Drug Recall Lawyer Blog

News reports in the past couple of days have hit on part two of the CT radiation overexposure. Before, the issue was whether certain CT devices, whether because of manufacturing, design, or technician error, provided too much radiation to patients. A secondary question was whether patients were receiving too much radiation through scans over the course of their lives (the FDA reports that the average person’s radiation exposure has doubled in the last thirty years).

Now, the question is focused on whether CT scans are a good idea for screening purposes where a patient has no indication that they have any disease—the three that have been most mentioned are whole-body CTs (to see if there is anything wrong); CT colonoscopy (to detect colon cancer), and CT scans of the heart (to detect heart disease). Most of the debate has been centered around the colonoscopy procedure.

On one side are those who believe that traditional methods—a colonoscopy, are best to detect colon cancer. Proponents (including the American College of Gastroenterology, who come out on the side of their financial interests in the question) state that CT colonoscopies are not as certain as the traditional visual colonoscopy; that removal of polyps would require a second procedure with a CT colonoscopy (versus being done at the same time in the traditional procedure), and that incidental findings on a CT scan may lead to unnecessary procedures. Additionally, repeating these scans increases patient exposure to radiation.

Detractors, those who support the “virtual colonoscopy” (including the American College of Radiology, who likewise come out on the side of their financial interests in the question) state that virtual colonoscopies are less invasive and more people will probably use them; that there is less chance of perforated bowel or anesthesia risks.

Even the FDA is undecided—there is a fight there about whether the procedure, which General Electric wants to have approved (it manufactures scanning equipment), should be approved (meaning GE would be able to market the virtual colonoscopy to patients and doctors). Some doctors and scientists believe the extra radiation exposure would cause actual harm, when even now between 1.5 and 2 percent of cancers are caused by CT scan radiation exposure.

As uncomfortable as the traditional method may be, it seems like the safest way to go. The problem with radiation exposure is that you don’t know how much you will have during your lifetime—a few major diseases, and your CT (and other) radiation exposure could magnify tenfold, meaning you might regret a virtual colonoscopy every few years. Additionally, the virtual colonoscopy, though perhaps effective to a degree, is not as certain as a traditional colonoscopy. And, peace of mind is a good thing.

The first federal Kugel Mesh hernia repair lawsuit began in the U.S. District Court for the District of Rhode Island, yesterday. Plaintiff John Whitfield claims that the mesh, manufactured by Davol, Inc., was defective and broke after it was implanted, causing bowel obstruction, abdominal pain, nausea, permanent bowel injuries, and necessitating additional surgery.

This is the first of four bellwether trials, designed to give lawyers on both sides a sampling of how jurors will deal with the information and trial strategies. This may assist the parties to reach settlement in remaining cases, after they learn the strengths and weaknesses of each side.

There are 1,300 other hernia mesh cases that are consolidated in the Rhode Island federal court MDL. An additional 1,774 cases are in Rhode Island state court, with the first trial expected later in the summer. Many of the hernia patches were recalled since 2004.

Defendants have a great deal of risk with these cases—though damages in the average individual case are not extreme, the volume of the cases and the record of manufacturer indifference to the problems makes punitive damages a possibility.

For more information on Kugel Hernia Mesh Patches, see our website and our prior blog post.

Here are the stories we’re following this week:

• Fosamax and Statute of Limitations: Recent Fosamax case and application of American Pipe mass tort/class action tolling (HT: Drug and Device Law Blog)
• Drug Pushers: Are sales reps who promote their companies drugs with direct-to-consumer (DTC) advertising “pushers?” (HT: Pharma Marketing Blog)
• Anemia Drugs: Anemia drugs by Johnson & Johnson and Amgen may exacerbate heart problems and survival in kidney patients (HT: FiercePharma)
• Price-fixing: According to a Bloomberg report, Germany cuts costs of drugs by precluding manufacturers from setting their own prices.
• Neurontin: Reuters reports that Pfizer loses a RICO trial to the tune of $141 million.
• Boston Scientific Defibrillators: Another perspective here. You can see our previous blog post here.
• CT Scan Radiation: New York Times article about whether FDA ignored warnings about radiation problems.

Today in sunny San Diego, the Judicial Panel on Multidistrict Litigation (JPML) is hearing plaintiffs’ requests (see our blog post on the December 2009 petition) to convert the individual federal pain pump cases into one MDL, centralized before the District of Minnesota. See page 4 of the Notice of Hearing Session. Right now there are at least 104 federal pain pump cases proceeding in 28 distinct federal courts. The great majority of them are the same in numerous ways:

1. A pain pump was -placed into the intra-articular space following open or arthroscopic shoulder surgery.
2. The pump remained there for approximately 24-72 hours, providing post-surgical pain relief.
3. The patient, despite physical therapy, continued to have worsening shoulder pain beginning about three months after surgery.
4. Later x-rays, MRIs and surgeries show that the patients cartilage, located in the glenhumeral joint, has totally wasted away.

The defendants in the pain pump cases are the manufacturers of the pain pumps and, in some cases, the manufacturers of the anesthetic used in the pain pumps. Plaintiffs are proving that the pump manufacturers marketed their pumps to shoulder surgeons, telling them exactly how to place the pump’s catheter into the intra-articular space so the patient received maximum pain relief. However, the manufacturers never told doctors that the procedure was denied by the FDA three times for lack of safety data. And now, many patients cannot perform their jobs, cannot enjoy basic recreation (swimming, jogging, rock climbing, etc…), and even have difficulties sleeping because of the constant pain of bone-on-bone contact in their shoulder joints.

The goal of the motion (which was brought once before when the pain pump cases were brand new) is to bring the federal cases together before U.S. District Court Judge Tunheim in Minnesota. Judge Tunheim has been overseeing a large proportion of the pain pump cases in a sort of “mini-MDL” for some time, now. He has the experience with pain pump cases and the experience with MDLs to get the job done right. Consolidation would prevent duplicative discovery, and generally make the process of litigation more efficient. It is the right move, so we’re crossing our fingers that the JPML grants the petition.

For more information on Pain Pump lawsuits, contact us at 1.800.553.8082, or click here for an internet consultation.

The Avandia debacle heats up, this time in the medical journal community. The editor of the premier medical journal, The Journal of the American Medical Association (JAMA) has taken other journals to task for their methods of publishing articles. Using the Avandia RECORD study as the example of the conflicts of interest rampant in the medical publishing community, the editor explains “concerns about preserving market share apparently trumped concerns about the potential for causing patient harm.” For the past ten years, JAMA has required:

…at least 1 author must indicate that she or he “had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Additionally, that author cannot be funded by any commercial funding source. The source for this criterion is simply the age-old Hippocratic Oath—that physicians, above all else, must do no harm. The JAMA editor clearly understands that when industry pressures are brought to bear, physicians may be (and have been) influenced to in a manner inconsistent with good science. And the result is that people rely on bad studies, and patients take bad drugs with incomplete and faulty information. The editor further recommends that drug study data be freely available to academic researchers.

Not only will the editor’s suggestions (if enacted by other journals) provide a means to double-check data to ensure its quality, but it will provide an extra reason for scientists and researchers to do the right thing from the beginning, and to stay true to the scientific method.

Drug and medical device companies claim that the data from their studies are “proprietary property” and need not be shared. However, that clearly indicates a lack of concern for safety—data should be widely and freely available, because it is the right thing to do for patient safety.

So let’s get with the program, drug companies. Can you stand up in front of your consumers, tell them that you are making all data for your research fully available to anyone who wants to test it, and boldly stand up for patient safety? Please surprise me…

The results of a new study are out, which show the dangers Zocor in high doses or in conjunction with other drugs. Zocor is indicated as one component of multiple risk factor intervention for people at significantly increased risk of atherosclerotic vascular disease due to hypercholesterolemia. Evidence shows that high levels of Zocor, more so than similar cholesterol-reducing drugs (statins), can cause myopathy and rhabdomyolysis, which can cause severe kidney damage, kidney failure, and death.

Myopathy is a muscular disease that causes muscular weakness. Rhabdomyolysis is a very specific type of myopathy, the rapid break down of skeletal muscle due to muscle tissue injury. The broken down material can be released into the bloodstream and may cause acute kidney failure. Signs and symptoms for myopathy include unexplained muscle fatigue, muscle pain, tenderness and an elevation of a muscle enzyme in the blood (creatine kinase). Rhabdomyolysis is often characterized by fatigue and dark or red urine, in addition to the symptoms of myopathy.

In the trial (known as SEARCH), patients taking an 80mg dose were compared to patients taking a lower 20mg dose. 52 patients taking the higher dose developed myopathy, compared to one patient taking the lower dose. Eleven patients taking the higher dose developed rhabdomyolysis, compared to zero patients taking the lower dose.

Merck is hiding the ball somewhat—at first glance, it appears to have no comment—the Zocor website was removed (though, to be fair, I’m not sure when it was taken down). It’s a shame they couldn’t use the website to provide comprehensive information to their customers who no doubt have heard the bad news about Zocor and may want some guidance. But, for intrepid customers who dig a little deeper there is a small statement at Merck’s main website, stating that:

We support the FDA's recommendation that patients continue taking their medication as prescribed by their physicians, and that patients speak to their physician if they have symptoms or questions.

Continue reading " Zocor Warnings Rewritten " »

Drug Recall Lawyer Blog Round-Up (03-22-10)

Here are this week’s stories:

• Avandia: The MayoClinic investigated who authored articles supporting Avandia in medical journals, and discovered that 90% had ties to the manufacturer, GlaxoSmithKline (HT: FiercePharma).
• Seroquel: Trial number one is won by AstraZeneca (see blogs here and here).
• Zocor: FDA issues a new warning for Merck’s cholesterol drug Zocor (HT: Tom Lamb’s Drug Injury Watch).
• Sanofi-Aventis: More on their lessons from the botched Facebook experiment (HT: Pharma Marketing Blog).

Happy Monday!

Interesting developments in online social media and drug companies, in the past week. As you know, the FDA has been soliciting requests about how to manage online social media for drug and device manufacturers. This is clearly a lot for drug companies to deal with, and here are some things they should wrap their minds around:

1. Sanofi-Aventis VOICES Facebook Page: This drug company, maker of the cancer drug Taxotere, learned first-hand the downside of having a Facebook site that allows interaction with customers. That downside is that customers interact. One Taxotere user posted complaints to the FB page about the drug, only to have her post removed. Undeterred, she sent more posts, opened other Facebook accounts, sent more posts, had friends send posts, and just generally assaulted the Sanofi-Aventis stronghold. Finally, Sanofi-Aventis changed their information and stated on the FB page:

   This page is not intended as a forum for discussing sanofi-aventis’ or other companies’ products. As such, Postings that contain product discussions will be removed by sanofi-aventis.

   See John Mack’s Pharma Marketing Blog, which examines whether the complainant’s posts constitute a reportable adverse event that Sanofi-Aventis must share with the FDA.

   This exemplifies some of the problems drug companies will face in creating online social media—how much customer interaction is too much? The value of social media is that it is open to comments and questions and interaction. Otherwise, it becomes simply another mouthpiece for the company, and is bereft of actual benefits (though, to be fair, it would also limit possible damages). But, Sanofi-Aventis now just looks bad for canceling the conversation.

2. Use of hashtags for online social media: Again, John Mack’s blog has a good analysis of this as a possible partial solution to the problem of presenting consumers with a full and balanced view of drug risks and benefits. You can find Novartis’ comments regarding space-saving measures on Twitter here.

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More hip implant problems, this time with Johnson & Johnson’s DePuy Orthopaedics division (click here for Stryker and Zimmer hip implant issues).

Contrary to the good corporate responsibility of Boston Scientific for their quickly recalled defibrillators, DePuy seems to have taken their sweet time with their ASR hip implants, in addition to trying (and failing) to direct public misinformation on the issue.

First the background: the DePuy ASR hip implant is used for hip resurfacing (which is apparently not an issue), and more traditional hip replacement, which is at issue. The device is a metal-on-metal ball and socket, which can cause metal debris early in the life of the implant. That metal debris causes inflammation, and can lead to damaged muscles and soft tissue. The end result is that a very expensive and painful replacement surgery intended to last about 15 years ends up needing revision within two or three years.

Use of the device in the United States started in 2005. Since 2008, the FDA has received approximately 300 complaints (most people don’t complain to the FDA, so this indicates that the problem is much larger) from patients or their doctors about the early failure of the device.

Here’s where DePuy and Johnson & Johnson try to hide the ball from consumers. The product is more heavily used in Australia, and it was withdrawn from the Australian market in December of 2009—three to four months ago. A few months ago, the public was informed that DePuy would be phasing out the ASR hip implant here in the U.S. because of “slowing sales.” Indeed, last month DePuy’s worldwide vice president for regulatory affairs stated that “With declining sales of this particular product in its market segment, we are focusing on newer technologies.” So, according to the manufacturer, there was no safety issue. This "phasing out" seems to me to be diction-wrangling in order to avoid a technical recall, with its incumbent bad publicity.

But, with two years of reports of device failures, the experience of the Australian market, and DePuy’s own statements now indicate that the ASR has significant problems, and the failure rate directly impacts patient safety. The March 6 letter from DePuy states that the device has a higher failure rate when used on “certain types of patients,” which include those of short stature (often women) and people with certain bone weaknesses. This very statement seems to encourage doctors to stop using it. I wouldn't be surprised if DePuy is offering surgeons a refund (or perhaps DePuy credit) on returned ASR hip implants.

Add to this the fact that there is no information for consumers about the hip replacement problems anywhere on DePuy’s website or Johnson & Johnson’s website, and it is clear that the manufacturers are simply trying to avoid their responsibilities. The "phasing out" should have come sooner (at least at the same time as the Australian "withdrawal" from the market), and the manufacturer should have confessed its problems early, instead of lying to the public about “slowing sales.”

If you have a questions about a potential hip replacement lawsuit, call 800-553-8082 or go online for an internet consultation.

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 " »

Here are the stories we’re following this week.

• Marketing: Bayer Schering Pharma is set to double its Indian sales team, and triple its workforce in Vietnam in anticipation of a larger market share in the region (Wall Street Journal).
• Plavix: Black-box warning mandated by FDA: it may be less effective for patients who cannot metabolize it (FDA News Release; see safety announcement).
• DuPuy Hip Replacement Lawsuits: Johnson & Johnson is ending sale (though, not recalling) its DuPuy ASR metal-on-metal hip replacement system due to a high failure rate. (HT: Maryland Injury Lawyer Blog).
• Vaccines and Autism: The link between autism and vaccines become more and more attenuated in light of three rulings last week (The New York Times).
• Nerd link of the week: Click here.

We've updated our YAZ lawsuit webpage (which includes claims against Yasmin and the generic birth control pill Ocella). Check it out here.

To follow up on our March 2, 2010 post BigPharma Goes All “Social Media” is a website that features all comments submitted to the FDA on the social networking question. A somewhat more readable version (though, less complete) is at www.fdasm.com. Here are links to some of the heavy hitters (including law firms and internet providers) who have commented. The papers are downloadable directly from the website.

• Abbott
• AstraZeneca
• Bayer Healthcare
• Covidien
• Eli Lilly
• Google
• Hogan & Hartson
• Johnson & Johnson
• Medtronic
• Merck
• Novartis
• Pfizer

In Bruesewitz v. Wyeth, the plaintiffs are appealing to the United States Supreme Court from the Third Circuit Court of Appeals. They believe that the administrative set-up of the National Childhood Vaccine Injury Act (est’d 1988) is an insufficient remedy for vaccine-related injuries. Under the Act, designed to encourage drug companies to create vaccines, injured consumers receive damages under a no-fault system, decided by the U.S. Court of Federal Claims. The petition was granted on March 8.

In this case, the Bruesewitz’s child received a standard DPT vaccine, which caused seizures and permanent neurological injury. The question presented is whether the national Childhood Vaccine Injury Act preempts all vaccine design defect claims, regardless whether the vaccine’s side effects were unavoidable.

So what do you think? Has the National Childhood Vaccine Injury Act outlived its usefulness (assuming it was ever useful to begin with)?

For more information:

• National Vaccine Injury Compensation Program
• Decision by Third Circuit Court of Appeals
• Petition for writ of certiorari
• Wyeth’s brief in response
• Petitioner’s supplemental brief
• Amicus brief of National Vaccine Information Center

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The New Jersey Superior Court Case (Middlesex County) of Baker v. AstraZeneca Pharmaceuticals LP is now focusing on the drug manufacturer’s advertising strategy. The plaintiff in that case is alleging that he should have been better warned about the risks for weight gain and developing diabetes.

On the plaintiff’s side is Dr. Wayne Geller, a former AstraZeneca employee—a global safety officer—who testified that the company rebuffed his efforts to strengthen internal documents describing the weight gain issue. He testified that “I found out there were people from the commercial side” who opposed the changes. This is another indication of marketing trumping. AstraZeneca is defending the case, noting that it adequately warned about the risk of diabetes, and that Seroquel doesn’t cause diabetes, anyway. They rely on several studies that showed favorable data, but other reports show average weight gain for users on Seroquel is 27 pounds.

Continue reading " Seroquel Trial Update " »

Time to wake up and face the week! Here are the stories we’re following:

• Avandia: The U.K.’s Guardian blogs about GlaxoSmithKline’s potential $6 billion liability. @TomLamb and I are skeptical.
• Vioxx: Australian judge finds for plaintiff in defective drug lawsuit against Merck, though rules that Merck was not negligent. (HT: Pharmalot). Merck’s press release is here.
• FDA: The FDA is going to step up criminal prosecutions of corporate officials.
• Insulin Pump Defects: Insulin pumps have been beset by problems, spanning across the spectrum of manufacturers (HT: Drug Injury Lawyer Blog).
• 510k Approvals in February: See the list here.
• Direct-to-Consumer Advertising: BigPharma’s DTC advertising increased by a “paltry” 1.9% in 2009, but Pfizer leads the pack with $1.1 billion.
• BPA: Wisconsin is added to the list of states banning BPA in baby bottles and cups.
• Nerd Link of the Week: You’ll just have to click to find out…

Happy Monday!

Yesterday I clicked a link from @pharmaguy: End-of-Life Warning at $618,616 Makes Me Wonder Was It Worth It, an article in Bloomberg by Amanda Bennett. Don’t read it unless you have 5-10 minutes of quiet time—this is a powerful story.

This story, the story of Amanda Bennett, Terrence Bennett and their children and doctors and the U.S. healthcare system and drugs and drug companies and life and death raises a number of issues. It questions whether medical cost spending, much of which occurs in the finals days and weeks of life, is worth it. Ms. Bennett calculates that his seven-year medical bill was $618,616, discounted to $254,176. She notes that:

Would I do it all again? Absolutely. I couldn’t not do it again. But I think had he known the costs, Terence would have fought the insurers spending enough, at roughly $200,000, to vaccinate almost a quarter-million children in developing countries. That’s how he would have thought about it.

The last four days of Mr. Bennett’s life cost his insurance company $43,711. My mom, a respiratory therapist in Colorado, says that extraordinary measures and costs in the last days of life are the norm. My review of medical records and bills in my own clients' catastrophic cases confirms it.

The story also brings this to mind: though the focus of this blog is on defective drugs and medical devices, it goes without saying that drug companies and medical device manufacturers do great things. They develop products that frequently do help people to live better (if not longer), lives. Of course, our focus is on the negative 5-10% of their behavior and products (I’m just making numbers up, here. You get the idea). The majority of the time, the products are good, and the decisions are responsible. Genetech Inc. and Bayer AG paid for experimental medications for Mr. Bennett. That’s a responsible and noteworthy thing to do.

Clearly, as Dr. Ross notes in his editorial from yesterday’s post, there is a cost-benefit analysis to bringing new drugs to market and approving them. Everyone agrees to that. And, when we decide where the line is that allows some drugs and excludes others, someone is going to be unhappy. But the line has to be drawn somewhere, and we need to do it with the best information possible.

Today’s New York Times featured commentary by Dr. Gilbert Ross (maybe this Gilbert Ross?). “When Senators Play Doctor: Risk-mongering can stifle innovation, cost lives.”

Dr. Ross essentially argues that the senators have completely misinterpreted the Avandia data, whether intentionally or not, in order to fulfill their objective of creating an independent drug safety division within, but separate from, the FDA. Perhaps Dr. Ross thinks that’s a bad thing—it’s not clear from his commentary. It seems to me that, erecting another level of safety in the regulation of drugs can only be a good thing. But, that’s another blog post.

The criticism boils down to the fact that these are senators—mere politicians—who are sticking their noses where they don’t belong—in areas of science of medicine. Unfortunately, we don’t have a separate job for “scientist politicians” who can this job, so our political system is left having to deal with it as it is. Also, the senators criticizing the FDA’s handling of Avandia are undoubtedly relying on the opinions and conclusions of doctors and scientists, not the least of which is Dr. David Graham, employed by the FDA (the commentary paints him to be an anti-Pharma crusader—perhaps this is true, but perhaps he just puts patient safety a little higher on his list than others do).

Continue reading " Avandia: Much Ado About Nothing? " »

Up until now, online social networking has been treated mostly as a plaything for some pharmaceutical manufacturers. They will post a few updates on Twitter, maybe start a Facebook page or post a YouTube video or two, but I have not seen much indication that the companies have really bought in, much less that they “get it” (though, some like AstraZeneca may be playing it safe while the FDA works out the regulation aspect).

Eye on FDA has a good summary of what’s happened to get us to this point. Initially, the FDA was more concerned with the content of pharmaceutical and medical device manufacturers’ messages. However, last year the FDA realized that there is only so many contraindications you can fit in 140 characters. So, in September 2009, they took the proactive step of setting a meeting (which BigPharma interestingly did not attend), and encouraging comments (open through last month). The hope is that they will be able to draft some sort of guidelines, so everyone knows where the line is.

Continue reading " BigPharma Goes All “Social Media” " »

Here are this week’s stories:

• 2009 Adverse Event Reports: Avandia (GlaxoSmithKline) and Seroquel (AstraZeneca) topped the charts for most adverse events for the third quarter of 2009, with 1,218 reports and 977 reports, respectively. See The Institute for Safe Medicine Practices (HT: FiercePharma).
• Avandia: “Glaxo Strikes Back at Drug Critics, But It’s a Big Swing and a Miss.” ‘Nuff said.
• $13 Million Zyprexa Settlement: Lilly settled a suit brought by the state of Montana over off-label marketing of Zyprexa, used to treat bi-polar disorder and schizophrenia. Most of the funds will be used to pay for mental health services in the state. See BusinessWeek.
• BPA: Maryland is considering legislation to ban or limit the use of BPA in plastics used by children. See the Baltimore Sun.
• Seroquel Trial: The Seroquel trial (New Jersey), alleging the drug causes diabetes, is in full force. The parties are arguing over whether marketing took precedence over safety research. See Bloomberg.

Happy March!