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In Witt v. Stryker Corp., 2016 WL 1583816 (11th Cir. Apr. 20, 2016), a Daubert decision in a Stryker knee replacement case, even ipse dixit seemed a bit generous. Roughly translated, ipse dixit means “he himself said it.” But it’s not clear that the expert in Witt said “it.” His report didn’t seem to venture an opinion at all, no less one that came from applying a scientific process to true and accurate data. It offered a feeling, seemingly a timid one hoping not to be noticed: “I feel that the mechanical failure of the EIUS [the knee replacement system] Stryker components was the competent producing cause for the need for surgery on 04/17/2009 and for a revision arthroplasty to a total knee replacement.” Id. at *5 (emphasis added). In case you thought this was just careless terminology, he did it again: “I feel that the mechanical failure of the EIUS System installed on 04/18/2008 was a competent cause for the need for subsequent surgeries on 03/30/2011 and on 01/17/2012.” Id. (emphasis added).

We haven’t studied the case law on feelings. But we are confident that, if it exists, it won’t be favorable to this expert.

Things grew more timid from there. At has deposition, it wasn’t even clear what the expert was feeling:

Indeed, he explicitly disclaimed having any expert opinion about why the EIUS design was defective. Besides broadly referencing the likelihood that the device suffered some mechanical failure, Dr. Lubliner offered no explanation for why the defect was one of design and not of manufacture.

Id. (emphasis added). Oof.

Continue Reading Not Hooked on a Feeling, the Eleventh Circuit Upholds Exclusion of Expert

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Can you get sued over a picture of a banana? It seems the answer might depend on where you live and probably not in Oregon. That is one takeaway from a good preemption case that came out of the District of Oregon last week, Henry v. Gerber Products Co., No. 3:15-cv-02201, 2016 U.S. Dist. LEXIS (D. Or. Apr. 18, 2016). In Henry, a concerned mother sued because the baby “Puffs” she purchased depicted a banana on the label, but contained only “natural banana flavor.” Not actual bananas. Never mind that label stated the product’s ingredients truthfully and clearly in black and white. Never mind that if a parent wants his or her toddler to snack on bananas, he or she could purchase, you know, bananas. For whatever reason, this parent preferred banana puffs, with bright yellow bananas on the label. And it resulted in a federal lawsuit.

How did we get here? Like most every other state, Oregon has an Unfair Trade Practices Act that prohibits product sellers from representing that their products have “particular characteristics, ingredients, benefits, or qualities that they do not have.” See Or. Rev. Stat. § 646.608(1)(e). A right and just law when applied properly, to be sure.

It becomes interesting, however, when talking about food because federal law is extraordinarily specific in regulating food labels. Surely you read our guest post on the FDA’s regulation of non-functional slack-fill (whatever that is) and its impact on product packaging. Or our post on food “standards of identity” which dictate what food sellers can and cannot call their products. You probably also knew that a food label’s Nutrition Facts have to appear in a certain place on the package, unless the package has less than 40 square inches of surface area, except when the packaging includes a cellophane window, which does not count as available surface area, unless the window is itself used as a label (such as with a sticker), in which case the window does count as available surface area, and provided that the manufacturer has not applied for special allowance to affix something to the packaging that might obscure the Facts, such as a straw. See 21 C.F.R. § 101.9. You get the idea—the FDA has put a lot of thought into the uniform regulation of food labels.

Continue Reading Preemption: Oregon Has Not Gone Bananas

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We talk a lot about PMA preemption on this blog. And why shouldn’t we. It’s probably been the most consistent source of defense wins in the last five plus years. The body of preemption law that has grown out of Riegel v. Medtronic, Inc. is something we’ve watched with admiration. Likewise, we’ve watched plaintiffs’ counsel try to thwart, dodge, and squeeze by or around PMA preemption for just as long. Plaintiffs have met with occasional limited success, which while not our favorite topic, doesn’t usually give us significant pause because even if a claim or two sneaks by – preemption usually guts most of plaintiffs’ causes of action. But then every so often, we get the complete win. Total victory, dismissal with prejudice. And as routine as a PMA preemption win might be – the complete win is still something blog-worthy.

That brings us to today’s case – Yosowitz v. Covidien, Civil Action No. H-15-2902 (S.D. Tex. Apr. 25, 2016). Plaintiff underwent a surgical procedure to repair intracranial aneurysms during which defendant’s embolization device was implanted. Plaintiff alleges that a defect in the device caused her to suffer a blocked blood vessel which led to mini-strokes and resultant injuries. Yosowitz, slip op. at 1-2. The device was a Class III, Pre-Market Approved device. So, the court’s first stop in its decision was a fairly thorough of PMA preemption law. Id. at 7-13. Following that discussion, you’ll see this section heading: Plaintiffs’ Claims are All Preempted or Fail to Properly Allege a Claim which was followed by Plaintiffs Have Not Pleaded Any Parallel Claim. Id. at 13. Pretty much guaranteed we were going to like the rest of the opinion.

Applying all that preemption law to the claims in Yosowitz, the court started with the state law claims for negligence, strict liability, breach of express warranty and breach of implied warranty. Since all four impose requirements on medical devices, they must not be different from or in addition to the requirements imposed by the FDCA. Id. at 16-17. To establish that, plaintiff’s allegations must identify the “specific PMA requirements that have been violated.” Id. at 14. “[S]cattered allegations of federal law violations” do not suffice. Id. at 13.

Continue Reading Complete PMA Preemption Win in Texas

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The plaintiff in Frere v. Medtronic, Inc., 2016 WL 1533524 (C.D. Cal. April 6, 2014), was an 80 year-old woman who had an infusion pump implanted to treat her chronic low-back pain. According to the plaintiff, the device never delivered the pain relief she had experienced during her pre-implantation pump trial, and she ultimately suffered complications. The device is a Class III medical device, requiring FDA premarket approval. Product liability litigation involving Class III devices does not get very far without bumping into federal preemption issues. Frere is no exception.

The problem with the plaintiff’s complaint was that it was either unclear or clearly preempted. The strict liability claims failed because they consisted of conclusory allegations that the purported defects or failure to warn caused her injuries. For example, in the manufacturing defect claim, the plaintiff alleged: (1) that “the catheters at issue were occluded, fractured, obstructed, and/or malfunctioning, which caused Plaintiff to suffer severe injuries and which required multiple surgeries and medical procedures to correct these defects”; and, (2) “as a direct result of the defects, Plaintiff suffered crippling injuries which left Plaintiff with permanent and significant disabilities compensable under the law.” There is no there there. Similarly, in connection with her failure to warn claim, the plaintiff alleged that “[a] foreseeable, direct and proximate result of [Defendants’] failure to warn Plaintiff, Plaintiff’s medical providers, and the FDA . . . about the defective condition of the [Device], Plaintiff suffered crippling injuries that left Plaintiff with permanent and significant disabilities.” The court refused to accept those mere “labels and conclusions.” The complaint was bereft of any facts as to how the alleged manufacturing defect and failure to warn caused her injuries. All we get is the conclusion of causation itself.

Continue Reading C.D. Cal. Dismisses Infusion Pump Complaint

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For years we’ve advocated about ediscovery for defendants – consisting mostly of material gathered from a plaintiff’s social media postings. OK, so let’s assume some degree of success. Defense-side ediscovery has generated some good stuff, and come trial, we want to get it admitted into evidence. Now what?

That’s the subject of today’s rather short post. Since we’re hardly the source of all useful information, we’d like to pass along a handy 4-page checklist for the admissibility of electronic evidence. It covers evidence in the form of: e-mail, internet website posts; text messages/tweets; computer stored information; animations and simulations; and digital photos. It has the following headings:

  1. Preliminary Rulings on Admissibility
  2. Is the Evidence Relevant?
  3. If Relevant, Is It Authentic?
  4. Is Evidence Hearsay?
  5. Original Writing Rule
  6. Practice Tips

It’s what it purports to be – a checklist – it doesn’t provide case law, but it’s the kind of thing that lends itself to use in trial, rather than pretrial, situations.

This nifty guide was prepared jointly by Hon. Paul W. Grimm and Kevin F. Brady of Redgrave LLP, so give credit where credit is due. We’ve been in touch with both of them, and they have graciously allowed us to disseminate their work.

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As we’ve discussed previously, and as the legal profession is by now well aware, the discovery provisions of the Federal Rules of Civil Procedure were significantly amended effective December 1, 2015. One of the foundational changes was to Rule 26(b)(1), and was intended to reduce the scope of discovery generally. The old excuse for ridiculous over-discovery – “reasonably calculated to lead to the discovery of admissible evidence” – is no more. The new, more restrictive, language defining the scope of discovery is “any nonprivileged matter that is relevant to any party’s claim or defense and proportional to the needs of the case.” Fed. R. Civ. P. 26(b)(1). As the committee notes to this amendment explain, the old language was frequently misunderstood to permit discovery into material that was itself irrelevant to litigation:

The former provision for discovery of relevant but inadmissible information that appears “reasonably calculated to lead to the discovery of admissible evidence” is also deleted. The phrase has been used by some, incorrectly, to define the scope of discovery. As the Committee Note to the 2000 amendments observed, use of the “reasonably calculated” phrase to define the scope of discovery “might swallow any other limitation on the scope of discovery.” The 2000 amendments sought to prevent such misuse by adding the word “Relevant” at the beginning of the sentence, making clear that “‘relevant’ means within the scope of discovery as defined in this subdivision …” The “reasonably calculated” phrase has continued to create problems, however, and is removed by these amendments. It is replaced by the direct statement that “Information within this scope of discovery need not be admissible in evidence to be discoverable.”

Committee Note to Rule 26, 2015 US Order 0017 (April 29, 2015).

That’s all well and good, but since amended Rule 26 became effective, it has become evident that some courts continue to do the same thing they’ve always done, giving lip service to the new rule, but effectively applying the old standard. One recent example is Hodges v. Pfizer, Inc., 2016 WL 1222229 (D. Minn. March 28, 2016) – yet another Stevens-Johnsons Syndrome case, this time against Advil − in which the plaintiff sought, and obtained, excessive discovery concerning: (1) dealings with foreign regulators (“seven countries and three areas,” id. at *3) who do not follow the same standards as the FDA; (2) “financial documents” concerning Advil, including “profits (gross and net) . . . sales forecasts, advertising budgets, business plans, marketing plans, and financial plans” for a ten-year period, id. at *4; and (3) old “sales and marketing documents . . . from before June 2005, when the FDA required manufacturers to include new warnings about” this condition. Id. at *4. While the opinion doesn’t mention the date of injury, we thought it might be 2010 (five years after the label change) and since we have a PACER account and know how to use it, we were able to confirm that date as correct.

Continue Reading Discovery − Oppenheimer’s Half Life Has Long Been Exceeded

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According to Black’s Law Dictionary, “a fortiori” is legal Latin meaning:

By even greater force of logic; even more so it follows .

We’ve been arguing for some time – since PLIVA v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), were first decided that − because they apply implied impossibility preemption − the principles that these cases enunciate are equally applicable to non-generic drug products, such as branded drugs and §510k-cleared medical devices. Some cases have agreed with us. You can find those (at least as to innovator drugs) on our post-Levine drug preemption cheat sheet.

The contrary cases, and there are a number of them, largely refuse to evaluate implied preemption on its merits. Instead, they state that innovator drugs/§510k medical devices are “not generic drugs” and leave it at that. E.g., Shipley v. Forest Laboratories, Inc., 2015 WL 4199739, at *9 (D. Utah July 13, 2015); In re DePuy Orthopaedics, Inc. Pinnacle Hip Implant Products Liability Litigation, 2014 WL 3557392, at *10-11 (N.D. Tex. July 18, 2014);, 2014 WL 60298, at *8 (W.D. La. Jan. 7, 2014). Occasionally a court gets into more detail, and the result is really hard to follow. For example, Mullins v. Ethicon, Inc., ___ F. Supp.3d ___, 2015 WL 7761033 (S.D.W. Va. Dec. 2, 2015), gets off on the wrong track by holding the express preemption analysis in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), “directly applicable” to implied impossibility preemption. Mullins, 2015 WL 7761033, at *5. Cf. Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 352 (2001) (“neither an express pre-emption provision nor a saving clause bars the ordinary working of conflict pre-emption principles”) (citation and quotation marks omitted). Then Mullins invoked the “uniqueness” of generic drugs to reject preemption of design claims even though it was undisputed that the FDA would have to approve a supplement before the design change could be implemented:

The impossibility in Mensing arose from the unique “duty of sameness” imposed on generic drugs, which has no corollary in the medical device context. . . . The Supreme Court has cited Mensing in two subsequent majority opinions, but has nowhere referred to “special permission and assistance” in a preemption analysis. . . . In Mensing, there was no official regulatory process by which a generic could change its label, so the generic manufacturer was “barred” from taking the action state law required. This is completely different from the defendants’ situation . . . [where] [t]he law simply requires that manufacturers making a “significant change” submit another 510(k) notification, which the FDA will clear if making a “significant change” submit another 510(k) notification, which the FDA will clear if it determines the device is substantially equivalent to a device already on the market.

Mullins, 2015 WL 7761033, at *5-6 (citations omitted).

Continue Reading Innovator Drug/510k Medical Device Impossibility Preemption and the Meaning of “A Fortiori”

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We aren’t going to mince words today. We don’t like Christiansen v. Wright Medical Technology Inc., MDL 2329, 2016 U.S. Dist. LEXIS 46409 (N.D. Ga. Apr. 5, 2016). It is an opinion on post-trial motions in a case that went to trial in the Conserve Hip Implant Products Liability Litigation. It’s a beautiful spring day here in the Mid-Atlantic and we hope that’s true where you are. If it is, and if anything in this post makes you interested in the greater details and nuances of the decision, we recommend taking it outside, sitting under a tree, and enjoying some fresh air. You should at least have pleasant surroundings while you try to get through it. It’s long, and tedious, and frankly, muddled. So, we are going to try to focus in on the key parts – so that we might also try to get out and enjoy some of this fine weather.

Christiansen is a hip implant case. It went to trial on 5 theories of liability: strict liability design defect, negligent design defect, fraudulent misrepresentation, fraudulent concealment, and negligent misrepresentation. Id. at *2-3. Apparently the court had dismissed plaintiff’s failure to warn claim on summary judgment. Id. at *69 n.18. The jury ultimately returned a verdict finding the hip implant was defectively designed and caused plaintiff’s injuries and awarded $550,000 in compensatory damages. The jury also found in favor of the defendant on the fraudulent misrepresentation and concealment claims, but awarded another $450,000 to plaintiff on his negligent misrepresentation claim and $10 million in punitives. Id. at *18.

But that wasn’t the jury’s first verdict. It’s first verdict, delivered days earlier, answered the first question on the Verdict Form – do you find the hip implant was defectively designed – in the negative. Id. at *6. While that should have been the end of the inquiry, the jury didn’t understand the instruction to not go any further and they kept answering the verdict form. So, they went on to find that defendant had made negligent misrepresentations and awarded plaintiff $662,500 in compensatory damages and $2.5 million in punitives. Id. at *7.

Continue Reading Georgia MDL Court Muddles Utah Law

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In third party payor litigation over prescription medical products, we have often marveled at the causation arguments that plaintiffs have offered and the willingness of some courts to accept collective proof over what really should involve individualized proof. Like here, here and here. (This same dynamic plays out when governmental entities seek reimbursement for such products too.) Usually, though, the plaintiffs allege that the manufacturer’s fraud—under whatever particular statutes or headings it is pursued—was unknown to them during the time for which they seek damages for amounts paid for the product and that the damages stopped once they found out. In Teamsters Local 237 Welfare Fund v. Astrazeneca Pharms. LP, No. 415, 2015, 2016 Del. LEXIS 236 (Del. Apr. 12, 2016), the plaintiff payors were undone by their concession that they knew about the alleged fraud and kept paying for the drug at issue anyway. Based on its self-described common sense analysis, the Delaware Supreme Court affirmed the dismissal for lack of causation without weighing in on the Superior Court’s rejection of causation where individual physicians made individual decisions about what to prescribe. This is a good result, but we are concerned about the implications for the practices of payors who seem increasingly interested in signing up with contingency fee lawyers to sue medical product manufacturers. (In case you were wondering, that was a teaser, designed to get you to read all the way to the end of the post.)

The basic facts are that the plaintiff filed a purported nationwide class action on behalf of third-party payors in Delaware state court in 2004, alleging that the defendant violated state consumer fraud laws by falsely marketing Nexium as being more effective than Prilosec, an older product with allegedly one-half of the same active ingredient per dose. Adding some facts omitted in the opinion, the initial NDA for Prilosec had been approved in 1989 (under the name Losec) and lost exclusivity in 2001, around which time FDA approved the NDA for Nexium, which had an enantiomer (here, the left hand chiral image) of the Prilosec’s active ingredient as its active ingredient. The indications for both drugs were expanded through the years, with Prilosec going over-the-counter in 2015. These drugs together accounted for a large chunk of the prescriptions written for heartburn, gastroesophageal reflux disease, and related complaints. Plaintiffs claimed that the development of Nexium and the marketing campaign after its introduction were designed to get the defendant paid a high price for its newer branded product instead of money going to pay for cheaper generic versions of the older product. They claimed they had been harmed by paying for the Nexium prescribed by physicians for the patients participating in their plans. The same group of lawyers apparently filed other “essentially identical class actions” with different sets of named plaintiffs, including one in Delaware federal court that resulted in the dismissal of a New York consumer fraud claim. Ignoring some history and details much like the plaintiffs ignored the marketing for Prilosec over the last fifteen years and the difference between a racemic mixture and an enantiomer, the Delaware state court action woke up from a long slumber in 2014 with its second amended complaint asserting the same claims the federal court had disposed of a few years before.

The Superior Court first determined that the law of New York, where the named plaintiffs were based, applied instead of the law of Delaware, where the defendant was based, or the laws of thirteen other states. Id. at *9. The court found that plaintiffs had not alleged the causation required for a consumer fraud claim: the “purported chain of causation that runs from the allegedly deceptive advertisements that may have influenced the decisions of individual doctors to prescribe a drug to their patients to causally affect the payer unions in this case is simply too attenuated,” as the doctors would be “presumed to go beyond advertising medium and use their independent knowledge in making medical decisions.” Id. at **9-10. We certainly like this reasoning, which would apply to a bunch of these cases. We also like that the court did not give plaintiffs a fourth chance to frame a complaint that stated a claim.

Continue Reading TPPs Fail to Put Their Money Where Their (Litigation) Mouth Is and Lose

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This week, as Drug and Device Law Jews, we are preparing for Passover, which, like most Jewish holidays, begins with a multi-generational dinner at the home of the Drug and Device Law Bubbie (our mother). Although we of the second generation (there are now four) still fancy ourselves to be the “kids’ table” at this dinner – giggling at the solemn points of the reading, singing endless choruses of our favorite Passover song in defiance of the “just one time” edict, and generally disrupting the proceedings as much as possible – the reality is that we are all upper-middle-aged adults. And, as our matriarch ages (at least on paper), we assume more and more of the food preparation for the Seder dinner. And there’s the rub. For, much as we would enjoy the occasional stroke of rogue creativity, we know that nothing unfamiliar will be allowed on the table and that each of the traditional dishes must taste exactly as it has tasted for the past 50-plus (if not 2,000) years. Every ingredient and every step of preparation is subject to scrutiny, and Bubbie is the gatekeeper. (You know where this is going).

As everyone knows, under SCOTUS’s Daubert decision, the trial court is the gatekeeper when it comes to admitting or excluding the testimony of expert witnesses. We who practice in the mass tort space have gratefully experienced judges who take this responsibility seriously and have endured those who “punt” these determinations, nearly always to the benefit of plaintiffs whose dime-store experts – lacking qualifications, methodologies, or both – are permitted to peddle their wares to unsuspecting juries.

The Lipitor MDL judge falls resoundingly into the former camp. In In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices, and Prods. Liab. Litig., 2016 WL 1251828 (D.S. C. Mar. 30, 2016), considered the defendant’s Daubert motions addressed to the plaintiffs’ four causation experts, and wholly or partially excluded all four. But there is backstory. Lipitor is prescribed in four different doses – 10 mg, 20 mg, 40 mg, and 80 mg. This is an MDL, so our readers can guess which doses most of these plaintiffs took. While several studies show a statistically significant association between higher doses and new-onset diabetes, none shows such an association at the lowest dose. After the plaintiffs’ experts submitted their initial reports, the court “was concerned as to whether Plaintiffs’ experts had sufficient facts and data to support their causation opinions at all doses . . . , and even whether the experts would be willing to offer an opinion at low doses, given the available data.” In re Lipitor, 2016 WL 1251828 at *3. Over the defendant’s objections, the court allowed all four of the plaintiffs’ experts to submit supplemental reports addressing whether the drug caused diabetes at particular doses. Id. at *5. The defendant’s Daubert motions followed submission of the supplemental reports.

Continue Reading Gutsy Gatekeeping: Plaintiffs’ Experts Excluded in Lipitor MDL

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