Search results for: gadolinium

Well, at least that’s true when we are blogging about defense wins.  And this week, we have another good gadolinium case.  This time from New York.

Just a quick reminder – gadolinium is a contrast agent that is injected into a patient before undergoing an MRI.  The gadolinium is intended to pass through the body,…

Back in 2012, we published our “Distribute This!” post about In re Fosamax (Alendronate Sodium) Products Liability Litigation (No. II), 2012 WL 181411 (D.N.J. Jan. 17, 2012), lauding its ruling that, under the “independence principle” of PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett,…

Multidistrict Litigation – the name says it all.  It is an amalgamation of related cases from multiple federal district courts across the country.  Think about the journey a single case in an MDL may take.  Plaintiff files in state court.  Defendants remove the case to federal court based on diversity.  But as soon as the…

“Ignorance is like a delicate fruit; touch it and the bloom is gone.”  – Oscar Wilde

March 25 is a significant day in legal history.  On this date in 1911, the Triangle Shirtwaist factory in New York City caught on fire, killing 146 workers.  (One of those lost souls was the great-grandmother of a member of the DDL blogging team.)  The factory owners were charged with manslaughter on the theory that they had locked the fire exits to keep the workers from taking smoking breaks on the fire escapes.  The formidable trial lawyer Max Steuer represented the owners and secured a defense verdict by showing that a key plaintiff witness had rehearsed her story a little too well.  Two decades later, on March 25, 1931, the Scottsboro Boys were arrested for rapes they never committed. Witnesses made up inculpatory testimony.  The trials were a sorry, sordid affair, resulting in death sentences, followed by multiple U.S. Supreme Court decisions on the issues of effective assistance of counsel and racial exclusion of jurors.  To Kill a Mockingbird might have drawn on some aspects of the Scottsboro Boys case, but the real life matter was much more complicated and dramatic.  One of the defendants escaped and was later (much later: 1976) pardoned by, of all people, Governor George Wallace.

Today’s case is not nearly so epic, but it is nevertheless notable for the trial court’s smart and stout decision to stop a plaintiff expert witness from testifying about things she had no business talking about.  The case is Heineman v. American Home Products Corp., 2015 U.S. Dist. LEXIS 30445 (D. Col. March 11, 2015).  We were far less happy about the Heineman case when we wrote about it here last Summer, when the court missed an opportunity to end the case on clean learned intermediary grounds because it overcomplicated the issue of identifying who was the prescriber.  This time, the court was confronted with the plaintiffs’ proffer of opinions by an expert to the effect that (1) the risks of diet drugs outweighed their benefits, and (2) the defendant’s post-marketing surveillance stunk and it knew its labelling was inadequate.  The expert was Dr. Cheryl Blume.  She is a pharmacologist.  We have blogged about several other cases involving Dr. Blume.  Here, for example.  And here.  And here.  There are others.  You get the idea.  Since, as Dr. Parisian told us at a deposition last year, she is retiring soon, we suppose that Dr. Blume will become the go-to expert for saying what needs to be said, at least as far as DDL plaintiff lawyers are concerned.  We are reminded of something Bill Buckley once said about a former ambassador: “He knows a lot about the Soviet Union, all of it wrong.”   Dr. Blume comes into every case knowing A Lot.Continue Reading Pruning ‘Expert’ Opinions on Risk-Benefit and Corporate Knowledge

Bad news arrives in all sorts of vehicles, not just product  liability suits.  For example, in a medical malpractice case, the E.D. of Tenn recently issued a ruling that admitted an FDA Alert into evidence.  Guthrie v. Ball,  2014 U.S. Dist. LEXIS 148900 (E.D. Tenn. October 17, 2014).  That ruling displeased us, but since to be forewarned is to be forearmed, we share it with you in an effort to get all of the week’s nasty rulings behind us before we are halfway through hump day.

In Guthrie, the plaintiff’s counsel sought to use an FDA Alert sent to physicians regarding the risks of fentanyl patches.  Specifically, the plaintiff’s counsel used the FDA Alert during depositions of expert witnesses.  It appeared that the plaintiff’s counsel was attempting to use the FDA Alert to establish the standard of care.  The doctor defendant filed a motion in limine to exclude the FDA Alert on the ground that it was inadmissible hearsay to which no exception applied, including the 803(8) hearsay exception.  Among other things, the defendant argued that the FDA Alert did not contain a statement identifying the office responsible for the alert or reflect the FDA’s activities, did not indicate whether it pertained to a matter observed under a legal duty to report, and did not appear to reflect actual findings from a legally authorized investigation.  Rule 803(8) creates an exception to the hearsay bar for “[a] record or statement of a public officer if: (A) it sets out: (i) the office’s activities; (ii) a matter observed while under a legal duty to report …; or (iii) in a civil case …. factual findings from a legally authorized investigation; and (B) the opponent does not show that the source of information or other circumstances indicate a lack of truthworthiness.”  Fed.R.Evid. 803(8).Continue Reading FDA Alert based on Adverse Event Reports Admitted in Med-Mal Case

Every state has its peculiarities, oddities, firsts, and little known facts. For instance, did you know that New Jersey (this blogger’s home state) has the tallest water tower in the world or that it was the site of the first baseball game? Well, our case for today is from Tennessee.  So, did you know?

The world’s largest artificial skiing surface is located in Gatlinburg

Tennessee was the last state to secede from the Union during the Civil War and the first state to be readmitted after the war.
  • Bristol is known as the Birthplace of Country Music
  • Oak Ridge is known as the Energy Capital of the World
  • Tennessee has more than 3,800 documented caves
  • Nashville’s Grand Ole Opry is the longest continuously running live radio program in the world. It has broadcast every Friday and Saturday night since 1925
  • Coca-Cola was first bottle in 1899 at a plant in downtown Chattanooga after two local attorneys purchased the bottling rights to the drink for $l.00

Continue Reading Quirky Facts About Tennessee and Choice of Law

We’ve already provided our readers with our list of the testimony (trial and deposition) of the seemingly ubiquitous plaintiff’s expert Dr. Suzanne Parisian, although we admit that our readers have not been very conscientious in updating us with new transcripts.

Be that as it may, in this post we’re taking the next logical step – we’re looking at the numerous court decisions where the admissibility of Dr. Parisian’s testimony was successfully challenged, in whole or in part.  We’re categorizing the exclusions by topic, starting with those that exclude her altogether as a witness, and working our way down.  Because we don’t believe in doing the other side’s research for them, we’re not listing topics on which she was allowed to testify, however, be aware that, if a decision is not in the first paragraph, it did allow her to testify, at least as to something.

Here goes:

Cases Totally Excluding Dr. Parisian’s Testimony:  Miller v. Stryker Instruments, 2012 WL 1718825, at *10-12 (D. Ariz. Mar. 29, 2012) (no coherent methodology; unhelpful; legal conclusions; narrative testimony; unqualified to give medical testimony; ipse dixit; reliance on after-the-fact events); Kaufman v. Pfizer Pharmaceuticals, Inc., 2011 WL 7659333, at *6-10 (S.D. Fla. Aug. 4, 2011) (ipse dixit; conclusory; lack of methodology; opinions not tied to FDA regulations or to facts; irrelevant bases; intent/state of mind; outside scope of expertise; outside relevant time period), reconsideration denied, 2011 WL 10501233 (S.D. Fla. Aug. 10, 2011) (narrative testimony; lack of methodology; outside relevant time period); Hogan v. Novartis Pharmaceuticals Corp., 2011 WL 1533467, at *2-3 (E.D.N.Y. April 24, 2011) (FDA issues irrelevant; unqualified as to industry standards); Lopez v. I-Flow Inc., 2011 WL 1897548, at *9-10 (D. Ariz. Jan. 26, 2011) (legal conclusions; conclusory; improper state of mind/intent opinions; narrative testimony; bases not connected to conclusions; ipse dixit; speculative; outside expertise); In re Trasylol Products Liability Litigation, 709 F. Supp.2d 1323, 1336-51 (S.D. Fla. 2010) (unqualified as to foreign regulations and medical causation; narrative testimony; ipse dixit; corporate knowledge and intent; FDA violation testimony conclusory and not tied to regulations; opinions beyond scope of report; improper reliance on internal documents; lack of methodology; speculation; advocate not an expert), certification denied, 2010 WL 2541892 (S.D. Fla. June 22, 2010); In re Prempro Products Liability Litigation, 554 F. Supp.2d 871, 879-87 (E.D. Ark. 2008) (erroneous admission of Parisian testimony required new trial on punitive damages; narrative testimony, ipse dixit; testimony not connected to FDA regulations), aff’d in pertinent part, reversed in part on other grounds, 586 F.3d 547, 571 (8th Cir. 2009); Jacobs v. Caesars Entertainment, Inc., 2007 WL 594714, at *4 (E.D. La. Feb. 21, 2007) (insufficient factual basis; unreliable methodology), reconsideration denied, 2007 WL 1558717, at *2 (E.D. La. May 30, 2007), aff’d, 280 Fed. Appx. 424 (5th Cir. 2008); Nelson v. C.R. Bard, Inc., 2006 WL 6225071 (D.D.C. Sept. 26, 2006) (minute order); Barnes v. EBI Medical Systems, Inc., 2001 WL 36105533 (Vir. Cir. Spotsylvania Co. Jan. 26, 2001) (legal opinion; lack of qualifications; no foundation; speculation).Continue Reading Which Decisions Have Excluded Dr. Parisian, And About What?

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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