Drug Recall Lawyer Blog

It’s a winter wonderland here in Maryland, and our office is running on a skeleton crew. Here are the top drug injury-related stories for the past few days:

• Digitek: Tom Lamb and the Drug Injury Watch post on the status of this litigation (surprisingly, it is not defunct yet, despite long problems in finding the mythical creature, “The Double-Dose Pill.”
• Preemption: An upcoming article by Mary J. Davis in the Hastings Law Journal titled “The ‘New’ Presumption Against Preemption.”
• Gadolinium: A Danish radiologist complains to The Guardian that the United Kingdom’s laws on libel are preventing him from speaking about the dangers of General Electric’s MRI contrast dye, Omniscan. He states that, "I am not giving lectures any more in the UK where it seems you can be sued for telling the truth." He is being sued by GE Healthcare. GE: “We Bring Good Things to Light [or, do our best to quash them through litigation].”
• Fosamax: Exposé by NPR about how Fosamax came to be so popular, and whether it actually works. (Hat tip to Shearlings Got Plowed)

Happy Monday!

The United States Court of Appeals for the Eighth Circuit yesterday issued its opinion in Scroggin v. Wyeth, et al. The opinion is overwhelmingly positive for women and their families who have been injured by the hormone therapy. Donna Scroggins, like many women who took hormone therapy, suffered from breast cancer in both of her breasts and later had both of them removed.

In the underlying 2008 Arkansas trial, the jury found Defendants liable to the tune of $2.75 million in compensatory damages, and $27 million in punitive damages.

Continue reading "Next Step: Punitive Damages" »

Remember Wyeth v. Levine, U.S. Supreme Court decision that held federal approval of labels drug warning labels does not preclude lawsuits under state law claiming inadequate warnings? Well, the government, through the FDA, has now added a final chapter to that story.

The drug at issue in Wyeth v. Levine was Phenergen, an antihistamine. The drug was administered using a method known as an “IV push,” however the drug was inadvertently injected into Dina Levine’s artery. She developed gangrene, the arm had to be amputated (Diana Levine is a musician, and the tragedy of her injury is simply incomprehensible. See John Bratt’s blog post).

The label originally warned that the IV push method could lead to inadvertent injection into arteries, but the label did not expressly forbid that procedure. Now, after the conclusion of the Wyeth case, the FDA has allowed the Court’s decision to lead the way, and has amended the label to include a black box warning: “due to the risks of intravenous injection, the preferred route of administration is deep muscular injection and that subcutaneous injection is contraindicated.”

Can anyone doubt that if Wyeth was truly concerned with patient safety, it would provide full warnings as soon as possible? Unfortunately, it seems as though the almighty dollar is the reason for holding back on warnings, with the fear that fewer patients will take drugs when the risks are appropriately disclosed. It is a game of “hide the ball.” The results: ask Diana Levine’s.

It's Friday, so this post will be as discombobulated as I feel.

I came across the Supreme Court of the United States wiki ("SCOTUS Wiki") today while trying to hunt down a copy of the recent Journal of the American Medical Association (JAMA) letter to the editor published by Michael D. Green. Green is a torts law professor at the Wake Forest University School of Law in North Carolina.

The SCOTUS Wiki is a terrific concept--it features links to the innumerable documents associated with many Supreme Court cases--check out the wiki on Wyeth v. Levine. I'd love to see some enterprising young techno-lawyer do something similar with the Judicial Panel on Multidistrict Litigation--at the very least, shouldn't the JPML join the 21st century and get their documents on PACER?

At any rate, Green's JAMA letter to the editor is only available to subscribers, but here's the link if you have a subscription. But, if you'd like to see his amicus brief from Wyeth v. Levine, head here.
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Preemption is typically a bad thing (big business and their lawyers typically disagree with me on this). In a nutshell, preemption is the ability to one set of laws to override another set. Typically, the context is that the federal law says ‘A,’ a state’s laws say ‘B,’ and so ‘A’ wins. Of course, the way our country was set up, we encouraged states to experiment with their own laws.

Applied to the medical arena, many medical device manufacturers believe they should be immune from lawsuits for defective devices (devices may be defective for any number of reasons—they may have been designed incorrectly, the manufacturing process may have had errors, or they may come with improper warnings). Sadly, the Supreme Court agreed that the law allowed that conclusion in Riegel v. Medtronic, Inc.

Continue reading "Medical Device Safety Act of 2009" »

Last week, the President issued a memo for the executive department on preemption. In a nutshell, preemption refers to the supremacy of a federal law where it conflicts with or is inconsistent with a state law. In the context of drug and device cases, this has been something of a hot topic lately, with the legislature and courts wrestling with the question of whether particular federal laws preempt the ability of the states to permit certain product liability suits.

The memorandum shows that the executive branch is taking a traditional approach—“preemption of State law by executive departments and agencies should be undertaken only with full consideration of the legitimate prerogatives of the States and with a sufficient legal basis for preemption.” The directive to executive agencies and departments is clear—they should not make statements about preemption, even in regulatory preambles, unless the underlying regulation addresses preemption. Furthermore, they are asked to review the past 10 years of regulations to determine whether existing statements about preemption are accurate.

This is a phenomenal memo. Preemption has lately been the scourge of victims and injured consumers (see Riegel), but we are making good ground to provide avenues of relief for people who have been hurt by others (see also Wyeth v. Levine).

Lobbying efforts, particularly by injured victims and their counsel (as well as manufacturers of medical devices), are continuing for the Medical Device Safety Act of 2009. It’s no surprise that each side takes the position it takes—the victims hoping to pass the legislation to prevent more blanket immunity for manufacturers of devices that hurt or kill patients; and manufacturers hoping to reap the benefits of zero liability for some of their devices which cause injury. However, it is interesting to note that one group, which has typically opposed the desires of victims, has also weighed in.

Physicians are coming out in support of the Medical Device Safety Act. Typically, they support tort reform and anything to prevent or limit lawsuits against healthcare providers. However, in a New England Journal of Medicine Editorial of April 9, 2009, three physicians took a stand behind the proposed legislation.

Continue reading "Medical Device Safety Act of 2009--Rebuilding the Status Quo" »

Yesterday, the Health Subcommittee of the U.S. House Committee on Energy and Commerce held a hearing on the Medical Device Safety Act of 2009 (H.R. 1346). This new law that would restore important the rights of defective medical devices that was eradicated by the U.S. Supreme Court decision in Riegel v. Medtronic. The Medical Device Safety Act would restore the right of victims injured by a defective medical device to seek tort remedies for injuries and deaths.

Rep. Bruce Braley (D-Iowa) said at the hearing that the Supreme Court's decision was flawed because preventing injured patients from suing devicemakers over FDA-approved products results in shifting the cost of caring for injured patients away from medical device companies who cause the injuries onto the already burdened American taxpayer.

Point of Law has a full list of those who testified before the subcommittee. One of those speakers is Michael Kinsley, a liberal columnist who wrote a silly editorial on Medtronic v. Riegel that showed off his complete lack of understanding of the facts of the case. I'm not saying an argument can't be made - Justice Scalia did just that.

But Kinsley column was riddled with confusion. He can’t figure out why we don’t defer blindly to the powers that be at the FDA. He seems blithely ignorant of the fact that fact that the FDA does not have anything resembling equal post-marketing information about a medical device the drug manufacturer does. Kinsey's argument really should be that we should just get rid of juries and let the "smart people" decide. But President Obama can make decisions about the national security and the economy even though he is not a general or an economist. He does what juries do: listen the the arguments and make the call. It is called the jury trial system and it has a long history.

I think Kinsley is doing what liberals sometimes do: flash conservative ideology by pretending to be balanced by picking on targets with populist appeal. When Kinsley wants to appear balanced, he attacks things like deficit spending (which he supports while atttacking - its bizarre) and, everyone's favorite target, trial lawyers.