[Update: Drug & Device Law has also released their list of “best” cases, and so I have responded.]

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 ActosPradaxa, 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. 
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Read more about our legal work for rape and molestation victims.

I’ve written several times before how difficult it is to sue the government for failing to do its job, like how you can’t sue the police department for failing to enforce a court order. It’s tough to sue the government even when they wrongly entrap and then kill your son for the trivial ‘crime’ of sports betting. The government doesn’t even need to train its prosecutors in the basics of constitutional law.

“Civil rights” is a tough area in which to practice law, if you’re representing the plaintiffs. There aren’t “typical” civil rights cases, because typical isn’t good enough under the law. The facts need to be extraordinary and egregious. “Shocks the conscience” is the verbage ordinarily used by courts to deny claims:

To this end, for half a century now we have spoken of the cognizable level of executive abuse of power as that which shocks the conscience. We first put the test this way in Rochin v.California, supra, at 172-173, where we found the forced pumping of a suspect’s stomach enough to offend due process as conduct “that shocks the conscience” and violates the “decencies of civilized conduct.” In the intervening 847*847 years we have repeatedly adhered to Rochin `s benchmark. See, e. g., Breithaupt v. Abram, 352 U. S. 432, 435 (1957) (reiterating that conduct that “`shocked the conscience’ and was so `brutal’ and `offensive’ that it did not comport with traditional ideas of fair play and decency” would violate substantive due process);Whitley v. Albers, 475 U. S. 312, 327 (1986) (same); United States v. Salerno, 481 U. S. 739, 746 (1987) (“So-called `substantive due process’ prevents the government from engaging in conduct that `shocks the conscience,’. . . or interferes with rights `implicit in the concept of ordered liberty’ “) (quoting Rochin v. California, supra, at 172, and Palko v. Connecticut, 302 U. S. 319, 325-326 (1937)). Most recently, in Collins v. Harker Heights, supra, at 128, we said again that the substantive component of the Due Process Clause is violated by executive action only when it “can properly be characterized as arbitrary, or conscience shocking, in a constitutional sense.” While the measure of what is conscience shocking is no calibrated yard stick, it does, as Judge Friendly put it, “poin[t] the way.” Johnson v. Glick, 481 F. 2d 1028, 1033 (CA2), cert. denied, 414 U. S. 1033 (1973).

County of Sacramento v. Lewis, 523 U.S. 833 (1998)(emphasis added). Unfortunately, the lack of a “calibrated yard stick” often leaves civil rights victims at the whim of courts. If the federal district judge or two of the federal appellate judges assigned to a case believe the conduct in question doesn’t “shock the conscience,” then the case is dismissed, without a minute of testimony in front of a jury.

All of those barriers apply to cases even where the government actor — a police officer, parole officer, a prison guard, et cetera — is the one who directly caused the harm. If the harm was caused by someone else, like an abusive spouse the police refused to enforce an order against (the situation in the Gonzales case in the first link), then there are even more barriers. A basic precept of tort law is that there is no duty to control the conduct of a third person to prevent him from causing harm to another absent a “special relationship” between either the dangerous person or potential victim. Restatement (Second) of Torts Section 315.

It doesn’t take too much of a logical leap to see how a parole board has a “special relationship” with a parolee or how child protective services have a “special relationship” with both the children they’re supposed to protect and the suspected abusers they’re supposed to protect those children from, and some courts have adopted that approach — perhaps most notably, the Supreme Court of Arizona in Grimm v. Arizona Bd. of Pardons & Paroles, 564 P.2d 1227 (1977), but many courts don’t see it that way, particularly not for constitutional claims. In DeShaney v. Winnebago County Dept. of Social Servs., 489 U.S. 189 (1989),

Poor Joshua! Victim of repeated attacks by an irresponsible, bullying, cowardly, and intemperate father, and abandoned by respondents who placed him in a dangerous predicament and who knew or learned what was going on, and yet did essentially nothing except, as the Court revealingly observes, ante, at 193, “dutifully recorded these incidents in [their] files.” It is a sad commentary upon American life, and constitutional principles — so full of late of patriotic fervor and proud proclamations about “liberty and justice for all” — that this child, Joshua DeShaney, now is assigned to live out the remainder of his life profoundly retarded. Joshua and his mother, as petitioners here, deserve — but now are denied by this Court — the opportunity to have the facts of their case considered in the light of the constitutional protection that 42 U. S. C. § 1983 is meant to provide.

Justice Blackmun’s “Poor Joshua!” lament, though, as a dissent. Joshua wasn’t even allowed to present his case that the Winnebago County Department of Social Services failed him and put him in further danger by leaving him with his father. He lost without his day in court.

That’s what came to mind for me when I read that Jaycee Dugard had sued the United States and a variety of its parole officers (complaint here; a summary here) for a litany of astonishingly lapses in judgment during Phillip Garrido’s parole for rape:

Garrido’s federal parole officers, therapists and counselors described him at various times throughout his federal parole term as follows: ‘a time bomb,’ ‘like a pot boiling with no outlet valve,’ ‘potentially very volatile,’ ‘potential for causing great physical harm is present,’ ‘problems with sexual overtones,’ ‘did not seem honest … as if he was putting on an act,’ ‘possible danger to the community is high,’ ‘major problems are presented in this case,’ ‘there is always threat of repeat [kidnap/rape],’ ‘still seems dangerous to the public … is liable to give little or no warning,’ ‘substantial risk to women,’ ‘is always a threat to women,’ ‘potential rapist.’” …

Despite Garrido’s well-known propensities, federal parole authorities ignored report after report of sexual misconduct by Garrido. For example, Garrido’s parole officers were informed by his 1976 rape victim that shortly after being paroled, Garrido appeared at her workplace and made an alarming comment to her. Inexplicably, the federal parole authorities responsible for Garrido’s direct supervision disregarded the victim’s concerns as mere ‘hysteria’ even though Garrido’s time cards indicated he was not at work during the hours he was alleged to have been seen by the victim. Upon learning of the victim’s statement, Garrido’s own counselor suggested that Garrido be placed on electronic monitoring. Garrido’s parole officer, however, ignored this recommendation and concluded that ‘to subject this individual to electronic monitoring would be too much of a hassle.

The Dugard kidnapping — which, as the complaint alleges, would never happened had the federal government taken the threat Garrido posed towards women seriously — should have become part of the national conversation about the ways that government agencies systematically downplay and under-report rape and sexual assault, but that’s an issue for another day.

For now, there’s the question of the United States’ liability for Dugard’s ordeal. Dugard and her daughters already collected $20 million from the State of California for its role; I don’t know if that reflected an assessment of the merits of her claim or a recognition that the social contract required we do what we can for Dugard and her kids.
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It’s no secret that pharmaceutical companies are among the more litigious businesses in America. Up until 2003, when Congress stepped in, the big drug makers had a good thing going: whenever the patent was about to expire on one of their blockbuster drugs, they would file a new patent for trivial modifications to the medicine, and thereafter would sue generic drug manufacturers claiming that the generic version of the old drug somehow infringed on the new patent.

Here’s the kicker: the big drug makers knew these patent infringement claims were frivolous, so they would enter into a “settlement” in which the big drug company — which nominally brought the case to recover monetary damages — would pay the generic company not to manufacture the generic drug anymore. Crazy, huh?

So crazy and so hopelessly anticompetitive that in 2003 Congress amended the Hatch-Waxman Act to force the major drug companies to report all of these “exclusive-payment” patent settlements to the Federal Trade Commission. The FTC still keeps an eye on them and keeps filing amicus briefs to make sure courts realize how damaging that practice is. As I’ve discussed before, some unions and health plans, stymied by the Illinois Brick decision precluding antitrust claims by indirect purchasers, have tried recovering the inflated health care expenses by filing unfair trade practices lawsuits.

The pharmaceutical companies are also not strangers to deceiving the federal government; over the past decade they’ve paid several billion dollars in qui tam cases, the result of brave whistleblowers exposing the fraud at great personal cost.

So pardon me if I don’t think that pharmaceutical companies deserve a special exception from the basic legal responsibilities we all have to one another just because they claim litigation is expensive or because they claim that always tell the FDA the truth. That sort of special treatment is what they’re trying to get with “tort reform” in the Pennsylvania legislature, and what they’re claiming they’re owed in the courts:

In questioning during oral argument Tuesday in Philadelphia, a state Supreme Court justice characterized the drugmaker Wyeth as asserting that there is enough protection for persons harmed by prescription drugs in federal regulation of the release of drugs onto the market, and limiting plaintiffs to lawsuits for drugmakers’ alleged failures to adequately warn of risks.

Plaintiffs are arguing in a case that could change the landscape of pharmaceutical products liability law in Pennsylvania that drugmakers can be sued for the negligent design defect of their drugs.

Questioning the plaintiffs’ lawyer, Justice Max Baer also said that Wyeth asserts that Pennsylvania would chill the manufacturing of prescription drugs if pharmaceutical companies can be sued for the negligent design defect of their drugs. He asked the lawyer to address why that may not be so.

The case, Lance v. Wyeth, arises from a primary pulmonary hypertension death allegedly caused by Redux, a hopelessly dangerous diet drug that causes a host of medical conditions which was yanked from the market for causing valvular heart disease. No one credibly disputes that the drug should never have been marketed or sold in the first place: it combined two drugs known to cause cardiovascular problems. Had Wyeth (now owned by Pfizer) properly tested it, they probably would never have sold it. Had they properly warned doctors and patients of the real risks, no doctor would have prescribed it and no patient would have taken it.

If dangerous drugs were automobiles with defective air bags (like Gaudio v. Ford Motor Co.), or rollover-prone all-terrain vehicles (like Smith v. Yamaha Motor Corp.) there wouldn’t be a question of the applicable law. Everybody — you, me, lemonade stands, multinational corporations, and everyone in between — has the same general legal duty to exercise reasonable care not to cause injuries to others. If we don’t exercise that reasonable care, we’re negligent, and we’re responsible to pay for the damage we cause.

That’s how the tort of negligence works. It’s quite simple.

In addition to their responsibility to pay for all negligently caused damages, everyone who sells products — again, from the lemonade stand to the multinational corporation — has “strict liability” for all damages caused by defective products. Consider that defective air bags case above:

[W]e will briefly review the history of products liability law and the crashworthiness doctrine in this Commonwealth. Our Supreme Court first adopted section 402A of the Restatement (Second) of Torts in Webb v. Zern, 422 Pa. 424, 220 A.2d 853 (1966). To state a section 402A products liability claim in Pennsylvania, the plaintiff must prove that the defendant sold a product “in a defective condition,” that the defect existed when the product left the defendant’s hands, and that the defect caused the plaintiff’s injuries. See, e.g., Hadar v. AVCO Corp., 886 A.2d 225, 228 (Pa.Super.2005). A product is “in a defective condition” when it lacks “any element necessary to make it safe for its intended use or possessing any element that renders it unsafe for the intended use.” Azzarello v. Black Bros. Co., Inc., 480 Pa. 547, 559, 391 A.2d 1020, 1027 (1978). Because the key inquiry in all products liability cases is whether or not there is a defect, it is the product, and not the defendant’s conduct, that is on trial. See, e.g., Hutchinson v. Penske Truck Leasing Co., 876 A.2d 978, 983 (Pa.Super.2005), affirmed, 592 Pa. 38, 922 A.2d 890 (2007).

Gaudio v. Ford Motor Co., 976 A. 2d 524 (Pa. Super. Ct. 2009)(remanding for trial a crashworthiness claim).

But Section 402A of the Second Restatement of Torts has a pesky “comment k” for defective drug cases which says:

There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. . . .  Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous.  The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician. . . .  The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.

Defense lawyers contend that comment k promises pharmaceutical companies total and complete immunity from all potential theories of liability except for a narrow class of “failure to warn” claims. Wyeth argued that the sole question is “whether the risk information conveyed to prescribing physicians was sufficient to permit them to conduct an individualized risk-benefit analysis.”

Nonsense.

The plaintiffs in Lance were smart to hire Howard Bashman, friend of the blog, for their appeal, and his excellent opening brief and reply are both online. So, too, is the joint American Association for Justice and Pennsylvania Association for Justice amicus brief.

The briefs quite adequately cover Pennsylvania law on the subject, all the Incollingo v. Ewing, 444 Pa. 263, 282 A.2d 206 (1971)(a Jim Beasley case), Baldino v. Castagna, 505 Pa. 239, 478 A.2d 807 (1984), and Hahn v. Richter, 543 Pa. 558, 673 A.2d 888 (1996) a drug liability law nerd could ask for.

Personally, I think two arguments should decide Lance v. Wyeth.
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If you were diagnosed with bladder cancer after using Actos and are reviewing your legal options, please see my Actos Bladder Cancer Lawyers page for patients. 

I wrote this post for my legal blog, which is ordinarily read by other lawyers. Patients looking for legal help should read the Actos page linked above. 

Personal injury law isn’t like running an ordinary business, not even an ordinary law practice, because of the risk involved in taking cases. Defective drug and consumer products lawsuits exemplify both extremes of our work: the cases are enormously expensive to pursue and require a tremendous amount of attorney time, but they also have the potential to be lucrative blockbusters.

Problem is, once a drug or product is shown to be unreasonably harmful by a study or a recall, there’s no way for us to know for certain what the courts will do with the lawsuits. We don’t roll the dice — it’s much more rational and systematic than that — but we have to play the odds. So it will be with Actos lawsuits: we believe the drug was inadequately tested and didn’t warn patients of the risks, and will vigorously pursue cases against their manufacturer, but the cases aren’t without considerable risk.

Consider the denture cream lawsuits. To paraphrase what I wrote last week while discussing asbestos lawyers, GlaxoSmithKline settled the vast majority of Super Poligrip claims, but Proctor and Gamble fought the Fixodent cases, resulting a judge dismissing one of the bellwhether cases on Daubert grounds.

One of the drug cases trial lawyers are pursuing these days involve Actos (pioglitazone), the best-selling Type 2 Diabetes drug in the world. The Associated Press recently wrote about the “wave of lawsuits” filed against Takeda Pharmaceuticals:

TRENTON, N.J. — The maker of the world’s best-selling diabetes drug is facing hundreds of lawsuits and likely a big sales drop as suspicion grows that taking the pill for more than a year raises the risk of bladder cancer. …

both the U.S. Food and Drug Administration and the European Medicines Agency have issued warnings about the cancer risk based on new research, but they have allowed sales to continue. Doctors are being told not to prescribe Actos for people who have or have had bladder cancer.

The warning will limit patient choices and could spell the end for a once-promising class of Type 2 diabetes drugs that debuted more than a decade ago amid heavy promotion.

An FDA warning that a popular drug increases the risk of any type of cancer or heart disease virtually guarantees the filing of thousands of lawsuits, and pioglitazone is no exception: it raises the risk of bladder cancer by more than 40%, or an “extra 28 cases a year for every 100,000 people taking it.” The irony is why Actos is so popular:

Actos, despite links to heart failure risk and other serious side effects, became the No. 1 diabetes pill after Avandia, the only other drug in that class, was found in 2007 to sharply increase risk of heart attacks. Avandia’s use was banned in the EU and sharply restricted here. Actos sales jumped from about $2.9 billion in 2006 to more than $4.3 billion last year.

Avandia’s restriction, of course, prompted its own wave of lawsuits, and GlaxoSmithKline has settled about 12,000 of them for around $700 million. Assuming the clients are on one-third contingent fee agreements, that’s over $200 million for the lawyers. I don’t say that to be critical; one of those firms, for example, recently spent hundreds of thousands of dollars on an antitrust action just to lose and then also get hit with almost $600,000 in costs. It’s a big-risk, big-reward kind of business, and one of the few elements of society keeping medical products safe in light of the broken clearance processes we have for new drugs and devices.

Which brings me to one of the lessons this episode has for lawyers trying to build a personal injury or product liability law practice.
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