Articles Posted in Pharmaceutical Drugs

The first line in this editorial adequately summarizes the problem that leads to unsafe drugs and medical devices:

What would your reaction be if the results of a football match were reported as 5:0 by one of the teams and as 3:1 by the other team?

This editorial underscores a point that I think the “FDA approval is the gold standard” crew completely ignores: it is painfully easy to rig drug testing to get the desired results at any stage of the research and testing process. Most of the injuries were at the end of the study? Change the endpoint. Most of the adverse effects were in patients with blonde hair? Take them out of the study.drug research safety

A hospital did not breach a duty of care as a matter of law to a police officer who suffered injuries while responding to a traffic accident allegedly caused by a just-released colonoscopy patient, Massachusetts’ highest court has ruled, affirming the trial court below.

The police officer responded to an emergency report of a pedestrian-automobile accident. On his way to the scene of the reported accident, another car hit the Plaintiff’s police car, causing what were apparently serious injuries. The pedestrian involved in the accident to which the Plaintiff was responding had earlier that day undergone sedation after a colonoscopy at Brockton Hospital. Plaintiff’s theory was had the hospital provided an escort for the patient/pedestrian, he would not have had to respond and the accident would not have occurred.

Specifically, Plaintiff argued that a duty of care existed under two theories to back door the foreseeability problem: (1) a “special relationship” the hospital had with the patient and with Plaintiff, (2) a voluntary assumption of a duty of care by the hospital to protect third parties from harm caused by “impaired” patients.

The case generated some attention. Amicus briefs filed by the Massachusetts Academy of Trial Attorneys to support Leavitt, and by the Massachusetts Defense Lawyers Association and the Professional Liability Foundation, Ltd., to support the hospital.

The Massachusetts high court found that both theories were no distinctions from the duty and foreseeability problem in finding that a hospital owes a duty of care to a non-patient third party to prevent a sedated patient from causing injury after the patient leaves the hospital.

Whether negligence extends to “an innocent third-party bystander” was recently decided in Maryland in Gourdine v. Crews. In that case, the family of a man killed in an auto accident sued Eli Lily claiming that his death was caused by a diabetic who blacked out while under treatment with two insulin medications. Continue reading

Wyeth v. Levine!!!! Plaintiffs’ lawyers have seen drug (and medical device) injury victims take punch after punch. But in a huge win for patient safety, the Supreme Court upheld in a 6-3 ruling today that in a Vermont woman’s verdict against Wyeth for injuries she suffered after taking one of the drug maker’s medicines. Justice John Paul Stevens, writing for the majority, said FDA oversight of drug labeling doesn’t prevent the filing of state tort claims.

It is a little pathetic that this is a huge win. Gee, the law for the last 90 years will not be completely uprooted. Yippy! But the Drug and Device Law Blog predicted victory and those guys have been on the winning side of most everything lately. (A guest Drug and Device Law blogger also broke down the justices individually and predicted victory but I cannot find the post to link to it.) So I’ll admit I was more than a little scared. Now, I’m thrilled that even this conservative Supreme Court found decisively in favor of the Plaintiff.

The one downside: a loss may have mobilized Congress to act. This win in Wyeth v. Levine could ironically slow progress on a bill to overturn Medtronic v. Riegel.

The Wall Street Journal has an editorial with an anti products liability lawyer spin. No surprise. But what is surprising is that I agree with it.

Considering Enron and other business collapses that left stockholders holding the bag with no actual picture of the company’s financial condition, the Financial Accounting Standards Board wants to tighten standards. One requirement would make companies account for the potential cost of ongoing litigation not just regarding attorneys’ fees but regarding the actual value of the claims. The Wall Street Journal editorial says product liability lawyers will use the information to extort settlements and influence jury verdicts.

I’m not worried about either of those outcomes no matter how many times the editorial uses the phrase “extort settlements.” But I think there is a risk of forcing a defendant to publicly estimate settlement and verdict values because I think it tips off product liability lawyers and creates a floor for the value of any mass tort claim. I also think the editorial is correct, that predicting the trajectory of long and complex litigation is inherently unscientific. Mass tort cases are like the stock market in that their values are always changing. A good trial outcome or even a good expert deposition in an MDL can increase or decrease the value of a case. I’ve been involved with mass torts from both sides and believe knowledge of the true value is rarely known even to the insiders until the advanced stages of the settlement process.

The Wall Street Journal has a good article online about the preemption battle that is being waged the FDA’s bureaucrats in the courts and in Congress.

The last line of the article says that “Some drug companies are telling plaintiffs’ lawyers that if they settle their cases now, they won’t pay as much to the plaintiffs as they would have six months ago, before the Supreme Court announced that it would hear the Wyeth case. A lawyer negotiating a settlement with one drug maker said company executives told him it wants the ‘Wyeth discount.'”

I don’t think many cases will settle for a “Wyeth discount” because both sides seem to think they will win. I cannot imagine how the court could find that there is a conflict between state and federal law in drug cases because I think federal labeling requirements create a floor for state tort claims, not a ceiling.

A New York Times article yesterday on the Zimmer Durom Cup’s problems underscores the post-market surveillance problem with drugs and medical devices, pointing to the Zimmer Durom Cup problems that have led to Zimmer recalling their hip replacement component. This is a Zimmer fault; they should have a system of tracking and honestly responding to reports of problems with their hip replacement components. But we cannot expect drug and medical device companies to police themselves. Here, the Zimmer Durom Cup recall was precipitated by Larry Dorr, an orthopedic surgeon who is the medical director of the Dorr Institute for Arthritis Research and Education in California, who outed Zimmer, who previously paid him as a consultant, by speaking up in public about the problems and Zimmer’s blind eye to them.

Safety and speed are the yin and yang of regulating drugs and medical devices. Americans want both; we want safe and well-tested medical devices, but we also want instant access to breakthrough products. But not we should not treat all new drugs and devices equally. We needed to rush new AIDS drugs onto the market with little testing 10 years ago because the risk-benefit analysis demanded it. But some of this other stuff? Sure, the marketing department of the drug and device companies would prefer it that way, but is that the best thing for the consumer or even the pharmaceutical company in the long run?

Adding to the problem is the Prescription Drug User Fee Act in 1992, which was a deal between the FDA and the drug industry. Drug and medical device companies agreed to pay millions of dollars in fees, and the FDA promised that they would complete drug and medical device reviews within a year for those products on the fast track.

Since the Supreme Court’s disaster in Riegel v. Medtronic, I have been hoping and expecting Congress would step in to fix the Supreme Court’s ruling, because it was clear from the amicus briefs submitted in Riegel, from history, and from common sense, that Congress did not intend to prevent medical device tort claims. Yesterday, California Congressmen Henry Waxman and New Jersey Congressman Frank Pallone, along with 62 bipartisan supporters, introduced HR 6381, the Medical Device Safety Act. This bill would undo the wrong the Riegel does to medical device victims. We expect the Senate to offer a similar bill next month.

As the Wolf said in Pulp Fiction, we can’t start congratulating ourselves yet (I’m paraphrasing). This bill has not even made it out of a committee yet. But at least something is happening.

On Wednesday, the House Committee on Oversight and Government Reform began hearings on the reversal of the Riegel v. Medtronic holding that preempted state tort claims regarding medical devices if the FDA granted the product a pre-market approval.

Pharmaceutical drug manufacturers have been on a real hot streak of late before this conservative Supreme Court. They are looking to extend their streak by asking the Supreme Court to extend the preemption umbrella to pharmaceutical drugs in Wyeth v. Levine, which is expected to be heard this fall. Congress could cut this pro-business Supreme Court off at the knees, although I doubt they could get a bill past President Bush. Things may change in 2009.

The star-studded cast of witnesses includes Dennis Quaid (whom I imagine will speak to the heparin overdose of his twins), William Maisel, (Medical Device Safety Institute), Aaron Kesselheim (Harvard Medical School’s Division of Pharmacoepidemiology), David Kessler (former FDA head), David Vladeck, (Georgetown law professor who has written on preemption) Gregory Curfman (New England Journal of Medicine editor); Christine Ruther (drug company consultant) and State Representative David Clark (Republican state legislator from Utah, who I suspect is in favor of preemption).

The FDA said yesterday it is looking into an association between Merck’s allergy and asthma drug Singulair and suicide. The FDA has received reports of mood changes, suicidal ideation, and suicide in patients who have taken Singulair. Trying to get out on the front of the curve with its package insert, Merck has previously updated Singular’s drug labeling four times to include potential risks of tremors, anxiousness, depression, and suicidal behavior reported in some users of Singulair.

To call Singulair a popular drug is an understatement. Singulair is Merck’s biggest selling drug and one of the world’s top-selling medicines with $4.3 billion in sales. Singulair is also a leukotriene receptor antagonist. These types of drugs have been linked to suicidal ideation and suicide. Two similar drugs, AstraZeneca’s Accolate and Critical Therapeutics’s Zyflo, will also be reviewed by the FDA. Neither of these drugs’ labels include suicide warnings.

Singulair/suicide litigation just might be the next big mass tort. But I doubt it. Unfortunately, 40,000 people a year commit suicide and when you have a drug like Singulair that millions use, some of those people will take Singulair and commit suicide. Some will even take Singulair and commit suicide in a close temporal relationship with the initiation of the drug which really leads people to assume that it must be the drug. But it does not automatically follow that Singulair causes suicide. That remains to be seen and my guess is that Singulair does not cause suicidal behavior. Either way, it is nice to see the FDA is trying to get out in front of potential risk (for once). This is probably a byproduct of the errors that the FDA made with Chantix, where the FDA rushed Chantix – a drug that alters mood – onto the market without fully assessing the suicide risk.

Alexandra D. Lahav, a law professor and editor of the Mass Tort Litigation Blog, has an interesting blog post on choice of law made by the MDL Panel in cases merged for discovery where the applicable law chosen may foretell the outcome of the case.

To receive certification by the MDL Panel, under Rule 23 you must have: (1) plaintiffs so numerous that joinder is impossible (numerosity); (2) class claims which present common questions of law or fact (commonality); (3) plaintiffs’ claims typical of those of the class (typicality); and (4) plaintiffs who are adequate representatives of the putative class (adequacy).

This blog post addresses the third prong, the commonality of law. Sometimes, like the Michigan law at issue in Warner-Lambert v. Kent, with different statutes of limitations, the issue can be a case breaker for the plaintiffs. In MDL cases now, the MDL Panel determines which law will be applied by selecting where to send the case – wherever the case is sent, that forum’s law applies. As Ms. Lahav’s post points out, the MDL Panel is placed in a terrible situation when the outcome of the case is based on transfer and is already known before the transfer.

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