April 2016

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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

Photo of Michelle Yeary

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

Photo of John Sullivan

This post is not from the Reed Smith side of the blog.

A federal court in the Ninth Circuit has held that PMA preemption extends beyond claims involving medical devices approved through the more traditional PMA process. It now also includes claims involving devices that were approved under the FDA’s humanitarian device exemption, or HDE.…

Photo of Bexis

The FDA recently released draft guidance concerning the labeling of biosimilar products (analogous in the biologic context to generic drugs). It’s called, not surprisingly “Labeling for Biosimilar Products Guidance for Industry.” Here’s a link to it on the FDA’s website.

When we think of bioequivalence, we think of generic drugs, and more specifically generic drug preemption under PLIVA v. Mensing, 131 S. Ct. 2567 (2011), and its progeny. Generic preemption, as we’ve discussed many times, depends on the impossibility of making an immediate change to a product (including its labeling) as required by state law, where the same change necessitates prior approval by the FDA under federal law. So we took a look at the guidance to see whether biosimilar products were likely to enjoy the same protection from state-law product liability.

It doesn’t look that way.Continue Reading FDA Biosimilars Guidance Not Conducive To Preemption

Photo of Michelle Yeary

Samples, samples, samples. We dare you to make it through your local supermarket or bulk supply store without finding at least one table set up asking you to sample the latest offerings from peanut butter to frozen breakfast sandwiches; from hummus to pre-made meatballs; and don’t forget the cheese. And it’s usually more than one. By the time you’re done shopping you can have eaten an entire meal – from salsa to cheesecake. Shopping alone, this doesn’t really present much of an obstacle. Shopping with children, however, and it adds a whole new dimension. Children want to try every sample. In sample size, children love almost everything they taste. So, you then get to listen to “please, please, please” for ten aisles. “I loved it.” “I promise I’ll eat every last frozen pierogi you buy.” In occasional moments of weakness, you say yes. To nobody’s surprise, however, you’re throwing away a nearly full bag of pierogis that you found wedge in the back corner of your freezer 10 months later. Because, what tasted so good in a sample size, simply didn’t have enough flavor to desire an entrée-sized portion.

That’s sort of how we feel about today’s decision, overall it tosses out most of plaintiffs’ claims – we like those samples. But, the decision is long and when you get down to digesting all of it – some of it is a bit hard to swallow.

The case is McLaughlin v. Bayer Corp, 2016 U.S. Dist. LEXIS 37516 (EDPA Mar. 22, 2016). It’s actually five cases with identical complaints all alleging injury from plaintiffs’ use of Bayer’s contraceptive device, Essure. The device is a Class III, PMA device, so Riegel express preemption and Buckman implied preemption are both viable defenses and both were raised by the defendant in response to each of plaintiffs’ twelve claims. That’s part of the problem. Plaintiffs raised novel claims to try to avoid preemption. In fact, none of the specific theories that were allowed to survive preemption have ever actually been recognized by Pennsylvania. So, we’re sure you’re expecting an Erie discussion – but Erie isn’t even mentioned in the decision. Fortunately, TwIqbal was also successfully used by the defense, so plaintiffs really do have to go back to the drawing board on their claims. We hope that after the claims are both stripped down and beefed up, the court will see it left some really indigestible morsels on the table. We’ll take the claims in the order the court did.Continue Reading A Federal Pennsylvania Decision That We Like in Small Bites

Photo of Steven Boranian

The Zoloft MDL has finally collapsed. We started to see the writing on the wall in June 2014, when the MDL judge ruled that none of the plaintiffs’ experts could testify that taking Zoloft while pregnant could cause birth defects. That is to say, the plaintiffs had no admissible expert opinion establishing general causation. That’s a major problem, and the other shoe finally dropped on Tuesday, when the district court granted summary judgment in all but a handful of cases in the MDL. Or, as the district court put it, “At the end of the day, Plaintiffs have failed to raise a jury question on the necessary predicate to success in any case: that Zoloft was capable of causing their injuries.” In re Zoloft Prods. Liab. Litig., No. 12-MD-2342, 2016 WL 1320799, at *11 (E.D. Pa. Apr. 5, 2016) (emphasis added).

We don’t often see entire MDLs go down like this. The District of Minnesota famously dismissed the entire Sprint Fidelis defibrillator MDL on preemption grounds in 2009, which was particularly noteworthy because it was an order on the pleadings. The Accutane MDL ended a few years ago in Florida with an order granting summary judgment in all but one case on the basis that the drug’s manufacturer adequately warned about the risk of bowel injury. Our only beef with that result was that it took so long—many years of tortured litigation, although several good orders came out of that MDL on experts and otherwise.

So the district court’s order showing the Zoloft plaintiffs the way to the courthouse exit is not unprecedented. But still, essentially ending an MDL with a stroke of a pen is big news, and the order shows not only that the plaintiffs did not have the goods, but also that the district court showed remarkable patience in allowing the plaintiffs multiple opportunities to develop what they needed.Continue Reading So Long Zoloft MDL

Photo of Stephen McConnell

For once, our happy birthday wish really has something to do with births, specifically the significance of birth cohorts for litigation strategies and tactics. The actor Paul Rudd is celebrating his birthday today. We like Paul Rudd. We liked him when we first saw him in Clueless. We liked him in all those Judd Apatow and Apatow-esque movies, such as The 40 Year Old Virgin, Knocked Up, Forgetting Sarah Marshall, and I Love You Man. Rudd is likeable even when he is playing a jerk, as in Wet Hot American Summer (both the film and the Netflix series). IMDB lists 100(!) acting credits for Rudd. Rudd usually plays comedy, but we also saw him in a grim Broadway play called “Grace” a couple of years ago. We liked him in that. Pretty much everybody likes Rudd. There’s even a current Bud Light ad campaign where Seth Rogen and Amy Schumer mention how everybody likes Paul Rudd. Rudd seems to have lots of friends in Hollywood. He shows up in projects with the same people again and again, as in the Anchorman films. He has been in five films with Elizabeth Banks, for example. In fact, this ensemble-ness is something we’ve noticed with Generation X entertainers. They seem very collaborative. They show up in each others’ projects, sometimes uncredited, in a free-flowing, generous manner. (Contrast that with the leering booziness of the Rat Pack). Gen X has been defined in various ways, but those definitions seem to cluster around the cohort of people born between 1965 and 1981. Rudd was born in 1969. Ben Stiller was born in 1965. John Cusack was born in 1966. Apatow was born in 1967. Banks was born in 1974. Gen X is a much smaller cohort (approx. 47 million) than the Baby Boomers (80 million) and the Boomers’ children, the Millennials (76 million).

Has there ever been a more maligned generation than X? They were called slackers and whiners. They were deemed the sandwich generation, bitter about the Boomers’ relentless self-centeredness and the Boomers’ seeming determination to keep the seats in corporate America warm for the Millennials. The economy seemed to have no great love for X-ers, and the X-ers returned the favor. These generational generalizations are necessarily wrong almost as often as they are right, but everybody plays this game, so we’ll play along. According to the conventional wisdom, as in a widely read 1990 article in Time Magazine, Gen X-ers are indecisive, have low SAT scores and short-attention spans, and sneer at status. It was also said that a huge chunk of Gen X has been wounded, maybe even scarred, by divorce. Every generation is said to have its big childhood (or ‘emerging adulthood” – a term invented for Gen X) imprint moments. For Boomers, the JFK assassination, Vietnam, and Watergate are the unforgettable events. Gen X’s biggest moment was supposedly sitting in a classroom and watching the Challenger shuttle blow up with a schoolteacher aboard. But the conventional wisdom ( e.g., a 1997 article in Time) has shifted. It’s as if we fogies woke up one day and realized that Gen X cuts a pretty pleasant profile. It’s a stereotype, of course, but Gen X is now viewed as prizing work-life balance, multiculturalism, tolerance, and collaboration. The X-ers still resist snobbery, but express that sentiment by prizing and elevating the quotidian. Is it any accident that Aaron Franklin, the reigning guru of barbecue, is an X-er? Take a stroll through your average downtown, and much of what makes that downtown wonderful is the work of X-ers. Who do you think is responsible for all those microbrews on tap, as opposed to the bad old days where Schlitz was the exotic option?Continue Reading Talkin Bout Your (?) Generation

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We recently read an interesting new empirical study that confirms what we’ve long suspected − that so-called “no-injury” class actions, those that allege that a product was “worth less” than it should have been due to some inchoate, unmanifested defect, are a litigation boondoggle, benefiting nobody but the lawyers who bring them.

The study is Joanna M. Shepherd, “An Empirical Survey of No-Injury Class Actions,” available through the Social Science Research Network, here. Ms. Shepherd, a professor at the Emory University School of Law, started with all class action settlements between 2005 and 2015 that could be located on Lexis or Westlaw – 2158 cases. She applied four criteria for identifying “no-injury” classes:

  1. the plaintiffs suffered no actual or imminent concrete harm giving rise to an injury in fact;
  2. the only harm alleged was a technical statutory violation (primarily of the Fair Debt Collection Practices Act, the Telephone Consumer Protection Act, the Fair Credit Reporting Act, and the Electronic Funds Transfer Act);
  3. if any out-of-pocket economic loss was negligible or infinitesimal; or
  4. the recovery sought was unrelated to compensating plaintiffs for economic or other harm.

Shepherd Empirical Study at 1. After applying those criteria, Professor Shepherd included only cases about which information existed on both attorneys’ fees and settlement funds. Id. This culling produced 432 class actions that could be studied.Continue Reading Empirical Study Confirms That No-Injury Class Actions only Benefit Lawyers

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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