A (relatively) long time ago in a state not so far away, the Michigan Legislature enacted the Michigan Product Liability Act.  It contained a provision providing the manufacturers of FDA-approved drugs with immunity from product liability absent the application of two narrow exceptions.  A challenge to the constitutionality of the provision soon followed and the Michigan Supreme Court, in Taylor v. Smithkline Beecham Corp., 658 N.W.2d 127 (Mich. 2003), basically said the legislature can enact a law like that and the immunity on drug manufacturers was as broad as it seemed.  (This guest post provides a nice history.)  Other decisions followed, like Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961 (6th Cir. 2004), and Desiano v. Warner-Lambert & Co., 467 F.3d 85, 98 (2d Cir. 2006), aff’d by equally divided court, 552 U.S. 440 (2008), coming down on opposite sides of the issue of whether the first exception—the defendant “before the event that allegedly caused the injury . . . intentionally withholds from or misrepresents to [FDA] information concerning the drug that is required to be submitted” under the FDCA that would have prevented original or continued approval—runs into Buckman preemption.  What also followed was that Michiganders who wanted to sue over alleged drug started to go elsewhere.  (Not to galaxies several parsecs—a unit of distance, not time—away, but just to other states.)  They did so because they hoped that the immunity in § 600.2946(5) would not follow them.

We have called this phenomenon the Michigan diaspora, and, while the dispersal of the Michigan litigation tourists is merely temporary, their cases do keep popping up in some likely spots.  Just last month, we discussed how West Virginia state courts have applied Michigan law to the claims of Michiganders hoping to find more plaintiff-friendly law.  We have also discussed how the claims of Michiganians claiming gynecomastia from Risperdal have fared in the Philadelphia Court of Common Pleas, a jurisdiction that has seen plenty of action in that particular litigation.  We praised the court’s application of the Michigan statute to bar the claims.  The plaintiffs in that case appealed to the Superior Court of Pennsylvania, which has reversed more than a few defense rulings we have liked.  Instead In re Risperdal Litig., __ A.3d __, 2017 WL 5712521 (Pa. Super. Nov. 28, 2017), respected the force of the Michigan Legislature’s clear enactment and affirmed.

On appeal, the plaintiffs agreed that Michigan law applied, but argued that the statute provided no protection where the use was off-label.  When the plaintiffs (actually all but one of them) were prescribed the drug it had been approved but did not yet have an indication for use in juveniles, which they were at the time.  The statute, however, hinged on whether “the drug was approved for safety and efficacy,” not whether the particular indication had been approved.  Federal courts had followed “the plain language of the statute” and found off-label use was irrelevant to the application of immunity as long as the drug was approved.  2017 WL 5712521, **5-6.  “Thus, we conclude that as long s a drug has received approval, and its label is compliant with FDA regulations, the MPLA applies to bar any product liability claim, despite the drug’s indicated uses.” Id. at *6.

Next, plaintiffs argued that they had enough evidence to raise a genuine issue as to the statutory exception based on a fraud on the FDA.  Defendants claimed that any attempt to meet the exception would be preempted because the FDA had never found such a fraud.  The Superior Court did not take the opportunity to add to either side of the preemption ledger because plaintiffs did not have the evidence they needed anyway. Id. at *7.  The statute did not just require any fraud on FDA, but a withholding of information such that its proper submission would have meant “the drug would not have been approved” or FDA “would have withdrawn approval for the drug.”  Plaintiffs argued that their evidence of purported fraud was relevant to the approval of the additional indication for juvenile use, but they never contended that the drug would not have been approved or would have been withdrawn.  “[T]he proof of fraud a plaintiff is required to present in order to receive the benefit of the fraud exception must relate to the initial FDA approval.” Id. at *8.  Given that FDA had denied a citizen’s petition in 2014 that requested the drug be withdrawn, it was clear that any purported fraud related to the application to add the juvenile use indication almost a decade earlier was insufficient to trigger the exception. Id. We all know Yoda famously said “Do or do not.  There is no try.”  Here, plaintiffs tried and tried again, but they did not get around the statutory immunity despite their sojourn to Pennsylvania.


We remember how, shortly after the atrocious decision in Johnson & Johnson v. Karl, 647 S.E.2d 899 (W. Va. 2007), rejecting altogether the learned intermediary rule, litigation tourists visiting West Virginia argued that Karl represented that state’s “public policy” and therefore the learned intermediary rule could not apply even to their out-of-state cases under the “public policy” exception to the ordinary rules for sorting out choice of law issues.  This was also back in the halcyon days (for the other side) of essentially unlimited plaintiff forum shopping pre-Bauman, so the specter existed that, if this argument succeeded, plaintiffs from all over the country, or even the world, would flock to West Virginia, and by the mere fact of their litigation tourism, thereby rid themselves of one of our side’s most significant arguments.

A couple of West Virginia federal courts were sufficiently pro-plaintiff to buy that “public policy” choice-of-law analysis.  Woodcock v. Mylan, Inc., 661 F. Supp.2d 602, 609 (S.D.W. Va. 2009) (“[b]ecause West Virginia has rejected the learned-intermediary doctrine on public-policy grounds and applying Alabama law to the marketing defect claim would violate that public policy, West Virginia law applies to that claim”); Vitatoe v. Mylan Pharmaceuticals, Inc., 696 F. Supp.2d 599, 610 (N.D.W. Va. 2010) (“it is impossible to apply the substantive law of Louisiana to [plaintiff’s] inadequate warning claim without violating West Virginia public policy”; following “Woodcock’s helpful public policy analysis”).  For doing this, we trolled Woodcock with eighth place on our 2009 bottom ten decisions list:

This decision invoked “forum public policy” to apply West Virginia’s rejection of the learned intermediary rule to a forum shopping plaintiff from Alabama – a staunch learned intermediary state.  That can’t be right.  Practically all major tort law doctrines are grounded in a court’s sense of “public policy.”  Thus the “forum public policy” exception (previously limited to legislatively set policy) becomes another constitutionally suspect means of applying forum law to cases with no significant ties to the state in question.  Any other forum shopper can presumably make the same argument. We’re sure we haven’t seen the last of this.  We blogged about Woodcock here.

Fortunately, the West Virginia legislature stepped in and did the right thing, making its own declaration of West Virginia public policy in 2011:

Choice of Law in Pharmaceutical Product Liability Actions.

It is public policy of this state that, in determining the law applicable to a product liability claim brought by a nonresident of this state against the manufacturer or distributor of a prescription drug for failure to warn, the duty to warn shall be governed solely by the product liability law of the place of injury (“lex loci delicti”).

W. Va. Code §55-8-16(a).  We cheered that development here.

Of course, the entire Karl learned intermediary brouhaha became moot (or so we thought) several years later when the legislature did themselves one better and directly overruled Karl on the merits.  See W. Va. Code 55-7-30 (restoring the learned intermediary rule).  Even more vigorously, we cheered on that development – after the fact, of course, since we made sure not to breathe a word about this before it was a done deal (we know the other side reads our blog, so there are some things we do keep quiet about).

Given this background, it is with no small degree of schadenfreude that we bring to you M.M. v. Pfizer, Inc., ___ S.E.2d ___, 2017 WL 5077106 (W. Va. Nov. 1, 2017).  M.M. involved the West Virginia sojourn of other litigation tourists, this time from Michigan.  Id. at *2.  Michigan, as anyone involved in the defense of prescription medical product liability litigation knows, has a statute that provides the strongest FDA compliance defense in the country (although Texas is close):

In a product liability action against a manufacturer or seller, a product that is a drug is not defective or unreasonably dangerous, and the manufacturer or seller is not liable, if the drug was approved . . . by the [FDA], and the drug and its labeling were in compliance with the [FDA’s] approval at the time the drug left the control of the manufacturer or seller. . . .

Mich. Comp. Laws Ann. §600.2946(5).  As we’ve mentioned before, that statute has produced a “diaspora” of Michigan plaintiffs all running away from the policy judgment made by the legislature of their chosen state of residence.  Those prior plaintiffs didn’t have much luck, and as it turns out, neither did this one.

This time, even if West Virginia courts might have been inclined to cut the Michigan plaintiffs a break, they ran headlong into the West Virginia choice-of-law statute mentioned above.  Even though it was passed to overturn half-baked Karl-based “public policy” determinations, the statute’s literal terms establish West Virginia choice of law “public policy” as to all prescription drug warning cases.  Thus, the M.M. plaintiff – despite having nothing to do with Karl – was entirely out of luck.  “Here, there is no dispute that the injuries alleged by [plaintiffs] all occurred in the State of Michigan.  Thus, [the] failure to warn claim is governed by Michigan law, which forecloses such a claim if the drug was approved by the FDA and the manufacturer complied with the FDA’s labeling requirements.”  2017 WL 5077106, at *3 (also discussing why fraud-on-the-FDA exception to statute doesn’t apply).  Thus, “Michigan law forecloses [plaintiffs’] failure to warn claim.” Id. Interestingly, the court added:

To recognize such a claim under West Virginia law where the same already is foreclosed in the same case by the law of another jurisdiction, however, would contradict the full faith and credit due our sister jurisdictions.

Id. (citations omitted).  “Full faith and credit”?   We confess we haven’t seen that much, indeed ever, before in prescription medical product liability litigation, but anything that keeps a plaintiff from relitigating something they’ve already lost finds favor here.

Unfortunately for these plaintiffs, they were also entirely unable to come up with any defect claim that wasn’t really a statutorily covered warning claim.  “[B]oth the strict liability and negligence claims allege that [defendant] improperly failed to include . . . warnings on its labeling, which, again, constitute allegations that [defendant] failed to warn.”  Id. at *4.  Even if West Virginia law could apply, the choice-of-law statute meant that West Virginia law kicked things back to Michigan, and was “foreclosed thereby.”  Id.  Both their strict liability and negligence claims, although making boilerplate allegations, were “merely a restatement of [plaintiffs’] failure to warn claim,” id. (strict liability), or “merely a reiteration of [plaintiffs’] failure to warn claim.”  Id. at *5 (negligence).  Any way one looked at the case, plaintiffs alleged only a failure to warn, and failure to warn claims had to be determined by Michigan law, where plaintiffs lost.

[B]ecause [plaintiffs’] failure to warn claim is governed by Michigan law, and the governing Michigan statutes provide that a manufacturer cannot be held liable where it has complied with the FDA reporting, disclosure, and labeling requirements, there exists no duty that could have been breached so as to establish a claim for negligence.

Id. at *5.

Now that BMS has pulled the welcome mat away from litigation tourists, we don’t expect much more of a Michigan diaspora, but even if there were, the West Virginia choice-of-law statute, enacted for an entirely different purpose, will preclude any of them from relying on more favorable West Virginia law.  See Id. at *3 n.2 (noting that §55-8-16(a) has since been expanded so that it applies to “all liability claims at issue,” not just warnings).

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

Usually when we are talking about Michigan, it’s to praise the Michigan Products Liability Act which cuts off civil liability for drug manufacturers “if the drug was approved for safety and efficacy by the United States food and drug administration, and the drug and its labeling were in compliance with the United States food and drug administration’s approval at the time the drug left the control of the manufacturer or seller.” M.C.L. § 600.2946(5). However, under Michigan law, the distinction between a drug and a device is significant. That is because device manufacturers are not afforded the same immunity. See M.C.L. § 600.2945(b).  Of course, device manufacturers do have the broad preemption provided by the Medical Device Amendments. See Riegel v. Medtronic, Inc., 552 U.S. 312, 317 (2008). So it’s somewhat rare to get to post on a Michigan law case that isn’t focused on the statute or preemption, but we found one – Avendt v. Covidien, Inc., 2017 WL 2868487 (E.D. Mich. Jul. 5, 2017).

Avendt involves a biologic (as opposed to synthetic) mesh product that was used by plaintiff’s surgeon in plaintiff’s hernia repair surgery. Plaintiff suffered complications following surgery, including an infection and chronic non-healing wound that required multiple revision surgeries and eventual removal of the product. Id. at *1. The biologic mesh product at issue was approved by the FDA via the 510(k) substantial equivalence process. It was cleared to market for use only in “Class I/Clean wounds.” Id. at *17. Plaintiff did not dispute that his wound was Class I and clean, in other words this is an on-label use case. Id. at *19.   In addition, the product’s labeling contained a warning that the mesh could weaken or breakdown if used in a contaminated or infected wound or if exposed to “high concentrations of digestive enzymes.” Id. at *17.

Against this background, plaintiff filed suit alleging that defendant’s product was defective due to failure to test and subsequent failure to warn. Id. at *1. More specifically, plaintiff argued that defendant’s insufficient testing led it to market the product as a “biologic mesh,” when in fact it performs like a synthetic mesh which was the characteristic of the product that led to plaintiff’s injuries. Id. at *22.

In support of his claim, plaintiff disclosed only one expert, Dr. Michael J. Rosen. Dr. Rosen was plaintiff’s treating surgeon who performed the surgery removing the mesh. Plaintiff opted not to have Dr. Rosen prepare a full Rule 26 expert report, the consequences of which were that he would be limited to testifying as a treating physician and so only permitted to testify as to those opinions that were formed “for purposes of, and within the scope of, his care and treatment of [plaintiff].” Id. at *2. Most of Dr. Rosen’s opinions were not.

For example, Dr. Rosen’s opinion that the mesh was unsafe for use in Class I wound was excluded as not being related to his care and treatment of the plaintiff. That may have been an opinion he held at the time he treated plaintiff, but it was not formed for the purpose of or within the scope of his care and treatment of plaintiff. Id. at *23. He had no reason to form a safety opinion to care for and treat plaintiff and he didn’t include any such opinion in his medical records or in any discussion with plaintiff or any of his colleagues. Id. Moreover, Dr. Rosen did not report plaintiff’s case to the FDA as an adverse event. Id. Dr. Rosen’s opinions on the sufficiency of the testing and adequacy of the warning suffered the same fate – to even be considered potentially admissible Dr. Rosen needed to prepare a proper Rule 26 expert report “setting forth the scientific or experiential basis” of his theories. Id. at *25.

But that wasn’t the only fatal flaw for Dr. Rosen’s opinions. His opinions were also unsupported. Unlike his litigation opinion that defendant’s biologic mesh was unsafe for Class I wounds, Dr. Rosen had opined in numerous peer-reviewed articles that defendant’s product was acceptable in that precise situation. Id. at *23-24. The blatant contradiction was another ground for exclusion. Id. at *25. These same peer-reviewed publications also discussed the need for further study of the biologic mesh for treating Class II and III wounds, but nowhere suggested that further testing was needed regarding treatment of Class I wounds such as plaintiffs. So, Dr. Rosen’s opinions on adequate testing were also unsupported. Id. at *26.

As to the adequacy of the warning, plaintiff argued that the product’s labeling should have included a warning to remove the mesh in the event of a seroma (what plaintiff had) or an infection. Id. Dr. Rosen, however, could only opine that “there should be more information” about the types of cases for which the mesh should be used. Id.  That was not enough to clear plaintiff’s hurdle of proving as a matter of law that defendant had a duty to warn. Id. Moreover, as noted above, the label did warn about weakening and breakdown – the very side effects plaintiff suffered. Id.

Finally, Dr. Rosen also offered an opinion on causation. He testified that he saw the mesh “sitting on a bed of pus,” removed it, and concluded that the mesh caused the infection because the infection cleared up after removal. Id. at *29. The court didn’t question that Dr. Rosen knew an infection when he saw it.  But “the ability to diagnose medical conditions is not remotely the same … as the ability to deduce … in a scientifically reliable manner, the causes of those medical conditions.” Id. (citation omitted). Bottom line – nowhere in his opinion did Dr. Rosen rule out the other potential causes of plaintiff’s infection and failure to heal; such as his diabetes, obesity, blood pressure, and use of immunosuppressants. Id. *29-30.

But Dr. Rosen wasn’t the only problem with plaintiff’s case. Plaintiff’s failure to warn claim also failed for lack of causation. First, the learned intermediary doctrine applies to a medical device. Id. at *21-22. So any duty to warn ran to plaintiff’s surgeon. Second, there was no evidence that plaintiff’s surgeon read the product’s labeling. Id. at *29.   He had not met with the defendant’s representative, had not read the instructions for use, and had not read any of the literature about the product. Under this circumstance, no additional or different warning would have made a difference because the doctor wouldn’t have seen it. No failure to warn.

Defendant also had no duty to conduct a randomized prospective clinical trial before marketing the product. There was no evidence that such a clinical trial was the standard of care for 510k mesh products at the time defendant’s product was approved. Id. at *27.

Plaintiff paid dearly for failing to serve a Rule 26 expert report for their sole medical expert, although it appears that even with a report very little of what their expert was offered to opine on would have been admissible under Daubert anyway. And with no causal nexus between the doctor and the warning, plaintiff’s failure to warn claim was dubious regardless of whether the expert testimony was admissible or not. While any one of these things would have sunk the case, we’re glad the court explored them all. The opinion is loaded with good precedent.

What follows is a post authored by Jaclyn Setili, a Reed Smith associate.  She is discussing what we believe is the first extension of Mensing/Bartlett preemption to claims involving pharmacies – something we’ve previously proposed as theoretically possible, but had yet to see.  As always, our guest posters are entitled to 100% of the credit (and any blame) for their blogposts.


As a Mitten native (that’s Michigan for the uninitiated), this guest blogger is regularly on the lookout for good news connected with her home state.  Typically this involves events of the sporting championship variety, but cause for celebration has been scarce of late on that front (see, e.g., Michigan football, an impressive early season dominance culminating in two close late season losses and a devastating defeat in the Orange Bowl; the Red Wings, currently sitting in last place in their division and slipping progressively further away from a Stanley Cup title since their last championship win in 2008; and the Lions, every year, forever). Even reports of Detroit’s flourishing restaurant scene and a slot in the New York Times’ 52 Places to Go in 2017 fail to inspire much collective awe from this guest blogger’s big-coastal-city friends and colleagues.

As it turns out, however, we need only look a few months back to the In re Lipitor MDL (which we have blogged about before, most recently here, and in which all but one of the cases have now been dismissed) for such news.  In In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices and Products Liability Litigation, 2016 WL 7368203 (D.S.C. Nov. 1, 2016), the district court ultimately granted plaintiffs’ motions to remand, but in the process became the first court ever (as far as we know) to apply impossibility preemption to bar warning claims against a pharmacist selling a branded drug.

The details: The two actions at issue were originally filed in Michigan state court; each plaintiff alleged that Lipitor caused her to develop Type II diabetes, and that the manufacturer failed to properly disclose the risks associated with the drug.  That defendant removed both cases to the Eastern District of Michigan based on diversity jurisdiction; from there the cases were transferred to the MDL court.  Plaintiffs named a local pharmacy in order to destroy diversity.  While the parties agreed that the pharmacy and at least one named plaintiff in each case were residents of Michigan, defendants claimed that the pharmacy was fraudulently joined and that the non-Michigan plaintiffs were fraudulently misjoined.  Plaintiffs moved to remand.

As we and the MDL court know all too well, to establish that a nondiverse defendant has been fraudulently joined, a removing party in the Fourth Circuit must show either:  (1) “outright fraud” in plaintiff’s pleading of jurisdictional facts, or (2) that there is no possibility that plaintiff would be able to establish a cause of action against the in-state defendant in state court.  2016 WL 7368203, at *1 (emphasis added).  That is always an uphill battle.  Here, defendants argued that there was no possibility that plaintiffs could state a claim against the pharmacy where plaintiffs allegedly purchased the drug under Michigan law for four reasons:  (a) their claims were preempted by federal law, (b) Michigan’s seller immunity statute bars pharmacy claims, (c) the pharmacy had no duty to warn plaintiffs, and (d) the learned intermediary theory further barred plaintiffs’ claims.

Of primary importance for our purposes is the court’s analysis of the first ground, preemption.  The court first noted plaintiffs’ admission that they “may not have a claim regarding labeling with respect to . . . a pharmacy.”  Id. at *2.  The court swiftly concluded that even if it were possible to state such a claim, it would be preempted by federal law because, under the Federal Drug and Cosmetic Act, “a pharmacy has no authority to unilaterally change a drug’s label.”  Id.  Thus, any claims based on labeling were preempted under PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2571 (2011).  In other words, the court concluded that there was no possibility that plaintiffs could establish a cause of action against a pharmacist based on labeling.  That result is a first, and could be a big deal.

Continue Reading Guest Post – MDL Court: Preemption Leaves No “Glimmer of Hope” for Labeling Claims Against a Pharmacy

Delve into the crime stories of Elmore Leonard, whether in the form of the books, movies, or television shows, and you are likely to spend considerable time in Michigan and Florida.  True, Justified was set in Kentucky.  But Marshall Givens was forced to leave the Sunshine State after shooting a suspect (“Let’s just keep it simple: he pulled first,  I shot him”), and the big criminal organization he often contended with hailed from Detroit.  Leonard, also known as the Dickens of Detroit, was a native of Michigan and later spent much time in Florida.  Those two locations furnish a nice contrast between city and swamp, both settings being utterly sweaty and corrupt.

There is nothing especially sweaty about what we do, and we’d like to think that corruption is far, far away, but if you delve into our litigation docket, you are likely to encounter a tug of war between Michigan and Pennsylvania.  We live in Pennsylvania.  Our courts and laws seem inordinately fond of drug and device law plaintiffs.  By contrast, Michigan has just about the best, most pro-defense laws on the books, and, consequently, Michigan plaintiffs look to hightail it out of there and file their cases in a more hospitable jurisdiction – like, say, ours.

Recently in the Philly mass tort Risperdal litigation, a local judge did the right thing and told Michigan plaintiffs that they were stuck with Michigan law.  In Re Risperdal Litigation, 2015 Phila. Ct. Com. Pl. LEXIS 254 (Phila. CCP October 1, 2015).  The 13 plaintiffs were Michigan residents who claimed that they developed gynecomastia after taking Risperdal during adolescence.  The defendants filed summary judgment motions arguing that Michigan’s Products Liability Act applies and affords the defendants immunity on the plaintiffs’ claim for 1) negligence, 2) negligent design defect, 3) fraud, 4) strict liability – failure to warn, 5) strict liability – design defect, 6) breach of express warranty, 7) breach of implied warranty, 8) conspiracy, and 9) medical expense incurred by parents.  The plaintiffs disagreed.  They needed Pennsylvania law to apply, otherwise they would lose.

They lost.

Continue Reading Philly Court Applies Michigan Law to Dismiss Risperdal Cases

The short answer is “no.”  We are just borrowing a line from one of the original gangster movies, “Little Caesar,” which readers other than McConnell would most likely know from references in “The Sopranos,” if they know it at all.  (Or from here.)  The titular character in that flick was known as “Rico.”  RICO (Racketeer Influenced and Corrupt Organizations Act), on the other hand, was an anti-gangster law, enacted in 1970 as part of the Organized Crime Control Act.  In a number of posts (like here), we have decried the gangster tactics used by plaintiffs—particularly quasi-public plaintiffs—to use the threat of RICO’s treble damages and cost-shifting provisions to extort settlements from drug and device manufacturers.  Particularly for prescription medical products, RICO seems like an inappropriate vehicle for addressing alleged harms allegedly caused by such standard product liability allegations as inadequate disclosure of risks or off-label promotion.  A small blow to curtail the expansion of RICO was struck in Short v. Janssen Pharms., Inc., No. 1:14-CV-1025, 2015 U.S. Dist. LEXIS 61123 (W.D. Mich. May 11, 2015).

Short is yet another case stemming from pediatric use of Risperdal.  We have posted many times on various Risperdal cases with various theories of recovery, usually tied to the idea that the drug was improperly promoted for off-label use without disclosing the true risk of gynecomastia and other prolactin disorders, like hereherehere and here.  In Short, the plaintiff allegedly took Risperdal as a minor, developed gynecomastia, and sued in his own behalf under RICO and state consumer protection and product liability acts.  His problems were that he never paid a cent for the drug and that he was from Michigan.  We suspect the latter may be why RICO was at issue at all.

Continue Reading Is This The End of RICO?

We’ve seen an increase in allegations of “unjust enrichment,” particularly in strike suits seeking recovery of purely economic loss. A number of states don’t even recognize this theory as a separate cause of action (according to Bexis’ book, these include California, New Jersey, Pennsylvania, and Tennessee), and others preclude it when there is an “adequate remedy at law” (Florida, Louisiana, Massachusetts, Minnesota). But last week we ran across a case dismissing an unjust enrichment claim on a ground we hadn’t considered – privity.

In Smith v. Glenmark Generics, Inc., 2014 WL 4087968 (Mich. App. Aug. 19, 2014), the court dismissed a garbage class action for unjust enrichment based on alleged loss of value of birth control pills that had been mislabeled. As to such “losses,” the defendant asserted “that it sought to remedy the problem by directing patients to return the product to their respective pharmacies for replacement or reimbursement,” but the court never had to go there. Id. at *1. Instead, it affirmed dismissal on the basis of lack of “direct” enrichment, which in the case of products sold through supply chains, appears indistinguishable from privity:

[O]ur courts only employ the doctrine of unjust enrichment in cases where the defendant directly receives a benefit from the plaintiff.   Notably, caselaw does not specifically state that the benefit must be received directly from the plaintiff, but these decisions make it clear that it must. This is particularly true where emphasis is placed on the fact that the defendant must receive a benefit from the plaintiff, and where the facts show that a benefit received indirectly is not enough to establish a claim for unjust enrichment.

Smith, 2014 WL 4087968, at *1 (citations omitted). This “direct benefit” requirement killed off all unjust enrichment claims under Michigan law because:

[D]efendant did not receive a direct benefit from plaintiff. Defendant did not sell the contraceptives directly to plaintiff, and plaintiff admitted that she did not purchase the contraceptives from defendant, but rather from a pharmacy.

Id. (emphasis added).

We confess that we haven’t looked very deeply at this cause of action, which is usually something of a throw-away, so we don’t know whether the direct benefit/privity defense discussed in Smith is widespread or peculiar to Michigan. Since we’re always on the lookout for “new” (or at least so old as to be new to us) defenses to any and all of the causes of action we encounter, we thought this one was worth passing along.

Some states have statutes that we find very helpful.  Louisiana has the Louisiana Product Liability Act, with its strong exclusivity clause; New Jersey’s PLA provides some very helpful presumptions, including a presumption of adequacy for FDA-compliant drug labeling.  We have often cited the Texas statute that creates a presumption that pharmaceutical manufacturers and sellers are not liable for allegedly inadequate warnings if the labeling was approved, unless the plaintiffs can rebut the presumption in specific ways.  Michigan has a good statute too, which we will get to in a moment.

We like these statutes because they are one step closer to the high-regulation, low-litigation model of product liability that we favor.  We say that not just because we represent drug companies and medical device manufacturers, but also because it is the best approach for the consistent and effective regulation of medical products. Regular readers are familiar with the conundrum created when drug and medical device labeling is regulated through civil litigation.  As we recently wrote in connection with primary jurisdiction, when the FDA determines what drug labeling should and should not say, it applies its expertise to a balanced view of the product’s risks and benefits. When regulating that same labeling through civil litigation, the jury sees only the one plaintiff who has experienced an alleged injury.  It is a skewed and incomplete depiction of the product’s true risk profile and, by extension, the adequacy of the labeling that accompanies it.  A balanced view ensures that life-saving and life-improving products will remain available to patients in need and that doctors will have the information regarding risks and benefits necessary to make informed treatment decisions.

Because we feel this way, we lament the fact that state product liability statutes often deal with drugs, but not medical devices.  Texas and Michigan are both that way, and we don’t know why that should be.  All drugs have risks and cannot be made one-hundred percent risk free.  Same with medical devices.  That’s why a doctor’s prescription is required.  Drugs are regulated by federal law administered by the FDA.  So are medical devices.  Drugs are accompanied by approved written information stating their indications and setting forth their risks in a regimented way.  Medical devices?  Check.  Ditto the common law.  Courts overwhelmingly apply both the learned intermediary rule and comment k in the same fashion to drugs and medical devices.  The same policy considerations apply, and urge the application of those laws in medical device cases when we have the opportunities.  If bills were introduced to expressly extend those states’ laws to medical devices, we would vote for them.

Imagine then our disappointment when we read Miller v. Mylan, Inc., No. 12-2502, 2013 U.S. App. LEXIS 1077 (6th Cir. Jan. 21, 2014), where the Sixth Circuit actually narrowed the application of Michigan’s statute (we told you we would get back to Michigan’s statute) and expanded the role of litigation in regulating a drug.  In Miller, the patient used an analgesic skin patch and sadly died, which resulted in a lawsuit against the product’s manufacturer.  The manufacturer moved to dismiss the complaint under Michigan’s statute, which states that

a drug is not defective or unreasonably dangerous, and the manufacturer or seller is not liable if the drug was approved for safety and efficacy by the [FDA], and the drug and its labeling were in compliance with [FDA’s] approval at the time the drug left the control of the manufacturer or seller.

Id. at *3 (quoting Mich. Comp. Laws § 600.2946(5)).  The manufacturer argued that it was entitled to the statute’s protection, and the district court agreed and dismissed the complaint.  This was the correct result.  The Michigan statute does not “immunize” drug manufacturers like they are diplomats who freely ignore parking laws.  It cuts off civil liability if the manufacturer fully complies with the federal regulatory regime set up to ensure the safety and efficacy of prescription drugs.  That’s what we were talking about before—high regulation, low litigation.

The case went off the rails in the Sixth Circuit, where two judges took a look at the product and decided that maybe it was not a drug after all.  Maybe it was a “combination product,” which is an FDA term of art.  And if that’s the case, then a Michigan statute “that immunizes manufacturers of ‘drugs’ from suit” would not apply.  Id. at **1-2.  Oddly, the plaintiffs made this argument neither in the district court nor in the Court of Appeals, and the term “combination product” did not appear in the parties’ briefs until after the Sixth Circuit sua sponte requested supplemental briefs on whether the product was a “combination product” and whether the statute would apply to such a product.  Appellate clerks have a term for this:  It’s called a “rescue mission,” which is when an appellate court really wants to reverse a judgment and does its own research to re-craft the appellant’s argument to enable that result.

We feel sympathy for the decedent too, but the Sixth Circuit’s mission took Michigan law in the wrong direction.  To be clear, the analgesic skin patch was a drug.  How do we know that?  Well, the plaintiff (the decedent’s successor) alleged it was a drug in her initial complaint, and when given the opportunity to amend her complaint she again alleged it was a drug.  Id. at *17.  The manufacturer said the product was a drug; the FDA regulated the product as a drug; and the district court based its ruling on the fact that the product was a drug.  The analgesic patch achieved its primary intended purpose through metabolization of its active ingredient, which is what “drugs” do.  (Compare, for example, a combination product such as antibiotic-coated surgical mesh, which fights infection and mechanically repairs a body structure.)  When everyone agreed that the analgesic patch was a drug, including the relevant federal regulator, we scratch our heads wondering what piqued the interest of these two Circuit Judges.  They should have deferred to the FDA’s determination; and even if the court thought that the FDA’s treatment of the product was somehow ambiguous, it should have deferred to the FDA’s primary jurisdiction and allowed the FDA the first opportunity to take a clear position.

The Sixth Circuit therefore took a clear state statutory provision with bright-line rules that, if anything, should be expanded to include other FDA-regulated products and made them less clear and more narrow.  As we’ve said time and time again (and so has the Sixth Circuit when it’s not determined to rescue a plaintiff), it’s not the role of a federal court sitting in diversity to expand liability under state law where the state courts have not done so.

The concurring opinion adds insult to injury by stating that rather than deferring to the FDA’s regulatory determination, a product’s identity as a drug is a factual issue subject to discovery.  The manufacturer had requested judicial notice of FDA documents to establish that the analgesic patch was a drug, which was a perfectly appropriate request to make.  The concurring opinion took exception with that, noting that the only document it reviewed as relevant “is not central to plaintiff’s claim” and “seems central to the defense.”  Id. at *13 (emphasis in original).  According to the concurring judge, such a document should be introduced in support of a motion for summary judgment, which “would of course be made after plaintiff had an opportunity for discovery about all the exchanges between [the manufacturer] and the FDA with regard to the patch.”  Id. at **13-14.

For one thing, we do not see how it matters whether a request for judicial notice aids the plaintiffs or the defense.  More importantly, the principal benefit of statutes that defer to regulatory systems and expertise, such as Michigan’s, is that drug manufacturers who comply with the rules do not have to endure civil litigation, including and especially expensive discovery.  The concurring opinion stood this point on its head by reading the statute to permit, or even require, more litigation to get to a result.  This is exactly the sort of case that should have been determined on the pleadings, and the district court had it right in the first instance under Michigan law.

Here’s another guest post this time by Clem C. Trischler and Jason M. Reefer, of Pietragallo Gordon, about a recent litigation involving the Michigan immunity statute and when a “drug” (according to plaintiffs) isn’t a “drug.”  You’ll like it – the plaintiff lost.

As always our intrepid contributors deserve all the credit, and any blame, although there’s not likely to be any this time around.


We cheer them again

We cheer and cheer again

For Michigan, we cheer for Michigan

We cheer with might and main

We cheer, cheer, cheer

With might and main we cheer!

Those words were written in 1898 by Louis Ebel after the University of Michigan’s football team defeated the heavily-favored Maroons by one point. But if you didn’t know the history of “The Victors,” you might have thought the lyrics were written by Bexis. That is because “[i]n 1995, the [Michigan] Legislature amended M.C.L. 600.2946 to provide immunity for products-liability claims against a manufacturer or seller of a drug that was approved for safety and efficacy by the FDA and labeled in compliance with FDA standards.”  Attorney Gen. v. Merck Sharp & Dohme Corp., 807 N.W.2d 343, 347 (Mich. Ct. App.), appeal denied, 803 N.W.2d 696 (2011).

Quite simply, “the Michigan Legislature made a policy judgment intending to shield drug manufacturers from liability.”  Devore v. Pfizer Inc., 58 A.D.3d 138, 141 (N.Y. App. Div. 2008). Accord Taylor v. Smithkline Beecham Corp., 658 N.W.2d 127, 131 (Mich. 2003) (“[T]he Legislature has determined that a drug manufacturer or seller that has properly obtained FDA approval of a drug product has acted sufficiently prudently so that no tort liability may lie.”).  As such, unless a plaintiff alleges and proves an exception, “MCL 600.2946(5) now establishes an absolute defense for drug manufacturers and sellers in a product liability action . . . .”  Duronio v. Merck & Co.,, No. 267003, 2006 WL 1628516, at *3 (Mich. Ct. App. June 13, 2006).

Those exceptions are (1) selling the drug after the FDA withdraws it from the market; (2) bribing an FDA official; and (3) committing fraud on the FDA. See M.C.L. §600.2946(5)(a)-(b). The first two should rarely arise, and the third is preempted by federal law.  See Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961, 966 (6th Cir. 2004) (holding that a drug manufacturer is immune from suit unless “the FDA itself determines that a fraud has been committed on the agency during the regulatory-approval process”) citing Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 350 (2001) (emphasis in original).

Continue Reading Hail! Hail! To Michigan

We haven’t heard the folks on the other side say it much, since ATRA’s pretty much taken over squatter’s rights to the phrase “Hellhole Jurisdiction,” but if they listed theirs, we suspect that Michigan would be right up there at the top of their list – at least where prescription drug product liability litigation is concerned.  The reason is Michigan’s statutory presumption of adequacy for FDA-approved warnings:

In a product liability action against a manufacturer or seller, a product that is a drug is not defective or unreasonably dangerous, and the manufacturer or seller is not liable, if the drug was approved . . . by the [FDA], and the drug and its labeling were in compliance with the [FDA’s] approval at the time the drug left the control of the manufacturer or seller. . . .

Mich. Comp. Laws Ann. §600.2946(5).  There are three exceptions to this otherwise conclusive presumption, but two of them – sale of a drug after a recall, and bribery of FDA personnel – are vanishingly rare, and the third, fraud on the FDA, has been held preempted by both Michigan state and federal courts.  Taylor v. Smithkline Beecham Corp., 658 N.W.2d 127 (Mich. 2003); Duronio v. Merck & Co., 2006 WL 16285165 (Mich. App. June 13, 2006) (unpublished); Garcia v. Wyeth-Ayerst Laboratories, 385 F.3d 961 (6th Cir. 2004); White v. SmithKline Beecham Corp., 538 F. Supp.2d 1023 (W.D. Mich. 2008); Zammit v. Shire US, Inc., 415 F. Supp.2d 760 (E.D. Mich. 2006).

Thus, for all intents and purposes, if a drug complies with the terms of the FDA’s approval and bears the FDA’s approved labeling, that drug isn’t defective or unreasonably dangerous and the defense wins.  If only every other state were that straightforward.

But they’re not.

So you can imagine (when we’re done, you won’t have to) that just like plaintiffs try every trick in the book to forum shop defendants into their favorite hellholes, Michigan plaintiffs have tried every trick in the book to flee their home state for somewhere – anywhere – else.  We’re happy to report that most of the time they haven’t been successful in avoiding Michigan law.

They came closest in Rowe v. Hoffman-La Roche, Inc., 917 A.2d 767 (N.J. 2007), where a Michigan resident plaintiff brought suit in the courts of the defendant manufacturer’s principal place of business – New Jersey.  The trial judge in Rowe did the right thing and applied the law of the plaintiff’s state of residence, but an intermediate appellate court reversed on the ground, essentially, that “New Jersey likes plaintiffs.”  Rowe v. Hoffmann-La Roche Inc., 892 A.2d 694, 705 (N.J. Super. A.D. 2006) (citing “New Jersey’s strong interest in encouraging the manufacture and distribution of safe products and, conversely, in deterring the manufacture and distribution of unsafe products within the state”); id. at 709 (citing a “strong governmental interest in deterring the manufacture of unsafe products within [New Jersey’s] borders” and an “interest” in “compensation”).

The New Jersey Supreme Court – in one of those decisions that signified the state’s retreat from hellhole status – reversed.  The court held that a Michigan resident who took a drug in Michigan prescribed by a Michigan doctor had no expectation of the application of any law other than Michigan’s, particularly since that plaintiff had never set foot in New Jersey.  Under New Jersey’s “flexible governmental interest analysis,” no other result maintained the comity between the states:

[C]omity precludes closing our eyes to Michigan’s interest. . . . The question is not whether Michigan or New Jersey passed the better law; that is a normative judgment best suited for the legislative process. . . . To allow a life-long Michigan resident who received a FDA-approved drug in Michigan and alleges injuries sustained in Michigan to by-pass his own state’s law and obtain compensation for his injuries in this State’s courts completely undercuts Michigan’s interests, while overvaluing our true interest in this litigation.

Rowe, 917 A.2d at 776 (various citations omitted).  Michigan’s legislative concern “that unlimited liability for drug manufacturers could add substantially to the cost and unavailability of many drugs” could not be ignored by pro-plaintiff New Jersey courts.  Id. at 775 (quoting Garcia, 385 F.3d at 967).  Thus, in the context of prescription drugs at least, the blather that allowing out-of-state plaintiffs to get around their home states’ legal restrictions so as to “encourage manufacture of safe products” by New Jersey companies was inoperative.

The court also corrected the lower court’s error of interpreting in favor of plaintiffs a similar non-conclusive New Jersey statutory FDA compliance presumption of adequacy. That didn’t warrant applying New Jersey law because, like Michigan, the New Jersey statute had been enacted to limit manufacturer liability.  To cite it as an excuse for broadening liability stood the intent of both the New Jersey and Michigan legislatures on their heads::

The predominant object of the law is not to encourage tort recoveries by plaintiffs, whether New Jersey citizens or not, in order to deter this State’s drug manufacturers. On the contrary, the law limits the liability of manufacturers of FDA-approved products by reducing the burden placed on them by product liability litigation. . . . New Jersey’s interest in applying its law to [plaintiff’s] failure-to-warn issue, when properly discerned, is not antithetical to Michigan’s interest but substantially congruent.

917 A.2d at 774 (more citations omitted).

The role of the FDA – the basis for both the Michigan and New Jersey presumptions – was also important.  Because of the FDA’s role in regulating drug manufacturers and the safety of their products, any state’s interest in doing the same through tort actions was correspondingly reduced:

The [New Jersey statute] impliedly accepts that the presumption of adequacy will not be rebutted in all cases. It accepts FDA regulation as sufficient, at least in part, to deter New Jersey pharmaceutical companies from manufacturing unsafe prescription drugs. . . . The Legislature also provides . . . that FDA approval of prescription drugs conclusively prohibits an award of punitive damages in products liability actions. This provision, along with the rebuttable-presumption . . . cede to FDA regulation some of this State’s interest in policing local pharmaceutical manufacturers, thereby reducing New Jersey’s interest in applying its law to this case.


In Devore v. Pfizer, Inc., 867 N.Y.S.2d 425 (N.Y.A.D. 2008), some Lipitor plaintiffs tried the same stunt in litigation against Pfizer, a New York headquartered company.  Notably New York did not have a statutory presumption of the sort that figured in the New Jersey Howe decision.  Still, the court applied New York’s “interest analysis” approach to conflict of law – telling Michigan plaintiffs, in effect, “you can run, but you can’t hide” from the law of their residence.  A “conduct regulating” statute, like the Michigan presumption, should apply to residents of the state enacting the statute:

The Michigan statute in question, since it in effect dictates the standard of care required for a product liability claim against a pharmaceutical company falls within the category of conduct-regulating rather than loss-allocating. When the purpose of the statute is to regulate conduct, the law of the jurisdiction where the tort occurred will generally apply because that jurisdiction has the greatest interest in regulating behavior within its borders.  The locus of a tort is generally defined as the place of the injury.

867 N.Y.S.2d at 427-28.  Michigan “ha[d] far greater significant contacts” since the plaintiffs lived there and suffered injury there.  Id. at 428.  Not only that, but the policy of the Michigan law was entitled to deference:

[W]e must recognize that the Michigan Legislature made a policy judgment intending to shield drug manufacturers from liability, and its interests in protecting the reasonable expectations of the parties who relied on it to govern their primary conduct and in the admonitory effect that applying its law will have on similar conduct in the future assume critical importance and outweigh any interests of New York State.

Id.  Accord Norris v. Pfizer, Inc., 2007 WL 969431 (N.Y. Sup. March 14, 2007) (reaching same result in another Michigan Lipitor case) (unpublished, in table at 839 N.Y.S.2d 434).

New York and New Jersey follow Restatement-based interest balancing in deciding choice of law questions.  Indiana – another state to which Michigan plaintiffs fled – does not.  That did not change the result, however, in Alli v. Eli Lilly & Co., 854 N.E.2d 372 (Ind. App. 2006).  Indeed, the “traditional lex loci delicti rule – the place of the wrong-will apply” is if anything even more conducive to making sure that Michigan plaintiffs can’t forum-shop their way around their home state’s law.  The court swatted aside the plaintiff’s claim that the Michigan conclusive presumption was “procedural.”  Id. at 378.  A statute designed to confer immunity from suit could not possibly be construed as anything other than substantive:

[T]he statute is not procedural. . . . [It] is an immunity statute that has been interpreted by the highest court in Michigan as a legislative determination as a matter of law of when a manufacturer or seller of a prescription drug has acted sufficiently reasonably, solely for the purpose of defining the limits of a cognizable products liability claim under Michigan law. As such, [the statute] is plainly substantive law.

Id. (quoting Taylor, 658 N.W.2d at 137).

The lex loci rule dictated application of the plaintiff’s state of residence in Alli, since:  (1) the “last act” necessary to the cause of action – the plaintiff’s injury – occurred there, (2) there was a substantial “connection” to the legal action, since the medical treatment involving the defendant’s drug occurred there; and (3) “public policy” was not offended by applying the Michigan act, there being “nothing immoral, unnatural, unjust, or prejudicial to the general interests of the citizens of Indiana” about Michigan deciding to confer immunity upon drug manufacturers where there has been compliance with FDA regulations.”  854 N.E.2d at 378-80.

Federal courts forced by forum-shopping Michigan plaintiffs to make choice of law determinations have come out in the same way.  In In re Prempro Products Liability Litigation, 2008 WL 1699211 (E.D. Ark. April 9, 2008), the court applied Illinois choice of law principles.  Why?  Because in MDL situations like Prempro the choice of law rules of the transferor court (where the action was originally filed) remain applicable no matter where the MDL court itself happens to be located.  Under Illinois interest analysis, Michigan law applied to plaintiffs who “purchased the product in Michigan, used it in Michigan, and w[ere] injured in Michigan.”  Id. at *3.  The place of injury could hardly be called “fortuitous.”  Id.  Where, as in Prempro neither plaintiff nor defendant resided in the forum state, that factor was “a wash.”  Id.  The “center” of the parties’ relationship in a product liability case “is where the plaintiff used the product,” Michigan.  Id.  Even assuming that the “conduct occurred” in the defendant’s principal place of business, that fact could not outweigh all of the other Michigan contacts.  Id. at *3-4.

Likewise in Henderson v. Merck & Co., 2005 WL 2600220 (E.D. Pa. Oct. 11, 2005), Michigan law was applied to a Michigan plaintiff’s Bextra-related claims (Vioxx claims were transferred to an MDL elsewhere).  The court applied Pennsylvania’s interest-analysis-based choice of law principles.  The plaintiff tried to get some law – any law – other than Michigan to apply, asserting that “Pennsylvania, New York, New Jersey, or Delaware law should apply” because to Michigan supposedly “lack[ed] an interest in the imposition of its law against out-of-state drug manufacturers.”  Id. at *3.  The various defendants were headquartered in one or the other of these four states.  The court found both actual and true conflicts, which necessitated choice of law analysis.  Id. at *4-7.  Michigan law applied because:  (1) plaintiff lived there; (2) the drug was prescribed there; (3) any reliance on inadequate information occurred there, and (4) plaintiff’s injuries occurred there.  Id. at *7.

Based upon these contacts, the Court finds that Michigan has a strong interest in applying its law to ensure that Michigan residents, including plaintiff, are not burdened with excessively high payments for prescription drugs, indeed, that such drugs remain financially available for all Michigan citizens, even if that means immunizing non-resident pharmaceutical companies who do business in Michigan from product-related claims brought by a Michigan resident for injuries suffered in Michigan.

Id.  The “importance” of principal place of business as a contact was “diluted by the fact that the remaining relevant events took place in Michigan,” and therefore any states’ interests “in applying their product liability laws to such extraterritorial conduct lose vigor.”  Id. at *8.  Thus:

Michigan has the greatest interest in applying its product liability laws to injuries suffered in Michigan by a Michigan resident based upon the sale, prescription, and consumption of a pharmaceutical drug in Michigan. This determination comports with the expectations of the parties and the policies of all interested states.

Id.  Reconsideration was denied in Henderson in 2005 WL 2864752 (E.D. Pa. Oct. 31, 2005), but plaintiffs did not revisit the choice of law ruling.

The only case going even somewhat the other way, Stupak v. Hoffman-La Roche, Inc., 287 F. Supp.2d 968 (E.D. Wis. 2003), did not involve principal place of business as the asserted contrary state interest.  Rather, the plaintiff, although a resident of Michigan, had gone to Wisconsin for medical treatment and had been prescribed the drug by a Wisconsin physician.  Id. at 971.  Wisconsin had a peculiar (and possibly unconstitutional) choice of law rule that “the law of the forum should presumptively apply.”  Id. at 970.  Because the plaintiff also brought malpractice claims against the Wisconsin physician, and it would have been difficult to apply different tort reform statutes to different defendants, the court in Stupak elected to apply Wisconsin, rather than Michigan law, although the Michigan plaintiff purchased, used, and was injured by the drug in Michigan.  Id. at 972-74.  The most important interest, the Stupak court held, was Wisconsin’s interest in the adjudication of malpractice claims against a Wisconsin physician.  Id. at 973-74.

Most plaintiffs treat with physicians in their home states.  Further, most plaintiffs who sue drug companies don’t sue their physicians for malpractice, since that only alienates the prescriber as a witness in the product liability claim.  So aside from the peculiar Stupak case (which remains unique), it appears that defendants have been able to corral Michigan plaintiffs with Michigan law, even when (as is frequent) they attempt to flee their home state in search of a more friendly forum.

Now, if we could only convince the other 49 states to follow Michigan’s lead.