation, 688 F. Supp.2d 130 (E.D.N.Y. 2009) (Earl) (applying Alabama law), except not bring a motion at all.  Not only was the prescriber “uncertain” about the state of his knowledge at relevant times, but he testified that he “would have pursued other options” had he known more.  Id. at 149.

For those keeping score, that puts the defendant’s summary judgment totals in Zyprexa at a still sterling 26-4 – although we’re still scratching our heads about raising warning causation as a defense in Earl.

Anyway, there’s our update, from A to Z.

Dear Doctor Letters As The Next Warning Frontier – Kapps Vs. Winter

Under the learned intermediary rule, for a warning claim to succeed, at a bare minimum the prescribing (or sometimes another) doctor at least has to read the allegedly defective warning.  After all, there’s a causation element to every warning claim – the defect (whatever’s allegedly wrong with the warning) has to cause the injury.  If the prescribing physician never even read the purportedly inadequate warning, none of those inadequacies could have affected his/her treatment of the patient.  This common-sense notion, that a warning that’s not read cannot be causal, has been bedrock law in prescription medical product liability litigation for decades:

 

Alabama

 

In re Trasylol Products Liability Litigation, 2011 WL 2117257, at *5 (S.D.Fla. May 23, 2011) (applying Alabama law) (“no record evidence indicating that [the prescriber] read the warning that Plaintiff claims was inadequate”); Emody v. Medtronic, Inc., 238 F. Supp.2d 1291, 1293, 1296 (N.D. Ala. 2003) (prescriber “did not even read the package insert”; thus he “he did not rely on [defendant’s] warnings”).

 

Arizona

 

Gebhardt v. Mentor Corp., 15 Fed. Appx. 540, 542 (9th Cir. 2001) (“evidence at trial showed that [the prescriber] did not read or rely upon the allegedly inadequate warnings of the [defendant’s] device”) (applying Arizona law).

 

California

 

Ramirez v. Plough, Inc., 863 P.2d 167, 177 (Cal. 1993) (where plaintiff “neither read nor obtained translation of the product labeling . . . there is no conceivable causal connection between the representations or omissions that accompanied the product”) (over-the-counter drug case; plaintiff did not read warning); Conte v. Wyeth, Inc., 85 Cal. Rptr.3d 299, 308, 318-319 (Cal. App. 2008) (“[t]here can be no proximate cause where, as in this case, the prescribing physician did not read or rely upon the allegedly inadequate warnings promulgated by a defendant about a product”); Lord v. Sigueiros, 2006 WL 1510408, at *3-4 (Cal. Super. April 26, 2006) (prescriber “admits that he had not read the [drug’s] label before prescribing it to the decedent”), aff’d, 2007 WL 4418019, at *4 (Cal. App. Dec. 19, 2007) (“evidence does not raise an issue of material fact regarding causation because [the prescriber] testified that he did not read the warning label prior to or after prescribing [the drug] to [plaintiff]”); Motus v. Pfizer, Inc., 358 F.3d 659, 661 (9th Cir. 2004) (“the doctor who prescribed [the drug] . . . failed to read [the defendant’s] published warnings before prescribing the drug.  Because the doctor testified that he did not read the warning label that accompanied [the drug] or rely on information provided by [the manufacturer's] detail men before prescribing the drug to [plaintiff], the adequacy of [the] warnings is irrelevant") (applying California law); Latiolais v. Merck & Co., 2007 WL 5861354, at *3 (C.D. Cal. Feb. 6, 2007) (the “inserts played no role in his decision to prescribe” because “[the prescriber] could not recall if he ever read the package insert”), aff’d, 302 Fed. Appx. 756 (9th Cir. 2008).

 

Connecticut

 

Allen v. Mentor Corp., 2006 WL 861007, at *5, *7 (D. Conn. March 31, 2006) (prescriber “failed to inform himself with respect to the [device] by reading the [package insert], a source of which he was aware and failed to find and read”; “nothing to suggest that the warnings . . . affected [the prescriber’s] conduct since he did not read them”).

 

District of Columbia

 

Mampe v. Ayerst Laboratories, 548 A.2d 798, 802 (D.C. 1988) (prescriber “specifically stated on several occasions that he did not rely on the manufacturer's warnings as a source of information”; plaintiff “therefore could not prove that the alleged inadequacy in [defendant's] warning was a proximate cause of her injuries”).

 

Florida

 

Rounds v. Genzyme Corp., 2011 WL 692218, at *3 (M.D. Fla. Feb. 18, 2011) (prescriber’s “failing to read the warning” warranted dismissal); Fields v. Mylan Pharmaceuticals, Inc., 751 F. Supp.2d 1260, 1263 (N.D. Fla. 2009) (“[w]here a physician fails to review the warnings issued by the manufacturer, proximate cause cannot be established”).

 

Illinois

 

Tongate v. Wyeth Laboratories, 580 N.E.2d 1220, 1228 (Ill. App. 1991) (“that the physician failed to read the package inserts and the PDR negated any possible negligence on the part of the defendant and that the physician’s negligence was the intervening, independent and sole proximate cause”); Ashman v. SK & F Lab Co., 702 F. Supp. 1401, 1405 (N.D. Ill. 1988) (“[p]laintiffs offer no evidence that [the prescriber] consulted the [drug’s] label at the time he prescribed”).

 

Indiana

 

Peters v. Judd Drugs, Inc., 602 N.E.2d 162, 165 (Ind. App. 1992) (“additional warnings would not have assisted [plaintiff] where the nurse [selecting the drug] did not read the label”).

 

Kansas

 

Wright v. Abbott Laboratories, Inc., 259 F.3d 1226, 1235 (10th Cir. 2001) ([the prescribing nurse’s] “failure to read the label - a basic task which she was trained to perform - was an efficient intervening cause of [plaintiff’s] injury”) (applying Kansas law).

 

Louisiana

 

Felice v. Valleylab, Inc., 520 So.2d 920, 927 (La. App. 1987) (in “[the prescriber’s] own testimony she admitted that she had never read the warning label on the device itself, and that she had never read the manual.  An adequate warning or instruction would have been futile”); Hall v. Elkins Sinn, Inc., 102 Fed. Appx. 846, 849 (5th Cir. 2004) (the prescriber “acknowledges that he never read the warning . . . therefore, [defendant’s] warning (adequate or inadequate) played no role in the events leading to [plaintiff’s] injury”) (applying Louisiana law); Dykes v. Johnson & Johnson, 2011 WL 2003407, at *5 (E.D. La. May 20, 2011) (the prescriber “never read the warning, and thus the warning played no role in the events leading to plaintiff's injury”).

 

Michigan

 

Dunn v. Lederele Laboratories, 328 N.W.2d 576, 583 (Mich. App. 1982) (“the doctor quit reading the inserts and PDR reprints.  Thus, further notice by way of drug labels would not have altered the doctor’s conduct”); Formella v. Ciba-Giegy Corp., 300 N.W.2d 356, 359 (Mich. App. 1981) (the “fact [the prescriber] failed to read the package inserts and PDR negates any possible negligence on the part of [the manufacturer] in not emphasizing the hazards in those publications”); Cronin v. Boots Pharmaceuticals, Inc., 1996 WL 149173, at *2 (Mich. App. Feb. 16, 1996) (“[g]iven the lack of evidence that [the prescriber] ever consulted or relied on defendants’ package insert warnings in treating plaintiff, it cannot be said that those warnings played any role in the doctor’s decision to prescribe”); William Beaumont Hospital v. Medtronic, Inc., 2010 WL 3998103, at *6 (E.D. Mich. Oct. 8, 2010 (“failure to heed clear warnings can be a superceding cause”).

 

Minnesota

 

Kapps v. Biosense Webster, Inc., ___ F. Supp.2d ___, 2011 WL 4470701, at *23 (D. Minn. Sept. 27, 2011) (“doctors don’t read instructions for use in great detail every time”; plaintiff conceded unread warnings not causal); Treuchel v. Eli Lilly & Co., 2009 WL 5216930, at *12 (E.D.N.Y. Dec. 21, 2009) (“[plaintiff’s] prescriber did not rely on printed warnings. . . .  [Plaintiff] cannot meet his burden.  He failed to elicit any testimony from [any] prescriber suggesting that a different warning . . . would have changed the prescribers' decisions to continue prescribing [the drug] to [plaintiff]”) (applying Minnesota law); Johnson v. Zimmer, Inc., 2004 WL 742038, at *9-10 (D. Minn. March 31, 2004) (no causation where surgeon “had never, in any context, seen the warnings”).

 

Montana

 

Oakberg v. Zimmer, Inc., 211 Fed. Appx. 578, 581 (9th Cir. 2006) (“it is undisputed that neither [the prescriber nor plaintiff] read the [product’s] package insert.  Accordingly, even if the additional warning were printed in the package insert, they would not have been read”) (applying Montana law).

 

New Hampshire

 

Bartlett v. Mutual Pharmaceutical Co., 731 F. Supp.2d 135, 146 (D.N.H. 2010) (the “[prescriber] made clear that he never reviewed [defendant’s drug] label before treating [plaintiff] and that nothing about it influenced his decision to prescribe the drug”); Bartlett v. Mutual Pharmaceutical Co., 2010 WL 3659789, at *7 (D.N.H. Sept. 14, 2010) (“[plaintiff’s] doctor did not read or rely upon [the drug’s] label before prescribing the drug to her”).

 

New Jersey

 

Perez v. Wyeth Laboratories Inc., 734 A.2d 1245, 1261 (N.J. 1999) (“a manufacturer who fails to warn the medical community of a particular risk may nonetheless be relieved of liability under the learned intermediary doctrine if the prescribing physician either did not read the warning at all”); Strumph v. Schering Corp., 606 A.2d 1140, 1148, 1150 (N.J. Super. App. Div. 1993) (the “[prescriber] testified that he had not even read the PDR entry”; “conclud[ing] that plaintiffs failed to present any evidence from which a jury could reasonably find that the alleged inadequacy of defendant’s warnings regarding [the drug] affected the decision of plaintiff’s doctors to prescribe the drug”) (dissenting opinion), rev’d, 626 A.2d 1090 (N.J. 1993) (expressly adopting dissenting opinion as the opinion of the court); Appleby v. Glaxo Wellcome, Inc., 2005 WL 3440440, at *5-6 (D.N.J. Dec. 13, 2005) (“there is every indication that Plaintiff's doctor, . . . did not read package inserts”).

 

New York

 

Mulhall v. Hannafin, 841 N.Y.S.2d 282, 287 (N.Y.A.D. 2007) (“to prove proximate cause, a plaintiff has the obligation to adduce proof that had a warning been provided, she would have read the warning and heeded it”; plaintiff “chose not to read the consent forms”) (direct plaintiff warning claim); Banker v. Hoehn, 718 N.Y.S.2d 438, 441 (N.Y.A.D 2000) (“in the absence of reviewing any operating manuals for the [device]” by the prescriber, summary judgment granted on lack of proximate cause).

 

North Dakota

 

Harris v. McNeil Pharmaceutical, 2000 WL 33339657, at *4 (D.N.D. Sept. 5, 2000) (“[c]ase law supports the proposition that a physician’s failure to read the warnings, including package inserts and the Physician Desk Reference, essentially negates any possible liability on the part of the manufacturer).”

 

Ohio

 

Oppenheimer v. Sterling Drug, Inc., 219 N.E.2d 54, 58-59 (Ohio App. 1964) (prescriber “specifically said – ‘I don't recall specifically reading the precautions’”; “[i]t can hardly be said that he relied upon anything produced by the defendant”).

 

Pennsylvania

 

Leibowitz v. Ortho Pharmaceutical Corp., 307 A.2d 449, 458 n.3 (Pa. Super. 1973) (“[e]ven if [the manufacturer] had failed to adequately warn of dangers, said reason is not actionable in the case of a prescription drug, where the prescribing physician did not rely on the package insert”); Nelson v. Wyeth, 2007 WL 4261046 (Pa. C.P. Phila. Co. Dec. 5, 2007) (“[defendant’s] alleged failure to adequately warn could not have been the factual cause of [plaintiff’s injuries] since the prescribing physician did not read nor rely upon any of [defendant’s] warnings as contained in the label accompanying the prescription drug”), aff’d mem., 970 A.2d 489 (Pa. Super. 2009); Berry v. Wyeth, 2005 WL 1431742, at *5 (Pa. C.P. Phila. Co. June 13, 2005) (“[the prescriber] testified that he never read any warnings provided, thus any different warning (even a more adequate warning) would also have gone unread.  Therefore, [plaintiff] was unable to establish that [defendant’s] alleged failure to warn was the proximate cause”); Mazur v. Merck & Co., 767 F. Supp. 697, 712 (E.D. Pa. 1991) (“it is solely the responsibility of the learned intermediary to read [the package insert] and inform the patient of its meaning”; “[t]hat [the learned intermediary] may not have seen the package circular does not implicate [the drug company]”), aff’d, 964 F.2d 1348 (3d Cir. 1992).

 

Tennessee

 

Rodriguez v. Stryker Corp., 2011 WL 31462, at *11 (M.D. Tenn. Jan. 5, 2011) (prescriber “made the decision to use the pain pump entirely on his own”), reconsideration denied, 2011 WL 672555 (M.D. Tenn. Feb. 17, 2011).

 

Texas

 

Pustejovsky v. Pliva, Inc., 623 F.3d 271, 277 (5th Cir. 2010) (prescriber “did not recall ever reading the package insert for the drug or consulting the Physician's Desk Reference.  Her lack of memory, of course, does not preclude the possibility that she had read these materials, but neither can it sustain [plaintiff’s] burden”) (applying Texas law); Porterfield v. Ethicon, Inc., 183 F.3d 464, 468 (5th Cir. 1999) (“[plaintiff] has failed to present evidence that the failure to warn was a producing cause of her injury [because] . . . the surgeon who . . . us[ed] the [product], testified that at no time prior to [plaintiff’s] surgery had he read [defendant’s] package insert or any other [of its] literature”) (applying Texas law).

 

Virginia

 

Stanback v. Parke, Davis & Co., 657 F.2d 642, 644, 645 (4th Cir. 1981) (prescriber’s testimony “established that he had not read the package insert accompanying the vaccine”; “[w]hatever may be said about [the prescriber’s] policies and . . ., it is clear that they precluded [defendant’s] failure to warn from having any effect whatsoever on [plaintiff’s] injury”) (applying Virginia law); Rule v. Best Industries, Inc., 1997 WL 499937, at *2, 121 F.3d 700 (4th Cir. Aug. 25, 1997) (“[the prescriber] did not even read the materials provided by [the defendant]. . . .  It would not have mattered what [defendant’s] warnings said, and the alleged lack of warning was not a proximate cause of [plaintiff’s] injury”) (applying Virginia law).

 

Washington

 

Douglas v. Bussabarger, 438 P.2d 829, 831 (Wash. 1968) (no proximate cause where the prescriber “did not read the labeling which was on the container)”.

 

West Virginia

 

Meade v. Parsley, 2010 WL 4909435, at *9 (S.D.W. Va. Nov. 24, 2010) (“[m]any courts have declined to find proximate causation in pharmaceutical failure-to-warn suits when the patient (or the prescribing physician if the learned intermediary doctrine is applicable) did not read the defendant manufacturer’s allegedly inadequate warning”) (plaintiff, since West Virginia does not recognize learned intermediary rule); In re Zyprexa Products Liability Litigation, 2009 WL 1514628, at *12 (E.D.N.Y. June 1, 2009) (“no evidence that [plaintiff] ever read any of defendant's warnings of possible risks”) (plaintiff, since West Virginia does not recognize learned intermediary rule) (applying West Virginia law).

 

Wyoming

 

Thom v. Bristol-Myers Squibb Co., 353 F.3d 848, 856 (10th Cir. 2003) (“when a physician fails to read or rely on a drug manufacturer's warnings, such failure constitutes the intervening, independent and sole proximate cause of the plaintiff's injuries, even where the drug manufacturer’s warnings were inadequate”) (applying Wyoming law).

 

We can see a few justifiable exceptions – such as affirmative overpromotion.  If a defendant’s detailer said “don’t bother reading the warnings” and the doctor didn't, then an obvious alternative means of causation presents itself.  Ditto, if the doctor read something else that originated with the defendant.  But the first seems vanishingly small (particularly nowadays), and the second is a reflection of changing media by which drug information is disseminated in the era of the Internet.

 

What we don’t want to see is a trend – possibly driven by post-Mensing plaintiffs forced by preemption to make Dear-Doctor-letter (called “Dear Health Care Provider (DHCP) Letters” by the FDA) claims – that Dear Doctor letters are some sort of deus ex machina Superman that makes causation problems vanish in failure-to-read situations.  It’s not really an argument to say “defendant should have sent a Dear Doctor letter at just the right time and the prescriber would have read it.”

 

So in that vein, we’ll look at two recent cases that have dealt with Dear Doctor letter issues – one that we think ultimately got it right, and another that we think didn’t delve nearly deeply enough into the nature of this sort of claim.

 

The first case – the good one – is the recent Kapps v. Biosense Webster, Inc., ___ F. Supp.2d ___, 2011 WL 4470701 (D. Minn. Sept. 27, 2011), decision that we overviewed here.  Kapps was also a failure-to-read case (so we've cited it above), since the skilled tertiary care heart specialists who used the device weren’t about to consult the package insert concerning a device that they had undoubtedly used many times before.  Id. at at *23.

 

Regular readers may recall – but may not, so we’ll remind you – that the most unusual thing about Kapps was that the device had been reprocessed by someone (Ascent) unaffiliated in any way with the original manufacturer (Biosense), and the reprocessor had gone so far as to substitute its own name and labeling for the original manufacturer’s.  That led to the plaintiff’s primary causation problem:

Ascent usurped one of Biosense’s functions as a manufacturer – the function of providing instructions to customers – when Ascent replaced Biosense’s instructions for use with Ascent’s own.  Thus, if [plaintiff’s] claim depended on an argument that Biosense negligently failed to include certain warnings in its instructions for use, [that claim] would fail for lack of causation:  [plaintiff’s] damages could not have been caused by the omission of a warning from Biosense’s instructions for use, because Ascent replaced Biosense’s instructions with its own, and thus Biosense’s instructions did not accompany the catheter that injured [plaintiff].

2011 WL 4470701, at *23.  That’s actually a variant of the failure-to-read argument when you think about it, because the manufacturer’s instructions weren’t with the product any longer, and thus weren’t available to be read by anyone.

 

The plaintiff in Kapps, aware of this problem, advanced a Dear Doctor letter claim to fix his causation problem.  Such a “supplemental” warning, according to plaintiff, should have said “Dear Doctor, we have had a few reports of entrapment of this catheter in the mitral valve.  Please be very careful with its use in the atrium, et cetera.”  2011 WL 4470701, at *23.  Of course, plaintiff’s Superman-style letter would be sent to the medical community at just the right time to be read and heeded by the plaintiff's prescriber.  Id.  That’s what Superman does – show up at just the right moment (usually to save somebody falling).

 

Well, the court in Kapps lets Superman leap over the first obstacle, “at least for the sake of argument” – the manufacturer’s warnings not being with the product anymore didn’t necessarily defeat a Dear Doctor letter claim:

The fact that Ascent, in reprocessing the catheters, also became a manufacturer in some respects does not change the fact that Biosense was the catheters’ original manufacturer and sold the catheters to doctors. The Court therefore finds – at least for the sake of argument – that Biosense had a duty to warn doctors of the risk of mitral-valve entrapment.

Kapps, 2011 WL 4470701, at *23.

 

So where’s the kryptonite?

 

It might be in another argument – unfortunately not developed by the defendant – that the FDA might limit either the timing or substance of a Dear Doctor letter.  The plaintiff’s expert certainly didn’t have any idea.  2011 WL 4470701, at *24.  We don’t claim to know for sure, either, since the only regulation we could find with reasonable effort was 21 C.F.R. §200.5, which discusses what Dear Doctor letters should look like, but shies away from the more important question of when they are required.  This regulation just states “occasionally,” which doesn’t help very much.

There’s also an FDA “draft guidance” about Dear Doctor letters – something utterly without binding legal effect – that states that the FDA "should" be "consulted" about whether to send a Dear Doctor letter and what it should say.  Again, not all that helpful in litigation (other than as the basis for an expert opinion).  But that draft does tell us this:  Dear Doctor letters are for “important new information” – they’re not for rehashing something that doctors already should know:

[A] DHCP letter is used to inform health care practitioners about important new information about a drug.  In most cases, the new information is about an important new safety concern that could affect the decision to use a drug or require some change in behavior by health care practitioners, patients, or caregivers to reduce the potential for harm from a drug.  In some cases, the new information is about how to improve the effectiveness of a drug.

Draft guidance at 3 (emphasis added).  New.  New.  New.  New.  Moreover, Dear Doctor letters should “avoid discussion of non-critical information that could obscure the more important information.”  Id. at 4. The only other FDA-recognized use for a Dear Doctor letter is “to correct misinformation in advertising or other types of prescription drug promotion.”  Id. at 3.

 

Because the defendant didn’t have any regulatory argument developed, Superman got a free pass to leap over another obstacle:

[I] it seems reasonable to expect [plaintiff] to show that Biosense could have sent out the type of “Dear Doctor” letter that [plaintiff] calls for without violating those [unknown FDA] regulations.  But neither party has discussed the regulations covering “Dear Doctor” letters. The Court therefore will assume, for the sake of argument, that Biosense could have issued the warning advocated by [plaintiff].

Kapps, 2011 WL 4470701, at *24.

 

The court next identified, but passed by, another possible generalized causation argument, “also assum[ing], again for the sake of argument, that [plaintiff’s physicians] would have paid closer attention to a “Dear Doctor” letter than to instructions that accompanied the [device].”  Id.  No kryptonite yet.

 

Still, the plaintiff lost in Kapps.

Why?

Causation on the most fundament level.

Would the hypothetical letter have done any good in the plaintiff’s case?  No.  “[Plaintiff] cannot show that either [physician] would have done anything differently if Biosense had sent out the “Dear Doctor” letter proposed.”  2011 WL 4470701, at *24.  In short, the court found no evidence that Superman would have been able to save the day.

 

First, the plaintiff's Dear Doctor letter was garbage – or, as the opinion more gently puts it, “virtually content-free.”  2011 WL 4470701, at *24.  All it would have said was for surgeons “to be very careful” in light of “a few reports of entrapment of this catheter in the mitral valve.”  Id.  So what?  Doctors threading heart catheters are probably being “careful” anyway.

Would a doctor who is manipulating a catheter inside a patient’s heart near the mitral valve become more careful if he read a warning saying, “Be careful not to get this catheter trapped in the mitral valve”?  Surely doctors know, based both on their training and on common sense, that they must be “very careful” when manipulating an instrument inside a human heart.

Id. Well, duh.

 

Second, plaintiff in Kapps had no evidence – in particular no affirmative statements from either doctor – what different actions a Dear Doctor letter of the sort being proposed would have prompted.  One of the physicians wasn’t even deposed.  Thus as to him, “[t]here is not a shred of evidence in the record that, had [he] been warned that he should be careful about mitral-valve entrapment, he would have done anything differently.”  Id. at *25.  As to the other physician, who was deposed, he “testified that in the time since [plaintiff’s] procedure, [he] has not changed anything about how he uses [the device].”  Id.  If “direct personal knowledge” of a risk didn’t change anything, plaintiff’s vague Dear Doctor letter certainly wouldn’t have.  Id.

 

Third, not even a heeding presumption (not adopted in Minnesota) would have saved the claim.  Assuming (the Kapps opinion made a lot of pro-plaintiff assumptions, before throwing out the case) that such a thing existed, it only presumes heeding, not causation:

What is presumed under the heeding presumption is that the omitted warning would have been heeded, not that the heeding of the omitted warning would have prevented the plaintiff's injury. . . .  Biosense is being faulted for not warning [the physician] to “be very careful” in manipulating the [using the device].  But there is no reason to believe that [he] was not being very careful.  Put differently, there is no evidence that, if [he] had heeded the warning to be very careful, he would have done something differently – and thus there is no evidence that the absence of that warning caused [plaintiff’s] injuries.

Kapps, 2011 WL 4470701, at *25 n.22.

 

Finally, we have some kryptonite to kill the Dear Doctor letter Superman.

 

Kapps thus gives defense counsel a decent roadmap of the types of arguments that can defeat Dear Doctor letter-based warning claims:

 

• Is a Dear Doctor letter within the scope of the defendant’s duty to warn?  If the prescription medical product is not the defendant’s own product, unlike Kapps, where that was an important point, then probably not.  That’s why a Dear Doctor letter shouldn’t help a generic-only plaintiff against the branded manufacturer.  If the branded product isn’t being sold anymore – generally, or to this particular physician, or to this particular patient’s health plan – there shouldn’t be any duty to send such a letter.
• Is the defendant allowed by FDA regulations to send a Dear Doctor letter concerning the risk at issue?  From what little we’ve been able to discover in a few minutes on the FDA’s website, we’d have to say that the kind of “reminder” letters, "consistent" with existing labels, mentioned in some of the generic cases aren’t likely to pass muster.
• Is there evidence that Dear Doctor letters in general are likely to influence the plaintiff’s prescriber’s behavior?  How many such letters does he get?  Does s/he read them?  What kind of information actually changes prescribing behavior?  Examples?  Here, it would really help if either the defendant or, even better, the prescriber, had software installed that kept track of the prescriber’s receipt of and opening of Dear Doctor letters.
• Is there evidence that this particular proposed Dear Doctor letter would have changed the outcome of this particular case?  Other causation evidence – failure to read warnings; prior knowledge of the risk; “I wouldn’t do anything differently” testimony – will help here.  So would information that the same physician received Dear Doctor letters about other, equally or more serious, risks and still uses those products in the same way.  Again, software that keeps track of this kind of thing would be most useful.

So that’s Kapps.  On the other side of the ledger is Winter v. Novartis Pharmaceuticals Corp., 2011 WL 5008008, slip op. (W.D. Mo. Oct. 20, 2011).  Winter let a Superman-type warning claim (maybe a Dear Doctor letter; maybe something else – the opinion isn't entirely clear) save the day for the plaintiff.  Winter is a blatant failure-to-read case.  The prescriber wasn’t just ignorant – he was loudly ignorant.  He testified that he didn’t ever read any of the defendant’s drug labeling because the lot of it was “useless”:

[The prescriber] cannot recall a patient with [cancer] to whom he did not prescribe [the drug] prior to that point.  [The prescriber] has testified that he never read the package inserts for [drug] while practicing . . ., but that this was because [the defendant] produced them in a way that made them useless to a practitioner.

Id. at *1.

 

Here’s the first point where Winter sluffs off an issue.  Exactly how were the warnings “useless”?  The opinion doesn’t say.  We think that could be plenty important.  The format, almost entirely, as well as a lot of the content, of drug warnings is prescribed by FDA regulations.  Is this doctor saying that the FDA-mandated aspects of the label are why he finds it “useless.”  Does the doctor not read any drug labeling at all?  That would make causation impossible to prove, since such aspects of the label would be impossible for  the manufacturer to change.  Winter, however, passes by this issue entirely.

 

Anyway, for whatever reason, the doctor in Winter proclaimed his failure to read the relevant warnings.  Under the abundant precedent cited above, that should lead to a no-causation summary judgment ruling.

 

But here comes Superman (called “communications”) to the rescue.  Dear Doctor letters?  Sure.  In fact, one was apparently sent to onr non-reader prescriber in Winter.  But here comes an issue of fact – the same doctor who didn’t bother with package inserts, may not have bothered with Dear Doctor letters either, only we can’t be sure:

[Defendant] highlighted these latest changes in a Dear Doctor letter dated September 24, 2004, but the parties dispute whether [the prescriber] ever received this letter.

Winter, 2011 WL 5008008, at *1.  The same doctors who don’t read drug labels, probably don’t read anything else either – but when caught, they plead ignorance, and ta-da, that’s a “dispute.”  Here’s another example of a problem needing a technological fix.  Paper Dear Doctor letters leave no paper trail, unfortunately.  Software does.  Sending Dear Doctor letters by email means that a doctor who, as in Winter “ma[kes] himself ignorant,” id. at *2, won’t be able to hide behind that ignorance any longer.
 
Get modern - win cases.

 

Rather than actually grapple with (or at least mention) the causation questions, as Kapps did, the opinion in Winter contented itself with vague generalities:

But even assuming [defendant’s] claims are true, [plaintiff] has still shown that genuine issues of material fact exist as to causation on her claims.  First, [the prescriber] has testified that he did not read the package inserts for [the drug] medication because [defendant] produced these inserts in a way that made them useless to practitioners.

2011 WL 5008008, at *2.  Okay, but there’s not a scrap of affirmative evidence of causation in that statement.  How could anything different in an insert that’s “useless” change this doctor’s treatment?  No idea.  And if it’s inherent in how the FDA requires inserts to be drafted, then it would be afirmatively impossible.

 

Next.

Further, [plaintiff] has argued that [defendant] had a duty to reflect the known side effects of its medication in articles and communications through sales representatives, both of which could have reached [the prescriber] and changed the course of events despite his not reading package inserts.

Id. There's Superman.  Something, who knows what, saying exactly the right thing at exactly the right time.  What “communications”?  Could it be a Superman Dear Doctor letters – timed, of course, just right so that Superman can save the day?  Stay tuned.

 

But to us this sort of rank “could have” speculation doesn’t cut it – not where the plaintiff has the burden of showing causation.  There’s no mention of any evidence that this doctor – who didn’t read drug warnings, and couldn’t say if he’d even received Dear Doctor letters – read articles, let alone changed his practice in reliance on them.  Nor is there evidence that this doctor ever did anything in reliance on “communications,” either via Dear Doctor letters or in person via sales representatives.  If such evidence existed, we’d expect to see some mention of it in the Winter opinion, but we’re left scratching our heads.

 

Superman causation arguments – be they Dear Doctor letters, articles, or some sort of "underpromotion" by sales representatives, should require affirmative proof.  If a Dear Doctor letter is postulated, there needs to be evidence that the same doctor reacted positively to other similar letters involving comparable risks.  If an article (or a Dear Doctor letter) is postulated, there must be some basis that a proper basis for such an article (or letter) in fact existed at the “just in time” moment that the plaintiff's Superman swoops in.  The kind of mushy non-evidentiary, non-analysis in Winter makes a mockery of the burden of proof.

 

Not too long ago we took to task a pro-plaintiff law review article that whined about “evidence based medicine.”  Right now, we’d be happy just to have evidence-based litigation., instead of the Winter of our discontent.