Personal Injury Lawyer Blog

Supreme Court Limits Lawsuits on FDA-Approved Medical Devices - Thursday, February 21, 2008

In a major decision in favor of the pre-emptive power of the Federal government, the Supreme Court decided on February 20, 2008 that the Medical Device Amendments of 1976 (MDA) created a standard of safety oversight for medical devices that supersedes any requirements for "design, testing, inspection, distribution, labeling, marketing, and sale" of medical devices that might be interpreted as deriving from state law in the case of Riegel v. Medtronic. They decided that under the terms of the law, any medical device that has received FDA approval cannot be held to any higher standard of strict liability, breach of implied warranty, and negligence Furthermore, the Court decided that the FDA requirements provided for "reasonable assurance of safety and effectiveness."

Apparently, the Supreme Court is considering a different FDA and its process than the one I know. If one looks at devices like the Davol's Composix Mesh products, there was nothing like "reasonable assurance of safety and effectiveness provided by the FDA." In fact, the FDA never evaluated the company's quality control procedures or its manufacturing process until after issuing a Class 1 recall of the company's hernia patches, indicating that the product posed an imminent health threat. When it did carry out the inspection, it found that the quality control procedures were so ineffectual and the manufacturing so inconsistent that it expanded its recall to encompass all hernia patches produced by the company.

How can the FDA provide "reasonable assurance of safety and effectiveness" if it only carries out inspections of a company AFTER finding out a device is deadly? I agree with the Court that medical product manufacturers should be held to only one standard of quality and not have to deal with numerous conflicting regulations, but I think that this ruling only makes sense in a country where the FDA actually protects us, instead of simply giving medical device manufacturers a merge lane onto the highway of profits.

Note that this ruling only applies to suits involving medical devices. Next term, the court will consider a case involving whether FDA-approved drugs. Of course, we know the FDA's record in this area, since it responded so quickly to safety concerns about Trasylol, Vioxx, and others.

This ruling does not quite, however, ban defective product lawsuits against manufacturers of medical devices, it only makes the suits more difficult to argue and to win because they have to be argued under federal law only now, whereas many cases have been argued under state law in the past. Because of this restriction, it is even more important that you get a qualified and experienced personal injury lawyer to represent you. If you or someone you love has been injured by a defective medical device, contact PersonalInjury.com today to get in touch with a local personal injury lawyer who can represent your interests under the new restrictions.

Labels: defective medical device, FDA, preemption, Supreme Court

Trasylol Story a Sad Tragedy - Monday, February 18, 2008

As more facts come out about Bayer's antihemorrhagic drug Trasylol, it seems the story is more tragic and sordid that anyone might have guessed. When a Food and Drug Administration (FDA) panel voted to keep Trasylol on the market, it was acting in relative ignorance, an ignorance fostered and promoted by Bayer itself.

Although studies published in 2006 showed that the drug as much as doubled the risk of kidney failure in patients, the FDA was unconvinced, and on September 21,2006, 8 months after the largest of the studies was published in the New England Journal of Medicine by Dr. Dennis Mangano of the Ischemia Research and Education Foundation, voted to let the drug stay on the market with a caution about possible kidney failure.

By that time, however, Bayer's aggressive marketing of the drug had given it an equal share of the antihemorrhagic drug market for use during open-heart surgery. Over 200,000 people were being given the drug every year, often multiple doses. At $1000 a dose, Bayer was making $700 million a year from the drug. The two alternative drugs were nearly as effective at controlling bleeding, and were much cheaper at $50 per dose.

And now it seems that money was made with foreknowledge of Trasylol's possible side effects. In fact, in the early 1980's, a researcher at the University of Cologne went to Bayer with evidence that animals given the drug suffered kidney damage, but the company brushed him off. The company refused to accept that the drug was dangerous, and when Dr. Mangano's study was published, it hired Harvard professor Alexander Walker to conduct its own study, to be completed before the September meeting. However, when Dr. Walker's results came out the same as Dr. Mangano's, Bayer quashed the study and didn't report its results to the FDA.

A week after the committee voted to keep Trasylol on the market, Dr. Walker came to the FDA independently of Bayer and turned over his results, revealing that Bayer had tried to conceal them. However, the FDA did not at that time request a suspension of the drug. It was not until over another year later that this action occurred.

So let's review. Here's what the FDA did not consider sufficient to suspend the drug:

• Three studies showing that the drug increased the risk of death by 50-100%
• The possibility that more than 30 people were dying daily as a result of the drug
  
• Evidence that Bayer concealed results of damaging studies
• The existence of alternatives that in most cases were equally effective

All these things led to a label revision on the drug. So what was sufficient to ultimately prompt the removal of Trasylol from the market?

In 2007, a trial by the Ottawa Health Research Institute was halted because the group being given Trasylol showed an increased risk of death. This was considered the final result necessary to suspend the drug.

This is another situation in which our neighbor to the north has shown its strength in standing up to drug companies, similar to the Avandia ban late last year. In this country, the FDA seems content kowtow and toady to a drug industry eager to make profits despite the risks to patients. In this country, our only option is to try and make it unprofitable for pharmaceutical companies to market dangerous drugs, and the only way to do this is to make ruinous penalties for doing so. If you or someone you love has suffered dangerous side effects from taking Trasylol or another defective pharmaceutical, you have a responsibility to pursue your claim against the manufacturer. Contact PersonalInjury.com today to get in touch with a local defective pharmaceutical lawyer who can take your fight to the drug companies.

Labels: Canada, defective pharmaceutical, FDA, Trasylol

Vioxx Lawsuits from Overseas - Tuesday, February 12, 2008

Although Vioxx manufacturer Merck has offered a $4.85 billion settlement, that settlement is only available to US citizens or people who had their heart attacks or strokes in the US. For people who were prescribed the medication overseas, such as the thousands of Britons who received the drug, the settlement has no meaning. So, for those who suffered heart attacks or strokes as a result of the drug, there is no option but the courts.

Some people who took Vioxx experienced heart attacks or strokes within months of beginning treatment. Although Merck had tried to claim that Vioxx actually reduced the chances of heart attack, studies showed that it actually doubled the risks for people taking the drug, and in addition increased the risks of ischemic stroke. Since the drug was recalled, it has been shown that Merck should have known of these risks, and that the Food and Drug Administration (FDA)'s oversight was negligent in the approval process.

Although the Vioxx settlement is not available for those who might want to file a new claim, there are many new drugs coming out constantly whose side effects are ill-understood. If you or someone you love has suffered an adverse side effect from taking a new drug, you may not be alone. Contact PersonalInjury.com today to get in touch with a local pharmaceutical injury lawyer who can help you find out whether the drug may be responsible for your side effects.

Labels: defective pharmaceutical, FDA

Zetia Approved Despite Ineffectiveness, Risks - Wednesday, January 16, 2008

The big story this week has been that Merck (the same drug makers who profited from the deadly Vioxx drug) and its partner firm Schering-Plough have been concealing evidence from studies showing that their popular anti-cholesterol medication Zetia is not only ineffective in reducing fatty plaques that clog arteries as the companies claim, but that the drugs may cause liver damage. One of the studies was completed several years ago, but the data was never published. A troubling component of the study's results is that the drug is apparently far more dangerous when combined with other anti-cholesterol drugs called statins, while Merck has been extensively marketing a pill that combines both Zetia and the statin Zocor.

What is even more troubling about these studies is what they tell us about the drug approval system in the Food and Drug Administration (FDA). How can a drug be approved which has not been proven effective in its advertised claim? Why are drug companies allowed to conceal data that reveals a drug is potentially hazardous in combination with another drug, then put that hazardous combination together as a single product for marketing purposes? This despite the fact that one FDA reviewer said the drug should not be cleared for use in that combination. And why, now that people are suffering severe liver damage from the drug combination, is the drug allowed to remain on the market.

The answer seems to be that the FDA is indeed too close to the drug manufacturers and has ceded too much of its control over the approval process to the industry itself. This means that we are likely to face more and more deadly drugs, and if the Supreme Court sides with drug manufacturers, there may be nothing we can do about it. If the FDA is powerless to stop pharmaceutical manufacturers from putting defective pharmaceuticals on the market, the tort system seems to be the only part of the process that can keep us safe from dangerous drugs. If you or a loved one has been hurt by a serious side effect of Zetia or another dangerous drug, you have a responsibility to use the tort system to punish drug manufacturers making profit on your suffering. Contact PersonalInjury.com today to get in touch with an experienced pharmaceutical injury lawyer who can take press your fight to protect you, your family, and the rest of us from reckless profiteering.

Labels: defective pharmaceutical, FDA

Wyeth in Trouble with FDA - Friday, January 4, 2008

Following a loss in a suit against it for the relationship between breast cancer and its menopause hormone replacement therapy (HRT) drugs Premarin and Prempro, pharmaceutical manufacturer Wyeth has been struggling with the FDA over several drugs, including two products designed to fill the market niche earlier occupied by the HRT products. The most recent hang-up is the FDA's demand that Wyeth answer more questions and hand over more data before the agency rules on the new experimental osteoporosis medicine bazedoxifene. This demand for additional information is a good thing, since hearings on Premarin and Prempro have revealed that the company had reason to expect the various problems that arose from users of the drugs. Suspicions about the drugs became clear as soon as sufficiently large studies were conducted. Hopefully, the new data demanded by the FDA will prevent a similar situation from occurring with the new drug. Wyeth claims it has already submitted data supporting approval of the drug, a study covering nearly 1,000 women, that had not yet been considered by the agency.

Osteoporosis is the loss of calcium-based minerals in the bones, making them more susceptible to breakage, and particularly affects women immediately following menopause. The disease only hit public awareness after Wyeth promoted its cure as a side effect of HRT.

Wyeth has a separate application in for approval of bazedoxifine for the treatment of osteoporosis in progress, although a decision on that application is not expected until May.

Other recent setbacks for Wyeth include the August 10 rejection of its experimental schizophrenia drug, bifeprunox, because the drug was not as effective as other treatment options available. The main advantage claimed by Wyeth for this drug is that it did not result in weight gain for its users. The FDA also declined to approve Pristiq, a nonhormonal menopause treatment, because of possible side effects on the heart and liver, until Wyeth conducts additional trials to ensure the drug's safety. (Note that Wyeth was hoping to replace HRT with two separate products, doubling its sales for the same treatment.)

Although these struggles may signal that the FDA is not so much in the power of the pharmaceutical companies as some fear, these demands for more information and study are as much a show to prove the agency's power as real attempts to protect the public health. In December alone, the FDA approved or gave tentative approval to over 30 new drugs, many of which will be manufactured and marketed under numerous trade names by several companies. With this flood of new drugs, how can we hope to know which will prove dangerous in the near future?

If you or someone you love has been injured as a result of a pharmaceutical, or you fear that you may be suffering unanticipated side effects of your medication, contact PersonalInjury.com today to get in touch with a pharmaceutical injury lawyer who can get compensation for you and protect others by getting those dangerous drugs off the market.

Labels: defective pharmaceutical, FDA, HRT

Health Canada Shows Its Strength - Wednesday, December 12, 2007

A recent study by the Canadian Institute for Clinical Evaluative Sciences (ICES) has not only increased concerns about Avandia and drugs in its class that are used to treat type 2 diabetes, but also raised increased concerns about why the FDA has not pulled the drug. The study compared patients treated with glitazones and those treated with other classes of diabetes drugs. The glitazone patients had a 60 percent higher risk of heart failure requiring hospitalization. They also had a 40 percent higher risk of heart attack, and a 30 percent higher risk of premature death compared to those on the other drugs. The study was conducted by analyzing data for 160,000 diabetics aged 65 and older from the Ontario Drug Benefit (ODB) database.

The data represents a study that is more than an order of magnitude larger than the largest prior study of Avandia. It definitively shows the heart risks attendant on the use of the class of medications and raises questions as to why this dangerous drug is still on the market. The figures show that there were three additional cases of heart failure, four additional heart attacks, and five premature deaths whose cause might be attributed to the drug for every 100 patients taking the drugs for the four years covered by the study, or approximately 8,000 deaths total. Health Canada withdrew approval of the drug for all but patients who could not tolerate other diabetes drugs early in November, but the US Food and Drug Administration (FDA) has been reluctant to do so, although it did put a black-box warning on the drug.

Is this an example of the FDA maintaining too close a relationship with the pharmaceuticals industry? It is impossible to say, but it sure seems likely. The study also points out the disparity between the weak, decentralized regulatory agency in the United States, and the comprehensive, independent, powerful health department in Canada. Although those whose wealth and power would allow them to buy expedited care in the US might complain that socialized medicine makes them wait in line with the hoi polloi, this case shows that the agency seems better equipped to look after the health of the population as a whole. In this country we rely on small studies, usually sponsored by the industry, of barely 14,000 individuals, and the majority of the studies are "inconclusive." Health Canada, on the other hand, is able to draw conclusions based on its own, wide-ranging data, data that cannot be concealed or cooked by pharmaceutical companies.

It is probably impossible that we would ever be able to reform the US health care system into anything like the socialized care in Canada. Instead, our only recourse to do the job that the FDA is either reluctant or unwilling to do is through the court system. Litigation is our last lever of power against major corporate interests in this country. Remember what Archimedes said, "Give me a lever long enough and a fulcrum on which to place it, and I shall move the world." If you or someone you love has suffered as a result of a defective pharmaceutical drug, contact PersonalInjury.com today, to get in touch with a local lawyer who can find his own fulcrum.

Labels: Avandia, Canada, defective pharmaceutical, FDA, federal government

Supreme Court may ban lawsuits on FDA-approved drugs - Tuesday, December 11, 2007

The Supreme Court has yet to give a verdict in the case of Riegel v. Medtronic. In this case, the wife of a man who claims he was injured when a balloon catheter burst in his artery. The defense being used by Medtronic, the maker of the catheter, is that the catheter was approved by the FDA and therefore should be immune to liability under state laws. Essentially, this is another case of an industry attempting to use Federal preemption to protect itself from litigation. If this defense is granted, it could have grave implications for people seek restitution for injuries suffered as a result of defective pharmaceuticals or medical devices, including another Medtronic product, defective defibrillators and leads.

The industry charges that the FDA is responsible for making sure drugs are safe for marketing, and if an industry does its best to comply with FDA guidelines, it should not be held responsible for unforeseen side effects that become evident after the product comes into common use.

However, as I discussed in yesterday's entry, the FDA works closely with drug companies, and actually allows drug companies to do most of the testing of their products. This testing, although expensive for drug companies, is worth it to them, because it gives them the opportunity to falsify data or use incomplete or poorly-recorded results to get their drugs approved. In fact, it is often only through litigation that the truth has come to light.

The outcome of this case, and another one on the docket for later this session, involving the drug Rezulin, might be bad news for people who are prescribed defective drugs by their doctors, as it might remove the last avenue for recompense they have: the courts. If you or someone you love has been injured by a defective drug or medical device, the time to act is now. Contact PersonalInjury.com today to get in touch with a local defective pharmaceuticals lawyer to get your voice heard.

Labels: defective pharmaceutical, defective product, FDA, federal government, preemption

Does the FDA serve us or the drug companies? - Monday, December 10, 2007

According to many industry critics, the FDA has conceded too much power to drug companies in the battle between safety and profits in the pharmaceuticals market. Essentially, critics say, the FDA "has allowed companies to set the standards and handle the reviews." Drug companies conduct their own trials of drugs, at their own expense, and usually report the results they want.

Most revelations about defective drugs show not only that the drug is unsafe, but that its manufacturer knew it was unsafe. Most recently, documents have revealed that Johnson & Johnson altered or withheld numerous reports that would reveal the serious health risks that went along with its Ortho Evra birth control patches. In addition, it has been shown that the makers of Premarin and Prempro (Wyeth), Vioxx (Merck), Baycol (Bayer AG), and Avandia (GlaxoSmithKline), all had reason to believe their drugs were more dangerous than their marketing implied, and many of them asked employees to play down risks to the point of being deceptive. Essentially, all drug manufacturers seem to put profits before patient safety. By allowing drug companies to do their own studies, critics charge, the FDA essentially lets the companies write checks to themselves, leaving patients to pay the bill.

In addition, many critics charge that the FDA itself tries to squelch critics within its organization that attempt to raise alarms about unsafe drugs. And the recent drug-safety bill passed by congress is seen by some as a public-relations move posing as real reform. Although the bill allows for tracking of adverse reactions after a drug is approved, a measure long-fought by the pharmaceuticals industry lobbyists, it does not reform the drug approval process. Nor does it alter the membership of drug-review panels, which often have significant ties to the industry. For example, a panel re-approved Trasylol on September 13, despite studies that linked the drug to kidney failure and death, asking only that additional studies be done. Then, only a month and a half later, Bayer decided to pull the drug voluntarily, rather than reveal what it must already have known about the drug.

With the FDA too close to the pharmaceutical companies, personal injury lawyers may be the last line of defense against dangerous drugs. If you or someone you love has been injured as a result of taking one of these drugs, you have a responsibility to pursue your suit to protect others who may be affected. Contact PersonalInjury.com today to get in touch with an experienced defective drug lawyer in your area.

Labels: defective pharmaceutical, FDA