West Palm Beach Personal Injury Lawyer

Tort Reform, Lies, and Lady Justice

John Hopkins — Thu, 05 Nov 2009 16:37:17 GMT

It is all about reforming our tort system, right? I mean fixing the health insurance problem for millions of uninsured people is all about preventing the filing of lawsuits against negligent doctors and hospitals, right? We need to limit or eliminate the constitutional right to jury try for a certain class of citizen to provide health insurance for our citizens, right? We need to provide special immunities to certain professionals to fix the health insurance problem?

Who has a “problem” that any of this fixes? One class of “people” has a problem that this will fix: insurance companies. The insurance industry wants tort reform so the insurance industry can increase profits. It is, in fact, that simple.

No one has ever been able to provide me with objective evidence that contradicts any of the following:

There are not an abundance of frivolous malpractice suits being filed now and there has not been in recent memory.
Malpractice claims do not, watch my lips, do not drive up insurance costs. In fact, under oath, many insurance executives have repeatedly testified as such.
Doctors are not fleeing states because of malpractice claims. In fact it is the very, very small minority of doctors who are sued for malpractice.
Malpractice claims do not drive up insurance premiums across the whole population of physicians. Empirical evidence demonstrates that little correlation exists between malpractice claims and increased premiums. Insurance executives have, under oath, also testified to that fact.
Tort reform will never lower insurance costs. The insurance industry simply does not have a track record for doing that.

All of this is a distraction from accomplishing a solution to the real problem. How do we provide health insurance to millions of citizens who are without it? Legislators indebted to the insurance industry need to throw up road blocks and provide distraction they can trump up to be popular with many people in this country.

When 98,000 people die every year and many more are injured from medical malpractice. I must wonder if the tort reformers would be making statements they know are not true if medical negligence killed their wife, their husband, their mother, or their child. Of course they would not. In the height of absolute indifference to the suffering of victims, tort reformers fabricate, invent, and misrepresent; all to benefit an industry who is dumping big dollars into their pockets.

So, if they are successful with roadblocks and propaganda campaigns, the victim will include justice herself.

Originally posted at InjuryBoard by John Hopkins

The Drug Business, Broadway, and Casper the Friendly Ghost

John Hopkins — Tue, 27 Oct 2009 09:13:35 GMT

“Ghost writing”: a person who writes books, articles, etc. for another who professes to be the author. Drug companies spend billions of dollars advertising drugs that neither I nor you can go to the store and buy.

Drug companies produce million dollar ad campaigns filled with beautiful fields of flowers; balloons flying around beautiful actors; and very sophisticated, successful, or just plain fun people who take the drug du jour, much to the better fulfillment of their lives. Then these same drug companies spend millions to market these drugs to physicians; ultimately the only class of people who can really open the gate to consuming of drug company products. Quite a long way around the block and a huge investment to sell a product.

On the direct marketing side, virtual Broadway productions are put together to convince consumers to ask their physician to prescribe this drug or that drug to cure the ills they have; or the ills they have finally realized they have after seeing the well heeled drug company ad. We are entertained and we are informed of all the symptoms we did not know we had; the diseases we might have; and the drugs available to treat one or the other.

Drug companies have traditionally justified the effectiveness of their drugs through “independent” research, usually funded by the drug company manufacturing the drug being researched. Once the research was conducted and the conclusions reached, the findings were published in responsible, self-regulating medical journals. These various articles served to demonstrate to the medical community, largely physicians, that the particular drug was a good one for patients.

We now find that at least some drug companies have been ghost writing supposed “independent” research articles for physicians, researchers, and experts. I am guessing that the way it works is Big Drug Company marketing person calls well established, expert physician and says something like:

“Gee, doc, we have this research we have done that leads us to the well founded conclusion that our new drug can cure the common cold. We need someone like you (an expert with a well heeled reputation) to sign off on the legitimacy of the research in an article we intend to submit to one of the well respected, self-regulated journals. What? Oh, of course its all true. We did this research entirely independently and our, er your conclusions are well supported. Yes, we stand to make a kazillion dollars on this one. Well, we can’t pay you a kazillion in fees, but maybe something in the high multiple figure range."

We then see a big production commercial about drugs and our learned physicians, for good reason, are forced to rely on Big Pharma’s Fairy Tales for evaluation of whether to prescribe a given drug.

Some publications like the Journal of the American Medical Association are questioning the real extent of ghostwriting, but frankly in my book, any is too much. The New England Journal of Medicine opines that maybe around 10% of articles involve some amount of ghostwriting.

Senator Charles Grassley has been spearheading Senate bill 309, Physician Payments Sunshine Act of 2009:

Physician Payments Sunshine Act of 2009 - Amends part A (General Provisions) of title XI of the Social Security Act to provide for transparency in the relationship between physicians and applicable manufacturers with respect to payments and other transfers of value and physician ownership or investment interests in manufacturers. Requires any manufacturer of a covered drug, device, biological, or medical supply that makes a payment or another transfer of value to a physician, a physician medical practice, or a physician group practice to report annually, in electronic form, specified information on such transactions to the Secretary of Health and Human Services. Requires any such manufacturer, or related group purchasing organization, also to report annually to the Secretary, in electronic form, certain information regarding any ownership or investment interest (other than in a publicly traded security and mutual fund) held by a physician (or an immediate family member) in the manufacturer or group purchasing organization during the preceding year. Prescribes administrative penalties for failure to comply with these requirements. Requires report submission procedures to ensure public availability of required information on a website.

So what can the consumer do? When you see your physician, be open and candid about your actual symptoms and your entire medical history. Your physician is trying to help you.

Ask questions about any tests your physician wants to do; what your physician expects the tests may show; and what your physician thinks you could be suffering from. Ask your physician where you might go to read about the tests and his or her differential diagnosis.

If your physician suggests prescribing drug treatment, ask questions:

What condition is he or she trying to treat?

What is the drug intended to treat?

What are the potential complications of taking the drug?

What adverse reactions from the drug are possible and what reactions are more likely than some of the others.

Is there a period of time before you will begin to experience the effects of the drug?

How long will you need to take the drug?

Are there alternative drugs to the one being prescribed? If so, why is your physician prescribing this particular drug?

Are there alternatives to taking any drug for the particular medical condition? If so, why is the physician recommending drug therapy?

Ask anything else you want an answer to and insist on clear, understandable answers. It’s your body and your healthcare decisions to make with the guidance of a trusted physician.

Originally posted at InjuryBoard by John Hopkins

Correcting Injustice--The Medical Device Safety Act

John Hopkins — Mon, 26 Oct 2009 10:26:43 GMT

The decision in the Supreme Court case of Riegel v Medtronic created special protection for medical device manufacturers that defied all logic and contradicted 30 years of experience in medical device regulation. The Riegel case set forth that lawsuits against medical device manufacturers were preempted where the manufacturer had properly submitted the device to and received approval from the food & Drug Administration. This decision ignored real world issues. Nearly everyone knowledgeable at the FDA will tell you they have neither the time nor the budget to conduct sufficient independent analysis of every medical device. Largely, their approval relies on the truthfulness and sufficiency of the testing reported to them by the device manufacturer. By necessity, the FDA’s process is somewhat like the fox guarding the henhouse, in situations where the manufacturer has failed, intentionally or negligently, to put the medical device through the testing that would best evaluate the product’s safety. The Medical Device Safety Act, currently in Congress, would seek to correct this error and place consumers back on level footing with medical device manufacturers. US Representative Henry Waxman summarized the situation well when he said:

"As the Supreme Court affirmed in its Wyeth decision yesterday, lawsuits by injured consumers play a critical role in helping to ensure safety," said Chairman Waxman. "The Court noted that these lawsuits 'uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly.' The same is true for medical devices. We must act quickly to enact this important legislation that will restore the ability of patients injured by defective medical devices to seek compensation, and realign the incentives for manufacturers to ensure the ongoing safety of their products."

The bill has now garnered support from many organizations including:

AARP

Center for Justice & Democracy

Consumer Federation of America

Consumers Union

Homeowners Against Deficient Dwellings

National Association of Consumer Advocates

National Consumers League

OWL - The Voice of Midlife and Older Women

Progressive States Network Public Citizen

U.S. Public Interest Research Group

The New England Journal of Medicine

National Conference of State Legislators

National Research Center for Women & Families

What can you do?

Call your legislators and ask them to do the correct and just thing—vote in favor of the bill.

Go here to find contact information for congressional members!!

Originally posted at InjuryBoard by John Hopkins

Dragons, Tort Reform and Other Myths

John Hopkins — Tue, 20 Oct 2009 10:47:26 GMT

I am not just picking on Jay Hancock at the Baltimore Sun and his comments about tort reform. Actually, Mr. Hancock’s comments, although containing the typical unsubstantiated statements that sound like fact, are actually sane in comparison to some of the pundits out there shouting for tort reform to “fix the civil lawsuit system”.

I think it was in George Orwell’s book, 1984, that politicians grasped the repeat-it-to-fact approach to things. This is where you get enough people to say the same thing over and over; the media latches on to the notion and repeats it; and it does not matter that no real substantial evidence to support the notion exists, people begin to spout the notion as if it is fact. That is exactly what has happened to tort reform.

So, let me use a column by Mr. Hancock to address some of the myths made to sound like fact.

“…doctors over-scan and over-treat patients to fend off lawsuits, costs billions of dollars a year.” I am not sure anyone can fairly assess whether claimed over treating is defensive medicine or simply good, cautious medicine. I am sure that no reliable basis exists for this claim except based upon the anecdotal evidence from the subjects of the alleged over treatment, doctors themselves. “

Trial lawyers bring dubious cases…juries deliver nonsensical verdicts.” Are their cases brought by attorneys that I “hear about” and I think, “what in the world was the lawyer thinking?” Yes, there are cases I “hear about” and conclude that very thing; but they are rare, once I learn the details of the case.

That is exactly the problem. People “hear about” cases, have no objective or informed information about the cases, and conclude they were “dubious”. I have been involved with jury trials for over 30 years and it is rare that a jury reaches a “nonsensical verdict”; if you actually knew about the case, heard the evidence that the jury received, and were present in the courtroom during the entire trial. Politicians and journalists do not inform themselves to this extent because it is not practical to sit through an entire three week trial. Instead, we “hear about” a trial and we are told “dubious and nonsensical” conclusions, because the politician or journalist could not possibly have reached a well informed conclusion.

Yes, I know, you are reading this and thinking: “McDonald’s coffee case”! Do us all a favor and really learn the details of that case, along with what the courts finally did with it before you decide it was “dubious” or the jury reached a “nonsensical” verdict. There was much more than sufficient evidence for the jury to conclude what they did in that case.

So, what are some of the facts about tort reform do we have? (In fairness, cited by Mr. Hancock)

"Tort reform as discussed in the United States would probably have very little impact," says Gerard Anderson, a professor at the Johns Hopkins Bloomberg School of Public Health. "The states that have enforced tort reform have about the same amount of litigation - and the awards are comparable - as states that don't."

A more drastic malpractice makeover would deliver substantial gains - but only once. New Zealand has a no-fault medical injury system in which lawsuits are essentially banned and experts decide how much to award victims. But even such a system, which nobody is talking about in the United States, would cut health care costs by maybe 7 percent at the most, Anderson said.

The nonpartisan Congressional Budget Office, as usual the best source for this kind of analysis, says malpractice costs make up only 2 percent of health care spending. "The evidence available to date does not make a strong case that restricting malpractice liability would have a significant effect," the CBO says.

Before draconian tort reform was passed in Florida, insurance executives testified, under oath, that tort reform would have no effect on insurance premiums; the executives did not believe a medical malpractice lawsuit crisis existed; and the executives did not believe frivolous lawsuits were really a problem, at least in medical malpractice. If these executives would benefit from tort reform, you must wonder why they would testify in this way. It is simply because the insurance industry and their minions of politicians have done such a great job of creating the mythical need for tort reform, they knew they could tell the truth and still have tort reform passed.

Please do us all a favor. Before all of you politicians decide to take away or severely limit my constitutional rights, please be sure you are doing it for reasons that are not dubious and base it on real, objective evidence. If you do, you will sensibly conclude that tort reform is a myth and practicing defensive medicine might simply be practicing careful medicine.

Originally posted at InjuryBoard by John Hopkins

Loss of Sight Due to Possible Contamination of Ocular Drug-- Hyaluronidase

John Hopkins — Thu, 15 Oct 2009 16:14:32 GMT

Wydase (hyaluronidase) was manufactured by Wyeth until 2001 and was successfully used in various ocular surgeries to potentiate the effectiveness of anesthetics. Bupivicaine and Lidocaine are reportedly more efficacious when combined with hyaluronidase.

In 2001, Wyeth made the economic decision to stop manufacturing Wydase and subsequent manufacture of hyaluronidase based compounds were taken over by other manufacturers.

When Wyeth discontinued its manufacture of Wydase (hyaluronidase), ophthamologists were so entrenched in its use that many turned to compounding pharmacies to create the appropriate compound for them. Compounding pharmacists are supposed to be skilled in the actual combining of ingredients on premises for specific drug compounds. The FDA maintains jurisdiction over compounding pharmacies to the extent they are prohibited from compounding (combining ingredients) drugs without a patient-specific request from a physician. In addition, the FDA controls many of the ingredients compounding pharmacies use in arriving at their final product.

Fellow blogger, Cal Warriner, has discovered a potential contamination of hyaluronidase; believed to be specially prepared by a compounding pharmacy. In this instance I understand that hyaluronidase in a surgical procedure may have been the cause of the complete loss of sight in a patient.

Originally posted at InjuryBoard by John Hopkins

Pfizer Bigger and More Profitable--Victims Wait for Justice

Brenda Fulmer — Thu, 15 Oct 2009 09:17:55 GMT

Pfizer’s $68 billion merger with Wyeth should be completed on October 15, 2009, following recent approval by the Federal Trade Commission. The merger was approved by the European Union in July of 2009.

Wyeth and Pfizer have been embroiled as co-defendants in litigation over hormone replacement therapy products for many years now. It is unknown how the merger may affect the upcoming trials that need to be scheduled for nearly 13,000 women who developed breast and ovarian cancer after long-term use of the artificial hormones.

Wyeth, who touts itself as a leader in women’s health, manufactured both Premarin and Prempro. Pfizer was the manufacturer of Provera, a drug that was taken in combination with Premarin to avoid the risks of endometrial cancer that was first noted with regard to Premarin more than 30 years ago.

Premarin, Provera, and Prempro were the hormone replacement therapy drugs ingested by most of the 13,000 plaintiffs whose cases are pending in state and federal courts in Arkansas, Pennsylvania, New Jersey, Minnesota and elsewhere. Many of these lawsuits have been pending for more than five years, with less than fifteen trials completed so far and only a handful of cases confidentially settled. Several thousand of these women recently prevailed in an appeal to the highest court in Minnesota, after the drug manufacturers sought to dismiss their lawsuits as being barred by various state’s statues of limitations periods. Depositions and other discovery have been taken in a number of cases (known collectively as PPO #9 cases), which should be included in the first wave of remands from the multi-district litigation proceedings pending in Little Rock, Arkansas. An appeal of the Plaintiff’s verdict in the Scroggins trial is currently pending, and remands of federal cases are anticipated once that appeal is resolved. More than a dozen women who developed breast cancer after taking Premarin in combination with Provera or Prempro will present their cases to jurors in Philadelphia in the coming months, with the first verdict expected before the end of October. These cases are part of the state court coordinated mass torts proceedings pending in Philadelphia before Judge Moss.

Following completion of the merger, Pfizer will be the largest pharmaceutical company in the world. Pfizer posted earnings of $48.3 billion in 2008, while Wyeth reaped $23 billion in revenue. The irony that this merger would be completed during Breast Cancer Awareness Month is not lost on many of us. One can only hope that as Wyeth and Pfizer begin this new chapter, the companies will take responsibility for the lives of so many breast cancer victims and survivors who have suffered as a result of their drugs and work towards a quicker resolution of the HRT litigation.

For more information in connection with how you can be a part of the solution to help victims of breast cancer, visit the Susan G Komen site.

We encourage you to take time to care and make a difference in someone's life.

Originally posted at InjuryBoard by Brenda Fulmer

Tort Reform Lies and Illusions

John Hopkins — Tue, 13 Oct 2009 12:08:28 GMT

Is it okay with you if I limit your right to voice your opinion about the government? Good with you if you can not own a gun? You probably would appreciate me censoring what gets published in newspapers or talked about on your nightly news, right? You are happy to allow government to control what church you can or cannot attend?

You, of course, will not allow these rights to be taken away, but you will allow the right to trial by jury to be taken away, with little more than a thought, when lobbyists tell you (through your legislators) that tort reform is a good thing. You are happy to give up this fundamental right when told by the insurance lobby that tort reform is the only way to “save” the medical profession.

What these lobbyists and their political cronies really mean is that tort reform translates to higher insurance profits, with no down side for the insurance industry. It means lower exposure to the business of insurance, which means more money in insurance company profit margins.

When tort reform hearings were held in Florida, insurance company executives actually testified that tort reform would not lower malpractice insurance premiums for doctors. The same executives testified that frivolous lawsuits in medical negligence cases were extremely rare and did little to add to costs for malpractice insurance. They said that the very tort reform proposed (ultimately passed) would have little or no affect on availability of malpractice coverage or the cost of malpractice coverage.

There are no objective studies that correlate tort reform with lowering of so called defensive medicine; demonstrating that a tort crisis even exists; or showing any benefit to tort reform except to insurance companies.

See what the insurance companies and tort reform advocates have said in the past. They claim to be experts and none of them have the temerity to claim that tort reform works:

Representative of the Ohio Health Insurance Company testifying before the Wyoming Legislature: Tort reform will not lower rates. (Casper Star Tribune, May 4, 2003)

Medical Assurance Co. of Mississippi: “[T]ort reform does not provide a magical ‘silver-bullet’ that will immediately affect medical malpractice insurance rates.” (Medical Assurance Co. of Mississippi)

Patricia Costante, chairman and CEO of the MIIX Group of Insurance Companies: When asked by New Jersey Assemblyman Paul D’Amato whether, if caps are enacted in New Jersey, her insurance company will not raise premiums and will, in fact, reduce them, she said, “No, we’re not telling you that.” (Meeting of the New Jersey Assembly Joint Committee of Banking)

American Insurance Association: “[T]he insurance industry never promised that tort reform would achieve specific premium savings.”

Sherman Joyce, President, American Tort Reform Association: “We wouldn’t tell you or anyone that the reason to pass tort reform would be to reduce insurance rates.”

Victor Schwartz, General Counsel, American Tort Reform Association: “[M]any tort reform advocates do not contend that restricting litigation will lower insurance rates, and ‘I’ve never said that in 30 years.’”

Dick Marquardt, Washington Insurance Commissioner: It was “impossible to attribute stable insurance rates to tort-law changes or the damages cap,” since rates also improved in states that did not pass tort reform.

Chairman of Great American West Insurance Company: “[T]ort reform ‘will not eliminate the market dynamics that lead to insurance cycles,’ and ‘we must not over-promise—or even imply—that insurance cycles will end when civil justice reform begins.’

Connecticut State Lawmaker: “[T]he insurance industry now says [tort reform] measures will have no effect on insurance rates. We have been disappointed by the response of the insurance industry. The reforms we passed should have led to rate reductions because we made it more difficult to recover, or set limits on recovery. But this hasn’t happened.”

State Farm Insurance Company (Kansas): “[W]e believe the effect of tort reform on our book of business would be small. … [T]he loss savings resulting from the non-economic cap will not exceed 1% of our total indemnity losses.… [I]n our sample of liability claims, no claim was found that would have been affected by the joint and several restriction.” And any savings due to alternative payment methods would be “negligible.” (Letter from Robert J. Nagel, Assistant Vice President, State Filings Division, to Ray Rather, Kansas Insurance Department)

Aetna Casualty and Surety Co. (Florida): After Florida enacted what Aetna Casualty and Surety Co. characterized as "full-fledged tort reform," including a $450,000 cap on non-economic damages, Aetna did a study of cases it had recently closed and concluded that Florida’s tort reforms would not effect Aetna’s rates. Aetna explained that “the review of the actual data submitted on these cases indicated no reduction of cost.”

St. Paul (Florida): St. Paul’s found “a total effect of about 1% savings” from Florida’s 1986 tort reforms, but that even this 1% might be inflated. St. Paul concluded that “the noneconomic cap of $450,000, joint and several liability on the noneconomic damages, and mandatory structured settlements on losses above $250,000 will produce little or no savings to the tort system as it pertains to medical malpractice.”

General Accident Insurance Company (Washington State): “Given that liability losses constitute such a low proportion of business owners’ losses, GA feels it is prudent to continue with its original proposal of a 10 percent increase in base rates.” (The Seattle Times, July 1, 1986. The Times wrote that “the highly touted tort-reform legislation enacted by the Legislature early this year is not lowering liability-insurance rates as promised, according to preliminary filings made with the state insurance commissioner.”)

Allstate Insurance Company (Washington State) In asking for a 22% rate increase following passage of tort reform in Washington State, including a cap on all damage awards, the company said, “our proposed rate would not be measurably affected by the tort reform legislation.” (The Seattle Times, July 1, 1986)

Originally posted at InjuryBoard by John Hopkins

Yaz Ads Were Deceptive and Profitable

Brenda Fulmer — Wed, 07 Oct 2009 13:41:11 GMT

Bayer was recently sued by a union’s health insurer in Pennsylvania who alleges that the German manufacturer of one of the top-selling birth control pills engaged in deceptive trade practices and a three-year racketeering scheme in order to sell its drugs to young women and induce their health insurers to pay for them. This latest lawsuit focuses on the time period from March 17, 2006, through March 31, 2009 and alleges that Bayer misled doctors, patients and others regarding the safety risks associated with Yaz and Yasmin. The health insurer seeks to disgorge profits made during that time period, when sales of Yaz and Yasmin grew 17% to approximately $1.8 billion according to Bloomberg.

You may recall some of the advertising employed by Bayer early on in their marketing of Yaz; they looked more like commercials for a wonder drug than a contraceptive:

www.youtube.com/watch

In the past several months, Bayer has faced the following:

Establishment of MDL 2100 for the national coordination of lawsuits in federal court over Yaz and Yasmin with hundreds if not thousands of lawsuits expected to be filed by women and young girls who suffered pulmonary emboli, DVT, heart attacks, strokes, or gallbladder disease while taking the popular birth control pills
Publication of an article in the British Medical Journal that notes significantly increased risks of blood clotting adverse events in women using Yaz and Yasmin, especially in the months following first use of the products.
Investigation by Swiss authorities into the September 2009 death of a young woman who suffered a fatal pulmonary embolism after taking Bayer’s Yaz for approximately 10 months.
Reached $20 million settlement with the California Attorney General over claims of deceptive advertising for Yaz, which includes requirement that Bayer run corrective advertising to correct previous misleading claims. Similar agreements have been reached with 29 other states as well.

In response to the union health insurer lawsuit, Bayer spokeswoman Rose Talarico commented in the Law 360 Product Liability Reporter: “Bayer reaffirms and stands behind the safety of its drospirenone-containing oral contraceptives.”

Originally posted at InjuryBoard by Brenda Fulmer

Unsafe Children's Toys Recalled

Laurie Briggs — Tue, 06 Oct 2009 14:46:05 GMT

Target Corporation twice found itself in the news last week concerning the sale of children’s toys in its stores. First, Target was fined $600,000.00 last week by the Consumer Product Safety Commission for knowingly importing and selling children’s toys with paint or other coating which contained lead levels above the Federal legal limits. The toys specifically cited by the CPSC were Kool Toyz Products, Anima - Bamboo Collection Games, Happy Giddy Gardening Tools and Sunny Patch Chairs. Target denies knowingly breaking the law.

Then, following an inquiry from Mitch Lipka, who spends his time investigating consumer product safety, Target was in the news for children’s flashlights which begin melting when the battery is placed inside. Sold at Target in a 3-for $1 package, the mini flashlights were being marketed as a Halloween item. After Mr. Lipka contacted Target, the CPSC and the importer of the flashlights, from China, Debrian Global Industries, the product was immediately pulled from the shelves, an investigation into the cause of the problem was initiated and full refunds were offered by Target.

The Target fine is coupled with today’s news from the CPSC that Daiso California LLC has voluntarily recalled children’s toys, purses, pen cases and inflatable baseball bats it sold between March of 2008 and May of this year because the surface paint on the balancing toys and zippers of the purses and pen cases contain excessive levels of lead, violating the federal lead paint ban. In addition, the inflatable baseball bats contain excessive levels of DEHP, violating the federal phthalate standard.

As we head into the holiday gift buying season, these types of stories do little to quell the growing fear over children’s toys, oftentimes from China, which somehow find their way to our store shelves in violation of United States safety standards.

Originally posted at InjuryBoard by Laurie Briggs

All That Yaz is Dangerous

John Hopkins — Mon, 05 Oct 2009 14:12:35 GMT

The US Drug Watchdog group has now issued a press release warning women who have taken the birth control drug, Yasmin or Yaz of the very serious side effects of these drugs. Our firm has been warning consumers for some time. The group points out that the manufacturer, Bayer, has done a poor job in informing women who may have taken these drugs of the potential side effects. The watchdog group goes so far as to characterize this situation as possibly “the most important pharmaceutical initiative” in which they have ever been involved. Yaz and Yasmin contain a synthetic progestin called drospirenone, which has never before been used in a birth control pill before. Bayer paid for a study that demonstrated Yaz a safe, but at least one other study sets forth that Yaz and Yasmin can cause a whole host of problems, including:

Venous thrombosis
Arterial thrombosis
Thromboembolic events
Myocardial infarction
Heart attack
Stroke
Thromboembolism
Hepatic neoplasia
Gallbladder disease
Hypertension
Blood clots
Deep Vein Thrombosis
Pulmonary embolism
Death

In October of 2008 the FDA sent Bayer one of the most strongly worded warning letters I have seen. Although that letter largely dealt with the advertising being used by Bayer, it chastised Bayer for making claims about the conditions for which Yaz was demonstrated as being effective. In addition, it warned Bayer that its advertising failed to sufficiently disclose the potential risks of Yaz. Bayer apparently has a penchant for overstatement. Complaints have been filed by various groups including, with the Federal Trade Commission, Better Business Bureau, and, as said, the FDA. Bayer has been accused of making claims without real foundation. For example, it claimed that its One-A-Day WeightSmart vitamins could help with weight loss; reportedly without any true scientific basis. They also claimed that their One-A-Day vitamins could prevent prostate cancer; again without true science. Bayer was told to stop advertising its All-Day-Energy vitamin as “All-Day”, because it likewise is not demonstrated to scientifically perform All-Day. Yaz and Yasmin advertising cost Bayer $20 million in corrective ads they are required to put on the airwaves. You have seen the ones; where the actress in a snazzy bar seems less than repentant about Yaz’s advertising and that, well, shucks, maybe we didn’t tell you guys everything quite as clearly as we could have about Yaz. She says that the FDA wants them to clear a few things up. Unfortunately, in my opinion, the corrective ad campaign cleared little up and the action taken to inform the public about Yaz was lackluster at best.

Originally posted at InjuryBoard by John Hopkins