Litigation

Big Brother Pharma Wins Again

By Angel L. Reyes, III

In a crushing blow to consumers, on Thursday, February 21st, the United States Supreme Court again sided with big pharmaceutical medical device makers.  The decision in Reidel v. Medtronic shields medical devices from lawsuits so long as the FDA approved the device.  Consumer safety, as most people know, has not been the FDA’s forte the past decade.  The entire article is below.
 
Interestingly, just the day before that article was released, the Wall Street Journal wrote extensively about U.S. Congressman Bart Stupak who has argued for years that the FDA wasn’t doing a good job protecting Americans from unsafe drugs.  The entire article is also below.
 
For my money, the FDA has done a terrible job protecting American consumers for the past decade.  The list of bad drugs that were approved and then subsequently shown to be dangerous is a mile long.
 

Justices Shield Medical Devices From Lawsuits
By LINDA GREENHOUSE
Published: February 21, 2008

WASHINGTON — Makers of medical devices like implantable defibrillators or breast implants are immune from liability for personal injuries as long as the Food and Drug Administration approved the device before it was marketed and it meets the agency’s specifications, the Supreme Court ruled on Wednesday.

The 8-to-1 decision was a victory for the Bush administration, which for years has sought broad authority to pre-empt tougher state regulation.

In 2004, the administration reversed longstanding federal policy and began arguing that “premarket approval” of a new medical device by the F.D.A. overrides most claims for damages under state law. Because federal law makes no provision for damage suits against device makers, injured patients have turned to state law and have won substantial awards.

The Bush administration will continue its push for pre-emption in another F.D.A. case that the court has accepted for its next term, on whether the agency’s approval of a drug, as opposed to a device, pre-empts personal injury suits. Drugs and medical devices are regulated under separate laws.

The case before the court concerned only medical devices that had gone through the premarket approval process specified by the Medical Device Amendments of 1976. Most devices now available reached the market through a different process, under which the F.D.A. found them to be “substantially equivalent” to those marketed before the 1976 law took effect.

The Supreme Court ruled in 1996 that this less rigorous approval process does not pre-empt state damage suits against the manufacturers of “grandfathered” devices.

Devices subject to the premarket approval process, and thus affected by the court’s opinion, tend to be more technologically advanced, expensive and, in some instances, risky.

Examples of devices that have been the subjects of recent lawsuits include an implantable defibrillator, a heart pump, a spinal cord stimulator, a drug-coated stent, an artificial heart valve, and prosthetic hips and knees.

It was not immediately clear how many of the thousands of lawsuits against medical device manufacturers would be affected, though some pending cases will almost certainly be nullified.

The decision, for example, does not foreclose lawsuits claiming that a device was made improperly, in violation of F.D.A. specifications. Cases may also be brought under state laws that mirror federal rules, as opposed to supplementing them.

Next Monday, the court will hear another F.D.A. pre-emption case, on whether a state case can be based on the claim that a drug maker committed fraud by misrepresenting or withholding information from the agency during the approval process. The administration is supporting the manufacturer in that case, Warner-Lambert Co. v. Kent, No. 06-1498, which concerns the diabetes drug Rezulin.

Writing for the majority in Wednesday’s case, Riegel v. Medtronic Inc., No. 06-179, Justice Antonin Scalia said that permitting state juries to impose liability on the maker of an approved device “disrupts the federal scheme,” under which the F.D.A. has the responsibility for evaluating the risks and benefits of a new device and assuring that it is safe and effective for its intended use.

A jury, looking only at the injured plaintiff, will tend to weigh only the dangers of a device and “is not concerned with its benefits,” Justice Scalia said, adding, “the patients who reaped those benefits are not represented in court.”

The decision affirmed the dismissal of a lawsuit by a patient who was injured during an angioplasty when a balloon catheter burst while being inserted to dilate a coronary artery. The device won F.D.A. premarket approval in 1994, two years before the incident. The patient, Charles R. Riegel, died after the lawsuit was filed, and the case was carried on by his widow, Donna.

The medical device statute contains a pre-emption clause that bars states from imposing “any requirement” related to a medical device that is “different from, or in addition to” a federal requirement. The question of statutory interpretation at the heart of the case turned on what Congress meant by “any requirement.”

Justice Scalia said that state tort law, by imposing duties of care on product makers, amounted to such an additional requirement. He said the 1976 law “speaks clearly to the point at issue,” regardless of the federal government’s previous or current positions.

Justice Ruth Bader Ginsburg, the solitary dissenter, said the court had misconstrued Congress’s intent in adding the pre-emption clause to the 1976 law. The purpose, she said, was to prevent individual states from imposing their own premarket approval process on new medical devices. Devices were not regulated under federal law at the time, and California and other states had stepped in to fill the vacuum by setting up their own regulatory systems.

That was all that Congress had in mind, Justice Ginsburg said, not “a radical curtailment of state common-law suits seeking compensation for injuries caused by defectively designed or labeled medical devices.” She said that Congress had passed the 1976 law “to protect consumer safety,” not to oust the states from “a domain historically occupied by state law.” The decision was at odds with the “central purpose” of the 1976 law, Justice Ginsburg added.

Crucial Democratic lawmakers appear to agree with Justice Ginsburg, including Senator Edward M. Kennedy, Democrat of Massachusetts, who heads the Health, Education, Labor and Pensions Committee and was the sole Senate sponsor of the 1976 legislation in question.

“In enacting legislation on medical devices, Congress never intended that F.D.A. approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices,” Mr. Kennedy said in a statement. He added: “Congress obviously needs to correct the court’s decision.”

Representative Henry Waxman, the California Democrat who is chairman of the House Committee on Oversight and Government Reform and was on the House panel that approved the 1976 bill, expressed a similar view.

“The Supreme Court’s decision strips consumers of the rights they’ve had for decades,” Mr. Waxman said. “This isn’t what Congress intended, and we’ll pass legislation as quickly as possible to fix this nonsensical situation.”

The Food, Drug and Cosmetic Act of 1938, under which the F.D.A. regulates pharmaceuticals, does not contain a pre-emption clause. Nonetheless, the administration is arguing in the case the court has accepted for its next term, Wyeth v. Levine, No. 06-1249, that pre-emption is implicit in the structure of the statute.

The Supreme Court’s interest in pre-emption is not limited to the medical arena. In a similar case decided on Wednesday, this one unanimously, the court ruled that the federal law that deregulated the trucking industry in 1980 pre-empted two recent laws adopted by the State of Maine to regulate the shipment of tobacco products into the state.

The state laws were intended to prevent children who were not of legal age to buy cigarettes from ordering them over the Internet. The laws placed responsibility on shippers and delivery companies to verify the recipient’s identity and age.

Justice Stephen G. Breyer, writing for the court in this case, Rowe v. New Hampshire Motor Transport Association, No. 06-457, said the state law “produces the very effect that the federal law sought to avoid, namely, a state’s direct substitution of its own governmental commands for competitive market forces” in a deregulated environment.

Barnaby Feder contributed reporting from New York and Gardiner Harris from Washington.

Stupak Turns Up the Heat on FDA
Drug-Safety Issues
Stir Lawmaker's Bid
To Overhaul Agency
By ANNA WILDE MATHEWS
February 20, 2008; Page A5

Rep. Bart Stupak argued for years that the U.S. Food and Drug Administration wasn't doing a good job protecting Americans from unsafe drugs.

His focus on the FDA has a personal dimension. In 2000, his 17-year-old son, who was using the acne medication Accutane, committed suicide. Mr. Stupak personally investigated whether the drug could be tied to psychiatric side effects. He went to the FDA's Rockville, Md., headquarters to comb through records. During one hearing, he held up the packaging from the dead teen's prescription.

If Americans "knew how little the FDA did to assure the food and drug supply, if the truth ever came out...people would be marching in the street," he says. "That's just one drug. There are many like that."

Now, as the agency struggles to counter criticism over its international inspections and other issues, the former state trooper from northern Michigan is in a position to translate his views into action.

Mr. Stupak, an eight-term Democratic congressman, is chairman of the Subcommittee on Oversight and Investigations of the House's powerful Energy and Commerce panel, which has jurisdiction over the FDA. This puts Mr. Stupak at the center of an aggressive effort by congressional Democrats to spotlight what they say are problems with the Bush administration's position on consumer-safety issues.

Mr. Stupak's subcommittee is probing the FDA's handling of Baxter International Inc.'s heparin, the blood-thinning drug that has been potentially linked to hundreds of patient reactions and four deaths. That investigation will focus on why the FDA failed to inspect a Chinese plant making some of Baxter's active ingredient, and it is also likely to zoom in on broader concerns about the agency's technology.

The subcommittee is also examining a medicine cabinet's worth of blockbuster drugs, including Pfizer Inc.'s Lipitor, Vytorin from Schering-Plough Corp. and Merck & Co., and anemia drugs sold by Amgen Inc. and Johnson & Johnson. Ketek, an antibiotic from Sanofi-Aventis SA, has been under a microscope for more than a year. Mr. Stupak is holding hearings on the safety of imported food, medicines and medical devices.

Mr. Stupak says he has a bigger agenda than those specific probes. "It's a broken agency," he says. "It's not just a Democrat or a Republican in charge. I think that cancer developed in the FDA a long time ago and permeated every administration."

Mr. Stupak says his focus on the FDA and the drug industry doesn't stem from his family's tragedy. Still, his wife, Laurie, says that had it not been for their son's death, "maybe he would never have had quite the awareness he has now about how government oversight, or lack of oversight, affects people's lives. It hits home."

The FDA has put in place a tough plan to regulate access to Accutane, which is also tied to birth defects when taken by pregnant women.

Mr. Stupak has called for the resignation of the FDA's commissioner, Andrew von Eschenbach, and other top officials. But he says that position has nothing to with partisan politics. In fact, he thinks Republican Sen. Tom Coburn of Oklahoma, who is also a medical doctor, would make a good choice, although Sen. Coburn's opposition to abortion rights would make him unacceptable to many Democrats.

Democratic lawmakers are expected to pass only limited legislation this year, with the Senate divided and President Bush digging in against some Democratic initiatives. Republicans complain that some of the Democrats' moves seem aimed mainly at getting attention.

Rep. Michael Burgess, a Texas Republican who is a member of Mr. Stupak's subcommittee, says he wants to see the FDA examined, but "sometimes it just seems like we want to call names and point fingers, not pursue solutions."

The FDA declined to comment on Mr. Stupak's criticism. But in a recent hearing in front of his subcommittee, Dr. von Eschenbach, who was confirmed to lead the agency in late 2006, noted that the agency has introduced a new food-safety plan and hired a chief information officer to manage information-technology issues. He has also said he aims to place agency inspectors in countries including China and India. The Bush administration's budget included a proposed increase for the FDA.

Mr. Stupak, 55 years old, argues that the FDA's limits, and some of the drug industry's practices, can leave consumers in danger, or misled.

Mr. Stupak and Rep. John Dingell, the Michigan Democrat who is chairman of the full Energy and Commerce panel, say the investigations are building a case for broader efforts to overhaul the FDA. Both back a bill that would charge companies fees to fund inspections of imported food and drugs, though so far it hasn't moved forward.

Mr. Dingell says he plans far more ambitious FDA legislation. "The import bill is a good beginning, but it isn't far enough," Mr. Dingell says. "It's like the Augean stables. Hercules had to divert a river to clean the Augean stables." Mr. Stupak, for his part, says he'd like to look at issues including granting the FDA subpoena power, regulating drug-industry consumer ads more tightly and increasing the agency's funding.

Mr. Stupak's tough prodding from the dais, including of FDA officials, can have the unrelenting, skeptical flavor of the bad-cop half of a "Law & Order" tandem.

"He's got a very bulldog approach to things, which in oversight is a good thing," says Rep. Joe Barton of Texas, the ranking Republican on the full Energy and Commerce committee. Still, he says, Mr. Stupak "has made some mistakes," including his call for the FDA commissioner's resignation. Rep. Barton says Dr. von Eschenbach is a "dedicated public servant," and "he's certainly not done anything unethical or illegal."

Mr. Stupak's sprawling, rural district has no significant economic tie to the drug industry. According to opensecrets.org, a Web site maintained by the nonprofit Center for Responsive Politics, his major donors over the years have included labor unions and a plaintiff attorneys' group.

Billy Tauzin, a former Energy and Commerce chairman who is now chief executive of the Pharmaceutical Research and Manufacturers of America, says Mr. Stupak "is doing his job, and I have no problem with that." The industry agrees that "the FDA certainly would do a far better job if it were properly funded," Mr. Tauzin says. Still, he says the constant scrutiny of drug safety from Congress and elsewhere may be making the agency more cautious in reviewing new treatments.

Full post as published by Angel Reyes Blog on February 22, 2008 (boomark / email).