Recently in Vioxx/Drug Litigation Category

David Oliver has lots of good questions about the nonsensical Bartlett v. Mutual case that we discussed May 3.

Sulindac, like all NSAIDs, is capable of causing the rare (and horrific) reaction toxic epidermal necrolysis, and does so in about five or six patients a year. Nevertheless, the FDA, in evaluating the drug, recognized that the benefits outweighed the rare side effects, and approved the drug as "safe and effective." Karen Bartlett was in the very unfortunate one in a million, and suffered the rare side effect when she took generic sulindac. Her failure-to-warn theory was both a non-starter (her doctor never read the warnings) and, in any event, preempted by Pliva v. Mensing. But she was permitted to take a "design defect" theory to the jury. It's unclear how defendant Mutual Pharmaceutical was supposed to "design" sulindac differently; after all, it's a single molecule, and no one claimed that the inactive ingredients in the medication were at fault. But plaintiffs' theory was that the FDA was wrong, and that manufacturers should simply withdraw the drug from the market. A judge let this get to a jury, and let the jury consider the warning label in determining whether the drug was unreasonably dangerous, and, after the inevitable loss aversion bias kicked in, Mutual is now on the hook for $26 million. All this made possible by the Supreme Court's erroneous anti-business decision in Wyeth v. Levine. [Bartlett v. Mutual Pharmaceutical Co. (1st Cir. May 2, 2012) (via Bashman)].

Beck calls for Supreme Court review. I agree.

(Looking for good links on NSAIDs and SJS, I found that the search-engine-optimized websites for Stevens-Johnson Syndrome are all trial-lawyer sites, natch, with misleading names like "Skin Association.")

In The American Conservative, Ron Unz compares the Vioxx litigation to the Chinese melamine scandal, and finds the American justice system lacking. (Also: Sailer; Roberts; and a plaintiffs' lawyer who makes the lay mistake of confusing a mass tort with a "class action".) But Unz's entire argument is based on an incorrect premise. Unz assumes that David Graham is correct in implying that Vioxx had "probably been responsible for at least 55,000 American deaths during the five years it had been on the market." But Graham is not. While Graham's text in the Lancet made wild allegations, the headlines were not supported by his underlying data, which found a relative risk of low-dose Vioxx of 1.24, which was not statistically significant. A later Lancet study confirmed that Vioxx and other COX-2s were no worse than other NSAID pain relievers when it came to cardiovascular risk.

And, of course, Vioxx was not merely a product of corporate profit-seeking; it had benefits over other pain relievers. Since Vioxx has been withdrawn from the market, serious ulcerations have increased 21%.

Merck's total legal bill for Vioxx is in the range of $8 billion and counting, though it correctly won the vast majority of cases taken to final judgment; the only ones it lost, it lost due to junk science. Merck's experience with Vioxx is certainly a damning indictment of the American justice system, but for reasons opposite than the ones Unz thinks.

In the mid-1960s, Lt. Patrick O'Neil served on the USS Oriskany, a 1940s-era aircraft carrier. O'Neil's work in the boiler-room exposed him to asbestos insulation manufactured by Johns Manville, and, decades later, he contracted mesothelioma. O'Neil isn't allowed to sue the Navy; Johns Manville is bankrupt from previous asbestos litigation. So O'Neil sued innocent third parties that happened to sell products to the Navy that didn't contain asbestos on the theory that they should have warned users about the risks of asbestos from other products that might be used in conjunction with their harmless products. O'Neil also sued a company that sold a part in 1943 that did contain asbestos (pursuant to Navy requirements), but whose asbestos components had been replaced by the time O'Neil encountered them.

Fortunately, in last week's O'Neil v. Crane, the California Supreme Court unanimously rejected this attempt to expand tort law beyond all moorings. When "the consequences of a negligent act must be limited to avoid an intolerable burden on society, policy considerations may dictate a cause of action should not be sanctioned no matter how foreseeable the risk." Unfortunately, in the absence of federal law on the subject, this means that future plaintiffs are simply going to forum-shop their asbestos litigation to other states that have not so dispositively rejected such expansive theories, so innocent manufacturers who happened to sell products to the Navy are not going to be off the hook yet. But good precedent is good precedent, and it's important that the California Supreme Court is willing to acknowledge that the fact that there are some injured plaintiffs who don't have recovery does not require courts to invent theories to permit collection from distant defendants. And as Beck points out, the decision has consequences for intermediate California courts that have held that pharmaceutical manufacturers can be held liable for the sales of similar products by generic manufacturers. [Jackson; Beck; Wajert; PLF; PLF amicus; Stier; Cal Biz Lit via @walterolson; LNL; Recorder/law.com; Ruskin]

A missed opportunity in Snigdha Prakash's All the Justice Money Can Buy:

Prakash turns a series of trial transcripts into a high-school soap, where the cool kids try to take the Honors Society down a peg, and kind of succeed, but kind of don't. By the time she reaches the end of the trial, she is recounting a scene that could literally take place in a classroom, where a member of the trial team passes her a note mocking defense counsel and she laughs out loud, attracting the woman's attention. (Page 244.)

That attitude is endemic to Prakash's book. Her verdict at the end is not that the plaintiffs made a mistake in structuring the trial as they did or presenting the evidence as they did, but that the jury made a mistake in not believing the story as the plaintiffs presented it. There are some interesting nuggets along the way--Mark Lanier is clearly a talented storyteller, and provides some worthwhile analysis on day-by-day trial presentation--but the fact that the plaintiffs appeared to make such a large blunder at either the beginning or the end of the case, and that blunder goes unexamined for the two hundred thirty pages in between, or the twenty pages afterward, mean that they're not quite worth the slog through the shallow cheerleading that takes up the remainder of the book.

Earlier and see also.

Tuesday, junk science led a Philadelphia jury to award three women (ages 66 to 68) verdicts ranging from $20M to $28.75M in suits alleging that Pfizer's Prempro caused their breast cancer. [Bloomberg; Phil. Inquirer]

Pfizer has won over 3000 of these cases, including 44 that were set for trial, but when juries can award $20M/plaintiff (plus potential punitive damages: Bloomberg discusses a "second phase" of the trial without being clear what that means), it's still profitable to bring long-shot cases like these were, especially when the state courts are less skeptical than federal courts about allowing experts to quack-ily apply one study's results to disparate facts. Which is perhaps why plaintiffs' lawyers have twisted themselves in knots to avoid federal court. Coincidentally, Monday's WSJ discusses the problem of forum shopping for the Philadelphia judicial hellhole.

Gregory Conko, a senior fellow at the Competitive Enterprise Institute, a Washington D.C.-based public interest group, authored an interesting piece discussing the FDA's ban on off-label promotion published on our sister blog Medical Progress Today.

Greg writes,

The problem is that FDA bans not just false or misleading claims about an off-label use's safety and efficacy. That is, it's not just preventing snake oil salesmen from peddling quick fixes that don't work. The agency bans all promotion of off-label uses, even if those uses have been proven to be safe and effective in clinical trials. Even if those uses are considered to be the standard of care for a given ailment. And even if a physician could be liable for malpractice for not administering a drug off-label.

He also examines the ban in a First Amendment context,

Few would argue that false or misleading claims in a commercial context should be protected by the First Amendment. However, a few decades worth of now-well established case law concludes that government may not categorically bar truthful and non-misleading speech simply because its purpose is to promote a commercial transaction. Instead, government must have a substantial interest in regulating the speech in question, and the regulation must directly advance that governmental interest and be no more extensive than necessary to do so.

If you had any doubt about NPR reporter Snigdha Prakash's bias against Merck when covering the Vioxx litigation, she completely dispelled it with a wrong-headed piece in Slate about Merck CEO (and former general counsel) Charles Frazier being appointed to head the investigation on the Sandusky scandal at Penn State. Prakash slanders Merck with a variety of false claims, referencing the bogus Lancet study claiming Vioxx caused an additional 140,000 heart attacks; claiming "most of the five-and-a-half years it sold Vioxx, Merck knew the drug doubled the risk of cardiovascular problems among users" (they didn't and it didn't); "withholding clinical trial results that would have definitively proven Vioxx's risks to federal regulators" (they didn't and they didn't). Even today, it is unclear whether Vioxx produced a net benefit, with its gastroprotective aspects outweighing the slight increase in cardiovascular risk. Prakash complains that Merck settled its cases for "only" $5 billion (plus another $2 billion in defense costs): why does she think that the lawyers left tens of billions of dollars on the table if Merck had actually done something wrong? She mentions the tens of thousands of suits, but not that thousands of those suits involved plaintiffs who hadn't even taken Vioxx—and that the lawyers who committed fraud on the court suffered no consequences (and in fact were rewarded handsomely). To top it all off, she ignorantly suggests that the appointment of Frazier suggests a scorched-earth litigation strategy by Penn State, though Frazier will have nothing to do with Penn State's legal strategy (and is likely to have little role beyond editing and delivering an investigative report generated by other attorneys that he supervises). Earlier.

We've previously discussed a series of lawless cases in Nevada against Teva Pharmaceuticals and Baxter Healthcare over the misuse of propofol by the Desert Shadow Endoscopy Center, whose ludicrously unsanitary practices caused dozens of cases of hepatitis C: May 19, 2010; May 24, 2010; ; June 17, 2010; March 4. The culpable doctor and entities are bankrupt, so lawyers have been going after the deep pocket, aided by judges that refuse to apply federal law barring such lawsuits or to permit the corporate defendants to defend themselves by letting juries know the real facts of the case. As we noted in November, procedural shenanigans have promoted the scheduling of a case involving a plaintiff-friendly judge making improper rulings while staying a related case in another courtroom where the judge is following the law.

Over the last week, a jury in the Sacks v. Endoscopy Center of Southern Nevada LLC case found the pharmaceutical defendants liable again: $20 million in "compensatory" damages, and $162 million in punitive damages. A third jury awarded $14 million in compensatory damages to another plaintiff, and is considering punitives. None of the press or blog coverage adequately indicates how scandalous and abusive these verdicts are. [LVRJ; Reuters/Frankel; AP/WaPo; Pharmagossip; Pharmalot]

(I'll be at UNLV Law in February discussing the propofol litigation.)

MI's Marie Gryphon reviews Snigda Prakash's All the Justice Money Can Buy in the latest issue of Barron's. My take earlier; and related.