In these dog days of summer, few things bring as much joy and relief as ice cream. What does ice cream have to do with drugs or medical devices? Not much, we suppose. Sure, ice cream can affect the brain and the body. Our neurons vibrate with pleasure as they travel along a rocky road
Puffery about Regulatory Compliance is Not a Material Misstatement
Some Case-by-Case Comment K Mixed with Some Insufficient Pleading of Fraud
In Hawaii, from whence today’s case comes, tourists are encouraged to try poi, mashed up taro root, which looks like purple wallpaper paste and tastes like, well, purple wallpaper paste. The term is also used as a friendly descriptor of ethnically ambiguous looking people, whose roots have been mashed together to form something not readily identifiable by traditional visual stereotypes. (At least it seemed friendly when we heard it applied to our own offspring.) Personally, we think it is a nice concept and the less that categorizing people to determine their rights, opportunities, and expectations happens, the better. For a number of aspects of product liability law, however, the decision on whether to proceed categorically or case-by-case is still hotly contested. This is particularly true for comment k to the Restatement (Second) of Torts, § 402A, which forms the meat of the decision in Segovia v. Bristol-Myers Squibb Co., CV. No. 15-00519 DKW-RLP, 2016 U.S. Dist. LEXIS 52405 (D. Haw. Apr. 19, 2016).
Segovia involves a fatal hemorrhagic stroke with an anticoagulant prescribed and used for atrial fibrillation. We are not sure what was different from the first complaint, but the second try made vague allegations about misrepresentations to FDA and others that it was “tested and found to be safe and effective for its indicated uses” and that FDA and others had not been told of the drug’s “defects” in support of allegations of strict liability and negligent failure to warn and design defect theories. While it seems like this complaint asserted claims based on non-existent duties and clearly preempted claims, the only issues addressed by the court on the motion to dismiss were whether Hawaii law took comment k to preclude design defect claims for all prescription drugs categorically and whether any fraud-based claims had been pleaded with sufficient particularity.
As to the first question, the court did not look to our relatively recent discussions on this issue, but generally looked to older cases to find the public policy rationale for taking a case-by-case approach for prescription drugs—which was essentially determinative on a motion to dismiss. But we are getting ahead of ourselves. The first step was determining what Hawaii case law already said about comment k and only two cases were discussed. Larsen v. Pacesetter Sys., Inc., 837 P.2d 1273, 1286 (Haw. 1992), involved a pacemaker—not a drug—and concluded that summary judgment based on comment k was inappropriate where there was evidence that the “pacemaker was demonstrably capable of being made safe for its intended use.” Forsyth v. Eli Lilly & Co., 1998 WL 35152135, **3-4 (D. Haw. Jan. 5, 1998), involved a prescription drug, but did not decide the issue of categorical or case-by-case because a genuine issue as to the adequacy of warnings was sufficient to preclude summary judgment. Rather than view these cases are leaving the issue open, the Segovia court found “neither Larsen nor Forsythe create a blanket rule of design defect immunity for pharmaceutical manufacturers, and the Court declines to extend comment k in a fashion that the Hawaii courts themselves have thus far declined to do.” 2016 U.S. Dist. LEXIS 52405, *11. We think this misconstrues comment k, which does not provide “immunity,” and what it means to conclude that all prescription drugs are “unavoidably unsafe.”…
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New Jersey Federal Baked Goods Fraud Class Actions Are Toast
Almost on this date in 1901 (tomorrow actually), Teddy Roosevelt for the first time uttered in public the immortal phrase, “Speak softly and carry a big stick”. It is hard to find people who do not admire that statement. It is harder to find people who actually practice it. These days we are accustomed to wimpy parents and blowhard politicians who talk tough but do nothing. As a result, you get teenagers gobbling up the cheese-of-the-month delivery and Russia gobbling up Crimea. We also encounter some soft-hearted and -headed judges who speak loudly and wield no stick – at least when it comes to clamping down on bogus lawsuits. Corporate defendants hauled/haled/but-definitely-not-hailed into court are held to ludicrously high standards, while plaintiffs dwell in a world of do-overs and feckless flexibility.
A couple of weeks ago we discussed CD Cal Judge Wilson, who is as demanding as he is smart. One could say (and we have said) the same about Judges Posner, Boggs, Kozinski, and Rakoff. One could also say that about D NJ Judge Irenas who sits in the Camden federal courthouse, which we can see out our window if we crane our heads just so. If you read the Robing Room evaluations of Judge Irenas (which you must necessarily take with a grain of salt, since they are peppered with the comments of sore losers) a picture emerges of intelligence and rigor.
We can be an oath-helper on that fact. After our first year of law school, we summered at McCarter & English in Newark, NJ. Irenas was a partner there, and was universally acknowledged to be the smartest lawyer in the building. In our second or third week as a summer associate, we received an assignment from Irenas. The other summer associates cackled with glee. That is because in addition to having a reputation for being smart, Irenas had a reputation for not suffering fools gladly. And all of the summer associates were fools. An Irenas assignment was an opportunity, but a frightening one.
The assignment involved the inevitable research memo. After we turned it in to him and were grilled to a nice medium-well, we got on a conference call. At one point, the party on the phone voiced some trepidation and reservations, whereupon Irenas thundered a withering critique of said reservations. Loud dysphemisms filled the air. He must have seen us shaking with terror, because he smiled and gestured to show us that his finger, which was resting on the microphone (back then speakerphones were separate from the actual telephone, and were connected by a wire) was also pushing down on something we did not know existed – a mute button. He then released the button and rendered a much more temperate, but still piercing, dissection of the reservations. What he said was about a hundred times more insightful and felicitously expressed than our pathetic research memo. Lesson learned.…
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Almost, but Not Quite: No Summary Judgment for Mentor on Two of Plaintiff’s ObTape Claims
We flew to Pittsburgh this week for depositions. From Philadelphia, it takes only about 40 minutes in the air to get to Pittsburgh. But there are only a few nonstops each day. With no other options, we booked a nonstop flight scheduled for a 7:55 a.m. departure, coordinated plans with colleagues, clients and witnesses, and went to sleep with our overnight bag packed and waiting at the door. All in order, right? Until our phone rang at 3:30 a.m. bearing the robotic message, “Your flight has been canceled.” No explanation. We called back to find that we had been “protected” – re-booked – on the next available flight, a couple of hours later. So far, so good. (Well, not really, but as good as it gets at that point.) But then we discovered that our colleague, scheduled to fly with us, was not “protected” on our flight, but had been bumped to a much later flight so he could continue to take advantage of the first class upgrade he had not requested in the first place. Good times. The next day, our flight for home departed right on schedule. We landed in Philadelphia, taxied to the gate, stood up, and remained standing in the aisle for the next 30 minutes, informed that the jetway would not move to the door of the plane and “a mechanic has been called.” Twice in one trip, the airline stopped just short of getting it right.
Recently, defendant Mentor Corp, moving for partial summary judgment in the Mentor ObTape Transobturator Sling Products MDL, similarly found itself at the mercy of a Court that laid the groundwork for a correct decision then stopped just short of getting it right. Twice.
Plaintiff had been implanted with an ObTape transobturator sling in 2004 to address her stress urinary incontinence. It was apparently undisputed that plaintiff “did not speak with anyone from Mentor or see any brochures, videos, product inserts, or other materials from Mentor before the procedure.” In re Mentor Corp. Obtape Transobturator Sling Prods. Liab. Litig., 2015 U.S. Dist. LEXIS 93001 at *5 (M.D. Ga. July 17, 2015). Plaintiff was happy with her implant until 2010, when she “began experiencing pain in her thighs.” Id. Initially, plaintiff was diagnosed with a groin strain; however, after several months of worsening symptoms, she was diagnosed with an abscess caused by erosion of the ObTape. She underwent excision surgery during which as much of the ObTape as possible was removed. Id. at *6-7.…
Continue Reading Almost, but Not Quite: No Summary Judgment for Mentor on Two of Plaintiff’s ObTape Claims
Off-label Promotion, Securities Law Style
This week, we are attending the 139th annual Westminster Kennel Club dog show. We are Standard Poodle aficionados. Before the current passel of Drug and Device Rescue Dogs – mixed breeds – we always had a Standard Poodle or two. Though Standard Poodles were developed as hunting dogs in Germany – water retrievers — the Standard Poodle class at a dog show displays these tough, athletic creatures in extreme haircuts (we won’t waste blog space on the utilitarian origins of these haircuts) as they prance – “gait” – around a ring. Our all-time favorite movie, “Best in Show,” portrays this accurately. While we adore Westminster, it is startling for the uninitiated, some of whom recoil at the spectacle of these beautiful animals out of their natural context and in unfamiliar trappings. And that sets the stage for our weak transition to today’s case. It is a case about off-label promotion, but not in its familiar context. Rather, this interesting and sensible decision out of the (not always hospitable) First Circuit rejects plaintiffs’ attempt to dress off-label promotion in the trappings of a 10(b)(5) violation.
In Fire and Police Pension Association of Colorado v. Abiomed, No. 14-1502, 2015 U.S. App. LEXIS 1944 (1st Cir., Feb. 6, 2015) the First Circuit considered the appeal of the district court’s dismissal of a complaint alleging that defendant Abiomed and two of its officers had committed securities fraud when they told investors that the company’s policy was “to avoid off-label marketing” of its Impella 2.5 micro heart pump, when they were in fact “orchestrating and engaged in widespread off-label marketing promotion.” Fire and Police Pension Association, 2015 U.S. App. LEXIS 1944 at *2 (citation omitted). The complaint further alleged that defendants told investors that the company was cooperating with the FDA’s investigation into its marketing practices and working “to resolve a few discrete issues,” while it was actually “trivializing the concerns” and “continuing to off-label market.” Id. (citation omitted). The district court held that plaintiffs had not pleaded facts “giving rise to a cogent and compelling inference of scienter,” as required under the Private Securities Litigation Reform Act of 1995 (“PSLRA”). Id. at *2-3.…
Celebrating the Highs and Lows
It is the time of year for reflection and resolutions. We look back on the ups and downs of the year that is about to end and look forward to the New Year with hope, promises and predictions. As for 2015 here at the DDL Blog – we hope we will continue to be helpful and informative to our readers, we promise that Bexis will find at least one decision a quarter worthy of a full-blown tirade, and we predict that McConnell will keep us up-to-date on both legal trends and what’s hot on TV and at the movies.
As for 2014, Bexis is posting his annual Best Of and Worst Of lists. Keeping with that theme, we decided to post about a case that has some of both, the good and the bad. The case is Brown v. Johnson & Johnson, 2014 U.S. Dist. LEXIS 173800 (E.D. Pa. Dec. 9, 2014) and it involves the over-the-counter drug Children’s Motrin. Wanting to end on a high note, we’ll dispense with the low points of the decision first.
First up, the preemption rulings. The court held that plaintiff’s failure to warn claim was not preempted because the defendant had not shown that it could not have used the CBE process to change the warning label. Establishing warning preemption in a drug case is an “exacting burden” for defendants requiring clear and convincing evidence that the FDA would have rejected the warning proposed by plaintiff. Id. at *2-3. The court applied the same “exacting burden” to defendant’s design-related preemption defense, finding a lack of evidence that the FDA would have rejected a proposed design change as well. Id. at *6.…
Closing Time for the New Jersey Alcotest Product Liability Case
What is that sad, semi-clever thing bartenders have been known to say at closing time? “You don’t have to go home, but you can’t stay here.” Our days of being around at closing time are in the rear view mirror, growing tinier by the second. We are unlikely ever again to reenact that greatest of all Sinatra songs, “One for My Baby” (“It’s quarter to three/there’s no one in the place except you and me”). Odds are that at 2 am on any Saturday night, we will be deep asleep, enduring another of those dreams where we showed up late for our Contracts exam, naked and afraid.
This will be the third, and almost certainly last, post we do on the Johnson v. Draeger Safety Diagnostics, Inc. litigation, where a purported class challenged the accuracy of the Alcotest machine used in New Jersey to measure blood alcohol content for driving-while-intoxicated (DWI) arrests and prosecutions. In our first post, Three Dumb Legal Theories Walk Into a Bar, we reported how a New Jersey federal court rejected a claim brought by a pair of plaintiffs whose claim was basically that a defective Alcotest machine forced them to plead guilty to DWI. We thought the theory was wobbly, but let’s remind you of the background. The plaintiffs had been arrested for suspected drunk driving. Both submitted to breath tests administered using the Alcotest device, which reported, for each, a blood alcohol concentration (BAC) above .08%. Alcotest readings are admissible in DWI prosecutions as evidence of a per se violation of the DWI statute. The plaintiffs each pleaded guilty to DWI. They did not challenge the Alcotest readings at that time, and the reason for that (we surmise), requires even more background. During the roll-out of the Alcotest, twenty individuals charged with DWI challenged the admissibility of their Alcotest results, and their cases were consolidated for consideration of the evidentiary challenge. The case was called Chun. During the Chun case, a Vice-President of the company that manufactured the Alcotest testified that he was “100 percent convinced” that the device was capable of producing accurate readings; that he “strongly believed” that the device was scientifically reliable; and that no maintenance was needed other than verifying proper operation at the time when the unit is calibrated. In 2008, the Supreme Court of New Jersey concluded in the Chun case that the Alcotest was scientifically reliable and that its results would be admissible and could be used to prove a per se violation of the DWI statute.…
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A Collection of Ethicon Mesh Rulings
This post is from the non-Reed Smith side of the blog.
We’ve reported on multiple sets of in limine and summary judgment rulings coming out of the Pelvic Mesh MDLs (see here, here, here and here for example). And there is a new batch just in. Like the other rulings coming out of this litigation, they are a mixed bag. As is our usual procedure, we are going to primarily focus on the positive and we’ll skip over a lot of the redundant and more mundane rulings. It should make for a short, but hopefully informative post.
All of the rulings were entered in Bellew v. Ethicon, Inc., No. 2:13-cv-22473 (S.D. W. Va.), a bellwether case in the Ethicon Pelvic Mesh MDL. We’ll start with the in limine rulings which can be found at Bellew, 2014 U.S. Dist. LEXIS 165709. Many of the motions were standard – by defendant to exclude evidence of other allegedly bad acts (denied without prejudice); by plaintiff to exclude evidence of other allegedly good acts (denied in part (granted only as to things defendant agreed they would not introduce at trial)); by defendant to exclude that it no longer sells the product at issue (granted); by plaintiff to exclude evidence of 510k clearance (granted).
There was one motion in limine, however, that caught our attention as one we see more commonly brought by defendants. Although, this issue can cut both ways, so we aren’t going to offer much commentary here. Plaintiff moved to exclude “opinion testimony from treating physicians.” Id. at *24. The reason this is more often a defense motion is the unlevel playing field we’ve railed against for years. Plaintiffs have unfettered, ex parte access to the treaters. So, they often use that time to show the doctor things like medical literature the doctor had never read, corporate documents the doctor would never have otherwise seen, or information that post-dates the doctor’s treatment of the plaintiff. All of this is done in an attempt to secure opinion testimony on causation. Now, if the treater is retained by plaintiff as an expert and prepares an expert report, his opinions, like those of any other properly disclosed expert, are scrutinized under Daubert. The problem comes when plaintiff tries to proffer the causation opinion without the expert report.…
Negligence Per Se and Fraud Claims Dismissed in Risperdal Litigation
The Middle District of Florida in Gallant v. Ortho-McNeil-Jannsen Pharmaceuticals, Inc., 2014 U.S. Dist. LEXIS 131769 (M.D. Fla. Sept. 29, 2014), recently addressed a plaintiff’s negligence per se and fraud claims in the Risperdal litigation. It dismissed the negligence per se claim, a claim that is a bit unusual for a drug case. While…