Drug Recall Lawyer Blog

At the Medtronic annual shareholder meeting last week, CEO Bill Hawkins defended the company’s history of physician collaboration, though he noted that the relationships may create conflicts of interest.

However, the probes by the Justice Department and the Congress into the relationships prompted one shareholder to state that he was shocked by how much Medtronic paid physician “consultants.” For example, Medtronic paid Dr. David Polly the tidy sum of $1.2 million between 2003 and 2007. Hawkins says that his company monitors payments to physicians to avoid conflicts of interest.

Call us skeptical and jaded, but this is a story we’ve seen time and time again. It is interesting that Medtronic is professing themselves to be mostly free of blame—we look forward to the outcome of the investigations to see just how well Medtronic monitored the conflicts.

For more on this issue, see our previous post, “Doctors in their Pockets.”

The FDA just issued a warning letter to Johnson & Johnson over their athlete’s foot drug Ertaczo. The letter, located here, alleges that Johnson & Johnson’s advertisement features a broadening of the indication (misleadingly suggests that Ertaczo is approved for all patients, regardless of age or immune status, with any form of tinea pedis caused by any organism); unsubstantiated efficacy claims (ad says that the drug will “Crush. Kill. Destroy” when studies show it to be 13.1% to 27.2% effective); that the ad does not include significant drug risks, and that Johnson & Johnson failed to submit the ad for review prior to publication.

Let’s take a step back—this is for an anti-fungal cream. For athlete’s foot. If Johnson & Johnson is willing to go to such extreme measures for something like this, what are they willing to do for a blockbuster drug? And, after the drug company responds, is it too late—the ads have already hit the streets. No corrective action can be corrective enough to undue whatever damage was done. And, I bet the drug companies know that.

Of course, it may be that the efficacy issues (“Crush. Kill. Destroy”) qualifies as puffery. Most of us are jaded with regard to advertisements, and we know they overstate their products a fair bit.

Here’s a link to the advertisement. Puffery or false claims? You be the judge.

Stevens-Johnson Syndrome, courtesy MayoClinic.com

Johnson & Johnson’s HIV drug Intelence may cause deadly allergic reactions and liver damage. It has been linked to Stevens-Johnson Syndrome (also known as toxic epidermal necrolysis), an allergic reaction that starts with flu-like symptoms and a rash, and which may develop into blisters and shedding of skin. There has been one reported death from Intelence-related Stevens-Johnson Syndrome.

The drug company has appropriately warned physicians to watch for possible reactions, and the drug’s label has been revised. A copy of the letter (through Johnson & Johnson’s subsidiary, Tibotec Therapeutics) is posted here.

The Plaintiff has presented all of her evidence in the Fosamax trial in New York. Merck has filed for judgment as a matter of law--asking the judge to rule that, even if everything the Plaintiff said was true, she did not meet her burden to prove her case. These motions are routinely made, and routinely denied. The Plaintiff's case lasted about 10 days, and it is unlikely that the judge will find any significant errors in that presentation of evidence sufficient to take the case from the hands of the jury.

If the judge denies the motion, the defense will present their evidence.

See our original blog post on the trial here.

Last week, the FDA sent a warning letter to Johnson & Johnson over trials of its antibiotic drug, ceftobiprole. J&J hopes that Ceftobiprole will be approved for treatment of skin infections, including MRSA (which is frequently a hospital-acquired infection).

The FDA reports that J&J has been violating its own study protocols, including:

• Failure to ensure that patients properly store the drug
• Failure to perform appropriate patient examinations
• Failure to document some doses given to patients
• Hiring unqualified investigators
• Enrolling patients who do not meet J&J’s own eligibility criteria

These types of problems are systemic in the whole system. Many blame the FDA for allowing bad drugs to reach the market, but the primary failure is with the drug companies who fail to conduct adequate studies (or worse, hide the results of their otherwise-adequate studies). The FDA does not do independent studies of the drugs—that is not something taxpayers should have to pay for. Drugmakers have responsibility to perform studies of their own drugs to ensure they meet safety and efficacy requirements. Unfortunately, this is sometimes like the wolf guarding the hen house.

NuvaRing Victory for Plaintiffs

Earlier this month, plaintiffs won a nice victory in the NuvaRing MDL litigation, pending in the U.S. District Court for the Eastern District of Missouri. Judge Sippel denied defendants’ motion to dismiss a master consolidated complaint (that defendants themselves requested Plaintiffs file, and plaintiffs consented). The judge appropriately held that the master complaint was simply an administrative tool to place all of plaintiffs’ claims in one document, but that it could not be dismissed where defendants had already responded to the individual plaintiffs’ complaints (there are about 150 of them). According to procedural rules, a 12(b)(6) motion to dismiss cannot follow an individual answer. Defendants tried to be tricky by getting a global complaint filed (for convenience purposes), then trying to dismiss all the cases. Tricky, but the judge saw through it.

For more information on NuvaRing lawsuits, see our website here.

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 " »

A nice article from the Washington Post, Probing Doctors’ Ties to Industry, evaluates the recent movement for transparency in the relationships between the pharmaceutical and medical device companies and doctors. We’ve all been to the doctor and have seen pens and pads of paper touting the latest miracle drug, but that is only the tip of the iceberg. The pharmaceutical and medical device industry pays for doctors to attend symposiums (sometimes, these are actually just really fancy vacations with an very small lecture component), dinners, and provides them with gifts of all kinds (from pens to much more valuable objects). It is estimated that Big Pharma spends over $20 billion per year pitching their wares to doctors.

What’s the impact? Like the rest of us, doctors are influenced by marketing (if they weren’t, these industries would not be spending the money). So, a doctor is more likely to prescribe Drug A over Drug B if he just got a nice lunch from Drug A’s sales representative. You’d like to think that all doctors will sit in their library and compare the attributes of the drugs, poring over the Physician’s Desk Reference. But, time is at a premium, and it’s often easier to listen to the sales reps (who are very rarely medically-trained). The question is whether patients receive the proper drug, or the properly marketed drug.

Of course, some donations are for the advancement of science. Doctors frequently receive free samples of drugs or devices for research studies they are performing—this helps pharmaceutical companies and medical device companies to determine the safety and efficacy of their products. Those should be reported as well, but they are less likely to influence a doctor’s prescribing habits.

The article includes statements from a number of doctors who admit to being influenced by these marketing strategies. Many states and the federal government are starting to examine whether doctors should be required to report money and gifts. Some even want to make information available on-line. That way, before your appointment you can see who is paying your doctor. And, you can ask you doctor whether other manufacturers’ drugs might not be better. It’s good to know whether the doctor is prescribing a drug, or whether it’s basically coming straight from industry.

A flurry of new medical articles have come out in the past week regarding Yasmin and Yaz. Here are links and some “talking points.”

Vlieg, et al. The venous thrombotic risk of oral contraceptives, effects of oestrogen dose and progestogen type: results of the MEGA case-control study, BMJ 2009;339:b2921.

• This Netherlands study found that all oral contraceptives increase the risk for venous thrombosis by about five times (this is not new news). However, it also found that drospirenone-based oral contraceptives had an increased risk of 6.3 times that of non-users.
  
• The study concluded that many women do not use the safest brands of birth control pills.
• The safest option for women (with regard to venous thrombosis) is a birth control pill that contains levonorgestrel, combined with a low dose of estrogen.

Lidegaard, et al. Hormonal contraception and risk of venous thromboembolism: national follow-up study. BMJ 2009;339:b2890.

• Drosperinone-containing birth control pills are associated with a higher risk of venous thrombosis than contraceptives containing levonorgestrel.

Yasmin and Yaz both contain the progestin drospirenone—the dangerous one cited in the studies. As a reminder, venous thrombosis is a blood clot that forms in the vein. If the clot breaks off, it can be transported through the circulatory system to the heart or lungs (becoming an embolism). These can be fatal if not treated immediately.

Bayer’s comment on the studies: they haven’t seen the data, and can’t comment. If you listen hard, you can almost hear them circling their wagons.

For more on the Yasmin/Yaz saga, visit:

• Our main Yasmin/Yaz information page
• Yasmin/Yaz Lawsuits Blog (describing the other injuries associated with the birth control pills)
  
• Yasmin/Yaz MDL Motion Filed
  
• What is an MDL? -or- Yasmin/Yaz MDL Filed, Take 2

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The dangers of Seroquel.

Gabriel Myers, age 7 and in the Florida foster care system, deliberately hanged and killed himself with a detachable shower hose.

My wife and I recently signed up for foster care here in Baltimore, and we have been taking care of our first foster care child (an infant) for the past 3 months. Foster care is the temporary placement of a child, typically while the parent gets his or her life together in order to better care for the child. As we went through the process, we met a lot of foster care parents, and learned that many children are placed in foster care because they are physically, emotionally or sexually abused; or because they are neglected. The older the children are when they are pulled away from their parents, the more likely it is that they have significant emotional and psychiatric injuries.

So, this is an issue I feel strongly about. Children taken away from a volatile situation need the best care possible, and need to be safe and loved. Recent reports from Florida show that many children who have had tumultuous lives are being put on psychotropic medication when they enter the foster care system. In fact, an astounding number of children in the Florida Department of Children and Families are on these drugs:

• 22% of children aged 6-12


• 33% of children aged 13-17

Tellingly, a fewer percentage of foster care children who live with relatives or family friends are taking psychotropics—about 12%. And, that number even feels high.

Continue reading " Foster Care Children and Off-Label Drug Use " »

Daniel Schultz, the head of FDA’s Center of Device and Radiological Health for the past five years, has resigned. There’s no specific word about what prompted the resignation, but press reports detail that it was “by mutual agreement.” Of course, it is hard to avoid speculating that Dr. Schultz was asked to leave because of complaints from other FDA employees that he ignored science and favored requests from industry. He has been investigated at least twice in the past two years by the Senate, and last October nine FDA employees complained the House Energy and Commerce Committee that the FDA was approving devices even though formal safety and efficacy concerns were on file. And, some FDA scientists who opposed approval say they were retaliated against.

The Obama administration is working to bolster the FDA’s reputation and work product. President Obama previously named Dr. Margaret Hamburg to the post of Commissioner. She was formerly the health commissioner for New York City. She has a lot of work to do.

The first of three bellwether (“lead”) Fosamax trials is starting today in New York federal court. Fosamax is part of MDL-1789, in the Southern District of New York (Manhattan). The case is consolidated with about 700 other Fosamax cases; there are an additional 140 cases in a New Jersey state court.

As with all bellwether trials, this will give all litigants and their lawyers a good idea of what a jury does with the evidence and testimony. From there, settlement discussions typically ensue.

Fosamax was sold by Schering-Plough Corporation, which is being bought by Merck & Co. It is among the class of drugs known as bisphosphonates, and is used to treat osteoporosis. Plaintiffs claim that the manufacturer did not adequately warn that the drug could cause osteonecrosis of the jaw, which is the death of jawbone tissue.

In the trial, punitive damages will not be allowed. Plaintiffs claim that Merck was the only bisphosphonate-making company that did not adequately change their label, as requested by the FDA. Merck will defend their warnings, and will argue that the evidence does not show Fosamax causes osteonecrosis of the jaw. However, osteonecrosis of the jaw has only been found in users of the drug and some cancer patients receiving chemotherapy. Merck has an uphill battle on this one. It is impossible to predict the outcome, especially because all cases are fact-dependent, but these are awful injuries, causation seems clear, and we are predicting a plaintiff’s victory.

Merck & Co. announced last week that they are settling third-party claims related to Vioxx. These are not the personal injury cases (cases by patients and their loved ones for heart attacks or other Vioxx injuries, most of which have already been settled for $4.85 billion), but rather these are lawsuits by unions and insurance companies against Merck, claiming that they overpaid for Vioxx in light of the drug’s risks.

The settlement, which has not been finalized but has been agreed to in principle, pays $80 million to settle 190 claims about the recalled drug. The document disclosing the settlement, Merck’s filing with the U.S. Securities and Exchange Commission, also revealed that the SEC’s formal probe of Merck surrounding Vioxx has ended. There are still outstanding third-party claims not involved in this settlement.

These third-party claims do not see a lot of play in the press. They are “faceless” claims by states, insurance companies, and other payers, none of whom suffer serious personal injuries. They are, however, becoming an invaluable component of drug litigation. It is one more hurdle for drug companies who put out dangerous drugs, and one more way to make sure the bottom line for defective or negligently marketed drugs is not as high as it otherwise would be. And, these are damages to taxpayers and members of insurance plans—one more reason we all have higher taxes and higher premiums.

Law firms are filing more fentanyl pain patch lawsuits—more and more of them are against Mylan Inc. and its subsidiary, Mylan Technologies Inc. Mylan patches are different from the usual pain patches because they are not reservoir based, but instead use a mesh matrix. Experts agree that the mesh matrix is much safer than the reservoirs, which are prone to leaking toxic amounts of the opiate drug. Right now, there have been reports of about 28 deaths possibly related to the Mylan matrix patches. Further investigation will reveal whether the products were defective.

See our Fentanyl Pain Patch page for more information.

The FDA just issued a press release describing problems with TNF Blockers. TNF blockers have been approved for treatment of immune system diseases, including juvenile idiopathic arthritis, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn’s disease, and ankylosing spondylitis.

The problems are severe—these drugs may cause an increased risk of lymphoma, leukemia and other cancers, particularly in children. The FDA first disclosed problems in a June 4, 2008 communication, based on about 30 reports of cancer in children. The updated FDA analysis leading to this week’s warning is based on a review of 48 cases of malignancies, including 11 deaths. The FDA also had reports of 147 cases of leukemia in children and adults, including 30 deaths. It is still unclear how strong the association is, because there is a small population of children on TNF blockers, and those children are typically concurrently prescribed other immunosuppressive therapies.

Exmples of these TNF blockers include:

• Simponi (golimumab) by Johnson & Johnson
• Remicade (infliximab) by Johnson & Johnson
• Humira (adalimumab) by Humira
• Cimzia (certolizumab pegol) by UCB SA
• Enbrel (etanercept) by Amgen Inc. and Wyeth

We expect that lawsuits will be coming in, though there remains much work to be done on the science end. Hopefully there aren’t many children who have been affected by these drugs.

Here's a link to a good video on the ghostwriting behind Wyeth's hormone therapy, by CBS in Chicago.

Ghost(writing) Busters (08-06-09)

There’s been a flurry of newspaper and internet articles of late about Wyeth’s ghostwriting troubles. We broke the news here on July 27 with Judge Wilson’s order unsealing ghostwritten documents.

One terrifically written article is by the New York Times, which describes the specifics of the ghostwriting practice. See the article and an excellent chart showing the ghostwriting process.

The plaintiffs lawyers, led by Cleveland Ohio attorney Jim Szaller (the true Ghost(writing) Buster), really worked hard to bring these documents and practices to light. Essentially, ghostwriting is a company’s practice of writing a medical article (either on their own or with the help of an outside company), asking a medical doctor to “author” it after-the-fact, and then publishing it in otherwise reputable journals without disclosing the writing process or the financial interest of the actual writer or “author.” This is simply marketing masquerading as science. It works to the detriment of patients, who are prescribed these drugs because their physicians believe they have been well-vetted in the medical journals. In fact, those journals articles are simply clever advertisements.

In one article highlighted by the court, the physician received a manuscript from a company paid by Wyeth to write the document, and made “one correction.” That’s not authorship by any stretch of the imagination.

Merck & Co. and Schering-Plough have agreed to settle class action lawsuits over their joint cholesterol drugs, Vytorin and Zetia, in the amount of $41.5 million. The settlements are with consumers as well as health plans that purchased the drugs.

The class action lawsuits were not for personal injury damages, but rather for economic damages. The lawsuits alleged that, contrary to manufacturer marketing, the drugs provided no medical benefit over cheaper and generic competitors. The lawsuits came on the heels of a January 14, 2008 study (the Enhance Trial) which revealed that Vytorin was not more effective at reducing carotid artery plaque. In fact, the study was hotly investigated by lawmakers—it seems the drug companies concluded the study in April, 2006, but continued to market their products inappropriately well after the data became available. Why let a little thing like drug effectiveness get in the way of sales?

The plaintiffs in those cases sought to recover reimbursement for the cost of the prescriptions, or the difference between these drugs and the generic alternatives. Of course, compare the settlement to the annual sales of Vytorin since it was first marketed in 2004, which reached $5 billion per year. Granted, that is not all profit, and perhaps there was no bad behavior until January 2008, but it looks like the drug makers win again. It would be refreshing to see them divest all profits from the drug from the time they had data showing that it was basically useless.

Not going to happen.

Here’s what the Judicial Panel on MultiDistrict Litigation has been up to with regard to Reglan/metoclopramide:

MDL No. 2049 was denied on June 3, 2009, so for the time being these cases will continue to proceed individually right where they are at. The Panel concluded that there were common factual issues about whether Reglan causes neurological injuries including tardive dyskinesia; however, the eleven filed actions had no common defendant. Furthermore, five of the cases were in advanced stages of litigation, and to join them would have delayed resolution of those cases. All responding defendants (Actavis, Inc.; Actavis-Elizabeth, L.L.C.; Barr Pharmaceuticals, Inc.; Baxter Healthcare Corp.; Duramed Pharmaceuticals, Inc.; Pliva, Inc.; Pliva USA, Inc.; Schwarz Pharma, Inc.; Teva Pharmaceuticals USA, Inc.; and Wyeth) opposed centralization, as did one Plaintiff from Vermont.

See our website for more information on Reglan lawsuits.

We’re still waiting from the JPML for a ruling on Chantix, the smoking cessation drug, MDL No. 2092.