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.

It’s August, So . . . .

            It’s hot.  The Olympics are over (U.S. came out well ahead in medal count).  There are only about three weeks left to squeeze in a summer vacation.  ABC just announced the line up for the next season of Dancing With the Stars.  And the stores are jammed with notebooks, backpacks and sneakers (September always meant new sneakers!).  Sure, there are a few other things going on too – something about a vice-presidential candidate and are we taking pictures of Mars?  But really, as the summer winds down, we’d prefer to keep things simple.  So, our post today is nothing earth-shattering, but it is a nice decision we’d like you all to be aware of.

            The case is Smith v. Johnson & Johnson, Inc., 2012 U.S. App. LEXIS 16000 (5^th Cir. Aug. 2, 2012).  The product was a pelvic mesh used in surgery to repair complications plaintiff suffered following a hysterectomy.  Id. at *2.  A few months later, additional surgery was required to remove the mesh which had eroded causing pain and other complications requiring a 5-week hospital stay.  Id. at *3.  Plaintiff appealed two decisions by the district court.  The first struck her experts and the second granted summary judgment.  We like them both, so we’ll summarize both.

            First, the experts.  Here plaintiff (really her counsel) failed on several fronts.  First, they were untimely.  On the day expert designations were due, plaintiff only identified two experts by name and CV – but did not serve defendant with an expert report or any other statement of the experts’ proposed opinions or bases for them in violation of  Rule 26(b)(2).  Id. at *4.  Expert reports weren’t served until two months later.  Two months after that, in response to defendant’s summary judgment motion, plaintiff served an affidavit from a previously unidentified third expert.  Id. at *4. 

            Both the district and appellate courts struck the third expert as untimely.  Plaintiff offered no reasonable explanation for why that expert could not have been designated by the deadline and all of his opinions could be obtained from the other experts.  Id. at *8-9.

As to the first two experts, plaintiff was given a pass.  The magistrate judge denied defendant’s motion to strike the experts as untimely, holding that “the importance of the expert testimony weighed heavily in favor of permitting the late designation.”  Id. The court did, however, award defendant costs finding that defendant “had incurred unnecessary expenses due to the plaintiffs’ lateness.”  Id. at *4-5. 

But, that pass only got plaintiff over the lateness hurdle.  The court went on to strike the experts “based on its finding that their reports were conclusory and provided no factual support or reasons for their conclusions.”  Just how conclusory were these reports?  Well, according to the court’s decision essentially they said:  We are doctors.  We reviewed plaintiff’s medical records. We believe the pelvic mesh caused plaintiff’s injuries.  Id. at *6-7.  Pretty bare bones, huh?  The court agreed:

According to [the expert’s] report, he did not consult any of the medical literature concerning Mersilene mesh or any of the documentation about the product. He also gave no reasons or explanation for his conclusions. It is a well established rule that without more than his credentials and subjective opinion, an expert’s testimony that a medical condition simply is so is not admissible.   

Id. at *7 (citation and quotation marks omitted).

            And the court didn’t stop there either.  Not only were the reports completing lacking in substance, they also didn’t address the critical issue in the case – “whether the warning provided by the manufacturer . . . was sufficient and whether any inadequate warning caused Smith’s injuries.”  Id.  Plaintiff had no admissible expert testimony in response to defendant’s motion for summary judgment.  Id. at *8. 

            Which brings us to said summary judgment motion, governed by Mississippi law.  Mississippi recognizes, and has codified in its Products Liability Act, the learned intermediary doctrine.  Id. at *10-11.  So, on a failure to warn claim, the question before the court was whether the plaintiff had established that her surgeon would not have used the pelvic mesh if he had received an adequate warning.  Id. at *11.  Plaintiff focused on the adequacy of the warning and overlooked the part about what her surgeon would have done. 

            As to the warning itself, plaintiff contended that it should have included information about adverse event reports detailing injuries allegedly incurred as a result of the use of the product.  Id. at *12.  But, given her surgeon’s testimony, what was or was not on the product’s label didn’t really matter:

[Plaintiff’s surgeon] testified that he was aware of the risks inherent in using Mersilene mesh, and stated that he was personally aware of the possibility of adverse events including extrusion and erosion. . . . [He] also testified that he read the Contraindications section of the Mersilene package insert, which advised 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 Mersilene mesh was the best option for Smith.

Id. at *12-13.   Because her surgeon was aware of risks but decided to use the product anyway “the adequacy of the warning is not a producing cause of the injury and the plaintiff’s recovery must be denied.”  Id. at *13-14. 

            Like we said, a good decision.  One we hope you have some use for in your own cases.  Now, back to your regularly scheduled end of summer activities.

This Just In . . . Three New Jersey Accutane Plaintiff Verdicts Overturned

            In 2008, three Florida resident plaintiffs, in a joint trial, won jury verdicts in New Jersey state court on claims that Hoffman-La Roche had not adequately warned about the alleged link between ingesting Accutane and developing inflammatory bowel disease.  Two days ago, the New Jersey Superior Court Appellate Division reversed.  Sager v. Hoffman-La Roche, Inc., Docket No. A-3427-09T4 (N.J. Sup. Ct. App. Div. Aug. 7, 2012) (link here).   

            The court’s analysis is pretty straightforward – First, what law applies?  Answer:  The parties agreed to apply the substantive law of Florida.  Slip op. at 38.  Second, what is Florida law on a failure to warn claim?  Answer:  “the plaintiff must prove that the warning to the physician was inadequate, that the inadequacy of the warning proximately caused his or her injury, and that he or she suffered an injury from using the drug.”  Slip op. at 40.  Third, did plaintiff fail to prove any of these elements?  Answer:  Yes, no proximate cause.  Slip op. at 49.

            The deciding factor for the New Jersey Appellate Court was the controlling published decision by Florida’s intermediate appellate court in an Accutane case – Hoffman-La Roche, Inc. v. Mason, 27 So. 3d 75 (Fla. Dist. Ct. App. 2009), review denied, 37 So. 3d 848 (Fla. 2010).  The trial court had distinguished that case as a short, per curiam “outlier.”  But the appellate court ruled:  “It is not our place . . . to second guess the appellate courts of Florida and the wisdom of their decisions.  The published opinion in Mason, short and unsigned as it may be, is binding Florida precedent.”  Slip op. at 44-45.

On facts “markedly similar” to the New Jersey cases, the Mason court held that a critical consideration on proximate cause is “whether the doctors would have still prescribed the drug to plaintiffs, even if the manufacturer had supplied a more pointed warning.”  Slip op. at 42 (citing Mason).  In  Mason, the prescribing physician testified that he  “would still be willing to prescribe Accutane to his patients [today] even if there was evidence showing that it could cause IBD in rare cases.” Mason, 27 So. 3d at 77.  And “even if the warning label contained all of the information suggested by [plaintiff’s] expert, he would still have prescribed the medication for [plaintiff].” Id. 

Virtually identical testimony was given by the three prescribers in the New Jersey cases.  Slip op. at 46-49.  Therefore, because Mason is “the controlling Florida precedent, which must be applied here on the proximate cause issue,” slip op. at 44, the court held

This crucial testimony by each of the prescribing dermatologists clearly establishes that all three plaintiffs cannot surmount Mason’s binding legal test for proximate cause in a Florida learned intermediary situation.  . . . [T]he inescapable conclusion is that the trial proofs failed in this case to establish proximate causation under controlling Florida precedent.

Slip op. at 49. 

            Jury verdicts reversed – final judgments in favor of defendants in all three cases. 

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.

Chantix Warnings Adequate As a Matter of Law

            Last week we told you about a federal MDL court in Florida that found Accutane warnings adequate as a matter of law.   Ditto says the federal MDL court in Alabama presiding over the Chantix litigation. 

Since we haven’t spent much time talking about the Chantix MDL on this blog, here’s just a brief summary of the litigation.  Chantix is a drug approved by the FDA as a prescription medication to aid in smoking cessation.  In Re: Chantix Products Liability Litigation, 2012 U.S. Dist. LEXIS 101780, *11 (Jul. 23, 2012).  Plaintiffs allege that Chantix causes depression and other psychiatric disorders, including reports of suicide and attempted suicide.  Id. at *11-12.  As is true of all pharmaceuticals, the labeling accompanying Chantix changed over time and in 2009 a black box warning was added specifically warning about “[s]erious neuropsychiatric events, including, but not limited to depression, suicidal ideation, suicide attempt and completed suicide.”  Id. at *21.  In finding this 2009 warning adequate as a matter of law, the court offered some great language about the role of the learned intermediary.

            To start, the court framed the failure to warn question in the context of the doctor’s knowledge: 

Relevant to these arguments is whether the label sufficiently alerted medical professionals that their patients could suffer neuropsychiatric injuries from taking Chantix as prescribed. . . . Thus the court must consider the failure to warn claim in light of the warning's intended audience, medical doctors.

Id. at *24-25 (citations omitted).  The Chantix court also found that where the manufacturer warns of the very injury the plaintiff suffered – the warning is adequate. Id. at *29-30 n.10.

Faced with the law as stated above, plaintiffs couldn’t really argue that the 2009 label didn’t warn about neuropsychiatric injuries – because it did.  Indeed, their own expert’s report said the 2009 label contained a black box which is “the highest level warning possible, prominently displayed at the beginning of a drug's official prescribing information.”  Id. at *22.  So, instead, plaintiffs alleged that the warning was inadequate because it failed to “include a warning to prescribing doctors not to use Chantix as a first line treatment to assist in smoking cessation.”  Id. at *23-24.  The court recognized a novel and unsupported theory when it heard it:

Unlike the majority cases reviewed by this court, the plaintiffs seek to pursue their failure to warn claims post the 2009 black box warning, not for failing to warn of possible complications from Chantix, but for failing to tell physicians when to prescribe it.

Id. at *32.  The court wasn’t having it.  In taking apart plaintiffs’ argument, the decision offers up strong language about where a manufacturer’s duty ends and a physician’s begins.  Such as:

Yet surely the decision as to use a medication as a first-line treatment is uniquely up to the prescribing medical professional and based on a decision concerning his or her individual patient.

Id. at *25.  And:

Rather, as other courts have recognized, it is the responsibility of the physician as a learned intermediary to assess the risks and benefits of a particular course of treatment.

Id. at *31.  Quoting The Restatement (Third) of Torts: Products Liability § 6(d), comment b:

[O]nly health-care professionals are in a position to understand the significance of the risks involved and to assess the relative advantages and disadvantages of a given form of prescription-based therapy. The duty then devolves on the health-care provider to supply to the patient such information as is deemed appropriate under the circumstances so that the patient can make an informed choice as to therapy.

Id. at *31-32.  And finally, the court noted that a physician’s decision to prescribe a medication in the face of warnings is a matter of medical judgment: 

In other words, the label clearly sets forth potential side effects of Chantix. The decision to prescribe the medication anyway, given the severity of those side effects, is solely within the realm of medical judgment. An abuse or misuse of that judgment by a physician is far outside the scope of this action.

Id. at *32, n12.  Told you this was good stuff.         

            Another week, another MDL, another adequate warning.  Here’s hoping the streak continues. 

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.

Dismissing Pharmacy Defendants

While it may not be immediately obvious, the dismissal of pharmacy defendants from drug cases is almost always a good thing. 

The dismissals are often based on the learned intermediary doctrine, which says that a drug manufacturer’s obligation to warn about risks of its prescription medications runs to the doctors, not patients.  The doctrine recognizes the importance of the doctor-patient relationship under which such medications are prescribed.  Pharmacies are not part of that relationship.  So the law avoids putting on them a duty to warn customers about general medication risks.  It could erode the doctor-patient relationship.  Additionally, plaintiff’s lawyers often name pharmacists as defendants to defeat diversity jurisdiction.  So their dismissal, or imminent dismissal, is also a good thing.  It can be the basis for removal. 

We  saw yet another example of this in the Nevada courts, in Baymiller v. Ranbaxy Pharma. Inc., 2012 U.S. Dist. LEXIS 94339 (D. Nev. July 9, 2012).  The plaintiffs sued a whole host of pharmaceutical companies  and two pharmacies.  Id. at *1-3.  One of  the pharmaceutical defendants removed.  Id. at *1.  Once in federal court, the plaintiffs voluntarily dismissed all but one manufacturer and the two pharmacies.  Id. at *9-10.  Those pharmacies moved to dismiss. 

The court granted the motion on the basis of the learned intermediary doctrine:

In Klasch v. Walgreen Co., 264 P.3d 1155 (Nev. 2011), the Nevada Supreme Court addressed the duty of care that a pharmacist owes his or her customers.  Id. at 1156.  In doing so, the Nevada Supreme Court explicitly adopted the learned-intermediary doctrine in the context of pharmacist/customer tort litigation and held that pharmacists have no duty to warn of a prescribed medication’s generalized risks inherent in the prescriptions they fill.  Id. at 1157-59.  This doctrine “prevents pharmacists from constantly second-guessing a prescribing doctor’s judgment simply in order to avoid his or her own liability to the customer.”  Id. at 1159.  However, when a pharmacist has knowledge of a customer-specific risk, the pharmacist has a duty to exercise reasonable care in warning the customer or notifying the prescribing doctor of the customer-specific risk.  Id. at 1158, 1160.

In this case, the Court grants [the pharmacy’s] motion to dismiss all claims stated against it without leave to amend.  There is nothing in the complaint that alleges that [the pharmacy] had any knowledge of customer-specific risks related to [plaintiff]. As such, [the pharmacist] had no duty to warn [plaintiff] of the generalized risks inherent in her [medications].

Id. at *14-15. 

That’s a pretty good description of it. 

Now, it’s not immediately clear from the opinion that the pharmacies were named as defendants because their residences would defeat diversity jurisdiction.  But we wouldn’t be surprised if they were. 

In any event, the case started out in state court and with two pharmacy defendants.  Now it’s in federal court.  And the pharmacies have been dismissed.  As we said, that’s almost always a good thing.

D.D.C. Finds No Overpromotion Exception to Learned Intermediary Doctrine

We have long subscribed to the notion that many of the cases we defend end up looking very like a trashy romance novel: you lied to me, you damaged me, and you abandoned me. We half expect Fabio to be called to the witness stand. It's the lie that sets the drama in motion. Even when a product liability case includes claims of design defect and negligence, the real action resides in the claim of failure to warn. Understanding science can be hard. But everybody understands (or thinks they understand) a lie. What if there's no lie? A lie aligns with a legal theory of misrepresentation. Without a lie, no cause of action lies and there certainly isn't much of a heavy-breathing romance story, right? Well, we'd like to think so. But some plaintiffs have alleged that, even if there isn't a flat-out lie, the company made products too attractive to resist. Lip-stick was applied to a pig. And, somehow, the plaintiff was divorced from all rational faculties. The story changes only a little: you seduced me, you damaged me, and you abandoned me.


We can talk about what a lie is, and we can agree that lies are bad. What's a seduction? And what makes a seduction bad? Last week we were listening to an interview with Mike Nichols, the director of some great movies (Who's Afraid of Virginia Woolf? The Graduate), and currently directing Philip Seymour Hoffman in Death of a Salesman on Broadway. Nichols attended (here comes the weekly shameless plug) the University of Chicago and, along with Elaine May, raised comic improvisation to high-ish art. No Nichols-May, and maybe no Second City. And no Saturday Night Live. And no Bill Murray. And no Adam Sandler. (Say, wait a minute ….) Nichols talked about the intricacies of improvisation. Improvisation, by the way, is something that most litigators should study more. More "Yes-and"-ing and less "No, you're wrong"-ing, and we'd be more successful and less miserable. Nichols realized that all scenes can be broken down into three categories: seductions, fights, and negotiations. For us, that was what NPR calls a "driveway moment." We had arrived home, but we stayed in the car to hear the end of the interview. This idea of things breaking down into seductions, fights, and negotiations seemed like a key that could unlock a very big door. Most of what we do as lawyers falls into those three categories. (At least for litigators. We're not sure how much seduction is going on over at the Tax Group.) Seduction can be effective. Seduction can be fun. But can seduction be a cause of action, or save an otherwise defective cause of action?


We do not think so. Few plaintiff theories are as overused, overblown, and, ahem, overpromoted as overpromotion. Whenever we see a case that gives any credence to an overpromotion theory, we have mixed emotions the same way most tv critics have mixed emotions about the new HBO show Newsroom: we cannot decide if it is horrible or merely stupid. Plaintiffs claim that a drug or device manufacturer overpromoted a product when the plaintiffs do not have anything real to address. There is no data to support a finding of seduction. There might be 50 Shades of Gray, but there's no epidemiology supporting any of them. Jurors are finders of fact. An overpromotion theory essentially says that facts do not matter. How can a jury find that overpromotion -- whether the "over" pertains to quantity or quality of the promotion -- overwhelmed someone's ability to make a rational choice? Isn't that assessment especially hard when, because of the learned intermediary rule, the jury is being asked to discern whether overpromotion made a doctor stop thinking like a doctor?


Earlier this week, a federal judge granted the defendant summary judgment in a Seroquel case, and held that the plaintiffs' overpromotion theory could not save the case. Patteson v. AstraZeneca, L.P., Civ. No. 10-1760-JEB (D.D.C. July 9, 2012). [Disclosure alert:  While at a former firm, the author of this post worked for AstraZeneca on Seroquel litigation.  But (1) that is history; (2) he had nothing to do with the Patteson case, and (3) you do not really expect an unbiased review, do you?]   The facts in Patteson are straightforward. In May 2006, the doctor began prescribing Seroquel to the plaintiff to treat her insomnia. That was an off label use. The plaintiff's condition improved while she was on the drug. Nevertheless, within a year she began experiencing trouble walking and muscle spasms. It was not until January of 2008 that she was ultimately found to have tardive dyskinesia, a movement disorder linked to her Seroquel use. The plaintiffs (the patient and her husband) filed a complaint asserting nine claims against AstraZeneca and her doctor, all based on their alleged failure to warn her of the risks associated with Seroquel.


The central problem for the plaintiffs' lawsuit was that the doctor was aware of the possibility that Seroquel carried a risk of tardive dyskinesia at the time he prescribed the drug to the plaintiff. He did so after considering multiple factors. This scenario is, of course, a classic example of a learned intermediary exercising professional judgment. The learned intermediary doctrine "excuses a manufacturer from warning each patient who receives the drug where it has properly warned the prescribing physician of the dangerous propensities of its product." Slip op. at 7. The plaintiff did not dispute the existence of this doctrine here, but contended that it was called off both because the doctor did not know of the risks and because AstraZeneca's warnings were rendered ineffective by the "overpromotion" of Seroquel. Id.


The warnings on the Seroquel label could not have been more clear and explicit. AstraZeneca informed the doctor "of the risks associated with Seroquel by providing him with an FDA-approved product label, which contained clear, unambiguous language about the drug and, specifically, the risk of tardive dyskinesia." Id. at 8-9. Oddly, the plaintiff insisted that her doctor did not believe that Seroquel could cause tardive dyskinesia, even though the doctor repeatedly testified that "the risk[,] though present[,] was really very low," and later, he again discusses the risk of neuromuscular problems, including tardive dyskinesia, with Seroquel as "[r]are or infrequent." Id. at 9. Maybe the doctor thought (correctly as it so happens) that the risk of tardive dyskinesia was low, but "he clearly understood that it nonetheless existed." Id. We would say that the plaintiffs overpromoted their doctor's ignorance of the risks.


Now let's get to the overpromotion point. The plaintiff argued that "AstraZeneca should not be permitted to invoke the learned-intermediary doctrine where the drug manufacturer has 'overpromoted" the drug and 'erode[d] the effectiveness of otherwise adequate warnings' through its 'aggressive marketing tactics.'" Id. The Patteson court acknowledges that the overpromotion theory had not been "analyzed by the Courts of this jurisdiction." Id. at 10. So it looks at what other courts have done. Sadly, some judges have not laughed the overpromotion theory out of court. But even those courts that have given the overpromotion theory undue respect seem to have grasped how potentially overbroad and dangerous it is. The Patteson court never explicitly says whether it would recognize an overpromotion exception to the learned intermediary doctrine. What Patteson does say is that even if there was such an exception, it would not apply here. That is because the Patteson court read the precedents to require a plaintiff arguing in favor of application of the overpromotion exception with respect to a prescription drug to "establish with individualized proof that such overpromotion caused the physician to initiate or maintain the prescription at issue. General claims of overpromotion are not sufficient." Id. at 10, quoting In re Zyprexa Prods. Liab. Litig., 649 F. Supp.2d 18, 33 (E.D.N.Y. 2009)


Such "individualized proof" of an effective seduction is almost never going to happen. It did not happen here. While the plaintiffs in Patteson generally claimed that AstraZeneca directed "aggressive marketing tactics" towards the treating doctor, they pointed to no direct evidence in the record to suggest that the doctor "was ever exposed to messages minimizing the risk of Seroquel or promoting its off-label use." Id. at 11. All that the plaintiffs could do was direct the court to 31 visits by sales representatives to the treating doctor. Apparently, the plaintiffs sought to imply that the treating doctor simply must have been exposed to certain messages during those visits. That "evidence" does not cut it: "Repeated visits by sales representatives to a physician regarding a pharmaceutical drug alone, however, do not constitute overpromotion - there must be a link between these visits and misinformation that would make the prior warnings ineffective." Id.


Even read against the cases that most fully embraced the overpromotion theory, the facts in Patteson came up short. There was no evidence suggesting that AstraZeneca's representatives "minimized the risk of tardive dyskinesia or encouraged off-label use of Seroquel to treat insomnia during any of their visits" with the treating doctor. Id. at 12. Like the author of a bad work of history pretending to know what was going through the mind of Napoleon or Torquemada, the plaintiffs offer sheer speculation. For example: "it is probable that the AstraZeneca sales representative included the message that Seroquel was an effective sleep aid, and that the true dangers of the drug were misstated," and the doctor "was likely led to conclude that Seroquel was an appropriate treatment for Mrs. Patteson's insomnia." Id. quoting plaintiffs' brief (emphasis by the court). In any event, the plaintiffs' speculation was contradicted by the doctor. He was not seduced. And he ought to know, right?


Not according to the plaintiffs. They brought in another doctor -- who had nothing to do with the treatment of the plaintiff in this case -- to say that "AstraZeneca did in fact promote for numerous off label uses, including as a sleep aid. I make this assertion based on direct promotion to me as well as direct promotion to numerous psychiatric and neurological physicians known to me." Id. at 13. That statement was not based on any personal knowledge regarding the visits of AstraZeneca sales representatives to the treating physician. "[I] nstead, he bases his assertion on inferences from his own experience and his review of the representative call notes. Id. This doctor was presumably a purported expert witness on the objective reasonableness of the treater's conduct.  (Have we ever groused about that sort of nonsense before?  Yes, we have.)  It is as if this new expert doctor was saying that the treating doctor might not know he had been seduced, but this new doctor did, because he had been the target of another seduction. The plot thickens. In this bodice-ripping novel, the new doctor is smarter, more virtuous, and probably better-looking. It's quite a yarn. But it is not evidence that any alleged overpromotion had any effect whatsoever on the treating doctor's prescribing decision. With no real evidence regarding the doctor's "exposure to the alleged overpromotion of Seroquel and no evidence that such efforts influenced his treatment," the plaintiffs could not "avail themselves of the overpromotion exception-even if the exception were to be recognized in this jurisdiction." Id. at 14.


We won't lie. We found the Patteson case to be a joy to read -- a real page turner. The reasoning is seductive. Still, it was no tawdry flesharama.  Rather, it was almost as happy and heartfelt as a Rom-Com by the much-missed Nora Ephron.  And we loved the ending.

Congrats to Earl Austin and Aaron Davidson at Baker Botts.

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.

Putting It All Together

Our first reaction upon reading Metz v. Wyeth, 2012 U.S. Dist. Lexis 42432 (M.D. Fla. March 28, 2012), is boy, this case has a little of everything!  After it was over, the plaintiffs must have felt a little like the French after they went to war against the Prussians in 1870.

First, Metz has a little Conte (for the uninitiated, that’s shorthand for the branded liability in generic cases controversy), although only a little – the court notes (at *2 n.1) that it previously dismissed the claims against the non-manufacturing branded drugmaker.  See Metz v. Wyeth, Inc., ___ F. Supp.2d ___, 2011 WL 5826005, at *1-3 (M.D. Fla. Nov. 18, 2011).  That moves Metz onto our list of one-two punch cases that combine product identification with Mensing preemption.  It’s the seventh suit to achieve this distinction that we know of.

Second, as you might have guessed, Metz has Mensing/generic drug preemption issues all over it.  The court held that most of the plaintiff’s claims against the manufacturer of the generic drugs she took were preempted.  Those were:  (1) negligence claims, except for (possibly, the court used “may” and never definitively decided the point) allegations that the defendant could have “take[n] additional steps to warn doctors and/or consumers of information already appearing in, or recently added to, the label.”  Metz, 2012 U.S. Dist. Lexis 42432, at *8; (2) the defendant’s failure to “inform itself” of alleged risks, id. at *10; (3) all strict liability claims, including design defect and failure to withdraw the drug from the market, id. at *11-13; (4) warranty claims (unless based on the “additional steps” theory), id. at *13-15; and (5) misrepresentation/fraud.  Id. at *15-17.

In addition to Mensing-based preemption, the court invoked Buckman Co. v. Plaintiff’s Legal Committee, 531 U.S. 341 (2001), in holding that claims “that [defendant] failed to supply relevant information to the FDA” were also preempted.  2012 U.S. Dist. Lexis 42432, at *17 n.6.

Third, the court addressed another of our pet peeves, negligence per se claims based on alleged allegations of Food, Drug and Cosmetic Act (“FDCA”) violations.  As a matter of state law, Metz held that Florida did not recognize such an animal.  Only statutes that the legislature (Congress, in the case of the FDCA) intended be privately enforced could give rise to negligence per se.  Id. at *17-19. Furthermore, “failure to comply with administrative regulations rather than substantive regulations establishing a specific standard of care” also cannot be the basis of an negligence per se claim.  Id. at 19 n.8.  These are two of the grounds covered in our comprehensive negligence per se post on state-law defenses.

Fourth, the court noted the plaintiff’s improperly vague pleading at two points in the first half of the Metz opinion.  No facts concerning manufacturing defect were pleaded, leading to a dismissal under TwIqbal. 2012 U.S. Dist. Lexis 42432, at *11 n.4 . Plaintiff’s misrepresentation claims – mostly concerning post-marketing pharmacovigilance – failed the particularity requirements of Rule 9(b).  Id. at *16.

Fifth, all non-preempted claims failed on summary judgment under the learned intermediary rule because the labeling, specifically warning against long-term use, was adequate as a matter of law:

[T]he product label . . . contained the accurate, clear, and unambiguous warning that “[t]herapy should not exceed 12 weeks in duration.”  This warning, which was available both in the package insert and on the internet . . .. satisfied [defendant’s] duty to provide Plaintiff’s treating physician with adequate information about the risks associated with [the drug’s] use (including the FDA indicated prohibition on long term use).

Metz, 2012 U.S. Dist. Lexis 42432, at *23 (footnote omitted).

The warning discussion in Metz also accepted a couple other noteworthy propositions.  (1) Once an adequate warning is given, “[w]hether the physician in fact reads the warning, or passes its contents along to the recipient of the drug is irrelevant.”  Id. at *22.  “This is true even if [defendant] knew or should have known that the medical profession was not warning patients of allegedly known harmful side effects.”  Id. at *23 n.12.  Also, (2) “there is no duty to communicate an inadequate warning,” so the plaintiff cannot claim liability for not changing to a warning that they still allege is inadequate.  Id. at 23 n.11.  It would a good idea to save these quotes somewhere.  Both of these points are worth remembering for future cases.

Thus, the Metz case featured Conte, preemption, negligence per se, TwIqbal, and the learned intermediary rule – and the defendant won on all of them.  That’s what we call putting it all together.

The Plaintiff and The Known Risk

            As we are sure you can tell from many of our posts – we are television junkies (well, most of us).  We watch it all – comedies, dramas, news, sports, movies, documentaries, and yes, we’ll even admit to some knowledge of reality TV.  And while we are sitting on the couch taking in all that our high definition television can throw at us, we are at fairly low risk of injury – carpal tunnel remote control syndrome?  But, once we stand up and start moving around, all of that changes.  There is a risk we’ll stub our toe on the coffee table as we head to the kitchen to refill the popcorn bowl.  There is a risk of getting into a car accident driving to the movie theater (to again sit and become lost in another visual story).  There is a risk of choking on our hamburger at dinner following the movie.   

            Sometimes, like the examples above, the risks are things we just inherently know exist.  Other times, we need some additional warning.  Like the sign on our ride to work that warns of fog ahead or caution tape around a broken sidewalk.  How about a food label that says the product contains nuts – a warning to someone with a peanut allergy to avoid that food.    Bottom line -- we are surrounded by risks.  And in our everyday lives, we make decisions about how risk averse we want to be.  Will we walk around the broken sidewalk or jump over the caution tape?  But, if we decide to walk through rather than around, maybe because going around requires us to step into the street, presenting its own risks, we have to accept the fact that we might trip and fall on the broken concrete. 

            The same is every bit as true in the context of prescription drugs.  We don’t need to belabor the point that all prescription drugs contain risks.  All prescription drugs have side effects, that’s why they require a doctor’s prescription in the first place.  Where we rely on our own knowledge and experience in deciding whether the broken sidewalk or the street present the greater risk of injury, with prescription drugs we rely on our physicians.  When the drug label warns of a risk and the doctors are aware of the risk but decide that it is in the patient’s best interest to administer the drug in light of the risk and then the patient develops the very risk warned about – it is unfortunate but it is not a basis for liability against the drug manufacturer.

            So said the Connecticut Superior Court in Zelle v. Bayer Healthcare, LLC, 2012 Conn. Super. LEXIS 481 (Feb. 16, 2012).  Plaintiff was admitted to the hospital with symptoms that caused doctors to believe she was having a stroke.  The doctors ordered two MRIs, one with and one without contrast agent.  The contrast agent contains a known and warned of risk of anaphylactoid allergic reaction.  After administration of the agent, plaintiff did exhibit signs of an allergic reaction including respiratory arrest and hypotensive shock.  Plaintiff was treated for this reaction and released from the hospital.  Id. at *2-3.  Plaintiff alleged both failure to warn and design defect under the Connecticut Product Liability Statute and both claims were dismissed on summary judgment.

            First, failure to warn fell based on the learned intermediary doctrine.  The evidence of warning in this case was abundant.  It was documented in the label under the warnings, precautions and adverse reaction sections.  Id. at *13 n.4.  It was well-known by the doctors and nurses:

     The deposition testimony of each of the physicians and the MRI technician leave no doubt that they were well aware of the possibility of adverse effects as noted in the FDA approved warnings and had for years been well aware of the specific risk of an anaphylactic reaction to the contrast agent. Each confirmed that they had considered the risks versus the necessity to diagnose and treat a possible stroke and determined that the MRI with the contrast agent should be ordered.

Id. at *15.  In other words, the doctors decided to walk through the broken concrete (use contrast agent) because the risk of stepping into a busy street (the stroke) was greater.  Indeed, precisely due to this potentially fatal risk with the contrast agent, the doctors at the facility kept a “crash cart” in the MRI room.  Id. at *22.   

          The court also found that the “plaintiff [did] not present evidence or testimony that contradicts the adequacy of the warning, the nature of the warning, the approval by the FDA or the knowledge and understanding of the warnings by the treating physicians.”  Id. at *15-16.  In fact, apparently, plaintiff’s only “proof” was an unsigned consent form which the court found not only irrelevant, but detrimental to plaintiff’s argument:

the [learned intermediary] doctrine is applicable to the warnings being provided to the physicians and health care professionals and it is not relevant for purposes of this action whether the defendants provided specific warnings directly to the plaintiff.  What the testimony and existence of the Consent Form does confirm is that the health care professionals had specific information concerning the adverse reactions as evidenced by the inclusion of these reactions within a form created by the hospital. Therefore, the plaintiff's reliance upon the unsigned form to create a genuine issue of facts is misplaced. 

Id. at *12-13. 

            The court then turned to the design defect claim.  In dismissing the claim, the court made two good points.  First, plaintiff needed an expert to establish both the alleged design defect and proximate causation: 

     In an action involving the complications of prescription medication . . . where the claims are either scientific or medical, an expert opinion is required to discuss the development, manufacture, testing, handling and marketing of the product alleged to be defective.  Id. at *19-20.

. . . .

A finding of a defect in the drug is not within the common knowledge of an ordinary person. Without an expert as to the allegations that the product was in some manner defective causing serious unexpected and unforeseen physical injuries, the plaintiff has not been able to forge a sufficient link in the causal chain that would assist a jury in reaching an educated finding that the injuries were caused by a defect in the [drug] which was administered to her.  Id. at *23.

That was enough to grant the defendants’ motion for summary judgment.  But the court also had this to say about design defect in the context of a warned about risk:

[T]he plaintiff's allegations about the adverse effect of the drug which is noted in the product labeling information approved by the FDA does not, by itself, rise to the level of a defective product. Many courts have recognized that prescription drugs can cause adverse effects but do not create liability in every instance where there is an adverse effect. This is especially relevant for an action in which the plaintiff alleges she has suffered the adverse effects noted in the product labeling. This recognition impacts the plaintiff's obligation to prove not only that there are adverse impacts but that the plaintiff suffered because the drug was defective and the defect caused other adverse impacts or heightened in some manner the adverse impacts already recognized and addressed through precautions or warnings.

Id. at *21-22 (emphasis added).  Suffering from a warned about risk isn’t enough.  Even if the allergic reaction was connected to the injection of the contrast agent, that by itself does not create a defect.  Id. at *22.  As the court noted, “the product labeling . . . recognized the possibility of this exact reaction from a non-defective drug.”  Id. at *24.  Therefore, without expert testimony of a particular defect in the product, all plaintiff has proven is that she suffered from one of the potential, known, warned about side effects of the drug.  She tripped on the broken concrete.  Unfortunate, yes. A basis for liability, no.