About This Blog

I write this blog primarily for lawyers and others interested in the law. If you’re looking for a lawyer, start with my legal services page. The lawyers at my firm focus on catastrophic injuries, like medical malpractice or product liability, and lawsuits over prescription drug and medical implant side effects, including cases involving Mirena, diabetes drugs causing pancreatic cancer, antacids causing stomach cancer, Onglyza causing heart failure, and recalled hernia mesh. You can call me at 215-948-2718 or email me at msk@thlawyer.com.


Watch “The Bleeding Edge” And Demand Medical Device Safety Reform

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. Continue reading


The Solicitor General’s Brief In Fosamax – An End To Levine Preemption?

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.

Continue reading


DNC Lawsuit Part 2: U.S. Intervention, Mueller, Free Speech, And The End-Game

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

Continue reading


The Who, What, Where, When, & Why of the DNC Lawsuit

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.
  Continue reading


Sexual Harassment And The Enforcement Of Non-Disclosure Agreements

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. Continue reading


The Opioid Crisis, The Courts, And The Chamber of Commerce

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. Continue reading


Equifax And The Long Legal Road In Data Breach Class Actions

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. Continue reading


A Plaintiff’s Guide To Fed.R.Civ.P. 26 Discovery Proportionality

Civil litigators often spend more time in discovery disputes than in trials. Few plaintiffs or defendants are keen on spending time in a deposition, collecting documents, or handing over to their opponent evidence that could be used against them later. Yet, as the Supreme Court said 70 years ago while interpreting the original Rules of Civil Procedure, “[m]utual knowledge of all the relevant facts gathered by both parties is essential to proper litigation. To that end, either party may compel the other to disgorge whatever facts he has in his possession.”[1]
In December 2015, the “proportionality” amendments to Rule 26 of the Federal Rules of Civil Procedure were amended. One clause was removed as not reflecting the law (the “reasonably calculated” clause), one clause was omitted as unnecessary (the clause about discovering the existence of documents and witnesses), a phrase was moved from one subsection to another (the phrase about proportionality), and a proportionality factor was added (about the parties’ “relative access to information”).
In the big picture, these changes were exceedingly modest. Nonetheless, as Judge Pitman of the Southern District of New York wrote just a few weeks after thereafter, “[g]iven the recent amendments to the Federal Rules of Civil Procedure that became effective December 1, 2015, proportionality “has become ‘the new black,’” in discovery litigation, with parties invoking the objection with increasing frequency.”[2] These days, defense lawyers for massive corporations talk about “proportionality” non-stop, objecting to every discovery request, no matter how inexpensive or important to the case, as “not proportionate.” Judge Pitman was unimpressed: “the 2015 Amendments constitute a reemphasis on the importance of proportionality in discovery but not a substantive change in the law.”[3]
There are thousands of blog posts written by defense lawyers about how the proportionality amendments changed everything, and I’ve grown tired of seeing these arguments pop up in Court. So, without further adieu, here’s a Plaintiff’s Guide To Rule 26’s Discovery Proportionality Standard. Continue reading


Daubert In Product Liability Cases: Mid-2017 Update

I’ve written about the Supreme Court’s Daubert opinion many times before, tagging it with the label “junk science.” The phrase “junk science” never actually appeared in Daubert, but rooting it out has been the animating concern behind the application of Daubert. See, e.g., Amorgianos v. National RR Passenger Corp., 303 F. 3d 256, 267 (2nd Cir., 2002)(“The flexible Daubert inquiry gives the district court the discretion needed to ensure that the courtroom door remains closed to junk science while admitting reliable expert testimony that will assist the trier of fact.”)
In federal courts today, Daubert has become a magical incantation for defense lawyers in product liability lawsuits. Drug companies gleefully get drugs approved by the FDA with the thinnest of scientific evidence—often relying on “surrogate markers” or underpowered clinical trials—and then claim that plaintiffs injured by their drugs cannot present their case to a jury until they have produced vastly more scientific evidence than the company or the FDA would use. Car manufacturers regularly demand plaintiffs conduct testing that the companies themselves never did.
Today we’re going to review the state of the art, as it were, of Daubert in product liability cases by examining the four most recent published Court of Appeals opinions. Those opinions are:

  • Adams v. Toyota Motor Corp., No. 15-2507, 2017 WL 2485204 (8th Cir. June 9, 2017)
  • In re Zoloft (Sertraline Hydrochloride) Prod. Liab. Litig., 16-2247, 2017 WL 2385279 (3d Cir. June 2, 2017)
  • Wendell v. GlaxoSmithKline LLC, No. 14-16321, 2017 WL 2381122 (9th Cir. June 2, 2017)
  • Nease v. Ford Motor Co., 848 F.3d 219 (4th Cir. 2017)

Plaintiffs lost Zoloft and Nease, and won Adams and Wendell. But it would be foolish to look at these cases simply as a scorecard: the real issue here for future cases is how the courts decided the cases.
All of these cases have one thing in common: the defendants framed Daubert as a matter of pseudoscientific absolutes, and the Courts of Appeals rejected the defendants at every turn. In the cases that follow, defendants argued that any difference between a test and an accident renders the test unreliable, that plaintiffs cannot go to a jury without statistically significant evidence, that opinions developed in litigation are inherently unreliable, that a doctor’s differential diagnosis is an unacceptable scientific methodology, that plaintiffs’ experts must completely eliminate all potential alternative causes, and that case studies are scientifically irrelevant—and the appellate courts rejected each and every one of those arguments. Continue reading


Free Speech And Trump Tweets: When Twitter Is A Limited Public Forum

[Update, May 23, 2018: As I predicted almost a year ago, before the lawsuit was even filed, Trump’s twitter feed is indeed a public forum. A federal district court just denied his motion to dismiss. I haven’t read it in full yet, but I’ll update this post when I’ve had a chance.]
[Update, June 6, 2017: A week after I wrote the below, the Knight Institute wrote a letter to President Trump arguing the same. Eugene Volokh says there’s a “private capacity” argument. I addressed that below, the same way the Davison court ruled on it. Moreover, just today Press Secretary Sean Spicer admitted the tweets are “official statements by the President of the United States.” Also, Charles Ornstein has a good summary of other elected officials blocking constituents, and litigation over it.]
While in the White House, Donald Trump’s personal twitter timeline, @realDonaldTrump, remains a key method by which he communicates with the public. He uses it to conduct foreign policy, to urge specific action by Congress, to promote certain media articles, and, of course, to persuade the public on key issues, including with implied references to classified government information. And, critically for our purposes here, he allows the public, the media, and other elected representatives to post tens of thousands of comments in response to each tweet:
As Danny Sullivan pointed out, President Trump has recently become more aggressive in blocking people on Twitter, and so Sullivan has created a list of blocked users. Sullivan wonders if this creates a First Amendment issue, noting,

When Trump blocks, he doesn’t just impact himself. He blocks some Americans from speaking in arguably the most important forum, his tweets.

For our purposes here, I’ll refer to @realDonaldTrump’s tweets as “tweets,” and the responses to them as “replies,” so we don’t get confused. When @realDonaldTrump “blocks” someone on Twitter, they can no longer read his tweets or reply to them. That is in contrast to “muting,” which removes the person’s replies from @realDonaldTrump’s view but leaves them up for other users.
So, are President Trump’s tweets a public forum? If so, does that place limits on when President Trump can block users from replying?
I believe the answers are “yes” and “yes.” Because President Trump uses @realDonaldTrump for official business, and because President Trump allows (arguably, invites) replies on his tweets, he has made his Twitter timeline into a limited public forum. As such, the First Amendment applies. He can potentially impose content restrictions, but he can’t impose viewpoint restrictions.
Here’s why. Continue reading