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Bookends – Prof. Jewell’s Opinions Also Excluded in Lipitor MDL, and More

By Bexis on December 17, 2015

April might be the cruelest month according to T.S. Eliot, but the last month hasn’t been very kind to plaintiffs’ expert Nicholas Jewell, Ph.D. As we posted recently, at the beginning of December, Prof. Jewell was booted from the Zoloft MDL. See generally In re Zoloft (Sertraline Hydrocloride) Products Liability Litigation, 2015 WL 7776911 (E.D. Pa. Dec. 2, 2015). Only two weeks earlier, however, he was also given the bum’s rush in In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation, ___ F. Supp.3d ___, 2015 WL 7422613 (D.S.C. Nov. 20, 2015). His being shown the door in two MDLs in two weeks is pretty impressive defense work. Anybody out there in a position to turn this brace into a hat trick?

Prof. Jewell is a statistician, not a medical doctor. Lipitor, 2015 WL 7422613, at *14 (“Prof. Jewell is a statistician, not a medical doctor or medical professional. He has no expertise in diabetes, has never treated participants of any kind, and is not a clinician.”). As in Zoloft, the Lipitor plaintiffs called him in to second-guess the statistical bona fides of studies involving the drug and condition (diabetes) in question. As we discussed in detail in the Zoloft post, Prof. Jewell started with the “a priori opinion” needed by his plaintiff-side paymasters and “t[ook] a results-driven approach . . ., molding his methodology and selectively relying upon data so as to confirm his preconceived opinion.” Zoloft, 2015 WL 7776911, at *16. Thus, it’s no surprise at all that he committed the same statistical sins in Lipitor:

The Court finds that Prof. Jewell’s analysis of the [statistical] data was results driven, that Prof. Jewell’s methodology and selection of relevant evidence changed based on the results they produced, and that Prof. Jewell chose to ignore and exclude from his report his own analyses that did not support his ultimate opinions. It is apparent to the Court that rather than conducting statistical analyses of the data and then drawing a conclusion from these various analyses, Prof. Jewell formed an opinion first, sought statistical evidence that would support his opinion and ignored his own analyses and methods that produced contrary results.

Lipitor, 2015 WL 7422613, at *18.Continue Reading Bookends – Prof. Jewell’s Opinions Also Excluded in Lipitor MDL, and More

“You are unwise to lower your defenses!”

By Stephen McConnell on December 16, 2015

We do not have a case to blog about this week. Things in the DDL world are slow. Well, that is not exactly right. In fact, maybe it is exactly wrong. There is plenty going on, but virtually all the bloggable (that is, interesting and not yet already well-publicized) DDL cases involve our firm, Reed Smith, in some way, and blogging about such cases is like running through a gauntlet and minefield. It is probably a good problem to have – unless you are staring at an empty computer screen and Bexis is clamoring for content. So where does that leave us?

Usually we run into these doldrums during the Summer, when courts plunge into a blissful torpor. The first time we completely discarded the DDL script and blogged about no case was the Summer of 2011, when we went fully self-indulgent (or, at least, more self-indulgent than usual) and told a story about a deposition against a plaintiff lawyer who claimed to be the provocation behind Star Wars. In truth, it is probably the single best blog post that emerged from our clumsily pecking fingers. The folks at Abnormal Use recently linked to that post, so the number of views spiked. Our cheap immortality grows yet again.

So now comes our Return of the Nerdy. Put plainly, we are embarrassingly excited about the release of The Force Awakens later this week. Our childish enthusiasm is marred only a little by the grim undercurrent mantra of “Please Please Don’t Suck”. The prequel trilogy left psychological and aesthetic scars. From what we hear, this new entry is set 30 years after Return of the Jedi. And, in fact, it is about 30 years since Return of the Jedi. JH Abrams has taken the helm from George Lucas, which is almost certainly a Very Good Thing. Abrams did a nice job with the Star Trek reboot. And let’s not forget that Lucas did not direct the best Star Wars film, The Empire Strikes Back, while he did oversee the excrescence called The Phantom Menace. (The Simpsons episode where Bart watches in disbelief how that film centered on a tariff dispute is absolutely precious). The great Lawrence Kasdan wrote The Force Awakens screenplay. John Williams composed the score. We are weak-kneed with anticipation.Continue Reading “You are unwise to lower your defenses!”

A Civil Discussion

By Stephen McConnell on December 2, 2015

This week sees the annual ACI Drug and Medical Device Litigation get-together in New York. Here’s a shameless plug: we will take part in a panel discussion on civility, diversity, and ethics. We were assigned the dreaded end-of-conference Friday afternoon slot, so we are prepared to bellow over the din of retreating rollaboards. Always a good time. Rumor has it that some plaintiff lawyers are showing up. The panel will devote a few minutes to discussing how nice it is to be nice. We might also devote a few minutes to challenging that assumption.

Not that we have anything against conviviality, especially this time of year.

Conviviality is good in itself, but it can also serve a purpose. Recently we attended an MDL hearing. Part of the festivities included a cocktail party, complete with defense hacks, plaintiff lawyer pursuers of justice (in the form of wire transfers), and court staff. Talk about civility! Several times we were treated to an odd bit of theater where a lawyer would snicker about how something weird and wonderful happened, but how it dare not yet be revealed. Then, two or three sips later, that same lawyer would whisper out of a mouth corner something like, “Okay, here’s how it went down.” Most of what we learned was silly or possibly wrong. But we gathered at least one useful tidbit.
Continue Reading A Civil Discussion

Lost Chance Loses In Product Liability

By Bexis on November 30, 2015

Occasionally we see plaintiff-side experts attempt to opine, to a reasonable degree of medical certainty (or sometimes probability), that one of our clients’ products was a substantial factor – not in “causing” the purported injury, but in “increasing the risk” of that injury occurring. Such an opinion should be a red flag to any of our defense-side colleagues. It means that the plaintiff’s medical causation evidence is downright lousy.

It also means that a summary judgment motion on causation is probably appropriate. Causation allegations based only on “increased risk” are hallmarks of medical malpractice “lost chance” cases, not product liability. “Lost chance” is a medical malpractice concept derived from certain sections of the Second Restatement (§§321 and 323) applicable only where a pre-existing condition, not diagnosed in a timely fashion, gets significantly worse in the interim, and thereby arguably deprives the plaintiff of a “chance” for a cure. A number of courts have considered that “lost chance” to be a cognizable injury and have relaxed causation standards to permit recovery, because “but for” causation is virtually impossible to prove where the pre-existing condition was progressive to start
with.

We have always maintained that, regardless of the validity of “lost chance” causation in medical malpractice, it’s simply not a product liability theory – since in product liability the product must actually have caused whatever injury that the plaintiff claims occurred. We’re thinking about one of our 50-state surveys on this issue, and we invite our readers to chime in on whether they think it would be helpful.Continue Reading Lost Chance Loses In Product Liability

The Risks of Plaintiff Lawyer DTC Advertising

By Stephen McConnell on November 25, 2015

We have been riding the Philly subway for years, but only recently realized how much the ads on the car walls have changed. Not so long ago there were lots of ads for vocational schools, inducing today’s un- or underemployed to become tomorrow’s truck drivers and beauticians. But nowadays at least three quarters of the ads are from plaintiff lawyers hawking their ability to wring cash out of slip-and-falls or the latest mass tort. Mass transit advertising space that formerly advised riders to get skills is now dedicated to pleas to get paid. The same is true for daytime television advertising. Perhaps we are not alone in seeing this evolution as further proof, along with Keeping up with the Kardashians and the ascendancy of kale salad, that our culture is headed to Hell in a handbasket.

You won’t be surprised to hear defendants and their lawyers bemoan plaintiff lawyer advertising. But we are not alone. Recently, we heard a MDL judge express frustration about how plaintiff lawyer advertising was a blatant attempt to extend the tail of an over-mature mass tort. Some plaintiff lawyer advertising is naked poaching of other plaintiff lawyer inventories – e.g., why pay a 40% contingency fee if you can pay only 20%? But the most obvious aim and effect of such advertising is stirring up litigation. What might not be so obvious is the extent to which plaintiff lawyer adverting causes adverse health outcomes. A recent law review article looks into this issue and it is well worth reading. The article is by Elizabeth Tippett, a professor at the University of Oregon School of Law. The title is “Medical Advice from Lawyers: A Content Analysis of Advertising for Drug Injury Lawsuits,” 41 Am. J. L. & Med. 7 (2015).Continue Reading The Risks of Plaintiff Lawyer DTC Advertising

Medical Device Manufacturers as “Health Care Providers”

By Bexis on November 18, 2015

We’ve read a fascinating new case out of Texas, Verticor, Ltd. v. Wood, ___ S.W.3d ___, 2015 WL 7166024, No. 03-14-00277-CV, slip op. (Tex. App. Nov. 13, 2015), posing the question whether a medical device company can be a “health care provider” within the meaning of that state’s pretty restrictive laws regarding medical malpractice. While rejecting the manufacturer’s appeal on the record before it, the court in Verticor didn’t flatly say “no.” Instead, it held:

As the issue is framed here, [[manufacturer’s] license authorizes it “to provide” (at least in the sense of manufacturing and selling) the [device] − and nothing more. Consequently, [manufacturer] can be “licensed . . . by the State of Texas to provide health care” only if the [device] is, in itself, “health care” as the [statute] defines that term. . . . Under it, “health care” is distinguished by either of two nouns − “act” or “treatment” − that is “performed or furnished,” or should have been, “for, to, or on behalf of a patient during the patient’s medical care, treatment, or confinement.” The first alternative, an “act,” denotes some sort of deed or activity. As an inanimate object, [the device], in itself, could not be an “act,” although it might be utilized in acts that qualify as “health care,” such as surgery. Similarly, the other alternative, “treatment” also denotes some form of activity that is performed or furnished for or to a patient. Consequently, the [device] would not, in itself, be a “treatment,” although it might be utilized in a “treatment.”

Verticor, slip op. at 10 (footnotes omitted). All this manufacturer submitted was that it was licensed to manufacture medical
devices. That wasn’t enough. Texas medical malpractice tort reform was separate from that state’s product liability tort reform. Id. at 11-12. Further, the “common usage” (how such statutes are construed) of the term “health care” denoted something different from manufacturing:

In common usage, one associates “health care” with medical intervention, assistance, or other acts − e.g., one’s family doctor performing an annual physical or a nurse administering a flu shot − as opposed to the mere making or selling of a product used in providing such services. Focusing as it does on acts and treatment provided to patients, the [statute’s] definition of “health care” does not clearly depart from this basic notion.

Id. at 13.Continue Reading Medical Device Manufacturers as “Health Care Providers”

Never Say Never to Lone Pine Orders

By Stephen McConnell on November 4, 2015

After our last two posts, we received emails blasting us for being insensitive to the plight of injured plaintiffs. That struck us as unfair, given that the posts pertained to the technical issues of choice of law and choice of forum. There was certainly no display of mirth over anyone’s maladies. But now we are feeling a wee bit gun-shy, so this week’s report steers clear of anything remotely incendiary.

In fact, it is not even about a drug or device litigation. Rather, the case involves an environmental dispute. But it is interesting because it includes a “Lone Pine” order, something that mass tort defendants often ask for but less often actually get. Named after a case from New Jersey, a Lone Pine order forces mass tort plaintiffs to furnish some concrete proof, often in the form of an expert affidavit, establishing basic facts such as product usage and medical causation. Lone Pine orders can be an effective method for ensuring that mass tort inventories are not built up with frivolous cases.

This week’s case under review is Modern Holdings, LLC et al. v. Corning Inc., et al., 2015 WL 6482374 (E.D. Ky. Oct. 27, 2015). The magistrate judge apparently thought that discovery was moving along too slowly, and entered an order requiring personal injury plaintiffs to submit affidavits explaining: (a) the specific illness sustained, (b) the date of diagnosis and information about the medical provider rendering the diagnosis, (c) the toxic chemical allegedly causing extensive illness, including manner, pathway, dates, duration, and dose, and (d) the scientific literature supporting causation. Property damage plaintiffs were required to submit affidavits explaining: (a) property address, (b) facts re contamination, and (c) degree of diminution in value. The plaintiffs sought reconsideration from the district court.Continue Reading Never Say Never to Lone Pine Orders

What To Do About Junk Science That’s Published?

By Bexis on October 29, 2015

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?

Philly Court Applies Michigan Law to Dismiss Risperdal Cases

By Stephen McConnell on October 28, 2015

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

Another Smack Down for Cymbalta Plaintiffs’ Lawyers

By Michelle Yeary on October 27, 2015

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

Drug & Device Law