As lawyers, we have to get client approval before we can discuss their litigation substantively. Here are a couple just-in decisions where we’re doing that, but that are important enough our readers would want to know about them right away. In re Incretin-Based Therapies Products Liability Litigation, slip op. (S.D. Cal. Nov. 9, 2015)
Back in 2009 – when the blog was still a Bexis/Herrmann operation – we wrote a catch-all punitive damages post entitled (oddly enough) “On Punitive Damages.” That post identified and briefly discussed a variety of punitive damages-related issues, including what amount of increased risk is enough to justify an award of punitive damages under applicable state-law standards. We pointed out a couple of Restatement sections, Restatement (Second) of Torts §§500, 908, that defined “recklessness” for punitive damages purposes in relation to a “high degree of risk.”
That’s an interesting question, because a product that increases the possibility of death or serious injury due to some particular risk from one in a zillion to two in a zillion has doubled the relative risk – but in absolute terms the increase is tiny.
Ever since that post we’ve been meaning to come back and examine that punitive damages issue in greater detail. Today we finally get around to it. Because doing the job right would require research well beyond prescription medical products, we looked for research help, and enterprising (pun intended) Reed Smith associate Kevin Hara stepped up to handle the initial spadework. To put the question in the affirmative, can we defeat punitive damages, even where a relative increase in serious risk is high, where the absolute increase in risk remains minuscule? What increase in the risk of injury enough to warrant sending punitive damages to the jury? Is a one in 10,000, one in 5000 risk significant enough? How about one in 1000? One in 100?Continue Reading Punitive Damages – How Much Increased Risk Is Enough?
This post is not from the Dechert side of the blog.
“Failure to update” claims have multiple problems. You probably already know what we are referring to. Federal law requires that generic drug manufacturers distribute their products with drug labeling that is the same as their innovator counterparts—the so-called “duty of sameness.” A “failure to update” claim is where a plaintiff alleges that a generic manufacturer did not update its labeling to match the most current FDA-approved changes to innovator labeling and that the failure caused an injury. Because that involves an FDA-imposed duty, it is easy to conclude that it looks a lot like a disguised form of FDCA enforcement barred by Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), as we pointed out here.
In addition to the preemption issues, “failure to update” claims are highly contrived. We never saw them before the Supreme Court found most claims against generic drug manufacturers preempted by federal law, and the key principle under tort law is whether drug labeling adequately warns of known and reasonably knowable risks. Sameness might be relevant to adequacy, but it also might not. In this regard, “failure to update” claims are nothing more than plaintiffs’ lawyers trying to thread the eye of a needle after Mensing and Bartlett.
True, the duty of sameness does not seem all that onerous to our uneducated eyes: Just follow the leader. And it is not like we are talking about absolute liability. As we have discussed, the plaintiffs still have to prove all the elements of their claims, including (but not limited to) causation. On days when we are in this generous frame of mind, “failure to update” claims are something we can live with.Continue Reading Warnings Causation Sinks “Failure to Update” Claim
It’s not often that we get to blog about a new area of federal preemption, but we do so today. This isn’t a big area, otherwise we would have known about it before, but it is pertinent to drug and medical device product liability litigation to the extent that it affects our client’s customers – hospitals and prescribing physicians.
We’re talking about a statute called the “Patient Safety and Quality Improvement Act” (“PSQIA”). It was passed as part of HIPAA amendments in 2005 to create reporting systems for medical errors, so that such errors could be analyzed and the analysis used to prevent future medical errors. That’s all well and good, but we know how plaintiffs’ lawyers are anytime anything adverse has to be reported – and, more importantly, so did Congress. Just as FDA adverse event reporting is protected, 21 U.S.C. §360i(b)(3) (reports inadmissible); 21 C.F.R. §20.63(f)(2) (discovery of reports preempted), so too is peer review reporting under the PSQIA.
This information – data generated by reporting and analysis of medical errors – is called “patient safety work product” (“PSWP”). The PSQIA provides that it is privileged and confidential:
(a) Privilege
Notwithstanding any other provision of Federal, State, or local law . . ., patient safety work product shall be privileged and shall not be. . . .
(2) subject to discovery in connection with a Federal, State, or local civil, criminal, or administrative proceeding. . .;
(3) subject to disclosure pursuant to section . . . the Freedom of Information Act[] or any other similar Federal, State, or local law;
(4) admitted as evidence in any Federal, State, or local governmental civil proceeding . . . .
(b) Confidentiality of patient safety work product
Notwithstanding any other provision of Federal, State, or local law, and subject to subsection (c) of this section, patient safety work product shall be confidential and shall not be disclosed.
42 U.S.C. §299b-22(a-b). Just about every state has some form of peer review privilege, and now PSQIA provides a uniform federal overlay to those
state-created protections.Continue Reading Federal Preemption and Peer Review – A New Frontier
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
As we noted yesterday, Halloween may be behind us, but the scary decisions just keep on coming. Just about a month ago, we blogged about pending legislation (H.R. 3624), known as the “Fraudulent Joinder Prevention Act of 2015.” Today we blog about a case that demonstrates why that legislation is needed.
The case is Rosbeck v. Corin Group, PLC, 2015 U.S. Dist. LEXIS 145621 (D. Mass. Oct. 26, 2015). Plaintiff filed suit in state court in Massachusetts alleging he suffered injury as the result of the implantation of a hip resurfacing system. Plaintiff sued the manufacturers of the implant for negligence, breach of warranty, and consumer fraud. Plaintiff also sued the hospital at which the surgery was performed for breach of warranty. Id. at *6. The manufacturers, being diverse defendants, removed the case to federal court alleging that the non-diverse hospital was fraudulently joined. Id. at *2. Plaintiffs moved to remand.
Under First Circuit law, on a motion to remand, the manufacturing defendants had the burden of proving that plaintiff does not have a “reasonable possibility” of recovery against the non-diverse hospital. Id. at *7. Defendants asserted three reasons why they met that burden: (1) Massachusetts doesn’t recognize a claim for breach of warranty against a hospital for supplying a medical device as part of treatment; (2) the claim against the hospital is preempted; and (3) the claim against the hospital is barred by the stature of limitations. Id. at *10.Continue Reading Remand Run Amok
Halloween has come and gone. The Drug and Device Law Little Dogs stayed in their costumes (Batgirl and a rabbi) long enough to be photographed for (unsuccessful) entries for a pet costume contest. There was ample candy – about 15 pounds, which more than sufficed for the seven times the doorbell rang. And we enjoyed the modest stream of excited kids, flushed with the thrill of pretending to be something they weren’t.
We assume that the plaintiff/relator in United States ex rel Gerasimos Petratos v. Genentech, 2015 U. S. Dist. LEXIS 146525 (D.N.J. Oct. 29, 2015) is less thrilled. In this qui tam action, plaintiff pretended that the wrongdoing he alleged was something it wasn’t: a violation of the False Claims Act. The court summed it up in the first paragraph of its decision: “This case concerns whether the False Claims Act can be extended to cover wrongful behavior that does not lead to a false claim. It cannot, so Plaintiff’s Amended Complaint must be dismissed.” Petratos, 2015 U.S. Dist. LEXIS 146525 at *1. Two big issues were decided: (1) no product liability-style (prescriber specific) causation in FCA cases; and (2) the FCA is not a catch-all negligence per se statute for regulatory violations. The defense won both, so this case is significant.
The allegations surrounded defendant Genentech’s anti-cancer drug Avastin, a “monoclonal antibody cancer drug that limits the growth of tumors by preventing the growth of blood vessels that feed tumors.” Id. The court explained that, in 2010, the Oncologic Drugs Advisory Committee of the FDA recommended denying approval of Avastin for metastatic breast cancer due to concerns about clinical trial data Genentech had provided. Nevertheless, later that year, the FDA approved Avastin for treatment of patients with metastatic breast cancer. Id. at *3. The approval “was conditioned on completion of adequate studies showing the drug’s clinical benefit.” Id. Subsequent clinical studies failed to demonstrate such benefit, and the FDA removed the metastatic breast cancer indication from Avastin’s label in 2011. Id. The drug, which can cause serious side effects, remains approved to treat metastatic colorectal cancer, nonsquamous non-small cell lung cancer, glioblastoma, and metastatic renal cell carcinoma. Id. In addition, it is used off label for renal cancer, ovarian cancer, ovarian cancer, pancreatic cancer, and various eye diseases. Id. Continue Reading No False Claims Act Case Where There is No False Claim – DNJ Throws Out Qui Tam Action Against Genentech
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)
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:
Continue Reading What To Do About Junk Science That’s Published?
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