More New Stuff

Today’s post is of the “this and that” variety − dealing with things we’ve come across that we haven’t yet blogged about this week.

Medical Device Preemption − The Greatest

As defense counsel appreciate, PMA preemption post-Riegel floats like a butterfly and stings like a bee.  Anybody representing PMA medical device clients will want to read (and cite) Ali v. Allergan USA, Inc., 2012 WL 3692396 (E.D. Va. Aug. 23, 2012).  Ali involved a “lap band” − a PMA device that restricts the ability of the stomach to expand, used as a last-ditch weight control measure in cases of morbid obesity.

Ali involves several preemption issues, and is also good on TwIqbal and the Virginia Consumer Protection Act.  On preemption, as usual the battleground was the so-called “parallel claim” exception.  2012 WL 3692396, at *7.  Plaintiffs offered only “a series of conclusory allegations that that [defendant] violated federal law.”  Id.  Not surprisingly, that didn’t cut it. Thus, everything having to do with warnings was dismissed (albeit without prejudice).  Id.

Plaintiffs contended that they based their negligence and implied warranty claims in a manufacturing defect.  Again they faced TwIqbal.  “[T]the plaintiff must allege sufficient facts to support both the inference that the defendant manufactured the device in a way that violated federal regulations and the inference that this violation resulted in the defect that caused the plaintiff's injuries.”  Id. at *8.  The manufacturing defect claim required:  (1) that “the plaintiff identif[y] what went wrong in the manufacturing process and cite[] the relevant FDA manufacturing standards that were allegedly violated,” id., and (2) “sufficient facts to support the inference that the defendant's federal violations resulted in the defect that caused the plaintiff's injuries.”  Id. at *9 (citations and quotation marks omitted).  The Ali complaint didn’t come close, containing only “information and belief” allegations as to violations and nothing at all about causation.  Id. at *10.  As to what was violated, alleging “any regulations promulgated pursuant to the Act” somehow didn’t impress the court.  Id.  Nor do allegations that are nothing more than “simple recitations of regulatory language” enough.  Id. at *11.  Plaintiff can’t get away with copying sections of the Code of Federal Regulations.  That the plaintiff was injured does not mean that an FDCA violation occurred:

[T]he allegation that the [product] eroded does not, by itself, suggest that [defendant] violated federal requirements in manufacturing this device. At the time the [product] obtained PMA, the FDA was aware of [a] risk of erosion and [that it] could cause serious complications. . . .  Ultimately, the FDA determined that [this risk] was a rare occurrence and that serious complication resulting from [it] was an even rarer occurrence, and approved the device despite these risks.

2012 WL 3692396, at *11 (citations omitted).

The plaintiff threw in allegations that the defendant’s first try at PMA had been unsuccessful.  The court essentially held “so what?”  Even if PMA had at first failed, the defendant “obtained PMA more than eight years before it was first implanted in [plaintiff’s] body.  Id. at *12.  That there had been various recalls of similar models didn’t matter since none of them had involved the device in question or the risk in question.  Id.

To get around TwIqbal, the plaintiffs in Ali trotted out Hofts v. Howmedica Osteonics Corp., 597 F. Supp.2d 830 (S.D. Ind. 2009), the case we love to hate. The judge in Ali hated Hofts almost as much as we do:

This Court respectfully disagrees with the Hofts court’s application of the Rule 8 pleading standard. . . .  This Court finds the Hofts court unusually lax in its application of the standard.  In assessing the sufficiency of pleadings, district courts should not take conclusory allegations as true but must require factual support for any legal conclusions offered in pleadings.  Requiring such factual enhancement does not constitute a heightened pleading standard; it is the basic pleading standard established in Rule 8 as interpreted in [TwIqbal].  Without factual allegations supporting inferences of the defendant’s liability and the plaintiff’s right to relief, pleadings fail to provide adequate notice of the grounds upon which the plaintiff's claim rests.  In Hofts, the district court relaxed the facial plausibility standard out of existence with respect to the plaintiff's allegations that the defendant violated federal requirements.  This Court declines to adopt that approach in the context of this case.

This Court also respectfully disagrees with the Hofts court’s approach to the breach of implied warranty claim, where the court placed the burden on the defendant to show that the claim imposed standards different from applicable federal requirements.  Rule 8 places the burden of pleading a plausible claim for relief and the grounds for this claim on the claimant. . . .  This Court agrees with the majority of federal courts in holding, post-Riegel, that the facial plausibility standard applies to the pleading of a federal violation in this context and requires facts indicating noncompliance with federal requirements on the manufacture of the device.

2012 WL 3692396, at *13

The plaintiffs in Ali made a premature demand for discovery before meeting their Rule 8 pleading requirements.  The court had none of it, finding that request to be “precisely the sort of fishing expedition the Supreme Court [in TwIqbal] sought to avoid in requiring the plaintiff to plead facts demonstrating their entitlement to relief and the defendant's liability.”  Id. at *14.

Ali also followed the majority rule on preemption of express warranty claims.  If they impose duties on the purported warrantor that differ from or add to federal requirements, if they challenge the safety and effectiveness of the PMA device, or if they challenge the manufacturer’s FDA-approved labeling, express warranty claims are preempted.  Id. at *15.  The only way am express warranty claim survives is when there are allegations “based on representations made by the manufacturer about the device that was not approved by the FDA.”  Id. at *16.  The plaintiff didn’t plead anything of the sort, so the express warranty claims were also dismissed.  Id.

We’ve also collected cases holding that consumer fraud claims involving drugs and medical devices fail under “regulated activity” safe harbor provisions in the relevant state statutes.  Ali is another such case:

By its own terms, however, the VCPA does not apply to “[a]ny aspect of a consumer transaction which aspect is authorized under laws or regulations of this Commonwealth or the United States, or the formal advisory opinions of any regulatory body or official of this Commonwealth or the United States.” Va. Code Ann. §59.1-199(A).

Plaintiffs’ VCPA claim fails because it challenges conduct that is expressly excluded from the scope of the VCPA.  Plaintiffs base their VCPA cause of action on representations made by [defendant] . . . in advertisements and other marketing materials concerning the safety and effectiveness of the device.  Representations about the [PMA-approved device] in marketing materials for the device are authorized and regulated by the FDA under federal law.  The VCPA, therefore, does not apply to it and therefore no action challenging [defendant’s] marketing practices . . . may be brought under the VCPA.

2012 WL 3692396, at *19.  Gotta love it.  Ali is the greatest.

Prescription Drugs in Texas − You Can’t Get There from Here

We’re somewhat less enamored with Romero v. Wyeth, C.A. No. 1:03-cv-13467, slip op. (E.D. Tex. Aug. 31, 2012), sent to us by Janelle Davis of Thompson & Knight, although we must admit Romero does have its moments.

Romero evaluates a variety of claims purportedly arising under Texas law, in the wake of the big win in Centocor, Inc. v. Hamilton, ___ S.W.3d ___, 2012 WL 2052783 (Tex. June 8, 2012).  On the good side of the ledger, the court throws out all of the usual bread & butter claims in prescription drug product liability litigation − those involving failure to warn (specifically misrepresentation, fraud, negligence, misrepresentation, gross negligence, and consumer fraud).  The Texas statutory presumption of adequacy of FDA-approved warnings controlled, no matter what form the defendant’s information took:

“[I]f a claim is based upon a product’s labeling, its omissions, or inaccuracies, it falls under this purview of the [statutory presumption]. . . .  [Plaintiff] seeks to distinguish failure to warn claims based upon a drug manufacturer’s statements in a warning label from those premised on other representations contained, for example, in promotional and marketing materials. . . .  Because [plaintiff] cites no other authority [besides the lower court decision reversed in Centocor] for the proposition that [the statute’s] provisions should be so strictly applied, the court declines to make such a determination here.  Accordingly, whether [plaintiff’s] failure to warn claims are based on statements made in [defendant’s] labeling or promotional materials, they fall within the purview of [the statutory presumption of adequacy].

Romero, slip op. at 5.

That’s the good part of Romero. The parts responsible for our “you can’t get there from here” comment then follow.  For one thing the court allows a naked failure to test claim to continue.  Abundant precedent, including controlling precedent under Texas law, holds that “failure to test” isn’t a free-standing cause of action.  The Texas Supreme Court dealt with such a claim in American Tobacco Co., Inc. v. Grinnell, 951 S.W.2d 420 (Tex. 1997), twice holding “failure to test” to be “inextricably intertwined” with failure to warn, and rising or falling with it:

The [plaintiffs’] negligent testing claim is predicated on [defendant’s] duty to test and ascertain the dangers inherent in its products about which it must warn consumers. Because the negligent testing claim is inextricably intertwined with the [plaintiffs’] negligent failure to warn claim, we hold that summary judgment was also proper on this claim.

Id. at 437.

The [plaintiffs’] negligent testing claim is also preempted. . . . [Their] negligent testing claim is inextricably intertwined with advertising and promotional materials because the [plaintiffs] allege only that [defendant] should have tested its products to determine the dangerous characteristics about which [defendant] should have warned consumers.

Id. at 439.  Then there’s the Fifth Circuit.  In Dow Agrosciences LLC v. Bates, 332 F.3d 323, (5th Cir. 2003), reversed on other grounds, 544 U.S. 431 (2005) (preemption), the court held that, “a negligent testing claim is, as a matter of Texas law, a variation of an action for failure to warn.”  Id. at 333.  And again, in Skotak v. Tenneco Resins, Inc., 953 F.2d 909 (5th Cir. 1992):

[N]egligence claims, such as the alleged failure to adequately test [the product], are subsumed within this two-part standard. . . .  [Plaintiffs] were required to prove that an inadequate warning was given and that the inadequate warning was the cause of the injury.  [Plaintiffs] do not argue otherwise, nor do they assert here an independent, or separate, negligence claim.

Id. at 912 n.5 (affirming summary judgment).

Oh well, so much for appellate precedent.  Citing general “reasonable care” negligence cases and an old asbestos case involving failure to warn, Romero concocts some sort of “independent negligence cause of action based upon [defendant’s] failure to test” that no Texas court has ever allowed.  Slip op. at 7-8.  It may be our favorite legal proposition, and it sure applies here - a federal court sitting in diversity is not supposed to invent new, expansive state-law causes of action.

“[I]n hazarding an Erie guess, our task is to attempt to predict state law, not to create or modify it. The practical effect of adopting an exception like the one [plaintiffs] propose is the creation of a previously nonexistent state law cause of action.  Therefore, [plaintiffs] carry a heavy burden to assure us that we would not be making law.

Memorial Hermann Healthcare System Inc. v. Eurocopter Deutschland, GmbH, 524 F.3d 676, 678 (5th Cir. 2008) (applying Texas law).  We’re sure there’s plenty more where that comes from.

Romero also allows a design defect claim, holding that Restatement (Second) of Torts §402A, comment k should be applied on a case by case basis.  Slip op. at 11-12.  It gets to that result by characterizing comment k as an “affirmative defense” even though no Texas law says so (we reiterate the Erie federalism point) and in Centocor the Texas Supreme Court unanimously and emphatically rejected a similar argument about the learned intermediary rule:

The learned-intermediary doctrine is not an affirmative defense. . . .  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.

___ S.W.3d ___, 2012 WL 2052783, at *20.  With comment k, the analysis is the same, only it involves design rather than warning claims.  Several federal courts under Texas law cases have applied comment k to all prescription medical products, not requiring the individualized sort of product by product analysis demanded in Romero.  Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1273 (5th Cir. 1974) (vaccine); Woodhouse v. Sanofi-Aventis United States LLC, 2011 WL 3666595, at *3-4 (W.D. Tex. June 23, 2011); Holland v. Hoffman-La Roche, Inc., 2007 WL 4042757, at *3 (N.D. Tex. Nov. 15, 2007); Carter v. Tap Pharmaceuticals, Inc., 2004 WL 2550593, at *2 (W.D. Tex. Nov. 2, 2004); Hackett v. G.D. Searle & Co., 246 F. Supp.2d 591, 595 (W.D. Tex. 2002) (applying Texas law). Tellingly, Romero does not cite a single Texas prescription medical product case for its contrary proposition.

There’s more we could discuss but for now, suffice it to say that with respect to the non-warning claims, we don’t think Romero can get there from here under what Texas law really is rather than what plaintiffs might want it to be.

We Think That’s About Right

Finally, from our home turf here in Pennsylvania, we offer the decision in Boeynaems v. LA Fitness International, LLC, ___ F. Supp.2d ___, 2012 WL 3536306 (E.D. Pa. Aug. 16, 2012), which we received internally today.  This is not a drug case, but it is a class action in which the plaintiffs were harassing the defendants with massive pre-certification discovery requests.  The defendant asked the judge to require the plaintiffs to pay for that discovery themselves, and the court agreed, holding:

[T]he Court mandates cost allocation as fair and appropriate.  The Court concludes that where (1) class certification is pending, and (2) the plaintiffs have asked for very extensive discovery, compliance with which will be very expensive, that absent compelling equitable circumstances to the contrary, the plaintiffs should pay for the discovery they seek.

Id. at *11.  The court essentially told the plaintiffs that they had to put up or shut up − no more one-way discovery, at least pre-certification in class actions:

If the plaintiffs have confidence in their contention that the Court should certify the class, then the plaintiffs should have no objection to making an investment.  Where the burden of discovery expense is almost entirely on the defendant, principally because the plaintiffs seek class certification, then the plaintiffs should share the costs.

Id.

We think that’s just about right.  If the class isn’t certified because the claims are bogus, the defendant isn’t going to be able to recoup this sort of massive expense from the class plaintiffs, and the attorneys will try to walk away from the case.  If the case is good, then the common fund doctrine will plaintiffs’ counsel recoup their expense.  So as Ron Weasley might say, “put your Galleons where your gob is.”

Breaking News - Pain Pump State Of The Art Affirmed

As anyone following the Pain Pump litigation knows, the state-of-the-art issue - whether it was possible for the defendant to know of the alleged risk of its products given the state of scientific knowledge at the time of a plaintiff's surgery - is critical.  Well, today the first court of appeals to consider that question has affirmed summary judgment.  Rodriguez v. Stryker Co., No. 11-5335, slip op. (6th Cir. May 21, 2012) (applying Tennessee law).

The court in Rodriguez examined some 13 articles published over the course of seven decades that the plaintiffs claimed that established a jury question on the state of the art (that is, that the risk was knowable).  It concluded (as had the district court) that these articles proved nothing about this particular device at the time in question:

When all is said and done, not one of [plaintiff's] thirteen articles shows that medical experts understood in 2004 that infusing a joint with [the drug] for two days could cause irreversible cartilage damage.  [Defendant] had no duty to understand what the relevant medical literature did not.

Rodriguez likewise founs that the plaintiff's expert couldn't make anything more out of the same 13 articles than the articles themselves:

[Plaintiff's] theory requires two speculative leaps.  It requires the inference that evidence of harm resulting from other solutions meant that anesthetics would cause the same harm.  And it requires the inference that evidence of transient harm to joints meant that irreversible cartilage damage was likely.  Both are far too conjectural and too many steps removed from the problem that developed.

The court went on to demolish plaintiff's regulatory theory - that because the FDA had denied §510k clearance to the device, that that somehow put the manufacturer on notice of unknowable risks.

The FDA’s action means only that no other device on the market carried that indication for use.  It does not mean that the pump was (or might potentially be) dangerous to use in the joint space.  The 510(k) process does not comment on safety.

Slip op. at 8.  Ironically, the defendants won because of the adverse preemption decision in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).  Plaintiffs were thus prevented from having their cake and eating it, too.  That is, plaintiffs who deny preemption because a §510k clearance doesn't address safety, can't play fast and loose by turning around and claiming that lack of §510k clearance has safety connotations.

Rodriguez also becomes the last in a very long line of cases to confirm that an independent "duty to test" does not exist at common law.  Rather, such a duty "collapses into the failure-to-warn claim."   Slip op. at 8.  A plaintiff cannot resort to a "duty to test" to avoid the state-of-the-art defense.  "The law does not require a company to test for hidden risks that neither it nor the medical community had a reasonable basis to suspect."  Id.

Nor can a claim of off-label marketing succeed where plaintiff's other theories have failed.  The common law is unconcerned with mere off-label marketing.  It would be concerned with concealment of risks (regardless of on or off-label), but once again, the state of the art precluded the concealment claim:

[I]t makes no difference that [defendant] knew surgeons would use its pump in the joint space or even encouraged them to do so since [plaintiff] has failed to show that Stryker knew or should have known that the use was dangerous.

Slip op. at 9.

Next, putting state of the art and legal theorizing aside, the claim in Rodriguez failed independently on the facts of the case because the implanting physician knew all about this device (having used it many times) and thus did not rely on any of the defendant's warnings - so the opinion is also a good "already knew" learned intermediary warning causation case.  Slip op. at 10-11 (citing one of Bexis' Bone Screw summary judgment wins).

Finally, we've commented on plaintiffs' attempts in other cases to create some new duty to send a "Dear Doctor" letter in cases where their warning claims fail.  Well, last and least, the plantiff tried that tack in Rodriguez - and got nowhere. 

[Plaintiff] argues that [defendant] should have known that it needed to “revise its instructions or at least circulate a Dear Doctor Letter” when the FDA rejected its requests to approve the pump specifically for use in a joint.  As shown, however, the FDA position did not obligate [defendant] to send any such letter.

Slip op. at 11.  "Dear Doctor" letters are a regulatory invention.  If the FDA doesn't require them in a particular situation, the court in Rodriguez wasn't about to create some new, broader common-law Dear Doctor letter theory.

We can only hope that other courts are as sensible as the Sixth Circuit was in Rodriguez. Slip op. at 7 (emphasis added).  The expert had improperly attempted to substitute "hindsight negligence" for "common law negligence.  Id.Slip op. at 5. Actually, the court had a lot more to say, but that's the bottom line.

The Pain Pump Litigation Pumps Out another Good Decision

To us, sometimes plaintiffs’ lawyers sound like Cary Grant.  You know, “Duty, Duty, Duty.”  (By the way, “Judy, Judy, Judy” is a famous misquote.  Cary Grant never once said it in a movie.  But he did say it here – at the 0:50 and 1:30 marks.)  Plaintiffs’ lawyers are often looking for new duties and how companies failed to satisfy them.  When a traditional duty, such as failure to warn of a risk, doesn’t work, new alleged duties seem to crop up.  Susan Burnett of Bowman & Brooke kindly sent us a recent pain pump decision that’s a good example of this – Todd v. Stryker Corp., 2012 U.S. Dist. LEXIS 60953 (E.D. Cal. May 1, 2012).  And the court was having none of it.

In Todd, the traditional claim that the defendant company failed to warn of a risk of which it knew or should have known didn’t work.  The state of the science at the time that the pain pump was used in the plaintiff didn’t support the risk.  There had only been a tiny number of adverse events, a discussion of them at a medical conference, and a fairly weak set of medical literature.  Id. at *13-15 & *20-12.  And, worse for plaintiff, the company seemed to react responsibly to that information, conducting investigations of its files and the medical literature, reporting events to the FDA and seeking advice from outside experts.  Id. at *15-16.

So what’s a plaintiff to do?  Well . . . create a new duty.  While the FDA had cleared the pain pump’s 510(k) application and thereby allowed it to be marketed, it had denied another 510(k) application (apparently more than once) that sought to market it for the particular indication for which the pain pump was used in plaintiff.  Aha!  While maybe there was insufficient scientific evidence of an actual risk, the company should have warned doctors about this regulatory history.  Then maybe doctors would have some basis to speculate about a risk.

This is just what it sounds like: an attempt to sidestep the science.  But in a failure to warn case the science is not something to be worked around.  It defines the very duty that the defendant is supposed to satisfy.  Regulatory history adds nothing.  There’s a reason that labels include sections for indications, warnings, precautions, and adverse events, and not for regulatory history.  As the Todd court put it, regulatory history is simply not a risk about which a warning should be given:

There is no duty to warn the patient’s physician of a prescription product’s regulatory history, because the history is not a "dangerous propensity" about which an adequate warning must be given . . . . .

Id. at *9-10. 

That makes sense.  As we all know, the FDA denies clearance of 510(k) applications for many reasons.  Maybe the FDA decided that there was no substantially equivalent predicate device on the market, or that additional information was needed to clear the new indication. 

Putting regulatory history in a label would simply invite doctors to speculate on what it means.  That’s the opposite of what labels are for.  Doctors are experts in medicine, not regulation.  And, so, labels are places for scientific and medical information, not regulatory dockets.  (For this reason, the rule in informed-consent cases is that doctors need only inform patients of a drug's benefits and risks, not regulatory status.  See our post on this here.)  If the particular regulatory history in which plaintiff was interested was the result of science that supported the presence of a risk (which apparently was not the case), the science, not the regulatory history, should have been put in the label.  The court properly rejected this new duty. 

Plaintiff didn’t abandon regulatory history so easily, though.  She also argued that the mere fact that the FDA denied clearance for the indication signaled the need to warn of a risk.  But this thinking has the same deficiency as plaintiff’s “regulatory history” argument.  The FDA denies clearance for many reasons.  The denial isn’t what matters.  It’s the science.  And, the science didn’t support the risk. 

Undaunted, the plaintiff tried yet another new duty, one that we've seen tried before: the duty to test.  We already deconstructed here plaintiffs’ past attempts to create a claim out of the amorphous and open-ended concept of duty to test.  We even created a cheat sheet of plaintiffs’ many failed attempts.  Suffice it to say that the Todd court wasn’t buying it either.  It found, as have many other courts, that there is no such thing as an independent tort for failure to test:

When the warnings accompanying a prescription product adequately inform the prescribing physician of dangers inherent in its use, the manufacturer's alleged failure to test that product cannot, by itself, either cause injury or be a source of liability for the manufacturer.

Id. at *10.

Now, the Todd plaintiff’s claims had other, more ordinary deficiencies, including a proximate cause problem because the treating doctor decided to use the pain pump and medication on the basis of his own training and judgment, not any alleged influence by the company.  Todd, 2012 U.S. Dist. LEXIS 60953, at *23-25.  But what makes Todd most interesting, at least to us, was the court’s treatment of plaintiff’s less ordinary claims – the new duties, duties, duties.  The court wasn’t having any of it.

In Colorado, State-Of-The-Art Defense Is Up, Duty To Test Down

Once a mass tort becomes widely publicized, sometimes based on a combination of a bad study, a verdict or two for plaintiffs, internet sites, and late night television ads, lots of plaintiffs come out of the woodwork, including plaintiffs with weak, late, or marginal claims. Those plaintiffs and the clever lawyers who assist them believe that if they just get past the obstacles the law throws in their way – pesky things like the statute of limitations, product identification, causation, and the like – then they will be given the keys to the kingdom, or at least to the defendant’s vault. As a result, in the life cycle of a popular mass tort, courts often see and resolve almost every kind of claim and issue, including issues that have not been litigated in the jurisdiction for a while.

The pain pump litigation is a good example. It has generated tons of opinions, perhaps because it is not an MDL. The latest is Pavelko v. Breg, Inc., No. 09-cf-01461 (D. Colo. Feb. 28, 2011).

Plaintiff Pavelko had shoulder surgery in 2003 and had a Breg pain pump to alleviate post-surgical pain. Thirty-three months later, in March 2006, she went to a doctor complaining of shoulder pain, and he diagnosed her as having chondrolysis. She brought strict liability and negligence claims in 2009, alleging that defendant Breg was liable because it should have known and warned that pain pumps caused chondrolysis.

After discovery, Breg moved for summary judgment based primarily on the undisputed fact that no one reported any potential connection between shoulder pain pumps and chondrolysis until 2006, three years after plaintiff’s surgery. In other words, the state-of-the-art defense, although the court did not use that term. Plaintiff responded with the alleged duty to test. Plaintiff argued that Breg had a duty to disclose risks that would have been disclosed by reasonable testing and submitted a bunch of medical articles supposedly suggesting further tests.

The court smacked down this argument because plaintiff did not submit expert testimony supporting her argument that these articles put a reasonably prudent manufacturer on notice about the need for further testing, and the court’s own review of the articles found nothing to put the manufacturer on notice. Slip op. at 11-12. The court also bounced for lack of supporting expert evidence plaintiff’s claim that Breg’s general testing of the device was inadequate.

Plaintiff tried to get around these problems by arguing that Breg marketed its device for a purpose not cleared by the FDA, based on that popular notion among plaintiffs that allegations of off-label marketing cure all ills. The court disagreed, finding both that plaintiff failed to submit expert testimony supporting this claim (an unsworn report by the ubiquitous Suzanne Parisian about other manufacturers didn’t do it) and the evidence showed that use of the pain pump in the joint space was considered to be an approved use. Id. at 14-15.

All that stuff is good for our side. But the court put a blemish on this little gem by considering and denying summary judgment based on Colorado’s two-year statute of limitations. There was a factual dispute about whether plaintiff was told in 2006 that the pain pump could have caused her chondrolysis, and therefore summary judgment based on actual knowledge was denied. Fair enough. But Breg argued that plaintiff had a duty to ask her doctor about the potential cause of her chondrolysis in 2006. Her doctor testified that, if asked in 2006, he would have told her that the pain pump may have been the cause. The court, however, found that the plaintiff did not have knowledge of facts that would have put her on notice that her chondrolysis was caused by the wrongful conduct of another and therefore denied summary judgment on this ground.

Given that the court granted summary judgment based on the state-of-the-art defense, the court’s statute of limitations discussion was 100% unnecessary to its decision and therefore dicta. Despite the dicta, Pavelko is a good win for the defense based on the established legal principles that one bad apple don’t spoil the whole bunch and two out of three ain’t bad.