Friday, October 31, 2014

Halloween and Broken Devices Don’t Make a Defect

San Francisco has become a sea of orange and black.  As we post this missive, hundreds of thousands of Giants fans are flooding into the city for the third World Series parade in five years.  The 2010 parade was unlike anything we have ever seen in terms of size and ebullience.  Truth be told, we are Oakland Athletics fans, so while we are delighted at the triumph of the men in orange and black, our delight pales by comparison to the euphoria that would accompany another World Series title for the green and gold.  We attended the 2010 Giants parade therefore not because we are avid fans, but because the parade route runs one block north of our office and because we were firm in our belief that the Giants would never win another World Series for as long as we live.  Boy, were we wrong on that one! 
Of course, it is also Halloween, the other reason why orange and black is San Francisco’s color scheme du jour.  We are unsure of the origins of Halloween and its signature colors, although we are very sure that the Giants’ victory had nothing to do with All Hallows’ Eve, Celtic harvest festivals, or superstition.  Indeed, we are confident that the confluence of orange and black celebration on this one day is a coincidence, albeit one accompanied by ghouls, goblins, costumes of all sorts, children begging for candy, and skeletons displayed in front of our homes.
Which brings us to the topic of bones, the subject of an interesting case from the Western District of Louisiana holding that a medical device is not defectively constructed just because it broke.  In Lirette v. DePuy Mitek, LLC, No. 2:13-cv-2892, 2014 U.S. Dist. LEXIS 149725 (W.D. La. Oct. 20, 2014), the plaintiff injured her knee while jumping rope and underwent ACL reconstruction with a prosthetic graft in her shin bone.  The graft product, however, allegedly “split open” in the plaintiff’s knee, resulting in multiple additional surgeries to relieve her pain and to remove “pieces of loose matter” that appeared to be pieces of the “split” device.  Id. at **2-3. 
The plaintiff sued the product manufacturer under the Louisiana Products Liability Act (“LPLA”), a law that we like, mainly because of its strong exclusivity (and alternative design) provisions.  If you want to file a products liability claim in Louisiana, you get a claim for defect in design, defect in construction, inadequate warnings, or breach of express warranty – and that’s all.  Id. at *7.  The plaintiffs initially pleaded all four theories, but on the third round of pleading (much more common after TwIqbal), they were left with just one products liability claim for allegedly defective construction.  Id. at **8-9. 
It would seem that an allegation that the device broke would be a good start for a claim of defective construction.  The problem for the plaintiffs was that they alleged nothing further, i.e., their allegation that the device broke was the beginning, middle, and end of their claim.  They alleged, for example, that the “unreasonably dangerous condition” of the device caused it to “tear apart and split” and that it was not intended to do so.  Id. at **10-11.  This “unusual occurrence,” according to an amended complaint, gave rise to an “inference of a manufacturing defect.”  Id. at **11-12.  It also allegedly gave rise to “inference of negligence” or the doctrine of res ipsa loquitur.  Id. at *11. 
Not even close.
The district court did not bite on the plaintiff’s invitation to draw these “inferences” from the pleadings.  Under the LPLA, a product is unreasonably dangerous in construction if it deviated in a material way from the manufacturer’s specifications for the product or from otherwise identical products made by the same manufacturer.  Id. at *9.  Thus, a plaintiff has not stated a claim for a manufacturing defect “absent factual allegations addressing how the product deviated from the defendant’s normal production standards.”  Id. 
The plaintiffs failed to meet that pleading burden.  They alleged, as already noted, that the device “split.”  However,

the plaintiffs do not show how this split and fragmentation was caused by a deviation from the manufacturer’s specifications or standards.  It is not sufficient to allege that because a product broke, it must have deviated from performance standards.  Products can break for any number of reasons, including user negligence; every broken product does not automatically give rise to a cause of action under the LPLA.

Id. at *13 (emphasis added).  Other courts have come to the same conclusion, including in the multiple opinions listed here.  It is the correct result, and the Western District of Louisiana’s statement of its rationale is a solid base hit.
By the way, how did the court know that “products can break for any number of reasons”?  In our minds, the statement is self-evident, but the district court may also have been informed by the 24 adverse event reports that the plaintiffs attached to their opposition.  That was not the most brilliant of moves on the plaintiffs’ part.  Rather than support an “inference” of a manufacturing defect, the reports only reinforced that there are any number of reasons for product failures—misuse, ordinary wear and tear, problems with user technique, etc.—none of which involves a product defect.  As the district court pointedly observed, “None of the FDA adverse event reports—including the report filed about the plaintiff[’]s sheath—found that a defect in construction caused the sheath’s failure.”  Id. at **13-14. 
Finally, the district court rejected the plaintiffs’ allegations of res ipsa loquitur.  It seems that res ipsa loquitur can be used in the context of a claim under the LPLA, although we may have to explore exactly how that could be in another post.  Id. at *14.  The doctrine, however, does not apply at the pleadings stage, and the plaintiffs’ separate action for negligence against the surgeon prevented the plaintiffs from excluding an inference that someone else might be at fault.  Id. at *15. 
After two chances to amend, the plaintiffs could allege no more than the device broke, which fell short of stating a products liability claim.  The district court therefore denied further leave to amend as futile.  As they say in baseball, strike three and you’re out. 

Thursday, October 30, 2014

Guest Post on Adverse Event Reports & Updating Cheat Sheet

It takes time and effort to keep all our scorecards and cheat sheets up to date.  So we fell all over ourselves when a Reed Smith associate, Kevin Hara, offered to update our cheat sheed on adverse event reports.  The result is this guest post.  As you might guess, Kevin works out of the RS San Francisco office.  As with all guest posts, Kevin is due all the credit (and blame, if any) for what follows.  The AER cheat sheet has been simultaneously updated to include the case descriptions in Kevin's post.


            As the San Francisco Giants completed their biennial foray deep into the playoffs, on their way to a third World Series title in the last five seasons, it makes us think of Adverse Event Reports (“AERs”) and Medical Device Reports.  How exactly do we relate baseball to AERs?  The Giants have managed to advance to the World Series with a seemingly rhythmic frequency, in 2010, 2012, and again this year.  Baseball fans even joke that because 2014 is an even numbered year, that was why the Giants won.  Are the two things related?  Do people really believe that the digits on the calendar determine the fate of the Bay Area baseball franchise?  Or is it simply a coincidence, and not a cause and effect relationship? Is it not more likely that consistently good pitching, defense, and timely hitting along with good management are reason that the Giants are winning, and it just happens to fall on even numbered years (although until last night the Kansas City Royals of course disagreed)?  Although Kevin Costner’s soliloquy in Bull Durham captures the idea that baseball players in general take superstition to the extreme, and might argue that the Giants’ success is as simple as the calendar year, the answer of course, is yes, there is much more to the analysis. 

            A similar analogy can be drawn between using AERs as evidence of causation in pharmaceutical drug and medical device litigation.  There are numerous other potential explanations that may be more likely and one simply cannot draw a conclusion that a drug or device caused an adverse event based on AER data.  The publicly available FDA Adverse Event Reporting System “FAERS,” launched on September 10, 2012, clearly cautions that “[t]he appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk.  It means that FDA has identified a potential safety issue, but it does not mean that FDA has identified a causal relationship between the drug and the listed risk.”

            However, when required to submit evidence establishing medical causation of their injuries, plaintiffs in drug and device cases frequently attempt to submit expert opinions that rely heavily on AERs.  As this blog has reported before, here, and here, AERs, often referred to as case reports, are not reliable indicia of causation.  A recent decision, Wendell v. Johnson & Johnson, which the blog covered here, underscored the fact that anecdotal evidence is not a reliable source of medical causation.  2014 WL 2943572, at *3-5 (N.D. Cal. June 30, 2014).  Although the experts in Wendell “cite[d] a handful of studies and case reports discussing possible causes of HSTCL, none of these purports to show that the specific combination of drugs prescribed to [plaintiff] actually causes HSTCL.”  Id. at *5 (emphasis added).  This straightforward application of the law of medical causation is elegant in its simplicity – if the plaintiff cannot show that the medicine, or in this case – combination of medicines – is even capable of causing the alleged injury, the defendant (rightly so) prevails. 

            Baseball appears to be a beautiful and simple game when played well, but as anyone who has tried to hit a ball traveling more than 95 miles per hourwill tell you, there are few things more difficult.  Indeed, a hitter in the major leagues who succeeds merely one third of the time is not just good but great.  Therefore, just like the Giants’ winning ways are not simply a product of even numbers, but relate instead to numerous other factors such as pitching, defense, hitting, favorable matchups, managerial decisions, and even human error (although, as last night proved, replay review certainly helps), an injury or disease may have many possible explanations, or may instead be idiopathic.  There is much more to the outcome of the Major League Baseball playoffs than a single factor.  And that is precisely why courts should not infer causation from case reports.

With all that as prologue, here are the latest case updates to the blog’s adverse event report cheat sheet:

Chapman v. Procter & Gamble Distributors, LLC, 766 F.3d 1296 (11th Cir. Sept. 11, 2014) (Fixodent).   Affirming exclusion of causation testimony because reliance on “generalized case reports, hypotheses, and animal studies are insufficient proof of general causation,” because such information “could mislead the jury by causing it to consider testimony that was insufficient by recognized primary methodologies to prove using [denture cream] causes myelopathy.”

Wirt v. Sec'y of Health & Human Services, No. 11–118V S, 2014 WL 1911421 (Fed. Cl. Apr. 18, 2014) (HPV vaccine).  Adverse event data alone, “without the opinion of a medical expert and/or medical records showing a causal connection between vaccination and injury, is not proof of a causal connection,” and is insufficient to establish that a product caused a particular disease.

DeGidio v. Centocor Ortho Biotech, Inc., 3 F. Supp.3d 674 (N.D. Ohio Mar. 11, 2014) (Remicade).  Excluding expert testimony under Daubert, where there was “no question that plaintiffs’' experts based their general-causation opinions solely on case reports” because “[c]ase reports make little attempt to screen out alternative causes for a patient's condition,”  and simply describe phenomena without comparison to background rates, either “in the general population or in a defined control group; do not isolate and exclude potentially alternative causes; and do not investigate or explain the mechanism of causation.

Berman v. Stryker Corp., No. 11 C 1309, 2013 WL 5348324 (N.D. Ill. Sept. 24, 2013) (prosthetic knee).  Reliance on Manufacturer and User Facility Device Experience (“MAUDE”) medical device adverse event reports alone was inappropriate basis to infer causation are because “such reports can contain inaccurate and non-validated data,” and “[d]enominator data are missing which makes evaluation of the incidence or prevalence of reported events impossible.”

Trainer v. Sec’y of Health & Human Services, No. 10–865V, 2013 WL 4505803 (Fed. Cl. July 24, 2013) (hepatitis A vaccine).  Finding “no causal link” between” the product and the alleged harm where the claimant attempted to rely on case reports and anecdotal evidence because “there are too many unknown variables that make such raw information inherently unreliable.”

Klein v. TAP Pharmaceutical Products, Inc., 518 F. Appx. 583 (9th Cir. May 14, 2013) (Lupron).  Affirming exclusion of adverse event reports, as they “were hearsay reports of uncertain reliability, lacking information relevant to causation.”

Rhodes v. Bayer Healthcare Pharmaceutical, Inc., No. 10–1695, 2013 WL 1289050 (W.D. La. Mar. 26, 2013) (Avelox).  Granting Daubert motion to exclude expert testimony because “reliance on adverse event reports is also unimpressive, as such reports do not demonstrate the requisite degree of reliability.”

In re Aredia & Zometa Products Liability Litigation, 483 F. Appx. 182 (6th Cir. June 5, 2012) (bisphosphonate drugs).  Affirming grant of summary judgment.  Expert testimony was properly excluded as unreliable because general causation expert admitted that he could not “establish causation [based on 2] case reports, but simply a ‘very close association.’”

In re Denture Cream Products Liability Litigation 795 F. Supp.2d 1345 (S.D. Fla. June 13, 2011) (Fixodent).  Expert testimony on general causation was unreliable because there was “no evidence that Plaintiffs’ experts or the case reports they rely on [were] systematic in considering other plausible hypotheses and excluding background risk.”  AERs are “unreliable, as a general matter,” due to “inconsistencies in case definition,” which “limit[ed] the evidentiary value of the case reports to support an inference of causation.”

In re Zicam Cold Remedy Marketing, Sales Practices, & Products Liability Litigation., No. 09–md–2096–PHX–FJM, 2011 WL 798898 (D. Ariz. Feb. 24, 2011) (Zicam).  The FDA’s “AERs data and the agency’s reports are not admissible bases” for expert causation opinions.  Such reports “reflect complaints called in by product consumers without any medical controls or scientific assessment,” and are “uncontrolled anecdotal information [which] is not the foundation of a reliable causation methodology.”

Toni’s Alpacas, Inc. v. Evans, No. 09–cv–02045–REB–CBS, 2010 WL 3730382 (D. Colo. Sept. 16, 2010) (fiber supplement).  Rejecting anecdotal reports as foundation for proof of causation, since they do not isolate and exclude alternative causes and lack controls.

Kilpatrick v. Berg, Inc., 613 F.3d 1329 (11th Cir. Aug. 12, 2010) (pain pump).  Affirming that case study was an unreliable basis for expert testimony because it did not contain statistical analysis and did not draw medically valid conclusions.  The excluded expert “acknowledged that case reports . . . are ‘way down at the very bottom as far as medical strength of an article’ and cannot establish medical causation,” because of a “multitude of factors that could have caused” the alleged injuries.

Hendrix  v. Evenflo Co., Inc., 609 F.3d 1183 (11th Cir. June 22, 2010) (child restraint system).  Affirming exclusion of expert testimony.  “Case studies and clinical experience, used alone and not merely to bolster other evidence, are also insufficient to show general causation.”

Wednesday, October 29, 2014

FDA Alert based on Adverse Event Reports Admitted in Med-Mal Case


Bad news arrives in all sorts of vehicles, not just product liability suits.  For example, in a medical malpractice case, the E.D. of Tenn recently issued a ruling that admitted an FDA Alert into evidence.  Guthrie v. Ball,  2014 U.S. Dist. LEXIS 148900 (E.D. Tenn. October 17, 2014).  That ruling displeased us, but since to be forewarned is to be forearmed, we share it with you in an effort to get all of the week’s nasty rulings behind us before we are halfway through humpday. 


In Guthrie, the plaintiff’s counsel sought to use an FDA Alert sent to physicians regarding the risks of fentanyl patches.  Specifically, the plaintiff’s counsel used the FDA Alert during depositions of expert witnesses.  It appeared that the plaintiff’s counsel was attempting to use the FDA Alert to establish the standard of care.  The doctor defendant filed a motion in limine to exclude the FDA Alert on the ground that it was inadmissible hearsay to which no exception applied, including the 803(8) hearsay exception.  Among other things, the defendant argued that the FDA Alert did not contain a statement identifying the office responsible for the alert or reflect the FDA’s activities, did not indicate whether it pertained to a matter observed under a legal duty to report, and did not appear to reflect actual findings from a legally authorized investigation.  Rule 803(8) creates an exception to the hearsay bar for “[a] record or statement of a public officer if: (A) it sets out: (i) the office’s activities; (ii) a matter observed while under a legal duty to report …; or (iii) in a civil case …. factual findings from a legally authorized investigation; and (B) the opponent does not show that the source of information or other circumstances indicate a lack of truthworthiness.”  Fed.R.Evid. 803(8).   


The court held that the FDA Alert was relevant because it specifically mentioned the brand of patch used by the plaintiff and it was issued in 2007, years prior to the plaintiff’s treatment by the defendant doctor in 2010.  Additionally, unlike some other cases, the FDA Alert in question was not merely a proposed finding and did not invite public comment before final publication.  The FDA Alert in Guthrie was based upon adverse event reports submitted to the FDA.  Are such adverse events a source of trustworthiness?  You know what we think about that, right?  As we have said here and here, for example, adverse events are hardly enough to establish a scientific fact or the standard of care.  By relying upon such an unreliable source as adverse events reports, that “trustworthiness” concept has been transformed into what the Colbert Report calls “truthiness.” 


The Guthrie court acknowledged that “[s]ome courts have found that expert testimony based upon adverse event reports is likely inadmissible as unreliable because such opinion testimony is not based upon sufficient facts and data.”  2014 U.S. Dist. LEXIS 148900 at *13.  It is nice that the Guthrie court was aware of the smart, good, fair cases.  But, sadly, the Guthrie court was more moved by the dumb, awful, and wretched  cases:   “Other courts have found that such adverse event reports are reliable and an adequate scientific basis for expert testimony, given that such reports are often the only data available, and they are widely relied upon by both the FDA and experts in the industry.”  Id. at *14.  Which experts, exactly?  How many of them cavort around the country, singing loudly from sheet music placed in front of their snouts by plaintiff lawyers?  Anyway, as if purposely to administer injury and insult to this very blog, the Guthrie court cites an opinion from the Gadolimium-Based Contrast Agents litigation, that selfsame litigation that prompted Bexis to erupt into a post on “spherical error.” We’re not entirely certain what spherical error is, but it sounds pretty bad. 


The defendant in Guthrie mounted a spirited attack on the reliability of adverse event reports, but the court seemed comfortable with its error, whether such error was spherical, triangular, or trapezoidal.  Thus, the court did not believe that reliance upon a peer-reviewed article was a necessary requirement in establishing reliability.  Id. at *15. The court held that there is no authority to support the limitation of Rule 803(8)’s public records exception to only epidemiological studies or accident investigations, because “no formal proceedings are necessary to satisfy the prerequisites of the rule.”  Id. Further, the form of the record is not determinative of their admissibility, because the “indicia of reliability for the governmental investigative report is the fact that it is prepared pursuant to a duty imposed by law.”  Id.  It was enough that the FDA Alert “was based on the FDA’s investigation into adverse event reports which had been filed regarding the association between fentanyl patches, including Duragesic branded patches, with fatal respiratory depression from fentanyl overdose.”  Id. at *15-16.  [Speaking of finding an association, we cannot resist pointing out that there appears to be an association between fentanyl patch cases and dreadful judicial opinions.  One such case was selected by us as the single worst case of 2011.]  That’s all it took for the court to conclude “that the FDA Alert is admissible as a public records exception to the hearsay bar under Rule 803(8).”  Id. at *16. 


In the private sector, when someone jokingly admits that they did a less-than-thorough job, they sometimes use the phrase “close enough for government work.”  The Guthrie court really took that notion to heart – without understanding the joke. 


Tuesday, October 28, 2014

Qui Tam Off-Label Treat

            This post is from the non-Reed Smith side of the blog only.

            For the last two years during the week of Halloween, we’ve posted about the scary case of United States v. King-Vassel, 728 F.3d 708 (7th Cir. 2013), trial court decision at 2012 U.S. Dist. LEXIS 152496 (E.D. Wisc. Oct. 23, 2012).  It is an eerie tale in which one doctor tries to hold another doctor liable under the False Claims Act for prescribing a drug off-label.  The trial court dismissed the case but on narrow grounds – leaving the door open to resurrection.  Think Glenn Close springing out of the tub at the end of Fatal Attraction.  The district court only drowned the claims and instead of putting a bullet through the heart of the complaint, the Seventh Circuit administered CPR.    While there were a lot of weird and frightening things going on in that case, what was more important to us was why the case wasn’t thrown out on the general principle that off label prescriptions are not false claims.    

            Well if the last two years were all Freddy and Jason and Chucky -- this year is more like It’s the Great Pumpkin, Charlie Brown or Monsters, Inc., or even Casper, The Friendly Ghost.  No zombies, demons or ghouls this year.  This year we’re celebrating the treat of a judge who gets it. 

            The claim in United States v. DJO Global, Inc., __ F. Supp.2d __, 2014 WL 4783575 (C.D. Cal, Sep. 2, 2014) reads like a sequel – actually more like the 20th installment in a franchise.   The recurring plot being use of the False Claims Act to reap financial windfalls from appropriate off-label prescriptions involving federal payors.  Plaintiffs allege that the defendants, manufacturers of spinal stimulators (PMA, Class III medical devices), submitted false claims to Medicare seeking reimbursement for devices that were used off-label.  To be covered under Medicare, a medical device needs to be “reasonable and necessary” to diagnosis or treatment.  Part of the determination of whether something is reasonable and necessary is whether the device is safe and effective.  Id. at *3-4.  Because the FDA determines safety and efficacy as part of the pre-market approval process, the Department of Health and Human Services (HHS) has determined that PMA devices generally may be covered under Medicare.  Id. at *4. 

            Plaintiffs’ primary theory is not based on whether defendants’ reimbursement claims actually contained false information.  Rather, plaintiffs argue that when a device is prescribed for an off-label use, the device becomes “categorically” excluded from Medicare coverage.  Id. at *16.  Does this argument sound familiar?  It should.  It is how plaintiffs in products liability cases involving PMA devices try to get around preemption.  They argue that the off-label use negates the FDA’s pre-market approval determination that the device is safe and effective and therefore preemption no longer applies.  Fortunately, as seen recently through the InFuse litigation, most courts haven’t been willing to follow plaintiffs down that illogical path. 

            But, we always like to bolster our position.  So, it doesn’t hurt that the court in DJO Global, was likewise not persuaded by this argument in the qui tam context.  The first inkling that DJO Global wasn’t going to be another slasher flick disaster was the court’s up-front discussion about the valid, legitimate and perfectly lawful use of medical devices for off-label purposes:

If a medical device is used for a purpose other than that for which it has obtained PMA approval, the usage is “off-label.”  The FDCA explicitly protects physicians’ abilities to prescribe devices for such use.  Indeed, off-label use of medical devices is “generally accepted” within the medical community, and section 396 of the FDCA expressly disclaims any intent to directly regulate the practice of medicine.

Id. at *2 (citations omitted).  What is prohibited by the FDCA is marketing a PMA-approved device for an off-label use.  Id. at *3.  That distinction is key.  “[A] manufacturer is not liable [for having violated the FDCA] merely because it sells a device with knowledge that the prescribing doctor intends an off-label use.”  Id. (citation omitted). 

            With the proper regulatory background set, the court moves into its analysis of the plaintiffs’ claim which boils down to this – because HHS has determined that reimbursement is limited to devices approved through the PMA process, that means that Medicare can only cover on-label uses.  Replace HHS with Supreme Court and replace reimbursement/Medicare with preemption in that sentence and this is an argument we are all too familiar with.

            And just like the plaintiffs who make this argument in products cases, the qui tam plaintiffs’ argument is fatally flawed by their commingling of “devices” and “uses.”  The FDA regulates the former, not the latter.  The same holds true for Medicare.

The court agrees with defendants. The Medicare Manual states that “devices” approved through the PMA process are eligible for coverage, not that “the use of a device” that has been approved by the FDA is eligible for coverage. 

Id. at *18.  Therefore, if the FDA has approved a device for at least one purpose, Medicare can determine that a particular use (one that is reasonable and necessary) is reimbursable, even if that use is off-label.  Id. at *19.      

            There are many other aspects to this decision that are more closely tied to specific Medicare provisions, but for us those are more like the pretzels and raisins you move aside to get to the Snickers at the bottom of your trick-or-treat bag.  They’re tasty, but just not as sweet as that candy bar.  And, unfortunately, like Charlie Brown, this decision gives us one rock in our bag too.  The court found at least one theory asserted by plaintiffs that could plausibly survive and is giving them a chance to amend their complaint.  But if this decision didn’t deliver the fatal blow to False Claims Act suits based on nothing more than off-label use – it stabbed deep.  Plaintiffs are going to have to do some serious surgery to bring this claim back to life.  Here’s hoping we aren’t talking about a Dr. Frankenstein version of DJO Global next year.                 

Monday, October 27, 2014

Express Warranty Claim Survives Summary Judgment under West Virginia Law in Mesh Litigation

Today we have two summary judgment decisions recently issued out of one of the pelvic mesh litigation MDLs – the West Virginia federal court managing consolidated cases related to Boston Scientific’s mesh product.  See Tyree v. Boston Scientific Corp., 2014 U.S. Dist. LEXIS 148271 (S.D.W. Va. Oct. 17, 2014); Tyree v. Boston Scientific Corp., 2014 U.S. Dist. LEXIS 148371 (S.D.W. Va. Oct. 17, 2014).  The opinions are close to identical.  In each instance, with limited discussion, the court disposed of a number of the plaintiffs’ claims – e.g., manufacturing defect and fitness for a particular purpose – and allowed others to go forward to trial – e.g., failure to warn (remember, West Virginia has no learned intermediary doctrine) and implied warranty of merchantability.  

But it’s the court’s decisions on plaintiffs’ express warranty claims that merit discussion.  The defendant argued – convincingly, you would think – that it was entitled to summary judgment on these warranty claims because the plaintiffs admitted that they never received or read the written materials (the Directions for Use) in which the warranty was allegedly made.  2014 U.S. Dist. LEXIS 148271, at *14-15; 2014 U.S. Dist. LEXIS 148371, at *13.  That argument sounds pretty good.

But it won’t always work in West Virginia, not in federal court.  Three years ago, the Southern District of West Virginia issued Michael v. Wyeth, LLC, 2011 U.S. Dist. LEXIS 56157 (S.D. W. Va. May 25, 2011), which held in the HRT litigation that, if there is a statement of fact or promise made in connection with the sale of good, the plaintiff need not show reliance on that statement for an express warranty claim to go forward.  Rather, the mere existence of the statement creates a rebuttable presumption that the parties included it as part of their bargain.  

Adopting that reasoning, the Tyree court denied summary judgment on both plaintiffs’ express warranty claims.  It cited the Michael court, in particular its statement that, while the plaintiff in that case didn’t read any statements contained in materials provided by the defendant, she had relied on her doctor.  2014 U.S. Dist. LEXIS 148271, at *15; 2014 U.S. Dist. LEXIS 148371, at *14.  But the Michael court’s opinion also made explicit that the doctor had received and read such materials.  

There’s nothing in the Tyree opinion, however, to suggest that the two plaintiffs’ doctors received, no less read, the materials that allegedly created the express warranty.  Setting aside the advisability in a drug and device case of creating a rebuttable presumption of reliance on an express warranty despite the absence of evidence that the patient actually read the materials that created the warranty, creating that same presumption without evidence that even the patients’ doctors saw the materials could stretch express warranty claims beyond recognition.  

Now, it’s certainly possible that there was such evidence in the Tyree cases, and it just didn’t make it into the court’s two opinions – though, that’s a big piece to leave out.  But, as written, this decision could make it even easier to take express warranty claims to trial in West Virginia drug and device cases – at least in federal court.

Friday, October 24, 2014

Without Failure To Warn, Other Claims Collapse

The key to appreciating the latest order granting summary judgment for the defense in the Ortho-Evra birth control patch MDL is to start with the order’s last paragraph:

The Court has found that the Defendants provided adequate warnings sufficient to discharge their duty to warn.  Because the Defendants exercised reasonable care by communicating the risks involved with the Ortho Evra® patch to [the plaintiff’s] physician, and those warnings were not faulty, [the plaintiff] has not established a claim of negligent misrepresentation under Tennessee law.

Brown v. Janssen Pharmaceuticals, Inc., No. 3:12-oe-40003, 2014 U.S. Dist. LEXIS 145415 (N.D. Ohio Oct. 10, 2014).  Ah, the familiar ring of the learned intermediary doctrine, the beat to which the Drug and Device Law Blog most often marches.  But what’s this?  The doctrine applied to negligent misrepresentation?  Some background is in order:  The plaintiff in Brown alleged that her use of hormonal contraceptives caused blood clots, which is one of the most widely known drug risks ever known to medical science.  As we said when we first reported on this case, every doctor and medical student knows about the risk—so do most women—and the labeling for hormonal contraceptives has fully disclosed the risk of clots for decades. 
The defendants therefore moved for judgment on the pleadings, which the district court granted on the failure-to-warn claims back in April 2014.  See Brown v. Janssen Pharmaceuticals, Inc., No. 3:12-oe-40003, 2014 U.S. Dist. LEXIS 57319 (N.D. Ohio Apr. 24, 2014).  This was absolutely the correct result as far as it went, but there were still several claims left over—manufacturing defect, negligence, and fraud. 
We were not all that concerned.  With the failure-to-warn claims gone, we at the DDL observed that

. . . a plaintiff left with manufacturing defect, negligence, and fraud does not have much to work with going forward.  Manufacturing defects are extremely rare in pharmaceutical cases, and fraud is usually disposed of with one question posed to the plaintiff in written discovery or a deposition.  Question: “Have you ever had any contact or communication with the drug manufacturer?  Answer:  “No.”  Of course, negligence can raise a host of issues, but we would not be surprised if further exploration of negligence beats a path straight back to the adequacy of the warnings . . . .

Which brings us to the court’s latest order, which granted summary judgment and put an end to the case.  Brown, 2014 U.S. Dist. LEXIS 145415.  It turns out the plaintiffs had even less to work with that we thought.  On manufacturing defect and negligence, the plaintiffs merely cited the allegations in their own complaint, which obviously is not evidence.  The court saw it that way too, and summarily granted the defendant’s motion on those claims.  Id. at **5-7.  The plaintiffs converted their fraud claim into “deceit by concealment” and negligent misrepresentation, but they offered little to nothing in support of those claims either.  They based their concealment claim on a statute that did not apply.  The negligent misrepresentation claim failed because the plaintiff never communicated with the defendants, and there was no identifiable misrepresentation made to anyone else—such as the prescribing physician.  Id. at **9-10. 
The court’s order granting summary judgment therefore played out pretty much as we expected it might.  One of our mantras is that claims arising from the use of prescription drugs almost always come down to the adequacy of the warnings and their impact (or lack of impact) on prescribing physicians.  Thus, once warnings-based claims are knocked out of a case, everything else tends to collapse.  That is what we foresaw with the Brown case, and that is what in fact came to pass, although it was predictable enough that we will not break our arms patting ourselves on the back for our prodigious prognostication. 
The citation to the learned intermediary doctrine in connection with negligent misrepresentation is still interesting.  Where the plaintiff has had no contact or communication with the defendant—which is almost always the case in prescription drug and medical device cases—he or she may try to base fraud and misrepresentation claims on communications with a physician.  We suppose you might call it misrepresentation by proxy.  We are not sure that should ever work, but even giving credence to such a concept, what representation has a drug manufacturer made to prescribing physicians?  At the risk of sounding like a broken record, claims arising from the use of prescription drugs almost always come down to the adequacy of the warnings. 
So the court’s application of Tennessee’s learned intermediary doctrine to cut off alleged negligent misrepresentation is not as far-fetched as it seemed at the outset, but it still goes to show that defendants are in good stead when asserting warnings-based defenses as broadly as they can and across as many causes of action as conceptually possible.  The defendants in Brown appear to have done that, and with the help of the incredibly well developed blood-clot warnings that accompany hormonal contraceptives, they won. 

Thursday, October 23, 2014

On “Right To Try” Legislation

Since the beginning of 2014, five states that we know of have enacted what is called “Right to Try” statutes.  See Ariz. R.S.A. §36-1311 to -1314; Colo. R.S.A. §§25-45-101 to -108; La. R.S. §1300.381-386; Mich. C.L.A. §§16221, 26451; V.A. Mo. S. §191.480.  “Right to Try” (a play on right to die) legislation addresses a serious subject as to which there is no easy answer.  There are still a lot of incurable diseases out there.  When somebody is afflicted with such a disease, all established treatments have failed, and that person is facing certain death, can that person have access to unapproved drugs – those that are still “investigational” in FDA parlance – on the theory that s/he has nothing to lose?

We’ve been interested in the issue of what is sometimes referred to “compassionate use” of unapproved products still in the pipeline ever since the we blogged on the Abigail Alliance litigation back in 2007.  For those of you not reading us then, we praised the D.C. Circuit’s rejection of any constitutional right for terminally–ill patients to demand access to investigational drugs.  Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, 495 F.3d 695, 710-11 (D.C. Cir. 2007).

We did that because the next step, after establishing such a constitutional right as against the FDA, would have been to file suit against our clients (the government usually doesn’t have the drugs, the manufacturers do) to “enforce” that right by demanding that drug companies supply them with the unapproved drugs they sought.  Sure enough, that’s happened, too, even without the purported constitutional right.  We discussed a number of such cases (all, thankfully unsuccessful) here.

The “Right To Try” statutes seek to accomplish much the same thing, albeit with more consideration given to the rights of manufacturers (the earlier lawsuits mostly tried to get investigational drugs for free) and reasonable procedural steps included for health care providers as well.  One key feature of these statutes – we’ll pick the Arizona statute for no reason other than alphabetical order, but all the statutes are the same on this – is that participation by drug companies is voluntary:

A manufacturer of an investigational drug, biological product or device may make available the manufacturer's investigational drug, biological product or device to eligible patients pursuant to this article.  This article does not require that a manufacturer make available an investigational drug, biological product or device to an eligible patient.

Ariz. R.S.A. §36-1312(A).

Right to Try statutes also typically include robust informed consent requirements (more on that in a minute), id. §1311(1)(d-e), see Colo. R.S.A. §25-45-103(4) (very detailed informed consent provision); Mich. C.L.A. §26451(d) (same), as well as provisions for payment of whatever the owner of the investigational product chooses to charge.  Ariz. R.S.A. §§36-1312(B)(2).  Nor are these statutes the equivalent of those infamous “Laetrile bills” that underwent a brief efflorescence in the late 1970s.  Those sought to legalize quackery.  These statutes are limited to investigational drugs that have successfully passed FDA Phase I trials.  Id. §1311(2).  In Phase I, investigational new drugs are tested on a few dozen human subjects (20-80) “to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.”  21 C.F.R. §312.21(a).

Still, we don’t think these statutes are going to accomplish much, let alone achieve their purpose of making investigational drugs generally available to terminally ill patients having no other choices.  For one thing, there’s the FDA.  States can pass all the laws they want, but unless the FDA gives its okay to programs more expansive than its compassionate use (“expanded access”) program, nothing’s going to happen.  It's called "preemption."  You may have read a bit about that on this blog.

But putting the FDA to one side, even if states could start their own compassionate use programs, these statutes aren’t likely to help much.


The reason, as is the case for so many things these days, is the threat of liability.  Nothing in any Right to Try statute allows companies to insist upon ironclad releases of liability as a condition of their participation, and absent that state courts (which tend to read releases parsimoniously) could well hold such releases invalid as coercive.  “If you don’t sign this release, you’re sure to die” isn’t exactly a situation calling for the unfettered exercise of equal bargaining power.  A Right to Try statute could override other law in this limited circumstance by expressly allowing such releases, but none of them do.

The other way to eliminate the liability disincentive to the provision of drugs/devices of unknown safety and effectiveness (for any use) to desperately ill people is through statutory preclusion of liability.  Once again the Right to Try statutes come up short.  Some of these statutes have no limitations on tort liability at all (at least as to manufacturers, we’re not discussing doctors and other health care providers).  Arizona’s doesn’t.  Neither does Louisiana.  In fact Louisiana is worse, since it's statute provides blanket tort immunity to any “physician who prescribes an investigational drug, biological product, or device to an eligible patient pursuant to the provisions of this Part.”  La. R.S. §1300.385.  The practical result of such immunity would be that, should anyone in Louisiana sue for injuries caused by the unknown risks of an “investigational” drug, the manufacturer would stand alone in the cross-hairs, without even the right to join the physician that made the prescribing decision, no matter how negligent that decision might have been.  You won't induce a manufacturer to participate in a voluntary program by painting a target on its back.

The Colorado and Michigan statutes provide that the Right to Try law itself doesn’t “create a private cause of action.”  Sort of:

This article does not create a private cause of action against a manufacturer of an investigational drug, biological product, or device or against any other person or entity involved in the care of an eligible patient using the investigational drug, biological product, or device, for any harm done to the eligible patient resulting from the investigational drug, biological product, or device, so long as the manufacturer or other person or entity is complying in good faith with the terms of this part 1, unless there was a failure to exercise reasonable care.

Colo. R.S.A.§ 25-45-107 (emphasis added); see Mich. C.L.A. §26457 (identical language).  Let’s break that down.  There’s not a private cause of action created under the Colorado or Michigan Right to Try statutes unless:  (1) the defendant doesn’t act in “good faith,” whatever that is, or (2) “fail[s] to exercise reasonable care,” in other words, is negligent.

So not only do the Colorado and Michigan statutes fail to give any relief to a participating manufacturer from any pre-existing common-law tort liability, but they create new statutory causes of action for “bad faith” and negligence (with no statute of limitations stated) against any participating manufacturer.  That’s a particular drawback in Michigan, which otherwise has a statute (blogged about here) that precludes ordinary negligence (let alone bad faith) liability against makers of FDA-approved drugs.  Historically, negligence is already quite capacious in what “reasonable care” encompasses, and the experience of the insurance industry is that “bad faith” can mean just about anything.  Any rational economic actor would think long and hard about distributing a product having – by definition – an unknown risk/benefit profile under these conditions.

The Missouri statute is better.  It does not purport to create a private statutory cause of action under any circumstances, although it doesn’t expressly preclude such new liability either (as you may have guessed, it’s silent).  Even more importantly, it does eliminate some common-law liability:

Except in the case of gross negligence or willful misconduct, any person who manufactures, imports, distributes, prescribes, dispenses, or administers an investigational drug or device to an eligible patient with a terminal illness in accordance with this section shall not be liable in any action under state law for any loss, damage, or injury arising out of, relating to, or resulting from:

(1) The design, development, clinical testing and investigation, manufacturing, labeling, distribution, sale, purchase, donation, dispensing, prescription, administration, or use of the drug or device; or

(2) The safety or effectiveness of the drug or device.

V.A. Mo. S. §191.480.8 (emphasis added).  In other words a participating manufacturer can still be liable to any plaintiff who can plead gross negligence or wilful conduct under Missouri’s ostensible fact pleading rules.  That’s better than any other extant Right to Try statute, but is still dependent on how strictly pleading requirements are enforced.

On the other hand, Missouri uniquely requires the manufacturer of an investigational drug – not just the prescribing physician – “notify the patient” directly in the event that the drug’s “clinical trial is closed due to lack of efficacy or toxicity.”  V.A. Mo. S. §191.480.7.  Where that fits into the partial immunity from suit provided by §191.480.8 is unclear, but a plaintiff’s lawyer could certainly be expected to argue that if this direct-to-patient notice were not given, then the manufacturer was not acting “in accordance with this section” as required by the immunity provision.  If such an interpretation were accepted, such plaintiffs could further argue that the statutory requirement of direct-to-patient notice vitiates the learned intermediary rule, also not a happy situation for a defendant.

In fairness, it must also be acknowledged that proving causation would not be easy in any civil action concerning investigational products dispensed under Right to Try statutes, given their augmented informed consent requirements.  Nor would such cases otherwise be attractive to our opponents, since the damages that could be recovered on behalf of persons by definition already in terminal condition are not likely to be very large.

Conversely, it must also be kept in mind that Right to Try statutes are seeking to get manufacturers to take actions – voluntarily, since no statute requires an participation at all – that they don’t ordinarily do, and that are well outside their comfort zone.  They are not allowed by the FDA to “promote” such products for any use, so even providing routine information to those outside of FDA-regulated clinical trials is fraught with difficulty.  What warning could a manufacturer give, anyway?  “CAUTION:  This drug may not be safe or effective for any use and has unknown risks, that may include death or serious injury of any sort.”  What good would that do?

Right to Try statutes seek to induce manufacturers to make available to desperate persons products with no track record and that have not had their safety or effectiveness established for any purpose, and indeed that have not been studied adequately so that their risk/benefit profile is known to anyone, even to the manufacturer.  Manufacturers are not heartless, regardless of what our opponents might say, but they are usually rational economic actors.  They are not going to go out of their way unless assured that, at least, they are not going to get sued for their trouble.  The five statutes enacted to date do not provide that assurance.  The Colorado, Louisiana, and Michigan statutes would leave participating manufacturers in a worse position than the plain common law (much worse than under Michigan’s statutory presumption of non-defectiveness).  Arizona doesn’t address the common-law at all.  While Missouri’s statute does, it leaves a significant hole in its protections – and creates a potentially scary exception to the learned intermediary rule for participants.  Thus, we doubt that Right to Try statutes are going to be any more effective than previous litigation in making investigational drugs available to terminally ill patients who are willing to try them.

In closing, we should mention that we do find one possible benefit to Right to Try statutes – especially those like Colorado and Michigan that have very detailed informed consent prerequisites to participation.  Such informed consent provisions demonstrate that a legislature knows how to impose detailed informed consent requirements when it wants to.  Since we still see occasional common-law attempts to create novel informed consent duties concerning FDA regulatory status in cases involving off-label use, statutes like these Right to Try laws are useful to defendants.  They demonstrate that expansion of informed consent should be left to the legislature, and further that lawmakers are quite capable of strengthening informed consent standards if and when they see fit.

But in terms of achieving their intended purpose, we don’t think that Right to Try statutes, as currently drafted, are going to save any lives.  That's unfortunate.