October 2015

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Way back when – before Restatement (Second) of Torts §402A (1965) crystallized the concept of strict liability – courts around the country were poking around, trying to come up with viable theories of what we would now call “product liability.”  One method that gained some traction, prior to the advent of strict liability, was to strip contractual implied warranty of its historical requirement that the buyer and seller have been in “privity” (that is, that they dealt directly with each other).  New York was one of the states that started down that road.  In Goldberg v Kollsman Instrument Corp., 191 N.E.2d 81 (N.Y. 1963), the court held 4-3 that the manufacturer of a “thing of danger” (not otherwise defined, but in Goldberg, an airplane part that allegedly caused a crash) could be liable for breach of implied warranty without being in contractual privity with the plaintiff.  Id. at 83 (“at least where an article is of such a character that when used for the purpose for which it is made it is likely to be a source of danger to several or many people if not properly designed and fashioned, the manufacturer as well as the vendor is liable, for breach of law-implied warranties, to the persons  whose use is contemplated”).  This was problematic, because until §2-318 was amended in 1975, New York’s UCC hadn’t done away with privity in all personal injury cases.

But along came strict liability, and New York’s tentative steps down the road of privity-less implied warranty were largely forgotten.  Nobody paid much attention to warranty in the Empire State until the Court of Appeals held that strict liability and implied warranty were “not identical” in Denny v. Ford Motor Co., 662 N.E.2d 730, 739 (N.Y. 1995), in that strict liability utilized a risk/utility approach whereas implied warranty focused on consumer expectations.  Id. at 736.  While this distinction “may have little or no effect in most cases,” it can in some.  Id. at 738.Continue Reading The Citadel Revisited – New York’s “Thing of Danger” Privity Exception Is Obsolete (and Another New York Note)

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We’ve been corresponding recently with long-time friend-of-the blog, Dr. Frank Woodside over the unfortunate fact that junk science these days doesn’t only mean stuff (in the Jeb! sense) that isn’t published in what passes for scientific journals – and what can be done about it.  Dr. Frank has just written a law review article about this problem.  F. Woodside & M. Gray, “Researchers’ Privilege:  Full Disclosure,” 32 Cooley L.R 1 (2015), which is available online here.  Here’s the abstract:

An ever-growing chorus of academicians report that with the expanding number of academic journals there is a concomitant increase in the number of articles based on questionable methodology.  Many published studies contain improper statistical conclusions, flawed methodology, and results that cannot be replicated.  The recent controversy concerning the failure of parents to vaccinate their children because of the recommendations of flawed research exemplifies this crisis. This epidemic of faulty research has been exacerbated recently by the spread of low-quality academic journals and “pay-to-publish” journals, which will publish virtually anything for a fee.  This Article provides an analysis of a growing crisis of reliability in scientific research and how the so-called “researchers’ privilege” allows faulty research to go undetected.  This Article delineates the reasons why it is difficult, if not impossible, to evaluate published research findings without access to the underlying information that researchers have in their possession.  The Article then analyzes the state of the law regarding the ability of researchers to withhold records and data based on the so-called “researchers’ privilege.”  Finally, the Article explains why courts should favor the disclosure of research data and that confidentiality concerns should be addressed by a confidentiality order.

Id. at 1-2.  Here are the articles subheadings, which describe the material in it in more detail:

  • Misunderstanding and Misuse of Statistics and Research Methods
  • An Ever-Growing Number of Journals and “Pay to Play”
  • Fraud and Questionable Research Practices
  • Pre- and Post-Publication Peer Review Does Not Work

Continue Reading What To Do About Junk Science That’s Published?

Photo of Stephen McConnell

Delve into the crime stories of Elmore Leonard, whether in the form of the books, movies, or television shows, and you are likely to spend considerable time in Michigan and Florida.  True, Justified was set in Kentucky.  But Marshall Givens was forced to leave the Sunshine State after shooting a suspect (“Let’s just keep it simple: he pulled first,  I shot him”), and the big criminal organization he often contended with hailed from Detroit.  Leonard, also known as the Dickens of Detroit, was a native of Michigan and later spent much time in Florida.  Those two locations furnish a nice contrast between city and swamp, both settings being utterly sweaty and corrupt.

There is nothing especially sweaty about what we do, and we’d like to think that corruption is far, far away, but if you delve into our litigation docket, you are likely to encounter a tug of war between Michigan and Pennsylvania.  We live in Pennsylvania.  Our courts and laws seem inordinately fond of drug and device law plaintiffs.  By contrast, Michigan has just about the best, most pro-defense laws on the books, and, consequently, Michigan plaintiffs look to hightail it out of there and file their cases in a more hospitable jurisdiction – like, say, ours.

Recently in the Philly mass tort Risperdal litigation, a local judge did the right thing and told Michigan plaintiffs that they were stuck with Michigan law.  In Re Risperdal Litigation, 2015 Phila. Ct. Com. Pl. LEXIS 254 (Phila. CCP October 1, 2015).  The 13 plaintiffs were Michigan residents who claimed that they developed gynecomastia after taking Risperdal during adolescence.  The defendants filed summary judgment motions arguing that Michigan’s Products Liability Act applies and affords the defendants immunity on the plaintiffs’ claim for 1) negligence, 2) negligent design defect, 3) fraud, 4) strict liability – failure to warn, 5) strict liability – design defect, 6) breach of express warranty, 7) breach of implied warranty, 8) conspiracy, and 9) medical expense incurred by parents.  The plaintiffs disagreed.  They needed Pennsylvania law to apply, otherwise they would lose.

They lost.Continue Reading Philly Court Applies Michigan Law to Dismiss Risperdal Cases

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Twice this month we’ve reported on “the saga of Cymbalta plaintiff lawyers who keep pushing the litigation up a hill in an effort to create a class action, mass action, MDL, or whatever will allow them to park as many meritless cases in one place, only to have that litigation roll back down the hill, resulting in crushed toes, directed verdicts, and jury findings of no liability.”  Let’s make it a trifecta.  Both with our third post and with three more decisions severing the claims of misjoined plaintiffs who have nothing in common except that they each used Cymbalta and they each allege injury.  The cases are Jones v. Eli Lilly, 2015 U.S. Dist. LEXIS 141925 (S.D. Ind. Oct. 19, 2015) (15 plaintiffs from 11 states); DeCrane v. Eli Lilly, 2015 U.S. Dist. LEXIS 141924 (S.D. Ind. Oct. 19, 2015) (2 plaintiffs); Boles v. Eli Lilly, 2015 U.S. Dist. LEXIS 141922 (S.D. Ind. Oct. 19, 2015) (19 plaintiffs from 11 states).

We set out the background of plaintiffs’ counsel’s numerous attempts to create a mass tort in our prior posts here and here.  Based on theses earlier decisions, the result in these three cases is really no surprise. But, it does make for more great precedent on misjoinder and severance.  So, today we’ll throw you some sound bites.  For instance, it is hard to argue claims are properly joined when they are described as:

the claims of fifteen Plaintiffs from eleven different states whose allegations rest on distinct, unrelated factual scenarios: Cymbalta treatment over fifteen different time periods, presumably in eleven different states, for several different conditions….; use of the medicine under the care of multiple healthcare professionals from a range of medical subspecialties, affiliated with different practices and, potentially, varying degrees of exposure to the relevant product labeling; a host of potential co-medications and comorbidities; and, finally, Plaintiffs’ particular discontinuation methods (whether abrupt or tapered over varying lengths of time) which allegedly resulted in a range of symptoms of varying type, severity, and duration.

Jones, 2015 U.S. Dist. LEXIS 141925 at *16-17 (all three decisions are virtually identical, so we cite to Jones throughout).Continue Reading Another Smack Down for Cymbalta Plaintiffs’ Lawyers

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The collateral source rule rarely sits well with defense attorneys.  To us, it runs counter to a core purpose of tort law, which is to compensate plaintiffs for damages actually suffered.  Under the collateral source rule, a defendant’s liability for a plaintiff’s financial damages is not reduced by any payments that the plaintiff receives as to those very same damages from a third-party source.  So the plaintiff gets a double recovery—once from the collateral source and once from the defendant.  This happens most often in connection with a plaintiff’s medical bills.  While the plaintiff’s insurance pays all or most of those bills, the defendant remains liable to plaintiff for the entire amount.

There are policy reasons for the rule, and the Louisiana Supreme Court recently laid them out in Hoffman v. 21st Century North Am. Ins. Co., 2015 WL 5776131 (La. Oct. 2, 2015), a decision that addresses an attempt to expand the collateral source rule:

The most oft-cited reason is that the tortfeasor should not gain an advantage from outside benefits provided to the victim independently of any act of the tortfeasor.  We have also recognized the collateral source rule promotes tort deterrence and accident prevention.  Finally, absent such a rule, the reasoning goes, victims would be dissuaded from purchasing insurance or other forms of reimbursement available to them.

Id. at *2.  OK.  We get it, and we can live with it.  We’ve become somewhat numb to the effects of the rule.Continue Reading Should We Expand the Collateral Source Rule? No Thanks.

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We understand that not everyone shares our view of class actions, but we hold certain truths to be self-evident:  The government, including its courts, cannot order someone to give money to someone else without due process of law, in most cases a jury trial.  In addition, in order to win a judgment ordering a defendant to pay money, a plaintiff generally bears the burden of proof on each element of his or her claims, with very rare exceptions.  These principles are cornerstones of the protection that our laws offer to defendants who are haled into court, or at least ought to offer.

Class actions are an exception to these rules.  A limited exception, but an exception nonetheless.  With a class action, a defendant can become legally obligated to pay money to people who never proved their claims, or even had to try.  Instead, class representatives are allowed to stand in as proxies, and proof of their claims is deemed sufficient proof to force defendants to pay the other class members, possibly thousands of them, without any individualized proof.  On the other side of the coin, absent class members can be bound by a judgment that awards them nothing, even though they did not participate in the proceeding.  How can this be?  The potential for abuse is obvious, and that is why there are strict requirements for certifying class actions—Federal Rule 23 and its state-law analogs—and why courts should certify classes only after a “rigorous analysis” demonstrates that the proposed class meets all applicable requirements.  See Wal-Mart Stores v. Dukes, 131 S. Ct. 2541, 2551 (2011).

We wax on about these rules because a case in the Southern District of California recently departed from them in not only certifying, but expanding a class of women who allegedly purchased hormone replacement therapy products.  The case is Krueger v. Wyeth, Inc., No. 03-cv-2496, 2015 U.S. Dist. LEXIS 137548 (S.D. Cal. Oct. 7, 2015), and it has been around seemingly forever.  First filed in 2003, the case was transferred to the In re Prempro MDL, where the MDL judge denied the plaintiff’s motion to certify a class of California patients asserting claims for consumer fraud.  Id. at **5-6.  Not to be deterred, the plaintiff tried again with a different judge after the case was remanded back to California, and this time they found a more receptive audience.Continue Reading California Court Gets It Wrong On HRT Class Action

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Some of our bloggers are speaking at two more continuing legal education (“CLE”) events, one free, the other … not so free.

First, the freebie. On November 18, 2015 Reed Smith’s Life Sciences Group is hosting a half-day CLE program from 9:00 a.m. ET until 1:30 p.m. ET at the firm’s Philadelphia Office (1717 Arch Street, Three Logan Square (formerly the Verizon building)).  Here are the topics:

  • Adventures in Personal Jurisdiction: Can One Have the Bauman Cake and Eat it Too?
  • Turning the Tables – How to Secure Sanctions in the Frivolous Case
  • Tips for Proactively Defending False Claims Act Allegations by Whistleblower Employees
  • Buying Justice? An Ethical Examination of Third Party Litigation Funding

Two of our bloggers, McConnell and Bexis, will present the Bauman personal jurisdiction segment.  Blogger Rachel Weil is co-presenting the ethics segment on litigation funding.

This CLE is approved for four hours (or the equivalent) of CLE credit in both Pennsylvania and New Jersey – including an hour of ethics.  Breakfast and lunch are included.  Like we said, there’s no charge, but space is limited so attendees do have to register.  You can do that here.Continue Reading Shameless Plugs Redux − Two More Blog-Related CLE Events

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Today we discuss a couple of developments involving (actually or potentially) the application of the First Amendment to the FDA’s increasingly battered prohibition against truthful promotion of off-label use.

First, we’ve mentioned Pacira Pharmaceuticals v. FDA before as the latest First Amendment follow-up action to Amarin Pharma, Inc. v. FDA, ___ F. Supp.3d ___, 2015 WL 4720039 (S.D.N.Y. Aug. 7, 2015).  What we have for you now are the two industry-side amicus briefs filed in support of Pacira’s First Amendment motion against the FDA.  This one was filed by PhRMA, and this one was filed by something called the Medical Information Working Group, which is a consortium consisting of Amgen, Bayer, Boehringer, Lilly, Genentech, GSK, J&J, Novartis, Novo Nordisk, Pfizer, and Sanofi.  Impressive lineup.  And to think we can remember when nobody was willing to take on the FDA about truthful off-label promotion for fear of retaliation….  What a difference a few wins make.

We’ve read through the two amicus briefs and we heartily recommend them to anyone interested in bringing the FDA’s reign of (t)error in this area to long-overdue end.  Briefly, the MIWG brief makes the following points:  (1) the FDA’s ban is an “ambiguous tangle of regulations, nonbinding guidance documents, and severe enforcement practices”; (2) pharmaceutical promotion is First Amendment protected speech under Sorrell v. IMS Health, Inc., 131 S. Ct. 2653 (2011); (3) truthful off-label promotion provides valuable information to physicians and patients alike; (4) what FDA claims is “misbranding” is the same information it has pledged in other contexts to “work hard to address”; (5) Pacira’s speech is really on-label promotion that the FDA has attempted to suppress through an improperly crabbed reading of the drug’s intended use; (6) off-label use is legal, common-place, medically valuable, and sometimes the medical standard of care; (7) more truthful speech about off-label use is better than less; (8) the FDA’s ban unconstitutionally discriminates on the basis of both speaker and content; (9) the basis for the FDA’s ban is unconstitutionally vague and ambiguous; (10) FDA’s “safe harbors” are arbitrary and constitutionally inadequate; (11) the FDA has taken inconsistent positions on what off-label promotion is allowed; (12) the FDA has never even defined “promotion”; (13) the FDA’s vagueness and contradictory policies chills protected speech − truthful pharmaceutical promotion; and (14) because of this chilling effect there is both standing and justiciability.Continue Reading First Amendment Notes: Amicus Briefs In Pacira & Application of IMS v. Sorrell

Photo of Stephen McConnell

A couple of weeks ago we discussed the latest entry in the “the saga of Cymbalta plaintiff lawyers who keep pushing the litigation up a hill in an effort to create a class action, mass action, MDL, or whatever will allow them to park as many meritless cases in one place, only to have that…

Photo of Rachel B. Weil

We spent the weekend in the Boston area, visiting the Drug and Device Law Rock Climber for “parents’ weekend.” Saturday’s schedule was replete with activities:  a keynote speech by the university president, lectures on topics academic and not, an informative session on the school’s “semester abroad” program (the DDLRC has informed us that she hopes to spend next spring in Australia), and dozens of presentations by student arts groups (theatre, improv, orchestra, a cappella).

We didn’t get to do any of that.  By mid-morning, the DDLRC had tired of being trailed around campus by her parents.  All were shepherded to the “T,” where, several stops down the line, our procession (and its credit cards) descended on the downtown shopping district.  But before we left campus, we insisted on attending one lecture, a sparkling presentation by the head of the theatre department.  The subject was a famous circus mogul who was one of the university’s founding trustees and whose best-remembered donation was the carcass of his equally-famous circus elephant, who has since lent his name to all of the university’s sports teams.  According to legend, the elephant died while pushing a baby elephant out of the way of a speeding train.  The truth was a less-heroic, but equally fatal, elephant vs. train collision. In any event, he was duly stuffed and sent to live in a university museum.  Years later, he was incinerated in a building fire.  Some of his ashes were scooped into a container and displayed in the rebuilt museum, but a grander tribute awaited.  Just this year, a massive bronze statue of the elephant was erected outside the building bearing his patron’s name.  We love this campus attraction, and we wax irrationally sentimental about the whole story.

We are trying to think of a smooth transition to today’s discussion, but this is the best we can do:  like legendary elephants, Daubert and Frye standards for admissibility of expert testimony, as applied by modern courts, frequently defy segregation into discrete containers.  Notwithstanding a hybrid analysis squeezed into a Frye box, the conclusion was clear: plaintiff’s causation experts in a Philadelphia Zoloft case did not meet any relevant admissibility standards, and both were properly excluded.Continue Reading A Frye Opinion By Any Other Name: Zoloft Plaintiffs’ Experts Excluded in Philadelphia

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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