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

What happens when a case involving a medical device that received Pre-Market Approval from the FDA survives, or at least some part of it survives, a motion to dismiss based on preemption? In recent years, as the law has developed and become increasingly favorable for defendants, most of our posts about PMA preemption are at the motion to dismiss stage. That’s because usually not much survives beyond that point. So when we happened upon Delfino v. Medtronic, Inc., 2018 WL 2688420 (Minn. Dist. May 18, 2018), we decided it warranted more than just a notch on our PMA preemption scorecard.

It looks like all the claims in this case were originally tossed back in 2012 but plaintiff was given an opportunity to amend her complaint to properly allege parallel violation claims. Now, almost 6 years since that decision – during which time we assume significant discovery was conducted – all of plaintiff’s claims are being dismissed again. Plaintiff’s negligence and strict liability claims are preempted for lack of evidence of a violation of a federal requirement and plaintiff’s warranty claims are barred by the express terms of the limited warranty of the device.

The device at issue is an implantable cardioverter defibrillator (“ICD”) and there is no dispute that it is a Class III, PMA medical device and therefore subject to preemption under Riegel v. Medtronic, 552 U.S. 312 (2008). Any state law tort claim must therefore parallel, rather than add to, federal requirements. Id. at *3. In other words plaintiff has to prove the violation of a federal requirement applicable to the device, violation of an identical state-law duty, and causation. Id. It is also not disputed that the device’s battery prematurely depleted and required replacement earlier than anticipated. Id. at *1.

We won’t walk through all the nitty-gritty, but section I.C of the opinion documents how Medtronic went about introducing manufacturing and testing records to refute plaintiff’s manufacturing defect claim. Via records, deposition testimony, and affidavits Medtronic was able to demonstrate “the manufacturing and inspection history” of the device which in turn proved that the device “passed all quality control inspections, and complied with the FDA-imposed requirements.” Id. at *4. Defendant also established that they learned that a subset of the ICD’s were suffering from premature battery depletion due to the copper used in certain of the electrodes in the device’s capacitors. It was found that copper from one supplier was at the root of the problem and defendant stopped using that copper going forward. Id.

Against that history, the question for the court was whether there was any violation of a federal requirement. Plaintiff first argued that by using copper in it capacitors, defendant was violating a federal manufacturing specification that the end terminations of the capacitors consist of plated tin over nickel. Putting aside that the copper was not used in the end terminations and that defendant’s end terminations were plated tin over nickel – there was nothing in the requirement that barred the use of copper. Id. at *5-6. As the court more fully explains, PMA silence doesn’t mean PMA forbiddance. The court points first to the language of the requirement at issue to show that when the FDA wanted to impose a prohibition it did so expressly. Id. at *6. And, if plaintiff’s theory were correct, no PMA would ever have to include prohibitory language because everything not expressly allowed would in fact be prohibited. If silence is going to be so all-encompassing, the result would be an even greater review burden on the FDA. Id. Otherwise the silence would almost assuredly be deafening.

Moreover, if plaintiff wants to rely on a “prohibited-unless-expressly-authorized” theory, she’s walking herself away from a parallel violation claim. “If the federal requirements are silent on a particular matter, than any state-law requirement as to that matter is necessarily ‘in addition to’ federal requirements.” Id.  That means plaintiff’s attempt to circumvent preemption actually ran her head first into it.

Finally, in opining that the ICD should have been made without copper, plaintiff’s expert neglects to explain how the capacitors could function without it. It’s a technical argument about electrodes (and that’s not this blogger’s area of expertise) but the more general takeaway is that you can’t argue a design that is non-functional. “State tort law that requires a manufacturer’s [device] to be safer, but hence less effective, than the model the FDA has approved disrupts the federal scheme no less than a state regulatory law to the same effect.” Id. at *7 (citation omitted).

Plaintiff’s next argument centered on device longevity. In its PMA submission, defendant included a projection that the ICD would generally perform for 5.1 years. Plaintiff argued that that projection became a requirement when the PMA was approved. But while the FDA could have established a performance standard for the ICD, it did not. Id. “Indeed, the mere fact that a device malfunctioned is not evidence that the device violated any federal requirement. Id. at *8 (with a lengthy list of citations to demonstrate the point). PMA approval is a “reasonable assurance” of safety, not a guarantee. In fact, PMA devices are by definition those with higher risks. That’s why they go through the heightened scrutiny and a risk/benefit analysis for approval. “If premature device failure were enough to withstand preemption, then few if any medical device claims would be preempted.” Id. The MDA and Riegel would be “dead letters.” Id.

Plaintiff’s final argument to try to establish a parallel violation claim was that at the time the ICD was returned to defendant, three years after manufacture, the capacitor leakage current measured higher than allowed. Id. But that’s an irrelevant fact. “For her claim to survive preemption, Plaintiff must offer evidence that [defendant] violated a federal manufacturing requirement during the device’s manufacture.” Id. To which we point you back to the really nice way Medtronic confirmed that its manufacturing process was fully compliant.

That left only plaintiff’s warranty claims. First, they were barred by the terms of defendant’s limited warranty, which defendant honored and under which plaintiff made no claim. Id. at *10. But, they were also impliedly preempted. To prevail on a warranty claim that implicates safety or effectiveness, plaintiff must convince the jury that the device was not safe and effective – directly contrary to the FDA’s conclusions. Juries can’t be allowed to “substitute their own cost-benefit analysis in place of that applied by the experts at the FDA.” Id. at *10-11.

Would we prefer an early out on a motion to dismiss? Sure. But, sometimes a few claims squeak by and when they do, as we’ve always opined, plaintiffs still face a daunting uphill battle to survive summary judgment scrutiny.

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

It’s been awhile since we’ve posted about PMA preemption in an Infusion case – but that litigation continues to make good law.  This time in Minnesota state court which fortunately took a lot of its cues from strong federal law.  In Stiltner v. Medtronic Inc., 2016 WL 4005471 (Minn.Dist.Ct. Jul. 25, 2016) the court dismissed all of plaintiffs’ claims as preempted and while the dismissal is without prejudice, the court laid down tough pleading standards for plaintiff to meet if he wants to try a comeback.

Plaintiff had an Infusion pain pump installed and that particular pump model was recalled about one year later.  Three years after the recall, plaintiff began experiencing complications which necessitated revision and re-implantation surgeries.  Id. at *1.   Plaintiff brought claims for manufacturing defects, failure to warn, negligence, breach of express and implied warranties, and violations of the Minnesota Consumer Fraud Act.  Id.  Because the Infusion pain pump was Pre-Marketed Approved (“PMA”) by the FDA, it is subject to both Riegel express preemption and Buckman implied preemption.  Therefore, in response to defendants’ motion to dismiss, plaintiff had to demonstrate that his claims fit within the “narrow gap” left open between Riegel and Buckman – emphasis on the “narrow” part.  To pass through, plaintiff needs to be suing for conduct that violates the FDCA (the state law claim must parallel device-specific regulations to survive express preemption) but not suing solely because the conduct violates the FDCA (such a claim would be impliedly preempted).  Id. at *4.

Plaintiff attempted to overcome preemption by relying on the recall and by citing to certain FDA actions such as warning letters issued to defendants to establish that defendants violated Current Good Manufacturing Practices (“CGMP”) regulations.  Id. at *1.  But in assessing the sufficiency of plaintiff’s pleadings, the court concluded that plaintiff simply surmised that “because of the [FDA warnings] and Defendants’ . . . recall of the Device, Defendants must have violated federal regulations which must have resulted in injury to Plaintiff.”  Id. at *6.  “Must have” is about on par with “would of, should of, could of.”  Not nearly enough.

Continue Reading In Minnesota PMA Preemption Requires Plaintiffs to be Specific, Very Specific

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

Last week we reveled in the Tenth Circuit affirming the Caplinger decision – a complete rejection of plaintiffs’ attempt to utilize allegations of off-label promotion to slip through the exceedingly narrow gap that remains in Pre-Market Approval device cases.  Think of it like taking a shot on goal.  The shot deflects off the goalie’s stick and goes wide – that’s express preemption.  The shot hits the goalpost and sails over the net – that’s implied preemption. Between the puck and the net are the sticks of the opposing team – they’re pleading requirements.  You don’t give the who, what, where and when – the puck’s going to be stolen. Plaintiffs have been trying to push the puck into the net with diversion.  Get the courts thinking off-label use changes the rules; that it should force a penalty on the manufacturers that opens up the lane for a clean shot.  Wrong. No free shot.  No empty net.  All the obstacles remain in place.  Only, in PMA cases plaintiffs are less likely to score than Sidney Crosby facing Henrik Lundqvist (sorry Pittsburgh, and to be clear this blogger is not supporting Lundqvist in the next series.  Go Capitals!).

Continue Reading InFuse State Court Appellate Win

Even a casual reader of the blog would know that we like it when drug or device manufacturers defeat dubious claims.  It is also no secret that we are enamored of the learned intermediary doctrine and challenging the link of proximate cause for failure to warn.  We also value decisions that use common sense, at least what our biased perspective allows us to see as common and sensical.  When these things come together, we are as pleased as a robin finding juicy, wriggling worms after the spring thaw.

The decisions in Averhart v. Ortho-McNeil Pharm., Inc., No. 3:09 oe 40028, 2014 U.S. Dist. LEXIS 38446 (N.D. Ohio Mar. 24, 2014), and Casso v. Ortho-McNeil Pharm., Inc., No. 1:11 oe 40006, 2014 U.S. Dist. LEXIS 38443 (N.D. Ohio Mar. 24, 2014), largely satisfy our annelid cravings.  First, the defense won summary judgment on the warnings claims they moved on in each case.  (The defense moved for judgment on the pleadings on some other claims and apparently raised some new arguments for summary judgment in reply briefs. Defendants were rebuffed in almost all of those attempts.  We cannot tell from the decisions why summary judgment was not sought across the board or if the plaintiffs had any evidence for their non-warnings claims, so we will focus of the warnings part of the decisions.)  Second, the warnings claims fell because the prescribers testified to their understanding of the risk at issue and the plaintiffs had nothing else suggesting that the warnings were inadequate in any material way.  Third, the warnings analysis, despite some quirks of the phrasing of the applicable Mississippi and Minnesota law, was pretty straightforward, focusing on the actual testimony of the prescribers and some of the basics of how drugs are prescribed to patients.

The drug at issue in these cases was Ortho-Evra, a combination hormonal contraceptive patch; “combination” means that there is estrogen with the progestin.  It has long been common knowledge in the medical community, and, we think, the population of patients who use hormonal contraceptives, that this class of products has a risk of blood clots.  Patient package inserts started forty years ago because of this risk with these products. Advertisements for these products on television and in popular magazines have identified this risk since the 1990s. There has been litigation for decades over various hormonal contraceptives and their risk of blood clots (among other things).  Because of this, to say nothing of medical journals, medical schools, and medical education, it is hard to imagine healthcare providers making decisions on prescribing hormonal contraceptives without being aware of the risk of blood clots and at least thinking about what to tell the patient about the risk with the product or products that might be prescribed.  Because of the nature of hormonal contraception, it is particularly important that the prescriber and patient work together to identify the particular medication that the patient will actually use as directed.  The risk of blood clots present in all marketed prescription combination hormonal contraceptives goes up with pregnancy–that is, when contraception fails—so the risk-benefit decision for prescribing a particular contraceptive is very much tied up patient-specific considerations. Thus, for warnings claims on blood clots, there are some obvious challenges for plaintiffs:  (1) that the claims are for inadequate warnings rather than failure to warn completely, (2) that prescribers will typically be well-versed in the risks regardless of the label, and (3) decisions to prescribe one combination hormonal contraceptive instead of another will usually not be based on a comparison of their blood clot risk.  This means the manufacturers of these products should have a good chance of getting summary judgment on inadequate warnings claims for the risk of blood clots.

Continue Reading Common Sense Contraceptive Warnings Cases

For some reason, just as pharmaceutical manufacturing is concentrated in New Jersey and Southeastern Pennsylvania, and just as there are an abnormal number of Class II implant manufacturers in Indiana, the epicenter of American pre-market approved medical device manufacturing seems to be in Minnesota.

Similarly, preemption is at the epicenter of medical device product liability litigation involving PMA devices.

Since plaintiffs are able to avoid federal court through the simple stratagem of suing defendants (all defendants, not just medical device manufacturers) in their “home” courts, we have been wondering how PMA preemption would fare in Minnesota state court.  Minnesota already has a relatively expansive consumer protection statute and (until recently) an extremely long (six-year) statute of limitations for personal injury cases.  If there were also an indication that Minnesota courts would view PMA preemption in a pro-plaintiff fashion, we could see Philadelphia-style influx of litigation tourism.

Fortunately that doesn’t appear to be in the offing.  A couple of years ago, Medtronic scored big with In re Medtronic Sprint Fidelis Leads State Court Litigation, 2009 WL 3417867 (Minn. Dist. Hennepin Co. Oct. 20, 2009), which as we discussed at the time, adopted just about all the pro-preemption holdings in In re Medtronic Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147 (D. Minn. 2009), aff’d, 623 F.3d 1200 (8th Cir. Oct 15, 2010).  There were a lot of good holdings, which we gloated over here.

Still, Sprint Fidelis was just a county-level trial court.  The Sprint Fidelis plaintiffs chose not to take their chances on appeal.  One bad decision from the Court of Appeals of Minnesota could wipe everything out.

Or, conversely, one good appellate decision could cement everything in place and send the litigation tourists scurrying elsewhere.

Fortunately, the latter happened the other day.  See Lamere v. St. Jude Medical, Inc., ___ N.W.2d ___, 2013 WL 599178, slip op. (Minn. App. Feb 19, 2013).  Lamere involved a Class III PMA approved mechanical heart valve, and the court affirmed summary judgment on the basis of preemption.  Not even the Public Citizen Litigation Group (probably the other side’s biggest guns on preemption) could sway the result in Lamere.

Continue Reading Preemption in the Land of 10,000 Medical Devices

A couple of weeks ago we praised a primary jurisdiction case
out of California. It was a food case, but we wondered whether primary
jurisdiction could be a more active, robust line of defense in drug and device
cases now that Wyeth v. Levine has curtailed the preemption defense.  Just last week we showered praise upon a Minnesota judge for showing the door to a
forum-shopping plaintiff.  Now we have the privilege of reporting on a
Minnesota case that applied the primary jurisdiction doctrine to put the brakes
on a product liability case.  Again, it is a food case, but this is the
time of the year when we often end up with unexpected food gifts.  And the
next time we get disappointed by such a gift or turn it down will be the
first.  Yes, that even goes for fruitcake.

 

In Taradejna v. General Mills, Inc., 2012 U.S. Dist. LEXIS
174264 (D. Minn. Dec. 10, 2012), the plaintiff brought a class action alleging
violations under the Minnesota Prevention of Consumer Fraud Act, the Minnesota
Unlawful Trade Practices Act, and the Minnesota Uniform Deceptive Trade
Practices Act, related to the alleged mislabeling of Yoplait Greek yogurt
products.  The plaintiff contended that “Yoplait Greek yogurt is neither
yogurt nor Greek.”  Taradejna, 2012 U.S. Dist. LEXIS 174264 at *3. 
(We are reminded of that European History class we took, where one could be
assured of at least a B on the final exam by beginning the essay with
this:  “The Holy Roman Empire was neither Holy nor Roman nor an
empire.”  To this day, we do not know what that means, but we still
declaim it whenever we want to show off the benefits of a liberal arts
education.  It’s like referring to Proust without ever having read a word
he wrote.  We also remember the Linda Richman character from the old Saturday Night Live “Coffee Talk” skits, who would pose similar topics for her audience.  For example, “Rhode Island is neither a road nor an island.  Discuss.”)

 

How can yogurt lie?  The plaintiff has a story to
tell.  According to that story, the defendants were unprepared for the
popularity of Greek yogurt.  So far so good.  We confess that we feel
ambushed by Greek yogurt – ambushed by luscious goodness.  Be that as it may, the
unexpected huge demand for Greek yogurt prompted the defendants to use Milk Protein
Concentrate (MPC). A blend of dry dairy products, MPC is sold in a powdered
form.  We do not know whether that is good or bad.  We do not know
whether that MPC is somehow anti-Greek.  But we do know this much: 
the labeling of Yoplait Greek yogurt discloses MPC as an ingredient.  It
is not as if that MPC is being smuggled in via a dairy Trojan Horse. 

 

Nevertheless, the plaintiff argued that the inclusion of MPC makes the
Yoplait Greek yogurt an impostor.  In 1981, the FDA promulgated standards
of “identity” for yogurt.  21 C.F.R. § 131.200.   As
part of yogurt identity (admit it – you never expected a legal blog to discuss
“yogurt identity”  did you?), the FDA proposed to limit “other optional
ingredients” that could be included in yogurt.  47 Fed. Reg. 41519 (Sept.
21, 1982). The FDA drafted a provision limiting the use of “other optional
ingredients” in yogurt to certain milk-derived ingredients (e.g., concentrated
skim milk, nonfat dry milk, buttermilk, whey), sweeteners, flavorings, color
additives, and stabilizers. 21 C.F.R. §131.200 (d)(1)-(5).  Surely you
noticed that the FDA’s list of “other optional ingredients” does not include
MPC. Bad news for our defendant yogurt-slingers, right?

 

Well, because we are in FDA-land, nothing is as clear as one
would like.  In response to comments and objections, the language
regarding “other optional ingredients” was stayed,
and the limitation, while published, was not put into effect. We are in yogurt
limbo.  But the key to the plaintiff’s claim in the Taradejna case is that
because MPC is not an ingredient expressly listed or described within the
applicable standards of identity for yogurt, use of this ingredient is not
permitted in yogurt.  Okay, says the defendant, we see your FDA paralytic
reticence, and we raise you a belated FDA answer to a public question at a 2004
milk seminar: “May whey protein concentrate (WPC) and/or milk protein
concentrate (MPC) be used as ingredients in yogurt to increase the nonfat solids
content? Yes, 21 C.F.R. 131.200(d), which would have precluded WPC or MPC use,
was one of several provisions of the standard of identity for yogurt that were
stayed in 1982.”

 

Still with us, or have you decided to put the lid on this
yogurt stuff and get yourself a proper breakfast, like waffles?  (Mmmmm …
waffles.)

 

Now let’s turn to the FDA’s issuance of a Proposed Rule in
2009 (mind you, this yogurt saga started in 1981).  The rule would allow
for certain modifications to the standards of identity for yogurt, including
“the use of reconstituted milk and whey protein concentrate as standard dairy
ingredients.” 72 Fed. Reg. 2443 (Jan. 15, 2009). The FDA observed that while
the published standards do not permit the use of certain ingredients such as
preservatives or a reconstituted dairy ingredient as a basic ingredient,
“because of the stayed provisions, FDA has not taken enforcement action against
the use of these ingredients in yogurt.…” 74 Fed. Reg. at 2224.  The FDA
explained that, as of 2009, it has not held a public hearing to resolve these
issues “due to the competing priorities and limited resources.” Id. at
2444.  It was apparently a very busy 28 years.  (True that – think
about all the stuff that happened between 1981 and 2009.  The Soviet Union
collapsed.  Then there were all those disasters:  Chernobyl, the
Challenger explosion, Tiananmen Square, O.J., Katrina, the Wyeth v. Levine decision, Ishtar).

 

In the 2009 Proposed Rule, the FDA advocated incorporation
of “technological flexibility into standards so long as the basic nature and
essential characteristics of the food are not adversely affected.” 
Therefore, the FDA proposed to permit the optional use of any safe and suitable
milk-derived ingredient as an optional dairy ingredient in the manufacture of
yogurt to increase the nonfat solids content of the food above the minimum
required 8.25 percent, provided the ratio of protein to total nonfat solids of
the food and the protein efficiency ratio of protein present in the food are
not decreased as a result of the use of such ingredients.  That Proposed
Rule remains a Proposed Rule.  The Taradejna court points out, perhaps ruefully,
that “[i]t appears that no public hearing has yet been held on the 2009
Proposed Rule.”  2012 U.S. Dist. LEXIS 174264 at *10.   As we
said, the FDA has been busy.

 

The plaintiff, an Illinois resident, filed the complaint in
March 2012, in Minnesota state court. The defendants removed the case to federal court.  The plaintiff alleged that in March 2012,
he “purchased a serving of Yoplait Greek yogurt, which brandished the label
developed and approved by Defendants” at a Chicago grocery store. (So, as in
the Minnesota case discussed last week, we have another carpet-bagging
plaintiff in pursuit of snowdrifts and hospitable jurisprudence.)  The
plaintiff alleged that while MPC was listed as an ingredient on the label, the
label was “inadequate to disclose the fact that what Plaintiff was going to
purchase and ultimately eat, was not actually ‘yogurt’ as marked.”  Id. at
*11.

 

The defendant interposed a number of defenses.  The one
that worked was primary jurisdiction.  Primary jurisdiction “applies where
a claim is originally cognizable in the courts, and comes into play whenever
enforcement of the claim “requires the resolution of issues which, under a
regulatory scheme, have been placed within the special competence of an
administrative body.” Id. at * 14-15.  Agency expertise is the most common
reason that courts apply the doctrine of primary jurisdiction. “In addition,
courts apply the doctrine to promote uniformity and consistency within the
particular field of regulation.”  Id. at 15.  When the primary
jurisdiction doctrine applies, the “district court has discretion either to
stay the case and retain jurisdiction or, if the parties would not be unfairly
disadvantaged, to dismiss the case without prejudice.”  Id.

 

In the Taradejna case, the underlying issue was whether MPC
is a proper, permitted ingredient in yogurt. The court reasoned that
“resolution of this question falls squarely within the competence and expertise
of the FDA.”  Id. at *16.   Issues of food labeling are
sufficiently complex that they “are best left to FDA for consideration prior to
judicial review.” Id.  And here, just as with last week’s case, the
Minnesota judge delivers some prose that is precise and delicious:  “The
current standard of identity for yogurt, the stayed 1982 limitations, the
Agency’s subsequent public statements about the standard, and the 2009 Proposed
Rule do not constitute a model of clarity.”  Id. at *16-17.  
The FDA is in the best position to resolve any ambiguity about the standard of
identity for yogurt – a matter requiring scientific and nutritional expertise.
Moreover, “given that the FDA has issued its 2009 Proposed Rule on the standard
of identity for yogurt, it would be imprudent for the Court, at this juncture,
to substitute its judgment for that of the Agency’s while revision of the
standard of identity is pending.”  Id. at *17. 
 

And then of course
there is that concern for uniformity and expertise.  Either it’s all Greek
to America, or it isn’t.  Or something like that.  And here’s a
non-surprise:  “several recently-filed yogurt lawsuits throughout the
country involve the same or similar issues as found in the instant suit. The
increasing volume of this litigation creates the potential for inconsistent
judicial rulings.”   Id.  Accordingly, the court dismissed the
case without prejudice and directed the parties to initiate the proper
proceedings with the FDA. 

Call it a blow against an overly litigious culture. 

 

As we said a couple of weeks ago, FDA expertise and the need
for uniformity also exist in the drug and device arena.  If primary jurisdiction applies in Taradejna, imagine how much stronger the primary jurisdiction argument would be where the FDA has actually done more on a subject than one proposed rule in 30 years.  Moreover, now that we know
that FDA-created confusion can also be a factor in favor of applying primary
jurisdiction, we are rubbing our hands together and getting ready to fire up
some motions. 

 

   *  *  *  *  *  *  *  *  *  *  *  *  *  *  *  *  *  *  *  *  *  *  *  *  *  *

 

One week ago, the post was entitled “Good News and BadNews.”  Some bad news is especially tough to endure.  Some bad news
is beyond our capacity to understand.  Some bad news is beyond our capacity
to discuss without fury or despair. 

 

For most schools in this area, Winter break starts in the
middle or end of this week.  The commuter trains have been full of little
kids, some on field trips and some accompanying their parents to the holiday displays
in Philadelphia.  We have been laying down our newspaper, closing our eyes, and
listening to the laughter of the children.  It is much needed music. 

 

 

 

 

Good news/Bad news jokes are a staple of the Great American
Joke Machine. Not surprisingly, a lot of the jokes involve doctors. For
example:

 

Doctor: I have good news and bad
news for you. The good news is that these test results say you have 24 hours to
live. The bad news ….

Patient: Wait a minute! What could
possibly be worse than that?

Doctor: The bad news is that I
received these test results yesterday.

 

Sometimes the pattern is extended:

 

Doctor: I have good news and bad
news.

Patient: (Gulp) Well, give me the
bad news first.

Doctor: You have terminal cancer.
You won’t see the end of the year.

Patient: Cancer?! Well, what’s the
good news?

Doctor: The good news is that you
also have Alzheimer’s.

Patient: Alzheimer’s?! Well, what’s
the bad news?

 

Or the pattern can be elegantly compressed:

 

Doctor: I have good news and bad
news.

Patient: Please give me the good
news first.

Doctor: They’re going to name a
disease after you.

 

We’re a fan of the misdirection versions. Like this one
(cleaned up because this is, after all, a G-rated blog):

 

Doctor: I have some good news and
bad news. Which shall I tell you first?

Patient: Give me the bad news
first, I guess.

Doctor: You have only one week to
live.

Patient: Oh no! What good news can
you possibly tell me now?

Doctor: Did you see that hot-looking
nurse out at the reception desk? Well, I am taking her out to dinner, and who
knows how the night will end!

 

Over the last couple weeks, we’ve gotten good news and bad news
out of the Aredia-Zometa litigation. Like most of the patients in those jokes,
we’ll take the bad news first.

 

The Bad News

 

Hill v. Novartis Pharmaceuticals Corp., 2012 U.S. Dist.
LEXIS 170650 (E.D. Cal. Nov. 30, 2012), is yet another case where a plaintiff claimed to
suffer osteonecrosis of the jaw after taking Zometa for treatment of cancer.
The defendant moved for summary judgment, the court denied the motion, and the
court’s reasoning is disappointing. The defendant argued that the plaintiff’s
expert testimony did not adequately rule out potential alternate causes. The
expert’s testimony does, indeed, seem fairly thin. The expert claimed to
perform a “differential diagnosis,” though it does not seem to resemble the
differential diagnosis that doctors actually do when they treat patients.
Hill, 2012 U.S. Dist. LEXIS 170650 at *9.  Rather, it was a litigation-driven ‘differential etiology.’ In any event, the
court concluded that the expert had submitted a “reasoned explanation” that
could convince a jury that Zometa more likely than not caused the injury.

The defendant also argued that the failure to warn claim
should fail because (a) the company changed the label warning almost as soon as
the key article came out (and after the plaintiff was prescribed the Zometa),
and that there was no evidence that any additional warning would have prompted
the prescriber to make a different decision. The court held that there was
evidence that the company possessed information about the causal relationship
much earlier. What that evidence is, the court does not tell us. But the court
does tell us that “Dr. Suzanne Parisian’s testimony would be sufficient for a
trier of fact to conclude [the label] was not adequate.” Hill, 2012 U.S. Dist.
LEXIS 176050 at *12-13. Now it is our jaw that is in pain, doubtless  from
gnashing of teeth.
 

What about warning causation? The prescriber, Dr. Thompson,
testified that he weighed the risks and that he believes today that the
benefits of Zometa outweigh the risks. Good stuff, right? Here is how the court
handles the issue: “But that is today. There is simply no indication Thompson
would have held such a belief if he had known osteonecrosis was a risk at the
time of Plaintiff’s treatment.” Id. at * 15-16 (emphasis in original). Huh? So
even with the doctor knowing the current information about risks and still prescribing the medicine, we have to assume that the
doctor might have known something more or different back at the time of treatment?
Does that make even a smidgen of sense?  Doesn’t medical knowledge grow over time?  Since when does it shrink? Moreover, doesn’t the plaintiff have the burden of proof here?
 
The Hill court apparently
recognizes how weak its reasoning is, because it offers another way out for the
plaintiff. The prescriber had changed its informed consent form to include
osteonecrosis. The plaintiff testified that if she had seen the new form,
instead of the old form, she would have refused to consent to the procedure.
Yep.  Sure. Right.  You betcha.  Putting our native skepticism
aside, doesn’t the court’s position render the learned intermediary doctrine
an empty gesture?   Plus, if Hill is like most cases, there
probably is lots of evidence that the plaintiff was not quite so punctilious
about risk assessment as is after-the-fact pretended in this litigation-play (which now is
revealed to be a farce or tragi-comedy).
 
By the way, this is not our first brush with bad law from the Hill case.  We posted here about the E.D. Cal.’s choice of California punitive damages law in that case, where the court called the increased economic exposure “nothing more than the cost of doing business.”  Gee, that’s a swell message to anybody trying to do business in the Golden State.   
 

The Good News

 

What’s not to like about Minnesota? Any place that produces
the likes of F. Scott Fitzgerald, Judy Garland, Garrison Keillor, Bob Dylan,
the Andrews Sisters, and the Coen Brothers must be pretty good. And that’s just
sticking with real people. Add in fictional characters, such as Paul Bunyan,
Betty Crocker, and Rocky & Bullwinkle, and you’re talking about a
population of true folk heroes. Our favorite United States Senator, Amy
Klobuchar, is the senior Senator from The Land of 10,000 Lakes. She may well be
the smartest and nicest member of the World’s Greatest Deliberative Body, and
if she is not the funniest, it is only because the junior Senator from
Minnesota is Al Franken. (Maybe we should mention that Klobuchar was in our law
school class.)
 
 
People make fun of the Minnesota Vikings for their prolonged
inability to win a Super Bowl, but the team’s all-time greatest defensive
player, Alan Page, is not only a member of the National Football League Hall of Fame, but is also a
Justice on the Minnesota Supreme Court. Page must have one of the best resumes
in American history, perhaps slotting in after William Howard Taft (Solicitor
General, President, Yale Law professor, and Chief Justice of the Supreme Court)
and Sam Houston (Governor of two states, senator from one state, General, President of a foreign country, and giver of name to the city housing some of our favorite plaintiff lawyers), and just in front of Diane Keaton (female lead
in both the greatest film drama and film comedy ever). In addition to Justice
Page, Minnesota also has some brilliant federal judges. We’ve been on panels
with a couple of these judges, and they possess brilliant
intellects, turbo-charged work ethics, and vibrant senses of humor.

 

So, again, what’s not to like about Minnesota? Well, there
is that ridiculously long statute of limitations (six years). As we have written about
(here, for example), Minnesota’s statute of limitations inspires plaintiffs
having no connection to the Gopher State to file their cases in Minnesota. For
years, the courts there treated statutes of limitations as procedural rather
than substantive, and thus automatically applied the Minnesota statute of
limitations. In 2004, the Minnesota legislature passed a law providing that if
an out of state plaintiff brings a claim based on the substantive law of another
state, the other state’s statute of limitations applies. Nevertheless, as we
discussed here, filings by out-of-state plaintiffs significantly increased
after passage of the new law. The law was prospective only, so perhaps
plaintiff lawyers decided to get in while the getting was good.
 

Minnesota still attracts filings by out of state plaintiffs.
But the courts now seem a tad less tolerant of such litigation tourism. In
Caraballo v. Novartis Pharmaceuticals Corp., No. 07-4598 (D. Minn. Dec. 4,
2012) (slip op. available here), the court granted a motion to transfer a case to the Northern District
of Ohio and denied the plaintiff’s request to attach Minnesota’s statute of
limitations prior to transfer. The plaintiff was an Ohio resident. She filed
her case in Minnesota. The case was then transferred to the Aredia-Zometa MDL
in Tennessee. After close of discovery, the case was remanded to Minnesota. And
here we are, in the home of Jesse “the Body” Ventura and The Mary Tyler Moore Show. As for
why we are here, the court authors a paragraph startling in its clarity and
candor:

 

“This is one of thousands of product-liability actions filed
in the District of Minnesota by plaintiffs who have no connection to Minnesota
against defendants who have no connection to Minnesota regarding events that
did not occur in Minnesota and that had no impact within Minnesota. The vast
majority of these actions have been filed in this district because, if they
were filed by the plaintiffs in their home states (or almost anywhere else),
they would be dismissed under the applicable statutes of limitations.”

 

Caraballo, slip op. at 2.

 

The issue was whether the case should be transferred
pursuant to 28 U.S.C. section 1404 (a) for the convenience of the parties and
in the interest of justice. The court concluded that “Minnesota does not appear
to be convenient for anyone – including Ms. Caraballo, who lives in
Ohio.”  Id. at 3.  The prescribing and treating physicians were also
in Ohio.  As for the interests of justice, only one of the factors — the
plaintiff’s choice of forum — helped the plaintiff.  But all the others,
such as judicial economy, costs to the parties, ability to enforce judgment,
conflict of law issues, and advantages of having a local court determine local
questions of law, were either neutral or favored transfer to Ohio.
 

But plaintiff lawyers are persistent.  As an
“ancillary” matter, the plaintiff asked the court to rule that
Minnesota’s statute of limitations would govern the case following transfer to
Ohio.  The fig leaf of support for this request is that actions
transferred under section 1404(a) typically retain the law of the transferor
forum.  But the Minnesota court rejected the plaintiff’s request, and
thereby frustrated what can only be called a scheme, because “judicial
comity disfavors such a declaration.”  Slip op. at 5.  The
Minnesota court left it to the Ohio court to resolve the statute of limitations
issue. 

 

We are glad to see this logical, fair-minded result, and are
glad that Joe Hollingsworth was kind enough to make sure that we had some good
Aredia-Zometa news to report to help offset the bad news.  

 

Today’s post is by a guest blogger, Reed Smith’s own Jobina Jones-McDonnell.

She gets all the credit, and you can just blame Bexis.

*************

This post discusses a recent Minnesota Supreme Court opinion rejecting a “duty to train” claim in a non-drug/device case.  The Court held that a manufacturer doesn’t have a duty to train persons how to use its products, even where the manufacturer undertook to provide training as part of the purchase price of the product at issue.

The case, Glorvigen v. Cirrus Design Corp., ___ N.W.2d ___, 2012 WL 2913203 (Minn. 2012), decided on July 18, 2012, involved an airplane crash where the pilot/owner and his passenger died.  The estates of the pilot and passenger filed suit against (guess who?) the manufacturer and seller of the plane. The Minnesota Supreme Court was reviewing the appellate court’s reversal of the jury’s special verdict in plaintiffs’ favor.  That procedural posture meant that, if the defendant was going to win on appeal, it essentially had to do it as a matter of law, and that’s just what happened.

The pilot purchased the plane about a month prior to the crash.  As part of the purchase price, the manufacturer defendant provided a 2-day on the ground and in-flight transition training course.   Transition training is standard in the aviation industry.  It builds on the pilot’s previous experience and gives the pilot individualized training in the new plane.  We’ve seen similar programmes offered by makers of complex medical devices.

Continue Reading Minnesota’s High Court Says No “Duty to Train”

We really don’t like it when state aspiring governors (that’s what “AG” stands for, isn’t it?) come after our clients − especially when our clients were merely exercising their First Amendment rights to make truthful statements about this or that off-label use.  But then, the state AGs never cared what we thought before, so why should they start now.

Stuff, like state AG litigation, happens.

But we’d like to let folks know about a possible silver lining around at least some of those big, dark, state AG clouds.  We’re talking about the recent Minnesota Supreme Court decision, Curtis v. Altria Group, Inc., No. A10-0215, slip op. (Minn. May 30, 2012).  It’s not a drug/device case (it involves cigarettes), but the legal principles should carry over with respect to at least some state AGs and their copycats who come to play in our sandbox.

The relevant legal rule recognized in Curtis is this: since a state AG acts on behalf of the citizens of that state (we lawyers call that “parens patriae”), the resolution (usually by settlement) of a state AG action precludes private copycat plaintiffs from later suing over the same allegations.

Here’s what happened in Curtis.  In 1994, the Minnesota state AG brought a consumer fraud action against the defendants over “light” cigarettes (but it could have been anything), seeking among other things, restitution and damages.  Slip op. at 4-5.  This AG action settled a few years later for over $100 million.  Id. at 6.  Not too long after that, copycat plaintiffs came to Minnesota and brought private suits under the same consumer protection statutes, alleging the same violations, and also seeking restitution and damages.  Id. at 7.

The issue before the Court was, can private plaintiffs get away with this kind of repetitive litigation?

Fortunately, the Minnesota Supreme Court said no.  We’ll spare you a lot of detailed discussion because the important points are well-encapsulated in the Court’s syllabus:

Under [the Minnesota act], the Minnesota Attorney General (State AG) has the authority to bring a lawsuit . . . and to seek not only the relief available to the State . . ., but also the relief available to a private litigant. . . . It logically follows that the State AG has the authority to settle and release a private litigant’s claims.

The 1998 Settlement Agreement entered into by the State AG and [defendant] expressly released and barred [copycat plaintiffs’] consumer protection claims . . . and is binding on [those plaintiffs].

Curtis, slip op. at 2-3, syllabus points 1, 3 (emphasis added).  Syllabus point 2 dealt with the reverse situation, and isn’t really relevant to this discussion.

What this means − at least in Minnesota − is that, if our clients have the misfortune to be sued by a state AG, and they settle the action, that settlement can preclude copycat private litigation involving the same allegations.  Given that the state AG can assert the public’s consumer protection rights, the Court concluded that private consumer protection litigation was merely “part of the broader authority of the State AG to bring a lawsuit . . . to enforce all remedies available to it,” including those remedies also provided to private litigants.  Curtis, slip op. at 11-12.  “[I]t logically follows” that since the AG can pursue private as well as public remedies, the AG “has authority to settle and release” those claims, including those of subsequent private litigants.  Id. at 14.

That “release,” moreover, was a nice, big, fat general one − including “all claims that the State of Minnesota made, or could have made.”  Curtis, slip op. at 17.  The release had the usual “broad and comprehensive” provisions we expect to see in general releases:  “any and all manner,” “known or unknown, suspected or unsuspected, accrued or unaccrued, whether legal, equitable or statutory,” “relating to the subject matter,” “directly or indirectly based on, arising out of or in any way related to” – that kind of thing.  Id. at 18.  The Court applied the general release generally.  The copycat plaintiffs’ claims easily satisfied the “related to” test since they “assert[ed] violation of the same consumer protection statutes arising from the same fraudulent and deceptive misrepresentations.”  Id. at 18-19 (emphasis original).

The copycats’ last stand was a provision in the settlement providing that “no portion . . . shall bind any non-party.”  Curtis, slip op. at 20.  Because the state AG was acting on behalf of the public, members of the public couldn’t claim to be “nonparties”:

We read the words “representatively” and “derivatively” to encompass [private copycats’] right as private litigants to bring [monetary] claims against [defendant].  Because the State AG brought and released those claims, including [monetary] consumer protection claims that could have been brought on behalf of private litigants, the release expressly determined [private copycats’] right to bring a [monetary] consumer protection claim.

Id. at 21.  Bingo.  The tagalongs got tagged out.

Since our clients are all too often on the receiving end of the same sort of litigation − both state AG actions and follow-up copycat litigation − Curtis suggests to us that the same silver lining might be available in elsewhere.  The relevant state law would have to allow the state AG to recover the same monetary damages as private litigants, but once that happens, the rest should flow.  Since the AGs almost always claim to act on behalf of the public, their monetary settlements using general release language should also bind individual copycat plaintiffs and thus preclude relitigation of those claims.

Thanks to Scott Smith at Nilan Johnson (who filed a amicus brief for the right side of the “v.”) for passing Curtis along.

We’re involved in HT litigation, so we can’t comment much, but readers will want to look at Rick v. Wyeth, Inc., ___ F.3d ___, Nos. 3354, et al., slip op. (8th Cir. Oct. 25, 2011).  Trying to take advantage of Minnesota’s notoriously long statute of limitations, the plaintiffs, who had originally filed in their home state (New York), filed diversity actions in the District of Minnesota, as soon as the defendant moved for summary judgment on the original, state court action based on their home state’s statute of limitations.  The defendant won the summary judgment motion in the plaintiffs’ home state.  In Minnesota federal court, the plaintiff argued that the home state ruling was “procedural” and didn’t require dismissal.  The district court agreed with the defendant and held that the home state ruling required dismissal on grounds of res judicata.

Well, now the Eighth Circuit has affirmed, holding that, where the defendant has obtained a final order of dismissal of a plaintiff’s original action under the plaintiff’s home state statute of limitations, that order also requires dismissal of any subsequent action filed in Minnesota in an attempt to take advantage of the longer statute of limitations.  Rick, slip op. at 8-9.

The Rick ruling should put an end to at least one form of shenanigans involving the Minnesota statute of limitations (now changed by statute, by the way, but only prospectively) no matter what product is involved.