Charlottesville Personal Injury Lawyer - device

DOJ Indicts Stryker Biotech On Charge Of Fraud

Greg Webb — Mon, 16 Nov 2009 14:45:31 GMT

The Justice Department has reported that Stryker Biotech LLC, the medical device manufacturing division of Stryker Corp., and its top management have been indicted on federal charges of fraud due to a marketing scheme for bone-growth products OP-1 implant and OP-1 putty. These two products were promoted for use in a manner different from the use approved by the Food and Drug Administration (FDA). Although Stryker did have a federal exemption that authorized it to sell the products for "humanitarian" reasons to treat a rare condition, it instead promoted a combination of the devices with a bone void filler called Calstrux and provided "recipes" on how to combine Calstrux with OP-1 in ways never approved by the FDA.

The indictment charged Stryker Biotech, its former president, and three current sales managers with a scheme that involved devices used during invasive long bone and spinal surgeries; the former president and the company were also charged with making false statement to the FDA. If the company is convicted, it could face serious fines and possible exclusion from participating in federal and state healthcare programs. The former president and the three sales managers could also face jail time if convicted of wire fraud conspiracy and misbranding charges.

Because of the potentially negative ramifications of a conviction, Stryker is expected to aggressively pursue a settlement.

Originally posted at InjuryBoard by Greg Webb

Vermont Law Makes Payments to Doctors Public

Greg Webb — Sat, 30 May 2009 22:06:08 GMT

In an attempt to crack down on the medical industry’s payment to physicians, Vermont legislators have passed a law that requires drug and device manufacturers to publicly release the amount of all money given to doctors and other healthcare providers, naming names and listing the actual dollar amounts. This law is scheduled to go into effect July 1, and would also ban almost all industry gifts, even meals, to nurses, doctors, medical staff, pharmacists, health care facilities and healthcare administrators. It is believed to be the strictest state effort to regulate the marketing of medical products to physicians, though Minnesota and Massachusetts have less stringent laws in place. Ideally, the measure would allow residents of Vermont to annually learn how much each doctor was paid by makers of the brand-name drugs for which they wrote patients’ prescriptions, or how much money surgeons received from the manufacturers of certain devices, like stents, that they implant.

National legislators and medical groups are monitoring the different state laws, like the one in Vermont, in their quest to discover a link between health care costs and industry marketing. In Congress, Republican Senator Grassley and Democratic Senator Kohl have sponsored a bill that would require disclosure of the pharmaceutical industry’s payment to doctors. Vermont’s law, however, goes even further by showing the issue is inappropriate gift giving. It requires all payments to any health care provider be disclosed, as well as requiring device manufacturers to disclose information as well; the law is also the first to ban all free meals, which was a favored gift used in marketing to doctors, and closed a loophole that allowed companies to not disclose information by calling them “trade secrets”. The required disclosures, however, do not include payments for clinical research on products that are still under examination by the Food and Drug Administration (FDA).

Vermont legislators passed the measure after information was released by the attorney general stating manufacturers of medical products spent about $2.9 million in fiscal year 2008 on marketing to healthcare personnel in their state. About half of Vermont’s physicians were also given compensation from pharmaceutical companies; the manufacturers focused mainly on those doctors they considered “elite”, with only four percent of these doctors receiving more than sixty percent of the payments. The reports also raised the point that if drug manufacturers were willing to spend that much money in the small state of Vermont, what would the results be in the big states of New York and California?

This law is, at least at first glance, a positive step in curbing the corporate greed of the medical device and pharmaceutical industries. It will be interesting to see how this law plays out over the coming years as far as its success in actually accomplishing its goal and, perhaps, curbing health care costs. Hopefully, there are no bad, unintended consequences.

Originally posted at InjuryBoard by Greg Webb

Congress Debates Medical Device Safety Act to Counter Riegel v. Medtronic

Greg Webb — Mon, 25 May 2009 21:25:32 GMT

The House Energy and Commerce Subcommittee on Health began hearing testimony on the Medical Device Safety Act of 2009, which proposes the Supreme Court decision in Riegel v. Medtronic, Inc be overturned. The Reigel ruling prevents patients that were injured by certain federally approved medical devices from seeking compensation via state product liability suits – in other words, federal law trumps (preempts) state law in these cases. The House bill has been a catalyst in the legal community. The American Tort Reform Association, for example, claims the bill would be an economic stimulus for personal injury attorneys. The American Association for Justice, on the other hand, says the bill would restore victims’ rights.

The subcommittee’s hearing was just as divided. While the arguments within the subcommittee hearing were relatively tame, an argument broke out between Subcommittee Chairman Henry Waxman (Democrat) and Steve Buyer (Republican). Waxman argued the FDA’s ability to protect the American public has plummeted due to severe underfunding. Buyer claimed this was “bizarre logic.”

A former chief counsel of the Food and Drug Administration (FDA) testified at the hearing and argued ultimate authority should rest with the FDA and not a group of people that listen to lawyers “rant” at them. He further argues that making it easier for the companies to be sued would lead to limits in innovation because companies would be deterred from taking risks in developing new products. David Vladeck, who will become the Federal Trade Commission’s consumer protection chief next month, claims the Riegel decision gave consumers the “worst of both worlds” since the FDA cannot assure every medical device is safe and with Riegel, consumers can no longer rely on the tort system if they are injured.

Mr. Vladeck is dead-on with his comment. There have to be checks and balances on any system. It is no secret that the FDA (and most other federal oversight agencies) do not have adequate resources to police drug companies, medical device companies, automobile manufacturers, and much of the banking industry (Exhibit A being what has occurred in our economy over the past 12-24 months), just to name a few. While lawyers, especially trial lawyers, are not a favorite profession of most citizens, trial lawyers (of which I am a card-carrying member) are needed as an enforcement mechanism. The possibility of litigation is a deterrent, and it is also a means to hold those who place profits ahead of safety accountable.

Originally posted at InjuryBoard by Greg Webb

Medtronic Heart Device Linked To a Possible Thirteen Deaths

Greg Webb — Mon, 06 Apr 2009 08:00:00 GMT

Medtronic admitted that at least thirteen people might have died in correlation with a heart device, known as Sprint Fidelis, that it recalled in 2007 but was still in widespread use. This number includes four patients who died while surgeons were attempting to remove the product and is the first new data to reflect fatalities since the device was first recalled; the other nine deaths may be tied to the device’s failure to work properly. The Food and Drug Administration (FDA) has also said it received about 2,200 reports of serious injuries related to the device. The heart device is a thin electrical cable that connects an implanted defibrillator to the patient’s heart. It was recalled due to fractures in the cable that may cause the defibrillator to fire for no reason or fail to deliver a life saving shock to a patient’s irregular beating heart. Presently about 150,000 patients still have the Sprint Fidelis leads in their bodies.

A previously disclosed Food and Drug Administration (FDA) report shows Medtronic began receiving reports about the problem in 2004, three years before they declared a recall; they even conducted their own internal investigations. This report is based on a visit by regulators to the Medtronic facility soon after the device was taken off the market, where officials interviewed executives and reviewed records. The company also changed their manufacturing process in the months leading up to taking the device off the market. A top Medtronic official, however, claims this “acute” change had nothing to do with the recall and even at the time of the recall, internal data did not suggest the device was fracturing at higher rates than other company leads.

By 2006, it is believed Medtronic knew there was a problem. The timeline regarding exactly when Medtronic knew about the problems with Sprint Fidelis could be a significant factor if patient lawsuits begin again. The Supreme Court recently agreed that patients may not sue device manufacturers whose products were approved by the FDA, however, new legislation introduced by Democrats in Congress may nullify this decision.

Originally posted at InjuryBoard by Greg Webb

Tattoos, Nicotine Patches And Other Medical Devices May Pose Problem During M.R.I.s

Greg Webb — Tue, 31 Mar 2009 17:44:35 GMT

Federal health officials warn that patients who wear nicotine or other drug patches during M.R.I. scans may get burned due to the machine’s huge magnet that can heat tiny metal elements found in the patches. Not all patches contain these aluminum elements. The Food and Drug Administration (FDA) has received at least five reports of patients wearing patches who experienced a skin burn similar to a sunburn during an M.R.I. screening; federal officials are usually only alerted to a fraction of the injuries associated with a particular drug or device so the number may be much more.

About sixty different types of drug patches are sold in the United States, and about twenty contain the small metal fragments. Some of the patches do not warn patients about these metal fragments, and since few people review the box after donning the patch, the FDA will soon require that all manufacturers put warnings, such as "Remove Before M.R.I." on the patch itself. Patients should consult their physician regarding whether or not to replace or reuse the patches after removing them for scans.

This patch alert is the latest in an assortment of safety warnings involving increasingly powerful M.R.I. devices, due to the unpredictable effects of strong magnets used in the devices that are continuing to be discovered. Radiologists are now warning patients that they can experience discomfort or injury if they have tattoos, implanted medical devices or shrapnel. Tattoos also contain metallic elements in some cases, which can lead to warming in the skin that can grow uncomfortable. Some M.R.I. screening rooms place metal detectors in front of the rooms to prevent the problem of patients forgetting to remove metal objects before entering.

Originally posted at InjuryBoard by Greg Webb

Medical Device Bill To Be Introduced Following Recent Supreme Court Decision

Greg Webb — Tue, 31 Mar 2009 17:37:06 GMT

Democrats in Congress are moving to overturn a Supreme Court decision that allowed medical device manufacturers to be shielded from lawsuits after the Supreme Court Justices recently decided drug makers should not receive the same protection. Last Wednesday, the Court ruled against Wyeth’s contention that it should not be subject to lawsuits in state courts for Phenergan, its anti-nausea drug, because the Food and Drug Administration (FDA)approved the medication. This ruling upheld a $6.7 million award to a Vermont woman who lost her arm when she was improperly injected with Phenergan.

Seizing the opportunity introduced by the Court’s decision, Democrats reintroduced the Medical Device Safety Act, which would allow similar lawsuits against companies that manufacture heart devices, replacement hips, catheters and other apparatuses. The medical device lobbying group quickly criticized the act, claiming it would impede medical innovation, create more lawsuits and result in higher health care costs for all Americans. However, many interest groups, including the AARP, trial lawyers and consumer advocates, support the bill. Many analysts believe this measure will soon become a law.

Let there be no mistake, this is a good bill and it needs to be passed. No one, absolutely no one, including corporations, should be immune from being held accountable for wrongful conduct, including negligence. For years the medical device manufacturers and pharmaceutical companies, among many other large business industries, have been seeking immunity from lawsuits. Some of them achieved partial victories during the last presidential administration through back-door preemption regulations via federal agencies. It looks as if the Obama Administration (and Congress) is proceeding on a more consumer-oriented track, looking out for the little guy. Hopefully, this philosophy will continue.

Originally posted at InjuryBoard by Greg Webb

Congressmen Push To Nullify Supreme Court’s Medical Device Decision

Greg Webb — Tue, 03 Mar 2009 08:00:00 GMT

Some members of Congress are attempting to remove a 2008 Supreme Court decision that stands as a barrier against suing medical device manufacturers. This ruling has barred patients, or their survivors, from suing manufactures of complex medical devices if the Food and Drug Administration (FDA) has approved the products sale. Since this ruling, judges from around the country have cited it in dismissing cases against a wide range of manufacturers. For example, situations in which a woman was burned internally by a device that was meant to reduce menstrual bleeding, and numerous patients who claim they were injured by faulty heart implants or joints.

Recently, however, some members of Congress have decided they want to give potential plaintiffs a chance at legal action. Two House Democrats plan to reintroduce legislation that will nullify the Supreme Court Decision. A similar bill introduced in the Senate last year is also expected to be reintroduced. The legislators, as well as patient advocates, say the Supreme Court’s decision has left patients legally powerless against “spotty oversight of products” by the FDA. With the Supreme Court ruling, patients are facing a dangerous situation in which the FDA is incapable of keeping dangerous products off the market and patients cannot sue companies for restitution.

The House Energy and Commerce Committee is expected to hold hearings this session to determine whether the FDA’s process for device approval is adequate after numerous claims that it does not have the necessary resources to asses all risks that a device poses once it gets on the market. Opposition to the legislation claims the FDA is the appropriate body to set national safety standards and allowing juries to undermine its decisions will hinder product innovation.

Many believe the Supreme Court’s decision does not reflect the unpredictability of the FDA review process. Recently, for example, when doctors extracted a faulty electronic cable from a patient’s heart, a vessel was punctured causing excessive bleeding. The patient died two days later and a lawsuit against Medtronic, the manufacturer of the faulty device, was thrown out. This cable, called a lead, was never tested in humans before it went on the market and before Medtronic could recall the product, it was implanted in more than 235,000 patients; five of these patients may have died due to the problem.

The Supreme Court is currently deciding whether it should give the same type of legal protections to drug manufacturers in the case of Wyeth v. Levine. Hopefully, the Court will not grant such broad-reaching immunity for drug manufacturers. Drug companies, like all persons and entities in our country, should be held responsible for wrongful conduct, especially when such conduct sacrifices safety in the name of profits.

Originally posted at InjuryBoard by Greg Webb

Report Suggests FDA Should Improve Oversight of Doctor Conflicts

Greg Webb — Tue, 27 Jan 2009 08:00:00 GMT

The Food and Drug Administration needs to improve its oversight of the financial conflicts of doctors who participate in clinical testing before a drug is approved for sale, according to a government watchdog report.

The FDA lacks a complete list of doctors conducting research on new medicines, and it cannot determine which companies have submitted financial information for doctors working on studies, according to a report by the Department of Health and Human Services inspector general.

Of the 118 marketing applications of medicines or medical devices approved in 2007 which were examined by investigators, 42 percent of the applications lacked financial information, and 31 percent of the applications had no documented review of any financial data.

The report urged the FDA to take steps to ensure companies submit complete financial information, and that the submissions are reviewed by the agency. It also said that the FDA should require companies to submit doctors’ financial information before clinical trials on humans begin.

While the FDA agreed with most of the report’s ideas, it rejected the last, saying it “could have the unintended effect of adding to the complexity and cost of the clinical trial enterprise with no commensurate gain in the protection of human subjects or the quality of data.”

Once more, it sounds as if the medical device manufacturers and pharmaceutical companies are, through big money, controlling or deeply influencing governmental decisions and oversight. This has also occurred with the Consumer Product Safety Commission (CPSC) and the toy industry, and NHTSA and the auto industry, for other examples. When the fox watches over the henhouse, something is wrong. I cannot imagine how the costs of such oversight would so dramatically impact the “complexity and cost of the clinical trial enterprise” so as to outweigh associated benefits of helping to prevent defective medications or medical devices from being too readily and quickly approved for public consumption. Perhaps I am too cynical.

Originally posted at InjuryBoard by Greg Webb