Drug Recall Lawyer Blog

Last week was a busy one--our firm had two trials (one continuing on this week with closing arguments tomorrow), and one that concluded very favorably with a plaintiff's verdict. But, now that I'm back, here's this week's edition of the Round-Up:

• The Sixth Circuit and Preemption: As mentioned by Drug & Device Law Blog, the 6th Circuit wants the FDA's viewpoint on preemption by July 29.
• Testosterone Gel: The Drug Injury Lawyer Blog reports on the links between testosterone gel and heart attacks/strokes. We've blogged about Testim, one version of the drug, before.
• Fosamax: I'm really sorry to have missed reporting such a big event. Here's a bunch of stories on the $8 million plaintiff's victory in the Boles Fosamax trial: Drug Injury Watch; Shearlings Got Plowed (victory notice)(post-trial motions)(next trials)
• Vioxx: Can Louisiana sue Merck to recover for money spent on Vioxx?
• BPA: The National Resources Defense Council (NRDC) sued the FDA over the FDA's failure to ban BPA in selected products. We'll see how that goes.... Here's an update on BPA from the FDA.

Hope you had a happy 4th!

There is an upcoming battle in the U.S. Supreme Court over generic drug preemption. The Supreme Court has asked the DOJ to file a brief about whether failure to warn claims can be brought against manufactures of generic drugs. The generic drug manufacturers are arguing that their products have basically been pre-approved, and they should nor really be responsible for knock-off products and their knocked-off warnings.

However, the contrary (and correct) trend of the U.S. District Courts, and now the 8th and 5th Circuit Courts of Appeals, is that Wyeth v. Levine controls and generic drug manufacturers may be sued based on state law for failure to warn.

Related Information

• Wyeth v. Levine: Background Information


• FDA Law Blog: Supreme Court Wants DOJ’s Insight


• FDA Law Blog: PA. District Court Rules Against Generic Drug Manufacturer

The New York Times published an article yesterday, “When Heart Devices Fail, Who Should Be Blamed?” The article puts a nice gloss on how and whether a company and people in charge of a company can properly make amends and taking personal/corporate responsibility.

The backstory is of course that a federal judge is considering whether to accept a $296 million fine, and a guilty plea to two criminal misdemeanors by Guidant (now Boston Scientific). Two cardiologists are urging the judge to reject the deal, and instead want prosecution of the company “and the individuals responsible.” The cardiologists, who cared for 21-year old patient who died because his Guidant device did not properly function, further state:

Manufacturers control the quality of their products. Manufacturers are the first to know when a medical device is dangerous or underperforming. Thus, it is in the best interest of patients, and society in general, for manufacturers to be liable for the safety and effectiveness of their products. To allow a repeat offender, like Guidant, to escape with a fine (that is entirely borne by the shareholders of Boston Scientific) does not hold the guilty parties fully accountable and inevitably undermines patient safety.

Sadly, it’s hard to know what the cardiologists are really looking for. I suspect they want the executives in charge to be put in jail, or have to pay fines from their own pockets. But, this may be a situation where there is no relief, as thousands of patients and their families know because they are prevented from filing meaningful civil lawsuits. The only thing we can do is work to repair the damage caused by medical device immunity.

For more on the Guidant topic, see our prior blog posts.

Sometimes, personal responsibility is hard to come by. The same can be true of corporate responsibility, which is simply another version of personal responsibility (under the law, corporations are entities capable of suing and being sued, and doing many of the same things that people do).

Exhibit A is Guidant’s plea in federal court on Monday. Guidant (recently acquired by Boston Scientific) pleaded guilty to criminal violations of the Federal Food, Drug and Cosmetic Act. Specifically, it pleaded guilty to two violations:

1. making a materially false statement in a required submission to the FDA (Ventak Prizm 2DR)
2. Failing to notify the FDA of a “correction” made to reduce a health risk caused by defibrillators (Contak Renewal)

As part of the plea, Guidant is agreeing to pay over $296 million in criminal penalties, the largest criminal penalty ever imposed on a device manufacturer. Judge Donovan Frank is reviewing the plea agreement.

The defibrillators are devices implanted near the heart, designed to provide life-saving electrical jolts to patients with heart defects. Because of the defective devices, people have died when the devices did not function as they were expected to. Prosecutors allege that the manufacturer, which had notice of the problems, tried to cover up the fact that those deaths were caused by the defibrillators.

It is important to remember that none of the $296 million is going to Guidant’s victims or their families. The company is being held criminally responsible, but civil responsibility is elusive here. Even though Guidant admitted its wrongdoing, the U.S. Supreme Court decision in Riegel v. Medtronic holds that medical device manufacturers cannot be held civilly responsible for devices approved by the FDA’s premarket approval process.

So, there’s only limited responsibility here. The Medical Device Safety Act (introduced in Congress as S. 540 and H.R. 1346) is designed to remedy that situation.

If a rich man clubs a child with a baseball bat, shouldn’t he be sent to jail and subject to paying for the child’s injuries? Same thing should hold true for corporations.

Heart devices and the companies that manufacture them have had a rocky road the past few years (excluding Medtronic’s failed sprint fidelis leads: despite needlessly shocking patients, claims for injuries have been found by a federal trial court to be preempted). These include Guidant, which was subject recall and numerous lawsuits over its defibrillators because of a short-circuiting problem.

Now, Boston Scientific (which acquired Guidant in 2006) has voluntarily recalled all (non-implanted) implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). An ICD is a device that monitors heart rhythms and delivers life-saving shocks if dangerous rhythms are detected. A CRT-D treats certain types of heart failure by coordinating the pumping of the heart’s ventricles. The units recalled fall under the COGNIS, CONFIENT, LIVIAN, PRZM, RENEWAL, TELIGEN and VITALITY lines.

Continue reading "Boston Scientific Defibrillators Recalled " »

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.