On May 20, 2019, the United States Supreme Court decided Merck v. Albrecht (In re Fosamax), No. 17-290 (text version available here), destroying most of the arguments routinely used by drug companies to claim that plaintiffs’ cases are “preempted” and have to be dismissed. The law for people injured by branded prescription drugs is far better now than it was before Albrecht, and as a result, it is likely that far more victims will get to see their day in court.

After Albrecht, a branded prescription drug manufacturer can establish impossibility preemption — which happens when federal law makes it “impossible” for defendants to comply with state tort laws that enable victims to seek compensation — only if they can show:

  • The manufacturer “fully informed” the FDA by providing both all “material” safety information and an “evaluation or analysis concerning the specific dangers” raised by the plaintiff; and,
  • The FDA took action, “carrying the force of law,” to disapprove the warning proposed by the plaintiffs.

The Supreme Court’s analysis in Albrecht is far more narrow than any preemption argument ever proposed by drug manufacturers, and far more narrow than the “clear evidence” tests many lower courts have been using since Wyeth v. Levine, 555 U.S. 555 (2009). As the Supreme Court itself said, “a drug manufacturer will not ordinarily be able to show that there is an actual conflict between state and federal law such that it was impossible to comply with both.” Albrecht at *17.

Let’s dig in.
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On March 29, 2019, a divided Fifth Circuit panel issued their decision Gibson v. Collier, No. 16-51148, involving a transgender inmate. The majority’s opinion by Judge James Ho is outrageous, an example of the very worst sort of result-driven judicial activism. The majority cast aside multiple foundational principles of law — including basic respect for the litigants, the right to be heard before judgment is entered, the requirement that a party which seeks court relief meet its burden, the right to present contrary evidence, and the right to have a case decided on its own evidentiary record — all so the majority could publish their personal opinions on a subject that has been in the news lately: gender reassignment surgery.

The Fifth Circuit’s opinion in Gibson v. Collier reflects an ugly truth about our current politics: although some people claim “trans rights” are “special rights,” the movement for “trans rights” is really an effort to provide transgender persons the same rights everyone else has, because they are often denied those rights simply because they are trans. All the plaintiff wanted in her lawsuit was the same treatment every prisoner is entitled to have under the Constitution, i.e., appropriate treatment for what everyone agreed was a “serious medical need.” She didn’t get it, and her case did not benefit from the same procedural and evidentiary rights that every litigant in court is entitled to receive. As the dissent from Judge Rhesa Hawkins Barksdale correctly observed, procedurally, the case violated “bedrock bases for ensuring fundamental due process,” and, substantively, “numerous reasons” compelled the Court to rule the other way.

But this post is not just about trans rights. It is also about how cavalier federal courts can be in deciding cases. If a transgender inmate’s case can be decided by way of a federal court denying her any opportunity to present her arguments and evidence, cherry-picking factual conclusions from other cases, and deeming itself a medical expert, then your case can be decided that way, too.
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Over a century ago, in 1906, law professor Roscoe Pound outlined “The Causes of Popular Dissatisfaction with the Administration of Justice” in a speech to the American Bar Association. After conceding “dissatisfaction with the administration of justice is as old as law,” Pound went on to perform a “diagnosis” of the “more than the normal amount of dissatisfaction with the present-day administration of justice in America.”

One particularly “potent source of irritation” was “our American exaggerations of the common law contentious procedure,” which produced a bizarre, unjust, and “sporting” sense of justice:

It grants new trials because by inability to procure a bill of exceptions a party has lost the chance to play another inning in the game of justice. It creates vested rights in errors of procedure, of the benefit whereof parties are not to be deprived. The inquiry is not, What do substantive law and justice require? Instead, the inquiry is: Have the rules of the game been carried out strictly? If any material infraction is discovered, just as the football rules put back the offending team five or ten or fifteen yards, as the case may be, our sporting theory of justice awards new trials, or reverses judgments, or sustains demurrers in the interest of regular play.

Pound’s discussion about the inherent lawlessness of a “sporting” justice system — one that over-emphasizes procedural “correctness” and judicial “umpiring” as if justice were a game — feels like it was written in our time, not over a hundred years ago:
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Imagine if lights, kitchen equipment, and home electronics didn’t need to be tested for electrical shock and fire hazards, and that no one ever certified that the devices were safe. Would you put them in your home?

What about a car that had just one crash test, at low speed, and Congress had passed a special law making it impossible for anyone to sue the car company, so the company couldn’t be held responsible for people’s injuries? Would you put your family in one?

Yet, those examples above describe the state of the $156 billion American medical device market. Most medical devices aren’t tested with clinical trials. The medical devices which are tested can pass with a minimal showing, and Congress passed a special law that says that this minimal showing is enough to shut the courthouse doors on victims.

The Bleeding Edge, a documentary just released on Netflix, details the many problems with medical devices today, with an emphasis on the suffering of thousands of people due to Bayer’s Essure contraceptive, DePuy’s ASR hip implant, Johnson & Johnson’s transvaginal mesh, and the Da Vinci surgical robot. I know these awful products well; most of my law practice is representing victims of medical devices and pharmaceuticals.

If no one ever watched The Bleeding Edge, the film would still be a remarkable success: soon after it premiered, Bayer announced it will discontinue sales of Essure.

But everyone should watch it. Essure was just one part of a broken regulatory system and a corrupted market, and medical device companies often lobbying Congress to make it even worse.

It doesn’t have to be this way.
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Updated June 28, 2018 in light of the Supreme Court’s grant of certiorari. See more at the bottom of this post.

I’ve written many times before about the Supreme Court’s opinion Wyeth v. Levine, 555 U.S. 555 (2009), such as when the opinion came out in 2009 and when opioid manufacturers tried to use it and related preemption case law to stop the cases filed against them. Levine is by and large a good case: the Supreme Court held that, when a drug manufacturer fails to warn patients about the real harms of their drugs and injured patients bring lawsuits, the drug manufacturer can’t blame the FDA for the problem (for having approved the drugs) and demand the court throw out the patients’ cases.

The underlying logic of Levine was quite simple: the Food, Drug, and Cosmetic Act (“FDCA”) says that drug manufacturers, not the FDA, are responsible for the “Prescribing Information” and “Medication Guide” provided with each medication, and the FDCA does not say that injured patients can’t bring state tort lawsuits.

The Supreme Court, however, appeared to leave open the potential that some lawsuits could be “preempted” — as in, kicked out of court, even if the patient could prove the drug company was negligent — if the drug company could show “clear evidence that the FDA would not have approved a change to [the drug’s] label.” Levine at 571. Years later, the Supreme Court stated the rule a little bit more clearly: a drug company can “show, by ‘clear evidence,’ that the FDA would have rescinded any change in the label and thereby demonstrate that it would in fact have been impossible to do under federal law what state law required.” Pliva, Inc. v. Mensing, 564 U.S. 604, 624 fn 8.


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My prior post went through the basics of the DNC Lawsuit against Russia, the Trump campaign, Wikileaks, and the individuals affiliated with each of them, specifically:

  1. Why Now
  2. Why The Complaint Alleges Those Causes Of Action
  3. Whether Russia And Its Agents Have “Sovereign Immunity”
  4. The “Plausibility” Pleading Requirement For The Case To Go Forward

Today we’ll follow up with four big-picture issues:

  1. The Potential Role Of The U.S. Government
  2. The Role Of Parallel Criminal Prosecutions
  3. The First Amendment Issues
  4. What This Lawsuit Can Actually Accomplish


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Earlier today, the Democratic National Committee filed a massive lawsuit against almost everyone arguably associated with the hack on the DNC’s servers, including the Russian Federation, Russia’s foreign military intelligence agency (GRU), the hacker known as “Guccifer 2.0,” Wikileaks, Donald J. Trump for President, Inc., Donald Trump, Jr., Jared Kushner, Roger Stone, and others who have been, in press reports or in filings from the Special Counsel, alleged to have served as conduits between Russia and the Trump campaign. (Notably, Donald Trump was not himself named.) The complaint raises a host of claims ranging from the Computer Fraud & Abuse Act, the Stored Communications Act, the Racketeer Influenced and Corrupt Organizations Act, to the Digital Millennium Copyright Act, and a couple of state law tort claims too.

I’ve discussed almost all of these types of claims on this blog before (see, e.g., CFAA here and here, SCA here, RICO here, DMCA here), so the archive is rich with information if you want to learn more. For our purposes here, we’ll break everything in this lawsuit down into manageable chunks:

  1. Why Now
  2. Why The Complaint Alleges Those Causes Of Action
  3. Whether Russia And Its Agents Have “Sovereign Immunity”
  4. The “Plausibility” Pleading Requirement For The Case To Go Forward
  5. The Potential Role Of The U.S. Government (Next Post)
  6. The Role Of Parallel Criminal Prosecutions (Next Post)
  7. The First Amendment Issues (Next Post)
  8. What This Lawsuit Can Actually Accomplish (Next Post)

If you’ve already read the below, click here for my follow-up post.

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Sparked by the #MeToo movement, several legislatures (including Pennsylvania, California, and New York) are considering prohibiting employers from including non-disclosure agreements (NDAs) and confidentiality clauses in the settlement of sexual harassment claims. It’s not hard to see why: to take just one example, the gold-medal-winning gymnast McKayla Maroney could potentially have to pay USA Gymnastics $100,000 if she testifies at the sexual abuse sentencing hearing of her former coach because, in December 2016, she agreed to a settlement that included a non-disclosure agreement. Other examples show how these agreements enable sexual predators: Zelda Perkins, Harvey Weinstein’s assistant, was bound by a non-disclosure clause in a settlement agreement and kept her allegations secret for 19 years.

Putting aside pending legislation, there’s a fundamental legal question underlying this issue: were these non-disclosure agreements ever enforceable in the first place? There’s virtually no case law addressing the question head-on, but, as I explain below, I believe that most courts would be loath to enforce them.

Before we get into the details, none of this is to say the victims could have or should have come forward at an earlier point, or that anyone currently under an NDA or confidentiality clause is free to disregard it. There’s a big difference between thinking about what a court might do and actually going through years of stressful, expensive litigation, particularly on an unsettled issue like this one. These victims had every reason to be concerned about the repercussions of breaking their agreements. If you’re a sexual harassment victim who agreed to a confidential settlement and are wondering if you can speak publicly, call a lawyer.

Now, the law.
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On Sunday, the Washington Post published a detailed investigative report about how the drug industry snuck through Congress a bill that ruined one of the Drug Enforcement Agency’s key tools in the fight against the opioid epidemic. The DEA’s own chief administrative judge, John Mulrooney, has a forthcoming law review article about how the new law made it “all but logically impossible” for the DEA to stop drug manufacturers and distributors from dumping opioids out onto the streets, even when they are doing so in obvious violation of federal law.

That outrageous bill is just one part of the war that the drug companies are fighting to keep bringing in massive profits from the opioid epidemic that they created. Today we’re going to talk about the pharmaceutical industry’s lobbying of courts, which they do through amicus briefs filed by groups like the “Pharmaceutical Research and Manufacturers of America” (also known as “PhRMA”), the “Medical Information Working Group,” and the U.S. Chamber of Commerce.
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Equifax, which knows more about you than your own mother, (1) failed to maintain its servers, (2) was hacked and lost sensitive personal data for 143 million people, (3) concealed that fact for months, (4) blamed another company for the problem, then (5) finally admitted it caused the problem. To make matters worse, after the hack but before disclosing it, three executives sold off nearly $2 million in Equifax stock.

“What should I do to protect myself?” is a difficult question to answer. The Federal Trade Commission put up a page recommending checking your credit reports, placing a credit freeze, placing a fraud alert, and filing your taxes early so that a scammer doesn’t file them for you and obtain your tax refund. Brian Krebs has a much more thorough FAQ over here.

To call this situation “frustrating” would be an understatement. Virtually everyone with a credit history now bears the burden of making sure their own identity is safe due to Equifax’s negligence. People have already filed class-action lawsuits, and rightly so.
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