Drug Recall Lawyer Blog

The FDA is warning patients and doctors about possible risks posed by 280,000 defibrillators, manufactured by Cardiac Science of Bothell. These are external defibrillators, the kind you find in airports, at hospitals, nursing homes and at swimming pools.

The devices may not provide the correct shocks, may not properly evaluate heart rhythms. There are 14 devices subject to the warning, including Cardiac Science Powerheart, CardioVive, Nihon Kohden (NK) and GE Responder External Defibrillators manufactured between 2003 and 2009.

Users should continue to use the defibrillators (which are potentially better than nothing) until they can get replacements or repairs. Obviously, the FDA recommends that high risk locations (hospitals, nursing homes, etc…) immediately arrange for repair/replacement and use alternative devices in the meantime.

See the FDA’s notice here.

We’ve been getting a lot of questions over the past few days about Seroquel. That usually means I need to put up a new post, especially in light of recent events.

Earlier this week, AstraZeneca (the manufacturer of Seroquel) agreed to pay $520 million to settle a federal inquiry into Seroquel marketing practices. As we have stated before, Seroquel is approved to treat schizophrenia and bipolar disorder. However, investigators and plaintiffs believe that AstraZeneca marketed the drug for myriad other unapproved uses, including depression, obsessive-compulsive disorder, dementia, and post-traumatic stress disorder.

There are no criminal charges associated with the deal. Giving credence to plaintiffs’ claims (aside from the credibility arising from the mere fact of a whopping large settlement), is that federal investigators got much of their information from AstraZeneca whistleblowers, drug sales rep, James Wetta (who had some involvement in the whistleblowing at Eli Lilly around 2003).

The deal comes at a time when such deals seem to be simply the cost of doing business. As just one example, Boston Scientific is in the midst of trying to settle with investigators for $296 million over the actions of a company it acquired, Guidant. Seroquel’s settlement pales in light of the fact that in 2009 alone, they made $4.9 billion in Seroquel sales. Isn’t that criminal?

Anyway—civil lawsuits are still continuing, but Plaintiffs are having a hard time of it. For more information, visit our Seroquel website and past Drug Recall Lawyer Blog posts on Seroquel.

In a bold move, Judge Donovan Frank rejected a $296 million plea deal, offered by Boston Scientific and prosecutors. The proposed agreement was offered for Guidant’s failure to timely report problems with some of its defibrillators, which have caused at least seven deaths and numerous injuries. Boston Scientific purchased Guidant back in 2006. The federal Minnesota judge considered the arrangement, but ultimately rejected deal (which included a guilty plea by Guidant for two misdemeanors: submitting a false and misleading report to the FDA, and failing to notify the FDA about a device safety correction).

Judge Frank stated that “[a]t a minimum, the public’s interest in accountability would be served by Guidant and Boston Scientific being placed on probation, regardless of the fact that Boston Scientific acquired Guidant after the events in question. And, the court believes that a period of probation would likely benefit, rather than harm, Guidant’s and Boston Scientific’s public image.” The judge indicated that some measure of community service would be appropriate.

The judge concluded that he could not properly order restitution to victims directly, because patients were not “directly harmed” by the misdemeanors that Guidant fessed up to.

Prosecutors and Boston Scientific will revisit the agreement, and seem likely to modify it to satisfy the judge’s concerns. If the monetary amount stays the same, this will be the largest such monetary “fine” levied on a medical device manufacturer. Many judges would have taken it, but Judge Frank is doing his best to do what is right.

I confess that I have a little soft spot for Boston Scientific in all of this—it purchased a company with a bad history in hopes of turning it around, and it’s getting a lot of grief for its trouble. But, it would be too easy to let them off the hook simply because Guidant changed its corporate form. I think the company will emerge stronger for the experience.

Here are the stories we’re following this week:

• Infusion pumps: The FDA is tightening regulation of infusion pumps, which have reportedly caused 710 deaths in the past five years, and have been subject to 79 recalls since 2005 (news links to The New York Times, The Wall Street Journal, Associated Press, Reuters).
• Guidant: Brian Nash’s perspective on the defective Guidant defibrillator settlement proposal.
• Fosamax: Apparently, the trial has been going on all week (HT: Shearlings Got Plowed).
• Sprint Fidelis Leads: Last week, the 8th Circuit Court of Appeals heard arguments in Case no. 9-2290, Anna Bryant v. Medtronic. You can hear the recording here.
• Pfizer: The FDA issues a warning to Pfizer about clinical trials where children received excessive dosages of antipsychotics (HT: FiercePharma).
• Boston Scientific: The Guidant-purchaser is set to resume sale of some defibrillators which were recalled last month after it notified the FDA that some paperwork wasn’t properly submitted. (see The Wall Street Journal (subscription req’d)).

Happy Monday!

The next Fosamax trial, alleging osteonecrosis of the jaw, is likely starting this upcoming Monday, with jury selection today (HT: Shearlings Got Plowed). The case will go before the U.S. District Court for the Southern District of New York (Manhattan).

In the Maley case, Merck tried to obtain a dismissal based on inadequate specific causation, but that attempt failed back in January. Merck contends that the plaintiff does not have osteonecrosis of the jaw but, instead, has a condition known as neuralgia-inducing cavitational osteonecrosis (NICO). Specific diagnosis of plaintiff’s condition is likely to be a big issue at trial.

For more on Fosamax, see prior posts of the Drug Recall Lawyer Blog.

This is something every blog must struggle with. What voice should the blog have? First-person (or the blogger variant--the royal first-person, where everything is about "we" and "us," though the blog is written by one person), or third-person?

Corporations frequently choose a corporate voice, making everything about the corporation. The voice of the blog is often the "voice" of the corporation (corporations are legal entities with rights, of course). But, this can be tough to read sometimes, and still manages to lose the personal flair of a first-person narrative.

So, when my Google Reader blog-feed listed AstraZeneca's recent post, "Connections for Cardiovascular Health," I was interested to see that they are gravitating toward a first-person voice. The side panel shows that the main contributor and "voice" is Earl Whipple, the blog editor and senior director in the AZ corporate communications group. The sidebar mentioned that others would contribute (the CEO had a post on March 23), but perusing the posts, it looks like Earl is the only contributor except for occasional guests.

I think first-person is the way to go, but only if you can actually convey a sense of the personality behind it--I suspect that AstraZeneca will not let loose the reigns, and we will not find out anything interesting about Earl. That's too bad, because personality is probably the largest reason people read blogs (except in my case, where if you spend any time reading my blog, knowing my intense love for all things sci-fi might actually turn you off--comments to the contrary appreciated!).

So how about it, Earl? Tell us about yourself. Maybe even give us some personal viewpoints that deviate from AZ's corporate perspective...

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.

Here are this week’s stories:

• Shoulder Pain Pump MDL Denied: The Judicial Panel on Multidistrict Litigation denied the plaintiffs’ request for consolidation in an Order. I disagree with the rationale).
• Hospira: Drug-maker Hospira received two FDA warning letters about manufacturing problems.
• Bayer Price-fixing: The Mississippi Supreme Court has overturned a trial court’s dismissal of a case alleging that Bayer inflated drug prices and “drove up the state’s Medicaid spending.” The attorney arguing the case told the Court that Mississippi lost over $1 billion because of Bayer’s fraud.
• YAZ: The LA Times has an article about the YAZ litigation and injuries. The picture’s caption says that “Studies have not found an increased risk with these pills”; though further in the article it acknowledges that “Research on the issue is divided . . . . some studies show a sixfold greater risk.”
• Kugel Mesh: Ron Miller reviews the recent trial.
• Epilepsy & Depression Drugs Linked to Suicide: A new study gives patients reason to talk to their doctors, especially about off-label uses of these drugs (HT: Drug Injury Lawyer Blog).

Have a great week!

I saw a link the other day to CNBC's "Pharma's Market" by Mike Huckman titled The Funny Business of Selling Drugs. Unsure if it was truly funny or more simply "funny" in the sense of "something funny is going on, here," I clicked the link.

Turns out it's a little of both. It's a brief article about an HBO Comedy, "The Life and Times of Tim" (which, admittedly, I've never seen nor heard of).

According to the article, one episode has the following premise:

The show is a bawdy, hilarious send-up of doctors' offices that are overrun by so-called "Meals on Heels." That's industry slang for the stereotypical short-skirted, wheely-bag toting, lunch-catering drug sales reps.

As funny as it may (or may not) be, there is usually a little truth behind most jokes. The description of the episode seems to be an indictment of sorts against the way things are done in the Pharm industry--drug companies selling their wares by plying doctors with gifts--little things, like office supplies, stress balls, gadgets, and trips to Hawaii. Is there a better way to keep doctors informed about your products? Well, we're all human, and without a personal incentive, we may not have any interest in learning about these products (I routinely refuse to see vendors who "stop by" the office without an appointment, though some in my office love to spend 30 minutes chatting for some complimentary swag).

Bribery (and that's what it is) doesn't exactly send the right message. I'm sure the drug companies will defend the practice, saying that doctors use their independent judgment, and they are using the gifts as a means to get in the door so they can have a really serious sit-down, but what human wouldn't want to "earn" the free gifts, or at least repay the favor? Surely there is a better way...

For more information on the Zimmer NexGen knee replacement lawsuits, see the new Miller & Zois Zimmer webpage. Of course, visit the Drug Recall Lawyer Blog for periodic updates.

The president of the American Association for Justice, Anthony Tarricone, comments about the extreme costs associated with medical device immunity. As one example, he cites to the Sprint Fidelis lead wires which have a high rate of breakage and unnecessary shocks. The manufacturer, Medtronic, is so far immune from claims of injury by people who had the device implanted.

In this day of concern over rising medical costs, the fact that consumers, taxpayers and insurance companies have to foot the bill for problems created by medical device companies should be an outrage. And, that doesn't even take into account the unquantifiable pain and human distress caused by defective devices.

Here is a short video featuring people who have experienced first-hand the pain of repeated electric shocks by the Sprint Fidelis lead, and a description of the legal issues.

Stop Corporate Immunity - Medical Device Safety Act from American Association for Justice on Vimeo.

Here are the stories we’re following this week:

• Yasmin: Bayer is updating its European warning label after recent Swiss studies (HT: Tom Lamb)
• Direct-To-Consumer Drug Advertising: FDA proposes new regulations (HT: Mass Tort Defense Blog)
• Zicam: Update on the Zicam (nasal spray that may cause loss of sense of smell) MDL, pending in Phoenix (HT: Searcy Blog)
• Pain Pumps: California state judge cuts up pain pump claims (HT: Drug & Device Law Blog)
• Drug Companies: Three drug companies (Pfizer, Solvay, and Procter & Gamble) found to have breached the British Pharmaceutical Industry’s code of practice (HT: PharmaGossip)

Happy Monday!

The medical journal The Lancet is chiming in on the Avandia debacle. Back in 2009, The Lancet published a paper about the RECORD study (funded by Avandia manufacturer GlaxoSmithKline) which was widely criticized. The major complaint is that the article did not include the drop-out rate—without knowing which patients went off the drug, it is impossible to calculate the risk of Avandia-caused heart attacks.

Now, The Lancet issued an editorial titled “Strengthening the credibility of clinical research.” It describes briefly the Avandia situation, likening the recent Senate Committee on Finance report to a John Grisham novel: “GlaxoSmithKline (GSK), intimidated researchers and manipulated the scientific process for commercial advantage.”

Here are some “talking points” from the editorial:

• at a time when some pharmaceutical firms have received record fines for misconduct, the saga of rosiglitazone [Avandia] tests the limits of tolerance
• such findings damage all who are involved in clinical research, and will likely make funding, ethical approval, and recruitment more onerous for future studies
• trust between doctor and patient, researcher and participant, or author and editor is undermined when the foundations on which evidence is built are treated with such casual contempt
• nothing can completely protect against scientific misconduct

The Lancet reported that it has strived to encourage and use better and more transparent protocols, but that a recent audit of those protocols found that “adherence to protocols was ambiguous and selective.” Like a Tiger Woods apology (or a Jesse James apology, or a Michael Richardson apology, insert your celebrity here), they have vowed to do better, and have spent the past three years working with others on Standard Protocol Items for Randomized Trials (SPIRIT). Heck, just having an acronym makes me feel better.

But seriously—The Lancet is a good publication, and its heart is in the right place, I think. Hopefully they can turn this around and restore confidence in scientific studies and pharmaceuticals.

The Seroquel cases are not going well for plaintiffs.

On April 6, the Eleventh Circuit Court of Appeals affirmed the summary judgment ruling of the Massachusetts federal trial court in a Seroquel case. The plaintiff alleged that Seroquel caused her to gain weight and develop diabetes, but at the trial level (and affirmed on appeal), she lost her specific causation expert on a Daubert ruling. The trial record showed that the excluded expert did not have sufficient medical history upon which to base her conclusions—at deposition, she lost points by not knowing the full history of plaintiff’s weight gain and loss. The Court stated:

In fact, Guinn's weight fluctuated before, during, and after her use of Seroquel, with her highest recorded weight during each period being roughly equivalent. Guinn also had a sedentary lifestyle, a poor diet, a significant family history of diabetes, hypertension, hyperlipidemia, schizophrenia, and prediabetes, all of which, in addition to her age of 61, put her at an increased risk for developing diabetes.

Tellingly, the plaintiff’s expert commented that the plaintiff would have likely developed diabetes, even absent taking Seroquel.

Experts must be given full access to information well before litigation commences. This highlights the need for plaintiffs’ attorneys to work with experts, to make sure they have everything they need, and to thoroughly examine their opinions and conclusions prior to naming them as experts. In mass torts this is especially important, and in bellwether cases this is crucial—to some degree, these cases set the precedent for following cases.

The scorecard brings that to seven grants of summary judgment (one affirmed on appeal), and one defense verdict. AstraZeneca, the manufacturer of Seroquel, has settled with the government to the tune of $520 million regarding improper Seroquel marketing. There are about 25,000 cases left to go.

For more information on Seroquel, 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.

Here are the stories we’re following this week:

• Pfizer: CNN reports on why Pharmaceia, Pfizer’s shell company, “took the fall” for Pfizer’s illegal marketing practices
• Crestor: will the marketing campaign persuade people to take it when they don’t need it? (HT: Patient Safety Blog).
• Seroquel: Two more summary judgment decisions in Delaware (HT: Drug & Device Law Blog).
• Fosamax trials: Scherlings Got Plowed has an update.
• Children and Medical Devices: The FDA is requiring medical device manufacturers to provide additional information on the effects of their devices on children.
• Pfizer Discloses Payments: Pfizer disclosed $35 million in payments to healthcare professionals in the last half of 2009. The payments were for development and marketing. (HT: FiercePharma).

Happy Monday!

Two prominent Chicago orthopaedic surgeons are calling for the recall of Zimmer’s NexGen CR-Flex Knee replacement devices. The porous femoral component (that is, the part of the replacement that covers the head of the femur, the bone that goes from the pelvis to the knee) is associated with a high rate of failure. The two Chicago surgeons calling for the Zimmer recall, Richard Berger and Craig Della Valle from Rush University Medical Center, have observed after two years’ of use that 36% of the implants were loose, and 9.3% were revised or set to be revised because of looseness and associated pain.

The doctors stated that “[t]his component is still commercially available but should not be used for any patient.” They also questioned the fact that the product was released for sale to the public without clinical testing. Dr. Berger described the failure rate as “horrific.”

Dr. Berger has contacted Zimmer, but observes that they have not been receptive to his concerns.

The exact reason for the failure of the device is not yet known. The CR-Flex Knee uses a porous, non-cement femoral component. In other brands, cementless femoral components tend to work fine. However, Zimmer’s product is another story.

Zimmer issued a statement, essentially claiming that Doctors Berger and Valle simply implanted their devices incorrectly, and noting that the Australian National Joint Replacement Registry reveals a high success rate. But, Zimmer has good reason to be concerned—the NexGen products made up 2% of the company’s $1.76 billion sales in 2009, with over 150,000 sales since they hit the market in 2003.

If you or a loved one has a Zimmer NexGen knee implant that causes pain, requires revision or replacement, or causes other complications, please contact us at 1.800.553.8082 or fill out our on-line evaluation form.