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The Ninth Circuit filed a preemption opinion the other day that should help prevent the “foodification” of medical device litigation. That made-up word refers to the wasteful food-related class action litigation that has somewhat thrived in California.  The template is familiar:  Opportunistic plaintiffs’ lawyers find some aspect of food labeling that they claim is misleading—e.g., that a product is “wholesome” or “natural”—and they recruit a plaintiff to say that he or she would not have purchased the food or would have paid less for it had truth been told.  We wrote more than two years ago about a class action claiming that Hershey chocolates made misleading “healthy diet claims.”  Who would possibly rely on “healthy diet claims” for chocolate treats?  That class action obviously had no legs, but others have gotten by.

Attempts to extend this business model to medical devices have failed, and one reason is federal preemption. That is our takeaway from DeBons v. Globus Medical, Inc., No. 14-5645, 2016 WL 4363171 (9th Cir. Aug. 16, 2016), where the Ninth Circuit affirmed the district court’s order dismissing a putative class action involving bone putty, an allograft tissue product that the FDA regulates as a medical device. See the district court’s dismissal order, DeBons v. Globus Medical, Inc., No. 2:13-cv-08518, 2014 WL 12495351 (C.D. Cal. Aug. 8, 2014).  Taking a page from the food playbook, the plaintiff claimed that the device was “not in fact FDA approved,” which we take to mean that product was “cleared” through the 510k process rather than formally “approved.”  He alleged therefore that “had made it known that the product was not FDA approved,” he would not have paid for it. Id. at *1.  He asserted a raft of consumer fraud claims, including a claim under California’s broadly written Unfair Competition Law, and purported to represent a class of other bone putty patients. Id. Bear in mind that the plaintiff alleged no surgical complication; the device evidently worked just fine.  This was strictly a play for a price refund.

Here is where it gets interesting. The main reason why medical device class actions are so rare these days is that medical treatment unavoidably presents individualized issues, making class treatment impossible.  Another reason is Section 337(a) of the FDCA, which gives the FDA exclusive authority to enforce the Act’s provisions.  This provision impliedly preempts any private action right of action filed because a device manufacturer’s conduct allegedly violates the FDCA. See Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001).  When combined with the Medical Device Amendments’ express preemption provision, would-be plaintiffs face the “narrow gap” between implied preemption and express preemption on which we often comment (such as here). On the one hand, the MDA’s express preemption provision bars states from enforcing requirements “different from or in addition to” federal requirements.  21 U.S.C. § 360k(a).  On the other hand, private litigants cannot enforce the FDCA.  A plaintiff therefore “must be suing for conduct that violates the FDCA (or else his claim is expressly preempted . . . ), but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted under Buckman).” DeBons, 2016 WL 43463171, at *1 (quoting Perez v. Nidek Co., Ltd., 711 F.3d 1109, 1120 (9th Cir. 2013)).

Continue Reading Another Reason Why Medical Device Class Actions Don’t Work

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

We’ve been posting for a few months about the procedural and evidentiary controversies that have arisen in the Pinnacle Hip Implant MDL bellwether process. The second bellwether trial involved significant evidentiary and procedural rulings that raised eyebrows across the defense bar (discussed here and here). After that trial unsurprisingly produced a ½ billion dollar jury verdict, the defense asked the MDL Court to stay further bellwether trials so that the Fifth Circuit could review those rulings. No luck. Instead, the MDL Court ordered that the next bellwether trial should happen—and quickly (discussed here). After all that, and with the third bellwether trial approaching fast, the defense must feel like the coyote lying flat on the ground staring up at the bottom of a plummeting anvil coming at him a second time.

Undaunted, however, the defense has now filed a motion to continue the third bellwether trial, a motion that raises serious concerns about the time allotted to “work-up” the plaintiffs’ cases that will be involved in the trial. The defense argues that the allotted time is simply too short, not providing enough time for the complex medical issues underlying each plaintiff’s case to be developed and understood so that a trial can produce the type of verdicts that can advance the MDL process. To illustrate this, the defense compared the discovery and pre-trial periods that led up to the second bellwether trial (Aoki) to those leading up to this trial:

  • In Aoki, there were 11 months between case selection and trial (2/27/2015-1/11/2016); here, by contrast, there are just 3 ½ months between case selection and trial (6/10/2016-9/26/2016).
  • In Aoki, there were more than seven months between case selection and the due dates for defendants’ expert reports (2/27/2015-10/9/2015); here, by contrast, there are just 2 ½ months between case selection and the due date for defendants’ expert reports (6/10/2016-8/26/2016).
  • The Aoki schedule afforded defendants eight weeks to respond to plaintiffs’ expert reports (8/14/2015-10/9/2015); here, by contrast, defendants are being given just two weeks to analyze and respond to plaintiffs’ expert reports.

(Defense Br. at 9.)

Continue Reading The Pinnacle Hip Implant MDL Continues—with a Motion for a Continuance

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You wouldn’t be the first to notice that some of our posts say more about television programs – and certainly with more gusto – than about the law.  We could make the case that pop culture and the law are related, and that familiarity with the former can make one a better advocate when engaged in the latter.  We could even cite an article on the value of pop culture that was written by an in-house lawyer who might be the smartest person we know.  But let’s not perpetrate a fraud.  Truth be told, it’s flat-out easier to tackle tv than preemption.  Would you rather binge watch Orange is the New Black or the latest judicial jibberings on the parallel violation exception?  Especially in these lingering dog days of Summer, not much in the law seems dramatic or even mildly entertaining.  To be sure, not so long ago the Summer was also a wasteland for television.  The good stuff concluded in the Spring.  Summer was strictly for repeats.  Under the old model, after fine offerings such as Game of Thrones and The Americans wrapped up before Memorial Day, there would be nothing worth watching until the Fall season, when a couple of decent shows might temporarily distract you from the decline of the West (by which we mean the American League West, the AFC West, and the overall culture of the Enlightenment).  But things have changed when it comes to programming.  Television comes through whilst the law remains in its mid-year torpor.  Of a sudden, Summer tv offers a bounty for couch potatoes seeking an escape from the inferno.  So hang up that seersucker suit, pour out a Pimm’s, and feast your eyes on these tv treasures:

Stranger Things (Netflix) – We love the 80s.  That was when we entered law school and, more importantly, exited law school.  A decade that starts with the eruption of Mt. St. Helens and ends with the collapse of the Berlin Wall, and that introduced Seinfeld and The Simpsons in-between, is special.  Stranger Things is a love letter to the 80s.  It is a Spielbergian, Stephen King-ian mash up of horror, sci-fi, government conspiracy, and teen-agers coming of age. Stranger Things also supplies a great role for Winona Ryder, who first grabbed our eyes in Heathers (1988). You know how at the end of a Netflix episode a clock starts counting down in the corner, and you have to decide either to exit or let the next episode start?  With Stranger Things, we always let the next episode take over the screen, and let all the next episodes take over our day.  Could.  Not.  Stop.  Watching.

Mr. Robot (USA) – Maybe this bold show is undergoing something of a sophomore slump, but the episode that mimics 90s sitcoms (e.g., Full House, Family Matters) may have been the best hour of tv since Cersei burned down the town and the Khaleesi set sail with a dragon escort.  If you watch this show, you might actually have something substantive to say to the techno-geeks who patrol your office.  And they might have something to say to you besides, “Have you tried rebooting?”

The Night Of (HBO) – One always has high expectations for any show in the 9 pm Sunday night slot on HBO, and The Night Of does not disappoint. It is based on a British show called Criminal Justice.  One of the writers for the American version is Richard Price, who has penned some fine novels (Lush Life) and some of the best episodes of The Wire.  The first couple chapters of The Night Of were blisteringly suspenseful, reminding us how modern technology spies on us, but how there are still tragedies that manage to evade the cameras and our understanding.  Then the show settled into a Law & Order-type procedural, complete with the requisite interview of someone at their workplace.  (Comedian John Mulaney does a bit about a guy calmly loading crates onto a truck while answering questions about a grisly murder.  “Tony Ramirez?  Yeah, I remember him.  Worked on Tuesdays, I think.”  Keeps lifting crates.  A detective puts a picture under the witness’s nose.  The witness hardly pauses as he flings a crate into the trailer.  “No, I don’t recognize him”  Picks up another crate.)   The workplace interview in The Night Of involved a hearse driver, so the creepiness level was turned up to 11.  The most recent entry of The Night Of featured a cross-examination of a defense expert by the prosecutor.   The expert and prosecutor clearly have been locking horns for many years.  By now, they know each other’s moves.  They even seem to enjoy each other’s company.  The wry back-and-forth reminded us of some mini-battles we have had with certain plaintiff experts we have deposed repeatedly.  Of course, in our case there was no murder — except, you know, for the expert’s occasional murder of the truth.

Watch these shows and you will thank us.

What’s that?  You came to this blog to learn a little something about the law, not television?  Okay, if you insist.  But how about if we split the difference, and discuss a case about television?  To be precise, it is a case about televisions, in the plural.  In Oliver v. Funai Corp., 2015 WL 930541 (D. N.J. Dec. 21, 2015), the plaintiffs claimed that the defendants sold them defective televisions.  The defect consisted in certain allegedly faulty components.  When those components went bad, the televisions would  “stop displaying a picture and sound.”  That does, indeed, seem like a problem.  The plaintiffs alleged that the televisions in question typically failed outside of the stated one-year warranty period and ninety-day warranty period for labor, leaving consumers with little reprieve.  The legal claims included fraudulent concealment and the like.  There were two plaintiffs, one in Massachusetts and one in Arizona.  One of the plaintiffs alleged that he purchased his television in September of 2012, and that the same television failed in January 2014, after only 190 hours of usage.  At this point, and not just because we are a crotchety defense hack, we grew suspicious of that plaintiff.  Four months of tv viewing, totaling only 190 hours?  That’s just a little more than an hour and a half a day.  Who watches so little tv?    Most people would burn through 190 hours just during the NFL playoffs.  Was this person confining their viewing to PBS specials on How Turtles Do Calculus, or the Cleveland Symphony’s production of an opera based on Kafka’s Metamorphosis, “Roach!”  Surely there is an issue in this case of credibility and/or limitation of damages.

What does any of this have to do with drug or device law?  The Oliver case involves one issue we have addressed a lot recently, personal jurisdiction, and one we hardly ever see, which is whether internet postings constitute information that can be attributed to a corporate defendant.

Personal Jurisdiction

The defendants in Oliver were (1) Funai Corp., which is incorporated and has its principal place of business in New Jersey, and (2) its parent, Funai Electric, a company incorporated and headquartered in Japan.   Was there personal jurisdiction over the Japanese parent company?  As most of our readers know by now, personal jurisdiction consist of both general jurisdiction and specific jurisdiction.  With general jurisdiction, a company can be sued for anything.  With specific jurisdiction, a company can be sued only for its conduct specifically in and targeted to that particular jurisdiction.  Under the Supreme Court’s decision in Bauman, general jurisdiction extends only to companies that are essentially “at home” in that jurisdiction, and that at-home-ness applies to place of incorporation, principal place of business, and extremely rare exceptions, such as temporary relocation of a company during war time.  The Oliver court easily decided that the plaintiffs could not show general jurisdiction under the paradigmatic examples laid out in Bauman.  In support of their general jurisdiction argument, the plaintiffs chiefly relied upon the fact that Funai Electric allegedly “funnels its televisions through the State of New Jersey.”  But it is well-settled by the Supreme Court that while “[f]low of a manufacturer’s products into a forum … may bolster an affiliation germane to specific jurisdiction… ties serving to bolster the exercise of specific jurisdiction do not warrant a determination that, based on those ties, the forum has general jurisdiction over a defendant.”

Continue Reading Television, Personal Jurisdiction, and Whether Corporate Knowledge Can be Imputed from Internet Drivel

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

Everybody lies, maybe even several times a day. Often we don’t even realize it because the lies are small. They are white lies like “of course that shirt looks good on you.” What about all those times we nod while someone is talking but we really aren’t listening. Aren’t those lies too? Then there are those lies we tell ourselves, sometimes necessary to get through the day with our self-esteem intact.

But what about the biggies? The look someone in the face and make up something that is simply not true just to benefit oneself type of lie. The type of lie that is told when someone cheats or steals. Or, the type of lie that is told when a lawyer doesn’t do his or her homework but makes representations to the court as if they did. Look, nobody is perfect and there are times, especially in mass torts with lots of plaintiffs, where facts get jumbled or twisted a bit. Times when a little more digging before filing a lawsuit would have revealed different product usage or dates of ingestion. And sometimes those minor differences in facts can lead to cases being dismissed that probably shouldn’t have been brought in the first place. But complete fabrications of the core facts on which a case rests, in multiple cases – that’s going to get you sanctioned. And worse than a sanction, you’re going to lose your credibility with the court.

Losing credibility with the court isn’t something any lawyer ever wants to have happen. It also doesn’t take the extreme misrepresentations we are going to tell you about with today’s case. Promising things by certain dates and not delivering. Overstating a position and not being able to back it up. Being unprepared generally and repeatedly. All of this can lead to a court’s disfavor; to a judge doubting a lawyer’s veracity. While today’s case is very unique and the court’s distrust is directed to plaintiffs’ counsel, the most important to keep in mind is you don’t want to be in this position. Every time you address a court, in writing or in person, know your facts, know your law, and be honest.

Continue Reading A Lesson in What Losing Credibility Can Cost

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Earlier this month the FDA issued a draft guidance entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device.” It’s long, and anyone interested in reviewing the whole thing can download it from the FDA’s website here.  Our interest in this draft guidance, as product liability litigators defending FDA-regulated products, is primarily due to the Agency’s numerous statements about when changes to the design and warnings of 510(k) medical device obligates their manufacturers to resubmit their products for additional FDA clearance prior to marketing.

As we’ve already discussed in much more detail in our September, 2015 “In Case of Good Judge, Break Glass” post, if a product change requires prior FDA review and assent, then that change cannot be mandated by common law tort actions.  The Supreme Court stated in PLIVA v. Mensing, 564 U.S. 604 (2011), “The question for ‘impossibility’ [preemption] is whether the private party could independently do under federal law what state law requires of it.” Id. at 620.  The new FDA draft guidance is all about when product changes to 510(k) devices require prior submission and Agency clearance:

This guidance, when finalized, will aid manufacturers of medical devices subject to premarket notification requirements who intend to modify a 510(k)-cleared device or a preamendments device subject to 510(k) (also referred to together as “existing devices”) during the process of deciding whether the modification exceeds the regulatory threshold of 21 C.F.R. §807.81(a)(3) for submission and clearance of a new 510(k).

Draft Guidance at 3 (“Scope”) (emphasis added).

Initially, we remind everyone that this document is both a “guidance” and a “draft.” It is subject to comment and is not final.  Even when final it has no legally binding effect.  But the guidance does interpret legally binding regulations that, as we discussed in our “Break Glass” post, mandate prior FDA review and clearance of changes to 510(k) devices.  The guidance is useful in that it provides a more comprehensive explication of the regulations, and thus more useful understanding of when a requirement for prior FDA submission of a device change gives rise to implied impossibility preemption under Mensing, Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), and Wyeth v. Levine, 555 U.S. 555 (2009).

Here are the principles that we think are most important to that determination.

Continue Reading New FDA Draft Guidance Helps Define the Scope of §510(k) Medical Device Preemption

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It’s August and several your valiant bloggers are on vacation, so the skeleton crew manning the fort is even more grateful for reinforcements than usual.  Here is another guest post, this time from Reed Smith‘s Court Chillingworth.  This is about a topic we’ve covered sporadically, the Biomaterials Access Assurance Act.  As always Court is entitled to full credit (and any blame) for everything appearing hereafter.  Except for this:  Edgar Allen Poe wrote on both.  Don’t worry, you’ll understand what it means by the end of Court’s post.

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When is a medical device an implant? When is it not? While far more drab than anything Lewis Carroll would have written, it is still a multi-layered riddle, and one that should be of particular curiosity – and possibly concern – to present-day medical device lawyers. It derives from the Biomaterials Access Assurance Act (“BAAA”), 21 U.S.C. §§ 1601 et seq., a statute that shields from liability in all state and federal courts the manufacturers of biomaterial and component parts that are supplied “for use in the manufacture of an implant.” Id., § 1601(1)(A) (emphasis added); see also id. § 1601(2), 1603(b)(1), 1604(a).  A Connecticut trial judge recently explored the question in Nolen-Hoeksema v. Maquet Cardiopulmonary AG, No. 146049888S, 2016 WL 4203030 (Conn. Super. New Haven Dist. July 11, 2016), and in particular, the question of whether one of the statute’s definitions of an “implant” – a device that is intended be “in contact with bodily fluids or internal human tissue through a surgically produced opening” [21 U.S.C. § 1602(5)(A)(ii) (emphasis added)] – would apply to a medical device that is used during surgery, but is not designed to be in direct contact with the patient.

Ultimately, the court found its answer from an otherwise simplistic source:  the Webster’s Dictionary and its definitions of the word “through.” But its analysis, which involved principles of statutory interpretation and federal preemption, was complex: which one of two Webster’s Dictionary definitions of the word “through” should be applied – one advocated by the defendant, meaning “by way of” in the abstract, or one advocated by the plaintiff, meaning “penetrating.” The court chose the latter, which effectively would require direct contact between the device and the patient for the BAAA to apply to component parts of the device under 21 U.S.C. § 1602(5)(A)(ii).

Continue Reading Guest Post – Through the Dictionary, and What One Court Found There: Adventures in the BAAA

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If you represented a large corporation or a wealthy individual, wouldn’t you want to know if your prospective jurors were campaigning for Bernie Sanders on Facebook? Or how about criminal prosecutors who might want to know if members of their jury panel had posted strong feelings on police conduct?  If you were adverse to a drug or medical device company, maybe you would want to know if a prospective juror wrote for the Drug and Device Law Blog (although we can guarantee that you will find no more thoughtful and impartial jurors than the seven individuals who make up the collective “we”).

Millions of potential jurors make information like this (and much more) publicly available on the Internet through social media or otherwise, and what trial advocate would not want to uncover it? We got to thinking about this topic a few months ago when we read a unique order that came out of the Northern District of California in Oracle America, Inc. v. Google Inc., ___ F. Supp.3d ___, 2016 WL 1252794 (N.D. Cal. Mar. 25, 2016).  The district judge in Oracle v. Google asked the parties in a high-stakes copyright action to abstain voluntarily from searching the jury panel’s social media.  If the parties would not agree to a complete ban, then the court would impose specific limitations.

We’ll get to the details in a minute. But first, we set out to see if there are any rules that govern searching jurors’ social media (with research assistance from Reed Smith attorney David Chang).  It turns out there are, mainly within the rules of ethics and professional conduct.  The first rules obviously are our duties of competence and diligence.  They are among the first duties listed under the ABA’s Model Rules and probably the rules governing lawyers in most every state. See Model Rules of Professional Conduct, Rules 1.1, 1.3.  If there is publicly available information that would help us identify jurors with potential biases, a competent and diligent trial advocate needs to consider gaining access to it.

There are, however, countervailing considerations. On April 14, 2014, the ABA’s Standing Committee on Ethics and Professional Responsibility published “Formal Opinion 466, Lawyer Reviewing Jurors’ Internet Presence.”  The ABA committee’s opinion came on the heels of an opinion from the Association of the Bar of the City of New York—“Formal Opinion 2012-2, Jury Research and Social Media.”  These are not the only publications on the topic, but they were at the cutting edge, and they cover the major considerations.

Continue Reading Did You Search Your Jurors’ Social Media? There Are Rules

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This is our vacation week, so it’s time once again to play the game of “Where in the World is Stevie Mac?”　 Last year, we wanted to visit a place with nice sights, great beer, and, most of all, zero chance of terrorism.　 We chose Belgium.　 Let that sink in for a moment.　 This year should be easier.　 The animating factors in 2016 — fear of jet-lag, fear of poverty, and, yet again, fear of terrorism – conspired to keep us fear-ly close to home.　 Enjoy these hints:

  • Hello misnomer!
  • It never ratified the 18th amendment (prohibition – so, yes, this is our kind of place).
  • There is a specific law against biting off someone’s leg.　 (The legislators here have obviously gotten a little too into The Walking Dead.)
  • The first American ever jailed for driving his car too fast earned that distinction by going a rip-roaring 15 mph here in 1904.
  • Cap guns are illegal in this state.
  • You will be fined if you throw pickle juice on a public trolley.　 That rule will frustrate the DDL Son to no end.
  • Finally, our all-time favorite basketball player, Marvin Barnes, hailed from these parts.　　 Barnes (nicknamed “Bad News”) was part of a gang of high schoolers arrested for robbing a bus.　 The victim had no trouble identifying Barnes, who had been wearing a letter jacket with his name embroidered on it.　 That brush with the law did not stop Bad News (later shortened to “News”) from having a remarkable hoops career.　 Barnes began his professional career with the ABA’s St. Louis Spirits.　 Once upon a time, his team was scheduled to fly home from Louisville at 8 o’clock.　 Because of the East-to-Central time zone change, the flight was scheduled to arrive in St. Louis at 7:56.　 Barnes refused to board the flight.　 In his immortal words, “I ain’t getting on no time machine.”　 Instead, he rented a car and drove home.　 Sadly, Barnes died way too young (62) a couple of years ago.　 Let’s pour out a little White Ship Lovecraft IPA in his honor this week.

Continue Reading DDL Summer Vacation: Another Sequel

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Here’s another guest post, this time from Reed Smith‘s Elizabeth Graham Minerd.  This post concerns PMA preemption, and a second opinion largely getting rid of a case that we blogged about before.  As always, Elizabeth deserves all the credit, and any blame, for what follows.  Without further ado:

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In the recent decision of Marion v. Smith & Nephew, Inc., 2016 WL 4098608 (D. Utah July 27, 2016), the Court dismissed all but one of the plaintiffs’ claims relating to a premarket approved medical device from the amended complaint.  This was the Court’s second time finding the plaintiffs’ pleading largely deficient.  This blog previously discussed the Court’s first order dismissing plaintiffs’ original complaint with leave to amend here.  In that order, the Court provided the plaintiffs with a road map to navigating the “Scylla and Charybdis” of pleading a legally viable claim related to a premarket approved device.  But even with a road map, the plaintiffs were only able to navigate one of their nine claims through Scylla and Charybdis and that one claim did not escape unscathed.

In Marion, the plaintiff was implanted with the defendant’s hip resurfacing device—a device that received premarket approval a little over a year prior to the plaintiff’s surgery.  2016 WL 4098608, at *1.  After six years, the device allegedly failed and the plaintiff had it surgically removed. Id. The plaintiffs filed a lawsuit asserting various claims against the defendant for the device’s purported failure. Id.

The Court dismissed the plaintiffs’ original complaint, but granted the plaintiffs leave to amend. Id. In doing so, the Court provided “clear guidance” regarding the three issues that the plaintiffs would need to address in the amended complaint in order to state a parallel claim that would survive both preemption and Twombly/Iqbal [editorial note: regular bloggers call this “TwIqbal“]:

First the court required the [plaintiffs] to identify with specificity the federal law requirements that parallel the state law claims. Second, the court required the [plaintiffs] to identify with specificity the state law duties that existed prior to but allegedly parallel the requirements for the [device] under federal law.  Finally, the [plaintiffs] were required to plead adequate facts to make their parallel state law claims plausible on their face.

Id. at *3.

Continue Reading Guest Post − Marion − Even with a Road Map, Only One Dubious Claim Navigates Preemption

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

Looking back at our posts on innovator liability, it’s becoming more and more difficult to title them. According to the DDL blog, innovator liability has been rejected, abolished, denied, refused, disallowed. You get the idea. With the news from earlier this summer that the California Supreme Court is going to consider the issue – which will hopefully spell the demise of Conte – we may be nearing the end of the chapter on innovator liability. In the meantime, we’ll keep bringing you the wins as they stack up.

Today’s case was actually decided right around the time the California Supreme Court decided to take on the issue. Gillette v. Boehringer Ingelheim Pharm., Inc., 2016 WL 4217758 (Mag. D. Minn. Jun. 16, 2016). The decision didn’t come to our attention, however, until the magistrate’s report and recommendation was adopted last week. See 2016 WL 4203422 (D. Minn. Aug. 9, 2016).

The Gillette decision comes out of the Mirapex MDL and involves the application of Indiana law. Indiana products liability claims are governed by the Indiana Products Liability Act (“IPLA”) which provides a single cause of action subsuming all common law strict liability and negligence claims, as well as tort based warranty claims. Gillette, 2016 WL 4217758 at *3-4, *6. So, plaintiff in this case had one cause of action based on her allegations that her use of Mirapex caused her to gamble compulsively.

But was it Mirapex that plaintiff was taking at the time she suffered her injuries? According to her pharmacy records, plaintiff was prescribed Mirapex from 2001 until 2015. Id. at *1-2. It appears that from 2001 until April 2010, plaintiff’s pharmacy filled her prescriptions with brand name Mirapex. In April 2010, when her prescribing physician increased plaintiff’s dosage, her pharmacy began filling her Mirapex prescriptions with its generic equivalent – pramipexole dihydrochloride. Id. at *1. From April 2010 until late 2015, plaintiff received the generic version of the drug manufactured by a succession of four different generic drug manufacturers. Id. at *1-2.

Continue Reading Brand Defendants Thwart Another Innovator Liability Claim

Drug & Device Resources

Bexis’ Book

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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