First, a bow to my opponent. I reference the pharmaceutical company defense lawyers from Dechert at Drug & Device Law a lot here on this blog even though, as a plaintiff’s lawyer, I’m always on the other side from them (one might even say they’re on the wrong side of the law) because they write a great blog. They write detailed, passionate arguments about substantive issues of law, and they link liberally, involving others in the conversation. It’s not that I haven’t noticed you folks over at Weil Gotshal with your competing Product Liability Monitor (link nofollowed), but you need to add some hot sauce and link out if you want to roll with the big boys. Maybe it’s because Dechert’s in Philadelphia and Weil Gotshal’s in New York, or maybe it’s because we Philadelphia lawyers punch a little bit harder.
Now, on to the fight. Drug & Device Law has compiled their “Ten Worst Drug/Medical Device Decisions of 2011.” It must have been a Herculean task: from my perspective, you have to look really hard to find court decisions against the pharmaceutical and medical device industry. As I’ve written before, the deck is stacked against innocent people injured by these drugs and medical devices: it’s almost impossible to sue pharmaceutical companies for anything other than inadequate warnings on their labels (a claim that is itself in peril, even as drugs like Actos, Pradaxa, and Propecia warn of their minor risks but not their major risks), and it’s virtually impossible to sue implant and medical device manufacturers for anything other than violating FDA regulations.
Of course, none of the court opinions on the D&D Law list were really against the drug and medical device companies; no court ever rules that a drug company was negligent or that medical device company has to pay compensation. When a plaintiff “wins” a court decision, that really means the plaintiff gets a chance to prove their case in front of a jury. Instead, when drug and device companies complain about courts, it’s because they think the court should have dismissed the cases entirely, without a trial, without a word of testimony or a shred of evidence shown to a jury. The bulk of the cases cited by Drug & Device Law follow that pattern, with the defense lawyers complaining either that a court didn’t buy some preposterous defense theory or that a court didn’t let a company walk away scot-free after violating FDA regulations and hurting people.
Indeed, the D&D Law list of cases is revealing because of just how reasonable these “worst” court opinions are. There’s been a lot of press lately about how more Americans are killed annually by prescription medication overdoses than car accidents; coincidentally, D&D Law’s “worst” decision of the entire year, DiCosolo, involved a consumer indisputably killed by a defectively manufactured prescription painkiller patch, and they argue we’re supposed to let the maker of that deadly product walk away from any accountability because the DiCosolo’s weren’t compulsive hoarders that held on to every used disposable product in their house? Because Janssen Pharmaceuticals failed to convince a jury of its ridiculous fentanyl fairy theory? What’s so wrong with letting a jury hear those factual arguments and deciding what’s true and what’s not, the way we’ve settled disputes since ancient times?
Let’s unpack a couple of these “worst” opinions and see just how bad they really are.
#1 — DiCosolo v. Janssen Pharmaceuticals, Inc., 951 N.E.2d 1238 (Ill. App. 2011)
38-year-old Janice DiCosolo, who suffered from suffered from a horribly painful nerve root problem in her neck that required she constantly take a variety of painkillers, died while using a Duragesic skin patch. Duragesic delivers fentanyl, a powerful narcotic (fentanyl’s so powerful it’s used in anesthesia), through a gel and ethanol mixture embedded within the patch. When it functions properly, the Duragesic provides a bloodstream fentanyl level of 1.7 nanograms per milliliter (ng/mL). After DiCosolo died, the medical examiner found she had a whopping 28.2 ng/mL of fentanyl in her blood, more than sixteen times the level the patch was supposed to produce. The day after she died, Janssen Pharmaceuticals announced an “Urgent Class I Drug Recall” of a certain lot of its Duragesic patches — the same lot that DiCosolo’s last patches came from. The patches were defectively manufactured and could leak excessive fentanyl.
It doesn’t take a genius to figure out what happened. Problem was, DiCosolo’s husband didn’t keep every patch she used (who would?), so only the one he had available for testing was the one she was wearing when she died, and it wasn’t clear if it had the problem or not. So, in addition to relying on good old common sense — where else could the fentanyl have come from? — DiCosolo’s lawyers called an expert with an Ph.D. in chemical engineering who specialized in transdermal drug delivery, and the expert testified that the penultimate patch probably leaked and caused DiCosolo’s death.
In their defense, the defendant drug companies argued that the fentanyl fairy secretly slapped 15 additional patches on DiCosolo while she was wide awake. At least, that’s what I think they argued, because nothing they actually argued at trial made any sense: they implicitly admitted that 28.2 ng/mL of fentanyl in someone’s bloodstream is fatal (as they had to, considering that a level one-tenth of that can be fatal), but claimed, without any proof, that DiCosolo also took a bunch of other prescription pain killers, none of which were found in her autopsy, and that those drugs caused her death, not the fentanyl.
Drug & Device Law complains the case should never have gone to a jury at all. Instead, they argue, the judges should have overruled common sense, ignored the fact-finding role of the jury, and denied DiCosolo’s family a jury trial by holding, as a matter of law, that the fentanyl fairy defense was the only reasonable explanation of what happened. Count me unconvinced of how terrible this decision was.
Bonus issue! In the trial, Janssen Pharmaceuticals repeatedly claimed they were fully cooperating with the FDA for the recall, and that the FDA approved all of their conduct in the recall. In response, DiCosolo produced an internal email someone at the drug company wrote in the middle of the recall that said, “It is very difficult to partner with the FDA if we keep deceiving them. If we keep deceiving them, we can’t partner with them.” Janssen Pharmaceuticals argued it was “inherently prejudicial” to admit that email into the jury, as if drug companies had special license to lie to juries about deceiving the FDA. The court didn’t buy it.
#2 — Hughes v. Boston Scientific, 631 F.3d 762 (5th Cir. 2011)
Jan Hughes was being treated for menorrhagia, or excess uterine bleeding, with a HydroThermAblator manufactured by Boston Scientific. The medical device works by circulating hot saline solution (194° F) through the uterus, causing the lining of the uterus to slough off and discharge. According to the court opinion, the device leaked during Hughes’ procedure, “caus[ing] a three-inch by two-inch burn on Hughes’s outer perineal body and an area of similar size inside the vaginal introitus, which [her doctor] characterized as second-degree burns.” Burns are bad enough, but burns on the inside and outside of a person’s genitals are a different matter entirely. Does anyone other than pharmaceutical defense lawyers doubt that Hughes deserves compensation?
But the HydroThermAblator had gone through the FDA’s not-particularly-rigorous premarketing approval (“PMA”) process, and so the bulk of potential negligence claims against Boston Scientific for making an expensive medical device that didn’t work as well as a $10 tea kettle were “expressly preempted” by § 360k of the Medical Device Amendments of 1976 as interpreted by the Supreme Court in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) and “impliedly preempted” — “implied preemption” is a code-phrase conservative judicial activists use when they want to pretend Congress tried to stop state tort lawsuits even when it didn’t — under § 337a of the MDA as interpreted by Buckman v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001).
Thus, thanks to a Congress in the pocketbook of the drug and device companies and the Riegel and Buckman opinions, Hughes can’t win even if she proves that Boston Scientific was negligent in making a defective medical device (that’s Riegel) and can’t win even if she proves that Boston Scientific failed to follow FDA regulations (that’s Buckman). It’s a terribly unfair example of special interest legislation and judicial activism for the benefit of the medical device manufacturers, but at least there’s one tiny exception to those dismal cases: if a person injured by a PMA medical device can prove that the manufacturer was negligent in a way that also violated FDA regulations, then they can recover compensation.
After extensive discovery, Hughes was prepared to prove to a jury that Boston Scientific failed to follow FDA regulations requiring a manufacturer of a Class III device report incidents in which the device may have caused or contributed to a death or “serious injury” by ignoring reports first degree burns entirely and disregarding a large number of reports of second degree burns. Two years after Hughes’ burns, the FDA itself directed Boston Scientific to stop disregarding so many reports of leaks of burn-related injuries. After that direction, reports of those leaks and burn-related injuries shot up more than ten-fold — undeniable evidence that they had turned a blind eye to the problem and hadn’t warned doctors or patients of the real risks.
Of course, Hughes still hasn’t “won” this case yet — all the court said was that she could take the case to a jury. To recap, then, in the “second worst” opinion, the manufacturer of a defective device that repeatedly burned patients violated FDA regulations by trying to downplay the number and extent of injuries they caused, and we’re supposed to agree that burn victims shouldn’t even get a chance to present their case to a jury.
#3 — In re Yasmin & Yaz (Drospirenone) Marketing, Sales Practices & Products Liability Litigation, 2011 WL 6302287 (S.D. Ill. Dec. 16, 2011)
Yaz / Yasmin, the oral contraceptive and premenstrual syndrome (PMS) treatment, was found by studies to cause a six-fold increase in the risk of venous thromboembolism, in which blood clots form the in leg and can travel to the lungs. (Shocking, NuvaRing is even more deadly, with double the risk of DVT and pulmonary embolism.) The big multi-district litigation (MDL) is getting closer to the first bellwether trials, and so pre-trial motions are up for disposition, including motions by Bayer Healthcare Pharmaceuticals to strike or limit the testimony of plaintiffs’ experts. Just two weeks ago Judge Herndon denied most Bayer’s motions, and thus will permit most of the plaintiffs’ experts to testify at trial.
Drug & Device Law complains about the experts that will be allowed to testify but don’t mention which experts they have a problem with (I assume “the Red Queen, the Mad Hatter and the rest” is hyperbole), but it bears mentioning that plaintiffs’ experts include David A. Kessler, M.D., who was appointed by President Bush as the Commissioner of the FDA in 1990 and continued to serve under President Clinton until 1997. According to the court ruling allowing his testimony, Dr. Kessler’s going to testify about how:
“[t]he manufacturer, not FDA, is primarily responsible for the safety of its products”; that “FDA regulations and state law provide independent and complementary layers of consumer protection”; that “Bayer violated its duties under FDA regulations and state law by selectively presenting data as to thromboembolic events, which did not adequately inform FDA, doctors or consumers of the thromboembolic risks, from premarketing to the present”; and that “Bayer engaged in extensive off-label promotion of Yasmin and YAZ for unapproved uses, in violation of FDA regulations, to increase sales” and “[t]hat off-label promotion increased the risk of thromboembolic events in patients in violation of state law duties.”
But, what does he know, it’s not like he ran the FDA or anything.
Otherwise, the plaintiffs’ lawyers are calling, for example, John D. Abramson, M.D., a lecturer at Harvard Medical School who has researched and written books and peer-reviewed articles about about the influence of the pharmaceutical industry on the practice of medicine, including the marketing of prescription drugs to physicians and the public; Suzanne Parisian, M.D., a former commissioned officer in the United States Public Health Service who was one of the first clinical instructors in FDA’s Center for Devices and Radiological Health Staff College, where she taught FDA reviewers about pre-market application design, informed consent, and methods available to protect human subjects, and review of clinical data submitted to the agency by sponsors of pre-marketing applications; and Cheryl D. Blume, Ph.D., who spent nearly twenty years in executive positions throughout the pharmaceutical industry before running her own pharmaceutical development consulting company.
If they’re not “qualified as an expert by knowledge, skill, experience, training, or education” under Federal Rule of Evidence 702 to testify about the testing, approval, and marketing of Yaz / Yasmin, then who is?
#4 — Forman v. Novartis Pharmaceuticals Corp., 793 F. Supp.2d 598 (E.D.N.Y. 2011)
Beth Forman alleges that Zometa, a biphosphonate used to treat low calcium levels in cancer patients (it’s the same drug as Reclast), caused her husband to develop osteonecrosis of the jaw. The Forman case isn’t really about prescription medications or medical devices, it’s about an issue only law nerds could love: whether a federal district court should follow a state intermediate appellate court’s ruling that a state law was preempted by federal law or if the federal district court should follow the federal appellate court in its own circuit. Any second-year law student could tell you the answer is “go with the federal appellate court,” but the defense lawyers seem to think otherwise, and call Forman an example of “judicial hubris.” It’s not.
Specifically, the New Jersey Products Liability Act has a wonky provision that allows punitive damages against the maker of FDA-approved products only “where the product manufacturer knowingly withheld or misrepresented information required to be submitted under the agency’s regulations, which information was material and relevant to the harm in question.” As I explained above in the Hughes case, that sort of claim should be permissible under Supreme Court precedent because it doesn’t conflict with FDA regulations, but a New Jersey appellate court previously held punitive damages claims in those circumstances to be “impliedly preempted” (that dreaded term again). McDarby v. Merck & Co., 401 N.J. Super. 10, 949 A.2d 223 (N.J. App. Div. 2008).
As every law student learns, federal courts are “supreme” over state courts (under the Supremacy Clause of the United States Constitution), but federal courts are nonetheless bound to follow a state supreme court’s interpretations of its own state’s law, and federal courts usually follow state intermediate appellate courts’ (like the court that decided McDarby) interpretations of state law. The pharmaceutical defense lawyers seem to think that means a federal court in New York is required to apply McDarby case. Problem for them, though, is that McDarby was a New Jersey state court interpreting federal preemption law, and so the case has no binding effect in federal courts. A court in New York, however, is required to follow the opinions of the federal Court of Appeals for the Second Circuit, and that court quite plainly held that common law tort claims pharmaceutical companies are not impliedly preempted in a decision affirmed without opinion by an equally-divided Supreme Court. Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006).
As you can tell, we’re only four court decisions in, and they’re already 0-4 and starting the scrape the bottom of the barrel for issues. It only gets worse…
#5 — Smith v. Bayer, 131 S. Ct. 2368 (2011)
By this point, only on #5, D&D Law resorts to criticizing a decision of one of the most anti-patient, anti-consumer Supreme Courts in generations, and it gets even worse: the Smith case decided an issue that’s moot — and already decided in favor of the pharmaceutical and medical device companies — for the vast majority of class action cases filed after 2005.
#6 — Lefaivre v. KV Pharmaceutical Co., 636 F.3d 935 (8th Cir. 2011)
Lefaivre involved a massive drug recall in which KV Pharmaceuticals (the same one behind the dubious effort to replace all progesterone shots to prevent premature birth with ludicrously expensive Makena) recalled dozens of medications, and eventually stipulated with the FDA in a consent decree that the medications were manufactured so poorly that they were “adulterated” under the meaning of the Federal Food, Drug, and Cosmetic Act.
A class action was brought alleging that the drug manufacturer breached its implied warranty of merchantability and violated Missouri consumer protection laws by selling that crap in violation of FDA regulations. Like with Hughes, defense lawyers think that, just because a drug company admittedly broke the law and violated FDA regulations by shipping out drugs that weren’t even the right size doesn’t mean they owe consumers anything.
And here’s the best part: the plaintiffs eventually lost the case on another issue, and both the consumers and their lawyers walked away with nothing. Including Smith above, we now have two of the “worst” opinions that resulted in the drug or device company walking away scot-free.
#7 — Daniel v. Wyeth Pharmaceuticals, Inc., 15 A.3d 909 (Pa. Super. 2011)
Mary Daniel was prescribed a hormone therapy drug, Prempro, that’s a combination of estrogen and progestin manufactured by Wyeth. Two years later, she was diagnosed with breast cancer, which Wyeth later acknowledged was a risk of Prempro. The Drug & Device Law crew raise two complaints, one about the expert the plaintiff used supposedly recanting his testimony and one about the availability of punitive damages.
On the expert recanting his testimony, they’re just plain wrong. As the Pennsylvania Superior Court held (after quoting and describing the testimony extensively), “Comparing Dr. Layfield’s Zandi testimony with his deposition testimony read to the jury in this case, it is clear that there was no recantation. To the contrary, the testimony in both depositions was remarkably consistent.” The “recentation” was wholly contrived by Wyeth’s (now Pfizer’s) defense lawyers.
On punitive damages, the trial court didn’t let the jury even consider the issue, because the court felt there was “simply no evidence that Wyeth knew that additional studies were necessary given the great body of scientific literature on hormone replacement therapy.” But, as the Superior Court described, that’s just wrong:
The Daniels presented expert testimony and documentary evidence that Wyeth knew as early as the middle 1970s of the potential risk of breast cancer associated with the use of estrogen. In 1975, researchers proved that the use of estrogen substantially increased the risk of endometrial cancer by triggering receptors responsive to the hormone. … [I]n a 1976 internal memorandum, Wyeth researchers recognized a “valid concern as to whether or not the use of exogenous estrogen leads to the increase of the incidence of breast cancer.”
The record does not reflect Wyeth, despite acknowledging the existence of unanswered questions regarding possible links between the use of estrogen (independently or in combination with progestins), undertook any studies on these issues at this time. … [In 1983,] Wyeth then applied to the FDA to initiate a study of the combined use of estrogen and progestin, representing to the FDA that “we believe it is reasonably safe to initiate a definitive study conducted to demonstrate the efficacy and safety of the sequential usage of first Premarin and then of the Medroxyprogesterone, the progestin.” According to Dr. Blume, although the FDA granted Wyeth permission to conduct the study, Wyeth never did so. …
In 1990, Drs. Andrew Glass and Robert Hoover published a study of their conclusions after reviewing a large data base maintained by Kaiser-Permanente, an insurance carrier on the west coast that also operates cancer treatment centers. Based upon their review of this data base, which tracked the health of women from 1960 to 1985, Drs. Glass and Hoover reported a 130% increase in hormone positive breast cancers in menopausal women in the United States over that period of time. Dr. Blume testified that Wyeth had a contract with Kaiser for use of its data base, and thus could have performed similar studies on the rise in the number of breast cancer cases during the same period of time when the use of drug hormones (many of which were manufactured and sold by Wyeth) had steadily increased.
Could a reasonable jury find Wyeth’s conduct to have been “reckless?” Of course, and that’s why the issue should be sent to the jury to decide.
* * *
Is it worth going on? I don’t think so. We’re already through the seven “worst” decisions of the year and each one of them is not only reasonable, but required under our current laws. #1 upheld a jury verdict following a wrongful death indisputably caused by a defectively manufactured pain patch. #2 allowed a jury to hear a case arising from burns caused by an obviously defective medical device that had burned hundreds of patients, injuries concealed from the FDA. #3 permitted a former FDA commissioner to testify about prescription drugs at trial. #4 involved a trial court applying the decisions of the appellate court above it, despite a non-binding opinion from an unrelated court. #5 is moot for any case filed in the past few years. #6 allowed plaintiffs to bring a lawsuit based upon “adulterated” drugs, but the case was dismissed later anyway on another issue. #7 allowed a jury to hear evidence that a drug company recklessly disregarded, over the course of decades, evidence that its prescription medication caused breast cancer.
Truth is, pharmaceutical and medical device / implant companies make billions in profits and then shovel most of that money into marketing, including illegal off-label marketing and payments to prescribing physicians. When their products hurt patients, though, the laws are so biased against plaintiffs that there’s often no recourse at all, or there’s only recourse in a handful of situations. We need more liability for these companies, not less.