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Starks v. Coloplast Corp., 2014 U.S. Dist. LEXIS 19611 (E.D. Pa. Feb. 18, 2014), brings us another favorable preemption ruling.  This is not a mass tort.  It appears to be a one-off complaint filed in Pennsylvania state court and, since Coloplast is a Minnesota company, removed to federal court where Coloplast’s preemption motion might be better received.  It was.

The product was the Titan OTR Inflatable Penile Implant.  It had been implanted in the plaintiff and failed, requiring revision surgery and resulting in the type of difficulties that often come with that.  The Titan is a Class III medical device, however, so that brought Riegel preemption into play.

And from there, it was relatively simple.  Plaintiff’s negligence, strict liability and implied warranty claims were all preempted – and rather ordinarily.  But there are two interesting notes.  First, the plaintiff tried to concoct a claim by simply regurgitating (roughly) the standard to be met to state a parallel violation claim: the company failed to satisfy “state duties equal to, or substantially identical to, federal requirements.”  Id. at *15.  Nice try, but a whole lot more is required.  The complaint must identify the actual standard that was not met and a state law that enforces the same standard.  Plaintiff did neither.  Two, while the court on a number of occasions underscored plaintiff’s failure to identify an FDA regulation or statute that the defendant failed to satisfy, id. at *15-18, we want to highlight once again that even doing so wouldn’t have been enough.  Plaintiffs do not have the authority to bring a private right of action for violating FDA regulations.  The FDCA explicitly disallows it.  Plaintiff must instead identify a state law that independently allows private plaintiffs to sue based on the conduct that resulted in those violations.  Nothing in the court’s opinion indicates that plaintiff did so.

Not all of plaintiff’s claims were preempted.  He also brought  breach of express warranty and breach of contract claims.  The court held that such claims, if properly pleaded, can survive preemption.  Id. at *18-22.  But plaintiff hadn’t pleaded facts to support the existence of an express warranty or a contract.  Plaintiff relied, for the most part, on statements made about the product in a brochure.  The brochure, however, was given to plaintiff’s doctor, not plaintiff.  Alleging the existence of an undated brochure given to a third party doesn’t state a contract or warranty claim, particularly given the lack of factual allegations surrounding an offer or acceptance of a contract or warranty. Id. at *21-22.  So the court dismissed these claims, but without prejudice.

Finally, this is another case in which the court accepted and considered publicly available FDA documents without converting the motion to dismiss into a summary judgment motion. Id. at *2-3.  This is becoming more and more common and is, we believe, proper.  Considering such documents allows the defense to inject a dose of reality into a motion that is based on a complaint that might be trying to tiptoe around it.

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Not too long ago we were asked what we thought about warning claims involving medication guides.   Our off-the-cuff reaction was that such suits have been occasionally filed over the years, but were largely unsuccessful in achieving the plaintiffs’ primary goal, which almost always was to avoid the learned intermediary rule.

That was our gut reaction, but since we also have to feed the blog, we decided that the question warranted a closer look.

First, a little on the current regulatory status of medication guides, which are also sometimes referred to as “patient package inserts,” or “patient brochures.”  They are “FDA-approved patient labeling conforming to the [Agency’s] specifications.” 21 C.F.R. §208.3(h).  Such guides were authorized by the FDA in 1998 under 21 C.F.R. §208.1, which states:

(a) This part sets forth requirements for patient labeling for human prescription drug products, including biological products, that the Food and Drug Administration (FDA) determines pose a serious and significant public health concern requiring distribution of FDA-approved patient information. . .

(b) The purpose of patient labeling for human prescription drug products required under this part is to provide information when the FDA determines in writing that it is necessary to patients’ safe and effective use of drug products.

(c) Patient labeling will be required if the FDA determines that one or more of the following circumstances exists:

(1) The drug product is one for which patient labeling could help prevent serious adverse effects.

(2) The drug product is one that has serious risk(s) (relative to benefits) of which patients should be made aware because information concerning the risk(s) could affect patients’ decision to use, or to continue to use, the product.

(3) The drug product is important to health and patient adherence to directions for use is crucial to the drug’s effectiveness.

Emphasis added.  See also 21 C.F.R. §208.24(a) (“The manufacturer of a drug product for which a Medication Guide is required under this part shall obtain FDA approval of the Medication Guide before the Medication Guide may be distributed”) (emphasis added); 21 C.F.R. § 201.57(c)(18) (requiring all “FDA-approved patient labeling” to appear in the “Patient counseling information” section of drug labeling).

We added all this emphasis to underscore the point that requiring a medication guide – as distinguished from what it might say − is another of those decisions that requires FDA pre-approval.  See Bartlett v. Mutual Pharmaceutical Co., 2010 WL 3659789, at *5 (D.N.H. Sept. 14, 2010) (“FDA may require that a drug be accompanied by a medication guide”) (citing §208.1).  As we’ve explained elsewhere, a mandate for FDA pre-approval such as this calls into play the Mensing/Bartlett impossibility preemption rationale, since a hypothetical state immediate tort duty to include a medication guide would conflict with the federal agency preapproval requirement.  Bowdrie v. Sun Pharmaceutical Industries Ltd., 909 F. Supp. 2d 179, 186 (E.D.N.Y. 2012) (finding preemption because “a specific FDA directive, is a necessary predicate to . . . any medication guide”).

Continue Reading A Guide To Medication Guides

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Sometimes we hear people say that they know just enough to be dangerous.  Homeowners who do their own electrical work fall into this category, as do friends and family who offer to cut our hair.  Running wires and cutting hair look so straightforward, and thousands of people do those things every day with nary a problem.  So why can’t anyone do them?  The answer is that we can, so long as we make the effort to learn the ins and outs, the basic rules, the tricks of the trade.  Without taking the time to gain that orientation, the results could be horrific—a house burned down or a hairstyle that causes others to look away suddenly.  And, unlike hair, houses do not grow back.

This is how we feel about federal preemption.  Courts and lawyers alike know that the Supremacy Clause says that federal law trumps state law.  Beyond that, it gets a little fuzzy, and when it comes to drugs and medical devices, a little knowledge can be dangerous.  Preemption comes in different types and subtypes, and a shallow understanding of the differences can lead (and has led) to confusing, contradictory, and unfair results.  Just the other day, we reported on a case where one party confused express preemption with implied preemption and imported concepts that apply only to one into a controversy dealing exclusively with the other.  The court went along with it, and the result was a predictably bad haircut that will not grow back (unless reversed by a higher stylist).

We are not criticizing.  We get that preemption can be complicated, and we routinely rely on Bexis and our many scorecards (here, here, and here) to keep it all straight.  We also take delight when we read an order where a clear-minded judge understands preemption and applies it correctly.  That is what happened in Rodriguez v. American Medical Systems, No. 7:12-CV-330, 2014 U.S. Dist. LEXIS 13803 (S.D. Tex. Feb. 4, 2014).  The Rodriguez order involved express medical device preemption and an argument that the plaintiff had alleged a so-called “parallel claim,” but there were a couple of twists that make the case unique.  First, the case involved an inflatable prosthesis that received approval through the FDA’s product development protocol (“PDP”) process, a method of premarket approval where a device’s clinical evaluation and the development of information for marketing approval are merged into one process.  There are not a lot of reported decisions involving PDP devices, but they typically treat PDP devices as premarket approved for express preemption purposes, and so does the district court in Rodriguez.  That is correct and good.

Second, because establishing approval through the less usual PDP process required explanation through a declaration—i.e., evidence outside the pleadings—the court converted the defendant manufacturer’s motion to dismiss under Rule 12(b) into a motion for partial summary judgment under Rule 56.  Looking back, this move was a signal that this court is careful and thinks things through before acting.

The court’s discussion and application of express preemption confirmed our impression.  The black-letter recitation of express preemption law under the Medical Device Amendments is about as good and clear as we have seen, including its discussion of the MDA’s express preemption provision and the marquee Supreme Court authority, Reigel v. Medtronic.  Id. at **7-11.  We are even sort of okay with the court’s description of “parallel claims”:  “[The MDA’s] protection ends, however, where the state-law claim is premised on the manufacturer’s violation of the applicable federal requirements. . . .  In such case, the state-law duties ‘parallel,’ rather than add to, those requirements . . . .”  Id. at *11.  Fair enough.  We generally do not like what has become known as the parallel claim doctrine because it conflicts with 28 U.S.C. § 337(a), which expressly forbids private enforcement of the FDCA.  A civil action claiming damages for violating the FDCA therefore should not be allowed, regardless of whether a state law claim “parallels” the federal requirement or not.  Separate and apart from this fundamental misgiving, we particularly do not like the inconsistency with which courts have ruled on parallel claims.  All that being said, we give the district court in Rodriguez credit for setting forth the rules in a straightforward manner, even if we do not completely agree with them.

The court’s analysis and application of the rules are equally disciplined, particularly in that the court realized that a parallel claim requires two components:  A state requirement and a federal requirement that are the same.  As the court put it,

[T]he fact that this device has received a declaration of PDP completion means that the FDA considers it to have survived the requisite cost-benefit analysis, and to be reasonably safe and effective.  It also means that the device must conform to FDA-approved specifications and applicable federal statutory provisions and regulations.  Thus, to identify a “parallel” claim, as Plaintiff is attempting to do, he must articulate how [the manufacturer’s] alleged violation of the duties imposed by the particular claims he asserts equates to a violation of the governing federal requirements.

Id. at *15.  We are often dismayed when courts trying to pave plaintiffs’ paths to recovery fail to understand this point.  Some courts give plaintiffs a break in identifying exactly what federal requirement the device or manufacturer has allegedly violated, and others are less than vigilant (or altogether forgiving) in forcing plaintiffs to identify a particular state requirement that applies.

The district court in Rodriguez held that the plaintiffs failed to state a parallel claim on both ends.  The plaintiff purported to allege a violation of Texas Deceptive Trade Practices Act, but left the court (and the defendant) to make “an educated guess” as to what he was actually claiming under state law.  Id. at *16.  Assuming that the plaintiff was alleging that the manufacturer’s promotional literature was somehow deceptive, the court found no alleged violation of a federal requirement either, concluding that the plaintiff “fails to articulate how [the manufacturer’s] marketing, through its brochures and literature, deviated from the FDA-approved form.”  The plaintiff’s claim for strict liability similarly “fail[ed] to plead or otherwise explain how [the plaintiff] has premised this claim on the violation of an applicable federal requirement.”  Id. at **17-18.

That is how medical device express preemption is supposed to work.  No articulated violation of a state requirement, no articulated violation of a federal requirement, no parallel claim.  No extra leeway from the vague pleading of claims.  The court concluded with this beauty of a holding:

Plaintiff essentially asks the Court to assume the violation of a federal requirement because he has alleged that the . . . device implanted into him caused him pain and/or did not work as promised, but governing case law does not recognize a parallel claim premised on such an assumption.

Id. at *18.  That statement sums up a lot of cases we see, and in Rodriguez all that remained was the plaintiff’s breach of contract claim, which the court dismissed as “conclusory and devoid of any factual support.”  Id. at **15-16.  We don’t know this judge, other than from reading this one order, but given the clarity of his analysis on preemption we would be surprised if he does his own electrical work or lets his clerks cut his hair.

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Today is the birthday of Copernicus, the great Polish astronomer who concluded that the earth revolved around the Sun.  Anyone who has consistently read this blog knows that our Sun is FDA preemption.  If the claims in a case are preempted by federal law, the case goes away, no matter how sympathetic the plaintiff or how ugly the company emails.  So enamored are we with preemption that we occasionally detour from drug and device cases to gaze at FDA preemption done right in other contexts.  For example, we have looked at food cases and cosmetic cases.  It seems that most of those cases come from California, and one could indulge in some dime-store cultural anthropology to figure out why that is so.   Perhaps it is simply because of the batty consumer protection laws out there.

Bottled water is considered a food, and we have a nice little preemption case in The Chicago Faucet Shoppe, Inc. v. Nestlé Waters North American Inc., 2014 U.S. Dist. LEXIS 16871 (N.D. Ill. Feb. 11, 2014). The case was a purported class action (remember that) alleging violations of the Illinois Consumer And Deceptive Business Practices Act “and the materially similar consumer protection acts of other states.” The plaintiff lawyers apparently wanted a very big class.  What was the alleged deception?  The plaintiff complained that the defendant failed to disclose “on its websites, invoices, and delivery trucks [wow!] the fact that Ice Mountain 5-gallon bottled water is resold municipal water and not natural spring water.”  The plaintiff claimed that it stopped buying the water as soon as it learned Ice Mountain was not from a natural spring, that it never would have bought the water if it knew the true facts, and that the company’s nondisclosure of the actual source permitted it wrongly “to charge a premium for inferior water.”

The plaintiff filed the action in Illinois state court, but the defendant successfully removed the case to federal court under the Class Action Fairness Act.  Good move. Or is it “good remove”?  Either way, the defendant had to be happy with the removal, because it got a very well-reasoned decision from the federal district court judge.

Right away we DDL lawyers feel a twinge of jealousy when we see that food products enjoy robust express preemption via 21 USC section 343, which provides that states or their political subdivisions (including juries) may not impose “any requirement for a food which is the subject of a standard of identity established under section 341 of this title that is not identical to such standard of identity.”  The “any” and the “identical” are nice words. They are almost musical. Ice Mountain water is considered to be “purified water” by the FDA, and the source of such water is not required to be disclosed.  Indeed, the FDA “considered but rejected a disclosure requirement for purified water, ultimately concluding that consumers purchasing that category of water were concerned with purity, not sourcing.”

The plaintiff tried to get around this express preemption with an argument that we DDL defense hacks will find familiar: that while labeling might be preempted, marketing is not. But the court did not buy that distinction, reasoning that “labeling is marketing”. The plaintiff furnished the company’s website as an example of marketing.  Guess what the website showed? The labels on the five-gallon bottles. The plaintiff’s attempt to circumvent preemption was all wet.

It is nice to see the federal judge pouring out the disingenuous plaintiff argument so swiftly and cleanly. As we look out our window at the happy land bounded by the Delaware and Schuylkill Rivers, we fondly hope that the lovely preemption analysis in The Chicago Faucet Shoppe will flow through our local courthouse and wash away spurious suits.

We recognize that not everyone might agree with the FDA’s decision that sourcing for purified water need not be disclosed.  But the FDA had its reasons, and manufacturers must live with those reasons and operate their businesses in accordance with that rule.  If you think the FDA is wrong-headed, then tell the FDA.  Or write your Congressman.  But chaotic nonsense would ensue if local philosopher kings or juries could announce their own standards and impose wildly varying requirements on companies trying to do business throughout the country.  In fact, companies could not comply with the inevitable myriad of crazy-quilt requirements. (Speaking of crazy-quilt requirements, Bexis reminded us that the ancients tried to explain the anomalies in the old earth-centered cosmology by conjuring up “epicycles.”  The term “epicycles” has since become a synonym for bad science.  Copernicus managed to toss epicycles into the dustbin of history.  What new Copernicus will emerge to eradicate plaintiff lawyer junk science?  But we digress.) Absent an honest, rigorous application of federal preemption, the tort system amounts to a tax, or a wealth transfer mechanism taking money from people who make things and giving it to people who make trouble.  The federal judge in The Chicago Faucet Shoppe case put it better than we can:  “state law cannot be used to fill what private litigants perceive to be gaps in the regulatory requirements imposed by federal law.”

There is an odd wrinkle in the case. The complaint also mentioned that in some communications the company might have affirmatively represented that the water was spring water.  The court allowed that affirmative misrepresentations might not enjoy the same preemptive effect.  But the plaintiff had “all but disavowed a misrepresentation theory of fraud.”  The court was not going to “force a theory of relief on the plaintiff that it cannot, or does not wish to, assert.”  That “cannot, or does not wish to” is interesting.  Reading between the lines, it appears that the “cannot” comes from the class representative’s lack of reliance on the alleged affirmative misrepresentation.   It appears that “the does not wish to” comes from the realization that the broad class definition would crumble under the requirement of such reliance.  Thus, the plaintiff lawyers seem to have been caught between TwIqbal and Fed. R. Civ. P. 21.

There was also a claim of unjust enrichment, but that claim is unavailable if there was an express contract, which there was (for purchase of the water) in this case.  In any event, the unjust enrichment claim rested upon the same alleged nondisclosure and was, therefore, subject to the same express preemption.

For any of you fellow DDL practitioners who read The Chicago Faucet Shoppe decision with approval and a bit of envy, we offer this quote from Smokey Robinson, another all-time great whose birthday is today: we “second that emotion.”

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The pelvic-mesh plaintiff wrote this in his affidavit:  “I do not know whether mesh was implanted in my body.”  Favor v. W.L. Gore Assocs., 2014 U.S. Dist. LEXIS 17134, *6 (S.D. Oh. Feb. 11, 2014).  We lead with that admission today because we thought it would be a good day to use the old literary trick of foreshadowing – though we’ll admit that this isn’t a subtle use of it.  But then again that sure isn’t a subtle affidavit.

Not missing the obvious, W.L. Gore Associates moved to dismiss.  Now, plaintiff did allege in his complaint that a Gore mesh product had in fact been implanted in him.  But then came the affidavit.  A plaintiff with a sworn statement contradicting his own pleadings sure seems like good grounds for dismissal.

But the court was able to sidestep all that and still dismiss the complaint.  Plaintiff failed to assert his claims under the Ohio Product Liability Act (“OPLA”), instead alleging common law claims.  The OPLA abrogates common law claims, so plaintiffs had asserted abrogated claims.  On this ground alone, the court dismissed the complaint.  Id. at *14-15.  Now, we’ve often seen courts take such improperly pleaded common law claims and simply treat them as if they were stated under the particular product liability act in play.  Not this court.  Why? We can’t be sure.  But there may be a clue found in plaintiff’s affidavit.

Gore wasn’t the only defendant.  Plaintiff also sued Bard and Davol.  But, this time, plaintiff simply made no factual allegations about the products of these defendants.  Bard and Davol moved for summary judgment.  Id. at *12.  And they got it.  It seems that plaintiff, in his opposition papers as to another defendant, admitted that “his counsel simply ‘researched all makers of surgical mesh and attempted to cast the broadest possible net in order to avoid future statute of limitations problems.””  Id. at *4-5.  That certainly seems like another doozy of an admission.  Making matters worse – or better, depending on how you look at it – plaintiff didn’t respond to the Bard and Davol motions at all.  The court granted summary judgment.  Id. at *14.

We should also note that plaintiff sued the doctors and hospital.  Such claims require an affidavit of merit.  Plaintiff didn’t provide one.  He didn’t even oppose the medical defendants’ motions for judgment on the pleadings.  The court granted the motions. Id. at *7-12.  (We suspect that the weakness of the claims against the medical defendants is the reason that the court had earlier denied plaintiff’s motion to remand the case to state court.)

Not surprisingly, the medical defendants and Bard and Davol moved for Rule 11 sanctions.  They seemed warranted.  But the court denied the motions.

As to the medical defendants, the court was concerned that awarding sanctions would require it to make evidentiary determinations at the pleadings stage.  Id. at *15-20.  (We suspect, though, that the court may have been concerned that there were inaccuracy issues with the medical records.)  Regardless, you’d think that the Bard and Davol defendants had a slam dunk.  The plaintiff all but admitted that he sued them for no reason other than that they were in the same industry as Gore.  But the court seemed dead set against imposing sanctions.  Bard and Davol had failed to file an affidavit confirming that they had given plaintiff the required 21 days to withdraw or correct his pleading.  Id. at *20.  Bard and Davol told the court that they had done so, but that wasn’t enough. Id. at *20-21.

We’re not sure what else to say about this case and these types of complaints.  You’d think that awarding sanction might be the best way to stop them.  But the court wasn’t willing to do so here.

So we’ll leave you with a completely unrelated recommendation.  Watch “Drunk History” on Comedy Central.  We saw a few episodes this weekend and found it hard to breathe through all the laughing.

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As large swaths of the country continue to get pounded by a variety of winter precipitation, we know that there are many over-the-counter cold and flu preparations being consumed by our readers. We assume many of our readers have minor children who are taking the pediatric versions of these preparations after suitable review of the labeling by their respective parents.  The labeling does not just tell the reader how much to take or how often to take it, but discloses actual risks.  Other than to whom the manufacturer’s duty to warn runs, the causes of action available for plaintiffs suing over OTC drugs are pretty much the same as for prescription drugs.  Some risks of OTC medications rival risks of prescription drugs, in terms of severity of the injury if not its frequency.  The risk we seem to post about most often in OTC drug cases is Stevens-Johnson Syndrome (and its related Toxic Epidermal Necrolysis), which is usually quite nasty.

The risk, however, is not new.  Without laying out a comprehensive labeling history, we can say that OTC ibuprofen-containing preparations have had warnings since before 2006, when the labels for adult and pediatric versions were revised in connection with FDA action on a Citizen’s Petition.  Yet, we still see cases where plaintiffs sue over SJS they say they got from ibuprofen in pediatric OTC cold preparation.  As we have said many times, we have a hard time seeing the basis for imposing liability on a drug manufacturer for an injury the risk of which was adequately described in the label, especially a label the FDA specifically revised in terms of how that risk was described.  We have also said, particularly since Bartlett, that claims based on the need to change one drug to a different drug, to the extent they could be cognizable under any state’s design defect law, should be preempted.  We posted last year on Newman v. McNeil Consumer Healthcare, No. 10 C 1541, 2013 U.S. Dist. LEXIS 113440 (N.D. Ill. Mar. 29, 2013), a case involving warnings and design defect (and other) claims over SJS from a pediatric OTC ibuprofen preparation.  In decrying that court’s ruling allowing design defect to proceed based on the contention that a different drug was an alternative feasible design, we wrote famously—checking to see if our readers’ collective ego-meter is working—“A cat is no more an alternative design of a dog than acetaminophen is an alternative design of ibuprofen.”

In Hunt v. McNeil Consumer Healthcare, Civ. No. 11-457, 2014 U.S. Dist. LEXIS 14263 (E.D. La. Jan. 17, 2014), we see a case with the same product and similar allegations that cites the Newman decision—but not our post.  Hunt involved alleged SJS from use of the product in February 2010—the date is not mentioned in this decision—and allegations of failure to warn and design defect under the Louisiana Product Liability Act. (We are not picking on Louisiana. We are told we have enjoyed some of our trips to the state.)  Defendants moved for partial summary judgment on the design defect claim and to exclude one of plaintiff’s experts.  We pause here to express some confusion.  The defendants did not move on the warnings claim even though the product was used with the FDA-mandated SJS warnings.  The partial motion for summary judgment was said to be “Granted in Part,” but it looks to us like it was denied except that plaintiff “clarified” that she “intends to offer evidence” only as one of three purported alternative designs identified by one of her experts.  Id. at **7-8.  (We wonder if plaintiff dropped acetaminophen as an alternative design because of the August 2013 FDA announcements about acetaminophen and SJS.)  The elephant in the room on design defect for a drug is impossibility preemption, but the court pointed out in a footnote that Defendants did not assert it and the court would not consider it sua sponte.  Id. at *8 n.1.  And, while part of this decision considers a motion to exclude one expert who opines on causation and damages, the Defendants apparently did not move on the expert who was opining on warnings and design defect.  That expert, Randall Tackett, is a fairly well-known and well-worn shill for the other side, who we have mentioned here and here.  As discussed below, his opinions that helped create the genuine issues of material fact to defeat the motion for partial summary judgment might have been excludable under strong Fifth Circuit Daubert law.  Maybe there is more going on in this case than is apparent from the decision itself or maybe the Defendants will get another shot to raise preemption and/or knock out Tackett.

So, now that our expression of confusion has given away the result in Hunt, we can return to our analysis.  The court correctly assigned the burden on plaintiff to prove that “a safer alternative design existed at the time” the plaintiff’s product was manufactured and “that the risk avoided by using the alternative design (magnitude of damage discounted by the likelihood of its occurrence) would have exceeded the burden of switching to the alternative design (added construction costs and loss of product utility).”  Id. at *7 (quoting Roman v. W. Mfg., Inc., 691 F.3d 686, 700-01 (5th Cir. 2012)).  The alternative design that plaintiff urged, based on Tackett’s testimony, was dexibuprofen, which, as we explained before (but Hall did not), is the right-sided stereoisomer of racemic mixture ibuprofen.  The rub is that FDA rejected a New Drug Application for dexibuprofen in 1994 and it cannot be marketed in the U.S., let alone sold OTC.  Tackett’s opinion that “FDA would now grant an NDA for dexibuprofen” was unchallenged, even though—preemption aside—it is rank speculation and does not, as characterized, go to the potentially relevant issue.  Id. at *11.  The real question was whether a pediatric OTC containing dexibuprofen would have been approved in time for it to be on the shelves by February 2010.  Without a long regulatory discussion, where the active ingredient is not already legally marketed in any form, obtaining pediatric OTC approval would be harder than a “standard” NDA, which is not easy even without a prior rejection.  Presumably, Tackett’s guess was really as to this question and plaintiff had evidence from him or someone else satisfying the risk/burden part of LPLA design defect law. That meant the question for the court was a straight legal one:  Does the requirement that “[t]here existed an alternative design” mean that the alternative design had to have been legal?

The court concluded that the Louisiana legislature’s choice of “existed” was a rejection of requiring that the alternative design have been “feasible,” as is the law in many jurisdictions.  Id. at **8-9.  According to a law review article by a lawyer who helped draft the LPLA, “existed” really just means that someone somewhere had “conceived” the alternative design such “that the manufacturer had a realistic choice as to design” (between what was used and the identified alternative).  Id. at **9-10.  Based on this, the court concluded that a drug not on the market could be an alternative design if there was “evidence” like what Tackett offered.  Id. at *11.  Significantly, as far as we know, this non-FDA-approved alternative design theory has been rejected by every state court judge and every appellate decision to have considered it.  See Ackley v. Wyeth Labs., Inc., 919 F.2d 397, 401-02 (6th Cir. 1990) (applying Ohio law); White v. Wyeth Labs., Inc., 533 N.E.2d 748, 753-754 (Ohio 1988); Militrano v. Lederle Labs., 769 N.Y.S.2d 839, 847-848 (N.Y. Sup. 2003), aff’d, 810 N.Y.S.2d 506 (N.Y.A.D. 2006); Totterdale v. Lederle Labs., 2008 WL 972657 (W.Va. Cir. Mar. 19, 2008).

The court did not address the more fundamental question of how a different drug, approved or not, can be an alternative design, on which this plaintiff should lose under the LPLA.  See Theriot v. Danek Med., Inc., 168 F.3d 253 (5th Cir. 1999). If the idea is to test the reasonableness of a manufacturer’s choice—which sounds like negligence not strict liability—then the real choice of which drug to pursue happens years before any marketing application would be filed.  There may not be a real option of pursuing a product with the other drug if rights to its development are held by someone—like a competitor—who does not want to share under any terms.  (If the rights bear a Dr. Evil-like price of $100 billion, then is the theoretical choice still a “realistic” one?)  Even ignoring preemption, drugs are not like products where the manufacturer really has sole control over the design (e.g., adding a safety guard to a power tool). So, we do not see how “a realistic choice as to design” opens the door to liability for developing and selling one drug instead of another.  This leap was done by a federal court predicting what Louisiana courts would do, but without citing a single relevant Louisiana decision.  The decision did cite Newman, applying Illinois law, and a federal case applying Texas law, but none of the many decisions saying a different drug—even a stereoisomer—is not an alternative design.  This is not a proper result under Erie v. Tompkins.

By comparison, the rest of the decision was fairly restrained and narrow.  The plaintiff offered a burn surgeon to opine on general causation, specific causation, and damages.  He could not offer general or specific causation opinions because he merely parroted what other experts said without independent investigation of the issues. Hunt, 2014 U.S. Dist. LEXIS 14263,  **16-17.  The court actually cited some pretty good law Daubert law—we told you it was there—in dispensing with the opinions. The challenge to his damages opinions was apparently limited to qualifications and easily rejected.  Id. at **19-21.  A pretty obvious result. Nothing to see here.  Go play in the snow.  With your dog or, alternatively, your cat.

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This is a relatively short post because a(nother) snowstorm has closed the ReedSmith Philly office and we’re working remotely.  Over the week or so we’ve been sent a couple of articles that we think could be useful to defense counsel, so we’re passing them along today.

The first is a law review article, “The Odd State of Twiqbal Plausibility in Pleading Affirmative Defenses,” sent to us by its author, Charleston School of Law professor Bill Janssen.  While he sent it to us in hard copy (the cite is 70 Wash. & Lee L.R. 1573), it’s also available online, here.  The issue it addresses is not of cosmic importance, but it’s an annoyance – whether the other side can try to TwIqbal our affirmative defenses.  We’ve touched on this issue before, here, but only briefly, stating:

We won’t go any further than to re-emphasize the point that the Twombly/Iqbal requirements apply to every allegation governed by Rule 8(a) – which includes class action allegations, but presumably not affirmative defenses governed by Rule 8(c), which doesn’t contain the same “short and plain statement” language.  See, e.g., Davis v. Indiana State Police, 541 F.3d 760, 763 (7th Cir. 2008) (Twombly inapplicable to affirmative defenses).

Professor Janssen’s law review article takes on the issue of TwIqbal and affirmative defenses comprehensively – complete with a district-by-district chart of every decision he could find.  His conclusion:

The majority view held by the Nation’s district courts that have considered the question join Weddle v. Bayer AG Corp. [2012 WL 1019824 (S.D. Cal. March 26, 2012)] in holding that Twiqbal “plausibility” does not apply to the pleading of affirmative defenses. . . .  The persistent minority view . . . holds that TwIqbal applies.

70 Wash. & Lee L.R. at 1634.  So if some plaintiff tries to TwIqbal your affirmative defenses, you can save yourself considerable research time by checking out this article.

A second time saver is a 50-state survey – complete with helpful charts – of the comparative fault/contributory negligence law of every state and the District of Columbia.  This article was compiled by the (primarily subrogation) law firm Matthiesen, Wickert & Lehrer.  It separates out the various states by pure contributory negligence, pure comparative fault, modified comparative fault, and “slight/gross” comparative fault.  This article is the kind of thing we would have done, if we’d focused on this question – which we haven’t.  Because this other firm has, we’re passing their article along as a helpful resource.

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

It was the best of decisions (Scovil v. Medtronic, Inc., __ F. Supp.2d __, 2014 WL 502923 (D. Ariz. Feb. 7, 2014), it was the worst of decisions (Coleman v. Medtronic, Inc., No. B243609, slip op. (Cal. App. Jan. 27, 2014).  Scovil may not be truly the “best” of decisions and Coleman isn’t all bad either.  So what?  We have a little artistic license to make our point – that being the several inconsistencies between the most recent decisions to come out of the InFuse litigation. In fact, our point may be better made by the second clause of the opening to Dickens’ classic tale:  “It was the age of wisdom, it was the age of foolishness.”  We’ll begin with wisdom.

We’ve been reporting on the notable success Medtronic has had in the InFuse cases across the country (see here, here, here, and here).  And, to be fair we acknowledged the couple of cases that went the other way.  The worst of which is Ramirez v. Medtronic, Inc., __ F.Supp.2d __, 2013 WL 4446913 (D. Ariz. Aug. 21, 2013).  But Ramirez just had its wings clipped − being significantly limited by the ruling in Scovil.  Like in all of the other InFuse cases, plaintiff here alleged that the device was used in an off-label manner and that as a result he suffered injury. Plaintiff brought ten causes of action: manufacturing defect, failure to warn, design defect, negligence, fraud, intentional misrepresentation, violation of the Arizona Unfair Competition Law, breach of express and implied warranties, negligence per se, and strict liability.  Scovil, 2014 WL 502923 at *2.  For reasons that will be apparent when we get to the foolishness portion of this post, we note that the plaintiff here conceded that his negligence per se action is preempted.  Id. at *13 n.3.

The Scovil court spent ten pages discussing FDA preemption generally, including the poor Ninth Circuit Stengel decision and the equally unpleasant Ramirez decision.  It doesn’t appear that plaintiff pleaded a Stengel-claim (failure to warn the FDA) here and fortunately the court opted not to follow Ramirez. First the court held plaintiff’s manufacturing and design defect claims were preempted finding that in approving the manufacturing and design for the InFuse device, off-label uses were “necessarily a consideration in the risk-benefit analysis the FDA undertakes during the PMA process.”  Scovil, at *9.  Thus, a “finding that the [manufacturing] process was unsafe would necessarily undermine the FDA’s finding that the benefits of its manufacturing process for on-label uses outweighed the risks presented by off-label uses.”  Id.  The court applied the same reasoning to the design defect claim, id., to plaintiff’s negligence claim to the extent it was based on negligence in researching, manufacturing, selling, labeling, testing, distributing and analyzing, id. at *10, and to plaintiff’s strict liability claim.  Id.  at *12.

The court similarly dismissed plaintiff’s failure to warn claim “because it would create an additional duty to disclose information to patients and doctors that the FDA does not require to be disclosed.”  Id. at *10.   The Scovil court was unpersuaded that off-label use required a different conclusion, rejecting almost entirely the reasoning of Ramirez.

Marketing and promotion claims, however, were carved out as not preempted. The court equated negligent marketing with off-label promotion in violation of federal law.  Id.  But, because plaintiff’s claim was grounded in negligence, the court found it fit within the “narrow gap” of non-preempted claims.  The court also found plaintiff’s fraud and misrepresentation claims to be parallel violation claims.   The claims are based on allegedly false statements which are prohibited by both state and federal law.  Id. 

While Scovil wasn’t a complete victory, it significantly pared down plaintiff’s claims but more importantly it opened up a split in authority in Arizona – watering down Ramirez in that jurisdiction and limiting plaintiffs’ ability to effectively use it elsewhere.

So, if Scovil was our “season of light,” Coleman is our “season of darkness.”  It is another InFuse decision in which allegations of off-label use and promotion take center stage.  Plaintiff Coleman based his claims on allegations of manufacturing defect, failure to warn and off-label promotion.  Coleman, slip op. at 2. Plaintiff apparently opted not to appeal the dismissal of his fraud, misrepresentation and unfair competition claims.  Id. at 5 n.2.  The Coleman decision also contains a lengthy discussion of preemption law, but with cites to Stengel, Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011), and Bausch v. Stryker Corp., 630 F.33d 546 (7th Cir. 2010) it’s not a version we support. Toss in misplaced reliance on In re Farm Raised Salmon Cases, 42 Cal.4th 1077 (2008) and we had generally lost any hope for a happy ending.

Like we mentioned at the start, not all of Coleman is bad.  The first thing the court did was separate plaintiff’s failure to warn claim into three different theories and dismissed two of them.  Failure to warn based on a claim that Medtronic should have given warnings different than those approved by the FDA is preempted.  Coleman, slip op. at 13.  Also preempted is any failure to warn claim premised on off-label promotion.  The court found that federal “adulteration” and “misbranding” regulations are not “genuinely equivalent” to the requirements imposed by state common law in the failure to warn context.  Id. at 16.  On this point, the Coleman court directly rejects the reasoning and conclusion of Ramirez. Id. at 17-18.  But that’s where the good news ends.

Plaintiff’s third failure to warn theory is a Stengel claim – failure to provide adverse event information to the FDA after FDA approval.  California state courts aren’t bound by Stengel, but this one “elected” to follow it.  Id. at 14.  Disappointing, but not unbelievable.  You all know what we think of Stengel; we won’t re-hash.  Similarly, you know what we think of Bausch.  So, you won’t be surprised that we weren’t happy with Coleman’s reliance on it to allow plaintiff’s manufacturing defect claim.  Coleman accepts the legal proposition that a plaintiff can state a claim for a manufacturing defect premised on non-specific allegations of failure to comply with Current Good Manufacturing Practices (CGMPs).  Id. at 22-24.  In other words, plaintiff doesn’t have to plead how the defendant violated federal regulations – a “general allegation” is enough.  At least the court acknowledged that the claim might be preempted, but was willing to defer that ruling until after some discovery.  Id. at 24.

While the Stengel and Bausch claims aren’t to our liking, our real problem with Coleman is that it allows negligence per se to escape preemption.   Remember what we mentioned above?  The plaintiff in Scovil conceded that his negligence per se claim was preempted.  Even Ramirez, for all its flaws, found negligence per se preempted:

[A] claim for negligence that is premised solely on a manufacturer’s violation of a federal standard—here the FDCA and MDA—is impliedly preempted. . . .The responsibility for enforcing the FDCA and MDA lies exclusively with the federal government. 21 U.S.C. § 337(a); Buckman, 531 U.S. at 352, 121 S.Ct. 1012.

Accordingly, federal regulations cannot be hijacked by private plaintiffs. As a practical matter, manufacturers that have to comply with the FDA’s detailed regulatory requirements knowing that they have to answer to the FDA for any violations would also face the knowledge that any of the 50 states could also be policing the manufacturer’s compliance with those laws under the guise of negligence actions. Id. at 350–51, 121 S.Ct. 1012. That regime might produce a situation where “disclosures to the FDA, although deemed appropriate by the Administration, will later be judged insufficient in state court.” Id. at 351, 121 S.Ct. 1012. That was the problem in Buckman. Negligence claims where the duty and breach are imported from the FDCA and MDA produce those very same concerns.

[Plaintiff]’s negligence per se claim is premised wholly on violations of the FDCA and MDA. That is the entirety of this claim, and like the fraud claim premised solely on the violations of the FDCA in Buckman, is impliedly preempted.

Ramirez, __ F.Supp.2d __, 2013 WL 4446913 at *18-19. The critical point is that the FDCA gives exclusive enforcement authority to the federal government. “[A]ll such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States.” 21 U.S.C. §337(a). That means that nobody – not even a plaintiff – is supposed to be able to come into court claiming that somebody else violated the FDCA or any FDA regulation.

So, how did Coleman get it so wrong? Here comes the misplaced reliance on Farm Raised Salmon’s “it’s not federal, it’s state law” rationale.  Coleman, slip op. at 22.  Farm Raised Salmon was a food case and as such, the California Supreme Court based its decision on a food-specific amendment to §337(a).  That section, part of the 1990 Nutrition Labeling Act, provides that “no State. . .may directly or indirectly establish under any authority or continue in effect as to any food. . .any requirement for the labeling of food. . .that is not identical to the [federal] requirement.” 21 U.S.C. §343-1(a).  As we discussed at considerable length, the ruling against preemption in Farm Raised Salmon is entirely and exclusively based on the “negative implication” of §343-1(a) – that states may enforce “identical” requirements” with respect to “food” pursuant to the Nutrition Act amendments to the FDCA.  Indeed, when we first commented on Farm Raised Salmon, we noted that the court’s extensive reliance upon §343-1(a) was a silver-lining for prescription drug and device cases.  To this day Congress has not enacted anything that detracts from or contradicts its original decision to prohibit private enforcement with respect to drugs and devices.  But Coleman ignores this critical difference.

Ignoring that distinction means that there’s nothing to prevent the craziness of California food litigation from now spilling over into prescription drug and medical device litigation.  Look at the result here.  The court found failure to warn based on off-label promotion to be expressly preempted because FDA adulteration and misbranding regulations are not parallel to state law failure to warn.  But, a negligence per se claim

based on the theory of off-label promotion is neither expressly nor impliedly preempted, because if parallels the federal requirements prohibiting misbranding and adulteration. . . In pursuit of a state negligence claim, Coleman is arguing that Medtronic violated its duty of reasonable care, which would parallel the federal duty to comply with the regulations prohibiting misbranding and adulteration.

Id. at 20-21.  The court is allowing plaintiff to use negligence per se as a state-law end run around §337(a)’s prohibition against private enforcement, on the basis of a food case that turned on an exception to §337(a) that only applies to food cases. That’s simply wrong.

And it’s worse than just wrong.  At least manufacturers of PMA devices like InFuse have the Riegel preemption defense, but drug companies and 510k device manufacturers don’t even have that.  The potential is that they could wind up in a worse position than even food manufacturers, who also at least have partial preemption defenses.  Coleman leaves us very concerned that in California we could be on the brink of a “winter of despair.”

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The MDL court in the pelvic mesh litigation issued in limine rulings for an upcoming trial involving Ethicon’s TVT Secur system.  In re Ethicon, Inc., 2014 U.S. Dist. LEXIS 14088 (S.D.W Va.  Feb. 5, 2014).  There were almost 30 rulings.  The motions addressed topics that ranged from the mundane, such as clinical trials and complication rates, to the much more interesting, such as TV ads by plaintiff-lawyers.  Most of the topics are familiar to those of you who have been through these types of trials.  The good news is that the defense won most of the motions, and here are some highlights:

Conclusions from Clinical Trials.  Plaintiffs wanted to prevent Ethicon from testifying or arguing that a certain number of clinical trials supported the safety of the TVT system.  Plaintiffs claimed the conclusions of the clinical trials were hearsay.  The court didn’t rule, punting on a decision until trial.  But the plaintiffs appear to have already lost.  The court held that testimony about the conclusions of clinical trials was not hearsay if an Ethicon employee testified that Ethicon relied on the studies, which it no doubt did.

Complication Rates.  Plaintiffs moved to exclude complication rates related to the use of TVT system, arguing that such rates couldn’t be reliably calculated because the complications themselves are underreported and the number of the TVT systems that have actually been used is unknown.  The court agreed only to the extent that anecdotal evidence would be excluded.  The defense is otherwise free to introduce complication rates that are derived from reliable statistical methods and/or peer-reviewed literature.

Gold Standard and Standard of Care.  Plaintiffs took a few shots at keeping out evidence that the TVT system was the “standard of care” or the “gold standard” for treating stress urinary incontinence.  It didn’t work.  First, plaintiffs argued that terms like standard of care and gold standard would confuse the jury and create mini-trials.  It’s a design defect case, and those arguments didn’t fly.  The court held that this type of testimony is relevant to whether the TVT is unreasonably dangerous or has safer alternative designs.  Next, Plaintiffs tried to exclude statements from medical organizations describing the TVT system as the standard of care.  The court denied this too.  Such statements are admissible in a number of ways, including as learned treatises, as reliance material for experts, and as evidence of Ethicon’s state of mind.  Finally, Plaintiffs sought to exclude Ethicon from presenting testimony that alternative treatments to the TVT system were rarely taught in medical schools.  That is clearly evidence relevant to whether safer-alternatives were available, and, not surprisingly, the court denied the motion.

Attorney-Driven Litigation.  Plaintiffs anticipated – no doubt, correctly – that the defense would argue that the lawsuit was attorney-driven, and so they moved to exclude that type of evidence or argument – to mixed results.  The court prohibited Ethicon from presenting evidence that the surgeon who performed the plaintiff’s TVT surgery had been recommended to her by her lawyer because the court saw nothing to suggest that the surgeon acted outside the standard of care.  That seems like one of those ironic-type victories, doesn’t it?  Stipulation anyone?  The court, on the other hand, allowed the defense to present evidence that the plaintiff chose to sue only after seeing a lawyer ad on TV, holding that such evidence is probative of plaintiff’s credibility as to her injuries.  That’s a big victory for the defense.

Instructional and Marketing Materials.  The court had already dismissed plaintiffs’ warning and warranty claims, leaving only design defect and punitive damages claims.  So the defense moved to exclude the TVT system’s Instructions For Use and marketing materials.  The court was coy in its ruling.  But it sure reads like a defense victory.  While the court denied the motion, it said that the motion was, in essence, asking the court to reaffirm the rule that only relevant material is admissible.  It then said, “I have already ruled that evidence related to the TVT’s IFU and patient education brochures is not relevant to the plaintiffs’ design defect claim.”  That sure reads like a defense victory to us.

Bad Acts.  The court excluded many of the types of bad-act evidence that we often see plaintiffs try to introduce at trial, including state AG actions, DOJ settlements, SEC settlements, and governmental investigations.  None of these investigations, actions or settlements were related to the TVT system.  The court withheld until trial rulings on any other “bad act” evidence that plaintiffs might seek to introduce.  But the court also gave the plaintiffs a Heisenberg-like warning: “tread carefully.”

Other TVT System Lawsuits.  The court excluded all of this, holding that evidence of other TVT lawsuits is unduly prejudicial and would confuse or mislead the jury.

Financial Support of Articles and Payments to the Inventor of the TVT
System.  The defense lost these motions.  The court held that, even if Ethicon had no obligation to disclose its financial support of a published article, the jury is still entitled to consider whether it was reasonable for Ethicon to rely on financially-conflicted articles.  The court also allowed plaintiffs to introduce evidence that Ethicon paid the professor who invented the TVT system and lead one of its key studies through milestone payments, which the court held could be relevant to negligence and punitive damages.

Referring to Confidential Designation in Front of the Jury.  We’ve seen this move.  Plaintiffs’ lawyers suggest something nefarious is behind “confidential” designations placed on documents, even when those designations were affixed as part of the litigation.  It’s based on guesswork that the only reasons for confidentiality are illicit.  The court understood that such suggestions were unduly prejudicial and based on speculation, and it excluded plaintiffs from making them.

Emails with Off-Color Comments.
The court considered two internal Ethicon emails that contained off-color comments, one addressing an adverse event report.  The court held that bad-taste does not equal wanton or malicious conduct and excluded the emails.

Material Safety Data Sheets and Complications Unrelated to Plaintiff’s Injury.  Plaintiffs intended to use MSDS from suppliers of companies other than Ethicon and/or that reflected complications unrelated to those suffered by plaintiff. For obvious reasons, the court excluded these.  It also generally excluded evidence of alleged complications unrelated to plaintiff’s injuries.

There are more rulings, but these give you the gist.

Next comes trial.

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We have reported before on defendants’ efforts to remove cases from the Philadelphia County Court of Common Pleas to federal court.  We don’t spend a lot of time examining their motives, other than to express our wholehearted approval of the strategy and noting at times that the Philadelphia CCP has taken its share of criticism.  The fact is your bloggers have spent considerable parts of their legal careers representing clients in the Philadelphia CCP, and we are the first to sing its praises when we believe praise is due.  We also have voiced our disagreement, sometimes vigorously, when we believe proceedings or results should go a different way.  As the old saying goes, we call them like we see them.

Recent efforts to remove cases in Philadelphia have focused on establishing principal places of business outside of Pennsylvania.  As the removal jurisdiction nerds among us know all too well, the forum defendant rule set forth in 28 U.S.C. § 1441(b)(2) prohibits removal of a case to federal court if a properly joined and served defendant is a citizen of the forum state, even where there is complete diversity of citizenship.  As a result, establishing a principal place of business—and thus citizenship—outside Pennsylvania can make the difference between proceeding in federal court and proceeding in the CCP, as good or as bad as that might be.
This is an issue worth fighting for, as the recent order in Sherfey v. Johnson & Johnson, No. 12-4162, 2014 U.S. Dist. LEXIS 10690 (E.D. Pa. Jan. 29, 2014), makes perfectly clear.  The plaintiffs sued the defendant over-the-counter drug manufacturer in the Philadelphia courts, and apparently staying in state court was really important to these plaintiffs:  Not only did that allege that defendant manufacturer’s principal place of business was in Pennsylvania, they also sued numerous company officials, all Pennsylvania residents.  Despite these measures—and we believe the fraudulent joinder of defendants is among the most transparent and offensive tactics that plaintiffs pursue in our cases—the district court denied the plaintiffs’ motion to remand.
The result is good for the defendants, but the order’s reasoning is not exceptional.  The drug manufacturer defendant’s principal place of business is actually in New Jersey, which explains a lot.  As we mentioned just the other day, New Jersey has a product liability statute that creates presumptions that are very helpful to the defense.  These plaintiffs could have sued this defendant in New Jersey state court, where they would not have had to worry about removal.  But could it be that the plaintiffs were trying to avoid the application of New Jersey law?  Just saying.  On the merits of the principal place of business dispute, we reported here on the order that this district judge followed.  In a nutshell, the bulk of the management functions for this defendant are carried out by executives who work in Skillman, New Jersey, which makes New Jersey the principal place of business.  The district judge in Sherfey adopted that conclusion without further commentary.
The court spent much longer explaining why the individual defendants had no potential liability under Pennsylvania law because the plaintiffs had alleged no more than ordinary nonfeasance, mainly the alleged failure to address quality issues and strengthen the warnings.  Id. at **17-33.  Under Pennsylvania’s “participation theory” of individual liability, the plaintiff “must establish that the individual officer or agent engaged in misfeasance rather than mere nonfeasance.”  Id. at **19-20.  In other words, the individuals must have engaged in affirmative bad acts, which the plaintiffs did not allege.  That means no potential liability, which means the individual defendants were fraudulently joined, which means their Pennsylvania citizenship did not matter one iota.  That is the correct result.
The remarkable feature of this order is the extent to which the parties litigated federal jurisdiction involving this drug manufacturer and this product.  The same dispute was playing out before four different judges in the Eastern District of Pennsylvania.  The parties files motions to remand and motions for reconsideration “including several briefings, an evidentiary hearing . . . , and post-evidentiary filings.”  Id. at *13.  The parties urged some judges to wait until another issued rulings, but then when the orders went uniformly against the plaintiffs, they renewed their efforts with the same judges they had previously asked to wait and see.  When all is said and done, Sherfey is another example of plaintiffs trying to manipulate the forum and block a defendant’s right to remove cases to federal court.  That right is important, and while we knock the plaintiffs for their gamesmanship, we commend the defendants for fighting the good fight and the district court for coming to the right conclusion.  We guess what goes on in the Philadelphia CCP does not always stay in the Philadelphia CCP.

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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