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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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From our prior personal jurisdiction posts concerning Daimler AG v. Bauman, 134 S. Ct. 746 (2014), and the plaintiff-side dodge of “general jurisdiction by consent,” regular blog readers were aware that one of the few jurisdictions where the consent theory appeared to have some traction was Delaware. Those adverse decisions were based on pre-Bauman Delaware state law, Sternberg v. O’Neil, 550 A.2d 1105 (Del. 1988), which had allowed general jurisdiction by consent.

No longer.

In an asbestos mass tort case, the Delaware Supreme Court has just overruled Sternberg – on the basis that general jurisdiction by consent merely by means of registration to do business is incompatible with Bauman:

We conclude that after [Bauman], it is not tenable to read Delaware‘s registration statutes as Sternberg did. Sternberg[] . . . rested on a view of federal jurisprudence that has now been fundamentally undermined by [Bauman] and its predecessor Goodyear Dunlop Tires Operations, S.A. v. Brown. . . . Sternberg represented just one plausible way to read a statute that on its face does not refer explicitly to personal jurisdiction, much less to consent to personal jurisdiction.

Genuine Parts Co. v. Cepec, No. 528, 2015, slip op. at 2 (Del. April 18, 2016) (footnote omitted). Thus, “Delaware‘s registration statutes must be read as a requirement that a foreign corporation must appoint a registered agent to accept service of process, but not as a broad consent to personal jurisdiction in any cause of action, however unrelated to the foreign corporation‘s activities in Delaware.” Id. at 3. That means, “[i]n most situations where the foreign corporation does not have its principal place of business in Delaware, that will mean that Delaware cannot exercise general jurisdiction over the foreign corporation.” Id. (footnote omitted).

Continue Reading Breaking News – No General Jurisdiction by Consent in Delaware

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In drug and device litigation, product identification can be a significant issue. Many of us have poured over medical records and worked through question modules at depositions to determine whether the plaintiff actually used our client’s drug or device. Undermining product identification can be one of the quickest ways to end a lawsuit. But it doesn’t get much quicker than it happened in Weddle v. Smith & Nephew, Inc., 2016 U.S. Dist. 48512 (N.D. Ill. Apr. 11, 2016). There, the plaintiff couldn’t (at least so far) get passed the pleadings.

In a variant of the old “when in doubt, pick C” approach to standardized tests, in Weddle, plaintiff went with, “when in doubt, pick them all.” Plaintiff had a Trident Hindfoot Fusion Nail system (“Trident), manufactured by Smith & Nephew, Inc., implanted in her foot. Id. at * 1-2. But other products, including nails and cement manufactured by Howmedica Osteonics Corp. and screws manufactured by DePuy Synthes Sales, Inc., were also implanted. After pain and other problems that required several more surgeries, plaintiff sued everybody. Id. at * 2. She alleged that Smith’s Trident, and/or Howmedica’s nails and cement, and/or DePuy’s screws caused her problems. Id. at * 8. In other words, she picked everybody. But, much like using your #2 pencil to fill in all the circles on a standardized test answer sheet, it didn’t work. The Court dismissed her complaint for failure to state a plausible claim. Id. at *20.

Continue Reading Court Dismisses Medical Device Claims That Named Many Defendants But Picked None Of Them

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How much is “enough?” Will we have enough money to retire someday? Did the Drug and Device Law College Sophomore study enough for her computer science midterm? Is there enough salt in the matzo ball soup? In the realm of summary judgment, we who represent defendants are painfully familiar with courts that dodge this question, allowing claims to proceed and avoiding the complicated issues of admissibility that determine whether a plaintiff has presented enough evidence to create a genuine issue of material fact.

Not so in United States of America ex rel. John King and Tammy Drummond, et. al. v. Solvay S.A., et al.. 2016 U.S. Dist. LEXIS 43133 (S.D. Tex. Mar. 31, 2016). In King, a False Claims Act case, the Relators claimed that the defendant promoted three drugs for off-label uses, and that the off-label promotion resulted in false claims being submitted for prescriptions paid for by government health care programs. King, 2016 U.S. Dist. LEXIS at *5. The defendants moved for summary judgment on these claims, arguing that the relators did not have any admissible evidence of false claims. Specifically, the defendants argued that the Relators relied on inadmissible Texas and New York claims data to create summary charts of supposed false claims and didn’t disclose who created the charts or explain how they were created. Further, the defendants objected to the Relators’ reliance on sales representatives’ “call notes,” arguing that the call notes contained hearsay and lacked foundation. Id. at *8-9.

New York Claims Data

The Relators claimed that the New York claims data was self-authenticating because it was produced in response to a subpoena. The court disagreed, holding, “. . .[W]hile certainly Relators’ assertion that the State of New York produced the New York Claims Data pursuant to a subpoena must be what was requested in the subpoena,” documents produced pursuant to a subpoena are not always self-authenticating. Id. at *13. In contrast to a case cited by the Relators, which involved documents that were going to be used against that producing party, the Relators, who sued on behalf of the State of New York, were using the documents to benefit New York. The court concluded that the New York claims data was not self-authenticating “simply because it was produced pursuant to a subpoena.” Id. at *13-14.

Continue Reading Summary Judgment for Defendants in FCA Action: No Admissible Evidence of False Claims

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It’s only been one month since we posted about the disappointing decision in the Xarelto MDL regarding plaintiffs’ ability to have unfettered ex parte conversations with treating and prescribing doctors before those doctors are deposed as critical fact witnesses. We noted then that it is a hotly contested issue in almost every mass tort. A fact acknowledged by the latest court to consider the issue in an MDL – In re: Benicar (Olmesartan) Products Liability Litigation, 2016 U.S. Dist. LEXIS 47067, *215 (D.N.J. Apr. 6, 2016) (don’t be daunted by the page number, that’s where the substance of the decision begins – after 214 Lexis pages of counsel appearances). Unfortunately, the trend seems to be to allow plaintiffs unequal and unregulated access to these key witnesses – to potentially “woodshed” the doctors – and hope that disclosure requirements even the playing field.

The Benicar decision relies heavily on the recent Xarelto decision, so it doesn’t offer a lot of new ground. As in Xarelto, the Benicar court found no evidence of improper communications to justify defendants’ request for limitations on ex parte communications. Id. at *220-21. Like we said last month, this is like saying we won’t close the barn door until after we see if the horses escape. Closing it after the fact doesn’t really help – the damage is done. The Benicar decision goes on to talk about its faith in doctors. That they will act professionally, won’t be duped by plaintiffs’ counsel, or defer to plaintiffs’ counsel on what medications to prescribe. Id. at *223. We hope this is all true, especially that last point. But there is more to “poisoning the well” than just trying to convince doctors the drug isn’t safe or effective. Plaintiffs like to show doctors internal company documents that no doctor would ever see in the normal course. And plaintiffs’ counsel love to ask: wouldn’t you have liked to see this? Knowing full well that defendants are highly regulated in what they can and cannot show or share with doctors. Which brings up another point that the courts seem to gloss over. They seem to buy into plaintiffs’ argument that defendants have had access to the doctors for years in marketing their drugs. Id. at *225. Unfettered, unfiltered, say anything communication? No way. Regulated, controlled, fairly-balanced communications? Yes, those we’ve had. So, if the courts seem to think that pharmaceutical representatives’ interactions with doctors are on the same footing as plaintiffs’ counsel’s, let’s make them the same and put some parameters in place. Isn’t that really what defendants are asking for?

Continue Reading Another Mediocre Decision on Ex Parte Contact with Treaters Has Us Thinking

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Every now and then even Bexis comes across a decision involving legal propositions he’d never heard of before. Such was the human tissue case Kennedy-McInnis v. Biomedical Tissue Services, Ltd., No. 13-CV-6545, slip op. (W.D.N.Y. April 12, 2016). Kennedy-McInnis introduced us to the common-law “right of sepulcher” – and more importantly to the defenses, including broad “good faith “ immunity, that limit this little known “right.”

First, why should anybody interested in drug/device product liability care? The answer is that a lot of products, particularly implantable medical devices, are used in conjunction with so-called “allograft bone.” As everyone knows, many other types of tissue are transplanted as well. Other medical devices, and some drugs, are typically used in conjunction with – or to support transplants of – various types of human tissue that doctors and hospitals typically obtain from tissue banks. Human tissue used in this manner can be extremely medically beneficial – and anything so beneficial is potentially worth a great deal.

Anything that’s worth a great deal creates a market for itself, and in our market-based society, there is always temptation for somebody in the chain of distribution to cut corners. When that happens, we’ve seen product manufacturers end up getting sued. Thus, we have blogged several times about litigation involving human tissue incorporated into certain medical devices, and allegations that fly-by-night (and convicted) intermediaries hadn’t bothered testing the tissue in question for communicable diseases. Ultimately, the litigation fizzled because, as bad as the intermediaries’ conduct had been, plaintiffs couldn’t prove that it actually caused anybody to get sick.

Continue Reading Learning Something New – Limits To Human Tissue Liability

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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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