Tag Archives: Drug Label Failure To Warn

Impossibility Preemption, Strict Liability, And The Troll Supreme Court Justice

This week’s U.S. Supreme Court argument in Bartlett v. Mutual Pharmaceutical (link goes to my thoughts on the case, which I posted back in December) has taken the issue of “impossibility preemption” for a brief stroll through the rest of the legal world, crossing paths with some major news outlets. Karen Bartlett was given a shot of a pain reliever, sulindac, which caused her to develop Stevens-Johnson Syndrome and toxic epidermal necrolysis so severe her burn surgeon called it “hell on earth.” There would be a handful of legal avenues available to her if she had received the brand-name drug, ... Continue Reading

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Will The Supreme Court Cheat The Woman Living In “Hell On Earth”?

[Update, June 24, 2013. The Supreme Court ruled against Karen, holding, in essence, that generic drug companies have no responsibilities whatsoever to patients.]   I’ve written before about the United Supreme Court’s dismal PLIVA v. Mensing opinion. Although Justice Scalia recently co-wrote a book on legal interpretation that admitted that a basic principle of federalism is that “a federal statute is presumed to supplement rather than displace state law,” he had no trouble joining Justice Thomas’ opinion finding “implied” pre-emption of all state tort lawsuits that alleged  generic drug manufacturers failed to adequately warn about their product’s risks.   Nevermind ... Continue Reading

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Do The Drugs Januvia, Byetta and Victoza Cause Pancreatic Cancer?

[Update, March 2013: I originally wrote this post in December 2012. Three months later, the FDA announced it "is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics." Several news agencies ran with the news, including AP and Bloomberg, as did some pharma industry bloggers. The JAMA Internal Medicine medical journal ran a column urging more research into the link between the drugs and pancreatic cancer, an ... Continue Reading

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When Should The Statute Of Limitations Run For Medication Lawsuits?

Last week, our firm blog posted a short note about how Actos patients with bladder cancer in Kentucky, Louisiana, and Tennessee should move quickly to file because those states have a one-year statute of limitations for personal injury actions. We (and a whole bunch of other lawyers) assume that Takeda Pharmaceuticals will argue that the statute of limitations began to run on June 15, 2011, when the FDA issued an updated warning that one year of Actos use increases the risk of bladder cancer by more than 40%. As if on cue, the next day Pfizer moved for summary judgment on a whole swatch of consolidated Chantix ... Continue Reading

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Yaz and Propecia Labels Updated; Are They Subsequent Remedial Measures?

As I've written before, anti-consumer legislators and judges have so thoroughly eviscerated claims against pharmaceutical companies that in most states there's only a single claim left: the claim that brand-name drug manufacturers failed to warn about the risks of the drug. As long as the company warned about the risks of the drugs, they're essentially immune from liability, even if the drugs weren't properly tested, even if they were deceptively marketed, and even if the drug didn't perform as promised. (Sometimes state and federal attorneys general can sue over drugs that were falsely marketed, like how Johnson & Johnson was ... Continue Reading

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Antidepressant Birth Defects and The First Amendment

The big shift in thinking about antidepressant use in pregnancy began in late 2005, when the FDA warned that Paxil "increases the risk for birth defects, particularly heart defects, when women take it during the first three months of pregnancy," and demanded  GlaxoSmithKline to change Paxil from a "Category C" drug to a "Category D" drug, i.e. a drug known to produce birth defects or injure fetuses.   In February 2006, the landmark "Selective Serotonin-Reuptake Inhibitors and Risk of Persistent Pulmonary Hypertension of the Newborn (PPHN)" study was published in the New England Journal of Medicine, showing that Prozac use in ... Continue Reading

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Pradaxa Bleeding Lawsuits Begin; Still No Reversal Agent Available

This post was written for my legal blog — patients injured by Pradaxa should read my Pradaxa bleeding problems  page. In our medical malpractice and nursing home abuse work, we see one case with disturbing frequency: warfarin overdoses. A recent CDC study confirmed that warfarin, anti-platelet medications, and diabetes control medications together accounted for a whopping two-thirds of all drug-related emergency hospitalizations of senior citizens. Errors in dosing and monitoring warfarin by health care professionals, too, account for a significant (over 1%) of medical malpractice claims. It’s a great drug, but a dangerous one. Warfarin has a fascinating history. In nature, the molecule on which ... Continue Reading

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New Jersey Supreme Court Re-affirms Discovery Rule For Statute of Limitations in Pharmaceutical Negligence Lawsuits

Some of the largest drug companies in the United States are based in, of have their U.S. headquarters in, New Jersey — e.g., Johnson & Johnson is in New Brunswick, Merck is in Whitehouse Station, Roche is in Nutley, Barr (now owned by Teva) is in Montvale, Sanofi is in Bridgewater — and so New Jersey state courts are home to a huge volume of pharmaceutical injury litigation. There's so many Accutane (Roche) and Fosamax (Merck) cases they're deemed a mass tort, and there's a good chance that Propecia (Merck) might end up as one, too. Same goes with a large number of ... Continue Reading

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The Most Unfair Prescription Drug And Medical Device Opinions Of 2011

A few days ago I reviewed the list of "worst" pharmaceutical and medical device liability court opinions of the last year as chosen by the defense lawyers at Drug & Device Law, so I feel obligated to follow-up on their post on the "best" prescription drug and medical device decisions. The short version is quite simple: drug and device companies really like activist judges legislating from the bench or overruling juries' factual findings. How else to explain the love for PLIVA, Inc. v. Mensing, in which the United States Supreme Court couldn't find a federal statute or regulation in support of ... Continue Reading

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The Unintentional Message Of The “Worst” Drug And Device Court Opinions

[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 ... Continue Reading

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