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

We don’t usually report on securities-law cases, but today we do. That is because the well-reasoned decision in question, In re Allergan PLC Securities Litigation, 2022 WL 17584155 (S.D.N.Y. 2022), has major implications for the parallel Textured Breast Implant MDL now pending in

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

Looking back on the blog, the last time we posted about the Pelvic Mesh MDL was this summer when we lauded a remand judge for not allowing plaintiffs to expand their expert reports to include opinions already excluded by the MDL judge. At that

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We confess, we can’t think of any good reason for admitting evidence concerning product risks that the plaintiff in a particular case never actually encountered – yet plaintiffs try it with a straight face all the time.  It’s another example of plaintiffs throwing mud against the wall to see if it will stick; anything to

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If you read the decision in Rossitto v. Hoffmann-LaRoche Inc., 2016 N.J. Super. Unpub. LEXIS 1714 (N.J. App. Div. Jul 22, 2016), we think you’ll agree with our calling it “strong” criticism of two trial rulings that the appellate court firmly believed led to undue prejudice of the defendant.  The $18 million verdict awarded to two of four plaintiffs in a joint trial was vacated and the case is being remanded for a new trial.  This is not the first Accutane plaintiff’s verdict to be vacated by New Jersey’s appellate division, but rather another notch in the demise of this litigation which has seen a turn in favor of defendant since coming under new management.  Indeed, a quick search of the DDL blog for Accutane will show how the tide has turned.

The Accutane litigation is primarily comprised of claims alleging that the manufacturer failed to adequately warn about the risk of inflammatory bowel disease (“IBD”).  Therefore, the drug’s label takes center stage.  Here, the plaintiffs both used the drug with its 1984 label that included a warning that “Accutane has been temporally associated with IBD.”  Id. at *8.  In May 2000, after plaintiffs had stopped using Accutane, the label was revised to remove the word “temporally” and to add information about persistent IBD symptoms.  Id. at *18.

Although only one of the plaintiffs was a New Jersey resident, the parties agreed that New Jersey law would apply to both.  Id. at *34.  So, New Jersey’s “super-presumption” applies – that is if the warning given has been approved by the FDA, there is a rebuttable presumption of adequacy.  Id. at *37.  Called a “super-presumption” because it is “virtually dispositive” on failure to warn, it can be overcome with evidence of intentional concealment of a known risk or “substantial evidence of economically-driven manipulation of the post-market regulatory process.”  Id. at *37-38.  Plaintiffs got to trial in these cases because the New Jersey courts have found that as to the 1984 label plaintiffs have put forth enough evidence from which a reasonable jury could conclude they had rebutted the presumption.  Id.  at *55-56 (citing prior Accutane decisions addressing this issue).   But it’s a strong presumption so we decided to take the time to remind you about it.Continue Reading New Jersey Accutane Plaintiff Verdict Vacated – Appellate Division Strongly Criticizes Evidentiary Rulings

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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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Happy Birthday, Eric Clapton. (Today is also the birthday of painters Goya and Van Gogh. Is there something about March 30 that breeds people who turn their blues into art?) Clapton has been around so long it is easy to take him for granted. He has built up a formidable body of musicianship. He is the only three-time inductee in the Rock and Roll Hall of Fame, for his solo work as well as his stints with the Yardbirds and Cream. We remember how, in the late 1960s, one of our sisters would scribble on her school notebooks that “Clapton is God.” That sister later married a very nice, very hip guy, who was also a Clapton fan. A couple of years ago Clapton’s autobiography came out. Our brother-in-law summarized the book thusly: “I made a lot of music, took a lot of drugs, caused a lot of damage to relationships and health, but in the end, everything was pretty cool.” Just so.

In the early 1990s, we were working at a law firm representing the Robert Stigwood Organization (RSO). You might remember RSO as the force behind the soundtracks for Grease and Saturday Night Fever. RSO also managed the careers of the Bee Gees, Andy Gibb, Yvonne Elliman, and Clapton. In our case, RSO, along with Eric Clapton, was being sued by Jim Gordon, the drummer in the short-lived rock group Derek and the Dominos. Gordon claimed he had been denied writing credit and money for the long piano coda in the all-time great song, “Layla.” By the time he filed the lawsuit, Gordon was a resident of the Atascadero Prison for the criminally insane. Somewhere along the way, Gordon had started hearing a voice. That voice told him to kill his mother. With a hammer and butcher knife. He obeyed that voice. Needless to say, the deposition of Gordon behind prison walls was odd. Earlier in the case, our firm sent a representative to London to meet with our co-defendant, Mr. Clapton. That assignment went to another associate – one who didn’t even like Clapton’s music that much – certainly not as much as we did. Our bitterness and envy were complete. We insisted that the lucky associate (a close friend of ours, but his musical tastes ran more toward c&w and happy pop than toward guitar gods) relay a message to Clapton that, of all the versions of “After Midnight,” the best was the slow one that ran on the Michelob beer commercials. Imagine our delight when we were told that after Clapton listened to that opinion, he paused thoughtfully, nodded, and gently assented: “Yes. That one is the most soulful.”

It would be hard to list all of the great songs that Clapton worked on, but here is a start:

  • “For Your Love” (with the Yardbirds. Clapton hated the poppy-ness of the song and left the group just before the song climbed the charts)
  • “White Room” (listen to that solo and try arguing that the Drug and Device Law Sister was wrong all those years ago about deifying Clapton – go ahead, we dare you!)
  • “Sunshine of Your Love”
  • “Badge” (written with George Harrison. On the track credits, the rhythm guitarist is listed as L’Angelo Misterioso- that’s Harrison, who couldn’t use his real name for legal reasons. Damn lawyers.)
  • “Crossroads”
  • While My Guitar Gently Weeps” (we read somewhere that John Lennon contemplated replacing Harrison with Clapton, but Clapton wasn’t interested in becoming a Beatle)
  • “Layla” (the title song of rock’s greatest double album. Like most of the songs on that magnum opus, it is about Clapton falling in love with Harrison’s wife, Patti Boyd. Ms. Boyd, by the way, was one of the screaming, predatory schoolgirls in the Hard Day’s Night movie)
  • “Why Does Love Got To Be So Sad”
  • “Bell Bottom Blues”
  • “I Shot The Sheriff” (Maybe the original version by Bob Marley is better, but Clapton’s is also superb)

[The founder of this blog wants us to include “Wonderful Tonight” on our list of Clapton favorites. Who are we to refuse? But who knew there was a softer side of Bexis?]

Another one of Clapton’s hits was “Cocaine.” And thus we have an introduction to today’s case, Tersigni v. Wyeth, 2016 U.S. App. LEXIS 5393 (1st Cir. March 23, 2016). Tersigni was a diet drug case, and the alleged injury was Primary Pulmonary Hypertension (PPH). PPH is a very bad disease. The claims were brought under Massachusetts law for negligent design and negligent failure to warn. The trial court dismissed the negligent design claim. The negligent failure to warn claim went to the jury, which returned a defense verdict. On appeal, the plaintiff raised these issues:

  • The negligent design defect claim should not have been dismissed
  • The court should not have admitted evidence at trial that the plaintiff had been incarcerated
  • The court should not have admitted evidence at trial of the plaintiff’s cocaine use

Continue Reading First Circuit Upholds Defense Verdict in Diet Drug Case

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

It landed with a concussing thud that surprised no one. The $498 million verdict came last Thursday after weeks of evidence that included suicide, racism, tobacco pseudo-science, cancer, the proliferation of pelvic mesh litigation, Saddam Hussein, and alleged fraudulent practices in foreign countries. You might be wondering what type of case the jury was considering. That evidentiary line-up might make you think it was a wrongful death civil rights trial, or something worse. But it wasn’t. It was a Pinnacle hip implant trial. Really.

Before the verdict came, we were worried that something like this could happen. We wrote about it just as the jury was beginning deliberations. And then it happened, which should have been no surprise given the grouping of five separate plaintiffs for one bellwether trial and the noise that defendants were making about evidentiary rulings.

The question now is, what does it mean? Will it promote the ultimate resolution of the mass tort? Well, there’s little to suggest that it will. In fact, it seems more likely to do the opposite.Continue Reading Trouble in Texas II