Articles Posted in Drug Companies

Nexium, or esomeprazole, is a drug that is used to treat heartburn and excessive amounts of acid in the stomach. Specifically, it is used to treat duodenal and gastric ulcers, esophagitis, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome. Nexium is a proton pump inhibitor (PPI) that decreases the amount of acid produced in the stomach. Other drugs that are in the same class as Nexium include Prevacid and Prilosec. Approximately 15 million Americans use PPIs that are sold both as prescription and over-the-counter. Nexium sales exceed $3 billion a year.

Nexium Class Action Lawsuit Updates 

March 2023: The bellwether trial in the Nexium PPI litigation that was supposed to get started this month has now been postponed to June 5, 2023. Two additional bellwether trials will follow in July and September. No explanation for the postponement was given, but many believe that was done because the parties are close to a settlement. 

August 2022:  Defendants in the PPI MDL had moved to dismiss all failure to warn claims in the PPI class action lawsuit because they are preempted. The argument, and it is a weak one, is that because the FDA (a federal agency) approved the warning labels, state law claims cannot be brought. 

Our lawyers talked about this in the last update in June – this motion is crucial because the crux of this class action lawsuit is that you knew of this problem with kidney injuries yet you did not change their product, instructions, guidelines, or, most importantly, warn doctors of the risk. 

The Special Master in the MDL likely put this issue to bed in the Prilosec-Nexium class action lawsuit. issued a report to the MDL Judge recommending that this argument be rejected because the defendants cannot show that the FDA would have rejected proposals for stronger warnings about kidney damage. The first bellwether trial in the MDL is set for November.

June 2022: The defendants in the Nexium-Prilosec PPI class action MDL have filed motions for summary judgment in the upcoming bellwether test trials. The primary legal argument in this motion is based on a doctrine called federal preemption. The preemption doctrine holds that victims are blocked from bring tort lawsuits under state law if there is a federal law that protects the defendants from liability. The Special Master in the MDL recently allowed both parties to submit additional briefing to address how a recently decided case on the preemption issue (In re Fosamax Alendronate Prod. Liab. Lit.) could potentially impact the issues in the Nexium-Prilosec cases. Our lawyers have read the Fosamax case (which rules in favor of defendants on a preemption argument) and in our opinion it is not applicable to the issues in the PPI cases.

April 2022: There are around 13,500 lawsuits pending in the Nexium-Prilosec PPI class action MDL.  The first trial will be in October.  The hope is that a few trials will set settlement amounts for Nexium kidney lawsuits. But many class action lawsuits – at least lately – have had trials and the parties still could not agree to a settlement amount for the victims.  So the judge, in this case, wants to keep the pressure on the lawyers.  So if a global settlement is not reached, the MDL Judge has identified a group of 200 cases that the parties will be preparing for trial over the next 16 months.

• These drugs have had a troubled history.  Zantac, which was long considered a great and safe drug, has now been associated with cancer.

Problems with Nexium

Nexium is a controversial drug.  At one point, bone fracture lawsuits were all the rage because there was data suggesting Nexium, particularly the long-term use of Nexium, would cause bone fractures and breaks.  Our lawyers believed many of these lawsuits were meritorious.  But the litigation did not get very far.

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Hundreds of farmers and agriculture workers have filed paraquat lawsuits alleging that their exposure to paraquat caused them to develop Parkinson’s disease. Back in June, a new Paraquat MDL was created and it already has around 200 pending cases. Last week, the MDL judge ordered all incoming plaintiffs to complete a Plaintiff’s Assessment Questionnaire (PAQ).

In this post, we will take a close look at the PAQ because it is essentially an outline of the key issues that will shape the paraquat litigation moving forward. It also gives prospective plaintiffs an idea of what type of facts they will need to support their case.

About the Paraquat Lawsuits

On June 10, 2021, U.S. District Judge Nancy J. Rosenstengel announced that the initial conference on the Paraquat class action MDL would take place on June 23th via Zoom.

The conference’s primary purpose was to discuss how to organize the plaintiffs’ leadership counsel. The court also heard both counsels’ position briefs that outlined their views on these cases’ facts, claims, and defenses. It ordered the parties to hold a case management plan meeting.

This is all garden-variety stuff, standard fare as an MDL class action gets underway.

Drug wholesaler McKesson Corp. has settled charges against it, agreeing to pay more than $190 million for government claims that it reported inflated drug prices that caused federal government – specifically Medicaid – to overpay for drugs.

McKesson put out the same press release that goes out in every single one of these cases:

We did not manipulate drug prices and did not violate any laws. However, when we weighed our conviction that we did not violate any laws against the inherent uncertainty of litigation, we determined that this settlement was in the best interest of our employees, customers, suppliers and shareholders.

The idea of an MDL is to consolidate discovery, figure out what the cases are about, and whether they can be settled without a gazillion trials. So you do some discovery and, more often than not, you try a few cases and see if you can limit or even eliminate trials getting sent back to their home jurisdictions for trial.

But in any piece of mass tort litigation, the quality of the individual cases is going to vary wildly. There are a lot of reasons for this that are case-specific, but one value driver thread that runs through every case is the quality of the plaintiff. There is no question that juries are going to pay more (and may even be more likely to find liability) in cases where you have a plaintiff that the jury likes and respects. So that begs the question: which cases get tried first? Plaintiffs’ lawyers look for good facts with a Mother Teresa-like plaintiff and defendants look for confounding facts Idi Amin-like. This we know.

So which cases are chosen to go first? One of the authors of the defense-oriented Drug and Device Law Blog crashed the plaintiffs’ attorneys’ seminar, Mass Torts Made Perfect, and listened to what the judges who spoke there had to say. This was their summary:

Two pharmaceutical manufacturers, Watson Pharmaceuticals and Sandoz/Geneva Pharmaceuticals, have settled drug pricing lawsuits for $145 million, according to a settlement agreement filed in federal court. Watson makes generic drugs; Sandoz is owned by Novartis’ generic drug division (did you know they had one?).

By now, the allegations in these claims are commonplace. The lawsuits alleged that these drug companies charged government health care programs with inflated prices for prescription drugs. This case spun out into an MDL in the District of Massachusetts.

Both lawsuits were filed under the U.S. False Claims Act – a whistleblower statute – by Ven-A-Care of the Florida Keys Inc., a specialty pharmacy. The law allows whistle-blowers to file on behalf of the government and share in any recovery. Their lawyers are pocketing some real cash, Ven-A-Care gets some found money (between the two, $8.3 million), and the states make out well, too. The big ones bring home the real bacon: Texas will receive $29.5 million, Florida $20.2 million, and New York $79 million.

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Last month, I took exception to a Drug and Device Law Blog post and wrote a semi snarly retort on the topic of the confidentiality of discovery documents.

Bad move. The Drug and Device Law Blog fired back a response pretty much took my post and beat me over the head with it. Adding insult to injury, they did it with good writing and good humor. I hate it when the bad guys are good and funny. It makes them seem almost human, an idea that fits in poorly with my worldview.

I thought they got some substance just dead wrong and there was lots of room for a good counterattack. But to find the time to write a cogent, witty response to rival theirs? They spit that response out in an hour; I bet. It would take me all day to come up with something and it still would not have been as well written.

Thankfully, my brother jumped in to stand up for me. My brother? Yes, for our purposes here, my brother. Justinian Lane stepped up and wrote the response I wanted to write (link since deleted, unfortunately). Even better, actually.

So instead of beating this topic any further, I’ll comment off-topic to the core issues in this debate and address another fascinating point Justinian makes about the economic disparity between plaintiffs’ lawyers and defense lawyers:

In DDL’s first post, they made a quip about plaintiffs’ lawyers buying Maybachs, and now they’re complaining that “plenty” of plaintiffs’ lawyers have private jets. While I don’t think that the authors of DDL are green with envy over the financial success of a few plaintiffs’ lawyers, plenty of their readership is. By and large, defense lawyers go to better schools than plaintiffs’ lawyers, earn better grades, write better briefs, and I’ll say it – are better lawyers. And they know it. It therefore irritates them to no end that lawyers who they perceive as being inferior to them are more financially successful than they are.

I don’t know that defense lawyers are better trial lawyers than plaintiffs’ lawyers in mass tort cases. Plaintiffs’ lawyers get more reps because, typically, plaintiffs’ lawyers have more trial experience. A lot of great mass tort defense lawyers can go a career without trying a case. I’m not saying they can’t do it effectively when called upon but, like with most things, experience counts. Pharmaceutical companies hire great trial lawyers but if cases are remanded all over the country, they don’t have as deep of a bench as plaintiffs’ lawyers.

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The FDA has started a “Safe Use” initiative to combat the growing problem of medication errors. An article by The Washington Post reports that greater care in the writing, filling, and taking of prescriptions can prevent 50,000 unnecessary hospitalizations per year. Other statistics of interest, according to the article and the Institute of Medicine:

• 1.5 million preventable injuries and deaths are caused by medication errors
• Medication errors cost $4 billion annually
• Between 2003 and 2006, more than 9,000 children were accidentally exposed to prescription drugs.

Much of the onus for preventing these injuries clearly rests on doctors, pharmacists, and patients. However, what responsibility do pharmaceutical companies have?

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Bayer, the manufacturer of other terrific products (YAZ and Yasmin birth control pills: improperly advertised, cause blood clots, and can cause gallbladder removal, among other things; gadolinium-based contrast agents: turn skin orange and hard, make movement difficult, and can harden organs; and Trasylol: a blood-clotting drug that causes clots, heart attacks, amputations, and kidney failure), also makes multi-vitamins. Today we’ll talk about the selenium-containing Men’s One A Day (MOAD) multivitamin.

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